ANNEX I - European Commission · Carenox 10 mg Retardtabletten : 10 mg . Prolonged-release tablet :...
Transcript of ANNEX I - European Commission · Carenox 10 mg Retardtabletten : 10 mg . Prolonged-release tablet :...
ANNEX I
List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states (EU/EEA)
1
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
AT - Austria
betapharm Arzneimittel GmbH Kobelweg 95 86156 Augsburg Germany
Carenox 10 mg Retardtabletten 10 mg Prolonged-release tablet Oral use
AT - Austria
betapharm Arzneimittel GmbH Kobelweg 95 86156 Augsburg Germany
Carenox 5 mg Retardtabletten 5 mg Prolonged-release tablet Oral use
AT - Austria
betapharm Arzneimittel GmbH Kobelweg 95 86156 Augsburg Germany
Merlodon 20 mg Retardtabletten
20 mg Prolonged-release tablet Oral use
AT - Austria
betapharm Arzneimittel GmbH Kobelweg 95 86156 Augsburg Germany
Merlodon 30 mg Retardtabletten
30 mg Prolonged-release tablet Oral use
AT - Austria
betapharm Arzneimittel GmbH Kobelweg 95 86156 Augsburg Germany
Merlodon 40 mg Retardtabletten
40 mg Prolonged-release tablet Oral use
AT - Austria
betapharm Arzneimittel GmbH Kobelweg 95 86156 Augsburg Germany
Merlodon 60 mg Retardtabletten
60 mg Prolonged-release tablet Oral use
AT - Austria
betapharm Arzneimittel GmbH Kobelweg 95 86156 Augsburg Germany
Merlodon 80 mg Retardtabletten
80 mg Prolonged-release tablet Oral use
AT - Austria
Ethypharm 21, rue St. Mathieu (Z.I.) F- 78550 Houdan 194 Bureaux de la Colline - Bâtiment D, 92213 Saint-Cloud CEDEX France
M - dolor retard 10 mg - Kapseln 10 mg Prolonged-release capsule, hard Oral use
AT - Austria
Ethypharm 21, rue St. Mathieu (Z.I.) F- 78550 Houdan 194 Bureaux de la Colline - Bâtiment D, 92213 Saint-Cloud CEDEX France
M - dolor retard 100 mg - Kapseln 100 mg Prolonged-release capsule, hard Oral use
2
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
AT - Austria
Ethypharm 21, rue St. Mathieu (Z.I.) F- 78550 Houdan 194 Bureaux de la Colline - Bâtiment D, 92213 Saint-Cloud CEDEX France
M - dolor retard 200 mg - Kapseln 200 mg Prolonged-release capsule, hard Oral use
AT - Austria
Ethypharm 21, rue St. Mathieu (Z.I.) F- 78550 Houdan 194 Bureaux de la Colline - Bâtiment D, 92213 Saint-Cloud CEDEX France
M - dolor retard 30 mg - Kapseln 30 mg Prolonged-release capsule, hard Oral use
AT - Austria
Ethypharm 21, rue St. Mathieu (Z.I.) F- 78550 Houdan 194 Bureaux de la Colline - Bâtiment D, 92213 Saint-Cloud CEDEX France
M - dolor retard 60 mg - Kapseln
60 mg Prolonged-release capsule, hard Oral use
AT - Austria
G. L. Pharma GmbH Schloßplatz 1 8502 Lannach Austria
Vendal retard 10 mg - Filmtabletten
10 mg Prolonged-release tablet Oral use
AT - Austria
G. L. Pharma GmbH Schloßplatz 1 8502 Lannach Austria
Vendal retard 100 mg - Filmtabletten
100 mg Prolonged-release tablet Oral use
AT - Austria
G. L. Pharma GmbH Schloßplatz 1 8502 Lannach Austria
Vendal retard 200 mg - Filmtabletten
200 mg Prolonged-release tablet Oral use
AT - Austria
G. L. Pharma GmbH Schloßplatz 1 8502 Lannach Austria
Vendal retard 30 mg - Filmtabletten
30 mg Prolonged-release tablet Oral use
AT - Austria
G. L. Pharma GmbH Schloßplatz 1 8502 Lannach Austria
Vendal retard 60 mg - Filmtabletten
60 mg Prolonged-release tablet Oral use
3
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
AT - Austria
GlaxoSmithKline Pharma GmbH Albert-Schweitzer-Gasse 6 1140 Wien Austria
Kapanol CSR 100 mg - Kapseln 100 mg Prolonged-release capsule, hard Oral use
AT - Austria
GlaxoSmithKline Pharma GmbH Albert-Schweitzer-Gasse 6 1140 Wien Austria
Kapanol CSR 50 mg - Kapseln 50 mg Prolonged-release capsule, hard Oral use
AT - Austria
Hexal Pharma GmbH Stella-Klein-Löw-Weg 17 1020 Wien Austria
Oxycodon Hexal 10 mg - Retardtabletten
10 mg Prolonged-release tablet Oral use
AT - Austria
Hexal Pharma GmbH Stella-Klein-Löw-Weg 17 1020 Wien Austria
Oxycodon Hexal 20 mg - Retardtabletten
20 mg Prolonged-release tablet Oral use
AT - Austria
Hexal Pharma GmbH Stella-Klein-Löw-Weg 17 1020 Wien Austria
Oxycodon Hexal 40 mg - Retardtabletten
40 mg Prolonged-release tablet Oral use
AT - Austria
Hexal Pharma GmbH Stella-Klein-Löw-Weg 17 1020 Wien Austria
Oxycodon Hexal 5 mg - Retardtabletten
5 mg Prolonged-release tablet Oral use
AT - Austria
Hexal Pharma GmbH Stella-Klein-Löw-Weg 17 1020 Wien Austria
Oxycodon Hexal 80 mg - Retardtabletten
80 mg Prolonged-release tablet Oral use
AT - Austria
Janssen - Cilag Pharma GmbH Vorgartenstraße 206b 1020 Wien Austria
Jurnista 16 mg - Retardtabletten
16 mg Prolonged-release tablet Oral use
AT - Austria
Janssen - Cilag Pharma GmbH Vorgartenstraße 206b 1020 Wien Austria
Jurnista 32 mg - Retardtabletten
32 mg Prolonged-release tablet Oral use
AT - Austria
Janssen - Cilag Pharma GmbH Vorgartenstraße 206b 1020 Wien Austria
Jurnista 4 mg - Retardtabletten 4 mg Prolonged-release tablet Oral use
4
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
AT - Austria
Janssen - Cilag Pharma GmbH Vorgartenstraße 206b 1020 Wien Austria
Jurnista 64 mg - Retardtabletten
64 mg Prolonged-release tablet Oral use
AT - Austria
Janssen - Cilag Pharma GmbH Vorgartenstraße 206b 1020 Wien Austria
Jurnista 8 mg - Retardtabletten 8 mg Prolonged-release tablet Oral use
AT - Austria
G. L. Pharma GmbH Schloßplatz 1 8502 Lannach Austria
Compensan retard 100 mg - Filmtabletten
100 mg Prolonged-release tablet Oral use
AT - Austria
G. L. Pharma GmbH Schloßplatz 1 8502 Lannach Austria
Compensan retard 200 mg - Filmtabletten
200 mg Prolonged-release tablet Oral use
AT - Austria
G. L. Pharma GmbH Schloßplatz 1 8502 Lannach Austria
Compensan retard 300 mg - Filmtabletten
300 mg Prolonged-release tablet Oral use
AT - Austria
Lannacher Heilmittel GmbH Schloßplatz 1 8502 Lannach Austria
Morphinhydrochlorid Lannacher retard 10 mg - Filmtabletten
10 mg Prolonged-release tablet Oral use
AT - Austria
Lannacher Heilmittel GmbH Schloßplatz 1 8502 Lannach Austria
Morphinhydrochlorid Lannacher retard 100 mg - Filmtabletten
100 mg Prolonged-release tablet Oral use
AT - Austria
Lannacher Heilmittel GmbH Schloßplatz 1 8502 Lannach Austria
Morphinhydrochlorid Lannacher retard 200 mg - Filmtabletten
200 mg Prolonged-release tablet Oral use
AT - Austria
Lannacher Heilmittel GmbH Schloßplatz 1 8502 Lannach Austria
Morphinhydrochlorid Lannacher retard 30 mg - Filmtabletten
30 mg Prolonged-release tablet Oral use
AT - Austria
Lannacher Heilmittel GmbH Schloßplatz 1 8502 Lannach Austria
Morphinhydrochlorid Lannacher retard 60 mg - Filmtabletten
60 mg Prolonged-release tablet Oral use
5
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
AT - Austria
Mundipharma GmbH Apollogasse 16-18 1070 Wien Austria
Hydal retard 16 mg - Kapseln 16 mg Prolonged-release capsule, hard Oral use
AT - Austria
Mundipharma GmbH Apollogasse 16-18 1070 Wien Austria
Hydal retard 2 mg - Kapseln 2 mg Prolonged-release capsule, hard Oral use
AT - Austria
Mundipharma GmbH Apollogasse 16-18 1070 Wien Austria
Hydal retard 24 mg - Kapseln 24 mg Prolonged-release capsule, hard Oral use
AT - Austria
Mundipharma GmbH Apollogasse 16-18 1070 Wien Austria
Hydal retard 4 mg - Kapseln 4 mg Prolonged-release capsule, hard Oral use
AT - Austria
Mundipharma GmbH Apollogasse 16-18 1070 Wien Austria
Hydal retard 8 mg - Kapseln 8 mg Prolonged-release capsule, hard Oral use
AT - Austria
Mundipharma GmbH Apollogasse 16-18 1070 Wien Austria
Hydal Uno retard 12 mg - Kapseln
12 mg Prolonged-release capsule, hard Oral use
AT - Austria
Mundipharma GmbH Apollogasse 16-18 1070 Wien Austria
Hydal Uno retard 16 mg - Kapseln
16 mg Prolonged-release capsule, hard Oral use
AT - Austria
Mundipharma GmbH Apollogasse 16-18 1070 Wien Austria
Hydal Uno retard 24 mg - Kapseln
24 mg Prolonged-release capsule, hard Oral use
AT - Austria
Mundipharma GmbH Apollogasse 16-18 1070 Wien Austria
Hydal Uno retard 32 mg - Kapseln
32 mg Prolonged-release capsule, hard Oral use
AT - Austria
Mundipharma GmbH Apollogasse 16-18 1070 Wien Austria
Mundidol retard 10 mg - Filmtabletten
10 mg Prolonged-release tablet Oral use
6
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
AT - Austria
Mundipharma GmbH Apollogasse 16-18 1070 Wien Austria
Mundidol retard 100 mg - Filmtabletten
100 mg Prolonged-release tablet Oral use
AT - Austria
Mundipharma GmbH Apollogasse 16-18 1070 Wien Austria
Mundidol retard 200 mg - Filmtabletten
200 mg Prolonged-release tablet Oral use
AT - Austria
Mundipharma GmbH Apollogasse 16-18 1070 Wien Austria
Mundidol retard 30 mg - Filmtabletten
30 mg Prolonged-release tablet Oral use
AT - Austria
Mundipharma GmbH Apollogasse 16-18 1070 Wien Austria
Mundidol retard 60 mg - Filmtabletten
60 mg Prolonged-release tablet Oral use
AT - Austria
Mundipharma GmbH Apollogasse 16-18 1070 Wien Austria
Mundidol Uno retard 120 mg - Kapseln
120 mg Prolonged-release capsule, hard Oral use
AT - Austria
Mundipharma GmbH Apollogasse 16-18 1070 Wien Austria
Mundidol Uno retard 200 mg - Kapseln
200 mg Prolonged-release capsule, hard Oral use
AT - Austria
Mundipharma GmbH Apollogasse 16-18 1070 Wien Austria
Mundidol Uno retard 30 mg - Kapseln
30 mg Prolonged-release capsule, hard Oral use
AT - Austria
Mundipharma GmbH Apollogasse 16-18 1070 Wien Austria
Mundidol Uno retard 60 mg - Kapseln
60 mg Prolonged-release capsule, hard Oral use
AT - Austria
Mundipharma GmbH Apollogasse 16-18 1070 Wien Austria
OxyContin retard 10 mg Filmtabletten
10 mg Prolonged-release tablet Oral use
AT - Austria
Mundipharma GmbH Apollogasse 16-18 1070 Wien Austria
OxyContin retard 20 mg Filmtabletten
20 mg Prolonged-release tablet Oral use
7
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
AT - Austria
Mundipharma GmbH Apollogasse 16-18 1070 Wien Austria
OxyContin retard 40 mg Filmtabletten
40 mg Prolonged-release tablet Oral use
AT - Austria
Mundipharma GmbH Apollogasse 16-18 1070 Wien Austria
OxyContin retard 5 mg Filmtabletten
5 mg Prolonged-release tablet Oral use
AT - Austria
Mundipharma GmbH Apollogasse 16-18 1070 Wien Austria
OxyContin retard 80 mg Filmtabletten
80 mg Prolonged-release tablet Oral use
AT - Austria
Mundipharma GmbH Apollogasse 16-18 1070 Wien Austria
Substitol retard 120 mg - Kapseln
120 mg Prolonged-release capsule, hard Oral use
AT - Austria
Mundipharma GmbH Apollogasse 16-18 1070 Wien Austria
Substitol retard 200 mg - Kapseln
200 mg Prolonged-release capsule, hard Oral use
AT - Austria
Mundipharma GmbH Apollogasse 16-18 1070 Wien Austria
Targin 10 mg/5 mg Retardtabletten
10 mg/5 mg Prolonged-release tablet Oral use
AT - Austria
Mundipharma GmbH Apollogasse 16-18 1070 Wien Austria
Targin 20 mg/10 mg Retardtabletten
20 mg/10 mg Prolonged-release tablet Oral use
AT - Austria
Mundipharma GmbH Apollogasse 16-18 1070 Wien Austria
Targin 40 mg/20 mg Retardtabletten
40 mg/20 mg Prolonged-release tablet Oral use
AT - Austria
Mundipharma GmbH Apollogasse 16-18 1070 Wien Austria
Targin 5 mg/2,5 mg Retardtabletten
5 mg/2,5 mg Prolonged-release tablet Oral use
AT - Austria
Pharmachemie B.V. Swensweg 5, P.O. Box 552 2003 RN Haarlem Netherlands
Relimal 200 mg Retardtabletten 200 mg Prolonged-release tablet Oral use
8
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
AT - Austria
Ratiopharm Arzneimittel Vertriebs-GmbH Albert-Schweitzer Gasse 3 1140 Wien Austria
Hydromorphon ratiopharm 16 mg Retardtabletten
16 mg Prolonged-release tablet Oral use
AT - Austria
Ratiopharm Arzneimittel Vertriebs-GmbH Albert-Schweitzer Gasse 3 1140 Wien Austria
Hydromorphon ratiopharm 24 mg Retardtabletten
24 mg Prolonged-release tablet Oral use
AT - Austria
Ratiopharm Arzneimittel Vertriebs-GmbH Albert-Schweitzer Gasse 3 1140 Wien Austria
Hydromorphon ratiopharm 4 mg Retardtabletten
4 mg Prolonged-release tablet Oral use
AT - Austria
Ratiopharm Arzneimittel Vertriebs-GmbH Albert-Schweitzer Gasse 3 1140 Wien Austria
Hydromorphon ratiopharm 8 mg Retardtabletten
8 mg Prolonged-release tablet Oral use
AT - Austria
Ratiopharm Arzneimittel Vertriebs-GmbH Albert-Schweitzer Gasse 3 1140 Wien Austria
Oxycodon-HCl-ratiopharm 5 mg Retardtabletten
5 mg Prolonged-release tablet Oral use
AT - Austria
Ratiopharm Arzneimittel Vertriebs-GmbH Albert-Schweitzer Gasse 3 1140 Wien Austria
Oxycodon-HCl-ratiopharm 20 mg Retardtabletten
20 mg Prolonged-release tablet Oral use
AT - Austria
Ratiopharm Arzneimittel Vertriebs-GmbH Albert-Schweitzer Gasse 3 1140 Wien Austria
Oxycodon-HCl-ratiopharm 40 mg Retardtabletten
40 mg Prolonged-release tablet Oral use
AT - Austria
Ratiopharm Arzneimittel Vertriebs-GmbH Albert-Schweitzer Gasse 3 1140 Wien Austria
Oxycodon-HCl-ratiopharm 80 mg Retardtabletten
80 mg Prolonged-release tablet Oral use
9
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
AT - Austria
Ratiopharm Arzneimittel Vertriebs-GmbH Albert-Schweitzer Gasse 3 1140 Wien Austria
Oxycodon-HCl-ratiopharm 10 mg Retardtabletten
10 mg Prolonged-release tablet Oral use
AT - Austria
Stada Arzneimittel GmbH Muthgasse 36 1190 Wien Austria
Oxycodon-HCl STADA 10 mg Retardtabletten
10 mg Prolonged-release tablet Oral use
AT - Austria
Stada Arzneimittel GmbH Muthgasse 36 1190 Wien Austria
Oxycodon-HCl STADA 20 mg Retardtabletten
20 mg Prolonged-release tablet Oral use
AT - Austria
Stada Arzneimittel GmbH Muthgasse 36 1190 Wien Austria
Oxycodon-HCl STADA 40 mg Retardtabletten
40 mg Prolonged-release tablet Oral use
AT - Austria
Stada Arzneimittel GmbH Muthgasse 36 1190 Wien Austria
Oxycodon-HCl STADA 5 mg Retardtabletten
5 mg Prolonged-release tablet Oral use
AT - Austria
Stada Arzneimittel GmbH Muthgasse 36 1190 Wien Austria
Oxycodon-HCl STADA 80 mg Retardtabletten
80 mg Prolonged-release tablet Oral use
AT - Austria
Yes Pharmaceutical Development Services GmbH Bahnstraße 42-46 61381 Friedrichsdorf Germany
Maridolor 20 mg Retardtabletten
20 mg Prolonged-release tablet Oral use
AT - Austria
Yes Pharmaceutical Development Services GmbH Bahnstraße 42-46 61381 Friedrichsdorf Germany
Maridolor 40 mg Retardtabletten
40 mg Prolonged-release tablet Oral use
AT - Austria
Yes Pharmaceutical Development Services GmbH Bahnstraße 42-46 61381 Friedrichsdorf Germany
Maridolor 80 mg Retardtabletten
80 mg Prolonged-release tablet Oral use
10
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
AT - Austria
Yes Pharmaceutical Development Services GmbH Bahnstraße 42-46 61381 Friedrichsdorf Germany
Oxycodon-HCl "YES" 10 mg Retardtabletten
10 mg Prolonged-release tablet Oral use
AT - Austria
Yes Pharmaceutical Development Services GmbH Bahnstraße 42-46 61381 Friedrichsdorf Germany
Oxycodon-HCl "YES" 5 mg Retardtabletten
5 mg Prolonged-release tablet Oral use
BE - Belgium
DOCPHARMA N.V. Ambachtenlaan 13H 3001 Leuven Belgium
DOC MORFINE 10 MG 10mg Prolonged-release tablet Oral use
BE - Belgium
DOCPHARMA N.V. Ambachtenlaan 13H 3001 Leuven Belgium
DOC MORFINE 100 MG 100 mg Prolonged-release tablet Oral use
BE - Belgium
DOCPHARMA N.V. Ambachtenlaan 13H 3001 Leuven Belgium
DOC MORFINE 30 MG 30 mg Prolonged-release tablet Oral use
BE - Belgium
DOCPHARMA N.V. Ambachtenlaan 13H 3001 Leuven Belgium
DOC MORFINE 60 MG 60 mg Prolonged-release tablet Oral use
BE - Belgium
Ethypharm 21, rue St. Mathieu (Z.I.) F- 78550 Houdan 194 Bureaux de la Colline - Bâtiment D, 92213 Saint-Cloud cedex France
ETHYPHARM MORPHINE SULPHATE 10 MG 10 mg Prolonged-release capsule, hard Oral use
BE - Belgium
Ethypharm 21, rue St. Mathieu (Z.I.) F- 78550 Houdan 194 Bureaux de la Colline - Bâtiment D, 92213 Saint-Cloud cedex France
ETHYPHARM MORPHINE SULPHATE 100 MG
100 mg Prolonged-release capsule, hard Oral use
11
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
BE - Belgium
Ethypharm 21, rue St. Mathieu (Z.I.) F- 78550 Houdan 194 Bureaux de la Colline - Bâtiment D, 92213 Saint-Cloud cedex France
ETHYPHARM MORPHINE SULPHATE 30 MG 30 mg Prolonged-release capsule, hard Oral use
BE - Belgium
Ethypharm 21, rue St. Mathieu (Z.I.) F- 78550 Houdan 194 Bureaux de la Colline - Bâtiment D, 92213 Saint-Cloud cedex France
ETHYPHARM MORPHINE SULPHATE 60 MG 60 mg Prolonged-release capsule, hard Oral use
BE - Belgium
Ethypharm 21, rue St. Mathieu (Z.I.) F- 78550 Houdan 194 Bureaux de la Colline - Bâtiment D, 92213 Saint-Cloud cedex France
OPIDUR 120MG 120 mg Prolonged-release capsule, hard Oral use
BE - Belgium
Ethypharm 21, rue St. Mathieu (Z.I.) F- 78550 Houdan 194 Bureaux de la Colline - Bâtiment D, 92213 Saint-Cloud cedex France
OPIDUR 200MG 200 mg Prolonged-release capsule, hard Oral use
BE - Belgium
Ethypharm 21, rue St. Mathieu (Z.I.) F- 78550 Houdan 194 Bureaux de la Colline - Bâtiment D, 92213 Saint-Cloud cedex France
OPIDUR 20MG 20 mg Prolonged-release capsule, hard Oral use
BE - Belgium
Ethypharm 21, rue St. Mathieu (Z.I.) F- 78550 Houdan 194 Bureaux de la Colline - Bâtiment D, 92213 Saint-Cloud cedex France
OPIDUR 40MG 40 mg Prolonged-release capsule, hard Oral use
12
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
BE - Belgium
Ethypharm 21, rue St. Mathieu (Z.I.) F- 78550 Houdan 194 Bureaux de la Colline - Bâtiment D, 92213 Saint-Cloud cedex France
OPIDUR 60MG 60 mg Prolonged-release capsule, hard Oral use
BE - Belgium
GLAXOSMITHKLINE S.A. Rue Du Tilleul 13 1332 Genval Belgium
KAPANOL 100 MG 100 mg Prolonged-release capsule, hard Oral use
BE - Belgium
GLAXOSMITHKLINE S.A. Rue Du Tilleul 13 1332 Genval Belgium
KAPANOL 20 MG 20 mg Prolonged-release capsule, hard Oral use
BE - Belgium
GLAXOSMITHKLINE S.A. Rue Du Tilleul 13 1332 Genval Belgium
KAPANOL 50 MG 50 mg Prolonged-release capsule, hard Oral use
BE - Belgium
I.P.S. (INTERN.PHARMAC.SERVICES)NV Garden Square, Gebouw C Laarstraat 16 2610 Wilrijk Belgium
MORPHISIN 10 10 mg Modified-release tablet Oral use
BE - Belgium
I.P.S. (INTERN.PHARMAC.SERVICES)NV Garden Square, Gebouw C Laarstraat 16 2610 Wilrijk Belgium
MORPHISIN 100 100 mg Modified-release tablet Oral use
BE - Belgium
I.P.S. (INTERN.PHARMAC.SERVICES)NV Garden Square, Gebouw C Laarstraat 16 2610 Wilrijk Belgium
MORPHISIN 30 30 mg Modified-release tablet Oral use
13
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
BE - Belgium
I.P.S. (INTERN.PHARMAC.SERVICES)NV Garden Square, Gebouw C Laarstraat 16 2610 Wilrijk Belgium
MORPHISIN 60 60 mg Modified-release tablet Oral use
BE - Belgium
MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800 Mechelen Belgium
MS CONTIN 10 MG 10 mg Prolonged-release tablet Oral use
BE - Belgium
MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800 Mechelen Belgium
MS CONTIN 100MG 100 mg Prolonged-release tablet Oral use
BE - Belgium
MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800 Mechelen Belgium
MS CONTIN 15 MG 15 mg Prolonged-release tablet Oral use
BE - Belgium
MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800 Mechelen Belgium
MS CONTIN 200 MG 200 mg Prolonged-release tablet Oral use
BE - Belgium
MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800 Mechelen Belgium
MS CONTIN 30 MG 30 mg Prolonged-release tablet Oral use
BE - Belgium
MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800 Mechelen Belgium
MS CONTIN 5 MG 5 mg Prolonged-release tablet Oral use
BE - Belgium
MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800 Mechelen Belgium
MS CONTIN 60 MG 60 mg Prolonged-release tablet Oral use
BE - Belgium
MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800 Mechelen Belgium
MS DIRECT 10 MG EX SEVREDOL
10 mg Film-coated tablet Oral use
14
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
BE - Belgium
MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800 Mechelen Belgium
MS DIRECT 20 MG EX SEVREDOL
20 mg Film-coated tablet Oral use
BE - Belgium
MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800 Mechelen Belgium
OXYCONTIN 10 MG 10 mg Prolonged-release tablet Oral use
BE - Belgium
MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800 Mechelen Belgium
OXYCONTIN 120 MG 120 mg Prolonged-release tablet Oral use
BE - Belgium
MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800 Mechelen Belgium
OXYCONTIN 15 MG 15 mg Prolonged-release tablet Oral use
BE - Belgium
MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800 Mechelen Belgium
OXYCONTIN 160 MG 160 mg Prolonged-release tablet Oral use
BE - Belgium
MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800 Mechelen Belgium
OXYCONTIN 20 MG 20 mg Prolonged-release tablet Oral use
BE - Belgium
MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800 Mechelen Belgium
OXYCONTIN 30 MG 30 mg Prolonged-release tablet Oral use
BE - Belgium
MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800 Mechelen Belgium
OXYCONTIN 40 MG 40 mg Prolonged-release tablet Oral use
BE - Belgium
MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800 Mechelen Belgium
OXYCONTIN 5 MG 5 mg Prolonged-release tablet Oral use
BE - Belgium
MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800 Mechelen Belgium
OXYCONTIN 60 MG 60 mg Prolonged-release tablet Oral use
15
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
BE - Belgium
MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800 Mechelen Belgium
OXYCONTIN 80 MG 80 mg Prolonged-release tablet Oral use
BE - Belgium
MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800 Mechelen Belgium
TARGINACT 10 MG/5 MG 10.5 mg Prolonged-release tablet Oral use
BE - Belgium
MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800 Mechelen Belgium
TARGINACT 20 MG/10 MG 21 mg Prolonged-release tablet Oral use
BE - Belgium
MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800 Mechelen Belgium
TARGINACT 40MG/20MG 42 mg Prolonged-release tablet Oral use
BE - Belgium
MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800 Mechelen Belgium
TARGINACT 5MG/2,5MG 5.25 mg Prolonged-release tablet Oral use
BE - Belgium
MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800 Mechelen Belgium
PALLADONE IMMEDIATE RELEASE 1,3 MG
1.3 mg Capsule, hard Oral use
BE - Belgium
MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800 Mechelen Belgium
PALLADONE IMMEDIATE RELEASE 2,6 MG
2.6 mg Capsule, hard Oral use
BE - Belgium
MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800 Mechelen Belgium
PALLADONE SLOW RELEASE 16 MG*
16 mg Prolonged-release capsule, hard Oral use
BE - Belgium
MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800 Mechelen Belgium
PALLADONE SLOW RELEASE 24 MG*
24 mg Prolonged-release capsule, hard Oral use
BE - Belgium
MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800 Mechelen Belgium
PALLADONE SLOW RELEASE 4 MG
4 mg Prolonged-release capsule, hard Oral use
16
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
BE - Belgium
MUNDIPHARMA CVA-SCA Schaliënhoevedreef 20H 2800 Mechelen Belgium
PALLADONE SLOW RELEASE 8 MG
8 mg Prolonged-release capsule, hard Oral use
BE - Belgium
SANDOZ N.V. Telecom Gardens Medialaan 40 1800 Vilvoorde Belgium
OXYCODON SANDOZ 10 MG 10 mg Prolonged-release tablet Oral use
BE - Belgium
SANDOZ N.V. Telecom Gardens Medialaan 40 1800 Vilvoorde Belgium
OXYCODON SANDOZ 10 MG 10 mg Prolonged-release tablet Oral use
BE - Belgium
SANDOZ N.V. Telecom Gardens Medialaan 40 1800 Vilvoorde Belgium
OXYCODON SANDOZ 20 MG 20 mg Prolonged-release tablet Oral use
BE - Belgium
SANDOZ N.V. Telecom Gardens Medialaan 40 1800 Vilvoorde Belgium
OXYCODON SANDOZ 20 MG 20 mg Prolonged-release tablet Oral use
BE - Belgium
SANDOZ N.V. Telecom Gardens Medialaan 40 1800 Vilvoorde Belgium
OXYCODON SANDOZ 5 MG 5 mg Prolonged-release tablet Oral use
BE - Belgium
SANDOZ N.V. Telecom Gardens Medialaan 40 1800 Vilvoorde Belgium
OXYCODON SANDOZ 5 MG 5 mg Prolonged-release tablet Oral use
BE - Belgium
TEVA PHARMA BELGIUM Laarstraat 16 2610 Wilrijk Belgium
MORPHINE TEVA 10 MG 10 mg Modified-release tablet Oral use
17
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
BE - Belgium
TEVA PHARMA BELGIUM Laarstraat 16 2610 Wilrijk Belgium
MORPHINE TEVA 100 MG 100 mg Modified-release tablet Oral use
BE - Belgium
TEVA PHARMA BELGIUM Laarstraat 16 2610 Wilrijk Belgium
MORPHINE TEVA 30 MG 30 mg Modified-release tablet Oral use
BE - Belgium
TEVA PHARMA BELGIUM Laarstraat 16 2610 Wilrijk Belgium
MORPHINE TEVA 60 MG 60 mg Modified-release tablet Oral use
BG - Bulgaria
Mundipharma Ges.m.b.H. Apollogasse 16-18, Postfach 83 1072 Vienna Austria
MST-Continus 10 mg Modified-release tablet Oral use
BG - Bulgaria
Mundipharma Ges.m.b.H. Apollogasse 16-18, Postfach 83 1072 Vienna Austria
MST-Continus 30 mg Modified-release tablet Oral use
BG - Bulgaria
Mundipharma Ges.m.b.H. Apollogasse 16-18, Postfach 83 1072 Vienna Austria
MST-Continus 60 mg Modified-release tablet Oral use
BG - Bulgaria
Mundipharma Ges.m.b.H. Apollogasse 16-18, Postfach 83 1072 Vienna Austria
MST-Continus 100 mg Modified-release tablet Oral use
BG - Bulgaria
Mundipharma Ges.m.b.H. Apollogasse 16-18, Postfach 83 1072 Vienna Austria
OxyContin 10 mg Modified-release tablet Oral use
BG - Bulgaria
Mundipharma Ges.m.b.H. Apollogasse 16-18, Postfach 83 1072 Vienna Austria
OxyContin 20 mg Modified-release tablet Oral use
BG - Bulgaria
Mundipharma Ges.m.b.H. Apollogasse 16-18, Postfach 83 1072 Vienna Austria
OxyContin 40 mg Modified-release tablet Oral use
18
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
BG - Bulgaria
Mundipharma Ges.m.b.H. Apollogasse 16-18, Postfach 83 1072 Vienna Austria
OxyContin 80 mg Modified-release tablet Oral use
BG - Bulgaria
Mundipharma Ges.m.b.H. Apollogasse 16-18, Postfach 83 1072 Vienna Austria
Substitol 120 mg Prolonged-release capsule Oral use
BG - Bulgaria
Mundipharma Ges.m.b.H. Apollogasse 16-18, Postfach 83 1072 Vienna Austria
Substitol 200 mg Prolonged-release capsule Oral use
BG - Bulgaria
Nycomed Danmark A/S Langebjerg 1 DK-4000 Roskilde Denmark
Doltard 10 mg Prolonged-release tablet Oral use
BG - Bulgaria
Nycomed Danmark A/S Langebjerg 1 DK-4000 Roskilde Denmark
Doltard 30 mg Prolonged-release tablet Oral use
BG - Bulgaria
Nycomed Danmark A/S Langebjerg 1 DK-4000 Roskilde Denmark
Doltard 60 mg Prolonged-release tablet Oral use
BG - Bulgaria
Nycomed Danmark A/S Langebjerg 1 DK-4000 Roskilde Denmark
Doltard 100 mg Prolonged-release tablet Oral use
BG - Bulgaria
Тева Фармасютикълс България ЕООД, ул. "Н.В.Гогол" 15, ет.1 1124 София България
Morphine Teva 10 mg Prolonged-release tablet Oral use
BG - Bulgaria
Тева Фармасютикълс България ЕООД, ул. "Н.В.Гогол" 15, ет.1 1124 София България
Morphine Teva 30 mg Prolonged-release tablet Oral use
BG - Bulgaria
Тева Фармасютикълс България ЕООД, ул. "Н.В.Гогол" 15, ет.1 1124 София България
Morphine Teva 60 mg Prolonged-release tablet Oral use
19
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
BG - Bulgaria
Тева Фармасютикълс България ЕООД, ул. "Н.В.Гогол" 15, ет.1 1124 София България
Morphine Teva 100 mg Prolonged-release tablet Oral use
CY - Cyprus
Mundipharma Pharmaceuticals Ltd 13 Othellos street, P.O.Box 23661 1685 Lefkosia Cyprus
MST CONTINUS PR TABLETS 100mg
100mg Prolonged-release tablet Oral use
CY - Cyprus
Mundipharma Pharmaceuticals Ltd 13 Othellos street, P.O.Box 23661 1685 Lefkosia Cyprus
MST CONTINUS PR TABLETS 10mg
10mg Prolonged-release tablet Oral use
CY - Cyprus
Mundipharma Pharmaceuticals Ltd 13 Othellos street, P.O.Box 23661 1685 Lefkosia Cyprus
MST CONTINUS PR TABLETS 30mg
30mg Prolonged-release tablet Oral use
CY - Cyprus
Mundipharma Pharmaceuticals Ltd 13 Othellos street, P.O.Box 23661 1685 Lefkosia Cyprus
MST CONTINUS PR TABLETS 60mg
60mg Prolonged-release tablet Oral use
CY - Cyprus
Mundipharma Pharmaceuticals Ltd 13 Othellos street, P.O.Box 23661 1685 Lefkosia Cyprus
OXYCONTIN PR TABLETS 10mg 10mg Prolonged-release tablet Oral use
CY - Cyprus
Mundipharma Pharmaceuticals Ltd 13 Othellos street, P.O.Box 23661 1685 Lefkosia Cyprus
OXYCONTIN PR TABLETS 20mg 20mg Prolonged-release tablet Oral use
CY - Cyprus
Mundipharma Pharmaceuticals Ltd 13 Othellos street, P.O.Box 23661 1685 Lefkosia Cyprus
OXYCONTIN PR TABLETS 40mg 40mg Prolonged-release tablet Oral use
CY - Cyprus
Mundipharma Pharmaceuticals Ltd 13 Othellos street, P.O.Box 23661 1685 Lefkosia Cyprus
OXYCONTIN PR TABLETS 5mg 5mg Prolonged-release tablet Oral use
CY - Cyprus
Mundipharma Pharmaceuticals Ltd 13 Othellos street, P.O.Box 23661 1685 Lefkosia Cyprus
OXYCONTIN PR TABLETS 80mg 80mg Prolonged-release tablet Oral use
20
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
CZ - Czech Republic
MUNDIPHARMA Ges.m.b.H Apollogasse 16-18 A-1070 Viena Austria
MST Continus 100 mg 100 mg Modified-release tablet Oral use
CZ - Czech Republic
MUNDIPHARMA Ges.m.b.H Apollogasse 16-18 A-1070 Viena Austria
MST Continus 30 mg 30 mg Modified-release tablet Oral use
CZ - Czech Republic
MUNDIPHARMA Ges.m.b.H Apollogasse 16-18 A-1070 Viena Austria
MST Continus 60 mg 60 mg Modified-release tablet Oral use
CZ - Czech Republic
MUNDIPHARMA Ges.m.b.H Apollogasse 16-18 A-1070 Viena Austria
OxyContin 10mg 10 mg prolonged-release tablet Oral use
CZ - Czech Republic
MUNDIPHARMA Ges.m.b.H Apollogasse 16-18 A-1070 Viena Austria
OxyContin 20mg 20 mg prolonged-release tablet Oral use
CZ - Czech Republic
MUNDIPHARMA Ges.m.b.H Apollogasse 16-18 A-1070 Viena Austria
OxyContin 40mg 40 mg prolonged-release tablet Oral use
CZ - Czech Republic
MUNDIPHARMA Ges.m.b.H Apollogasse 16-18 A-1070 Viena Austria
OxyContin 80mg 80 mg prolonged-release tablet Oral use
CZ - Czech Republic
MUNDIPHARMA Ges.m.b.H Apollogasse 16-18, A-1070 Viena, Austria
MST Continus 10 mg 10 mg Modified-release tablet Oral use
DE - Germany
1 A Pharma GmbH Keltenring 1 + 3 D-82041 Oberhaching Germany
Oxycodonhydrochlorid - 1 A Pharma 10 mg Retardtabletten
10 mg Prolonged-release tablet Oral use
DE - Germany
1 A Pharma GmbH Keltenring 1 + 3 D-82041 Oberhaching Germany
Oxycodonhydrochlorid - 1 A Pharma 20 mg Retardtabletten
20 mg Prolonged-release tablet Oral use
21
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
DE - Germany
1 A Pharma GmbH Keltenring 1 + 3 D-82041 Oberhaching Germany
Oxycodonhydrochlorid - 1 A Pharma 5 mg Retardtabletten
5 mg Prolonged-release tablet Oral use
DE - Germany
AbZ-Pharma GmbH Dr. Georg-Spohn-Str. 7 D-89143 Blaubeuren Germany
Morphinsulfat AbZ 10 mg Retardtabletten
10 mg Prolonged-release tablet Oral use
DE - Germany
AbZ-Pharma GmbH Dr. Georg-Spohn-Str. 7 D-89143 Blaubeuren Germany
Morphinsulfat AbZ 100 mg Retardtabletten
100 mg Prolonged-release tablet Oral use
DE - Germany
AbZ-Pharma GmbH Dr. Georg-Spohn-Str. 7 D-89143 Blaubeuren Germany
Morphinsulfat AbZ 30 mg Retardtabletten
30 mg Prolonged-release tablet Oral use
DE - Germany
AbZ-Pharma GmbH Dr. Georg-Spohn-Str. 7 D-89143 Blaubeuren Germany
Morphinsulfat AbZ 60 mg Retardtabletten
60 mg Prolonged-release tablet Oral use
DE - Germany
AbZ-Pharma GmbH Dr.Georg-Spohn-Str. 7 D-89143 Blaubeuren Germany
Oxycodon-HCl AbZ 10 mg Retardtabletten
10 mg Prolonged-release tablet Oral use
DE - Germany
AbZ-Pharma GmbH Dr.Georg-Spohn-Str. 7 D-89143 Blaubeuren Germany
Oxycodon-HCl AbZ 20 mg Retardtabletten
20 mg Prolonged-release tablet Oral use
DE - Germany
AbZ-Pharma GmbH Dr.Georg-Spohn-Str. 7 D-89143 Blaubeuren Germany
Oxycodon-HCl AbZ 40 mg Retardtabletten
40 mg Prolonged-release tablet Oral use
DE - Germany
AbZ-Pharma GmbH Dr.Georg-Spohn-Str. 7 D-89143 Blaubeuren Germany
Oxycodon-HCl AbZ 5 mg Retardtabletten
5 mg Prolonged-release tablet Oral use
DE - Germany
AbZ-Pharma GmbH Dr.Georg-Spohn-Str. 7 D-89143 Blaubeuren Germany
Oxycodon-HCl AbZ 80 mg Retardtabletten
80 mg Prolonged-release tablet Oral use
22
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
DE - Germany
ACINO AG Am Windfeld 35 D-83714 Miesbach Germany
Oxycodonhydrochlorid Acino 10 mg Retardtabletten
10 mg Prolonged-release tablet Oral use
DE - Germany
ACINO AG Am Windfeld 35 D-83714 Miesbach Germany
Oxycodonhydrochlorid Acino 20 mg Retardtabletten
20 mg Prolonged-release tablet Oral use
DE - Germany
ACINO AG Am Windfeld 35 D-83714 Miesbach Germany
Oxycodonhydrochlorid Acino 40 mg Retardtabletten
40 mg Prolonged-release tablet Oral use
DE - Germany
ACINO AG Am Windfeld 35 D-83714 Miesbach Germany
Oxycodonhydrochlorid Acino 5 mg Retardtabletten
5 mg Prolonged-release tablet Oral use
DE - Germany
ACINO AG Am Windfeld 35 D-83714 Miesbach Germany
Oxycodonhydrochlorid Acino 80 mg Retardtabletten
80 mg Prolonged-release tablet Oral use
DE - Germany
Actavis Deutschland GmbH & Co. KG Elisabeth-Selbert-Str. 1 D-40764 Langenfeld Germany
MORPHIN-PUREN 10 mg retard 10 mg Prolonged-release tablet Oral use
DE - Germany
Actavis Deutschland GmbH & Co. KG Elisabeth-Selbert-Str. 1 D-40764 Langenfeld Germany
MORPHIN-PUREN 100 mg retard
100 mg Prolonged-release tablet Oral use
DE - Germany
Actavis Deutschland GmbH & Co. KG Elisabeth-Selbert-Str. 1 D-40764 Langenfeld Germany
MORPHIN-PUREN 30 mg retard 30 mg Prolonged-release tablet Oral use
DE - Germany
Actavis Deutschland GmbH & Co. KG Elisabeth-Selbert-Str. 1 D-40764 Langenfeld Germany
MORPHIN-PUREN 60 mg retard 60 mg Prolonged-release tablet Oral use
DE - Germany
ALIUD PHARMA GmbH Gottlieb-Daimler-STr. 19 D-89150 Laichingen Germany
Hydromorphon-AL 16 mg Retardtabletten
16 mg Prolonged-release tablet Oral use
23
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
DE - Germany
ALIUD PHARMA GmbH Gottlieb-Daimler-STr. 19 D-89150 Laichingen Germany
Hydromorphon-AL 24 mg Retardtabletten
24 mg Prolonged-release tablet Oral use
DE - Germany
ALIUD PHARMA GmbH Gottlieb-Daimler-STr. 19 D-89150 Laichingen Germany
Hydromorphon-AL 4 mg Retardtabletten
4 mg Prolonged-release tablet Oral use
DE - Germany
ALIUD PHARMA GmbH Gottlieb-Daimler-STr. 19 D-89150 Laichingen Germany
Hydromorphon-AL 8 mg Retardtabletten
8 mg Prolonged-release tablet Oral use
DE - Germany
ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19 D-89150 Laichingen Germany
Morphin AL 10 retard 10 mg Prolonged-release tablet Oral use
DE - Germany
ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19 D-89150 Laichingen Germany
Morphin AL 100 retard 100 mg Prolonged-release tablet Oral use
DE - Germany
ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19 D-89150 Laichingen Germany
Morphin AL 30 retard 30 mg Prolonged-release tablet Oral use
DE - Germany
ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19 D-89150 Laichingen Germany
Morphin AL 60 retard 60 mg Prolonged-release tablet Oral use
DE - Germany
ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19 D-89150 Laichingen Germany
Oxycodon-HCl AL 10 mg Retardtabletten
10 mg Prolonged-release tablet Oral use
DE - Germany
ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19 D-89150 Laichingen Germany
Oxycodon-HCl AL 20 mg Retardtabletten
20 mg Prolonged-release tablet Oral use
DE - Germany
ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19 D-89150 Laichingen Germany
Oxycodon-HCl AL 40 mg Retardtabletten
40 mg Prolonged-release tablet Oral use
24
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
DE - Germany
ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19 D-89150 Laichingen Germany
Oxycodon-HCl AL 5 mg Retardtabletten
5 mg Prolonged-release tablet Oral use
DE - Germany
ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19 D-89150 Laichingen Germany
Oxycodon-HCl AL 80 mg Retardtabletten
80 mg Prolonged-release tablet Oral use
DE - Germany
AWD.pharma GmbH & Co. KG Wasastr. 50 D-01445 Radebeul Germany
Morphin AWD 10 mg retard 10 mg Prolonged-release tablet Oral use
DE - Germany
AWD.pharma GmbH & Co. KG Wasastr. 50 D-01445 Radebeul Germany
Morphin AWD 100 mg retard 100 mg Prolonged-release tablet Oral use
DE - Germany
AWD.pharma GmbH & Co. KG Wasastr. 50 D-01445 Radebeul Germany
Morphin AWD 30 mg retard 30 mg Prolonged-release tablet Oral use
DE - Germany
AWD.pharma GmbH & Co. KG Wasastr. 50 D-01445 Radebeul Germany
Morphin AWD 60 mg retard 60 mg Prolonged-release tablet Oral use
DE - Germany
AWD.pharma GmbH & Co.KG Wasastr. 50 D-01445 Radebeul Germany
Hydromorphon-AWD 16 mg Retardtabletten
16 mg Prolonged-release tablet Oral use
DE - Germany
AWD.pharma GmbH & Co.KG Wasastr. 50 D-01445 Radebeul Germany
Hydromorphon-AWD 24 mg Retardtabletten
24 mg Prolonged-release tablet Oral use
DE - Germany
AWD.pharma GmbH & Co.KG Wasastr. 50 D-01445 Radebeul Germany
Hydromorphon-AWD 4 mg Retardtabletten
4 mg Prolonged-release tablet Oral use
DE - Germany
AWD.pharma GmbH & Co.KG Wasastr. 50 D-01445 Radebeul Germany
Hydromorphon-AWD 8 mg Retardtabletten
8 mg Prolonged-release tablet Oral use
25
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
DE - Germany
betapharm Arzneimittel GmbH Kobelweg 95 D-86156 Augsburg Germany
M-beta 10 10 mg Prolonged-release tablet Oral use
DE - Germany
betapharm Arzneimittel GmbH Kobelweg 95 D-86156 Augsburg Germany
M-beta 100 100 mg Prolonged-release tablet Oral use
DE - Germany
betapharm Arzneimittel GmbH Kobelweg 95 D-86156 Augsburg Germany
M-beta 30 30 mg Prolonged-release tablet Oral use
DE - Germany
betapharm Arzneimittel GmbH Kobelweg 95 D-86156 Augsburg Germany
M-beta 60 60 mg Prolonged-release tablet Oral use
DE - Germany
betapharm Arzneimittel GmbH Kobelweg 95 D-86156 Augsburg Germany
Oxycodon-HCl beta 10 mg Retardtabletten
10 mg Prolonged-release tablet Oral use
DE - Germany
betapharm Arzneimittel GmbH Kobelweg 95 D-86156 Augsburg Germany
Oxycodon-HCl beta 20 mg Retardtabletten
20 mg Prolonged-release tablet Oral use
DE - Germany
betapharm Arzneimittel GmbH Kobelweg 95 D-86156 Augsburg Germany
Oxycodon-HCl beta 30 mg Retardtabletten
30 mg Prolonged-release tablet Oral use
DE - Germany
betapharm Arzneimittel GmbH Kobelweg 95 D-86156 Augsburg Germany
Oxycodon-HCl beta 40 mg Retardtabletten
40 mg Prolonged-release tablet Oral use
DE - Germany
betapharm Arzneimittel GmbH Kobelweg 95 D-86156 Augsburg Germany
Oxycodon-HCl beta 5 mg Retardtabletten
5 mg Prolonged-release tablet Oral use
DE - Germany
betapharm Arzneimittel GmbH Kobelweg 95 D-86156 Augsburg Germany
Oxycodon-HCl beta 60 mg Retardtabletten
60 mg Prolonged-release tablet Oral use
26
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
DE - Germany
betapharm Arzneimittel GmbH Kobelweg 95 D-86156 Augsburg Germany
Oxycodon-HCl beta 80 mg Retardtabletten
80 mg Prolonged-release tablet Oral use
DE - Germany
CT Arzneimittel GmbH Lengeder Str., 42 a D-13407 Berlin Germany
Morphinsulfat-CT 10 mg Retardtabletten
10 mg Prolonged-release tablet Oral use
DE - Germany
CT Arzneimittel GmbH Lengeder Str., 42 a D-13407 Berlin Germany
Morphinsulfat-CT 100 mg Retardtabletten
100 mg Prolonged-release tablet Oral use
DE - Germany
CT Arzneimittel GmbH Lengeder Str., 42 a D-13407 Berlin Germany
Morphinsulfat-CT 30 mg Retardtabletten
30 mg Prolonged-release tablet Oral use
DE - Germany
CT Arzneimittel GmbH Lengeder Str., 42 a D-13407 Berlin Germany
Morphinsulfat-CT 60 mg Retardtabletten
60 mg Prolonged-release tablet Oral use
DE - Germany
CT Arzneimittel GmbH Lengeder Str. 42 a D-13407 Berlin Germany
Oxycodon-HCl-CT 10 mg Retardtabletten
10 mg Prolonged-release tablet Oral use
DE - Germany
CT Arzneimittel GmbH Lengeder Str. 42 a D-13407 Berlin Germany
Oxycodon-HCl-CT 20 mg Retardtabletten
20 mg Prolonged-release tablet Oral use
DE - Germany
CT Arzneimittel GmbH Lengeder Str. 42 a D-13407 Berlin Germany
Oxycodon-HCl-CT 40 mg Retardtabletten
40 mg Prolonged-release tablet Oral use
DE - Germany
CT Arzneimittel GmbH Lengeder Str. 42 a D-13407 Berlin Germany
Oxycodon-HCl-CT 5 mg Retardtabletten
5 mg Prolonged-release tablet Oral use
DE - Germany
CT Arzneimittel GmbH Lengeder Str. 42 a D-13407 Berlin Germany
Oxycodon-HCl-CT 80 mg Retardtabletten
80 mg Prolonged-release tablet Oral use
27
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
DE - Germany
GlaxoSmithKline GmbH & Co. KG Theresienhöhe 11 D-80339 München Germany
Kapanol 100mg 100 mg Prolonged-release capsule, hard Oral use
DE - Germany
GlaxoSmithKline GmbH & Co. KG Theresienhöhe 11 D-80339 München Germany
Kapanol 20mg 20 mg Prolonged-release capsule, hard Oral use
DE - Germany
GlaxoSmithKline GmbH & Co. KG Theresienhöhe 11 D-80339 München Germany
Kapanol 50mg 50 mg Prolonged-release capsule, hard Oral use
DE - Germany
Grünenthal GmbH Zieglerstr. 6 D-52078 Aachen Germany
M-long 100mg 100 mg Prolonged-release capsule, hard Oral use
DE - Germany
Grünenthal GmbH Zieglerstr. 6 D-52078 Aachen Germany
M-long 10mg 10 mg Prolonged-release capsule, hard Oral use
DE - Germany
Grünenthal GmbH Zieglerstr. 6 D-52078 Aachen Germany
M-long 30mg 30 mg Prolonged-release capsule, hard Oral use
DE - Germany
Grünenthal GmbH Zieglerstr. 6 D-52078 Aachen Germany
M-long 60mg 60 mg Prolonged-release capsule, hard Oral use
DE - Germany
Grünenthal GmbH Zieglerstr. 6 D-52078 Aachen Germany
Morphin Grünenthal 10 mg 10 mg Prolonged-release tablet Oral use
DE - Germany
Grünenthal GmbH Zieglerstr. 6 D-52078 Aachen Germany
Morphin Grünenthal 100 mg 100 mg Prolonged-release tablet Oral use
DE - Germany
Grünenthal GmbH Zieglerstr. 6 D-52078 Aachen Germany
Morphin Grünenthal 30 mg 30 mg Prolonged-release tablet Oral use
28
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
DE - Germany
Grünenthal GmbH Zieglerstr. 6 D-52078 Aachen Germany
Morphin Grünenthal 60 mg 60 mg Prolonged-release tablet Oral use
DE - Germany
GRY-Pharma GmbH Wasastr. 50 D-01445 Radebeul Germany
Morphinsulfat-GRY 10 mg Retardtabletten
10 mg Prolonged-release tablet Oral use
DE - Germany
GRY-Pharma GmbH Wasastr. 50 D-01445 Radebeul Germany
Morphinsulfat-GRY 100 mg Retardtabletten
100 mg Prolonged-release tablet Oral use
DE - Germany
GRY-Pharma GmbH Wasastr. 50 D-01445 Radebeul Germany
Morphinsulfat-GRY 200 mg Retardtabletten
200 mg Prolonged-release tablet Oral use
DE - Germany
GRY-Pharma GmbH Wasastr. 50 D-01445 Radebeul Germany
Morphinsulfat-GRY 30 mg Retardtabletten
30 mg Prolonged-release tablet Oral use
DE - Germany
GRY-Pharma GmbH Wasastr. 50 D-01445 Radebeul Germany
Morphinsulfat-GRY 60 mg Retardtabletten
60 mg Prolonged-release tablet Oral use
DE - Germany
Heumann Pharma GmbH & Co. Generica KG Südwestpark 50 D-90449 Nürnberg Germany
Morphin 10 retard Heumann 10 mg Prolonged-release tablet Oral use
DE - Germany
Heumann Pharma GmbH & Co. Generica KG Südwestpark 50 D-90449 Nürnberg Germany
Morphin 100 retard Heumann 100 mg Prolonged-release tablet Oral use
DE - Germany
Heumann Pharma GmbH & Co. Generica KG Südwestpark 50 D-90449 Nürnberg Germany
Morphin 30 retard Heumann 30 mg Prolonged-release tablet Oral use
29
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
DE - Germany
Heumann Pharma GmbH & Co. Generica KG Südwestpark 50 D-90449 Nürnberg Germany
Morphin 60 retard Heumann 60 mg Prolonged-release tablet Oral use
DE - Germany
HEXAL AG Industriestr. 25 D-83607 Holzkirchen Germany
Hydromorphon-HEXAL retard 16 mg Retardtabletten
16 mg Prolonged-release tablet Oral use
DE - Germany
HEXAL AG Industriestr. 25 D-83607 Holzkirchen Germany
Hydromorphon-HEXAL retard 24 mg Retardtabletten
24 mg Prolonged-release tablet Oral use
DE - Germany
HEXAL AG Industriestr. 25 D-83607 Holzkirchen Germany
Hydromorphon-HEXAL retard 4 mg Retardtabletten
4 mg Prolonged-release tablet Oral use
DE - Germany
HEXAL AG Industriestr. 25 D-83607 Holzkirchen Germany
Hydromorphon-HEXAL retard 8 mg Retardtabletten
8 mg Prolonged-release tablet Oral use
DE - Germany
HEXAL AG Industriestr. 25 D-83607 Holzkirchen Germany
Kancodal HEXAL 10 mg Retardtabletten
10 mg Prolonged-release tablet Oral use
DE - Germany
HEXAL AG Industriestr. 25 D-83607 Holzkirchen Germany
Kancodal HEXAL 20 mg Retardtabletten
20 mg Prolonged-release tablet Oral use
DE - Germany
HEXAL AG Industriestr. 25 D-83607 Holzkirchen Germany
Morphin HEXAL 100mg Retardkapseln
100 mg Prolonged-release capsule, hard Oral use
DE - Germany
HEXAL AG Industriestr. 25 D-83607 Holzkirchen Germany
Morphin HEXAL 100mg Retardtabletten
100 mg Prolonged-release tablet Oral use
DE - Germany
HEXAL AG Industriestr. 25 D-83607 Holzkirchen Germany
Morphin HEXAL 10mg Retardkapseln
10 mg Prolonged-release capsule, hard Oral use
30
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
DE - Germany
HEXAL AG Industriestr. 25 D-83607 Holzkirchen Germany
Morphin HEXAL 10mg Retardtabletten
10 mg Prolonged-release tablet Oral use
DE - Germany
HEXAL AG Industriestr. 25 D-83607 Holzkirchen Germany
Morphin HEXAL 30mg Retardkapseln
30 mg Prolonged-release capsule, hard Oral use
DE - Germany
HEXAL AG Industriestr. 25 D-83607 Holzkirchen Germany
Morphin HEXAL 30mg Retardtabletten
30 mg Prolonged-release tablet Oral use
DE - Germany
HEXAL AG Industriestr. 25 D-83607 Holzkirchen Germany
Morphin HEXAL 60mg Retardkapseln
60 mg Prolonged-release capsule, hard Oral use
DE - Germany
HEXAL AG Industriestr. 25 D-83607 Holzkirchen Germany
Morphin HEXAL 60mg Retardtabletten
60 mg Prolonged-release tablet Oral use
DE - Germany
HEXAL AG Industriestr. 25 D-83607 Holzkirchen Germany
Oxyco HEXAL 10 mg Retardtabletten
10 mg Prolonged-release tablet Oral use
DE - Germany
HEXAL AG Industriestr. 25 D-83607 Holzkirchen Germany
Oxyco HEXAL 20 mg Retardtabletten
20 mg Prolonged-release tablet Oral use
DE - Germany
HEXAL AG Industriestr. 25 D-83607 Holzkirchen Germany
Oxycodon-HCl HEXAL 10 mg Retardtabletten
10 mg Prolonged-release tablet Oral use
DE - Germany
HEXAL AG Industriestr. 25 D-83607 Holzkirchen Germany
Oxycodon-HCl HEXAL 20 mg Retardtabletten
20 mg Prolonged-release tablet Oral use
DE - Germany
HEXAL AG Industriestr. 25 D-83607 Holzkirchen Germany
Oxycodon-HCl HEXAL 40 mg Retardtabletten
40 mg Prolonged-release tablet Oral use
31
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
DE - Germany
HEXAL AG Industriestr. 25 D-83607 Holzkirchen Germany
Oxycodon-HCl HEXAL 5 mg Retardtabletten
5 mg Prolonged-release tablet Oral use
DE - Germany
HEXAL AG Industriestr. 25 D-83607 Holzkirchen Germany
Oxycodon-HCl HEXAL 5 mg Retardtabletten
5 mg Prolonged-release tablet Oral use
DE - Germany
HEXAL AG Industriestr. 25 D-83607 Holzkirchen Germany
Oxycodon-HCl HEXAL 80 mg Retardtabletten
80 mg Prolonged-release tablet Oral use
DE - Germany
HEXAL AG Industriestr. 25 D-83607 Holzkirchen Germany
Oxycodonhydrochloridl HEXAL 5 mg Retardtabletten
5 mg Prolonged-release tablet Oral use
DE - Germany
Janssen-Cilag GmbH Johnson & Johnson Platz 1 D-41470 Neuss Germany
JURNISTA 16 mg Retardtabletten
16 mg Prolonged-release tablet Oral use
DE - Germany
Janssen-Cilag GmbH Johnson & Johnson Platz 1 D-41470 Neuss Germany
JURNISTA 32 mg Retardtabletten
32 mg Prolonged-release tablet Oral use
DE - Germany
Janssen-Cilag GmbH Johnson & Johnson Platz 1 D-41470 Neuss Germany
JURNISTA 4 mg Retardtabletten 4 mg Prolonged-release tablet Oral use
DE - Germany
Janssen-Cilag GmbH Johnson & Johnson Platz 1 D-41470 Neuss Germany
JURNISTA 64 mg Retardtabletten
64 mg Prolonged-release tablet Oral use
DE - Germany
Janssen-Cilag GmbH Johnson & Johnson Platz 1 D-41470 Neuss Germany
JURNISTA 8 mg Retardtabletten 8 mg Prolonged-release tablet Oral use
DE - Germany
Juta Pharma GmbH Gutenbergstr. 13 D-24941 Flensburg Germany
Morphanton 100mg Retardtabletten
100 mg Prolonged-release tablet Oral use
32
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
DE - Germany
Juta Pharma GmbH Gutenbergstr. 13 D-24941 Flensburg Germany
Morphanton 10mg Retardtabletten
10 mg Prolonged-release tablet Oral use
DE - Germany
Juta Pharma GmbH Gutenbergstr. 13 D-24941 Flensburg Germany
Morphanton 30mg Retardtabletten
30 mg Prolonged-release tablet Oral use
DE - Germany
Juta Pharma GmbH Gutenbergstr. 13 D-24941 Flensburg Germany
Morphanton 60mg Retardtabletten
60 mg Prolonged-release tablet Oral use
DE - Germany
Krewel Meuselbach GmbH Krewelstr. 2 D-53783 Eitorf Germany
Morphin-HCl Krewel 10 mg Retardtabletten
10 mg Prolonged-release tablet Oral use
DE - Germany
Krewel Meuselbach GmbH Krewelstr. 2 D-53783 Eitorf Germany
Morphin-HCl Krewel 100 mg Retardtabletten
100 mg Prolonged-release tablet Oral use
DE - Germany
Krewel Meuselbach GmbH Krewelstr. 2 D-53783 Eitorf Germany
Morphin-HCl Krewel 200 mg Retardtabletten
200 mg Prolonged-release tablet Oral use
DE - Germany
Krewel Meuselbach GmbH Krewelstr. 2 D-53783 Eitorf Germany
Morphin-HCl Krewel 30 mg Retardtabletten
30 mg Prolonged-release tablet Oral use
DE - Germany
Krewel Meuselbach GmbH Krewelstr. 2 D-53783 Eitorf Germany
Morphin-HCl Krewel 60 mg Retardtabletten
60 mg Prolonged-release tablet Oral use
DE - Germany
medac Gesellschaft für klinische Spezialpräparate mbH Fehlandtstr. 3 D-20354 Hamburg Germany
Capros 1 x täglich 120 mg Hartkapseln, retardiert
120 mg Prolonged-release capsule, hard Oral use
33
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
DE - Germany
medac Gesellschaft für klinische Spezialpräparate mbH Fehlandtstr. 3 D-20354 Hamburg Germany
Capros 1 x täglich 20 mg Hartkapseln, retardiert
20 mg Prolonged-release capsule, hard Oral use
DE - Germany
medac Gesellschaft für klinische Spezialpräparate mbH Fehlandtstr. 3 D-20354 Hamburg Germany
Capros 1 x täglich 200 mg Hartkapseln, retardiert
200 mg Prolonged-release capsule, hard Oral use
DE - Germany
medac Gesellschaft für klinische Spezialpräparate mbH Fehlandtstr. 3 D-20354 Hamburg Germany
Capros 1 x täglich 60 mg Hartkapseln, retardiert
60 mg Prolonged-release capsule, hard Oral use
DE - Germany
medac Gesellschaft für klinische Spezialpräparate mbH Fehlandtstr. 3 D-20354 Hamburg Germany
Capros 100mg 100 mg Prolonged-release capsule, hard Oral use
DE - Germany
medac Gesellschaft für klinische Spezialpräparate mbH Fehlandtstr. 3 D-20354 Hamburg Germany
Capros 10mg 10 mg Prolonged-release capsule, hard Oral use
DE - Germany
medac Gesellschaft für klinische Spezialpräparate mbH Fehlandtstr. 3 D-20354 Hamburg Germany
Capros 30mg 30 mg Prolonged-release capsule, hard Oral use
DE - Germany
medac Gesellschaft für klinische Spezialpräparate mbH Fehlandtstr. 3 D-20354 Hamburg Germany
Capros 60mg 60 mg Prolonged-release capsule, hard Oral use
DE - Germany
Mundipharma GmbH Mundipharma Str. 2 D-65549 Limburg Germany
MST 10 mg Mundipharma 10 mg Prolonged-release tablet Oral use
34
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
DE - Germany
Mundipharma GmbH Mundipharma Str. 2 D-65549 Limburg Germany
MST 100 mg Mundipharma 100 mg Prolonged-release tablet Oral use
DE - Germany
Mundipharma GmbH Mundipharma Str. 2 D-65549 Limburg Germany
MST 200 mg Mundipharma 200 mg Prolonged-release tablet Oral use
DE - Germany
Mundipharma GmbH Mundipharma Str. 2 D-65549 Limburg Germany
MST 30 mg Mundipharma 30 mg Prolonged-release tablet Oral use
DE - Germany
Mundipharma GmbH Mundipharma Str. 2 D-65549 Limburg Germany
MST 60 mg Mundipharma 60 mg Prolonged-release tablet Oral use
DE - Germany
Mundipharma GmbH Mundipharma Str. 2 D-65549 Limburg Germany
MST Continus 100mg 100 mg Prolonged-release capsule, hard Oral use
DE - Germany
Mundipharma GmbH Mundipharma Str. 2 D-65549 Limburg Germany
MST Continus 200mg 200 mg Prolonged-release capsule, hard Oral use
DE - Germany
Mundipharma GmbH Mundipharma Str. 2 D-65549 Limburg Germany
MST Continus 30mg 30 mg Prolonged-release capsule, hard Oral use
DE - Germany
Mundipharma GmbH Mundipharma Str. 2 D-65549 Limburg Germany
MST Continus 60mg 60 mg Prolonged-release capsule, hard Oral use
DE - Germany
Mundipharma GmbH Mundipharma Str. 2 D-65549 Limburg Germany
MSTW 10 mg Krugmann 10 mg Prolonged-release tablet Oral use
DE - Germany
Mundipharma GmbH Mundipharma Str. 2 D-65549 Limburg Germany
MSTW 100 mg Krugmann 100 mg Prolonged-release tablet Oral use
35
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
DE - Germany
Mundipharma GmbH Mundipharma Str. 2 D-65549 Limburg Germany
MSTW 200 mg Krugmann 200 mg Prolonged-release tablet Oral use
DE - Germany
Mundipharma GmbH Mundipharma Str. 2 D-65549 Limburg Germany
MSTW 30 mg Krugmann 30 mg Prolonged-release tablet Oral use
DE - Germany
Mundipharma GmbH Mundipharma Str. 2 D-65549 Limburg Germany
MSTW 60 mg Krugmann 60 mg Prolonged-release tablet Oral use
DE - Germany
Mundipharma GmbH Mundipharma Str. 2 D-65549 Limburg Germany
OXYGESIC 10 mg 10 mg Prolonged-release tablet Oral use
DE - Germany
Mundipharma GmbH Mundipharma Str. 2 D-65549 Limburg Germany
OXYGESIC 20 mg 20 mg Prolonged-release tablet Oral use
DE - Germany
Mundipharma GmbH Mundipharma Str. 2 D-65549 Limburg Germany
OXYGESIC 40 mg 40 mg Prolonged-release tablet Oral use
DE - Germany
Mundipharma GmbH Mundipharma Str. 2 D-65549 Limburg Germany
OXYGESIC 5 mg 5 mg Prolonged-release tablet Oral use
DE - Germany
Mundipharma GmbH Mundipharma Str. 2 D-65549 Limburg Germany
OXYGESIC 80 mg 80 mg Prolonged-release tablet Oral use
DE - Germany
Mundipharma GmbH Mundipharma Str. 2 D-65549 Limburg Germany
OxyContin 10 mg 10 mg Prolonged-release tablet Oral use
DE - Germany
Mundipharma GmbH Mundipharma Str. 2 D-65549 Limburg Germany
OxyContin 20 mg 20 mg Prolonged-release tablet Oral use
36
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
DE - Germany
Mundipharma GmbH Mundipharma Str. 2 D-65549 Limburg Germany
OxyContin 40 mg 40 mg Prolonged-release tablet Oral use
DE - Germany
Mundipharma GmbH Mundipharma Str. 2 D-65549 Limburg Germany
OxyContin 5 mg 5 mg Prolonged-release tablet Oral use
DE - Germany
Mundipharma GmbH Mundipharma Str. 2 D-65549 Limburg Germany
OxyContin 80 mg 80 mg Prolonged-release tablet Oral use
DE - Germany
Mundipharma GmbH Mundipharma Str. 2 D-65549 Limburg Germany
Oxynal 10/5mg Retardtabletten 10 mg 5 mg
Prolonged-release tablet Oral use
DE - Germany
Mundipharma GmbH Mundipharma Str. 2 D-65549 Limburg Germany
Oxynal 20/10mg Retardtabletten
20 mg 10 mg
Prolonged-release tablet Oral use
DE - Germany
Mundipharma GmbH Mundipharma Str. 2 D-65549 Limburg Germany
Palladon retard 16 mg 16 mg Prolonged-release capsule, hard Oral use
DE - Germany
Mundipharma GmbH Mundipharma Str. 2 D-65549 Limburg Germany
Palladon retard 24 mg 24 mg Prolonged-release capsule, hard Oral use
DE - Germany
Mundipharma GmbH Mundipharma Str. 2 D-65549 Limburg Germany
Palladon retard 4 mg 4 mg Prolonged-release capsule, hard Oral use
DE - Germany
Mundipharma GmbH Mundipharma Str. 2 D-65549 Limburg Germany
Palladon retard 8 mg 8 mg Prolonged-release capsule, hard Oral use
DE - Germany
Mundipharma GmbH Mundipharma Str. 2 D-65549 Limburg Germany
Targin 10 mg/5 mg Retardtabletten
10 mg 5,45
Prolonged-release tablet Oral use
37
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
DE - Germany
Mundipharma GmbH Mundipharma Str. 2 D-65549 Limburg Germany
Targin 10 mg/5 mg Retardtabletten
10 mg 5,45
Prolonged-release tablet Oral use
DE - Germany
Mundipharma GmbH Mundipharma Str. 2 D-65549 Limburg Germany
Targin 20 mg/10 mg Retardtabletten
20 mg 10 mg
Prolonged-release tablet Oral use
DE - Germany
Mundipharma GmbH Mundipharma Str. 2 D-65549 Limburg Germany
Targin 40 mg/20 mg Retardtabletten
40 mg 21,8 mg
Prolonged-release tablet Oral use
DE - Germany
Mundipharma GmbH Mundipharma Str. 2 D-65549 Limburg Germany
Targin 5 mg/2,5 mg Retardtabletten
5 mg 2,73
Prolonged-release tablet Oral use
DE - Germany
PS Pharma Service GmbH Lise-Meitner-Str. 10 D-40670 Meerbusch Germany
Morphin EINS PS Pharma 10 mg retard
10 mg Prolonged-release tablet Oral use
DE - Germany
PS Pharma Service GmbH Lise-Meitner-Str. 10 D-40670 Meerbusch Germany
Morphin EINS PS Pharma 100 mg retard
100 mg Prolonged-release tablet Oral use
DE - Germany
PS Pharma Service GmbH Lise-Meitner-Str. 10 D-40670 Meerbusch Germany
Morphin EINS PS Pharma 200 mg retard
200 mg Prolonged-release tablet Oral use
DE - Germany
PS Pharma Service GmbH Lise-Meitner-Str. 10 D-40670 Meerbusch Germany
Morphin EINS PS Pharma 30 mg retard
30 mg Prolonged-release tablet Oral use
DE - Germany
PS Pharma Service GmbH Lise-Meitner-Str. 10 D-40670 Meerbusch Germany
Morphin EINS PS Pharma 60 mg retard
60 mg Prolonged-release tablet Oral use
DE - Germany
PS Pharma Service GmbH Lise-Meitner-Str. 10 D-40670 Meerbusch Germany
Morphin PS Pharma 200 mg retard
200 mg Prolonged-release tablet Oral use
38
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
DE - Germany
PS Pharma Service GmbH Lise-Meitner-Str. 10 D-40670 Meerbusch Germany
Morphin VIER PS Pharma 10 mg retard
10 mg Prolonged-release tablet Oral use
DE - Germany
PS Pharma Service GmbH Lise-Meitner-Str. 10 D-40670 Meerbusch Germany
Morphin VIER PS Pharma 100 mg retard
100 mg Prolonged-release tablet Oral use
DE - Germany
PS Pharma Service GmbH Lise-Meitner-Str. 10 D-40670 Meerbusch Germany
Morphin VIER PS Pharma 30 mg retard
30 mg Prolonged-release tablet Oral use
DE - Germany
PS Pharma Service GmbH Lise-Meitner-Str. 10 D-40670 Meerbusch Germany
Morphin VIER PS Pharma 60 mg retard
60 mg Prolonged-release tablet Oral use
DE - Germany
PS Pharma Service GmbH Lise-Meitner-Str. 10 D-40670 Meerbusch Germany
Morphin ZWEI PS Pharma 10 mg retard
10 mg Prolonged-release tablet Oral use
DE - Germany
PS Pharma Service GmbH Lise-Meitner-Str. 10 D-40670 Meerbusch Germany
Morphin ZWEI PS Pharma 100 mg retard
100 mg Prolonged-release tablet Oral use
DE - Germany
PS Pharma Service GmbH Lise-Meitner-Str. 10 D-40670 Meerbusch Germany
Morphin ZWEI PS Pharma 200 mg retard
200 mg Prolonged-release tablet Oral use
DE - Germany
PS Pharma Service GmbH Lise-Meitner-Str. 10 D-40670 Meerbusch Germany
Morphin ZWEI PS Pharma 30 mg retard
30 mg Prolonged-release tablet Oral use
DE - Germany
PS Pharma Service GmbH Lise-Meitner-Str. 10 D-40670 Meerbusch Germany
Morphin ZWEI PS Pharma 60 mg retard
60 mg Prolonged-release tablet Oral use
DE - Germany
ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany
Hydromorphon-ratiopharm 16 mg Retardtabletten
16 mg Prolonged-release tablet Oral use
39
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
DE - Germany
ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany
Hydromorphon-ratiopharm 24 mg Retardtabletten
24 mg Prolonged-release tablet Oral use
DE - Germany
ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany
Hydromorphon-ratiopharm 4 mg Retardtabletten
4 mg Prolonged-release tablet Oral use
DE - Germany
ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany
Hydromorphon-ratiopharm 8 mg Retardtabletten
8 mg Prolonged-release tablet Oral use
DE - Germany
ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany
Morphin-ratiopharm 10 mg Retardtabletten
10 mg Prolonged-release tablet Oral use
DE - Germany
ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany
Morphin-ratiopharm 100 mg Retardtabletten
100 mg Prolonged-release tablet Oral use
DE - Germany
ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany
Morphin-ratiopharm 30 mg Retardtabletten
30 mg Prolonged-release tablet Oral use
DE - Germany
ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany
Morphin-ratiopharm 60 mg Retardtabletten
60 mg Prolonged-release tablet Oral use
DE - Germany
ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany
Oxycodon-HCl-ratiopharm 10 mg Retardtabletten
10 mg Prolonged-release tablet Oral use
DE - Germany
ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany
Oxycodon-HCl-ratiopharm 20 mg Retardtabletten
20 mg Prolonged-release tablet Oral use
DE - Germany
ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany
Oxycodon-HCl-ratiopharm 40 mg Retardtabletten
40 mg Prolonged-release tablet Oral use
40
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
DE - Germany
ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany
Oxycodon-HCl-ratiopharm 5 mg Retardtabletten
5 mg Prolonged-release tablet Oral use
DE - Germany
ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany
Oxycodon-HCl-ratiopharm 80 mg Retardtabletten
80 mg Prolonged-release tablet Oral use
DE - Germany
ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany
Oxycodonhydrochlorid-ratiopharm 10 mg Retardtabletten
10 mg Prolonged-release tablet Oral use
DE - Germany
ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany
Oxycodonhydrochlorid-ratiopharm 5 mg Retardtabletten
5 mg Prolonged-release tablet Oral use
DE - Germany
ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany
Oxycodonhydrochlorid-ratiopharm 20 mg Retardtabletten
20 mg Prolonged-release tablet Oral use
DE - Germany
ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany
Oxycodonhydrochlorid-ratiopharm 40 mg Retardtabletten
40 mg Prolonged-release tablet Oral use
DE - Germany
ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany
Oxycodonhydrochlorid-ratiopharm 5 mg Retardtabletten
5 mg Prolonged-release tablet Oral use
DE - Germany
ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany
Oxycodonhydrochlorid-ratiopharm 80 mg Retardtabletten
80 mg Prolonged-release tablet Oral use
DE - Germany
Sandoz Pharmaceuticals GmbH Raiffeisenstr. 11 D-83607 Holzkirchen Germany
Morph Sandoz 100mg Retardtabletten
100 mg Prolonged-release tablet Oral use
DE - Germany
Sandoz Pharmaceuticals GmbH Raiffeisenstr. 11 D-83607 Holzkirchen Germany
Morph Sandoz 10mg Retardtabletten
10 mg Prolonged-release tablet Oral use
41
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
DE - Germany
Sandoz Pharmaceuticals GmbH Raiffeisenstr. 11 D-83607 Holzkirchen Germany
Morph Sandoz 30mg Retardtabletten
30 mg Prolonged-release tablet Oral use
DE - Germany
Sandoz Pharmaceuticals GmbH Raiffeisenstr. 11 D-83607 Holzkirchen Germany
Morph Sandoz 60mg Retardtabletten
60 mg Prolonged-release tablet Oral use
DE - Germany
Sandoz Pharmaceuticals GmbH Raiffeisenstr. 11 D-83607 Holzkirchen Germany
Oxycodon-HCl Sandoz 10 mg Retardtabletten
10 mg Prolonged-release tablet Oral use
DE - Germany
Sandoz Pharmaceuticals GmbH Raiffeisenstr. 11 D-83607 Holzkirchen Germany
Oxycodon-HCl Sandoz 20 mg Retardtabletten
20 mg Prolonged-release tablet Oral use
DE - Germany
Sandoz Pharmaceuticals GmbH Raiffeisenstr. 11 D-83607 Holzkirchen Germany
Oxycodon-HCl Sandoz 20 mg Retardtabletten
20 mg Prolonged-release tablet Oral use
DE - Germany
Sandoz Pharmaceuticals GmbH Raiffeisenstr. 11 D-83607 Holzkirchen Germany
Oxycodon-HCl Sandoz 40 mg Retardtabletten
40 mg Prolonged-release tablet Oral use
DE - Germany
Sandoz Pharmaceuticals GmbH Raiffeisenstr. 11 D-83607 Holzkirchen Germany
Oxycodon-HCl Sandoz 5 mg Retardtabletten
5 mg Prolonged-release tablet Oral use
DE - Germany
Sandoz Pharmaceuticals GmbH Raiffeisenstr. 11 D-83607 Holzkirchen Germany
Oxycodon-HCl Sandoz 80 mg Retardtabletten
80 mg Prolonged-release tablet Oral use
DE - Germany
Sandoz Pharmaceuticals GmbH Raiffeisenstr. 11 D-83607 Holzkirchen Germany
Oxycodon-HCl Sandoz 10 mg 10 mg Prolonged-release tablet Oral use
DE - Germany
Stadapharm GmbH Stadastr. 2-18 D-61118 Bad Vilbel Germany
Hydromorphon-Stada 16 mg Retardtabletten
16 mg Prolonged-release tablet Oral use
42
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
DE - Germany
Stadapharm GmbH Stadastr. 2-18 D-61118 Bad Vilbel Germany
Hydromorphon-Stada 24 mg Retardtabletten
24 mg Prolonged-release tablet Oral use
DE - Germany
Stadapharm GmbH Stadastr. 2-18 D-61118 Bad Vilbel Germany
Hydromorphon-Stada 4 mg Retardtabletten
4 mg Prolonged-release tablet Oral use
DE - Germany
Stadapharm GmbH Stadastr. 2-18 D-61118 Bad Vilbel Germany
Hydromorphon-Stada 8 mg Retardtabletten
8 mg Prolonged-release tablet Oral use
DE - Germany
Stadapharm GmbH Stadastr. 2 - 18 D-61118 Bad Vilbel Germany
M-Stada 10 mg Retardtabletten 10 mg Prolonged-release tablet Oral use
DE - Germany
Stadapharm GmbH Stadastr. 2 - 18 D-61118 Bad Vilbel Germany
M-Stada 100 mg Retardtabletten
100 mg Prolonged-release tablet Oral use
DE - Germany
Stadapharm GmbH Stadastr. 2 - 18 D-61118 Bad Vilbel Germany
M-Stada 200 mg Retardtabletten
200 mg Prolonged-release tablet Oral use
DE - Germany
Stadapharm GmbH Stadastr. 2 - 18 D-61118 Bad Vilbel Germany
M-Stada 30 mg Retardtabletten 30 mg Prolonged-release tablet Oral use
DE - Germany
Stadapharm GmbH Stadastr. 2 - 18 D-61118 Bad Vilbel Germany
M-Stada 60 mg Retardtabletten 60 mg Prolonged-release tablet Oral use
DE - Germany
Stadapharm GmbH Stadastr. 2 - 18 D-61118 Bad Vilbel Germany
Oxycodon-HCl STADA 10 mg Retardtabletten
10 mg Prolonged-release tablet Oral use
DE - Germany
Stadapharm GmbH Stadastr. 2 - 18 D-61118 Bad Vilbel Germany
Oxycodon-HCl STADA 20 mg Retardtabletten
20 mg Prolonged-release tablet Oral use
43
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
DE - Germany
Stadapharm GmbH Stadastr. 2 - 18 D-61118 Bad Vilbel Germany
Oxycodon-HCl STADA 40 mg Retardtabletten
40 mg Prolonged-release tablet Oral use
DE - Germany
Stadapharm GmbH Stadastr. 2 - 18 D-61118 Bad Vilbel Germany
Oxycodon-HCl STADA 5 mg Retardtabletten
5 mg Prolonged-release tablet Oral use
DE - Germany
Stadapharm GmbH Stadastr. 2 - 18 D-61118 Bad Vilbel Germany
Oxycodon-HCl STADA 80 mg Retardtabletten
80 mg Prolonged-release tablet Oral use
DK - Denmark
Acino AG Am Windfeld 35 DE-83714 Miesbach Germany
Oxycodonhydrochlorid "Acino" 5 mg Prolonged release tablet Oral use
DK - Denmark
Acino AG Am Windfeld 35 DE-83714 Miesbach Germany
Oxycodonhydrochlorid "Acino" 10 mg Prolonged release tablet Oral use
DK - Denmark
Acino AG Am Windfeld 35 DE-83714 Miesbach Germany
Oxycodonhydrochlorid "Acino" 20 mg Prolonged release tablet Oral use
DK - Denmark
Acino AG Am Windfeld 35 DE-83714 Miesbach Germany
Oxycodonhydrochlorid "Acino" 40 mg Prolonged release tablet Oral use
DK - Denmark
Acino AG Am Windfeld 35 DE-83714 Miesbach Germany
Oxycodonhydrochlorid "Acino" 80 mg Prolonged release tablet Oral use
DK - Denmark
Ethypharm 17-21, rue St. Mathieu (Z.I.) F- 78550 Houdan 194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex France
Ethirfin 20 mg Prolonged-release capsule Oral use
44
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
DK - Denmark
Ethypharm 17-21, rue St. Mathieu (Z.I.) F- 78550 Houdan 194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex France
Ethirfin 40 mg Prolonged-release capsule Oral use
DK - Denmark
Ethypharm 17-21, rue St. Mathieu (Z.I.) F- 78550 Houdan 194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex France
Ethirfin 60 mg Prolonged-release capsule Oral use
DK - Denmark
Ethypharm 17-21, rue St. Mathieu (Z.I.) F- 78550 Houdan 194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex France
Ethirfin 120 mg Prolonged-release capsule Oral use
DK - Denmark
Ethypharm 17-21, rue St. Mathieu (Z.I.) F- 78550 Houdan 194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex France
Ethirfin 200 mg Prolonged-release capsule Oral use
DK - Denmark
Ethypharm 17-21, rue St. Mathieu (Z.I.) F- 78550 Houdan 194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex France
Morphinsulfat "Ethypharm" 20 mg Prolonged-release capsule, hard Oral use
DK - Denmark
Ethypharm 17-21, rue St. Mathieu (Z.I.) F- 78550 Houdan 194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex France
Morphinsulfat "Ethypharm" 40 mg Prolonged-release capsule, hard Oral use
45
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
DK - Denmark
Ethypharm 17-21, rue St. Mathieu (Z.I.) F- 78550 Houdan 194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex France
Morphinsulfat "Ethypharm" 60 mg Prolonged-release capsule, hard Oral use
DK - Denmark
Ethypharm 17-21, rue St. Mathieu (Z.I.) F- 78550 Houdan 194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex France
Morphinsulfat "Ethypharm" 120 mg Prolonged-release capsule, hard Oral use
DK - Denmark
Ethypharm 17-21, rue St. Mathieu (Z.I.) F- 78550 Houdan 194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex France
Morphinsulfat "Ethypharm" 200 mg Prolonged-release capsule, hard Oral use
DK - Denmark
Ethypharm 17-21, rue St. Mathieu (Z.I.) F- 78550 Houdan 194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex France
Zomorph 20 mg Prolonged-release capsule, hard Oral use
DK - Denmark
Ethypharm 17-21, rue St. Mathieu (Z.I.) F- 78550 Houdan 194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex France
Zomorph 40 mg Prolonged-release capsule, hard Oral use
DK - Denmark
Ethypharm 17-21, rue St. Mathieu (Z.I.) F- 78550 Houdan 194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex France
Zomorph 60 mg Prolonged-release capsule, hard Oral use
46
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
DK - Denmark
Ethypharm 17-21, rue St. Mathieu (Z.I.) F- 78550 Houdan 194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex France
Zomorph 120 mg Prolonged-release capsule, hard Oral use
DK - Denmark
Ethypharm 17-21, rue St. Mathieu (Z.I.) F- 78550 Houdan 194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex France
Zomorph 200 mg Prolonged-release capsule, hard Oral use
DK - Denmark
HEXAL A/S Kanalholmen 8-12 DK 2650 Hvidovre Denmark
Oxycodonhydrochlorid "Hexal" 5 mg Prolonged-release tablet Oral use
DK - Denmark
HEXAL A/S Kanalholmen 8-12 DK 2650 Hvidovre Denmark
Oxycodonhydrochlorid "Hexal" 10 mg Prolonged-release tablet Oral use
DK - Denmark
HEXAL A/S Kanalholmen 8-12 DK 2650 Hvidovre Denmark
Oxycodonhydrochlorid "Hexal" 20 mg Prolonged-release tablet Oral use
DK - Denmark
HEXAL A/S Kanalholmen 8-12 DK 2650 Hvidovre Denmark
Oxycodonhydrochlorid "Hexal" 40 mg Prolonged-release tablet Oral use
DK - Denmark
HEXAL A/S Kanalholmen 8-12 DK 2650 Hvidovre Denmark
Oxycodonhydrochlorid "Hexal" 80 mg Prolonged-release tablet Oral use
DK - Denmark
Janssen-Cilag A/S (TIBOTEC) Hammerbakken 19 DK-3460 Birkerød Denmark
Jurnista 4 mg Prolonged release tablet Oral use
DK - Denmark
Janssen-Cilag A/S (TIBOTEC) Hammerbakken 19 DK-3460 Birkerød Denmark
Jurnista 8 mg Prolonged release tablet Oral use
47
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
DK - Denmark
Janssen-Cilag A/S (TIBOTEC) Hammerbakken 19 DK-3460 Birkerød Denmark
Jurnista 16 mg Prolonged release tablet Oral use
DK - Denmark
Janssen-Cilag A/S (TIBOTEC) Hammerbakken 19 DK-3460 Birkerød Denmark
Jurnista 32 mg Prolonged release tablet Oral use
DK - Denmark
Janssen-Cilag A/S (TIBOTEC) Hammerbakken 19 DK-3460 Birkerød Denmark
Jurnista 64 mg Prolonged release tablet Oral use
DK - Denmark
Janssen-Cilag A/S (TIBOTEC) Hammerbakken 19 DK-3460 Birkerød Denmark
Fidestor 4 mg Prolonged release tablet Oral use
DK - Denmark
Janssen-Cilag A/S (TIBOTEC) Hammerbakken 19 DK-3460 Birkerød Denmark
Fidestor 8 mg Prolonged release tablet Oral use
DK - Denmark
Janssen-Cilag A/S (TIBOTEC) Hammerbakken 19 DK-3460 Birkerød Denmark
Fidestor 16 mg Prolonged release tablet Oral use
DK - Denmark
Janssen-Cilag A/S (TIBOTEC) Hammerbakken 19 DK-3460 Birkerød Denmark
Fidestor 32 mg Prolonged release tablet Oral use
DK - Denmark
Janssen-Cilag A/S (TIBOTEC) Hammerbakken 19 DK-3460 Birkerød Denmark
Fidestor 64 mg Prolonged release tablet Oral use
DK - Denmark
Janssen-Cilag A/S (TIBOTEC) Hammerbakken 19 DK-3460 Birkerød Denmark
Spanzar 4 mg Prolonged release tablet Oral use
DK - Denmark
Janssen-Cilag A/S (TIBOTEC) Hammerbakken 19 DK-3460 Birkerød Denmark
Spanzar 8 mg Prolonged release tablet Oral use
48
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
DK - Denmark
Janssen-Cilag A/S (TIBOTEC) Hammerbakken 19 DK-3460 Birkerød Denmark
Spanzar 16 mg Prolonged release tablet Oral use
DK - Denmark
Janssen-Cilag A/S (TIBOTEC) Hammerbakken 19 DK-3460 Birkerød Denmark
Spanzar 32 mg Prolonged release tablet Oral use
DK - Denmark
Janssen-Cilag A/S (TIBOTEC) Hammerbakken 19 DK-3460 Birkerød Denmark
Spanzar 64 mg Prolonged release tablet Oral use
DK - Denmark
Lannacher Heilmittel Ges.m.b.H. Schlossplatz 1 A-8502 Lannach Austria
Depolan 10 mg Prolonged release tablet Oral use
DK - Denmark
Lannacher Heilmittel Ges.m.b.H. Schlossplatz 1 A-8502 Lannach Austria
Depolan 30 mg Prolonged release tablet Oral use
DK - Denmark
Lannacher Heilmittel Ges.m.b.H. Schlossplatz 1 A-8502 Lannach Austria
Depolan 60 mg Prolonged release tablet Oral use
DK - Denmark
Lannacher Heilmittel Ges.m.b.H. Schlossplatz 1 A-8502 Lannach Austria
Depolan 100 mg Prolonged release tablet Oral use
DK - Denmark
Lannacher Heilmittel Ges.m.b.H. Schlossplatz 1 A-8502 Lannach Austria
Depolan 200 mg Prolonged release tablet Oral use
DK - Denmark
Norpharma A/S Slotsmarken 15 DK-2970 Hørsholm Denmark
OxyContin 80 mg Prolonged-release tablet Oral use
DK - Denmark
Norpharma A/S Slotsmarken 15 DK-2970 Hørsholm Denmark
OxyContin 15 mg Prolonged-release tablet Oral use
49
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
DK – Denmark
Norpharma A/S Slotsmarken 15 DK-2970 Hørsholm Denmark
OxyContin 60 mg Prolonged-release tablet Oral use
DK - Denmark
Norpharma A/S Slotsmarken 15 DK-2970 Hørsholm Denmark
OxyContin 120 mg Prolonged-release tablet Oral use
DK - Denmark
Norpharma A/S Slotsmarken 15 DK-2970 Hørsholm Denmark
OxyContin 5 mg Prolonged-release tablet Oral use
DK - Denmark
Norpharma A/S Slotsmarken 15 DK-2970 Hørsholm Denmark
OxyContin 10 mg Prolonged-release tablet Oral use
DK - Denmark
Norpharma A/S Slotsmarken 15 DK-2970 Hørsholm Denmark
OxyContin 20 mg Prolonged-release tablet Oral use
DK - Denmark
Norpharma A/S Slotsmarken 15 DK-2970 Hørsholm Denmark
OxyContin 40 mg Prolonged-release tablet Oral use
DK - Denmark
Norpharma A/S Slotsmarken 15 DK-2970 Hørsholm Denmark
OxyContin 80 mg Prolonged-release tablet Oral use
DK - Denmark
Norpharma A/S Slotsmarken 15 DK-2970 Hørsholm Denmark
OxyContin 160 mg Prolonged-release tablet Oral use
DK - Denmark
Norpharma A/S Slotsmarken 15 DK-2970 Hørsholm Denmark
Palladon 4 mg Prolonges release capsule, hard Oral use
DK - Denmark
Norpharma A/S Slotsmarken 15 DK-2970 Hørsholm Denmark
Palladon 8 mg Prolonges release capsule, hard Oral use
50
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
DK - Denmark
Norpharma A/S Slotsmarken 15 DK-2970 Hørsholm Denmark
Palladon 16 mg Prolonges release capsule, hard Oral use
DK - Denmark
Norpharma A/S Slotsmarken 15 DK-2970 Hørsholm Denmark
Palladon 24 mg Prolonges release capsule, hard Oral use
DK - Denmark
Norpharma A/S Slotsmarken 15 DK-2970 Hørsholm Denmark
Targin 5 + 2,5 mg Prolonged-release tablet Oral use
DK - Denmark
Norpharma A/S Slotsmarken 15 DK-2970 Hørsholm Denmark
Targin 10 + 5 mg Prolonged-release tablet Oral use
DK - Denmark
Norpharma A/S Slotsmarken 15 DK-2970 Hørsholm Denmark
Targin 20 + 10 mg Prolonged-release tablet Oral use
DK - Denmark
Norpharma A/S Slotsmarken 15 DK-2970 Hørsholm Denmark
Targin 40 + 20 mg Prolonged-release tablet Oral use
DK - Denmark
Nycomed Danmark ApS Langebjerg 1 DK-4000 Roskilde Denmark
Doltard 10 mg Prolonged-release tablet Oral use
DK - Denmark
Nycomed Danmark ApS Langebjerg 1 DK-4000 Roskilde Denmark
Doltard 30 mg Prolonged-release tablet Oral use
DK - Denmark
Nycomed Danmark ApS Langebjerg 1 DK-4000 Roskilde Denmark
Doltard 60 mg Prolonged-release tablet Oral use
DK - Denmark
Nycomed Danmark ApS Langebjerg 1 DK-4000 Roskilde Denmark
Doltard 100 mg Prolonged-release tablet Oral use
51
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
DK - Denmark
Pfizer ApS Lautrupvang 8 DK-2750 Ballerup Denmark
Contalgin 5 mg Prolonged-release tablet Oral use
DK - Denmark
Pfizer ApS Lautrupvang 8 DK-2750 Ballerup Denmark
Contalgin 10 mg Prolonged-release tablet Oral use
DK - Denmark
Pfizer ApS Lautrupvang 8 DK-2750 Ballerup Denmark
Contalgin 30 mg Prolonged-release tablet Oral use
DK - Denmark
Pfizer ApS Lautrupvang 8 DK-2750 Ballerup Denmark
Contalgin 60 mg Prolonged-release tablet Oral use
DK - Denmark
Pfizer ApS Lautrupvang 8 DK-2750 Ballerup Denmark
Contalgin 100 mg Prolonged-release tablet Oral use
DK - Denmark
Pfizer ApS Lautrupvang 8 DK-2750 Ballerup Denmark
Contalgin 200 mg Prolonged-release tablet Oral use
DK - Denmark
Pfizer ApS Lautrupvang 8 DK-2750 Ballerup Denmark
Contalgin 20 mg Prolonged-release granules, for oral suspension
Oral use
DK - Denmark
Pfizer ApS Lautrupvang 8 DK-2750 Ballerup Denmark
Contalgin 30 mg Prolonged-release granules, for oral suspension
Oral use
DK - Denmark
Pfizer ApS Lautrupvang 8 DK-2750 Ballerup Denmark
Contalgin 60 mg Prolonged-release granules, for oral suspension
Oral use
DK - Denmark
Pfizer ApS Lautrupvang 8 DK-2750 Ballerup Denmark
Contalgin 100 mg Prolonged-release granules, for oral suspension
Oral use
52
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
DK - Denmark
Pfizer ApS Lautrupvang 8 DK-2750 Ballerup Denmark
Contalgin 200 mg Prolonged-release granules, for oral suspension
Oral use
DK - Denmark
Pfizer ApS Lautrupvang 8 DK-2750 Ballerup Denmark
Contalgin Uno 30 mg Prolonged-release capsule Oral use
DK - Denmark
Pfizer ApS Lautrupvang 8 DK-2750 Ballerup Denmark
Contalgin Uno 60 mg Prolonged-release capsule Oral use
DK - Denmark
Pfizer ApS Lautrupvang 8 DK-2750 Ballerup Denmark
Contalgin Uno 90 mg Prolonged-release capsule Oral use
DK - Denmark
Pfizer ApS Lautrupvang 8 DK-2750 Ballerup Denmark
Contalgin Uno 120 mg Prolonged-release capsule Oral use
DK - Denmark
Pfizer ApS Lautrupvang 8 DK-2750 Ballerup Denmark
Contalgin Uno 150 mg Prolonged-release capsule Oral use
DK - Denmark
Pfizer ApS Lautrupvang 8 DK-2750 Ballerup Denmark
Contalgin Uno 200 mg Prolonged-release capsule Oral use
DK - Denmark
Ratiopharm GmbH Graf-Arco-Strasse 3 DE-89079 Ulm Germany
Oxycodonhydrochlorid "ratiopharm"
5 mg Prolonged-release tablet Oral use
DK - Denmark
Ratiopharm GmbH Graf-Arco-Strasse 3 DE-89079 Ulm Germany
Oxycodonhydrochlorid "ratiopharm"
10 mg Prolonged-release tablet Oral use
DK - Denmark
Ratiopharm GmbH Graf-Arco-Strasse 3 DE-89079 Ulm Germany
Oxycodonhydrochlorid "ratiopharm"
20 mg Prolonged-release tablet Oral use
53
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
DK - Denmark
Ratiopharm GmbH Graf-Arco-Strasse 3 DE-89079 Ulm Germany
Oxycodonhydrochlorid "ratiopharm"
40 mg Prolonged-release tablet Oral use
DK - Denmark
Ratiopharm GmbH Graf-Arco-Strasse 3 DE-89079 Ulm Germany
Oxycodonhydrochlorid "ratiopharm"
80 mg Prolonged-release tablet Oral use
DK - Denmark
Sandoz A/S Edvard Thomsens Vej 14 DK-2300 København S Denmark
Oxicos 5 mg Prolonged-release tablet Oral use
DK - Denmark
Sandoz A/S Edvard Thomsens Vej 14 DK-2300 København S Denmark
Oxicos 10 mg Prolonged-release tablet Oral use
DK - Denmark
Sandoz A/S Edvard Thomsens Vej 14 DK-2300 København S Denmark
Oxicos 20 mg Prolonged-release tablet Oral use
DK - Denmark
Sandoz A/S Edvard Thomsens Vej 14 DK-2300 København S Denmark
Oxycodonhydrochlorid "1A Farma"
5 mg Prolonged-release tablet Oral use
DK - Denmark
Sandoz A/S Edvard Thomsens Vej 14 DK-2300 København S Denmark
Oxycodonhydrochlorid "1A Farma"
10 mg Prolonged-release tablet Oral use
DK - Denmark
Sandoz A/S Edvard Thomsens Vej 14 DK-2300 København S Denmark
Oxycodonhydrochlorid "1A Farma"
20 mg Prolonged-release tablet Oral use
DK - Denmark
Teva Denmark A/S Parallelvej 10 DK-2800 Kongens Lyngby Denmark
Malfin 10 mg Prolonged-release tablet Oral use
DK - Denmark
Teva Denmark A/S Parallelvej 10 DK-2800 Kongens Lyngby Denmark
Malfin 30 mg Prolonged-release tablet Oral use
54
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
DK - Denmark
Teva Denmark A/S Parallelvej 10 DK-2800 Kongens Lyngby Denmark
Malfin 60 mg Prolonged-release tablet Oral use
DK - Denmark
Teva Denmark A/S Parallelvej 10 DK-2800 Kongens Lyngby Denmark
Malfin 100 mg Prolonged-release tablet Oral use
DK - Denmark
Teva Denmark A/S Parallelvej 10 DK-2800 Kongens Lyngby Denmark
Malfin 200 mg Prolonged-release tablet Oral use
EL-Greece
LAVIPHARM HELLAS AE Agias Marinas Str. Paiania Attikis 19002 Greece
MORFICONTIN 10 mg Prolonged release tablet Oral use
EL-Greece
LAVIPHARM HELLAS AE Agias Marinas Str. Paiania Attikis 19002 Greece
MORFICONTIN 30 mg Prolonged release tablet Oral use
EL-Greece
LAVIPHARM HELLAS AE Agias Marinas Str. Paiania Attikis 19002 Greece
MORFICONTIN 60 mg Prolonged release tablet Oral use
EL-Greece
LAVIPHARM HELLAS AE Agias Marinas Str. Paiania Attikis 19002 Greece
MORFICONTIN 100 mg Prolonged release tablet Oral use
EL-Greece
LAVIPHARM HELLAS AE Agias Marinas Str. Paiania Attikis 19002 Greece
MORFICONTIN 30 mg Prolonged release tablet Oral use
EL-Greece
LAVIPHARM HELLAS AE Agias Marinas Str. Paiania Attikis 19002 Greece
MORFICONTIN 60 mg Prolonged release tablet Oral use
EL-Greece
LAVIPHARM HELLAS AE Agias Marinas Str. Paiania Attikis 19002 Greece
MORFICONTIN 100 mg Prolonged release tablet Oral use
55
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
EL-Greece
LAVIPHARM HELLAS AE Agias Marinas Str. Paiania Attikis 19002 Greece
MORFICONTIN 5 mg Modified release tablet Oral use
EL-Greece
LAVIPHARM HELLAS AE Agias Marinas Str. Paiania Attikis 19002 Greece
MORFICONTIN 15 mg Modified release tablet Oral use
EL-Greece
MUNDIPHARMA GMBH GERMANY Mundipharma Strasse 2 POSTFACH 1350 D-620 Limbirg D-6270 Germany
OXYCONTIN 10 mg Prolonged-release tablet Oral use
EL-Greece
MUNDIPHARMA GMBH GERMANY Mundipharma Strasse 2 POSTFACH 1350 D-620 Limbirg D-6270 Germany
OXYCONTIN 20 mg Prolonged-release tablet Oral use
EL-Greece
MUNDIPHARMA GMBH GERMANY Mundipharma Strasse 2 POSTFACH 1350 D-620 Limbirg D-6270 Germany
OXYCONTIN 40 mg Prolonged-release tablet Oral use
EL-Greece
MUNDIPHARMA GMBH GERMANY Mundipharma Strasse 2 POSTFACH 1350 D-620 Limbirg D-6270 Germany
OXYCONTIN 80 mg Prolonged-release tablet Oral use
EL-Greece
P.N.G. GEROLYMATOS ΑΕΒΕ 13 Asklipiou Str. 145 68, Kryoneri Athens Greece
MONGOL 10 mg Modified-release capsule Oral use
EL-Greece
P.N.G. GEROLYMATOS ΑΕΒΕ 13 Asklipiou Str. 145 68, Kryoneri Athens Greece
MONGOL 30 mg Modified-release capsule Oral use
EL-Greece
P.N.G. GEROLYMATOS ΑΕΒΕ 13 Asklipiou Str. 145 68, Kryoneri Athens Greece
MONGOL 60 mg Modified-release capsule Oral use
56
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
EL-Greece
P.N.G. GEROLYMATOS ΑΕΒΕ 13 Asklipiou Str. 145 68, Kryoneri Athens Greece
MONGOL 100 mg Modified-release capsule Oral use
EL-Greece
P.N.G. GEROLYMATOS ΑΕΒΕ 13 Asklipiou Str. 145 68, Kryoneri Athens Greece
MONGOL 200 mg Prolonged-release capsule Oral use
ES - Spain
ARCHIMEDES PHARMA IBERICA S.L. C/ Jorge Juan 139 Madrid Spain
ZOMORPH10 MG Cápsulas 10mg Prolonged-release capsule Oral use
ES - Spain
ARCHIMEDES PHARMA IBERICA S.L. C/ Jorge Juan 139 Madrid Spain
ZOMORPH100 mg Cápsulas 100mg Prolonged-release capsule Oral use
ES - Spain
ARCHIMEDES PHARMA IBERICA S.L. C/ Jorge Juan 139 Madrid Spain
ZOMORPH30 mg Cápsulas 30mg Prolonged-release capsule Oral use
ES - Spain
ARCHIMEDES PHARMA IBERICA S.L. C/ Jorge Juan 139 Madrid Spain
ZOMORPH60 mg Cápsulas 60mg Prolonged-release capsule Oral use
ES - Spain
JANSSEN-CILAG S.A.Pº de Las Doce Estrellas, 5 – 7 28042 MADRID Spain
JURNISTA 64mg Prolonged-release tablet Oral use
ES - Spain
JANSSEN-CILAG S.A.Pº de Las Doce Estrellas, 5 – 7 28042 MADRID Spain
JURNISTA 32mg Prolonged-release tablet Oral use
ES - Spain
JANSSEN-CILAG S.A.Pº de Las Doce Estrellas, 5 – 7 28042 MADRID Spain
JURNISTA 16mg Prolonged-release tablet Oral use
ES - Spain
JANSSEN-CILAG S.A.Pº de Las Doce Estrellas, 5 – 7 28042 MADRID Spain
JURNISTA 8mg Prolonged-release tablet Oral use
57
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
ES - Spain
JANSSEN-CILAG S.A.Pº de Las Doce Estrellas, 5 – 7 28042 MADRID Spain
JURNISTA 4mg Prolonged-release tablet Oral use
ES - Spain
LANNACHER HEILMITTEL GES.M.G.H.Schlobplatz, 1 Lannach A-9502 Austria
MORFINA LANNACHER 10 MG 10 mg coated tablet Oral use
ES - Spain
LANNACHER HEILMITTEL GES.M.G.H.Schlobplatz, 1 Lannach A-9502 Austria
MORFINA LANNACHER 100 MG 100mg coated tablet Oral use
ES - Spain
LANNACHER HEILMITTEL GES.M.G.H.Schlobplatz, 1 Lannach A-9502 Austria
MORFINA LANNACHER 200 MG Comprimidos
200 mg coated tablet Oral use
ES - Spain
LANNACHER HEILMITTEL GES.M.G.H.Schlobplatz, 1 Lannach A-9502 Austria
MORFINA LANNACHER 30 MG 30 mg coated tablet Oral use
ES - Spain
LANNACHER HEILMITTEL GES.M.G.H.Schlobplatz, 1 Lannach A-9502 Austria
MORFINA LANNACHER 60 MG 60 mg coated tablet Oral use
ES - Spain
MUNDIPHARMA PHARMACEUTICALS S.L.Edificio Alvento (Torre D) Vía de los Poblados, 1 28033 Madrid Spain
MST 10 CONTINUS 10mg Prolonged-release tablet Oral use
ES - Spain
MUNDIPHARMA PHARMACEUTICALS S.L.Edificio Alvento (Torre D) Vía de los Poblados, 1 28033 Madrid Spain
MST 100 CONTINUS 100mg Prolonged-release tablet Oral use
ES - Spain
MUNDIPHARMA PHARMACEUTICALS S.L.Edificio Alvento (Torre D) Vía de los Poblados, 1 28033 Madrid Spain
MST 15 CONTINUS 15 mg Prolonged-release tablet Oral use
58
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
ES - Spain
MUNDIPHARMA PHARMACEUTICALS S.L.Edificio Alvento (Torre D) Vía de los Poblados, 1 28033 Madrid Spain
MST 200 CONTINUS 200 mg Prolonged-release tablet Oral use
ES - Spain
MUNDIPHARMA PHARMACEUTICALS S.L.Edificio Alvento (Torre D) Vía de los Poblados, 1 28033 Madrid Spain
MST 30 CONTINUS 30mg Prolonged-release tablet Oral use
ES - Spain
MUNDIPHARMA PHARMACEUTICALS S.L.Edificio Alvento (Torre D) Vía de los Poblados, 1 28033 Madrid Spain
MST 5 CONTINUS 5 mg Prolonged-release tablet Oral use
ES - Spain
MUNDIPHARMA PHARMACEUTICALS S.L.Edificio Alvento (Torre D) Vía de los Poblados, 1 28033 Madrid Spain
MST 60 CONTINUS 60mg Prolonged-release tablet Oral use
ES - Spain
MUNDIPHARMA PHARMACEUTICALS S.L.Edificio Alvento (Torre D) Vía de los Poblados, 1 28033 MADRID Spain
OXYCONTIN 10 mg comprimidos de liberación modificada
10mg Prolonged-release tablet Oral use
ES - Spain
MUNDIPHARMA PHARMACEUTICALS S.L.Edificio Alvento (Torre D) Vía de los Poblados, 1 28033 MADRID Spain
OXYCONTIN 20 mg comprimidos de liberación modificada
20mg Prolonged-release tablet Oral use
ES - Spain
MUNDIPHARMA PHARMACEUTICALS S.L.Edificio Alvento (Torre D) Vía de los Poblados, 1 28033 MADRID Spain
OXYCONTIN 40 mg comprimidos de liberación modificada
40mg Prolonged-release tablet Oral use
ES - Spain
MUNDIPHARMA PHARMACEUTICALS S.L.Edificio Alvento (Torre D) Vía de los Poblados, 1 28033 MADRID Spain
OXYCONTIN 5 mg comprimidos de liberación prolongada
5mg Prolonged-release tablet Oral use
59
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
ES - Spain
MUNDIPHARMA PHARMACEUTICALS S.L.Edificio Alvento (Torre D) Vía de los Poblados, 1 28033 MADRID Spain
OXYCONTIN 80 mg comprimidos de liberacion modificada
80mg Prolonged-release tablet Oral use
ES - Spain
MUNDIPHARMA PHARMACEUTICALS S.L.Edificio Alvento (Torre D) Vía de los Poblados, 1 28033 MADRID Spain
PALLADONE CONTINUS 4mg Prolonged-release capsule Oral use
ES - Spain
MUNDIPHARMA PHARMACEUTICALS S.L.Edificio Alvento (Torre D) Vía de los Poblados, 1 28033 MADRID Spain
PALLADONE CONTINUS 8mg Prolonged-release capsule Oral use
ES - Spain
MUNDIPHARMA PHARMACEUTICALS S.L.Edificio Alvento (Torre D) Vía de los Poblados, 1 28033 MADRID Spain
PALLADONE CONTINUS 16mg Prolonged-release capsule Oral use
ES - Spain
MUNDIPHARMA PHARMACEUTICALS S.L.Edificio Alvento (Torre D) Vía de los Poblados, 1 28033 MADRID Spain
PALLADONE CONTINUS 24mg Prolonged-release capsule Oral use
ET - Estonia
Johnson & Johnson UAB Gelezinio Vilko g. 18A LT-08104 Vilnius Lithuania
JURNISTA 4mg Prolonged-release tablet Oral use
ET - Estonia
Johnson & Johnson UAB Gelezinio Vilko g. 18A LT-08104 Vilnius Lithuania
JURNISTA 8mg Prolonged-release tablet Oral use
ET - Estonia
Johnson & Johnson UAB Gelezinio Vilko g. 18A LT-08104 Vilnius Lithuania
JURNISTA 16mg Prolonged-release tablet Oral use
ET - Estonia
Johnson & Johnson UAB Gelezinio Vilko g. 18A LT-08104 Vilnius Lithuania
JURNISTA 32mg Prolonged-release tablet Oral use
60
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
ET - Estonia
Johnson & Johnson UAB Gelezinio Vilko g. 18A LT-08104 Vilnius Lithuania
JURNISTA 64mg Prolonged-release tablet Oral use
ET - Estonia
LANNACHER HEILMITTEL GmbH Schlossplatz 1 A-8502 Lannach Austria
VENDAL RETARD 10 MG 10mg Prolonged-release tablet Oral use
ET - Estonia
LANNACHER HEILMITTEL GmbH Schlossplatz 1 A-8502 Lannach Austria
VENDAL RETARD 100 MG 100mg Prolonged-release tablet Oral use
ET - Estonia
LANNACHER HEILMITTEL GmbH Schlossplatz 1 A-8502 Lannach Austria
VENDAL RETARD 200 MG 200mg Prolonged-release tablet Oral use
ET - Estonia
LANNACHER HEILMITTEL GmbH Schlossplatz 1 A-8502 Lannach Austria
VENDAL RETARD 30 MG 30mg Prolonged-release tablet Oral use
ET - Estonia
LANNACHER HEILMITTEL GmbH Schlossplatz 1 A-8502 Lannach Austria
VENDAL RETARD 60 MG 60mg Prolonged-release tablet Oral use
ET - Estonia
MUNDIPHARMA Ges.m.b.H. Apollogasse 16-18 A-1072 Wien Austria
MST CONTINUS 30 MG 30mg Prolonged-release granules for oral suspension
Oral use
ET - Estonia
MUNDIPHARMA Ges.m.b.H. Apollogasse 16-18 A-1072 Wien Austria
MXL 120 MG 120mg Prolonged-release capsule, hard Oral use
ET - Estonia
MUNDIPHARMA Ges.m.b.H. Apollogasse 16-18 A-1072 Wien Austria
MXL 30 MG 30mg Prolonged-release capsule, hard Oral use
ET - Estonia
MUNDIPHARMA Ges.m.b.H. Apollogasse 16-18 A-1072 Wien Austria
OXYCONTIN 10 MG 10mg Prolonged-release tablet Oral use
61
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
ET - Estonia
MUNDIPHARMA Ges.m.b.H. Apollogasse 16-18 A-1072 Wien Austria
OXYCONTIN 20 MG 20mg Prolonged-release tablet Oral use
ET - Estonia
MUNDIPHARMA Ges.m.b.H. Apollogasse 16-18 A-1072 Wien Austria
OXYCONTIN 40 MG 40mg Prolonged-release tablet Oral use
ET - Estonia
MUNDIPHARMA Ges.m.b.H. Apollogasse 16-18 A-1072 Wien Austria
OXYCONTIN 80 MG 80mg Prolonged-release tablet Oral use
ET - Estonia
Nycomed Sefa AS Jaama 55B 63308 Põlva Estonia
DOLTARD 30mg Prolonged-release tablet Oral use
ET - Estonia
Nycomed Sefa AS Jaama 55B 63308 Põlva Estonia
DOLTARD 60mg Prolonged-release tablet Oral use
FI - Finland
Hexal A/S Kanalholmen 8-12 2650 HVIDOVRE Denmark
Oxycodone Hexal 20 mg Prolonged-release tablet Oral use
FI - Finland
Hexal A/S Kanalholmen 8-12 2650 HVIDOVRE Denmark
Oxycodone Hexal 40 mg Prolonged-release tablet Oral use
FI - Finland
Hexal A/S Kanalholmen 8-12 2650 HVIDOVRE Denmark
Oxycodone Hexal 80 mg Prolonged-release tablet Oral use
FI - Finland
Lannacher Heilmittel Ges.m.b.H. Schlossplatz 1 8502 Lannach Austria
Depolan 10 mg Prolonged-release tablet Oral use
FI - Finland
Lannacher Heilmittel Ges.m.b.H. Schlossplatz 1 8502 Lannach Austria
Depolan 30 mg Prolonged-release tablet Oral use
62
Member State (EU/EEA)
100 mg
Marketing Authorisation Holder
Prolonged-release tablet
Invented name
Oral use
Strength Pharmaceutical form
FI - Finland
Route of administration
Lannacher Heilmittel Ges.m.b.H.
FI - Finland
Lannacher Heilmittel Ges.m.b.H. Schlossplatz 1 8502 Lannach Austria
Depolan 60 mg Prolonged-release tablet Oral use
FI - Finland
Lannacher Heilmittel Ges.m.b.H. Schlossplatz 1 8502 Lannach Austria
Depolan
Schlossplatz 1 8502 Lannach Austria
Depolan 200 mg Prolonged-release tablet Oral use
FI - Finland
Mundipharma Oy Rajatorpantie 41 B 01640 Vantaa Finland
Docontin Unotard 30 mg Prolonged-release capsule Oral use
FI - Finland
Mundipharma Oy Rajatorpantie 41 B 01640 Vantaa Finland
Docontin Unotard 60 mg Prolonged-release capsule Oral use
FI - Finland
Mundipharma Oy Rajatorpantie 41 B 01640 Vantaa Finland
Docontin Unotard 90 mg Prolonged-release capsule Oral use
FI - Finland
Mundipharma Oy Rajatorpantie 41 B 01640 Vantaa Finland
Docontin Unotard 120 mg Prolonged-release capsule Oral use
FI - Finland
Mundipharma Oy Rajatorpantie 41 B 01640 Vantaa Finland
Docontin Unotard 150 mg Prolonged-release capsule Oral use
FI - Finland
Mundipharma Oy Rajatorpantie 41 B 01640 Vantaa Finland
Docontin Unotard 200 mg Prolonged-release capsule Oral use
FI - Finland
Mundipharma Oy Rajatorpantie 41 B 01640 Vantaa Finland
Dolcontin 20 mg Modified-release granules for oral suspension
Oral use
63
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
FI - Finland
Mundipharma Oy Rajatorpantie 41 B 01640 Vantaa Finland
Dolcontin 30 mg Modified-release granules for oral suspension
Oral use
FI - Finland
Mundipharma Oy Rajatorpantie 41 B 01640 Vantaa Finland
Dolcontin 60 mg Modified-release granules for oral suspension
Oral use
FI - Finland
Mundipharma Oy Rajatorpantie 41 B 01640 Vantaa Finland
Dolcontin 100 mg Modified-release granules for oral suspension
Oral use
FI - Finland
Mundipharma Oy Rajatorpantie 41 B 01640 Vantaa Finland
Dolcontin 200 mg Modified-release granules for oral suspension
Oral use
FI - Finland
Mundipharma Oy Rajatorpantie 41 B 01640 Vantaa Finland
Dolcontin 10 mg Prolonged-release tablet Oral use
FI - Finland
Mundipharma Oy Rajatorpantie 41 B 01640 Vantaa Finland
Dolcontin 30 mg Prolonged-release tablet Oral use
FI - Finland
Mundipharma Oy Rajatorpantie 41 B 01640 Vantaa Finland
Dolcontin 60 mg Prolonged-release tablet Oral use
FI - Finland
Mundipharma Oy Rajatorpantie 41 B 01640 Vantaa Finland
Dolcontin 100 mg Prolonged-release tablet Oral use
FI - Finland
Mundipharma Oy Rajatorpantie 41 B 01640 Vantaa Finland
Dolcontin 200 mg Prolonged-release tablet Oral use
FI - Finland
Mundipharma Oy Rajatorpantie 41 B 01640 Vantaa Finland
Oxycontin 5 mg Prolonged-release tablet Oral use
64
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
FI - Finland
Mundipharma Oy Rajatorpantie 41 B 01640 Vantaa Finland
Oxycontin 10 mg Prolonged-release tablet Oral use
FI - Finland
Mundipharma Oy Rajatorpantie 41 B 01640 Vantaa Finland
Oxycontin 15 mg Prolonged-release tablet Oral use
FI - Finland
Mundipharma Oy Rajatorpantie 41 B 01640 Vantaa Finland
Oxycontin 20 mg Prolonged-release tablet Oral use
FI - Finland
Mundipharma Oy Rajatorpantie 41 B 01640 Vantaa Finland
Oxycontin 30 mg Prolonged-release tablet Oral use
FI - Finland
Mundipharma Oy Rajatorpantie 41 B 01640 Vantaa Finland
Oxycontin 40 mg Prolonged-release tablet Oral use
FI - Finland
Mundipharma Oy Rajatorpantie 41 B 01640 Vantaa Finland
Oxycontin 60 mg Prolonged-release tablet Oral use
FI - Finland
Mundipharma Oy Rajatorpantie 41 B 01640 Vantaa Finland
Oxycontin 80 mg Prolonged-release tablet Oral use
FI - Finland
Mundipharma Oy Rajatorpantie 41 B 01640 Vantaa Finland
Oxycontin 120 mg Prolonged-release tablet Oral use
FI - Finland
Mundipharma Oy Rajatorpantie 41 B 01640 Vantaa Finland
Oxycontin 160 mg Prolonged-release tablet Oral use
FI - Finland
Mundipharma Oy Rajatorpantie 41 B 01640 Vantaa Finland
Palladon 4 mg Prolonged-release capsule, hard Oral use
65
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
FI - Finland
Mundipharma Oy Rajatorpantie 41 B 01640 Vantaa Finland
Palladon 8 mg Prolonged-release capsule, hard Oral use
FI - Finland
Mundipharma Oy Rajatorpantie 41 B 01640 Vantaa Finland
Palladon 16 mg Prolonged-release capsule, hard Oral use
FI - Finland
Mundipharma Oy Rajatorpantie 41 B 01640 Vantaa Finland
Palladon 24 mg Prolonged-release capsule, hard Oral use
FI - Finland
Mundipharma Oy Rajatorpantie 41 B 01640 Vantaa Finland
Targiniq 10 mg/ 5 mg Prolonged-release tablet Oral use
FI - Finland
Mundipharma Oy Rajatorpantie 41 B 01640 Vantaa Finland
Targiniq 20 mg/ 10 mg Prolonged-release tablet Oral use
FI - Finland
Mundipharma Oy Rajatorpantie 41 B 01640 Vantaa Finland
Targiniq 40 mg/ 20 mg Prolonged-release tablet Oral use
FI - Finland
Mundipharma Oy Rajatorpantie 41 B 01640 Vantaa Finland
Targiniq 5 mg/ 2,5 mg Prolonged-release tablet Oral use
FI - Finland
ratiopharm GmbH Graf-Arco-Strasse 3 89079 ULM Germany
Oxycodone ratiopharm 5 mg Prolonged-release tablet Oral use
FI - Finland
ratiopharm GmbH Graf-Arco-Strasse 3 89079 ULM Germany
Oxycodone ratiopharm 10 mg Prolonged-release tablet Oral use
FI - Finland
ratiopharm GmbH Graf-Arco-Strasse 3 89079 ULM Germany
Oxycodone ratiopharm 20 mg Prolonged-release tablet Oral use
66
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
FI - Finland
ratiopharm GmbH Graf-Arco-Strasse 3 89079 ULM Germany
Oxycodone ratiopharm 40 mg Prolonged-release tablet Oral use
FI - Finland
ratiopharm GmbH Graf-Arco-Strasse 3 89079 ULM Germany
Oxycodone ratiopharm 80 mg Prolonged-release tablet Oral use
FI - Finland
Sandoz A/S C. F. Tietgens Boulevard 40 5220 ODENSE SØ Denmark
Oxycodone Hydrocloride Sandoz
20 mg Prolonged-release tablet Oral use
FR - France
ARCHIMEDES PHARMA FRANCE SARL 12 rue du Sergent Bobillot 92400 Courbevoie France
ZOMORPH L.P. 120 mg, gélule à libération prolongée
120 mg Prolonged-release capsule, hard Oral use
FR - France
ARCHIMEDES PHARMA FRANCE SARL 12 rue du Sergent Bobillot 92400 Courbevoie France
ZOMORPH L.P. 20 mg, gélule à libération prolongée
20 mg Prolonged-release capsule, hard Oral use
FR - France
ARCHIMEDES PHARMA FRANCE SARL 12 rue du Sergent Bobillot 92400 Courbevoie France
ZOMORPH L.P. 200 mg, gélule à libération prolongée
200 mg Prolonged-release capsule, hard Oral use
FR - France
ARCHIMEDES PHARMA FRANCE SARL 12 rue du Sergent Bobillot 92400 Courbevoie France
ZOMORPH L.P. 40 mg, gélule à libération prolongée
40 mg Prolonged-release capsule, hard Oral use
FR - France
ARCHIMEDES PHARMA FRANCE SARL 12 rue du Sergent Bobillot 92400 Courbevoie France
ZOMORPH L.P. 60 mg, gélule à libération prolongée
60 mg Prolonged-release capsule, hard Oral use
FR - France
BRISTOL - MYERS SQUIBB 3, rue Joseph Monier 92500 Rueil-Malmaison France
SKENAN L.P. 10 mg, microgranules à libération prolongée en gélule
10 mg Prolonged-release micropillules in hard capsule
Oral use
FR - France
BRISTOL - MYERS SQUIBB 3, rue Joseph Monier 92500 Rueil-Malmaison France
SKENAN L.P. 100 mg, microgranules à libération prolongée en gélule
100 mg Prolonged-release micropillules in hard capsule
Oral use
67
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
FR - France
BRISTOL - MYERS SQUIBB 3, rue Joseph Monier 92500 Rueil-Malmaison France
SKENAN L.P. 200 mg, microgranules à libération prolongée en gélule
200 mg Prolonged-release micropillules in hard capsule
Oral use
FR - France
BRISTOL - MYERS SQUIBB 3, rue Joseph Monier 92500 Rueil-Malmaison France
SKENAN L.P. 30 mg, microgranules à libération prolongée en gélule
30 mg Prolonged-release micropillules in hard capsule
Oral use
FR - France
BRISTOL - MYERS SQUIBB 3, rue Joseph Monier 92500 Rueil-Malmaison France
SKENAN L.P. 60 mg, microgranules à libération prolongée en gélule
60 mg Prolonged-release micropillules in hard capsule
Oral use
FR - France
ETHYPHARM 194, Bureaux de la Colline -Bâtiment D 92213 Saint-Cloud Cedex France
SULFATE DE MORPHINE ETHYPHARM L.P. 10 mg, gélule à libération prolongée
10 mg Prolonged-release capsule, hard Oral use
FR - France
ETHYPHARM 194, Bureaux de la Colline -Bâtiment D 92213 Saint-Cloud Cedex France
SULFATE DE MORPHINE ETHYPHARM L.P. 100 mg, gélule à libération prolongée
100 mg Prolonged-release capsule, hard Oral use
FR - France
ETHYPHARM 194, Bureaux de la Colline -Bâtiment D 92213 Saint-Cloud Cedex France
SULFATE DE MORPHINE ETHYPHARM L.P. 30 mg, gélule à libération prolongée
30 mg Prolonged-release capsule, hard Oral use
FR - France
ETHYPHARM 194, Bureaux de la Colline -Bâtiment D 92213 Saint-Cloud Cedex France
SULFATE DE MORPHINE ETHYPHARM L.P. 60 mg, gélule à libération prolongée
60 mg Prolonged-release capsule, hard Oral use
FR - France
ETHYPHARM 194, Bureaux de la Colline -Bâtiment D 92213 Saint-Cloud Cedex France
SULFATE DE MORPHINE ETHYPHARM LP 200 mg, gélule à libération prolongée
200 mg Prolonged-release capsule, hard Oral use
FR - France
Laboratoire GLAXOSMITHKLINE 100, route de Versailles 78163 Marly-le-Roi Cedex France
KAPANOL L.P. 100 mg, gélule à libération prolongée
100 mg Prolonged-release capsule, hard Oral use
FR - France
Laboratoire GLAXOSMITHKLINE 100, route de Versailles 78163 Marly-le-Roi Cedex France
KAPANOL L.P. 20 mg, gélule à libération prolongée
20 mg Prolonged-release capsule, hard Oral use
68
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
FR - France
Laboratoire GLAXOSMITHKLINE 100, route de Versailles 78163 Marly-le-Roi Cedex France
KAPANOL L.P. 50 mg, gélule à libération prolongée
50 mg Prolonged-release capsule, hard Oral use
FR - France
Laboratoires STADA ARZNEIMITTEL AG Stada Strasse 2-18 Postfach 1260 61118 Bad Vilbel - Dortelweil Germany
MORPHINE STADA L.P. 10 mg, comprimé pelliculé à libération prolongée
10 mg Prolonged-release film-coated tablet
Oral use
FR - France
Laboratoires STADA ARZNEIMITTEL AG Stada Strasse 2-18 Postfach 1260 61118 Bad Vilbel - Dortelweil Germany
MORPHINE STADA L.P. 100 mg, comprimé pelliculé à libération prolongée
100 mg Prolonged-release film-coated tablet
Oral use
FR - France
Laboratoires STADA ARZNEIMITTEL AG Stada Strasse 2-18 Postfach 1260 61118 Bad Vilbel - Dortelweil Germany
MORPHINE STADA L.P. 200 mg, comprimé pelliculé à libération prolongée
200 mg Prolonged-release film-coated tablet
Oral use
FR - France
Laboratoires STADA ARZNEIMITTEL AG Stada Strasse 2-18 Postfach 1260 61118 Bad Vilbel - Dortelweil Germany
MORPHINE STADA L.P. 30 mg, comprimé pelliculé à libération prolongée
30 mg Prolonged-release film-coated tablet
Oral use
FR - France
Laboratoires STADA ARZNEIMITTEL AG Stada Strasse 2-18 Postfach 1260 61118 Bad Vilbel - Dortelweil Germany
MORPHINE STADA L.P. 60 mg, comprimé pelliculé à libération prolongée
60 mg Prolonged-release film-coated tablet
Oral use
FR - France
MUNDIPHARMA 2, rue du Docteur Lombard 92130 Issy-les-Moulineaux France
MOSCONTIN 10 mg, comprimé enrobé à libération prolongée
10 mg Prolonged-release coated tablet Oral use
FR - France
MUNDIPHARMA 2, rue du Docteur Lombard 92130 Issy-les-Moulineaux France
MOSCONTIN 100 mg, comprimé enrobé à libération prolongée
100 mg Prolonged-release coated tablet Oral use
FR - France
MUNDIPHARMA 2, rue du Docteur Lombard 92130 Issy-les-Moulineaux France
MOSCONTIN 15 mg, comprimé pelliculé à libération prolongée
15 mg Prolonged-release film-coated tablet
Oral use
69
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
FR - France
MUNDIPHARMA 2, rue du Docteur Lombard 92130 Issy-les-Moulineaux France
MOSCONTIN 30 mg, comprimé enrobé à libération prolongée
30 mg Prolonged-release coated tablet Oral use
FR - France
MUNDIPHARMA 2, rue du Docteur Lombard 92130 Issy-les-Moulineaux France
MOSCONTIN 5 mg, comprimé pelliculé à liberation prolongée
5 mg Prolonged-release film-coated tablet
Oral use
FR - France
MUNDIPHARMA 2, rue du Docteur Lombard 92130 Issy-les-Moulineaux France
MOSCONTIN 60 mg, comprimé enrobé à libération prolongée
60 mg Prolonged-release coated tablet Oral use
FR - France
MUNDIPHARMA 2, rue du Docteur Lombard 92130 Issy-les-Moulineaux France
MOSCONTIN L.P. 200 mg, comprimé pelliculé à libération prolongée
200 mg Prolonged-release film-coated tablet
Oral use
FR - France
MUNDIPHARMA 2, rue du Docteur Lombard 92130 Issy-les-Moulineaux France
OXYCONTIN L.P. 5 mg, comprimé pelliculé à libération prolongée
5 mg Prolonged-release film-coated tablet
Oral use
FR - France
MUNDIPHARMA 2, rue du Docteur Lombard 92130 Issy-les-Moulineaux France
OXYCONTIN LP 10 mg, comprimé pelliculé à libération prolongée
10 mg Prolonged-release film-coated tablet
Oral use
FR - France
MUNDIPHARMA 2, rue du Docteur Lombard 92130 Issy-les-Moulineaux France
OXYCONTIN LP 120 mg, comprimé pelliculé à libération prolongée
120 mg Prolonged-release film-coated tablet
Oral use
FR - France
MUNDIPHARMA 2, rue du Docteur Lombard 92130 Issy-les-Moulineaux France
OXYCONTIN LP 15 mg, comprimé pelliculé à libération prolongée
5 mg Prolonged-release film-coated tablet
Oral use
FR - France
MUNDIPHARMA 2, rue du Docteur Lombard 92130 Issy-les-Moulineaux France
OXYCONTIN LP 160 mg, comprimé pelliculé à libération prolongée
160 mg Prolonged-release film-coated tablet
Oral use
FR - France
MUNDIPHARMA 2, rue du Docteur Lombard 92130 Issy-les-Moulineaux France
OXYCONTIN LP 20 mg, comprimé pelliculé à libération prolongée
20 mg Prolonged-release film-coated tablet
Oral use
70
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
FR - France
MUNDIPHARMA 2, rue du Docteur Lombard 92130 Issy-les-Moulineaux France
OXYCONTIN LP 30 mg, comprimé pelliculé à libération prolongée
30 mg Prolonged-release film-coated tablet
Oral use
FR - France
MUNDIPHARMA 2, rue du Docteur Lombard 92130 Issy-les-Moulineaux France
OXYCONTIN LP 40 mg, comprimé pelliculé à libération prolongée
40 mg Prolonged-release film-coated tablet
Oral use
FR - France
MUNDIPHARMA 2, rue du Docteur Lombard 92130 Issy-les-Moulineaux France
OXYCONTIN LP 60 mg, comprimé pelliculé à libération prolongée
60 mg Prolonged-release film-coated tablet
Oral use
FR - France
MUNDIPHARMA 2, rue du Docteur Lombard 92130 Issy-les-Moulineaux France
OXYCONTIN LP 80 mg, comprimé pelliculé à libération prolongée
80 mg Prolonged-release film-coated tablet
Oral use
FR - France
MUNDIPHARMA 2, rue du Docteur Lombard 92130 Issy-les-Moulineaux France
SOPHIDONE L.P. 16 mg, gélule à libération prolongée
16 mg Prolonged-release capsule, hard Oral use
FR - France
MUNDIPHARMA 2, rue du Docteur Lombard 92130 Issy-les-Moulineaux France
SOPHIDONE L.P. 24 mg, gélule à libération prolongée
24 mg Prolonged-release capsule, hard Oral use
FR - France
MUNDIPHARMA 2, rue du Docteur Lombard 92130 Issy-les-Moulineaux France
SOPHIDONE L.P. 4 mg, gélule à libération prolongée
4 mg Prolonged-release capsule, hard Oral use
FR - France
MUNDIPHARMA 2, rue du Docteur Lombard 92130 Issy-les-Moulineaux France
SOPHIDONE L.P. 8 mg, gélule à libération prolongée
8 mg Prolonged-release capsule, hard Oral use
FR - France
MUNDIPHARMA 2, rue du Docteur Lombard 92130 Issy-les-Moulineaux France
TARGINACT 10 mg/5 mg, comprimé à libération prolongée
10 mg/5 mg prolonged-release tablet Oral use
FR - France
MUNDIPHARMA 2, rue du Docteur Lombard 92130 Issy-les-Moulineaux France
TARGINACT 20 mg/10 mg, comprimé à libération prolongée
20 mg/10 mg prolonged-release tablet Oral use
71
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
FR - France
MUNDIPHARMA 2, rue du Docteur Lombard 92130 Issy-les-Moulineaux France
TARGINACT 40 mg/20 mg, comprimé à libération prolongée
40 mg/20 mg prolonged-release tablet Oral use
FR - France
MUNDIPHARMA 2, rue du Docteur Lombard 92130 Issy-les-Moulineaux France
TARGINACT 5 mg/2,5 mg, comprimé à libération prolongée
5 mg/2,5 mg prolonged-release tablet Oral use
FR - France
NAPP Laboratories Limited Cambridge Science Park Milton Road CB4 4GW Cambridge United Kingdom
PALLADONE L.P. 16 mg, gélule à libération prolongée
16 mg Prolonged-release capsule, hard Oral use
FR - France
NAPP Laboratories Limited Cambridge Science Park Milton Road CB4 4GW Cambridge United Kingdom
PALLADONE L.P. 24 mg, gélule à libération prolongée
24 mg Prolonged-release capsule, hard Oral use
FR - France
NAPP Laboratories Limited Cambridge Science Park Milton Road CB4 4GW Cambridge United Kingdom
PALLADONE L.P. 4 mg, gélule à libération prolongée
4 mg Prolonged-release capsule, hard Oral use
FR - France
NAPP Laboratories Limited Cambridge Science Park Milton Road CB4 4GW Cambridge United Kingdom
PALLADONE L.P. 8 mg, gélule à libération prolongée
8 mg Prolonged-release capsule, hard Oral use
HU - Hungary
EGIS Gyógyszergyár nyrt. Keresztúri út 30-38. 1106, Budapest Hungary
M-ESLON 30mg Prolonged-release capsule, hard Oral use
HU - Hungary
EGIS Gyógyszergyár nyrt. Keresztúri út 30-38., 1106, Budapest Hungary
M-ESLON 60mg Prolonged-release capsule, hard Oral use
HU - Hungary
EGIS Gyógyszergyár nyrt. Keresztúri út 30-38., 1106, Budapest Hungary
M-ESLON 100mg Prolonged-release capsule, hard Oral use
72
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
HU - Hungary
EGIS Gyógyszergyár nyrt. Keresztúri út 30-38., 1106, Budapest Hungary
M-ESLON 200mg Prolonged-release capsule, hard Oral use
HU - Hungary Janssen-Cilag Kft. H-2045 Törökbálint, Tó Park Hungary
Jurnista 4mg Prolonged-release tablet Oral use
HU - Hungary Janssen-Cilag Kft. H-2045 Törökbálint, Tó Park Hungary
Jurnista 8mg Prolonged-release tablet Oral use
HU - Hungary Janssen-Cilag Kft. H-2045 Törökbálint, Tó Park Hungary
Jurnista 16mg Prolonged-release tablet Oral use
HU - Hungary Janssen-Cilag Kft. H-2045 Törökbálint, Tó Park Hungary
Jurnista 32mg Prolonged-release tablet Oral use
HU - Hungary Janssen-Cilag Kft. H-2045 Törökbálint, Tó Park Hungary
Jurnista 64mg Prolonged-release tablet Oral use
HU - Hungary
Mundipharma Ges.m.b.H. Apollogasse 16-18., A-1072 Vienna Austria
MST Continus 10mg Prolonged-release film coated tablet
Oral use
HU - Hungary
Mundipharma Ges.m.b.H. Apollogasse 16-18., A-1072 Vienna Austria
MST Continus 30mg Prolonged-release tablet Oral use
HU - Hungary
Mundipharma Ges.m.b.H. Apollogasse 16-18., A-1072 Vienna Austria
MST Continus 60mg Prolonged-release tablet Oral use
HU - Hungary
Mundipharma Ges.m.b.H. Apollogasse 16-18., A-1072 Vienna Austria
MST Continus 100mg Prolonged-release tablet Oral use
HU - Hungary
Mundipharma Ges.m.b.H. Apollogasse 16-18., A-1072 Vienna Austria
Oxycontin 10mg Prolonged-release film coated tablet
Oral use
73
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
HU - Hungary
Mundipharma Ges.m.b.H. Apollogasse 16-18., A-1072 Vienna Austria
Oxycontin 20mg Prolonged-release film coated tablet
Oral use
HU - Hungary
Mundipharma Ges.m.b.H. Apollogasse 16-18., A-1072 Vienna Austria
Oxycontin 40mg Prolonged-release film coated tablet
Oral use
HU - Hungary
Mundipharma Ges.m.b.H. Apollogasse 16-18., A-1072 Vienna Austria
Oxycontin 80mg Prolonged-release film coated tablet
Oral use
HU - Hungary
Mundipharma Ges.m.b.H. Apollogasse 16-18., A-1072 Vienna Austria
Palladone-SR 4mg Prolonged-release capsule Oral use
HU - Hungary
Mundipharma Ges.m.b.H. Apollogasse 16-18., A-1072 Vienna Austria
Palladone-SR 8mg Prolonged-release capsule Oral use
HU - Hungary
Mundipharma Ges.m.b.H. Apollogasse 16-18., A-1072 Vienna Austria
Palladone-SR 16mg Prolonged-release capsule Oral use
HU - Hungary
Mundipharma Ges.m.b.H. Apollogasse 16-18., A-1072 Vienna Austria
Palladone-SR 24mg Prolonged-release capsule Oral use
HU - Hungary
Mundipharma Ges.m.b.H. Apollogasse 16-18., A-1072 Vienna Austria
Palladone-XL 12mg Prolonged-release capsule Oral use
HU - Hungary
Mundipharma Ges.m.b.H. Apollogasse 16-18., A-1072 Vienna Austria
Palladone-XL 16mg Prolonged-release capsule Oral use
HU - Hungary
Mundipharma Ges.m.b.H. Apollogasse 16-18., A-1072 Vienna Austria
Palladone-XL 24mg Prolonged-release capsule Oral use
74
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
HU - Hungary
Mundipharma Ges.m.b.H. Apollogasse 16-18., A-1072 Vienna Austria
Palladone-XL 32mg Prolonged-release capsule Oral use
IE - Ireland
Ethypharm 21, rue St. Mathieu (Z.I.) F- 78550 Houdan 194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex France
ETHIRFIN 120 mg prolonged-release capsules, hard 120 mg Prolonged-release capsule Oral use
IE - Ireland
Ethypharm 21, rue St. Mathieu (Z.I.) F- 78550 Houdan 194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex France
ETHIRFIN 20 mg prolonged-release capsules, hard 20 mg Prolonged-release capsule Oral use
IE - Ireland
Ethypharm 21, rue St. Mathieu (Z.I.) F- 78550 Houdan 194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex France
ETHIRFIN 200 mg prolonged-release capsules, hard 200 mg Prolonged-release capsule Oral use
IE - Ireland
Ethypharm 21, rue St. Mathieu (Z.I.) F- 78550 Houdan 194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex France
ETHIRFIN 40 mg prolonged-release capsules, hard
40 mg Prolonged-release capsule Oral use
IE - Ireland
Ethypharm 21, rue St. Mathieu (Z.I.) F- 78550 Houdan 194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex France
ETHIRFIN 60 mg prolonged-release capsules, hard 60 mg Prolonged-release capsule Oral use
IE - Ireland
Napp Pharmaceuticals Ltd. Cambridge Science Park, Milton Road Cambridge CB4 0GW United Kingdom
MST CONTINUS 10 MG PROLONGED-RELEASE TABLETS
10 mg Prolonged-release tablet Oral use
75
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
IE - Ireland
Napp Pharmaceuticals Ltd. Cambridge Science Park, Milton Road Cambridge CB4 0GW United Kingdom
MST CONTINUS 100 MG PROLONGED-RELEASE TABLETS
100 mg Prolonged-release tablet Oral use
IE - Ireland
Napp Pharmaceuticals Ltd. Cambridge Science Park, Milton Road Cambridge CB4 0GW United Kingdom
MST CONTINUS 15 MG PROLONGED-RELEASE TABLETS
15 mg Prolonged-release tablet Oral use
IE - Ireland
Napp Pharmaceuticals Ltd. Cambridge Science Park, Milton Road Cambridge CB4 0GW United Kingdom
MST CONTINUS 200 MG PROLONGED-RELEASE TABLETS
200 mg Prolonged-release tablet Oral use
IE - Ireland
Napp Pharmaceuticals Ltd. Cambridge Science Park, Milton Road Cambridge CB4 0GW United Kingdom
MST CONTINUS 30 MG PROLONGED-RELEASE TABLETS
30 mg Prolonged-release tablet Oral use
IE - Ireland
Napp Pharmaceuticals Ltd. Cambridge Science Park, Milton Road Cambridge CB4 0GW United Kingdom
MST CONTINUS 5 MG PROLONGED-RELEASE TABLETS
5 mg Prolonged-release tablet Oral use
IE - Ireland
Napp Pharmaceuticals Ltd. Cambridge Science Park, Milton Road Cambridge CB4 0GW United Kingdom
MST CONTINUS 60 MG PROLONGED-RELEASE TABLETS
60 mg Prolonged-release tablet Oral use
IE - Ireland
Napp Pharmaceuticals Ltd. Cambridge Science Park, Milton Road Cambridge CB4 0GW United Kingdom
MST CONTINUS suspension 100 mg
100 mg Prolonged-release granules Oral use
IE - Ireland
Napp Pharmaceuticals Ltd. Cambridge Science Park, Milton Road Cambridge CB4 0GW United Kingdom
MST CONTINUS suspension 20 mg
20 mg Prolonged-release granules Oral use
IE - Ireland
Napp Pharmaceuticals Ltd. Cambridge Science Park, Milton Road Cambridge CB4 0GW United Kingdom
MST CONTINUS suspension 200 mg
200 mg Prolonged-release granules Oral use
IE - Ireland
Napp Pharmaceuticals Ltd. Cambridge Science Park, Milton Road Cambridge CB4 0GW United Kingdom
MST CONTINUS suspension 30 mg
30 mg Prolonged-release granules Oral use
76
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
IE - Ireland
Napp Pharmaceuticals Ltd. Cambridge Science Park, Milton Road Cambridge CB4 0GW United Kingdom
MST CONTINUS suspension 60 mg
60 mg Prolonged-release granules Oral use
IE - Ireland
Napp Pharmaceuticals Ltd. Cambridge Science Park, Milton Road Cambridge CB4 0GW United Kingdom
Oxycontin 10 mg Prolonged-release tablets
10 mg Prolonged-release tablet Oral use
IE - Ireland
Napp Pharmaceuticals Ltd. Cambridge Science Park, Milton Road Cambridge CB4 0GW United Kingdom
Oxycontin 20 mg Prolonged-release tablets
20 mg Prolonged-release tablet Oral use
IE - Ireland
Napp Pharmaceuticals Ltd. Cambridge Science Park, Milton Road Cambridge CB4 0GW United Kingdom
Oxycontin 40 mg Prolonged-release tablets
40 mg Prolonged-release tablet Oral use
IE - Ireland
Napp Pharmaceuticals Ltd. Cambridge Science Park, Milton Road Cambridge CB4 0GW United Kingdom
Oxycontin 5 mg Prolonged-release tablets
5 mg Prolonged-release tablet Oral use
IE - Ireland
Napp Pharmaceuticals Ltd. Cambridge Science Park, Milton Road Cambridge CB4 0GW United Kingdom
Oxycontin 80 mg Prolonged-release tablets
80 mg Prolonged-release tablet Oral use
IE - Ireland
Napp Pharmaceuticals Ltd. Cambridge Science Park, Milton Road Cambridge CB4 0GW United Kingdom
Palladone SR Capsules 16 mg 16 mg Prolonged-release capsule Oral use
IE - Ireland
Napp Pharmaceuticals Ltd. Cambridge Science Park, Milton Road Cambridge CB4 0GW United Kingdom
Palladone SR Capsules 2 mg 2 mg Prolonged-release capsule Oral use
IE - Ireland
Napp Pharmaceuticals Ltd. Cambridge Science Park, Milton Road Cambridge CB4 0GW United Kingdom
Palladone SR Capsules 24 mg 24 mg Prolonged-release capsule Oral use
IE - Ireland
Napp Pharmaceuticals Ltd. Cambridge Science Park, Milton Road Cambridge CB4 0GW United Kingdom
Palladone SR Capsules 4 mg 4 mg Prolonged-release capsule Oral use
77
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
IE - Ireland
Napp Pharmaceuticals Ltd. Cambridge Science Park, Milton Road Cambridge CB4 0GW United Kingdom
Palladone SR Capsules 8mg 8 mg Prolonged-release capsule Oral use
IE - Ireland
Napp Pharmaceuticals Ltd. Cambridge Science Park, Milton Road Cambridge CB4 0GW United Kingdom
Targin 10mg/5 mg Prolonged-release tablets
10mg/5mg Prolonged-release tablet Oral use
IE - Ireland
Napp Pharmaceuticals Ltd. Cambridge Science Park, Milton Road Cambridge CB4 0GW United Kingdom
Targin 20mg/10 mg Prolonged-release tablets
20mg/10mg Prolonged-release tablet Oral use
IE - Ireland
Napp Pharmaceuticals Ltd. Cambridge Science Park, Milton Road Cambridge CB4 0GW United Kingdom
Targin 40mg/20 mg Prolonged-release tablets
40mg/20mg Prolonged-release tablet Oral use
IE - Ireland
Napp Pharmaceuticals Ltd. Cambridge Science Park, Milton Road Cambridge CB4 0GW United Kingdom
Targin 5mg/2.5 mg Prolonged-release tablets
5mg/2.5 mg Prolonged-release tablet Oral use
IE - Ireland Rowex Ltd. Bantry, Co.Cork Ireland
DANCEX SR 10 mg Prolonged-release tablets
10 mg Prolonged-release tablet Oral use
IE - Ireland Rowex Ltd. Bantry, Co.Cork Ireland
DANCEX SR 20 mg Prolonged-release tablets
20 mg Prolonged-release tablet Oral use
IE - Ireland Rowex Ltd. Bantry, Co.Cork Ireland
DANCEX SR 5 mg Prolonged-release tablets
5 mg Prolonged-release tablet Oral use
IE - Ireland Rowex Ltd. Bantry, Co.Cork Ireland
Oxydon 10 mg Prolonged-release tablets
10 mg Prolonged-release tablet Oral use
IE - Ireland Rowex Ltd. Bantry, Co.Cork Ireland
Oxydon 20 mg Prolonged-release tablets
20 mg Prolonged-release tablet Oral use
IE - Ireland Rowex Ltd. Bantry, Co.Cork Ireland
Oxydon 40 mg Prolonged-release tablets
40 mg Prolonged-release tablet Oral use
IE - Ireland Rowex Ltd. Bantry, Co.Cork Ireland
Oxydon 5 mg Prolonged-release tablets
5 mg Prolonged-release tablet Oral use
78
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
IE - Ireland Rowex Ltd. Bantry, Co.Cork Ireland
Oxydon 80 mg Prolonged-release tablets
80 mg Prolonged-release tablet Oral use
IE - Ireland
Napp Pharmaceuticals Limited Cambridge Science Park, Milton Road Cambridge, CB4 0GW United Kingdom
OxyContin 60 mg prolonged release tablets
60mg Prolonged release tablet Oral use
IE - Ireland
Napp Pharmaceuticals Limited Cambridge Science Park, Milton Road Cambridge, CB4 0GW United Kingdom
OxyContin 120 mg prolonged release tablets
120mg Prolonged release tablet Oral use
IE - Ireland
Napp Pharmaceuticals Limited Cambridge Science Park, Milton Road Cambridge, CB4 0GW United Kingdom
OxyContin 160 mg prolonged release tablets
160mg Prolonged release tablet Oral use
IE - Ireland
Napp Pharmaceuticals Limited Cambridge Science Park, Milton Road Cambridge, CB4 0GW United Kingdom
OxyContin 15 mg prolonged release tablets
15mg Prolonged release tablet Oral use
IE - Ireland
Napp Pharmaceuticals Limited Cambridge Science Park, Milton Road Cambridge, CB4 0GW United Kingdom
OxyContin 30 mg prolonged release tablets
30mg Prolonged release tablet Oral use
IS - Iceland
Ethypharm 194 Bureaux de la Colline Batiment D 92213 Saint-Cloud Cedex France
Oxycodone Ethypharm 10 mg Prolonged-release capsule, hard Oral use
IS - Iceland
Ethypharm 194 Bureaux de la Colline Batiment D 92213 Saint-Cloud Cedex France
Oxycodone Ethypharm 20 mg Prolonged-release capsule, hard Oral use
IS - Iceland
Ethypharm 194 Bureaux de la Colline Batiment D 92213 Saint-Cloud Cedex France
Oxycodone Ethypharm 40 mg Prolonged-release capsule, hard Oral use
79
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
IS - Iceland
Ethypharm 194 Bureaux de la Colline Batiment D 92213 Saint-Cloud Cedex France
Oxycodone Ethypharm 80 mg Prolonged-release capsule, hard Oral use
IS - Iceland
Norpharma Slotsmarken 15 2970 Hørsholm Denmark
OxyContin 5 mg Prolonged-release tablet Oral use
IS - Iceland
Norpharma Slotsmarken 15 2970 Hørsholm Denmark
OxyContin 10 mg Prolonged-release tablet Oral use
IS - Iceland
Norpharma Slotsmarken 15 2970 Hørsholm Denmark
OxyContin 20 mg Prolonged-release tablet Oral use
IS - Iceland
Norpharma Slotsmarken 15 2970 Hørsholm Denmark
OxyContin 40 mg Prolonged-release tablet Oral use
IS - Iceland
Norpharma Slotsmarken 15 2970 Hørsholm Denmark
OxyContin 80 mg Prolonged-release tablet Oral use
IS - Iceland
Norpharma Slotsmarken 15 2970 Hørsholm Denmark
Palladon 4 mg Prolonged-release capsule, hard Oral use
IS - Iceland
Norpharma Slotsmarken 15 2970 Hørsholm Denmark
Palladon 8 mg Prolonged-release capsule, hard Oral use
IS - Iceland
Norpharma Slotsmarken 15 2970 Hørsholm Denmark
Palladon 16 mg Prolonged-release capsule, hard Oral use
IS - Iceland
Norpharma Slotsmarken 15 2970 Hørsholm Denmark
Palladon 24 mg Prolonged-release capsule, hard Oral use
80
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
IS - Iceland
Norpharma Slotsmarken 15 2970 Hørsholm Denmark
Targin 5/2.5 mg Prolonged-release tablet Oral use
IS - Iceland
Norpharma Slotsmarken 15 2970 Hørsholm Denmark
Targin 10/5 mg Prolonged-release tablet Oral use
IS - Iceland
Norpharma Slotsmarken 15 2970 Hørsholm Denmark
Targin 20/10 mg Prolonged-release tablet Oral use
IS - Iceland
Norpharma Slotsmarken 15 2970 Hørsholm Denmark
Targin 40/20 mg Prolonged-release tablet Oral use
IS - Iceland
Pfizer Aps Lautrupsvang 8 2750 Ballerud Denmark
Contalgin 5 mg Prolonged-release tablet Oral use
IS - Iceland
Pfizer Aps Lautrupsvang 8 2750 Ballerud Denmark
Contalgin 10 mg Prolonged-release tablet Oral use
IS - Iceland
Pfizer Aps Lautrupsvang 8 2750 Ballerud Denmark
Contalgin 30 mg Prolonged-release tablet Oral use
IS - Iceland
Pfizer Aps Lautrupsvang 8 2750 Ballerud Denmark
Contalgin 60 mg Prolonged-release tablet Oral use
IS - Iceland
Pfizer Aps Lautrupsvang 8 2750 Ballerud Denmark
Contalgin 100 mg Prolonged-release tablet Oral use
IS - Iceland
Pfizer Aps Lautrupsvang 8 2750 Ballerud Denmark
Contalgin 200 mg Prolonged-release tablet Oral use
81
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
IS - Iceland
Pfizer Aps Lautrupsvang 8 2750 Ballerud Denmark
Contalgin Uno 30 mg Prolonged-release capsule, hard Oral use
IS - Iceland
Pfizer Aps Lautrupsvang 8 2750 Ballerud Denmark
Contalgin Uno 60 mg Prolonged-release capsule, hard Oral use
IS - Iceland
Pfizer Aps Lautrupsvang 8 2750 Ballerud Denmark
Contalgin Uno 90 mg Prolonged-release capsule, hard Oral use
IS - Iceland
Pfizer Aps Lautrupsvang 8 2750 Ballerud Denmark
Contalgin Uno 120 mg Prolonged-release capsule, hard Oral use
IS - Iceland
Pfizer Aps Lautrupsvang 8 2750 Ballerud Denmark
Contalgin Uno 150 mg Prolonged-release capsule, hard Oral use
IS - Iceland
Pfizer Aps Lautrupsvang 8 2750 Ballerud Denmark
Contalgin Uno 200 mg Prolonged-release capsule, hard Oral use
IT - Italy
Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. Viale Amelia 70 00181 Roma Italy
ETHIRFIN 20 mg Prolonged-release capsule, hard Oral use
IT - Italy
Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. Viale Amelia 70 00181 Roma Italy
ETHIRFIN 40 mg Prolonged-release capsule, hard Oral use
IT - Italy
Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. Viale Amelia 70 00181 Roma Italy
ETHIRFIN 60 mg Prolonged-release capsule, hard Oral use
IT - Italy
Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. Viale Amelia 70 00181 Roma Italy
ETHIRFIN 120 mg Prolonged-release capsule, hard Oral use
82
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
IT - Italy
Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. Viale Amelia 70 00181 Roma Italy
ETHIRFIN 200 mg Prolonged-release capsule, hard Oral use
IT - Italy
Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. Viale Amelia 70 00181 Roma Italy
TWICE 10 mg Prolonged-release capsule, hard Oral use
IT - Italy
Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. Viale Amelia 70 00181 Roma Italy
TWICE 30 mg Prolonged-release capsule, hard Oral use
IT - Italy
Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. Viale Amelia 70 00181 Roma Italy
TWICE 60 mg Prolonged-release capsule, hard Oral use
IT - Italy
Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. Viale Amelia 70 00181 Roma Italy
TWICE 100 mg Prolonged-release capsule, hard Oral use
IT - Italy
BRUNO FARMACEUTICI S.P.A. Via delle Ande, 15 00100 Roma Italy
UNIMORF 20 mg Prolonged-release capsule, hard Oral use
IT - Italy
BRUNO FARMACEUTICI S.P.A. Via delle Ande, 15 00100 Roma Italy
UNIMORF 40 mg Prolonged-release capsule, hard Oral use
IT - Italy
BRUNO FARMACEUTICI S.P.A. Via delle Ande, 15 00100 Roma Italy
UNIMORF 60 mg Prolonged-release capsule, hard Oral use
IT - Italy
BRUNO FARMACEUTICI S.P.A. Via delle Ande, 15 00100 Roma Italy
UNIMORF 120 mg Prolonged-release capsule, hard Oral use
IT - Italy
BRUNO FARMACEUTICI S.P.A. Via delle Ande, 15 00100 Roma Italy
UNIMORF 200 mg Prolonged-release capsule, hard Oral use
83
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
IT - Italy
Ethypharm 21, rue St. Mathieu (Z.I.) F- 78550 Houdan 194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex France
SKENAN 10 mg Prolonged-release capsule Oral use
IT - Italy
Ethypharm 21, rue St. Mathieu (Z.I.) F- 78550 Houdan 194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex France
SKENAN 30 mg Prolonged-release capsule Oral use
IT - Italy
Ethypharm 21, rue St. Mathieu (Z.I.) F- 78550 Houdan 194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex France
SKENAN 60 mg Prolonged-release capsule Oral use
IT - Italy
Ethypharm 21, rue St. Mathieu (Z.I.) F- 78550 Houdan 194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex France
SKENAN 100 mg Prolonged-release capsule Oral use
IT - Italy
JANSSEN-CILAG SpA Via M. Buonarroti, 23 20093 Cologno Monzese (MI) Italy
JURNISTA 4 mg Prolonged-release tablet Oral use
IT - Italy
JANSSEN-CILAG SpA Via M. Buonarroti, 23 20093 Cologno Monzese (MI) Italy
JURNISTA 8 mg Prolonged-release tablet Oral use
IT - Italy
JANSSEN-CILAG SpA Via M. Buonarroti, 23 20093 Cologno Monzese (MI) Italy
JURNISTA 16 mg Prolonged-release tablet Oral use
IT - Italy
JANSSEN-CILAG SpA Via M. Buonarroti, 23 20093 Cologno Monzese (MI) Italy
JURNISTA 32 mg Prolonged-release tablet Oral use
84
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
IT - Italy
JANSSEN-CILAG SpA Via M. Buonarroti, 23 20093 Cologno Monzese (MI) Italy
JURNISTA 64 mg Prolonged-release tablet Oral use
IT - Italy
Mundipharma Pharmaceuticals Srl Via G. Serbelloni, 4 20122 Milano Italy
MS CONTIN 10 mg Prolonged-release tablet Oral use
IT - Italy
Mundipharma Pharmaceuticals Srl Via G. Serbelloni, 4 20122 Milano Italy
MS CONTIN 30 mg Prolonged-release tablet Oral use
IT - Italy
Mundipharma Pharmaceuticals Srl Via G. Serbelloni, 4 20122 Milano Italy
MS CONTIN 60 mg Prolonged-release tablet Oral use
IT - Italy
Mundipharma Pharmaceuticals Srl Via G. Serbelloni, 4 20122 Milano Italy
MS CONTIN 100 mg Prolonged-release tablet Oral use
IT - Italy
Mundipharma Pharmaceuticals Srl Via G. Serbelloni, 4 20122 Milano Italy
MS CONTIN 200 mg Prolonged-release tablet Oral use
IT - Italy
Mundipharma Pharmaceuticals Srl Via G. Serbelloni, 4 20122 Milano Italy
MS CONTIN 20 mg Controlled release granules for oral suspension
Oral use
IT - Italy
Mundipharma Pharmaceuticals Srl Via G. Serbelloni, 4 20122 Milano Italy
MS CONTIN 30 mg Controlled release granules for oral suspension
Oral use
IT - Italy
Mundipharma Pharmaceuticals Srl Via G. Serbelloni, 4 20122 Milano Italy
MS CONTIN 60 mg Controlled release granules for oral suspension
Oral use
IT - Italy
Mundipharma Pharmaceuticals Srl Via G. Serbelloni, 4 20122 Milano Italy
MS CONTIN 100 mg Controlled release granules for oral suspension
Oral use
85
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
IT - Italy
Mundipharma Pharmaceuticals Srl Via G. Serbelloni, 4 20122 Milano Italy
MS CONTIN 200 mg Controlled release granules for oral suspension
Oral use
IT - Italy
Mundipharma Pharmaceuticals Srl Via G. Serbelloni, 4 20122 Milano Italy
OXYCONTIN 5 mg Prolonged-release tablet Oral use
IT - Italy
Mundipharma Pharmaceuticals Srl Via G. Serbelloni, 4 20122 Milano Italy
OXYCONTIN 10 mg Prolonged-release tablet Oral use
IT - Italy
Mundipharma Pharmaceuticals Srl Via G. Serbelloni, 4 20122 Milano Italy
OXYCONTIN 20 mg Prolonged-release tablet Oral use
IT - Italy
Mundipharma Pharmaceuticals Srl Via G. Serbelloni, 4 20122 Milano Italy
OXYCONTIN 40 mg Prolonged-release tablet Oral use
IT - Italy
Mundipharma Pharmaceuticals Srl Via G. Serbelloni, 4 20122 Milano Italy
OXYCONTIN 80 mg Prolonged-release tablet Oral use
LT - Lithuania
Lannacher Heilmittel Ges. m . b. H Schlossplatz 1 8502 Lannach Austria
Vendal retard 10 mg Prolonged-release tablet Oral use
LT - Lithuania
Lannacher Heilmittel Ges. m . b. H Schlossplatz 1 8502 Lannach Austria
Vendal retard 30 mg Prolonged-release tablet Oral use
LT - Lithuania
Lannacher Heilmittel Ges. m . b. H Schlossplatz 1 8502 Lannach Austria
Vendal retard 60 mg Prolonged-release tablet Oral use
LT - Lithuania
Lannacher Heilmittel Ges. m . b. H Schlossplatz 1 8502 Lannach Austria
Vendal retard 100 mg Prolonged-release tablet Oral use
86
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
LT - Lithuania
Lannacher Heilmittel Ges. m . b. H Schlossplatz 1 8502 Lannach Austria
Vendal retard 200 mg Prolonged-release tablet Oral use
LT - Lithuania
Nycomed Danmark ApS Langebjerg 1 DK-4000 Roskilde Denmark
Doltard 30 mg Prolonged-release tablet Oral use
LT - Lithuania
Nycomed Danmark ApS Langebjerg 1 DK-4000 Roskilde Denmark
Doltard 60 mg Prolonged-release tablet Oral use
LU - Luxembourg
Ethypharm 21, rue St. Mathieu (Z.I.) F- 78550 Houdan France
Morphine Sulfate LP Ethypharm 200mg Prolonged-release capsule, hard Oral use
LU - Luxembourg
Ethypharm 21, rue St. Mathieu (Z.I.) F- 78550 Houdan France
Zomorph L.P. 40mg Prolonged-release capsule, soft Oral use
LU - Luxembourg
Ethypharm 21, rue St. Mathieu (Z.I.) F- 78550 Houdan France
Zomorph L.P. 60mg Prolonged-release capsule, soft Oral use
LU - Luxembourg
Ethypharm 21, rue St. Mathieu (Z.I.) F- 78550 Houdan France
Zomorph L.P. 120mg Prolonged-release capsule, soft Oral use
LU - Luxembourg
Ethypharm 21, rue St. Mathieu (Z.I.) F- 78550 Houdan France
Zomorph L.P. 200mg Prolonged-release capsule, soft Oral use
LU - Luxembourg
Mundipharma C.V.A. Schalienhoevedreef 20H B- 2800 Mechelen Belgium
Palladone Slow Release 4mg Capsule Oral use
LU - Luxembourg
Mundipharma C.V.A. Schalienhoevedreef 20H B- 2800 Mechelen Belgium
Palladone Slow Release 8mg Capsule Oral use
87
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
LU - Luxembourg
Mundipharma C.V.A. Schalienhoevedreef 20H B- 2800 Mechelen Belgium
Palladone Slow Release 16mg Capsule Oral use
LU - Luxembourg
Mundipharma C.V.A. Schalienhoevedreef 20H B- 2800 Mechelen Belgium
Palladone Slow Release 24mg Capsule Oral use
LU - Luxembourg
Mundipharma C.V.A. Schalienhoevedreef 20H B- 2800 Mechelen Belgium
Targinact-10/15 10/5mg prolonged-release tablet Oral use
LU - Luxembourg
Mundipharma C.V.A. Schalienhoevedreef 20H B- 2800 Mechelen Belgium
Targinact-20/10 20/10mg prolonged-release tablet Oral use
LV - Latvia
Lannacher Heilmittel Ges.mbH Schloβplatz 1 A-8502, Lannach Austria
Vendal retard 10 mg prolonged-release tablets
10 mg Prolonged-release tablet Oral use
LV - Latvia
Lannacher Heilmittel Ges.mbH Schloβplatz 1 A-8502, Lannach Austria
Vendal retard 100 mg prolonged-release tablets
100 mg Prolonged-release tablet Oral use
LV - Latvia
Lannacher Heilmittel Ges.mbH Schloβplatz 1 A-8502, Lannach Austria
Vendal retard 30 mg prolonged-release tablets
30 mg Prolonged-release tablet Oral use
LV - Latvia
Lannacher Heilmittel Ges.mbH Schloβplatz 1 A-8502, Lannach Austria
Vendal retard 60 mg prolonged-release tablets
60 mg Prolonged-release tablet Oral use
LV - Latvia
MUNDIPHARMA Ges.m.b.H. Apollogasse 16-18 A-1072 Viena Austria
OxyContin 10 mg prolonged release tablets
10 mg Prolonged-release tablet Oral use
LV - Latvia
MUNDIPHARMA Ges.m.b.H. Apollogasse 16-18 A-1072 Viena Austria
OxyContin 20 mg prolonged release tablets
20 mg Prolonged-release tablet Oral use
88
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
LV - Latvia
MUNDIPHARMA Ges.m.b.H. Apollogasse 16-18 A-1072 Viena Austria
OxyContin 40 mg prolonged release tablets
40 mg Prolonged-release tablet Oral use
LV - Latvia
MUNDIPHARMA Ges.m.b.H. Apollogasse 16-18 A-1072 Viena Austria
OxyContin 80 mg prolonged release tablets
80 mg Prolonged-release tablet Oral use
LV - Latvia
Nycomed Danmark ApS Langebjerg 1 DK – 4000 Roskilde Denmark
Doltard 30 mg prolonged-release tablets
30 mg Prolonged-release tablet Oral use
LV - Latvia
Nycomed Danmark ApS Langebjerg 1 DK – 4000 Roskilde Denmark
Doltard 60 mg prolonged-release tablets
60 mg prolonged-release tablet Oral use
MT - Malta
Napp Pharmaceuticals Ltd Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom
MST CONTINUS 10 mg tablets 10mg Prolonged-release tablet Oral use
MT - Malta
Napp Pharmaceuticals Ltd Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom
MST CONTINUS 30 mg tablets 30mg Prolonged-release tablet Oral use
MT - Malta
Napp Pharmaceuticals Ltd Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom
MST CONTINUS 60mg tablets 60mg Prolonged-release tablet Oral use
NL - Netherlands
Apothecon B.V. Nijverheidsweg 3 NL-3771 ME Barneveld The Netherlands
Morfine HCl retard 10 A, tabletten met verlengde afgifte 10 mg
10 mg Prolonged-release tablet Oral use
NL - Netherlands
Apothecon B.V. Nijverheidsweg 3 NL-3771 ME Barneveld The Netherlands
Morfine HCl retard 100 A, tabletten met verlengde afgifte 10 mg
100 mg Prolonged-release tablet Oral use
89
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
NL - Netherlands
Apothecon B.V. Nijverheidsweg 3 NL-3771 ME Barneveld The Netherlands
Morfine HCl retard 200 A, tabletten met verlengde afgifte 10 mg
200 mg Prolonged-release tablet Oral use
NL - Netherlands
Apothecon B.V. Nijverheidsweg 3 NL-3771 ME Barneveld The Netherlands
Morfine HCl retard 30 A, tabletten met verlengde afgifte 10 mg
30 mg Prolonged-release tablet Oral use
NL - Netherlands
Apothecon B.V. Nijverheidsweg 3 NL-3771 ME Barneveld The Netherlands
Morfine HCl retard 60 A, tabletten met verlengde afgifte 10 mg
60 mg Prolonged-release tablet Oral use
NL - Netherlands
Centrafarm Services BV Nieuwe Donk 9 NL-4879 AC Etten-Leur The Netherlands
Morfine HCl retard CF 10 mg, tabletten met gereguleerde afgifte
10 mg Modified-release tablet Oral use
NL - Netherlands
Centrafarm Services BV Nieuwe Donk 9 NL-4879 AC Etten-Leur The Netherlands
Morfine HCl retard CF 100 mg, tabletten met gereguleerde afgifte
100 mg Modified-release tablet Oral use
NL - Netherlands
Centrafarm Services BV Nieuwe Donk 9 NL-4879 AC Etten-Leur The Netherlands
Morfine HCl retard CF 200 mg, tabletten met gereguleerde afgifte
200 mg Modified-release tablet Oral use
NL - Netherlands
Centrafarm Services BV Nieuwe Donk 9 NL-4879 AC Etten-Leur The Netherlands
Morfine HCl retard CF 30 mg, tabletten met gereguleerde afgifte
30 mg Modified-release tablet Oral use
NL - Netherlands
Centrafarm Services BV Nieuwe Donk 9 NL-4879 AC Etten-Leur The Netherlands
Morfine HCl retard CF 60 mg, tabletten met gereguleerde afgifte
60 mg Modified-release tablet Oral use
NL - Netherlands
GlaxoSmithKline B.V. Huis ter Heideweg 62 NL-3705 LZ Zeist The Netherlands
Kapanol 100, capsules met gereguleerde afgifte 20 mg
100 mg Prolonged-release capsule Oral use
NL - Netherlands
GlaxoSmithKline B.V. Huis ter Heideweg 62 NL-3705 LZ Zeist The Netherlands
Kapanol 20, capsules met gereguleerde afgifte 20 mg
20 mg Prolonged-release capsule Oral use
90
Member State (EU/EEA)
Marketing Authorisation Holder
NL - Netherlands
Invented name
GlaxoSmithKline B.V.
Strength
Huis ter Heideweg 62
Pharmaceutical form
NL-3705 LZ Zeist
Route of administration
The Netherlands
Kapanol 50, capsules met gereguleerde afgifte 20 mg
50 mg Prolonged-release capsule Oral use
NL - Netherlands
Laboratoires UPSA (Rueil Malmaison), 128, Rue Danton FR-92500 Rueil Malmaison France
Skenan SR 10 mg, capsules met gereguleerde afgifte
10 mg Modified-release capsule Oral use
NL - Netherlands
Laboratoires UPSA (Rueil Malmaison), 128, Rue Danton FR-92500 Rueil Malmaison France
Skenan SR 100 mg, capsules met gereguleerde afgifte
100 mg Modified-release tablet Oral use
NL - Netherlands
Laboratoires UPSA (Rueil Malmaison), 128, Rue Danton FR-92500 Rueil Malmaison France
Skenan SR 200 mg, capsules met gereguleerde afgifte
200 mg Modified-release tablet Oral use
NL - Netherlands
Laboratoires UPSA (Rueil Malmaison), 128, Rue Danton FR-92500 Rueil Malmaison France
Skenan SR 30 mg, capsules met gereguleerde afgifte
30 mg Modified-release tablet Oral use
NL - Netherlands
Laboratoires UPSA (Rueil Malmaison), 128, Rue Danton FR-92500 Rueil Malmaison France
Skenan SR 60 mg, capsules met gereguleerde afgifte
60 mg Modified-release tablet Oral use
NL - Netherlands
Mundipharma Pharmaceuticals B.V. De Weil 20 NL-3871 MV Hoevelaken The Netherlands
MS Contin 10 mg, tabletten met gereguleerde afgifte
10 mg Modified-release tablet Oral use
NL - Netherlands
Mundipharma Pharmaceuticals B.V. De Weil 20 NL-3871 MV Hoevelaken The Netherlands
MS Contin 100 mg, tabletten met gereguleerde afgifte
100 mg Modified-release tablet Oral use
NL - Netherlands
Mundipharma Pharmaceuticals B.V. De Weil 20 NL-3871 MV Hoevelaken The Netherlands
MS Contin 15 mg, tabletten met gereguleerde afgifte
15 mg Modified-release tablet Oral use
NL - Netherlands
Mundipharma Pharmaceuticals B.V. De Weil 20 NL-3871 MV Hoevelaken The Netherlands
MS Contin 200 mg, tabletten met gereguleerde afgifte
2000 mg Modified-release tablet Oral use
91
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
NL - Netherlands
Mundipharma Pharmaceuticals B.V. De Weil 20 NL-3871 MV Hoevelaken The Netherlands
MS Contin 30 mg, tabletten met gereguleerde afgifte
30 mg Modified-release tablet Oral use
NL - Netherlands
Mundipharma Pharmaceuticals B.V. De Weil 20 NL-3871 MV Hoevelaken The Netherlands
MS Contin 5 mg, tabletten met gereguleerde afgifte
5 mg Modified-release tablet Oral use
NL - Netherlands
Mundipharma Pharmaceuticals B.V. De Weil 20 NL-3871 MV Hoevelaken The Netherlands
MS Contin 60 mg, tabletten met gereguleerde afgifte
60 mg Modified-release tablet Oral use
NL - Netherlands
Mundipharma Pharmaceuticals B.V. De Weil 20 NL-3871 MV Hoevelaken The Netherlands
OxyContin 10 mg, tabletten met gereguleerde afgifte
10 mg Modified release tablet Oral use
NL - Netherlands
Mundipharma Pharmaceuticals B.V. De Weil 20 NL-3871 MV Hoevelaken The Netherlands
OxyContin 20 mg, tabletten met gereguleerde afgifte
20 mg Modified release tablet Oral use
NL - Netherlands
Mundipharma Pharmaceuticals B.V. De Weil 20 NL-3871 MV Hoevelaken The Netherlands
OxyContin 40 mg, tabletten met gereguleerde afgifte
40 mg Modified release tablet Oral use
NL - Netherlands
Mundipharma Pharmaceuticals B.V. De Weil 20 NL-3871 MV Hoevelaken The Netherlands
OxyContin 5 mg, tabletten met gereguleerde afgifte
5 mg Modified release tablet Oral use
NL - Netherlands
Mundipharma Pharmaceuticals B.V. De Weil 20 NL-3871 MV Hoevelaken The Netherlands
OxyContin 80 mg, tabletten met gereguleerde afgifte
80 mg Modified release tablet Oral use
NL - Netherlands
Mundipharma Pharmaceuticals B.V. De Weil 20 NL-3871 MV Hoevelaken The Netherlands
Palladon-SR capsule 16 mg, capsules met verlengde afgifte
16 mg Prolonged release capsule Oral use
NL - Netherlands
Mundipharma Pharmaceuticals B.V. De Weil 20 NL-3871 MV Hoevelaken The Netherlands
Palladon-SR capsule 2 mg, capsules met verlengde afgifte
2 mg Prolonged release capsule Oral use
92
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
NL - Netherlands
Mundipharma Pharmaceuticals B.V. De Weil 20 NL-3871 MV Hoevelaken The Netherlands
Palladon-SR capsule 24 mg, capsules met verlengde afgifte
24 mg Prolonged release capsule Oral use
NL - Netherlands
Mundipharma Pharmaceuticals B.V. De Weil 20 NL-3871 MV Hoevelaken The Netherlands
Palladon-SR capsule 4 mg, capsules met verlengde afgifte
4 mg Prolonged release capsule Oral use
NL - Netherlands
Mundipharma Pharmaceuticals B.V. De Weil 20 NL-3871 MV Hoevelaken The Netherlands
Palladon-SR capsule 8 mg, capsules met verlengde afgifte
8 mg Prolonged release capsule Oral use
NL - Netherlands
Mundipharma Pharmaceuticals B.V. De Weil 20 NL-3871 MV Hoevelaken The Netherlands
Targinact 10 mg/ 5 mg, tabletten met verlengde afgifte
10 and 5 mg Prolonged release tablet Oral use
NL - Netherlands
Mundipharma Pharmaceuticals B.V. De Weil 20 NL-3871 MV Hoevelaken The Netherlands
Targinact 20 mg/ 10 mg, tabletten met verlengde afgifte
20 and 10 mg Prolonged release tablet Oral use
NL - Netherlands
Mundipharma Pharmaceuticals B.V. De Weil 20 NL-3871 MV Hoevelaken The Netherlands
Targinact 40 mg/ 20 mg, tabletten met verlengde afgifte
40 and 20 mg Prolonged release tablet Oral use
NL - Netherlands
Mundipharma Pharmaceuticals B.V. De Weil 20 NL-3871 MV Hoevelaken The Netherlands
Targinact 5 mg/ 2,5 mg, tabletten met verlengde afgifte
5 and 2.5 mg Prolonged release tablet Oral use
NL - Netherlands
Pharmachemie BV Swensweg 5 NL-2031 GA Haarlem The Netherlands
Morfinesulfaat retard 10 PCH, tabletten met gereguleerde afgifte 10 mg
10 mg Modified-release tablet Oral use
NL - Netherlands
Pharmachemie BV Swensweg 5 NL-2031 GA Haarlem The Netherlands
Morfinesulfaat retard 100 PCH, tabletten met gereguleerde afgifte 10 mg
100 mg Modified-release tablet Oral use
NL - Netherlands
Pharmachemie BV Swensweg 5 NL-2031 GA Haarlem The Netherlands
Morfinesulfaat retard 30 PCH, tabletten met gereguleerde afgifte 10 mg
30 mg Modified-release tablet Oral use
93
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
NL - Netherlands
Pharmachemie BV Swensweg 5 NL-2031 GA Haarlem The Netherlands
Morfinesulfaat retard 60 PCH, tabletten met gereguleerde afgifte 10 mg
60 mg Modified-release tablet Oral use
NL - Netherlands
Ratiopharm Nederland B.V. Ronde Tocht 11 NL-1507 CC Zaandam Florapark 4 2012 HK Haarlem The Netherlands
Oxycodon HCl ratiopharm 10 mg, tabletten met verlengde afgifte
10 mg Prolonged release tablet Oral use
NL - Netherlands
Ratiopharm Nederland B.V. Ronde Tocht 11 NL-1507 CC Zaandam Florapark 4 2012 HK Haarlem The Netherlands
Oxycodon HCl ratiopharm 20 mg, tabletten met verlengde afgifte
20 mg Prolonged release tablet Oral use
NL - Netherlands
Ratiopharm Nederland B.V. Ronde Tocht 11 NL-1507 CC Zaandam Florapark 4 2012 HK Haarlem The Netherlands
Oxycodon HCl ratiopharm 40 mg, tabletten met verlengde afgifte
40 mg Prolonged release tablet Oral use
NL - Netherlands
Ratiopharm Nederland B.V. Ronde Tocht 11 NL-1507 CC Zaandam Florapark 4 2012 HK Haarlem The Netherlands
Oxycodon HCl ratiopharm 50 mg, tabletten met verlengde afgifte
5 mg Prolonged release tablet Oral use
NL - Netherlands
Ratiopharm Nederland B.V. Ronde Tocht 11 NL-1507 CC Zaandam Florapark 4 2012 HK Haarlem The Netherlands
Oxycodon HCl ratiopharm 80 mg, tabletten met verlengde afgifte
80 mg Prolonged release tablet Oral use
NL - Netherlands
Sandoz B.V. Veluwezoom 22 NL-1327 AH Almere The Netherlands
Oxycodon HCl Sandoz 10 mg, tabletten met verlengde afgifte
10 mg Prolonged release tablet Oral use
NL - Netherlands
Sandoz B.V. Veluwezoom 22 NL-1327 AH Almere The Netherlands
Oxycodon HCl Sandoz 20 mg, tabletten met verlengde afgifte
20 mg Prolonged release tablet Oral use
NL - Netherlands
Sandoz B.V. Veluwezoom 22 NL-1327 AH Almere The Netherlands
Oxycodon HCl Sandoz 40 mg, tabletten met verlengde afgifte
40 mg Prolonged release tablet Oral use
94
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
NL - Netherlands
Sandoz B.V. Veluwezoom 22 NL-1327 AH Almere The Netherlands
Oxycodon HCl Sandoz 5 mg, tabletten met verlengde afgifte
5 mg Prolonged release tablet Oral use
NL - Netherlands
Sandoz B.V. Veluwezoom 22 NL-1327 AH Almere The Netherlands
Oxycodon HCl Sandoz 80 mg, tabletten met verlengde afgifte
80 mg Prolonged release tablet Oral use
NL - Netherlands
Sandoz B.V. Veluwezoom 22 NL-1327 AH Almere The Netherlands
Oxycodon HCl Sandoz retard 10 mg, tabletten met verlengde afgifte
10 mg Prolonged release tablet Oral use
NL - Netherlands
Sandoz B.V. Veluwezoom 22 NL-1327 AH Almere The Netherlands
Oxycodon HCl Sandoz retard 20 mg, tabletten met verlengde afgifte
20 mg Prolonged release tablet Oral use
NL - Netherlands
Sandoz B.V. Veluwezoom 22 NL-1327 AH Almere The Netherlands
Oxycodon HCl Sandoz retard 5 mg, tabletten met verlengde afgifte
5 mg Prolonged release tablet Oral use
NO - Norway
Hexal A/S Kanalholmen 8-12 DK-2650 Hvidovre Denmark
Oxycodone Hexal 20 mg Prolonged release tablet Oral use
NO - Norway
Hexal A/S Kanalholmen 8-12 DK-2650 Hvidovre Denmark
Oxycodone Hexal 40 mg Prolonged release tablet Oral use
NO - Norway
Hexal A/S Kanalholmen 8-12 DK-2650 Hvidovre Denmark
Oxycodone Hexal 80 mg Prolonged release tablet Oral use
NO - Norway
Hexal A/S Kanalholmen 8-12 DK-2650 Hvidovre Denmark
Oxycodone Hexal 10 mg Prolonged release tablet Oral use
NO - Norway
Hexal A/S Kanalholmen 8-12 DK-2650 Hvidovre Denmark
Oxycodone Hexal 5 mg Prolonged release tablet Oral use
95
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
NO - Norway
Mundipharma As Vollsveien 13c 1366 Lysaker Norway
OXYCONTIN 5 mg Prolonged-release tablet Oral use
NO - Norway
Mundipharma As Vollsveien 13c 1366 Lysaker Norway
OXYCONTIN 10 mg Prolonged-release tablet Oral use
NO - Norway
Mundipharma As Vollsveien 13c 1366 Lysaker Norway
OXYCONTIN 20 mg Prolonged-release tablet Oral use
NO - Norway
Mundipharma As Vollsveien 13c 1366 Lysaker Norway
OXYCONTIN 40 mg Prolonged-release tablet Oral use
NO - Norway
Mundipharma As Vollsveien 13c 1366 Lysaker Norway
OXYCONTIN 80 mg Prolonged-release tablet Oral use
NO - Norway
Mundipharma As Vollsveien 13c 1366 Lysaker Norway
PALLADON 4 mg Prolonged-release capsule, hard Oral use
NO - Norway
Mundipharma As Vollsveien 13c 1366 Lysaker Norway
PALLADON 8 mg Prolonged-release capsule, hard Oral use
NO - Norway
Mundipharma As Vollsveien 13c 1366 Lysaker Norway
PALLADON 16 mg Prolonged-release capsule, hard Oral use
NO - Norway
Mundipharma As Vollsveien 13c 1366 Lysaker Norway
PALLADON 24 mg Prolonged-release capsule, hard Oral use
NO - Norway
Mundipharma As Vollsveien 13c 1366 Lysaker Norway
PALLADON 1,3 mg capsule, hard Oral use
96
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
NO - Norway
Mundipharma As Vollsveien 13c 1366 Lysaker Norway
PALLADON 2,6 mg capsule, hard Oral use
NO - Norway
Mundipharma As Vollsveien 13c 1366 Lysaker Norway
Targiniq 5 mg/2,5 mg Prolonged-release tablet Oral use
NO - Norway
Mundipharma As Vollsveien 13c 1366 Lysaker Norway
Targiniq 40 mg/20 mg Prolonged-release tablet Oral use
NO - Norway
Mundipharma As Vollsveien 13c 1366 Lysaker Norway
Targiniq 10 mg/5 mg Prolonged-release tablet Oral use
NO - Norway
Mundipharma As Vollsveien 13c 1366 Lysaker Norway
Targiniq 20 mg/10 mg Prolonged-release tablet Oral use
NO - Norway
Pfizer As Postboks 3 1324 Lysaker Norway
DOLCONTIN 20 mg/dose Prolonged-release granules for oral suspension
Oral use
NO - Norway
Pfizer As Postboks 3 1324 Lysaker Norway
DOLCONTIN 5 mg Prolonged-release tablet Oral use
NO - Norway
Pfizer As Postboks 3 1324 Lysaker Norway
DOLCONTIN 10 mg Prolonged-release tablet Oral use
NO - Norway
Pfizer As Postboks 3 1324 Lysaker Norway
DOLCONTIN 30 mg Prolonged-release tablet Oral use
NO - Norway
Pfizer As Postboks 3 1324 Lysaker Norway
DOLCONTIN 60 mg Prolonged-release tablet Oral use
97
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
NO - Norway
Pfizer As Postboks 3 1324 Lysaker Norway
DOLCONTIN 100 mg Prolonged-release tablet Oral use
NO - Norway
Pfizer As Postboks 3 1324 Lysaker Norway
DOLCONTIN 200 mg Prolonged-release tablet Oral use
NO - Norway
Ratiopharm GmbH Graf-Arco-Strasse 3 89070 Ulm Germany
Oxycodone ratiopharm 20 mg Prolonged-release tablet Oral use
NO - Norway
Ratiopharm GmbH Graf-Arco-Strasse 3 89070 Ulm Germany
Oxycodone ratiopharm 40 mg Prolonged-release tablet Oral use
NO - Norway
Ratiopharm GmbH Graf-Arco-Strasse 3 89070 Ulm Germany
Oxycodone ratiopharm 80 mg Prolonged-release tablet Oral use
NO - Norway
Ratiopharm GmbH Graf-Arco-Strasse 3 89070 Ulm Germany
Oxycodone ratiopharm 5 mg Prolonged-release tablet Oral use
NO - Norway
Ratiopharm GmbH Graf-Arco-Strasse 3 89070 Ulm Germany
Oxycodone ratiopharm 10 mg Prolonged-release tablet Oral use
NO - Norway
Sandoz A/S C.F. Tietgens Boulevard 40 DK-5220 Odense SØ Danmark
Oxycodone Sandoz 5 mg Prolonged release tablet Oral use
NO - Norway
Sandoz A/S C.F. Tietgens Boulevard 40 DK-5220 Odense SØ Danmark
Oxycodone Sandoz 10 mg Prolonged release tablet Oral use
NO - Norway
Sandoz A/S C.F. Tietgens Boulevard 40 DK-5220 Odense SØ Danmark
Oxycodone Sandoz 20 mg Prolonged release tablet Oral use
98
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
PL - Poland
G.L. Pharma GmbH Schloβplatz 1 A-8502 Lannach Austria
Vendal retard 10 mg Prolonged-release film-coated tablet
Oral use
PL - Poland
G.L. Pharma GmbH Schloβplatz 1 A-8502 Lannach Austria
Vendal retard 30 mg Prolonged-release film-coated tablet
Oral use
PL - Poland
G.L. Pharma GmbH Schloβplatz 1 A-8502 Lannach Austria
Vendal retard 60 mg Prolonged-release film-coated tablet
Oral use
PL - Poland
G.L. Pharma GmbH Schloβplatz 1 A-8502 Lannach Austria
Vendal retard 100 mg Prolonged-release film-coated tablet
Oral use
PL - Poland
G.L. Pharma GmbH Schloβplatz 1 A-8502 Lannach Austria
Vendal retard 200 mg Prolonged-release film-coated tablet
Oral use
PL - Poland
Molteni Farmaceutici Polska Sp. z o.o. 3 Obroncow Modlina St. 30-733, Cracow Poland
Oramorph O.D. 20 20 mg Prolonged-release capsule, hard Oral use
PL - Poland
Molteni Farmaceutici Polska Sp. z o.o. 3 Obroncow Modlina St. 30-733, Cracow Poland
Oramorph O.D. 200 200 mg Prolonged-release capsule, hard Oral use
PL - Poland
Molteni Farmaceutici Polska Sp. z o.o. 3 Obroncow Modlina St. 30-733, Cracow Poland
Oramorph O.D. 40 40 mg Prolonged-release capsule, hard Oral use
PL - Poland
Molteni Farmaceutici Polska Sp. z o.o. 3 Obroncow Modlina St. 30-733, Cracow Poland
Oramorph O.D. 60 60 mg Prolonged-release capsule, hard Oral use
PL - Poland
Molteni Farmaceutici Polska Sp. z o.o. 3 Obroncow Modlina St. 30-733, Cracow Poland
Oramorph O.D.120 120 mg Prolonged-release capsule, hard Oral use
99
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
PL - Poland
Mundipharma Ges.m.b.H Apollogase 16-18 A-1072 Wien Austria
Palladone-XL 12mg 12 mg Prolonged-release capsule, hard Oral use
PL - Poland
Mundipharma Ges.m.b.H Apollogase 16-18 A-1072 Wien Austria
Palladone-XL 16mg 16 mg Prolonged-release capsule, hard Oral use
PL - Poland
Mundipharma Ges.m.b.H Apollogase 16-18 A-1072 Wien Austria
Palladone-XL 24mg 24 mg Prolonged-release capsule, hard Oral use
PL - Poland
Mundipharma Ges.m.b.H Apollogase 16-18 A-1072 Wien Austria
Palladone-XL 32mg 32 mg Prolonged-release capsule, hard Oral use
PL - Poland
Norpharma A/S Slotsmarken 15 2970 Hørsholm Denmark
MST Continus 10 mg Modified-release film-coated tablet
Oral use
PL - Poland
Norpharma A/S Slotsmarken 15 2970 Hørsholm Denmark
MST Continus 30 mg Modified-release film-coated tablet
Oral use
PL - Poland
Norpharma A/S Slotsmarken 15 2970 Hørsholm Denmark
MST Continus 60 mg Modified-release film-coated tablet
Oral use
PL - Poland
Norpharma A/S Slotsmarken 15 2970 Hørsholm Denmark
MST Continus 100 mg Modified-release film-coated tablet
Oral use
PL - Poland
Norpharma A/S Slotsmarken 15 2970 Hørsholm Denmark
MST Continus 200 mg Modified-release film-coated tablet
Oral use
PL - Poland
Norpharma A/S Slotsmarken 15 2970 Hørsholm Denmark
OxyContin 5 mg Prolonged-release tablet Oral use
100
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
PL - Poland
Norpharma A/S Slotsmarken 15 2970 Hørsholm Denmark
OxyContin 10 mg Prolonged-release tablet Oral use
PL - Poland
Norpharma A/S Slotsmarken 15 2970 Hørsholm Denmark
OxyContin 20 mg Prolonged-release tablet Oral use
PL - Poland
Norpharma A/S Slotsmarken 15 2970 Hørsholm Denmark
OxyContin 40 mg Prolonged-release tablet Oral use
PL - Poland
Norpharma A/S Slotsmarken 15 2970 Hørsholm Denmark
OxyContin 80 mg Prolonged-release tablet Oral use
PL - Poland Nycomed Pharma Sp. z o.o. Al. Jerozoimskie 146A 02-305 Warsaw, Poland
Doltard 10 mg Prolonged-release tablet Oral use
PL - Poland Nycomed Pharma Sp. z o.o. Al. Jerozoimskie 146A 02-305 Warsaw, Poland
Doltard 30 mg Prolonged-release tablet Oral use
PL - Poland Nycomed Pharma Sp. z o.o. Al. Jerozoimskie 146A 02-305 Warsaw, Poland
Doltard 60 mg Prolonged-release tablet Oral use
PL - Poland Nycomed Pharma Sp. z o.o. Al. Jerozoimskie 146A 02-305 Warsaw, Poland
Doltard 100 mg Prolonged-release tablet Oral use
PT - Portugal
Grünenthal, S.A. Rua Alfredo da Silva, 16 2610-016 Amadora Portugal
Grumorph 10 mg Prolonged-release capsule Oral use
PT - Portugal
Grünenthal, S.A. Rua Alfredo da Silva, 16 2610-016 Amadora Portugal
Grumorph 30 mg Prolonged-release capsule Oral use
PT - Portugal
Grünenthal, S.A. Rua Alfredo da Silva, 16 2610-016 Amadora Portugal
Grumorph 60 mg Prolonged-release capsule Oral use
101
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
PT - Portugal
Grünenthal, S.A. Rua Alfredo da Silva, 16 2610-016 Amadora Portugal
Grumorph 100 mg Prolonged-release capsule Oral use
PT - Portugal
Janssen-Cilag Farmacêutica, Lda. Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo 2734-503 Barcarena Portugal
Jurnista 8 mg Prolonged-release tablet Oral use
PT - Portugal
Janssen-Cilag Farmacêutica, Lda. Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo 2734-503 Barcarena Portugal
Jurnista 16 mg Prolonged-release tablet Oral use
PT - Portugal
Janssen-Cilag Farmacêutica, Lda. Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo 2734-503 Barcarena Portugal
Jurnista 32 mg Prolonged-release tablet Oral use
PT - Portugal
Janssen-Cilag Farmacêutica, Lda. Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo 2734-503 Barcarena Portugal
Jurnista 64 mg Prolonged-release tablet Oral use
PT - Portugal
Janssen-Cilag Farmacêutica, Lda. Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo 2734-503 Barcarena Portugal
Jurnista 4 mg Prolonged-release tablet Oral use
PT - Portugal
Mundipharma Farmacêutica, Lda. Praça Duque de Saldanha, 1 - 6º - Edifício Atrium Saldanha, 1050-094 São Jorge de Arroios – Lisboa Portugal
Mst 1 10 mg Prolonged-release tablet Oral use
PT - Portugal
Mundipharma Farmacêutica, Lda. Praça Duque de Saldanha, 1 - 6º - Edifício Atrium Saldanha, 1050-094 São Jorge de Arroios – Lisboa Portugal
Mst 10 100 mg Prolonged-release tablet Oral use
102
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
PT - Portugal
Mundipharma Farmacêutica, Lda. Praça Duque de Saldanha, 1 - 6º - Edifício Atrium Saldanha, 1050-094 São Jorge de Arroios – Lisboa Portugal
Mst 20 200 mg Prolonged-release tablet Oral use
PT - Portugal
Mundipharma Farmacêutica, Lda. Praça Duque de Saldanha, 1 - 6º - Edifício Atrium Saldanha, 1050-094 São Jorge de Arroios – Lisboa Portugal
Mst 3 30 mg Prolonged-release tablet Oral use
PT - Portugal
Mundipharma Farmacêutica, Lda. Praça Duque de Saldanha, 1 - 6º - Edifício Atrium Saldanha, 1050-094 São Jorge de Arroios – Lisboa Portugal
Mst 6 60 mg Prolonged-release tablet Oral use
PT - Portugal
Mundipharma GmbH Mundipharma Strasse 2 D-65549, Limburg Germany
Oxycontin 10 mg Prolonged-release tablet Oral use
PT - Portugal
Mundipharma GmbH Mundipharma Strasse 2 D-65549, Limburg Germany
Oxycontin 20 mg Prolonged-release tablet Oral use
PT - Portugal
Mundipharma GmbH Mundipharma Strasse 2 D-65549, Limburg Germany
Oxycontin 40 mg Prolonged-release tablet Oral use
PT - Portugal
Mundipharma GmbH Mundipharma Strasse 2 D-65549, Limburg Germany
Oxycontin 80 mg Prolonged-release tablet Oral use
PT - Portugal
Mundipharma GmbH Mundipharma Strasse 2 D-65549, Limburg Germany
Oxycontin 5 mg Prolonged-release tablet Oral use
PT - Portugal
Mundipharma GmbH Mundipharma Strasse 2 D-65549, Limburg Germany
Targin 9 mg + 4.5 mg
Prolonged-release tablet Oral use
103
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
PT - Portugal
Mundipharma GmbH Mundipharma Strasse 2 D-65549, Limburg Germany
Targin 18 mg + 9 mg Prolonged-release tablet Oral use
PT - Portugal
Mundipharma GmbH Mundipharma Strasse 2 D-65549, Limburg Germany
Targin 36 mg + 18 mg
Prolonged-release tablet Oral use
PT - Portugal
Mundipharma GmbH Mundipharma Strasse 2 D-65549, Limburg Germany
Targin 4.5 mg + 2.25 mg
Prolonged-release tablet Oral use
RO - Romania
Lannacher Heilmittel Ges.mbH Schloβplatz 1 A-8502, Lannach Austria
VENDAL RETARD 10 mg, comprimate cu eliberare prelungită
10 mg Prolonged-release tablet Oral use
RO - Romania
Lannacher Heilmittel Ges.mbH Schloβplatz 1 A-8502, Lannach Austria
VENDAL RETARD 100 mg, comprimate cu eliberare prelungită
100 mg Prolonged-release tablet Oral use
RO - Romania
Lannacher Heilmittel Ges.mbH Schloβplatz 1 A-8502, Lannach Austria
VENDAL RETARD 30 mg, comprimate cu eliberare prelungită
30 mg Prolonged-release tablet Oral use
RO - Romania
Lannacher Heilmittel Ges.mbH Schloβplatz 1 A-8502, Lannach Austria
VENDAL RETARD 60 mg, comprimate cu eliberare prelungită
60 mg Prolonged-release tablet Oral use
RO - Romania
MUNDIPHARMA Ges.m.b.H Apollogasse 16-18 A-1072 Viena Austria
MST CONTINUS 10 mg, comprimate cu eliberare modificată
10 mg Modified-release tablet Oral use
RO - Romania
MUNDIPHARMA Ges.m.b.H Apollogasse 16-18 A-1072 Viena Austria
MST CONTINUS 100 mg, comprimate cu eliberare modificată
100 mg Modified-release tablet Oral use
RO - Romania
MUNDIPHARMA Ges.m.b.H Apollogasse 16-18 A-1072 Viena Austria
MST CONTINUS 200 mg, comprimate cu eliberare modificată
200 mg Modified-release tablet Oral use
104
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
RO - Romania
MUNDIPHARMA Ges.m.b.H Apollogasse 16-18 A-1072 Viena Austria
MST CONTINUS 30 mg, comprimate fcu eliberare modificată
30 mg Modified-release tablet Oral use
RO - Romania
MUNDIPHARMA Ges.m.b.H Apollogasse 16-18 A-1072 Viena Austria
MST CONTINUS 60 mg, comprimate cu eliberare modificată
60 mg Modified-release tablet Oral use
RO - Romania
MUNDIPHARMA Ges.m.b.H. Apollogasse 16-18 A-1072 Viena Austria
OXYCONTIN 10 mg, comprimate cu eliberare modificată
10 mg Modified-release tablet Oral use
RO - Romania
MUNDIPHARMA Ges.m.b.H. Apollogasse 16-18 A-1072 Viena Austria
OXYCONTIN 20 mg, comprimate cu eliberare modificată
20 mg Modified-release tablet Oral use
RO - Romania
MUNDIPHARMA Ges.m.b.H. Apollogasse 16-18 A-1072 Viena Austria
OXYCONTIN 40 mg, comprimate cu eliberare modificată
40 mg Modified-release tablet Oral use
RO - Romania
MUNDIPHARMA Ges.m.b.H. Apollogasse 16-18 A-1072 Viena Austria
OXYCONTIN 80 mg, comprimate cu eliberare modificată
80 mg Modified-release tablet Oral use
SE - Sweden
Hexal A/S Kanalholmen 8-12 DK-2650 Hvidovre Denmark
Oxycodone Hexal 20 mg Prolonged-release tablet Oral use
SE - Sweden
Hexal A/S Kanalholmen 8-12 DK-2650 Hvidovre Denmark
Oxycodone Hexal 40 mg Prolonged-release tablet Oral use
SE - Sweden
Hexal A/S Kanalholmen 8-12 DK-2650 Hvidovre Denmark
Oxycodone Hexal 80 mg Prolonged-release tablet Oral use
SE - Sweden
Hexal A/S Kanalholmen 8-12 DK-2650 Hvidovre Denmark
Oxycodone Hexal 5 mg Prolonged-release tablet Oral use
105
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
SE - Sweden
Hexal A/S Kanalholmen 8-12 DK-2650 Hvidovre Denmark
Oxycodone Hexal 10 mg Prolonged-release tablet Oral use
SE - Sweden Lannacher Heilmittel Ges.m.b.H., Schlossplatz 1 8502 Lannach Austria
Depolan 10 mg Prolonged-release tablet Oral use
SE - Sweden Lannacher Heilmittel Ges.m.b.H., Schlossplatz 1 8502 Lannach Austria
Depolan 30 mg Prolonged-release tablet Oral use
SE - Sweden Lannacher Heilmittel Ges.m.b.H., Schlossplatz 1 8502 Lannach Austria
Depolan 60 mg Prolonged-release tablet Oral use
SE - Sweden Lannacher Heilmittel Ges.m.b.H., Schlossplatz 1 8502 Lannach Austria
Depolan 100 mg Prolonged-release tablet Oral use
SE - Sweden Lannacher Heilmittel Ges.m.b.H., Schlossplatz 1 8502 Lannach Austria
Depolan 200 mg Prolonged-release tablet Oral use
SE - Sweden Lannacher Heilmittel Ges.m.b.H., Schlossplatz 1 8502 Lannach Austria
Oxycodone Lannacher 5 mg Prolonged-release tablet Oral use
SE - Sweden Lannacher Heilmittel Ges.m.b.H., Schlossplatz 1 8502 Lannach Austria
Oxycodone Lannacher 10 mg Prolonged-release tablet Oral use
SE - Sweden Lannacher Heilmittel Ges.m.b.H., Schlossplatz 1 8502 Lannach Austria
Oxycodone Lannacher 20 mg Prolonged-release tablet Oral use
SE - Sweden Lannacher Heilmittel Ges.m.b.H., Schlossplatz 1 8502 Lannach Austria
Oxycodone Lannacher 40 mg Prolonged-release tablet Oral use
SE - Sweden Lannacher Heilmittel Ges.m.b.H., Schlossplatz 1 8502 Lannach Austria
Oxycodone Lannacher 80 mg Prolonged-release tablet Oral use
SE - Sweden
Mundipharma AB Mölndalsvägen 30 B 412 63 Göteborg Sweden
OxyContin 5 mg Prolonged-release tablet Oral use
106
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
SE - Sweden
Mundipharma AB Mölndalsvägen 30 B 412 63 Göteborg Sweden
OxyContin 10 mg Prolonged-release tablet Oral use
SE - Sweden
Mundipharma AB Mölndalsvägen 30 B 412 63 Göteborg Sweden
OxyContin 20 mg Prolonged-release tablet Oral use
SE - Sweden
Mundipharma AB Mölndalsvägen 30 B 412 63 Göteborg Sweden
OxyContin 40 mg Prolonged-release tablet Oral use
SE - Sweden
Mundipharma AB Mölndalsvägen 30 B 412 63 Göteborg Sweden
OxyContin 80 mg Prolonged-release tablet Oral use
SE - Sweden
Mundipharma AB Mölndalsvägen 30 B 412 63 Göteborg Sweden
OxyContin 160 mg Prolonged-release tablet Oral use
SE - Sweden
Mundipharma AB Mölndalsvägen 30 B 412 63 Göteborg Sweden
Palladon 4 mg Prolonged-release capsule, hard Oral use
SE - Sweden
Mundipharma AB Mölndalsvägen 30 B 412 63 Göteborg Sweden
Palladon 8 mg Prolonged-release capsule, hard Oral use
SE - Sweden
Mundipharma AB Mölndalsvägen 30 B 412 63 Göteborg Sweden
Palladon 16 mg Prolonged-release capsule, hard Oral use
SE - Sweden
Mundipharma AB Mölndalsvägen 30 B 412 63 Göteborg Sweden
Palladon 24 mg Prolonged-release capsule, hard Oral use
SE - Sweden
Mundipharma AB Mölndalsvägen 30 B 412 63 Göteborg Sweden
Targiniq 40 mg/20mg Prolonged-release tablet Oral use
107
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
SE - Sweden
Mundipharma AB Mölndalsvägen 30 B 412 63 Göteborg Sweden
Targiniq 5 mg/2,5mg Prolonged-release tablet Oral use
SE - Sweden
Mundipharma AB Mölndalsvägen 30 B 412 63 Göteborg Sweden
Targiniq 10 mg/5 mg Prolonged-release tablet Oral use
SE - Sweden
Mundipharma AB Mölndalsvägen 30 B 412 63 Göteborg Sweden
Targiniq 20 mg/10 mg Prolonged-release tablet Oral use
SE - Sweden Pfizer AB 191 90 Sollentuna Sweden
Dolcontin 20 mg Modified-release granules for oral suspension
Oral use
SE - Sweden Pfizer AB 191 90 Sollentuna Sweden
Dolcontin 30 mg Modified-release granules for oral suspension
Oral use
SE - Sweden Pfizer AB 191 90 Sollentuna Sweden
Dolcontin 60 mg Modified-release granules for oral suspension
Oral use
SE - Sweden Pfizer AB 191 90 Sollentuna Sweden
Dolcontin 100 mg Modified-release granules for oral suspension
Oral use
SE - Sweden Pfizer AB 191 90 Sollentuna Sweden
Dolcontin 10 mg Prolonged-release tablet Oral use
SE - Sweden Pfizer AB 191 90 Sollentuna Sweden
Dolcontin 30 mg Prolonged-release tablet Oral use
SE - Sweden Pfizer AB 191 90 Sollentuna Sweden
Dolcontin 60 mg Prolonged-release tablet Oral use
SE - Sweden Pfizer AB 191 90 Sollentuna Sweden
Dolcontin 100 mg Prolonged-release tablet Oral use
SE - Sweden Pfizer AB 191 90 Sollentuna Sweden
Dolcontin 200 mg Prolonged-release tablet Oral use
108
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
SE - Sweden Pfizer AB 191 90 Sollentuna Sweden
Dolcontin 5 mg Prolonged-release tablet Oral use
SE - Sweden Pfizer AB 191 90 Sollentuna Sweden
Dolcontin Unotard 30 mg Prolonged-release capsule, hard Oral use
SE - Sweden Pfizer AB 191 90 Sollentuna Sweden
Dolcontin Unotard 60 mg Prolonged-release capsule, hard Oral use
SE - Sweden Pfizer AB 191 90 Sollentuna Sweden
Dolcontin Unotard 90 mg Prolonged-release capsule, hard Oral use
SE - Sweden Pfizer AB 191 90 Sollentuna Sweden
Dolcontin Unotard 120 mg Prolonged-release capsule, hard Oral use
SE - Sweden Pfizer AB 191 90 Sollentuna Sweden
Dolcontin Unotard 150 mg Prolonged-release capsule, hard Oral use
SE - Sweden Pfizer AB 191 90 Sollentuna Sweden
Dolcontin Unotard 200 mg Prolonged-release capsule, hard Oral use
SE - Sweden
ratiopharm GmbH Graf-Arco-Strasse 3 DE-89079 Ulm Germany
Oxycodone ratiopharm 5 mg Prolonged-release tablet Oral use
SE - Sweden
ratiopharm GmbH Graf-Arco-Strasse 3 DE-89079 Ulm Germany
Oxycodone ratiopharm 10 mg Prolonged-release tablet Oral use
SE - Sweden
ratiopharm GmbH Graf-Arco-Strasse 3 DE-89079 Ulm Germany
Oxycodone ratiopharm 20 mg Prolonged-release tablet Oral use
SE - Sweden
ratiopharm GmbH Graf-Arco-Strasse 3 DE-89079 Ulm Germany
Oxycodone ratiopharm 40 mg Prolonged-release tablet Oral use
SE - Sweden
ratiopharm GmbH Graf-Arco-Strasse 3 DE-89079 Ulm Germany
Oxycodone ratiopharm 80 mg Prolonged-release tablet Oral use
109
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
SE - Sweden
Sandoz A/S C.F. Tietgens Boulevard 40 DK-5220 Odense SØ Danmark
Oxycodone Sandoz 5 mg Prolonged-release tablet Oral use
SE - Sweden
Sandoz A/S C.F. Tietgens Boulevard 40 DK-5220 Odense SØ Danmark
Oxycodone Sandoz 10 mg Prolonged-release tablet Oral use
SE - Sweden
Sandoz A/S C.F. Tietgens Boulevard 40 DK-5220 Odense SØ Danmark
Oxycodone Sandoz 20 mg Prolonged-release tablet Oral use
SI - Slovenia
Ethypharm 21, rue St. Mathieu (Z.I.) F- 78550 Houdan 194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex France
M-eslon 10 mg trde kapsule s podaljšanim sproščanjem
10 mg Prolonged-release capsule, hard Oral use
SI - Slovenia
Ethypharm 21, rue St. Mathieu (Z.I.) F- 78550 Houdan 194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex France
M-eslon 100 mg trde kapsule s podaljšanim sproščanjem 100 mg Prolonged-release capsule, hard Oral use
SI - Slovenia
Ethypharm 21, rue St. Mathieu (Z.I.) F- 78550 Houdan 194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex France
M-eslon 30 mg trde kapsule s podaljšanim sproščanjem 30 mg Prolonged-release capsule, hard Oral use
SI - Slovenia
Ethypharm 21, rue St. Mathieu (Z.I.) F- 78550 Houdan 194 Bureaux de la Colline - Bâtiment D 92213 Saint-Cloud cedex France
M-eslon 60 mg trde kapsule s podaljšanim sproščanjem 60 mg Prolonged-release capsule, hard Oral use
SI - Slovenia
Johnson & Johnson d.o.o. Šmartinska 53 SI- 1000 Ljubljana Slovenia
JURNISTA 16 mg tablete s podaljšanim sproščanjem
16 mg prolonged-release tablet Oral use
110
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
SI - Slovenia
Johnson & Johnson d.o.o. Šmartinska 53 SI- 1000 Ljubljana Slovenia
JURNISTA 32 mg tablete s podaljšanim sproščanjem
32 mg prolonged-release tablet Oral use
SI - Slovenia
Johnson & Johnson d.o.o. Šmartinska 53 SI- 1000 Ljubljana Slovenia
JURNISTA 4 mg tablete s podaljšanim sproščanjem
4 mg prolonged-release tablet Oral use
SI - Slovenia
Johnson & Johnson d.o.o. Šmartinska 53 SI- 1000 Ljubljana Slovenia
JURNISTA 64 mg tablete s podaljšanim sproščanjem
64 mg prolonged-release tablet Oral use
SI - Slovenia
Johnson & Johnson d.o.o. Šmartinska 53 SI- 1000 Ljubljana Slovenia
JURNISTA 8 mg tablete s podaljšanim sproščanjem
8 mg prolonged-release tablet Oral use
SI - Slovenia
LEK farmacevtska družba d.d. Verovškova 57 SI-1000 Ljubljana Slovenia
Carexil 10 mg tablete s podaljšanim sproščanjem
10 mg prolonged-release tablet Oral use
SI - Slovenia
LEK farmacevtska družba d.d. Verovškova 57 SI-1000 Ljubljana Slovenia
Carexil 20 mg tablete s podaljšanim sproščanjem
20 mg prolonged-release tablet Oral use
SI - Slovenia
LEK farmacevtska družba d.d. Verovškova 57 SI-1000 Ljubljana Slovenia
Carexil 5 mg tablete s podaljšanim sproščanjem
5 mg prolonged-release tablet Oral use
SI - Slovenia
LEK farmacevtska družba d.d., Verovškova 57 SI-1000 Ljubljana Slovenia
Oksikodon Lek 10 mg tablete s podaljšanim sproščanjem
10 mg prolonged-release tablet Oral use
SI - Slovenia
LEK farmacevtska družba d.d., Verovškova 57 SI-1000 Ljubljana Slovenia
Oksikodon Lek 20 mg tablete s podaljšanim sproščanjem
20 mg prolonged-release tablet Oral use
SI - Slovenia
LEK farmacevtska družba d.d., Verovškova 57 SI-1000 Ljubljana Slovenia
Oksikodon Lek 40 mg tablete s podaljšanim sproščanjem
40 mg prolonged-release tablet Oral use
111
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
SI - Slovenia
LEK farmacevtska družba d.d., Verovškova 57 SI-1000 Ljubljana Slovenia
Oksikodon Lek 5 mg tablete s podaljšanim sproščanjem
5 mg prolonged-release tablet Oral use
SI - Slovenia
LEK farmacevtska družba d.d., Verovškova 57 SI-1000 Ljubljana Slovenia
Oksikodon Lek 80 mg tablete s podaljšanim sproščanjem
80 mg prolonged-release tablet Oral use
SI - Slovenia
Medis, d.o.o. Brnčičeva 1 SI-1001 Ljubljana Slovenia
MST Continus 10 mg filmsko obložene tablete s podaljšanim sproščanjem
10 mg film-coated prolonged-release capsule, hard
Oral use
SI - Slovenia
Medis, d.o.o. Brnčičeva 1 SI-1001 Ljubljana Slovenia
MST Continus 100 mg filmsko obložene tablete s podaljšanim sproščanjem
100 mg film-coated prolonged-release capsule, hard
Oral use
SI - Slovenia
Medis, d.o.o. Brnčičeva 1 SI-1001 Ljubljana Slovenia
MST Continus 30 mg filmsko obložene tablete s podaljšanim sproščanjem
30 mg film-coated prolonged-release capsule, hard
Oral use
SI - Slovenia
Medis, d.o.o. Brnčičeva 1 SI-1001 Ljubljana Slovenia
MST Continus 60 mg filmsko obložene tablete s podaljšanim sproščanjem
60 mg film-coated prolonged-release capsule, hard
Oral use
SI - Slovenia
Medis, d.o.o. Brnčičeva 1 SI-1001 Ljubljana Slovenia
OxyContin 10 mg filmsko obložene tablete s podaljšanim sproščanjem
10 mg prolonged-release tablet Oral use
SI - Slovenia
Medis, d.o.o. Brnčičeva 1 SI-1001 Ljubljana Slovenia
OxyContin 20 mg filmsko obložene tablete s podaljšanim sproščanjem
20 mg prolonged-release tablet Oral use
SI - Slovenia
Medis, d.o.o. Brnčičeva 1 SI-1001 Ljubljana Slovenia
OxyContin 40 mg filmsko obložene tablete s podaljšanim sproščanjem
40 mg prolonged-release tablet Oral use
SI - Slovenia
Medis, d.o.o. Brnčičeva 1 SI-1001 Ljubljana Slovenia
OxyContin 80 mg filmsko obložene tablete s podaljšanim sproščanjem
80 mg prolonged-release tablet Oral use
112
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
SI - Slovenia
Medis, d.o.o. Brnčičeva 1 SI-1001 Ljubljana Slovenia
PALLADONE 16 mg trde kapsule s podaljšanim sproščanjem
16 mg Prolonged-release capsule, hard Oral use
SI - Slovenia
Medis, d.o.o. Brnčičeva 1 SI-1001 Ljubljana Slovenia
PALLADONE 2 mg trde kapsule s podaljšanim sproščanjem
2 mg Prolonged-release capsule, hard Oral use
SI - Slovenia
Medis, d.o.o. Brnčičeva 1 SI-1001 Ljubljana Slovenia
PALLADONE 24 mg trde kapsule s podaljšanim sproščanjem
24 mg Prolonged-release capsule, hard Oral use
SI - Slovenia
Medis, d.o.o. Brnčičeva 1 SI-1001 Ljubljana Slovenia
PALLADONE 4 mg trde kapsule s podaljšanim sproščanjem
4 mg Prolonged-release capsule, hard Oral use
SI - Slovenia
Medis, d.o.o. Brnčičeva 1 SI-1001 Ljubljana Slovenia
PALLADONE 8 mg trde kapsule s podaljšanim sproščanjem
8 mg Prolonged-release capsule, hard Oral use
SI - Slovenia
Medis, d.o.o. Brnčičeva 1 SI-1001 Ljubljana Slovenia
SUBSTITOL 120 mg trde kapsule s podaljšanim sproščanjem
120 mg Prolonged-release capsule, hard Oral use
SI - Slovenia
Medis, d.o.o. Brnčičeva 1 SI-1001 Ljubljana Slovenia
SUBSTITOL 200 mg trde kapsule s podaljšanim sproščanjem
200 mg Prolonged-release capsule, hard Oral use
SK - Slovakia
Johnson & Johnson s.r.o. Plynárenská 7/B Bratislava 82478 Slovak Republic
Jurnista 16 mg tablety s predĺženým uvoľňovaním
16 mg Prolonged-release tablet Oral use
SK - Slovakia
Johnson & Johnson s.r.o. Plynárenská 7/B Bratislava 82478 Slovak Republic
Jurnista 32 mg tablety s predĺženým uvoľňovaním
32 mg Prolonged-release tablet Oral use
SK - Slovakia
Johnson & Johnson s.r.o. Plynárenská 7/B Bratislava 82478 Slovak Republic
Jurnista 4 mg tablety s predĺženým uvoľňovaním
4 mg Prolonged-release tablet Oral use
113
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
SK - Slovakia
Johnson & Johnson s.r.o. Plynárenská 7/B Bratislava 82478 Slovak Republic
Jurnista 64 mg tablety s predĺženým uvoľňovaním
64 mg Prolonged-release tablet Oral use
SK - Slovakia
Johnson & Johnson s.r.o. Plynárenská 7/B Bratislava 82478 Slovak Republic
Jurnista 8 mg tablety s predĺženým uvoľňovaním
8 mg Prolonged-release tablet Oral use
SK - Slovakia
Lannacher Heilmittel Ges.m.b.H. Schlossplatz 1, 8502 Lannach Austria
Oxypro 10 mg tablety s predĺženým uvoľňovaním
10 mg Prolonged-release tablet Oral use
SK - Slovakia
Lannacher Heilmittel Ges.m.b.H. Schlossplatz 1, 8502 Lannach Austria
Oxypro 20 mg tablety s predĺženým uvoľňovaním
20 mg Prolonged-release tablet Oral use
SK - Slovakia
Lannacher Heilmittel Ges.m.b.H. Schlossplatz 1, 8502 Lannach Austria
Oxypro 40 mg tablety s predĺženým uvoľňovaním
40 mg Prolonged-release tablet Oral use
SK - Slovakia
Lannacher Heilmittel Ges.m.b.H. Schlossplatz 1, 8502 Lannach Austria
Oxypro 5 mg tablety s predĺženým uvoľňovaním
5 mg Prolonged-release tablet Oral use
SK - Slovakia
Lannacher Heilmittel Ges.m.b.H. Schlossplatz 1, 8502 Lannach Austria
Oxypro 80 mg tablety s predĺženým uvoľňovaním
80 mg Prolonged-release tablet Oral use
SK - Slovakia
Mundipharma Ges.m.b.H. Apollogasse 16-18 A-1072 Vienna Austria
MST Continus 100 mg 100 mg Modified-release tablet Oral use
SK - Slovakia
Mundipharma Ges.m.b.H. Apollogasse 16-18 A-1072 Vienna Austria
MST Continus 30 mg 30 mg Modified-release tablet Oral use
SK - Slovakia
Mundipharma Ges.m.b.H. Apollogasse 16-18 A-1072 Vienna Austria
MST Continus 10 mg 10 mg Modified-release tablet Oral use
114
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
SK - Slovakia
Mundipharma Ges.m.b.H. Apollogasse 16-18 A-1072 Vienna Austria
MST Continus 60 mg 60 mg Modified-release tablet Oral use
SK - Slovakia
Mundipharma Ges.m.b.H. Apollogasse 16-18 A-1072 Vienna Austria
OxyContin 10 mg 10 mg Modified-release tablet Oral use
SK - Slovakia
Mundipharma Ges.m.b.H. Apollogasse 16-18 A-1072 Vienna Austria
OxyContin 20 mg 20 mg Modified-release tablet Oral use
SK - Slovakia
Mundipharma Ges.m.b.H. Apollogasse 16-18 A-1072 Vienna Austria
OxyContin 40 mg 40 mg Modified-release tablet Oral use
SK - Slovakia
Mundipharma Ges.m.b.H. Apollogasse 16-18 A-1072 Vienna Austria
OxyContin 80 mg 80 mg Modified-release tablet Oral use
SK - Slovakia
Mundipharma Ges.m.b.H. Apollogasse 16-18 A-1072 Vienna Austria
PALLADONE - SR capsules 16 mg
16 mg Prolonged-release capsule, hard Oral use
SK - Slovakia
Mundipharma Ges.m.b.H. Apollogasse 16-18 A-1072 Vienna Austria
PALLADONE - SR capsules 2 mg 2 mg Prolonged-release capsule, hard Oral use
SK - Slovakia
Mundipharma Ges.m.b.H. Apollogasse 16-18 A-1072 Vienna Austria
PALLADONE - SR capsules 4 mg 4 mg Prolonged-release capsule, hard Oral use
SK - Slovakia
Mundipharma Ges.m.b.H. Apollogasse 16-18 A-1072 Vienna Austria
PALLADONE - SR capsules 8 mg 8 mg Prolonged-release capsule, hard Oral use
SK - Slovakia
Sandoz Pharmaceuticals d.d., Verovškova 57 1000 Ljubljana Slovenia
Oxykodón Sandoz 20 mg tablety s predĺženým uvoľňovaním
20 mg Prolonged-release tablet Oral use
115
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
SK - Slovakia
Sandoz Pharmaceuticals d.d., Verovškova 57 1000 Ljubljana Slovenia
Oxykodón Sandoz 40 mg tablety s predĺženým uvoľňovaním
40 mg Prolonged-release tablet Oral use
SK - Slovakia
Sandoz Pharmaceuticals d.d., Verovškova 57 1000 Ljubljana Slovenia
Oxykodón Sandoz 80 mg tablety s predĺženým uvoľňovaním
80 mg Prolonged-release tablet Oral use
SK - Slovakia
Sandoz Pharmaceuticals d.d., Verovškova 57 1000 Ljubljana Slovenia
Oxykosan 10 mg tablety s predĺženým uvoľňovaním
10 mg Prolonged-release tablet Oral use
SK - Slovakia
Sandoz Pharmaceuticals d.d., Verovškova 57 1000 Ljubljana Slovenia
Oxykosan 20 mg tablety s predĺženým uvoľňovaním
20 mg Prolonged-release tablet Oral use
SK - Slovakia
YES Pharmaceutical Devel. Services GmbH Bahnstrasse 42-46 D-61381, Friedrichsdorf Germany
Oxykodón YES 10 mg tablety s predĺženým uvoľňovaním
10 mg Prolonged-release tablet Oral use
SK - Slovakia
YES Pharmaceutical Devel. Services GmbH Bahnstrasse 42-46 D-61381, Friedrichsdorf Germany
Oxykodón YES 20 mg tablety s predĺženým uvoľňovaním
20 mg Prolonged-release tablet Oral use
SK - Slovakia
YES Pharmaceutical Devel. Services GmbH Bahnstrasse 42-46 D-61381, Friedrichsdorf Germany
Oxykodón YES 40 mg tablety s predĺženým uvoľňovaním
40 mg Prolonged-release tablet Oral use
SK - Slovakia
YES Pharmaceutical Devel. Services GmbH Bahnstrasse 42-46 D-61381, Friedrichsdorf Germany
Oxykodón YES 5 mg tablety s predĺženým uvoľňovaním
5 mg Prolonged-release tablet Oral use
SK - Slovakia
YES Pharmaceutical Devel. Services GmbH Bahnstrasse 42-46 D-61381, Friedrichsdorf Germany
Oxykodón YES 80 mg tablety s predĺženým uvoľňovaním
80 mg Prolonged-release tablet Oral use
116
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
UK - United Kingdom
Ethypharm 21, rue St. Mathieu (Z.I.) F- 78550 Houdan 194 Bureaux de la Colline - Bâtiment D, 92213 Saint-Cloud cedex France
ZOMORPH 100MG 100 mg Modified-release capsule Oral use
UK - United Kingdom
Ethypharm 21, rue St. Mathieu (Z.I.) F- 78550 Houdan 194 Bureaux de la Colline - Bâtiment D, 92213 Saint-Cloud cedex France
ZOMORPH 200MG 200 mg Modified-release capsule Oral use
UK - United Kingdom
Ethypharm 21, rue St. Mathieu (Z.I.) F- 78550 Houdan 194 Bureaux de la Colline - Bâtiment D, 92213 Saint-Cloud cedex France
ZOMORPH 30MG 30 mg Modified-release capsule Oral use
UK - United Kingdom
Ethypharm 21, rue St. Mathieu (Z.I.) F- 78550 Houdan 194 Bureaux de la Colline - Bâtiment D, 92213 Saint-Cloud cedex France
ZOMORPH 60MG 60 mg Modified-release capsule Oral use
UK - United Kingdom
Ethypharm 21, rue St. Mathieu (Z.I.) F- 78550 Houdan 194 Bureaux de la Colline - Bâtiment D, 92213 Saint-Cloud cedex France
ZOMORPH CAPSULES 10MG 10 mg Modified-release capsule Oral use
UK - United Kingdom
Ethypharm 21, rue St. Mathieu (Z.I.) F- 78550 Houdan 194 Bureaux de la Colline - Bâtiment D, 92213 Saint-Cloud cedex France
ZOMORPH CAPSULES XL 120MG PROLONGED-RELEASE CAPSULES
120 mg Prolonged-release capsule, hard Oral use
117
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
UK - United Kingdom
Ethypharm 21, rue St. Mathieu (Z.I.) F- 78550 Houdan 194 Bureaux de la Colline - Bâtiment D, 92213 Saint-Cloud cedex France
ZOMORPH CAPSULES XL 200MG PROLONGED-RELEASE CAPSULES
200 mg Prolonged-release capsule, hard Oral use
UK - United Kingdom
Ethypharm 21, rue St. Mathieu (Z.I.) F- 78550 Houdan 194 Bureaux de la Colline - Bâtiment D, 92213 Saint-Cloud cedex France
ZOMORPH CAPSULES XL 20MG PROLONGED-RELEASE CAPSULES
20 mg Prolonged-release capsule, hard Oral use
UK - United Kingdom
Ethypharm 21, rue St. Mathieu (Z.I.) F- 78550 Houdan 194 Bureaux de la Colline - Bâtiment D, 92213 Saint-Cloud cedex France
ZOMORPH CAPSULES XL 40MG PROLONGED-RELEASE CAPSULES
40 mg Prolonged-release capsule, hard Oral use
UK - United Kingdom
Ethypharm 21, rue St. Mathieu (Z.I.) F- 78550 Houdan 194 Bureaux de la Colline - Bâtiment D, 92213 Saint-Cloud cedex France
ZOMORPH CAPSULES XL 60MG PROLONGED-RELEASE CAPSULES
60 mg Prolonged-release capsule, hard Oral use
UK - United Kingdom
NAPP PHARMACEUTICALS LIMITED Cambridge Science Park, Milton Road Cambridge CB4 0GW United Kingdom
MST CONTINUS SUSPENSION 100MG
100 mg Prolonged-release granules Oral use
UK - United Kingdom
NAPP PHARMACEUTICALS LIMITED Cambridge Science Park, Milton Road Cambridge CB4 0GW United Kingdom
MST CONTINUS SUSPENSION 200MG
200 mg Prolonged-release granules Oral use
UK - United Kingdom
NAPP PHARMACEUTICALS LIMITED Cambridge Science Park, Milton Road Cambridge CB4 0GW United Kingdom
MST CONTINUS SUSPENSION 20MG
20 mg Prolonged-release granules Oral use
UK - United Kingdom
NAPP PHARMACEUTICALS LIMITED Cambridge Science Park, Milton Road Cambridge CB4 0GW United Kingdom
MST CONTINUS SUSPENSION 30MG
30 mg Prolonged-release granules Oral use
118
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
UK - United Kingdom
NAPP PHARMACEUTICALS LIMITED Cambridge Science Park, Milton Road Cambridge CB4 0GW United Kingdom
MST CONTINUS SUSPENSION 60MG
60 mg Prolonged-release granules Oral use
UK - United Kingdom
NAPP PHARMACEUTICALS LIMITED Cambridge Science Park, Milton Road Cambridge CB4 0GW United Kingdom
MST CONTINUS TABLETS 100MG
100 mg Prolonged-release tablet Oral use
UK - United Kingdom
NAPP PHARMACEUTICALS LIMITED Cambridge Science Park, Milton Road Cambridge CB4 0GW United Kingdom
MST CONTINUS TABLETS 10MG 10 mg Prolonged-release tablet Oral use
UK - United Kingdom
NAPP PHARMACEUTICALS LIMITED Cambridge Science Park, Milton Road Cambridge CB4 0GW United Kingdom
MST CONTINUS TABLETS 15MG 15 mg Prolonged-release tablet Oral use
UK - United Kingdom
NAPP PHARMACEUTICALS LIMITED Cambridge Science Park, Milton Road Cambridge CB4 0GW United Kingdom
MST CONTINUS TABLETS 200MG
200 mg Prolonged-release tablet Oral use
UK - United Kingdom
NAPP PHARMACEUTICALS LIMITED Cambridge Science Park, Milton Road Cambridge CB4 0GW United Kingdom
MST CONTINUS TABLETS 30MG 30 mg Prolonged-release tablet Oral use
UK - United Kingdom
NAPP PHARMACEUTICALS LIMITED Cambridge Science Park, Milton Road Cambridge CB4 0GW United Kingdom
MST CONTINUS TABLETS 5MG 5 mg Prolonged-release tablet Oral use
UK - United Kingdom
NAPP PHARMACEUTICALS LIMITED Cambridge Science Park, Milton Road Cambridge CB4 0GW United Kingdom
MST CONTINUS TABLETS 60MG 60 mg Prolonged-release tablet Oral use
UK - United Kingdom
NAPP PHARMACEUTICALS LIMITED Cambridge Science Park, Milton Road Cambridge CB4 0GW United Kingdom
MXL 120MG PROLONGED RELEASE CAPSULES
120 mg Prolonged-release capsule, hard Oral use
UK - United Kingdom
NAPP PHARMACEUTICALS LIMITED Cambridge Science Park, Milton Road Cambridge CB4 0GW United Kingdom
MXL 150MG PROLONGED RELEASE CAPSULES
150 mg Prolonged-release capsule, hard Oral use
119
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
UK - United Kingdom
NAPP PHARMACEUTICALS LIMITED Cambridge Science Park, Milton Road Cambridge CB4 0GW United Kingdom
MXL 200MG PROLONGED RELEASE CAPSULES
200 mg Prolonged-release capsule, hard Oral use
UK - United Kingdom
NAPP PHARMACEUTICALS LIMITED Cambridge Science Park, Milton Road Cambridge CB4 0GW United Kingdom
MXL 30MG PROLONGED RELEASE CAPSULES
30 mg Prolonged-release capsule, hard Oral use
UK - United Kingdom
NAPP PHARMACEUTICALS LIMITED Cambridge Science Park, Milton Road Cambridge CB4 0GW United Kingdom
MXL 60MG PROLONGED RELEASE CAPSULES
60 mg Prolonged-release capsule, hard Oral use
UK - United Kingdom
NAPP PHARMACEUTICALS LIMITED Cambridge Science Park, Milton Road Cambridge CB4 0GW United Kingdom
MXL 90MG PROLONGED RELEASE CAPSULES
90 mg Prolonged-release capsule, hard Oral use
UK - United Kingdom
NAPP PHARMACEUTICALS LIMITED Cambridge Science Park, Milton Road, Cambridge CB4 0GW United Kingdom
LONGTEC 10 MG FILM-COATED, PROLONGED RELEASE TABLETS
10 mg Prolonged-release tablet Oral use
UK - United Kingdom
NAPP PHARMACEUTICALS LIMITED Cambridge Science Park, Milton Road, Cambridge CB4 0GW United Kingdom
LONGTEC 20 MG FILM-COATED, PROLONGED RELEASE TABLETS
20 mg Prolonged-release tablet Oral use
UK - United Kingdom
NAPP PHARMACEUTICALS LIMITED Cambridge Science Park, Milton Road, Cambridge CB4 0GW United Kingdom
LONGTEC 40 MG FILM-COATED, PROLONGED RELEASE TABLETS
40 mg Prolonged-release tablet Oral use
UK - United Kingdom
NAPP PHARMACEUTICALS LIMITED Cambridge Science Park, Milton Road, Cambridge CB4 0GW United Kingdom
LONGTEC 5 MG FILM-COATED, PROLONGED RELEASE TABLETS
5 mg Prolonged-release tablet Oral use
UK - United Kingdom
NAPP PHARMACEUTICALS LIMITED Cambridge Science Park, Milton Road, Cambridge CB4 0GW United Kingdom
LONGTEC 80 MG FILM-COATED, PROLONGED RELEASE TABLETS
80 mg Prolonged-release tablet Oral use
UK - United Kingdom
NAPP PHARMACEUTICALS LIMITED Cambridge Science Park, Milton Road, Cambridge CB4 0GW United Kingdom
OXYCONTIN 10MG FILM-COATED, PROLONGED RELEASE TABLETS
10 mg Prolonged-release tablet Oral use
120
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
UK - United Kingdom
NAPP PHARMACEUTICALS LIMITED Cambridge Science Park, Milton Road, Cambridge CB4 0GW United Kingdom
OXYCONTIN 20MG FILM-COATED, PROLONGED RELEASE TABLETS
20 mg Prolonged-release tablet Oral use
UK - United Kingdom
NAPP PHARMACEUTICALS LIMITED Cambridge Science Park, Milton Road, Cambridge CB4 0GW United Kingdom
OXYCONTIN 40MG FILM-COATED, PROLONGED RELEASE TABLETS
40 mg Prolonged-release tablet Oral use
UK - United Kingdom
NAPP PHARMACEUTICALS LIMITED Cambridge Science Park, Milton Road, Cambridge CB4 0GW United Kingdom
OXYCONTIN 5MG FILM-COATED, PROLONGED RELEASE TABLETS
5 mg Prolonged-release tablet Oral use
UK - United Kingdom
NAPP PHARMACEUTICALS LIMITED Cambridge Science Park, Milton Road, Cambridge CB4 0GW United Kingdom
OXYCONTIN 80MG FILM-COATED, PROLONGED RELEASE TABLETS
80 mg Prolonged-release tablet Oral use
UK - United Kingdom
NAPP PHARMACEUTICALS LIMITED Cambridge Science Park, Milton Road, Cambridge CB4 0GW United Kingdom
PALLADONE SR CAPSULES 16MG
16 mg Modified-release capsule Oral use
UK - United Kingdom
NAPP PHARMACEUTICALS LIMITED Cambridge Science Park, Milton Road, Cambridge CB4 0GW United Kingdom
PALLADONE SR CAPSULES 24MG
24 mg Modified-release capsule Oral use
UK - United Kingdom
NAPP PHARMACEUTICALS LIMITED Cambridge Science Park, Milton Road, Cambridge CB4 0GW United Kingdom
PALLADONE SR CAPSULES 2MG 2 mg Modified-release capsule Oral use
UK - United Kingdom
NAPP PHARMACEUTICALS LIMITED Cambridge Science Park, Milton Road, Cambridge CB4 0GW United Kingdom
PALLADONE SR CAPSULES 4MG 4 mg Modified-release capsule Oral use
UK - United Kingdom
NAPP PHARMACEUTICALS LIMITED Cambridge Science Park, Milton Road, Cambridge CB4 0GW United Kingdom
PALLADONE SR CAPSULES 8MG 8 mg Modified-release capsule Oral use
UK - United Kingdom
NAPP PHARMACEUTICALS LIMITED Cambridge Science Park, Milton Road, Cambridge CB4 0GW United Kingdom
TARGINACT 10 MG/5 MG PROLONGED-RELEASE TABLETS
10 mg + 5mg Prolonged-release tablet Oral use
121
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
UK - United Kingdom
NAPP PHARMACEUTICALS LIMITED Cambridge Science Park, Milton Road, Cambridge CB4 0GW United Kingdom
TARGINACT 20 MG/10 MG PROLONGED-RELEASE TABLETS
20 mg +10 mg
Prolonged-release tablet Oral use
UK - United Kingdom
NAPP PHARMACEUTICALS LIMITED Cambridge Science Park, Milton Road, Cambridge CB4 0GW United Kingdom
TARGINACT 40 MG/20 MG PROLONGED-RELEASE TABLETS
40 mg +20 mg
Prolonged-release tablet Oral use
UK - United Kingdom
NAPP PHARMACEUTICALS LIMITED Cambridge Science Park, Milton Road, Cambridge CB4 0GW United Kingdom
TARGINACT 5 MG/2.5 MG PROLONGED-RELEASE TABLETS
5 mg +2.5 mg Prolonged-release tablet Oral use
UK - United Kingdom
RATIOPHARM GMBH Graf-Arco Strasse 3 Ulm, D-89079 Germany
CANDOX 10MG PROLONGED-RELEASE TABLETS
10 mg Prolonged-release tablet Oral use
UK - United Kingdom
RATIOPHARM GMBH Graf-Arco Strasse 3 Ulm, D-89079 Germany
CANDOX 20 MG PROLONGED-RELEASE TABLETS
20 mg Prolonged-release tablet Oral use
UK - United Kingdom
RATIOPHARM GMBH Graf-Arco Strasse 3 Ulm, D-89079 Germany
CANDOX 40 MG PROLONGED-RELEASE TABLETS
40 mg Prolonged-release tablet Oral use
UK - United Kingdom
RATIOPHARM GMBH Graf-Arco Strasse 3 Ulm, D-89079 Germany
CANDOX 5MG PROLONGED-RELEASE TABLETS
5 mg Prolonged-release tablet Oral use
UK - United Kingdom
RATIOPHARM GMBH Graf-Arco Strasse 3 Ulm, D-89079 Germany
CANDOX 80 MG PROLONGED-RELEASE TABLETS
80 mg Prolonged-release tablet Oral use
UK - United Kingdom
SANDOZ LIMITED 37 Woolmer Way, Borden Hampshire GU35 9QE United Kingdom
CAREXIL 10MG PROLONGED-RELEASE TABLETS
10 mg Prolonged-release tablet Oral use
UK - United Kingdom
SANDOZ LIMITED 37 Woolmer Way, Borden Hampshire GU35 9QE United Kingdom
CAREXIL 20MG PROLONGED-RELEASE TABLETS
20 mg Prolonged-release tablet Oral use
122
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
UK - United Kingdom
SANDOZ LIMITED 37 Woolmer Way, Borden Hampshire GU35 9QE United Kingdom
CAREXIL 5MG PROLONGED-RELEASE TABLETS
5 mg Prolonged-release tablet Oral use
UK - United Kingdom
SANDOZ LIMITED 37 Woolmer Way, Borden Hampshire GU35 9QE United Kingdom
CONTIROXIN 10 MG PROLONGED-RELEASE TABLETS
10 mg Prolonged-release tablet Oral use
UK - United Kingdom
SANDOZ LIMITED 37 Woolmer Way, Borden Hampshire GU35 9QE United Kingdom
CONTIROXIN 20 MG PROLONGED-RELEASE TABLETS
20 mg Prolonged-release tablet Oral use
UK - United Kingdom
SANDOZ LIMITED 37 Woolmer Way, Borden Hampshire GU35 9QE United Kingdom
CONTIROXIN 40 MG PROLONGED-RELEASE TABLETS
40 mg Prolonged-release tablet Oral use
UK - United Kingdom
SANDOZ LIMITED 37 Woolmer Way, Borden Hampshire GU35 9QE United Kingdom
CONTIROXIN 5 MG PROLONGED-RELEASE TABLETS
5 mg Prolonged-release tablet Oral use
UK - United Kingdom
SANDOZ LIMITED 37 Woolmer Way, Borden Hampshire GU35 9QE United Kingdom
CONTIROXIN 80 MG PROLONGED-RELEASE TABLETS
80 mg Prolonged-release tablet Oral use
UK - United Kingdom
Teva Uk Limited Brampton Road, Hampden Park, Eastbourne, E Sussex BN22 9AG United Kingdom
FILNARINE SR 100MG PROLONGED RELEASE TABLETS
100 mg Prolonged-release tablet Oral use
UK - United Kingdom
Teva Uk Limited Brampton Road, Hampden Park, Eastbourne, E Sussex BN22 9AG United Kingdom
FILNARINE SR 10MG PROLONGED RELEASE TABLETS
10 mg Prolonged-release tablet Oral use
UK - United Kingdom
Teva Uk Limited Brampton Road, Hampden Park, Eastbourne, E Sussex BN22 9AG United Kingdom
FILNARINE SR 200MG PROLONGED RELEASE TABLETS
200 mg Prolonged-release tablet Oral use
UK - United Kingdom
Teva Uk Limited Brampton Road, Hampden Park, Eastbourne, E Sussex BN22 9AG United Kingdom
FILNARINE SR 30MG PROLONGED RELEASE TABLETS
30 mg Prolonged-release tablet Oral use
123
124
Member State (EU/EEA)
Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of
administration
UK - United Kingdom
Teva Uk Limited Brampton Road, Hampden Park, Eastbourne, E Sussex BN22 9AG United Kingdom
FILNARINE SR 60MG PROLONGED RELEASE TABLETS
60 mg Prolonged-release tablet Oral use
UK - United Kingdom
WAYMADE PLC Sovereign House, Miles Gray Road, Basildon, Essex SS14 3FR United Kingdom
MORPHGESIC SR 100MG TABLETS
100 mg Modified-release tablet Oral use
UK - United Kingdom
WAYMADE PLC Sovereign House, Miles Gray Road, Basildon, Essex SS14 3FR United Kingdom
MORPHGESIC SR 10MG TABLETS
10 mg Modified-release tablet Oral use
UK - United Kingdom
WAYMADE PLC Sovereign House, Miles Gray Road, Basildon, Essex SS14 3FR United Kingdom
MORPHGESIC SR 30MG TABLETS
30 mg Modified-release tablet Oral use
UK - United Kingdom
WAYMADE PLC Sovereign House, Miles Gray Road, Basildon, Essex SS14 3FR United Kingdom
MORPHGESIC SR 60MG TABLETS
60 mg Modified-release tablet Oral use
ANNEX II
Scientific conclusions and grounds for suspension/amendment of the summaries of product characteristics, package leaflets and labelling presented by the European Medicines Agency
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Scientific conclusions
Overall summary of the scientific evaluation of modified-release oral opioid products in the level III of the WHO scale for the management of pain (intense sustained pain resistant to previous medications) (see Annex I)
1. Introduction
On 18 September 2009, the European Commission triggered a referral under Article 31 of Directive 2001/83/EC, as amended. In the context of marketing authorisation procedures for oxycodone-containing products, possible differences in the safety profile of the originator and generic products had been raised concerning the interaction with alcohol. The CHMP was then asked by the European Commission to determine whether there is a need to take specific measures to deal with the consequences of the interaction between strong-opioid modified-release oral products and alcohol. Therefore, the European Commission requested the CHMP to give its opinion on whether the marketing authorisations for authorised modified-release oral medicinal products of the WHO level III scale for the management of pain (intense sustained pain resistant to previous medications) (containing morphine, oxycodone, fentanyl and hydromorphone) should be maintained, varied, suspended or withdrawn. Modified-release products are complex dosage forms designed to release drugs in a controlled manner to achieve desired efficacy and safety profiles. If, however, the modified-release system is influenced by an external factor or substance (such as alcohol), it is possible that a large quantity of the active substance is released in a short timeframe so that it resembles an immediate-release dosage form. This effect is known as ‘dose-dumping’. In order to assess the potential for dose-dumping of each product, MAHs of products in the level III of the WHO scale for the management of severe pain were asked to submit data on their products. Level III of the WHO scale includes fentanyl, hydromorphone, morphine and oxycodone, however no oral modified-release products containing fentanyl are currently authorised in the EU, as due to a marked first pass effect, oral administration of fentanyl is not feasible.
2. Quality issues
Dissolution data was submitted for two different controlled release systems of hydromorphone, four different controlled release systems of oxycodone, and seven different controlled release systems containing morphine. From the products tested, fifty percent of the formulations were found to be affected by alcohol solutions in vitro. The effect of alcohol on the dissolution rate was mild in most cases, except for one morphine formulation (morphine once-daily capsules). This morphine formulation with polymethacrylate- triethylcitrate coating as modified-release mechanism has been identified as a product where dose dumping might occur when taken together with alcohol. The in vitro data showed a release of 80% of the drug within 15 minutes in 20% of alcohol solution. The polymethacrylate-triethylcitrate based formulation is highly sensitive to alcohol with its modified release properties being destroyed shortly after exposure, making it resemble an immediate release formulation. A product containing hydromorphone and a prolonged release system consisting of ammonio methacrylate co-polymer type B (Eudragit RS) also suffered a significant effect of high concentrations of alcohol on in vitro dissolution. This product has never been marketed. The remaining systems were not significantly affected by alcohol.
126
3. Clinical issues
For most of the products assessed, only in vitro data was submitted. In a limited number of cases, the MAH has also presented the results of in vivo studies and/or a review of adverse event reports which may have been related to the concomitant use of alcohol. In vivo studies conducted with a hydromorphone formulation based on ammonio methacrylate co-polymer type B (Eudragit RS) confirmed the existing in vitro data suggesting that alcohol affects the formulation. Another study conducted with a hydromorphone formulation based on cellulose acetate 398-10 and Macrogol 3350 formulation confirmed the conclusions of the in vitro studies that the effect of coadministered alcohol on PK parameters is rather limited. The results of the only study with a morphine product (ethylcellulose N-50, methacrylic acid copolymer type C, polyethylene glycol 6000 and diethyl phthalate formulation) indicate that a relatively high quantity of alcohol has almost no effect in vivo. A low number of cases of interaction between alcohol and opioid products have been reported, most reports involved intentional overdose or abuse in conjunction with other products and some were fatal. Given the type of products and patient population involved, it is acknowledged that underreporting is considerable. Alcohol use is common in patients with chronic pain due to the fact that it reduces pain perception. In the scientific literature, drinking alcohol is referred as a coping mechanism to deal with the stress associated with pain. This may be further aggravated by the fact that many patients with chronic pain will also suffer from depression. Concurrent depression and pain have a much greater impact than either disorder alone and, in patients with pain, depression is associated to more pain sites, greater pain intensity, longer duration of pain, and greater likelihood of poor treatment response (Bair, J et al., Psychosom Med. 2008 October; 70(8): 890-897). The association between pain and drinking was evaluated by Brennan et al in a cohort of 401 elderly with different drinking behavior (Brennan, Addiction. 2005; 100(6): 777-86). Both problem drinkers and non-problem drinkers were included. Both problem drinkers as non-problem drinkers reported to use alcohol to manage pain, although in the latter group to less extent (see figure 1). Pain at baseline was a significant predictive factor for alcohol use in the 3-years follow-up period.
Source; Brennan et al., Addiction 2005; 100 : 777-86
127
While it may be argued that patients may use less alcohol as a self-medication strategy if they are sufficiently treated with analgesics like opioids, the results of a recently published Danish Health survey (Ekholm et al. Eur J Pain 2009; 13: 606-12) reveal a different pattern of behavior. In this study, subjects were interviewed about their number of alcohol consumptions of the last week and frequency of binge drinking in the last month (5292 responders). About 20% of the responders reported chronic pain (>6 months). The association between chronic pain and alcohol use is summarized in the table below.
Patients being treated with opioids tend to drink less alcohol than patients who do not use opioids at all. However, a significant percentage of the patients with chronic pain who uses opioids still reports high alcohol intake (10.8%) and binge drinking at least once a month (22.3%), despite existing warnings.
4. Benefit-Risk balance
Having considered all the data submitted, it can be concluded that the large majority of modified-release oral opioid products in the European Union do not exhibit a clinically significant interaction with alcohol. While a pharmacodynamic interaction with alcohol may occur irrespective of the formulation, in most cases a pharmacokinetic interaction will not be clinically significant so as to warrant measures beyond the proposed wording for the product information. Fifty-percent of the formulations assessed are affected by alcohol solutions in vitro, but in most cases, the effect of alcohol on the dissolution rate is mild. The exception is one morphine formulation using polymethacrylate-triethylcitrate coating as modified-release mechanism, for which dose dumping might occur when taken together with alcohol. The dissolution profile of this product (80% dissolved substance within 15 min in 20% alcohol) is beyond the limit of the Ph. Eur. for conventional-release products (NLT 75% dissolved active substance within 45 minutes). In addition, as the medicinal product based on this release-mechanism is intended for once a day dosing, the content of morphine is high and therefore the risk of adverse events following dose-dumping is also higher. A significant effect was observed also in a hydromorphone once a day formulation which is not marketed in the EU.
128
In light of the existing data, including published data on the use of alcohol in patients treated with opioids, the Committee is of the opinion that the current warnings and contraindications are not sufficient to protect patients from the significant alcohol interaction observed with the polymethacrylate- triethylcitrate formulation. The Committee is also of the opinion that further minimisations measures would not adequately address the concern. Therefore, patients taking this particular formulation are exposed to a significantly greater risk of developing serious adverse reactions such as respiratory depression and death. For all other strong-opioid modified release oral products in the European market (formulations not containing polymethacrylate-triethylcitrate), no significant risk of dose-dumping due to alcohol use was identified. However, for all of these products, a pharmacodynamic interaction may occur and should be mentioned in the Product information of all products in a consistent manner. While most products already contain warnings and references to this interaction in the SPC, the wording should be harmonised to ensure the same level of awareness. The assessment within this procedure provided an overview of the modified-release systems used in the European Union in oral opioid products. Not all MAHs of modified-release oral opioid products in the level III of the WHO scale for the management of pain in the European market submitted data, and so it can not be guaranteed that all products approved in the EU have been assessed. The National Competent Authorities should therefore determine, based on the modified-release mechanism of the products approved in their Member State, the appropriate actions to be taken for individual products.
5. Re-examination procedure
Following the CHMP Opinion of 22 July 2010, one MAH submitted detailed grounds for the re-examination of the opinion. The MAH expressed the view that: 1. The CHMP had not addressed the issue of the additional risk to patients posed by modified release
formulations of opioids which exhibit a greater vulnerability to alcohol compared with the reference product, whilst conferring no additional patient benefit.
2. The Opinion did not take account of the earlier advice of its own working parties, namely the EWP
and QWP, which had been requested by the CMD(h); nor did it provide any proper reasons for discounting that advice.
3. The CHMP’s conclusions were arbitrary. Firstly, the Opinion does not provide any information
regarding the acceptance criteria to be applied in relation to the clinical significance of pharmacokinetic interactions with alcohol. Secondly, the CHMP’s approach to alcohol interaction is inconsistent with its approach to food interactions.
4. The Opinion was not properly reasoned. In particular, assumptions were made about the behaviour
of some formulations based solely on the excipients; in this respect the CHMP did not take into account the evidence provided in the Oral Hearing on 23 June 2010 that such assumptions are flawed.
Further to the request from the MAH, the CHMP convened an Ad-Hoc Expert meeting including experts on technology/formulation science, pharmacokinetics and clinical/medical practice in order to deliver answers on a consultative basis to specific questions in relation to the grounds for re-examination. Having assessed the detailed grounds for re-examination provided by the MAH, the rapporteurs assessment reports, the conclusions from the ad hoc expert meeting together with the MAH’s expressed concerns on the conclusions of the ad hoc expert meeting and all the information submitted during the referral procedure, the CHMP discussed each one of the grounds submitted:
129
1. The CHMP had not addressed the issue of the additional risk to patients posed by modified
release formulations of opioids which exhibit a greater vulnerability to alcohol compared with the reference product, whilst conferring no additional patient benefit.
The issue of additional risk to patients was addressed by CHMP in its initial opinion, and as a consequence a recommendation was adopted to suspend and reformulate the formulations where the interaction was of such magnitude that the products essentially resemble an immediate release formulation (while containing the opioid dose appropriate for a modified release formulation). In this context, the fact that the product is meant for use once or twice a day may be of importance given the higher dose usually contained in once a day formulations. In addition, the CHMP agreed on the inclusion for all other products in the European market of a pharmacodynamic warning. This is justified on the basis that a pharmacodynamic interaction between opioid products and alcohol may occur irrespective of the formulation. The Committee also discussed the possibility of the introduction of a pharmacokinetic warning in those cases where some degree of additional formulation interaction could be suspected. In this respect, it was noted that the in vitro - in vivo correlation is unclear in most cases, and therefore it would be inappropriate to assume a pharmacokinetic interaction. This is clearly demonstrated by the existing data for one specific product for which the in vitro interaction is significant but where the pharmacokinetic parameters did not differ significantly among subjects taking the product with water or with alcohol (ethylcellulose N-50, methacrylic acid copolymer type C, polyethylene glycol 6000 and diethyl phthalate product). The Committee also reflected on the usefulness for prescribers and patients of a pharmacokinetic warning in the Product Information referring to the in vitro data. Considering that the proposed pharmacodynamic warning already advises against concomitant use with alcohol, considering also the limitations of the in vitro data and difficulties in its interpretation by prescribers, the majority of the Committee was of the opinion that the addition of a pharmacokinetic interaction warning based on a description of the in vitro data would not favour the clarity of the message to patients and prescribers regarding the need to avoid concomitant use with alcohol. 2. The Opinion did not take account of the earlier advice of its own working parties, namely
the EWP and QWP, which had been requested by the CMD(h); nor did it provide any proper reasons for discounting that advice.
When adopting its 22 July 2010 opinion on this procedure, CHMP was fully aware of the positions of the different working parties. The advice of the QWP was that formulations should, if possible, be developed such that a physicochemical incompatibility with alcohol is avoided. Where not possible, the QWP recommended the inclusion of differential wording in the Product Information. The question of what could be considered as a clinical significant interaction with alcohol was left for the EWP to consider. The advice of the EWP was to consider the worst case scenario, including gastric residence times of 1-2 to hours and potential exposure to high concentrations of alcohol. As a consequence, where accelerated drug release is seen, the EWP’s recommendation was for label warnings and risk management strategies to be considered. In its detailed grounds for re-examination the MAH referred to statistical analysis confirming different behaviours in the presence of alcohol for a generic and its originator product. This aspect is outside the scope of this procedure and it does not provide any relevant information to the issue at stake. More than confirming that the generic and originator are bioequivalent, in this review it is important to consider whether the observed in vitro effect constitutes an unacceptable risk for patients. In its assessment, the Committee took into consideration data submitted for the different timepoints. An important interaction following alcohol consumption becomes progressively less likely with time due to dilution effect by gastric secretions and saliva, and gastric emptying. This is demonstrated by measurements of gastric-duodenal ethanol levels after consumption of alcohol in healthy volunteers. Gastric ethanol concentrations dropped rapidly after the consumption of alcohol by 70% in 10 min (Levitt et all, Am J Physiol Gastrointest Liver Physiol 273:951-957, 1997). With food the gastric emptying of alcohol is delayed, but still significant (50-60% in 1 hour, Levitt, 1997, and Cortot et al, Digestive Diseases and Sciences 1986; 31:343-48).
130
3. The CHMP’s conclusions were arbitrary. Firstly, the Opinion does not provide any
information regarding the acceptance criteria to be applied in relation to the clinical significance of pharmacokinetic interactions with alcohol. Secondly, the CHMP’s approach to alcohol interaction is inconsistent with its approach to food interactions.
The Opinion does not provide information on the acceptance criteria to be applied in relation to the clinical significance of pharmacokinetic interactions because there are currently no standard acceptance criteria to be applied in this context. Further to that, the IVIV correlation is, at present time, uncertain for most products. It follows from the above that data presented on the in vitro effects of alcohol on the dissolution profile of these products are not necessarily a reliable predictor of in vivo behaviour and therefore recommendations such as suspension and reformulation of products should only be adopted for products for which the in vitro interaction is of such magnitude that the products are considered to pose serious risks to the patients. In its detailed grounds for re-examination, the MAH referred to a competitor product in which the release of oxycodone is accelerated in the presence of alcohol as an example of a potentially clinically meaningful interaction. According to the data on a competitor product presented by the MAH requesting re-examination, this product starts to exhibit accelerated release of the active substance after approximately 30 min of exposition to alcohol, and is claimed to release 76.5% of the oxycodone dose within one hour of exposure to concentrations of alcohol around 24%. A product with this dissolution profile cannot be considered to behave as an immediate release formulation. A similar dissolution study from 2007 however, showed that at 60 minutes the dissolution rate of the reference product (considered by the MAH to be a safe product) in the absence of alcohol was actually higher that the dissolution rate of the competing product presented when exposed to 20% alcohol. It is of note that, in the data presented by the MAH for this competitor product, the most pronounced effect of alcohol is not at the highest alcohol concentrations tested (40%), but between 28%-32%. This further illustrates the limitations of the data presented. From all the above mentioned considerations, including the limitations of the existing data and the current status of scientific knowledge, it follows that general recommendations for acceptance criteria to be applied in relation to the clinical significance of pharmacokinetic interactions with alcohol can not be determined by the Committee at this time. The MAH further considered, in its grounds for re-examination, that the CHMP opinion was inconsistent in its approach regarding alcohol versus food interactions. It is well known that food can have an effect on the pharmacokinetic parameters of medicinal products. It is important to note in this regard that the effects of food related interactions are measured in vivo, and therefore the data on food effect reflects, as accurately as possible, the real extent of the interaction. Food related interactions are taken into consideration and reflected in the SPC and package leaflet for the benefit of patients and prescribers. For alcohol, the majority of the data available relates to in vitro testing only, and therefore cannot be assumed, for the reasons previously explained, to be directly reproduced in vivo. Considering that the proposed pharmacodynamic warning already advises against concomitant use with alcohol, considering also the limitations of the in vitro data and difficulties in its interpretation by prescribers, the majority of the Committee was of the opinion that the addition of a pharmacokinetic interaction warning based on a description of the in vitro data would not favour the clarity of the message to patients and prescribers regarding the need to avoid concomitant use with alcohol. It is therefore concluded that the approach is not inconsistent, firstly because in the case of alcohol, a recommendation not to take the product with alcohol will always exist regardless of the formulation. Secondly, because unlike alcohol, SPC information on food interactions will reflect in vivo studies and therefore have clear added value for the prescriber and the patient.
131
4. The Opinion was not properly reasoned. In particular, assumptions were made about the
behaviour of some formulations based solely on the excipients; in this respect the CHMP did not take into account the evidence provided in the Oral Hearing on 23 June 2010 that such assumptions are flawed.
The anticipated increase in dissolution rate observed for modified-release products is a result of the modified release system being rendered unstable in the presence of alcohol. This will be related to the specificities of each formulation, namely the physical characteristics of the excipients and the manufacturing process. It is however clear that, in the cases where the highest degree of in vitro interaction was observed, the high alcohol solubility of the excipients provided a clear explanation for the observation. The MAH mentioned in his grounds for re-examination a paper by Smith at al (In vitro dissolution of oral modified-release tablets and capsules in ethanolic media, International Journal of Pharmaceutics 398 (2010) 93-96) to illustrate that formulations should not be assumed to be unaffected by alcohol without data being evaluated. In its initial Opinion, the CHMP did not conclude that the formulations analysed were unaffected by alcohol. It is clearly stated in the Opinion that 50% of the formulations were found to be affected by alcohol in vitro. The question under discussion is, however, whether the magnitude of the interaction is such that it can be assumed to have clinical significance and represent a significant risk for the patient. It should be noted that, while the authors of the above mentioned paper go on to conclude that ‘in vitro dissolution may provide evidence regarding the ruggedness of formulations to ingested alcohol’, no recommendations are issued to specific products given that ‘…further research is needed to understand the relationship between dosage form, product formulation and configuration and drug release in the presence of ethanol.’ The CHMP having assessed all the detailed grounds for re-examination and argumentation presented by the MAH and having considered the views of the Rapporteurs, the scientific discussion within the Committee and the conclusions of the ad hoc expert group as well as the concerns raised by the MAH in this respect, concluded that products with a polymethacrylate-triethylcitrate coating are harmful under the normal conditions of use and that, for the remaining products, the Product Information should be amended to include a warning and recommendation for avoiding concomitant use with alcohol. The Committee is therefore of the opinion that its 22 July 2010 opinion should be maintained.
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Grounds for amendment of the summaries of product characteristics, package leaflets and labelling
Whereas The Committee considered the procedure under Article 31 of Directive 2001/83/EC, as amended
for modified-release oral opioid products in the level III of the WHO scale for the management of pain (intense sustained pain resistant to previous medications) on the EU market,
The Committee considered all the available data submitted by the MAHs,
The Committee considered that a pharmacodynamic interaction between opioid products and alcohol may occur irrespective of the formulation,
The Committee considered that, based on the published literature, a significant percentage of the patient population using these products does not abstain from alcohol consumption despite the existing warnings and contraindications,
The Committee considered that products without a polymethacrylate-triethylcitrate coating as modified-release mechanism do not suggest a significant interaction with alcohol considered to be harmful under normal conditions of use,
The Committee considered, however, that as a pharmacodynamic interaction with alcohol may occur, the product information of the above mentioned products should describe in a clear and harmonised manner the pharmacodynamic interaction between opioid products and alcohol,
The Committee therefore recommended the amendment of the Marketing Authorisation for which the relevant sections of the Summary of Product Characteristics and Package Leaflet are set out in Annex III. As not all medicinal products concerned by this review submitted data, the National Competent Authorities should ensure, based on the modified-release mechanism of the products approved in each Member State, that the appropriate actions are taken for individual products.
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Grounds for suspension of the marketing authorisation
Whereas The Committee considered the procedure under Article 31 of Directive 2001/83/EC, as amended
for modified-release oral opioid products in the level III of the WHO scale for the management of pain (intense sustained pain resistant to previous medications),
The Committee considered all the available data submitted by the MAHs,
The Committee noted that a pharmacodynamic interaction between opioid products and alcohol may occur irrespective of the formulation,
In addition, the Committee considered that the dissolution profile of products containing a polymethacrylate-triethylcitrate coating as modified-release mechanism is significantly affected in the presence of alcohol, leading to an uncontrolled rapid release of the majority of the active substance, and therefore the product exhibits a significant interaction with alcohol with potentially significant clinical effects (e.g. respiratory depression and death),
The Committee, based on the published literature, considered that a significant percentage of the patient population using these products does not abstain from alcohol consumption despite the existing warnings and contraindications, and that therefore the existing risk minimisation measures do not adequately address the concern,
The Committee is also of the opinion that further risk minimisation measures would not adequately address the concern,
The Committee therefore considered that patients exposed to the above mentioned products and concomitant intake of alcohol are at significantly greater risk of developing serious adverse reactions such as respiratory depression and death,
The Committee took the view that modified-release oral opioid products in the level III of the
WHO scale for the management of pain containing a polymethacrylate-triethylcitrate coating as modified-release mechanism are harmful under the normal conditions of use in accordance with article 116 of Directive 2001/83/EC, as amended.
Consequently, the CHMP has recommended the suspension of the marketing authorisation for modified-release oral opioid products in the level III of the WHO scale for the management of pain containing a polymethacrylate-triethylcitrate coating as modified-release mechanism (see annex I). For the suspension to be lifted, the Marketing Authorisation Holders need to provide evidence that the product has been reformulated, that it exhibits an acceptable release profile with the same quality, safety and efficacy profile of the currently authorised formulation but without the clinically significant interaction with alcohol. The new formulation must be approved by the National Competent Authorities of the concerned Member States (see Annex IV).
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Annex III
Relevant Sections of the Summary of Product Characteristics, Package Leaflet and labelling
Amendments to be included in the relevant sections of the Summary of Products Characteristics, Package Leaflet and labelling
Applicable to all products except those containing a polymethacrylate-triethylcitrate coating as modified-release mechanism. For products having warnings regarding the interaction with alcohol, the existing wording in the SPC and package leaflet should be replaced by the wording below. For products not having warnings regarding the interaction with alcohol in the currently approved SPC and package leaflet, the below wording should be added.
Summary of Product Characteristics
4.4 Special warnings and precautions for use
[…] Concomitant use of alcohol and {product name} may increase the undesirable effects of {product name}; concomitant use should be avoided. […]
4.5 Interaction with other medicinal products and other forms of interaction
[…] Alcohol may enhance the pharmacodynamic effects of {product name}; concomitant use should be avoided. […]
Package Leaflet
Section 2 – Before you take {product name}
[…] Drinking alcohol whilst taking {product name} may make you feel more sleepy or increase the risk of serious side effects such as shallow breathing with a risk of stopping breathing, and loss of consciousness. It is recommended not to drink alcohol while you’re taking {product name}. […]
Labelling
Any existing warnings on the interaction with alcohol should be deleted.
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Annex IV
Conditions for lifting the suspension
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Only applicable to products containing a polymethacrylate-triethylcitrate coating as modified-release mechanism For the suspension to be lifted the Marketing Authorisation Holders would need to provide the National Competent Authorities with the following: Evidence that the product has been reformulated, that it exhibits an acceptable release profile with the same quality, safety and efficacy profile of the currently authorised formulation but without the clinically significant interaction with alcohol. The new formulation must be approved by the National Competent Authorities of the concerned Member States.