List of nationally authorised medicinal products...Fripass 50 mg compresse IT/H/0529/001 045546114...
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Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands An agency of the European Union Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 © European Medicines Agency, 2020. Reproduction is authorised provided the source is acknowledged. 1 October 2020 EMA/542634/2020 Human Medicines Evaluation Division List of nationally authorised medicinal products Active substance: cilostazol Procedure no.: PSUSA/00010209/202002
Transcript of List of nationally authorised medicinal products...Fripass 50 mg compresse IT/H/0529/001 045546114...
Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands
An agency of the European Union
Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us
Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000
© European Medicines Agency, 2020. Reproduction is authorised provided the source is acknowledged.
1 October 2020
EMA/542634/2020
Human Medicines Evaluation Division
List of nationally authorised medicinal products
Active substance: cilostazol
Procedure no.: PSUSA/00010209/202002
List of nationally authorised medicinal products EMA/542634/2020 Page 2/24
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Cilostazol Aristo 50 mg
comprimidos EFG
ES/H/0729/001 78833 ARISTO PHARMA IBERIA, S.L. ES
Cilostazol Aristo 100 mg
comprimidos EFG
ES/H/0729/002 78832 ARISTO PHARMA IBERIA, S.L. ES
Cilostazol NORMON 100
mg comprimidos EFG
not available 78146 LABORATORIOS NORMON,
S.A.
ES
Cilostazol Trombicor 100
mg comprimidos EFG
not available 81.267 J. URIACH & CÍA., S.A. ES
Pladizol 100 mg tablety CZ/H/0805/001 83/205/14-C GLENMARK
PHARMACEUTICALS S.R.O.
CZ
PLADIZOL 100 mg
Tabletten
CZ/H/0805/001 93562.00.00 GLENMARK
PHARMACEUTICALS S.R.O.
DE
Cilostazol Libytec Tablets
100mg
MT/H/0168/001 MA 1024/00101-04 LIBYTEC PHARMACEUTICAL
S.A.
MT
CLAUDIASIL TAB
100MG/TAB
MT/H/0168/001 16274/18/08-02-2019 LIBYTEC PHARMACEUTICAL
S.A.
GR
INCLAUD 100 mg δισκία EE/H/0189/002 158474/18-12-2019 VIANEX S.A. GR
List of nationally authorised medicinal products EMA/542634/2020 Page 3/24
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
INCLAUD 50 mg δισκία EE/H/0189/001 158473/18-12-2019 VIANEX S.A. GR
Fripass 50 mg tablets IT/H/0529/001 MA1186/00101 ITALFARMACO S.P.A MT
Fripass 50 mg compresse IT/H/0529/001 045546013 ITALFARMACO S.P.A IT
Fripass 50 mg compresse IT/H/0529/001 045546025 ITALFARMACO S.P.A IT
Fripass 50 mg compresse IT/H/0529/001 045546037 ITALFARMACO S.P.A IT
Fripass 50 mg compresse IT/H/0529/001 045546049 ITALFARMACO S.P.A IT
Fripass 50 mg compresse IT/H/0529/001 045546052 ITALFARMACO S.P.A IT
Fripass 50 mg compresse IT/H/0529/001 045546064 ITALFARMACO S.P.A IT
Fripass 50 mg compresse IT/H/0529/001 045546076 ITALFARMACO S.P.A IT
List of nationally authorised medicinal products EMA/542634/2020 Page 4/24
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Fripass 50 mg compresse IT/H/0529/001 045546088 ITALFARMACO S.P.A IT
Fripass 50 mg compresse IT/H/0529/001 045546090 ITALFARMACO S.P.A IT
Fripass 50 mg compresse IT/H/0529/001 045546102 ITALFARMACO S.P.A IT
Fripass 50 mg compresse IT/H/0529/001 045546114 ITALFARMACO S.P.A IT
Cilostazol cinfa 100 mg
comprimidos EFG
not available 78222 LABORATORIOS CINFA, S.A. ES
Fripass 100 mg
compresse
IT/H/0529/002 045546126 ITALFARMACO S.P.A IT
Fripass 100 mg
compresse
IT/H/0529/002 045546138 ITALFARMACO S.P.A IT
Fripass 100 mg
compresse
IT/H/0529/002 045546140 ITALFARMACO S.P.A IT
Fripass 100 mg
compresse
IT/H/0529/002 045546153 ITALFARMACO S.P.A IT
List of nationally authorised medicinal products EMA/542634/2020 Page 5/24
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Fripass 100 mg
compresse
IT/H/0529/002 045546165 ITALFARMACO S.P.A IT
Fripass 100 mg
compresse
IT/H/0529/002 045546177 ITALFARMACO S.P.A IT
Fripass 100 mg
compresse
IT/H/0529/002 045546189 ITALFARMACO S.P.A IT
Fripass 100 mg
compresse
IT/H/0529/002 045546191 ITALFARMACO S.P.A IT
Fripass 100 mg
compresse
IT/H/0529/002 045546203 ITALFARMACO S.P.A IT
Fripass 100 mg
compresse
IT/H/0529/002 045546215 ITALFARMACO S.P.A IT
Fripass 100 mg
compresse
IT/H/0529/002 045546227 ITALFARMACO S.P.A IT
Cilostazol Tarbis 100 mg
comprimidos EFG
not available 78175 TARBIS FARMA, S.L. ES
Albaten 100 mg
compresse
IT/H/0638/001 043578018 PHARMACARE SRL IT
List of nationally authorised medicinal products EMA/542634/2020 Page 6/24
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
EKISTOL 50 mg
comprimidos
not available 70.126 LACER S.A. ES
EKISTOL 100 mg
comprimidos
not available 70.125 LACER S.A. ES
Cilostazol 100mg Tablets UK/H/5343/001 PL 20046/0271 FOCUS PHARMACEUTICALS
LIMITED
UK
Ноклауд 50 mg таблетки HU/H/0340/001-002/DC 20140056 EGIS PHARMACEUTICALS PLC BG
Noclaud 50 mg tablety HU/H/0340/001 83/148/14-C EGIS PHARMACEUTICALS PLC CZ
Noclaud 50 mg tabletta HU/H/0340/001/DC OGYI-T-22586/01-02, 05 EGIS PHARMACEUTICALS PLC HU
Sollazon 50 mg tabletes HU/H/0340/001-002/DC 14-0014 EGIS PHARMACEUTICALS PLC LV
Noclaud, 50 mg, tabletki HU/H/0340/001-002/DC 21766 EGIS PHARMACEUTICALS PLC PL
Noclaud 50 mg
comprimate
HU/H/0340/001/DC 6455/2014/01-02 EGIS PHARMACEUTICALS PLC RO
List of nationally authorised medicinal products EMA/542634/2020 Page 7/24
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Noclaud 50 mg tablety HU/H/0340/001/DC 16/0112/14-S EGIS PHARMACEUTICALS PLC SK
Ноклауд 100 mg
таблетки
HU/H/0340/001-002/DC 20140057 EGIS PHARMACEUTICALS PLC BG
Noclaud 100 mg tablety HU/H/0340/002 83/149/14-C EGIS PHARMACEUTICALS PLC CZ
Noclaud 100 mg tabletta HU/H/0340/002/DC OGYI-T-22586/03-04, 06 EGIS PHARMACEUTICALS PLC HU
Sollazon 100 mg tabletes HU/H/0340/001-002/DC 14-0015 EGIS PHARMACEUTICALS PLC LV
Sollazon 100 mg tabletės HU/H/0340/002/DC LT/1/14/3495/003-004;
LT/1/14/3495/006
EGIS PHARMACEUTICALS PLC LT
Noclaud, 100 mg, tabletki HU/H/0340/001-002/DC 21767 EGIS PHARMACEUTICALS PLC PL
Noclaud 100 mg
comprimate
HU/H/0340/002/DC 6456/2014/01-02 EGIS PHARMACEUTICALS PLC RO
Noclaud 100 mg tablety HU/H/0340/002/DC 16/0113/14-S EGIS PHARMACEUTICALS PLC SK
List of nationally authorised medicinal products EMA/542634/2020 Page 8/24
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Sollazon 50 mg tabletės HU/H/0340/001/DC LT/1/14/3495/001-002;
LT/1/14/3495/005
EGIS PHARMACEUTICALS PLC LT
Sollazon 50 mg tabletės HU/H/0340/001/DC LT/1/14/3495/001-002,005 EGIS PHARMACEUTICALS PLC HU
Цилостазол Стада 50 mg
таблетки
EE/H/0194/001 20140144 STADA ARZNEIMITTEL AG BG
Cilostazol AL 100 mg
Tabletten
EE/H/0194/002 89798.00.00 ALIUD PHARMA GMBH DE
Cilostazol AL 50 mg
Tabletten
EE/H/0194/001 89797.00.00 ALIUD PHARMA GMBH DE
Цилостазол Стада 100
mg таблетки
EE/H/0194/002 20140145 STADA ARZNEIMITTEL AG BG
Cilostazol STADA 100 mg
tablety
EE/H/0194/002 83/153/14-C STADA ARZNEIMITTEL AG CZ
CILOSTAD, 100 mg
tabletid
EE/H/0194/002 844414 STADA ARZNEIMITTEL AG EE
CILOSTAD, 50 mg tabletid EE/H/0194/001 844514 STADA ARZNEIMITTEL AG EE
List of nationally authorised medicinal products EMA/542634/2020 Page 9/24
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Cilostazol STADA 50 mg
tablety
EE/H/0194/001 16/0230/14-S STADA ARZNEIMITTEL AG SK
Stepcil, 100 mg, tabletki not available 23054 AFLOFARM FARMACJA
POLSKA SP. Z O.O.
PL
Fripass 100 mg
compresse
IT/H/0529/002 045546126 ITALFARMACO S.P.A IT
Fripass 100 mg
compresse
IT/H/0529/002 045546138 ITALFARMACO S.P.A IT
Fripass 100 mg
compresse
IT/H/0529/002 045546140 ITALFARMACO S.P.A IT
Fripass 100 mg
compresse
IT/H/0529/002 045546153 ITALFARMACO S.P.A IT
Fripass 100 mg
compresse
IT/H/0529/002 045546165 ITALFARMACO S.P.A IT
Fripass 100 mg
compresse
IT/H/0529/002 045546177 ITALFARMACO S.P.A IT
Fripass 100 mg
compresse
IT/H/0529/002 045546189 ITALFARMACO S.P.A IT
List of nationally authorised medicinal products EMA/542634/2020 Page 10/24
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Fripass 100 mg
compresse
IT/H/0529/002 045546191 ITALFARMACO S.P.A IT
Fripass 100 mg
compresse
IT/H/0529/002 045546203 ITALFARMACO S.P.A IT
Fripass 100 mg
compresse
IT/H/0529/002 045546215 ITALFARMACO S.P.A IT
Fripass 100 mg
compresse
IT/H/0529/002 045546227 ITALFARMACO S.P.A IT
Cilostazol 50 mg tablets not available PL 04569/1426 GENERICS [UK] LIMITED UK
Cilostazol 100 mg tablets not available PL 04569/1427 GENERICS [UK] LIMITED UK
Цилостазол Стада 50 mg
таблетки
EE/H/0194/001 20140144 STADA ARZNEIMITTEL AG BG
Cilostazol AL 100 mg
Tabletten
EE/H/0194/002 89798.00.00 ALIUD PHARMA GMBH DE
Cilostazol AL 50 mg
Tabletten
EE/H/0194/001 89797.00.00 ALIUD PHARMA GMBH DE
List of nationally authorised medicinal products EMA/542634/2020 Page 11/24
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Цилостазол Стада 100
mg таблетки
EE/H/0194/002 20140145 STADA ARZNEIMITTEL AG BG
Cilostazol STADA 100 mg
tablety
EE/H/0194/002 83/153/14-C STADA ARZNEIMITTEL AG CZ
CILOSTAD, 100 mg
tabletid
EE/H/0194/002 844414 STADA ARZNEIMITTEL AG EE
CILOSTAD, 50 mg tabletid EE/H/0194/001 844514 STADA ARZNEIMITTEL AG EE
Cilostazol STADA 50 mg
tablety
EE/H/0194/001 16/0230/14-S STADA ARZNEIMITTEL AG SK
Cilostazol VIR 100 mg
comprimidos EFG
not available 78.176 INDUSTRIA QUÍMICA Y
FARMACEÚTICA VIR, S.A.
ES
Cilostazol Galenica100 mg
tablets
MT/H/0167/001 MA 978/00201 GALENICA SA MT
Cilostazol/Galenica 100
mg δισκία
MT/H/0167/001 3053101 GALENICA SA GR
Antaclast 100 mg tabletta not available OGYI-T-22922/01 GEDEON RICHTER PLC. HU
List of nationally authorised medicinal products EMA/542634/2020 Page 12/24
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Cilostazol-Elpen 100 mg
Tabletten
DE/H/3921/001 90515.00.00 ELPEN PHARMACEUTICAL CO.
INC.
DE
Cilostazol Elpen, 100 mg
tablett
DE/H/3921/001 49734 ELPEN PHARMACEUTICAL CO.
INC.
SE
Aploxim 100 mg δισκία DE/H/3921/001 65447/2-10-2015 ELPEN PHARMACEUTICAL CO.
INC.
GR
Cilopeda 100 mg tabletta DE/H/3921/001 OGYI-T-22731/01 PANNONPHARMA KFT. HU
Cilopeda 100 mg tabletta DE/H/3921/001 OGYI-T-22731/02 PANNONPHARMA KFT. HU
Cilopeda 100 mg tabletta DE/H/3921/001 OGYI-T-22731/03 PANNONPHARMA KFT. HU
Cilostazol-Teva 100 mg
tabletta
MT/H/0159/001 OGYI-T-22564/02 TEVA GYÓGYSZERGYÁR ZRT HU
Cilostazol-Teva 100 mg
tabletta
MT/H/0159/001 OGYI-T-22564/03 TEVA GYÓGYSZERGYÁR ZRT HU
Cilostazol-Teva 100 mg
tabletta
MT/H/0159/001 OGYI-T-22564/01 TEVA GYÓGYSZERGYÁR ZRT HU
List of nationally authorised medicinal products EMA/542634/2020 Page 13/24
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Cilostazol-Teva 100 mg
tabletta
MT/H/0159/001 OGYI-T-22564/04 TEVA GYÓGYSZERGYÁR ZRT HU
Cilostazol 100 mg tablets MT/H/0159/001 MA715/03701 TEVA PHARMA B.V. MT
Cilostazol KERN PHARMA
100 mg comprimidos EFG
not available 78.148 KERN PHARMA, S.L. ES
CILOS® 50mg δισκία EL/H/0245/001 4255/21-1-2015 WIN MEDICA SA GR
CILOS® 100mg δισκία EL/H/0245/002 4256/21-1-2015 WIN MEDICA SA GR
Cilostazol LEK-AM, 50 mg,
tabletki
not available 24516 PRZEDSIĘBIORSTWO
FARMACEUTYCZNE LEK-AM
SP. Z O.O.
PL
Cilostazol LEK-AM, 100
mg, tabletki
not available 24517 PRZEDSIĘBIORSTWO
FARMACEUTYCZNE LEK-AM
SP. Z O.O.
PL
Cilostazolo Sandoz 100
mg compresse
MT/H/0161/001 042365080 SANDOZ S.P.A. IT
Cilostazolo Sandoz 100
mg compresse
MT/H/0161/001 042365092 SANDOZ S.P.A. IT
List of nationally authorised medicinal products EMA/542634/2020 Page 14/24
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Cilostazolo Sandoz 100
mg compresse
MT/H/0161/001 042365104 SANDOZ S.P.A. IT
Cilostazolo Sandoz 100
mg compresse
MT/H/0161/001 042365015 SANDOZ S.P.A. IT
Cilostazolo Sandoz 100
mg compresse
MT/H/0161/001 042365027 SANDOZ S.P.A. IT
Cilostazolo Sandoz 100
mg compresse
MT/H/0161/001 042365039 SANDOZ S.P.A. IT
Cilostazolo Sandoz 100
mg compresse
MT/H/0161/001 042365041 SANDOZ S.P.A. IT
Cilostazolo Sandoz 100
mg compresse
MT/H/0161/001 042365054 SANDOZ S.P.A. IT
Cilostazolo Sandoz 100
mg compresse
MT/H/0161/001 042365066 SANDOZ S.P.A. IT
Cilostazolo Sandoz 100
mg compresse
MT/H/0161/001 042365078 SANDOZ S.P.A. IT
Dilsatan 100 mg tabletes MT/H/0161/001 13-0225 SANDOZ PHARMACEUTICALS
D.D.
LV
List of nationally authorised medicinal products EMA/542634/2020 Page 15/24
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Cilostazol Sandoz 100mg
Tablets
MT/H/0161/001 MA1020/00101 HEXAL PHARMA GMBH MT
Dilsatan, 100 mg tabletid MT/H/0161/001 828913 SANDOZ PHARMACEUTICALS
D.D.
EE
Dilsatan 100 mg tabletės MT/H/0161/001 LT/1/13/3380/001 SANDOZ PHARMACEUTICALS
D.D.
LT
Dilsatan 100 mg tabletės MT/H/0161/001 LT/1/13/3380/002 SANDOZ PHARMACEUTICALS
D.D.
LT
Dilsatan 100 mg tabletės MT/H/0161/001 LT/1/13/3380/005 SANDOZ PHARMACEUTICALS
D.D.
LT
Dilsatan 100 mg tabletės MT/H/0161/001 LT/1/13/3380/006 SANDOZ PHARMACEUTICALS
D.D.
LT
Dilsatan 100 mg tabletės MT/H/0161/001 LT/1/13/3380/004 SANDOZ PHARMACEUTICALS
D.D.
LT
Dilsatan 100 mg tabletės MT/H/0161/001 LT/1/13/3380/007 SANDOZ PHARMACEUTICALS
D.D.
LT
Dilsatan 100 mg tabletės MT/H/0161/001 LT/1/13/3380/008 SANDOZ PHARMACEUTICALS
D.D.
LT
List of nationally authorised medicinal products EMA/542634/2020 Page 16/24
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Dilsatan 100 mg tabletės MT/H/0161/001 LT/1/13/3380/009 SANDOZ PHARMACEUTICALS
D.D.
LT
Dilsatan 100 mg tabletės MT/H/0161/001 LT/1/13/3380/010 SANDOZ PHARMACEUTICALS
D.D.
LT
Decilosal, 100 mg, tabletki MT/H/0161/001 21544 SANDOZ GMBH PL
ЦИЛОСТАЗОЛ САНДОЗ
100 MG ТАБЛЕТКИ
MT/H/0161/001 20130399 SANDOZ PHARMACEUTICALS
D.D.
BG
Dilsatan 100 mg tabletės MT/H/0161/001 LT/1/13/3380/003 SANDOZ PHARMACEUTICALS
D.D.
LT
Cilostazol HEXAL 100 mg
Tabletten
MT/H/0161/001 88746.00.00 HEXAL AG DE
Cilostazol Sandoz 100 mg
comprimidos EFG
MT/H/0161/001 78224 SANDOZ FARMACÉUTICA,
S.A.
ES
Cilostazol Ferrer 100 mg
comprimidos
not available 5666763 FERRER PORTUGAL, S.A. PT
Cilostazol Ferrer 100 mg
comprimidos
not available 5666771 FERRER PORTUGAL, S.A. PT
List of nationally authorised medicinal products EMA/542634/2020 Page 17/24
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Лостразин 100 mg
таблетки
not available 20160342 ACTAVIS GROUP PTC EHF. BG
Dilvas 100 mg
comprimate
RO/H/0166/001 13086/2020/01 LABORMED PHARMA S.A. RO
Fripass 50 mg tablets IT/H/0529/001 MA1186/00101 ITALFARMACO S.P.A MT
Fripass 50 mg compresse IT/H/0529/001 045546013 ITALFARMACO S.P.A IT
Fripass 50 mg compresse IT/H/0529/001 045546025 ITALFARMACO S.P.A IT
Fripass 50 mg compresse IT/H/0529/001 045546037 ITALFARMACO S.P.A IT
Fripass 50 mg compresse IT/H/0529/001 045546049 ITALFARMACO S.P.A IT
Fripass 50 mg compresse IT/H/0529/001 045546052 ITALFARMACO S.P.A IT
Fripass 50 mg compresse IT/H/0529/001 045546064 ITALFARMACO S.P.A IT
List of nationally authorised medicinal products EMA/542634/2020 Page 18/24
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Fripass 50 mg compresse IT/H/0529/001 045546076 ITALFARMACO S.P.A IT
Fripass 50 mg compresse IT/H/0529/001 045546088 ITALFARMACO S.P.A IT
Fripass 50 mg compresse IT/H/0529/001 045546090 ITALFARMACO S.P.A IT
Fripass 50 mg compresse IT/H/0529/001 045546102 ITALFARMACO S.P.A IT
Fripass 50 mg compresse IT/H/0529/001 045546114 ITALFARMACO S.P.A IT
Cilostazol Pharmagenus
100 mg comprimidos EFG
not available 78227 ARISTO PHARMA IBERIA, S.L. ES
CILOS® 50mg δισκία EL/H/0245/001 4255/21-1-2015 WIN MEDICA SA GR
CILOS® 100mg δισκία EL/H/0245/002 4256/21-1-2015 WIN MEDICA SA GR
Cilostazolo Mylan Pharma
100 mg compresse.
MT/H/0179/001 043577016 MYLAN S.P.A. IT
List of nationally authorised medicinal products EMA/542634/2020 Page 19/24
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Cilostazol Mylan 100 mg
tablets.
MT/H/0179/001 MA1270/00701 MYLAN IRELAND LIMITED MT
Cilostazol STADA 100 mg
comprimidos EFG
not available 78.181 LABORATORIO STADA, S.L. ES
CILOZEK, 50 mg, tabletki EE/H/0189/001 21739 ADAMED PHARMA S.A. PL
CILOZEK, 100 mg,
tabletki
EE/H/0189/002 21740 ADAMED PHARMA S.A. PL
Cilozek 50 mg tabletid EE/H/0189/001 840114 ADAMED EE
Cilozek 100 mg tabletid EE/H/0189/002 840014 ADAMED EE
Cilozek 50 mg tablety EE/H/0189/001 16/0170/14-S ADAMED PHARMA S.A. SK
Cilozek 100 mg tablety EE/H/0189/002 16/0171/14-S ADAMED PHARMA S.A. SK
Cilozek 50 mg tablety EE/H/0189/001 83/175/14-C ADAMED PHARMA S.A. CZ
List of nationally authorised medicinal products EMA/542634/2020 Page 20/24
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Cilozek 100 mg tablety EE/H/0189/002 83/176/14-C ADAMED PHARMA S.A. CZ
Cilozek 50 mg tabletta EE/H/0189/001 OGYI-T-22653/01 ADAMED HU
Cilozek 50 mg tabletta EE/H/0189/001 OGYI-T-22653/02 ADAMED HU
Cilozek 50 mg tabletta EE/H/0189/001 OGYI-T-22653/03 ADAMED HU
Cilozek 50 mg tabletta EE/H/0189/001 OGYI-T-22653/04 ADAMED HU
Cilozek 100 mg tabletta EE/H/0189/002 OGYI-T-22653/05 ADAMED HU
Cilozek 100 mg tabletta EE/H/0189/002 OGYI-T-22653/06 ADAMED HU
Cilozek 100 mg tabletta EE/H/0189/002 OGYI-T-22653/07 ADAMED HU
Cilozek 100 mg tabletta EE/H/0189/002 OGYI-T-22653/08 ADAMED HU
List of nationally authorised medicinal products EMA/542634/2020 Page 21/24
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Cilostazol 50 mg tablets not available PL 04569/1426 GENERICS [UK] LIMITED UK
Cilostazol 100 mg tablets not available PL 04569/1427 GENERICS [UK] LIMITED UK
Cilostazol Mylan 100 mg
comprimidos EFG
EE/H/0189/002 78988 MYLAN PHARMACEUTICALS
S.L.
ES
Cilostazolo Mylan Pharma
100 mg compresse.
MT/H/0179/001 043577016 MYLAN S.P.A. IT
Cilostazol Mylan 100 mg
tablets.
MT/H/0179/001 MA1270/00701 MYLAN IRELAND LIMITED MT
VELYN 100 mg
comprimate
EE/H/0189/002 12079/2019/01 TERAPIA S.A. RO
VELYN 100 mg
comprimate
EE/H/0189/002 12079/2019/02 TERAPIA S.A. RO
VELYN 100 mg
comprimate
EE/H/0189/002 12079/2019/03 TERAPIA S.A. RO
VELYN 100 mg
comprimate
EE/H/0189/002 12079/2019/04 TERAPIA S.A. RO
List of nationally authorised medicinal products EMA/542634/2020 Page 22/24
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
VELYN 100 mg
comprimate
EE/H/0189/002 12079/2019/05 TERAPIA S.A. RO
VELYN 100 mg
comprimate
EE/H/0189/002 12079/2019/06 TERAPIA S.A. RO
VELYN 100 mg
comprimate
EE/H/0189/002 12079/2019/07 TERAPIA S.A. RO
VELYN 100 mg
comprimate
EE/H/0189/002 12079/2019/08 TERAPIA S.A. RO
VELYN 100 mg
comprimate
EE/H/0189/002 12079/2019/09 TERAPIA S.A. RO
VELYN 100 mg
comprimate
EE/H/0189/002 12079/2019/10 TERAPIA S.A. RO
Cilostazol Pensa 100 mg
comprimidos EFG
not available 78.177 PENSA PHARMA, S.A.U. ES
Cilostazol STADA® 100
mg Tabletten
EE/H/0193/002 89799.00.00 STADAPHARM GMBH DE
Cilostazol STADA, 100 mg
tabletid
EE/H/0193/002 844614 STADA ARZNEIMITTEL AG EE
List of nationally authorised medicinal products EMA/542634/2020 Page 23/24
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
CILOSTAZOLO EG 100 mg
compresse
EE/H/0193/002 042770040 EG S.P.A. IT
CILOSTAZOLO EG 100 mg
compresse
EE/H/0193/002 042770091 EG S.P.A. IT
CILOSTAZOLO EG 100 mg
compresse
EE/H/0193/002 042770065 EG S.P.A. IT
CILOSTAZOLO EG 100 mg
compresse
EE/H/0193/002 042770115 EG S.P.A. IT
CILOSTAZOLO EG 100 mg
compresse
EE/H/0193/002 042770077 EG S.P.A. IT
CILOSTAZOLO EG 100 mg
compresse
EE/H/0193/002 042770038 EG S.P.A. IT
Cilostazol Evolan 50 mg
tabletter
SE/H/1516/001 50217 EVOLAN PHARMA AB SE
Cilostazol Evolan 100 mg
tabletter
SE/H/1516/002 50218 EVOLAN PHARMA AB SE
Cilostazol Apotex 100 mg
tablety
SE/H/1516/002 83/427/14-C APOTEX EUROPE B.V. CZ
List of nationally authorised medicinal products EMA/542634/2020 Page 24/24
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
CILOSTOP, 100 mg,
tabletki
not available 21780 BIOFARM SP. Z O.O. PL
CILOSTAZOL/ΕΝΟΡΑΣΙΣ
100 mg δισκία
not available 17276/17-02-2016 AENORASIS S.A. GR
