Annex I List of nationally authorised medicinal...

1

Annex I

List of nationally authorised medicinal products

2

Member State in EEA

Marketing authorisaton holder Product name Active substance + Strength Pharmaceutical form

Austria 3m Health Care Ltd Aerocortin Beclometasone Dipropionate 50µg/50 µl

Pressurised Inhalation, Solution

Austria Allen Pharmazeutika Gesellschaft M.B.H.

Fluticasonpropionat Fluticasone Propionate 50µg Dose Pressurised Inhalation, Suspension


Fluticasonpropionat Diskus Forte Allen

Fluticasone Propionate 500µg Dose Inhalation Powder


Fluticasonpropionat Diskus Junior Allen

Fluticasone Propionate 100µg Dose Inhalation Powder


Fluticasonpropionat „allen“ Fluticasone Propionate 125µg Dose Pressurised Inhalation, Suspension


Fluticasonpropionat „allen“ Fluticasone Propionate 250µg Dose Inhalation Powder


Fluticasonpropionat „allen“ Fluticasone Propionate 250µg Dose Pressurised Inhalation, Suspension


Samtoral Diskus Standard Fluticasone Propionate 250µg Dose, Salmeterol 50µg Dose

Inhalation Powder, Pre-Dispensed

Austria Astrazeneca österreich Gmbh Pulmicort Budesonide 400µg Dose Inhalation Powder

Austria Astrazeneca österreich Gmbh Pulmicort Turbohaler Budesonide 100µg Dose Inhalation Powder



Austria Astrazeneca österreich Gmbh Symbicort Forte Turbohaler Budesonide 320µg Dose, Formoterol Fumarate Dihydrate 9µg Dose

Inhalation Powder

3

Member State in EEA


Austria Astrazeneca österreich Gmbh Symbicort Turbohaler Budesonide 160µg Dose, Formoterol Fumarate Dihydrate 4.5µg Dose

Inhalation Powder

Austria Chiesi Pharmaceuticals Gmbh Budiair Budesonide 0.2mg/0.05ml Pressurised Inhalation, Solution

Austria Chiesi Pharmaceuticals Gmbh Budiair Jet Budesonide 0.2mg/0.05ml Pressurised Inhalation, Solution

Austria Chiesi Pharmaceuticals Gmbh Foster Beclometasone Dipropionate 100µg Actuation, Formoterol Fumarate Dihydrate 6µg Actuation


Austria Elpen Pharmaceutical Co. Inc. Salmeson Fluticasone Propionate 250µg Dose, Salmeterol 50µg Dose


Austria Elpen Pharmaceutical Co. Inc. Salmeson Fluticasone Propionate 500µg Dose, Salmeterol 50µg Dose


Austria Glaxosmithkline Pharma Gmbh. Flixotide Fluticasone Propionate 125µg Inhalation

Pressurised Inhalation, Suspension

Austria Glaxosmithkline Pharma Gmbh. Flixotide Fluticasone Propionate 250µg Dose Inhalation Powder, Pre-Dispensed

Austria Glaxosmithkline Pharma Gmbh. Flixotide Fluticasone Propionate 250µg Inhalation


Austria Glaxosmithkline Pharma Gmbh. Flixotide Diskus Forte Fluticasone Propionate 500µg Dose Inhalation Powder

Austria Glaxosmithkline Pharma Gmbh. Flixotide Diskus Junior Fluticasone Propionate 100µg Dose Inhalation Powder

Austria Glaxosmithkline Pharma Gmbh. Flixotide Junior Fluticasone Propionate 125µg Inhalation


Austria Glaxosmithkline Pharma Gmbh. Seretide Diskus Fluticasone Propionate 500µg Dose, Salmeterol Xinafoate 50µg Dose


4

Member State in EEA


Austria Pari Pharma Gmbh Buparid Budesonide 0.25mg Ampoule Nebuliser Suspension

Austria Pari Pharma Gmbh Buparid Budesonide 0.5mg Ampoule Nebuliser Suspension

Austria Pari Pharma Gmbh Buparid Budesonide 1mg Ampoule Nebuliser Suspension

Austria Sandoz Gmbh Airflusal Forspiro Fluticasone Propionate 233µg Dose, Salmeterol 45µg Dose

Inhalation Powder

Austria Sandoz Gmbh Airflusal Forspiro Fluticasone Propionate 465µg Dose, Salmeterol 45µg Dose

Inhalation Powder

Belgium Chiesi Sa-Nv Inuvair Formoterol Fumarate Dihydrate 6µg Actuation, Beclometasone Dipropionate Anhydrous 100µg Actuation


Belgium Cipla Europe Nv Salmeterol/Fluticasone Cipla

Salmeterol 25µg/Dose; Fluticasone Propionate 125µg/Dose


Belgium Elpen Pharmaceutical Co. Inc. Flusalio Fluticasone Propionate 250µg Dose, Salmeterol 50µg Dose


Belgium Elpen Pharmaceutical Co. Inc. Flusalio Fluticasone Propionate 500µg Dose, Salmeterol 50µg Dose


Belgium Glaxosmithkline Pharmaceuticals S.A.

Flixotide Fluticasone Propionate 0.05mg/2ml Nebuliser Solution


Flixotide Fluticasone Propionate 250µg Inhalation



Flixotide Fluticasone Propionate 2mg/2ml Nebuliser Solution




5

Member State in EEA



Flixotide Diskus Fluticasone Propionate 100µg Dose Inhalation Powder






Seretide Diskus Fluticasone Propionate 500µg Dose, Salmeterol Xinafoate 50µg Dose


Belgium Nv Astrazeneca Sa Pulmicort Turbohaler Budesonide 200µg Dose Inhalation Powder

Belgium Nv Astrazeneca Sa Symbicort Forte Turbohaler Budesonide 320µg Dose, Formoterol Fumarate Dihydrate 9µg Dose

Inhalation Powder

Belgium Nv Astrazeneca Sa Symbicort Turbohaler Budesonide 160µg Dose, Formoterol Fumarate Dihydrate 4.5µg Dose

Inhalation Powder

Belgium Orion Corporation Bufomix Easyhaler Budesonide 160µg Inhalation, Formoterol Fumarate Dihydrate 4.5µg Inhalation

Inhalation Powder

Belgium Orion Corporation Bufomix Easyhaler Budesonide 320µg Inhalation, Formoterol Fumarate Dihydrate 9µg Inhalation

Inhalation Powder

Belgium Pari Pharma Gmbh Buparid Budesonide 0.25mg Ampoule Nebuliser Suspension

Belgium Pari Pharma Gmbh Buparid Budesonide 0.5mg Ampoule Nebuliser Suspension

Belgium Pari Pharma Gmbh Buparid Budesonide 1mg Ampoule Nebuliser Suspension

Belgium Sandoz N.V. Airflusal Forspiro Salmeterol Xinafoate 50µg Dose, Fluticasone 500µg Dose

Inhalation Powder

Bulgaria Astrazeneca Ab Symbicort Turbuhaler Budesonide 160µg Dose, Formoterol Fumarate Dihydrate 4.5µg Dose

Inhalation Powder

6

Member State in EEA


Bulgaria Astrazeneca Ab Symbicort Turbuhaler Budesonide 320µg Dose, Formoterol Fumarate Dihydrate 9µg Dose

Inhalation Powder

Bulgaria Chiesi Pharmaceuticals Gmbh Foster Formoterol Fumarate Dihydrate 6µg Actuation, Beclometasone Dipropionate Anhydrous 100µg Actuation


Bulgaria Elpen Pharmaceutical Co. Inc. Flusamer Fluticasone Propionate 250µg Dose, Salmeterol 50µg Dose


Bulgaria Elpen Pharmaceutical Co. Inc. Flusamer Fluticasone Propionate 500µg Dose, Salmeterol 50µg Dose


Bulgaria Glaxosmithkline Eood Seretide Diskus Fluticasone Propionate 500µg Dose, Salmeterol 50µg Dose


Bulgaria Orion Oyj Bufomix Easyhaler Budesonide 160µg Inhalation, Formoterol Fumarate Dihydrate 4.5µg Inhalation

Inhalation Powder

Bulgaria Orion Oyj Bufomix Easyhaler Budesonide 320µg Inhalation, Formoterol Fumarate Dihydrate 9µg Inhalation

Inhalation Powder

Bulgaria Sandoz Pharmaceuticals D.D. Airflusal Forspiro Salmeterol Xinafoate 50µg Dose, Fluticasone 500µg Dose

Inhalation Powder

Bulgaria Sopharma Ad Flixotide Fluticasone Propionate 250µg Inhalation


Croatia Astrazeneca D.O.O Symbicort Turbuhaler Budesonide 160µg Dose, Formoterol Fumarate Dihydrate 4.5µg Dose

Inhalation Powder

Croatia Astrazeneca D.O.O Symbicort Turbuhaler Budesonide 160µg Dose, Formoterol Fumarate Dihydrate 4.5µg Dose

Inhalation Powder

Croatia Clinres Farmacija D.O.O. Dimenium Fluticasone Propionate 100 Mcg Dose, Salmeterol Xinafoate 50 Mcg Dose




7

Member State in EEA




Croatia Glaxosmithkline D.O.O. Salmeterol/Flutikazonpropionat Diskus Glaxosmithkline

Fluticasone Propionate 500µg Dose, Salmeterol 50µg Dose


Croatia Glaxosmithkline D.O.O. Seretide Diskus Fluticasone Propionate 500µg Dose, Salmeterol Xinafoate 50µg Dose


Croatia Providens D.O.O. Foster Formoterol Fumarate Dihydrate 6µg Actuation, Beclometasone Dipropionate Anhydrous 100µg Actuation


Croatia Salvus D.O.O. Saldisk Fluticasone Propionate 100 Mcg Dose, Salmeterol Xinafoate 50 Mcg Dose






Croatia Sandoz D.O.O. Airflusal Forspiro Fluticasone Propionate 233µg Dose, Salmeterol 45µg Dose


Croatia Sandoz D.O.O. Airflusal Forspiro Fluticasone Propionate 465µg Dose, Salmeterol 45µg Dose


Cyprus Astrazeneca Ab Symbicort Turbuhaler Budesonide 160µg Dose, Formoterol Fumarate Dihydrate 4.5µg Dose

Inhalation Powder

Cyprus Astrazeneca Ab Symbicort Turbuhaler Budesonide 320µg Dose, Formoterol Fumarate Dihydrate 9µg Dose

Inhalation Powder

Cyprus Costakis Tsisios & Co. Ltd Fluticapen Fluticasone Propionate 250µg Dose Inhalation Powder, Pre-Dispensed

Cyprus Costakis Tsisios & Co. Ltd Fluticapen Fluticasone Propionate 500µg Dose Inhalation Powder, Pre-Dispensed

Cyprus Costakis Tsisios & Co. Ltd Pulmoton Budesonide 100µg Dose, Formoterol Fumarate Dihydrate 6µg Dose


8

Member State in EEA






Cyprus Costakis Tsisios & Co. Ltd Rolenium Fluticasone Propionate 100µg Dose, Salmeterol 50µg Dose






Cyprus Glaxo Group Limited Flixotide Diskus Fluticasone Propionate 100µg Dose Inhalation Powder

Cyprus Glaxo Group Limited Flixotide Diskus Fluticasone Propionate 250µg Dose Inhalation Powder

Cyprus Glaxo Group Limited Seretide Fluticasone Propionate 500µg Dose, Salmeterol Xinafoate 50µg Dose


Cyprus Orion Corporation Bufomix Easyhaler Budesonide 160µg Dose, Formoterol Fumarate Dihydrate Ph.Eur. 4.5µg Dose

Inhalation Powder

Cyprus Orion Corporation Bufomix Easyhaler Budesonide 320µg Dose, Formoterol Fumarate Dihydrate Ph.Eur. 9µg Dose

Inhalation Powder

Cyprus Orion Corporation Orest Easyhaler Budesonide 160µg Dose, Formoterol Fumarate Dihydrate Ph.Eur. 4.5µg Dose

Inhalation Powder

Cyprus Orion Corporation Orest Easyhaler Budesonide 320µg Dose, Formoterol Fumarate Dihydrate Ph.Eur. 9µg Dose

Inhalation Powder

Czech Republic

Astrazeneca Ab Symbicort Turbuhaler Budesonide 160µg Dose, Formoterol Fumarate Dihydrate 4.5µg Dose

Inhalation Powder

Czech Republic

Astrazeneca Ab Symbicort Turbuhaler Budesonide 320µg Dose, Formoterol Fumarate Dihydrate 9µg Dose

Inhalation Powder

9

Member State in EEA


Czech Republic

Chiesi Pharmaceuticals Gmbh Combair Formoterol Fumarate Dihydrate 1,08 Mg, Beclometasone Dipropionate 18 Mg


Czech Republic

Elpen Pharmaceutical Co. Inc. Dimenium Fluticasone Propionate 500µg Dose, Salmeterol 50µg Dose


Czech Republic

Elpen Pharmaceutical Co. Inc. Dimenium Fluticasone Propionate 250µg Dose, Salmeterol 50µg Dose


Czech Republic

Glaxo Group Limited Flixotide Fluticasone Propionate 125µg Pressurised Inhalation, Suspension

Czech Republic


Czech Republic


Czech Republic

Glaxo Group Limited Flixotide Diskus Fluticasone Propionate 100µg Inhalation Powder

Czech Republic


Czech Republic


Czech Republic

Glaxo Group Limited Seretide Diskus Fluticasone Propionate 500µg, Salmeterol Xinafoate 72,5µg

Inhalation Powder

Czech Republic

Sandoz S.R.O. Airflusan Forspiro Fluticasone Propionate 0,25 Mg, Salmeterol Xinafoate 0,073 Mg


Czech Republic

Sandoz S.R.O. Airflusan Forspiro Fluticasone Propionate 0,5 Mg, Salmeterol Xinafoate 0,073 Mg


Denmark Astrazeneca A-S Symbicort Forte Turbuhaler Budesonide 320µg Dose, Formoterol Fumarate Dihydrate 9µg Dose

Inhalation Powder

10

Member State in EEA


Denmark Astrazeneca A-S Symbicort Turbuhaler Budesonide 160µg Dose, Formoterol Fumarate Dihydrate 4.5µg Dose

Inhalation Powder

Denmark Chiesi Farmaceutici S.P.A. Innovair Beclometasone Dipropionate 100µg Actuation, Formoterol Fumarate Dihydrate 6µg Actuation


Denmark Elpen Pharmaceutical Co. Inc. Flusaterol Fluticasone Propionate 250µg Dose, Salmeterol 50µg Dose


Denmark Elpen Pharmaceutical Co. Inc. Flusaterol Fluticasone Propionate 500µg Dose, Salmeterol 50µg Dose, Lactose Monohydrate 24.677mg Dose


Denmark Glaxosmithkline Pharma A-S Seretide Fluticasone Propionate 500µg Dose, Salmeterol Xinafoate 50µg Dose


Denmark Orion Oyj Bufomix Easyhaler Budesonide 160µg Inhalation, Formoterol Fumarate Dihydrate 4.5µg Inhalation

Inhalation Powder

Denmark Orion Oyj Bufomix Easyhaler Budesonide 320µg Inhalation, Formoterol Fumarate Dihydrate 9µg Inhalation

Inhalation Powder

Denmark Sandoz A-S Airflusal Forspiro Fluticasone Propionate 233µg Dose, Salmeterol 45µg Dose


Denmark Sandoz A-S Airflusal Forspiro Fluticasone Propionate 465µg Dose, Salmeterol 45µg Dose


Estonia Astrazeneca Ab Symbicort Turbuhaler Budesonide 160µg Dose, Formoterol Fumarate Dihydrate 4.5µg Dose

Inhalation Powder

Estonia Astrazeneca Ab Symbicort Turbuhaler Budesonide 320µg Dose, Formoterol Fumarate Dihydrate 9µg Dose

Inhalation Powder

Estonia Chiesi Pharmaceuticals Gmbh Foster Beclometasone Dipropionate 100µg Actuation, Formoterol Fumarate Dihydrate 6µg Actuation


Estonia Elpen Pharmaceutical Co. Inc. Flusamer Fluticasone Propionate 250µg Dose, Salmeterol 50µg Dose


11

Member State in EEA


Estonia Elpen Pharmaceutical Co. Inc. Flusamer Fluticasone Propionate 500µg Dose, Salmeterol 50µg Dose


Estonia Glaxo Wellcome Ltd Flixotide Diskus Fluticasone Propionate 250µg Dose Inhalation Powder

Estonia Glaxo Wellcome Ltd Seretide Diskus Fluticasone Propionate 500µg Dose, Salmeterol 50µg Dose


Estonia Sandoz Pharmaceuticals D.D. Airflusal Forspiro Fluticasone Propionate 250µg Dose, Salmeterol 50µg Dose


Estonia Sandoz Pharmaceuticals D.D. Airflusal Forspiro Fluticasone Propionate 500µg Dose, Salmeterol 50µg Dose


Finland Astrazeneca Oy Symbicort Forte Turbuhaler Budesonide 320µg Dose, Formoterol Fumarate Dihydrate 9µg Dose

Inhalation Powder

Finland Astrazeneca Oy Symbicort Turbuhaler Budesonide 160µg Dose, Formoterol Fumarate Dihydrate 4.5µg Dose

Inhalation Powder

Finland Chiesi Farmaceutici S.P.A. Innovair Beclometasone Dipropionate 100µg Actuation, Formoterol Fumarate Dihydrate 6µg Actuation


Finland Chiesi Farmaceutici S.P.A. Innovair Nexthaler Formoterol Fumarate Dihydrate 6µg Dose, Beclometasone Dipropionate Anhydrous 100µg Dose

Inhalation Powder

Finland Elpen Pharmaceutical Co. Inc. Salmeson Fluticasone Propionate 250µg Dose, Salmeterol 50µg Dose


Finland Elpen Pharmaceutical Co. Inc. Salmeson Fluticasone Propionate 500µg Dose, Salmeterol 50µg Dose


Finland Glaxosmithkline Oy Seretide Diskus Fluticasone Propionate 500µg Dose, Salmeterol Xinafoate 50µg Dose


Finland Orion Oyj Bufomix Easyhaler Budesonide 160µg Inhalation, Formoterol Fumarate Dihydrate 4.5µg Inhalation

Inhalation Powder

12

Member State in EEA


Finland Orion Oyj Bufomix Easyhaler Budesonide 320µg Inhalation, Formoterol Fumarate Dihydrate 9µg Inhalation

Inhalation Powder

France Astrazeneca France Symbicort Turbuhaler Budesonide 160µg Dose, Formoterol Fumarate Dihydrate 4.5µg Dose

Inhalation Powder

France Astrazeneca France Symbicort Turbuhaler Budesonide 320µg Dose, Formoterol Fumarate Dihydrate 9µg Dose

Inhalation Powder

France Chiesi S.A. Formodual Formoterol Fumarate Dihydrate 6µg Dose, Beclometasone Dipropionate Anhydrous 100µg Dose


France Chiesi S.A. Innovair Formoterol Fumarate Dihydrate 6µg Dose, Beclometasone Dipropionate Anhydrous 100µg Dose


France Laboratoire Glaxosmithkline S.A.S. Seretide Diskus Fluticasone Propionate 500µg Dose, Salmeterol 50µg Dose


Germany 3m Health Care Ltd Bronchocort Novo Beclometasone Dipropionate 100µg/50 µl


Germany 3m Health Care Ltd Junik Beclometasone Dipropionate 100µg Actuation


Germany Abz-Pharma Gmbh Beclomethasone Dipropionate Ct

Beclometasone Dipropionate 0.05mg/18.7 G


Germany Meda Pharma Gmbh & Co. Kg Budecort Novolizer Budesonide, Micronised 0.2mg Actuation

Inhalation Powder

Germany Meda Pharma Gmbh & Co. Kg Budecort Novolizer Budesonide, Micronised 0.4mg Actuation

Inhalation Powder

Germany Astrazeneca Gmbh Pulmicort Budesonide Budesonide 0,5 Mg Nebuliser Suspension

Germany Astrazeneca Gmbh Pulmicort Budesonide Budesonide 1,0 Mg Nebuliser Suspension

Germany Astrazeneca Gmbh Pulmicort Budesonide 400µg Dose Inhalation Powder

13

Member State in EEA


Germany Astrazeneca Gmbh Pulmicort Turbohaler Budesonide 200µg Dose Inhalation Powder

Germany Astrazeneca Gmbh Symbicort Turbohaler Budesonide 160µg Dose, Formoterol Fumarate Dihydrate 4.5µg Dose

Inhalation Powder

Germany Astrazeneca Gmbh Symbicort Turbohaler Budesonide 320µg Dose, Formoterol Fumarate Dihydrate 9µg Dose

Inhalation Powder

Germany Chiesi Farmaceutici S.P.A. Kantos Beclometasone Dipropionate 100µg Actuation, Formoterol Fumarate Dihydrate 6µg Actuation


Germany Chiesi Farmaceutici S.P.A. Kantos Master Beclometasone Dipropionate 100µg Actuation, Formoterol Fumarate Dihydrate 6µg Actuation


Germany Chiesi Gmbh Budiair Budesonide 200µg Spray Pressurised Inhalation, Solution

Germany Chiesi Gmbh Foster Beclometasone Dipropionate 100µg Actuation, Formoterol Fumarate Dihydrate 6µg Actuation


Germany Chiesi Gmbh Ribuvent Budesonide 200µg Puff Pressurised Inhalation, Solution

Germany Chiesi Gmbh Sanasthmax Beclometasone Dipropionate 250µg/59.2 Mg


Germany Chiesi Gmbh Sanasthmax Junior Beclometasone Dipropionate 50µg/59 Mg


Germany Elpen Pharmaceutical Co. Inc. Flusalio Fluticasone Propionate 250µg Dose, Salmeterol 50µg Dose


Germany Elpen Pharmaceutical Co. Inc. Flusalio Fluticasone Propionate 500µg Dose, Salmeterol 50µg Dose


Germany Elpen Pharmaceutical Co. Inc. Rolenium Fluticasone Propionate 250µg Dose, Salmeterol 50µg Dose


Germany Elpen Pharmaceutical Co. Inc. Rolenium Fluticasone Propionate 500µg Dose, Salmeterol 50µg Dose


14

Member State in EEA


Germany Glaxosmithkline Gmbh & Co. Kg Flixotide Diskus Fluticasone Propionate 250µg Dose Inhalation Powder

Germany Glaxosmithkline Gmbh & Co. Kg Flixotide Forte Fluticasone Propionate 250µg Inhalation


Germany Glaxosmithkline Gmbh & Co. Kg Flixotide Forte Diskus Fluticasone Propionate 500µg Dose Inhalation Powder

Germany Glaxosmithkline Gmbh & Co. Kg Flutide Diskus Fluticasone Propionate 250µg Dose Inhalation Powder, Pre-Dispensed

Germany Glaxosmithkline Gmbh & Co. Kg Flutide Forte Fluticasone Propionate 220µg Puff Pressurised Inhalation, Suspension

Germany Glaxosmithkline Gmbh & Co. Kg Flutide Forte Diskus Fluticasone Propionate 500µg Dose Inhalation Powder, Pre-Dispensed

Germany Glaxosmithkline Gmbh & Co. Kg Viani Forte Fluticasone Propionate 500µg Dose, Salmeterol Xinafoate 50µg Dose


Germany Heumann Pharma Gmbh & Co. Generica Kg

Budesonid Budesonide 0,2 Mg Inhalation Powder

Germany Hexal Ag Airflusal Forspiro Salmeterol Xinafoate 50µg Dose, Fluticasone 500µg Dose

Inhalation Powder

Germany Hexal Ag Budes N Budesonide 0.2mg Dose Pressurised Inhalation, Solution

Germany Janssen-Cilag Gmbh Inuvair Beclometasone Dipropionate 100µg Inhalation, Formoterol Fumarate 6µg Inhalation


Germany Meda Pharma Gmbh & Co. Kg Budesonid Novolizer Meda Pharma Gmbh & Co. Kg

Budesonide 400µg Inhalation Inhalation Powder

Germany Meda Pharma Gmbh & Co. Kg Novopulmon Novolizer Budesonide 200µg Dose Inhalation Powder

Germany Meda Pharma Gmbh & Co. Kg Novopulmon Novolizer Budesonide 400µg Dose Inhalation Powder

15

Member State in EEA


Germany Mylan Dura Gmbh Budesonid Mylan Budesonide 0,2 Mg Inhalation Powder

Germany Orion Corporation Beclomet Easyhaler Beclometasone Dipropionate 0.2mg Dose

Inhalation Powder

Germany Pari Pharma Gmbh Buparid Budesonide 0.25mg Ampoule Nebuliser Suspension

Germany Pari Pharma Gmbh Buparid Budesonide 0.5mg Ampoule Nebuliser Suspension

Germany Pari Pharma Gmbh Buparid Budesonide 1mg Ampoule Nebuliser Suspension

Germany Pb Pharma Gmbh Budesonid Budesonide 0,92 Mg Inhalation Powder, Hard Capsule

Germany Pb Pharma Gmbh Cyclocaps Beclometason Beclometasone Dipropionate 100µg Units

Inhalation Powder, Hard Capsule





Germany Pb Pharma Gmbh Cyclocaps Budesonid Budesonide 0.8mg Capsule Inhalation Powder, Hard Capsule

Germany Pb Pharma Gmbh Cyclocaps Budesonid Budesonide 100µg Units Inhalation Powder, Hard Capsule

Germany Pb Pharma Gmbh Cyclocaps Budesonid Budesonide 800µg Units Inhalation Powder, Hard Capsule

Germany Ratiopharm Gmbh Beclometason Ratiopharm Beclometasone Dipropionate 0.25mg/18.7g


Germany Ratiopharm Gmbh Beclomethasone Dipropionate Ratiopharm

Beclometasone Dipropionate 0.05mg/18.7g


16

Member State in EEA








Germany Teva Gmbh Aerobec N Beclometasone Dipropionate 100g/5ml


Germany Teva Gmbh Beclometason-Ct Beclometasone Dipropionate 0,1 Mg Pressurised Inhalation, Solution

Germany Teva Gmbh Beclometason-Ct Beclometasone Dipropionate 0,2 Mg Pressurised Inhalation, Solution

Germany Teva Gmbh Ventolair Beclometasone Dipropionate 100g/10ml


Germany Teva Gmbh Ventolair Beclometasone Dipropionate 100g/18.7g


Germany Teva Gmbh Ventolair Beclometasone Dipropionate 100g/5ml


Germany Teva Gmbh Ventolair Beclometasone Dipropionate 250g/18.7g


Germany Teva Gmbh Ventolair Beclometasone Dipropionate 250g/78mg


Germany Teva Gmbh Ventolair Mite Beclometasone Dipropionate 50g/18.7g


Germany Teva Gmbh Ventolair Mite Beclometasone Dipropionate 50g/78mg


Germany Ucb Pharma Gmbh (Monheim De) Atmadisc Forte Diskus Fluticasone Propionate 500µg Inhalation, Salmeterol 50µg Inhalation

Inhalation Powder

Greece Anfarm Hellas Sa Talgan Budesonide 100µg Dose Inhalation Powder

17

Member State in EEA


Greece Astrazeneca S.A. Pulmicort Turbuhaler Budesonide 100µg Dose Inhalation Powder



Greece Astrazeneca S.A. Symbicort Turbuhaler Budesonide 160µg Dose, Formoterol Fumarate Dihydrate 4.5µg Dose

Inhalation Powder

Greece Astrazeneca S.A. Symbicort Turbuhaler Budesonide 320µg Dose, Formoterol Fumarate Dihydrate 9µg Dose

Inhalation Powder

Greece Chiesi Hellas A.E.B.E. Foster Beclometasone Dipropionate 100µg Actuation, Formoterol Fumarate Dihydrate 6µg Actuation


Greece Chiesi Hellas A.E.B.E. Foster Nexthaler Formoterol Fumarate Dihydrate 6µg Dose, Beclometasone Dipropionate Anhydrous 100µg Dose

Inhalation Powder

Greece Chiesi Hellas A.E.B.E. Inuvair Beclometasone Dipropionate 100µg Actuation, Formoterol Fumarate Dihydrate 6µg Actuation


Greece Chiesi Hellas A.E.B.E. Inuvair Nexthaler Formoterol Fumarate Dihydrate 6µg Dose, Beclometasone Dipropionate Anhydrous 100µg Dose

Inhalation Powder

Greece D.A.S.T. Biotech Pharm επε Flihaler Fluticasone Propionate 250mcg/Dose Pressurised Inhalation, Suspension

Greece Elpen Pharmaceutical Co. Inc. Fluticapen Fluticasone Propionate 250µg Dose Inhalation Powder, Pre-Dispensed

Greece Elpen Pharmaceutical Co. Inc. Fluticapen Fluticasone Propionate 500µg Dose Inhalation Powder, Pre-Dispensed

Greece Elpen Pharmaceutical Co. Inc. Pulmoton Budesonide 100µg Dose, Formoterol Fumarate Dihydrate 6µg Dose


18

Member State in EEA






Greece Elpen Pharmaceutical Co. Inc. Rolenium Fluticasone Propionate 250µg Dose, Salmeterol 50µg Dose


Greece Elpen Pharmaceutical Co. Inc. Rolenium Fluticasone Propionate 500µg Dose, Salmeterol 50µg Dose


Greece Glaxosmithkline Aebe Flixotide Fluticasone Propionate 100µg Dose Inhalation Powder

Greece Glaxosmithkline Aebe Flixotide Fluticasone Propionate 125µg Dose Pressurised Inhalation





Greece Glaxosmithkline Aebe Flixotide Diskus Fluticasone Propionate 100µg Dose Inhalation Powder



Greece Glaxosmithkline Aebe Seretide Fluticasone Propionate 500µg Dose, Salmeterol Xinafoate 50µg Dose


19

Member State in EEA


Greece Iasis Pharma Olfo Haler Budesonide 200µg Dose Inhalation Powder

Greece Iasis Pharma Olfo Haler Budesonide 400µg Dose Inhalation Powder

Greece Medicair Bioscience Laboratories S.A Bocacort-S Fluticasone Propionate 250mcg/Dose Pressurised Inhalation, Suspension

Greece Orion Corporation Bufomix Budosenide 160mcg, Formoterol Fumarate Dihydrate 4.5mcg

Inhalation Powder

Greece Orion Corporation Bufomix Budosenide 320mcg, Formoterol Fumarate Dihydrate 9mcg

Inhalation Powder

Greece Orion Corporation Orest Budosenide 160mcg, Formoterol Fumarate Dihydrate 4.5mcg

Inhalation Powder

Greece Orion Corporation Orest Budosenide 320mcg, Formoterol Fumarate Dihydrate 9mcg

Inhalation Powder

Greece Png Gerolymatos Medical A.E. Asmaflex Fluticasone Propionate 250mgg Pressurised Inhalation, Suspension

Greece Rafarm Sa. Resata Budesonide 200µg Dose Inhalation Powder, Pre-Dispensed

Greece Rafarm Sa. Resata Budesonide 400µg Dose Inhalation Powder, Pre-Dispensed

Greece Verisfield (Uk) Ltd Flixocort Fluticasone Propionate 50µg Dose Nasal Spray, Suspension

Greece Verisfield (Uk) Ltd Flixocort Fluticasone Propionate 125µg Dose Pressurised Inhalation, Suspension

Greece Verisfield (Uk) Ltd Flixocort Fluticasone Propionate 250µg Dose Pressurised Inhalation, Suspension

20

Member State in EEA


Greece Verisfield (Uk) Ltd Pulmihal Budesonide 200µg Dose Inhalation Powder, Pre-Dispensed

Greece Win Medica Ltd Flusalair Fluticasone Propionate 250µg Dose, Salmeterol 50µg Dose

Inhalation Powder

Greece Win Medica Ltd Flusalair Fluticasone Propionate 500µg Dose, Salmeterol 50µg Dose


Greece Win Medica Ltd Flutiresp Fluticasone Propionate 250mcg/Dose Inhalation Powder

Greece Win Medica Ltd Flutiresp Fluticasone Propionate 500µg Inhalation

Inhalation Powder

Greece Zwitter Pharmaceuticals επε Salenga Fluticasone Propionate 250µg Dose Pressurised Inhalation, Suspension

Greece Pharmanel Commercial Pharmaceutical S.A.

Vernoral Budesonide 200µg Dose Inhalation Powder

Greece Pharmanel Commercial Pharmaceutical S.A.

Vernoral Budesonide 400µg Dose Inhalation Powder

Hungary Astrazeneca Kft. Symbicort Turbuhaler Budesonide 160µg Dose, Formoterol Fumarate Dihydrate 4.5µg Dose

Inhalation Powder

Hungary Astrazeneca Kft. Symbicort Turbuhaler Budesonide 320µg Dose, Formoterol Fumarate Dihydrate 9µg Dose

Inhalation Powder

Hungary Chiesi Pharmaceuticals Gmbh Formodual Formoterol Fumarate Dihydrate 6µg Actuation, Beclometasone Dipropionate Anhydrous 100µg Actuation


Hungary Chiesi Pharmaceuticals Gmbh Foster Beclometasone Dipropionate 100µg Actuation, Formoterol Fumarate Dihydrate 6µg Actuation


Hungary Elpen Pharmaceutical Co. Inc. Dimenio Fluticasone Propionate 250µg Dose, Salmeterol 50µg Dose

Inhalation Powder

21

Member State in EEA


Hungary Elpen Pharmaceutical Co. Inc. Dimenio Fluticasone Propionate 500µg Dose, Salmeterol 50µg Dose

Inhalation Powder

Hungary Elpen Pharmaceutical Co. Inc. Flumetor Fluticasone Propionate 250µg Dose, Salmeterol 50µg Dose


Hungary Elpen Pharmaceutical Co. Inc. Flumetor Fluticasone Propionate 500µg Dose, Salmeterol 50µg Dose


Hungary Glaxosmithkline Kft. Seretide Diskus Fluticasone Propionate 500µg Dose, Salmeterol Xinafoate 50µg Dose


Hungary Montrose Kft Thoreus Diskus Fluticasone Propionate 500µg Dose, Salmeterol Xinafoate 50µg Dose


Hungary Orion Oyj Bufomix Easyhaler Budesonide 160µg Inhalation, Formoterol Fumarate Dihydrate 4.5µg Inhalation

Inhalation Powder

Hungary Orion Oyj Bufomix Easyhaler Budesonide 320µg Inhalation, Formoterol Fumarate Dihydrate 9µg Inhalation

Inhalation Powder

Hungary Sandoz Hungária Kft Airflusol Forspiro Salmeterol Xinafoate 50µg Dose, Fluticasone 500µg Dose

Inhalation Powder

Iceland Astrazeneca A-S Symbicort Forte Turbuhaler Budesonide 320µg Dose, Formoterol Fumarate Dihydrate 9µg Dose

Inhalation Powder

Iceland Astrazeneca A-S Symbicort Mite Turbuhaler Budesonide 160µg Dose, Formoterol Fumarate Dihydrate 4.5µg Dose

Inhalation Powder

Iceland Elpen Pharmaceutical Co. Inc. Relanio Fluticasone Propionate 250µg Dose, Salmeterol 50µg Dose


Iceland Elpen Pharmaceutical Co. Inc. Relanio Fluticasone Propionate 500µg Dose, Salmeterol 50µg Dose


Iceland Glaxosmithkline Ehf. Flixotide Fluticasone Propionate 250µg Dose Pressurised Inhalation, Suspension

Iceland Glaxosmithkline Ehf. Flixotide Diskus Fluticasone Propionate 100µg Dose Inhalation Powder

22

Member State in EEA




Iceland Glaxosmithkline Ehf. Seretide Diskus Fluticasone Propionate 500µg Dose, Salmeterol 50µg Dose


Ireland Astrazeneca Uk Limited Pulmicort Turbohaler Budesonide 100µg Dose Inhalation Powder



Ireland Astrazeneca Uk Limited Symbicort Turbohaler Budesonide 160µg Dose, Formoterol Fumarate Dihydrate 4.5µg Dose

Inhalation Powder

Ireland Astrazeneca Uk Limited Symbicort Turbohaler Budesonide 320µg Dose, Formoterol Fumarate Dihydrate 9µg Dose

Inhalation Powder

Ireland Elpen Pharmaceutical Co. Inc. Flamerio Fluticasone Propionate 250µg Dose, Salmeterol 50µg Dose


Ireland Elpen Pharmaceutical Co. Inc. Flamerio Fluticasone Propionate 500µg Dose, Salmeterol 50µg Dose, Lactose Monohydrate 24.677mg Dose


Ireland Glaxosmithkline (Ireland) Limited Flixotide Diskus Fluticasone Propionate 250µg Blister Inhalation Powder, Pre-Dispensed

Ireland Glaxosmithkline (Ireland) Limited Flixotide Diskus Fluticasone Propionate 500µg Blister Inhalation Powder, Pre-Dispensed

Ireland Glaxosmithkline (Ireland) Limited Flixotide Evohaler Fluticasone Propionate 250µg Dose Pressurised Inhalation, Suspension

Ireland Glaxosmithkline (Ireland) Limited Seretide Diskus Fluticasone Propionate 500µg Dose, Salmeterol 50µg Dose


23

Member State in EEA


Ireland Glaxosmithkline (Ireland) Limited Viani Diskus Fluticasone Propionate 500µg Dose, Salmeterol 50µg Dose


Ireland Orion Oyj Bufomix Easyhaler Budesonide 160µg Inhalation, Formoterol Fumarate Dihydrate 4.5µg Inhalation

Inhalation Powder

Ireland Orion Oyj Bufomix Easyhaler Budesonide 320µg Inhalation, Formoterol Fumarate Dihydrate 9µg Inhalation

Inhalation Powder

Ireland Rowex Ltd Airflusal Forspiro Salmeterol Xinafoate 50µg Dose, Fluticasone 250µg Dose

Inhalation Powder

Ireland Rowex Ltd Airflusal Forspiro Salmeterol Xinafoate 50µg Dose, Fluticasone 500µg Dose

Inhalation Powder

Italy Astrazeneca S.P.A Sinestic Budesonide 160µg Dose, Formoterol Fumarate Dihydrate 4.5µg Dose

Inhalation Powder

Italy Astrazeneca S.P.A Sinestic Budesonide 320µg Dose, Formoterol Fumarate Dihydrate 4.5µg Dose

Inhalation Powder

Italy Astrazeneca S.P.A Symbicort Budesonide 160µg Dose, Formoterol Fumarate Dihydrate 4.5µg Dose

Inhalation Powder

Italy Astrazeneca S.P.A Symbicort Budesonide 320µg Dose, Formoterol Fumarate Dihydrate 9µg Dose

Inhalation Powder

Italy Elpen Pharmaceutical Co. Inc. Flamerio Fluticasone Propionate 250µg Dose, Salmeterol 50µg Dose


Italy Elpen Pharmaceutical Co. Inc. Flamerio Fluticasone Propionate 500µg Dose, Salmeterol 50µg Dose


Italy Elpen Pharmaceutical Co. Inc. Rolenium Fluticasone Propionate 250µg Dose, Salmeterol 50µg Dose


Italy Elpen Pharmaceutical Co. Inc. Rolenium Fluticasone Propionate 500µg Dose, Salmeterol 50µg Dose


Italy Glaxosmithkline S.P.A. Seretide Fluticasone Propionate 500µg Dose, Salmeterol Xinafoate 50µg Dose


24

Member State in EEA


Italy Menarini International Operations Luxembourg S.A.

Aliflus Diskus Fluticasone Propionate 100µg Dose, Salmeterol 50µg Dose








Italy Promedica S.R.L. Clenil Compositum Beclometasone Dipropionate 0.8mg/2 Ml, Salbutamol Sulfate 1.928mg/2 Ml

Nebuliser Suspension

Italy Promedica S.R.L. Clenil Compositum Beclometasone Dipropionate 50µg Actuation, Salbutamol Sulfate 120µg Actuation


Italy Simesa S.P.A. Assieme Budesonide 160µg Dose, Formoterol Fumarate Dihydrate 4.5µg Dose

Inhalation Powder

Italy Simesa S.P.A. Assieme Budesonide 320µg Dose, Formoterol Fumarate Dihydrate 9µg Dose

Inhalation Powder

Italy Valeas S.P.A. Plenaer Flunisolide 25mg Bottle, Salbutamol 10mg Bottle


Italy Valeas S.P.A. Plenaer Salbutamol Sulfate 0.602mg Vial, Flunisolide 0.5mg Vial

Nebuliser Solution

Latvia Astrazeneca Ab Pulmicort Turbuhaler Budesonide 100µg Dose Inhalation Powder

Latvia Astrazeneca Ab Pulmicort Turbuhaler Budesonide 200µg Dose Inhalation Powder

Latvia Astrazeneca Ab Symbicort Turbuhaler Budesonide 160µg Dose, Formoterol Fumarate Dihydrate 4.5µg Dose

Inhalation Powder

Latvia Astrazeneca Ab Symbicort Turbuhaler Budesonide 320µg Dose, Formoterol Fumarate Dihydrate 9µg Dose

Inhalation Powder

Latvia Chiesi Pharmaceuticals Gmbh Foster Beclometasone Dipropionate 100µg Actuation, Formoterol Fumarate Dihydrate 6µg Actuation


25

Member State in EEA


Latvia Elpen Pharmaceutical Co. Inc. Flamerio Fluticasone Propionate 250µg Dose, Salmeterol 50µg Dose


Latvia Elpen Pharmaceutical Co. Inc. Flamerio Fluticasone Propionate 500µg Dose, Salmeterol 50µg Dose


Latvia Glaxosmithkline Latvia Sia Flixotide Fluticasone Propionate 250µg Inhalation


Latvia Glaxosmithkline Latvia Sia Flixotide Diskus Fluticasone Propionate 250µg Dose Inhalation Powder

Latvia Glaxosmithkline Latvia Sia Flixotide Diskus Fluticasone Propionate 500µg Dose Inhalation Powder

Latvia Glaxosmithkline Latvia Sia Flosal Fluticasone Propionate 250µg Inhalation, Salmeterol Xinafoate 25µg Inhalation


Latvia Glaxosmithkline Latvia Sia Flosal Fluticasone Propionate 500µg Dose, Salmeterol Xinafoate 50µg Dose

Inhalation Powder

Latvia Glaxosmithkline Latvia Sia Seretide Fluticasone Propionate 250µg Inhalation, Salmeterol Xinafoate 25µg Inhalation


Latvia Glaxosmithkline Latvia Sia Seretide Fluticasone Propionate 500µg Dose, Salmeterol Xinafoate 50µg Dose

Inhalation Powder

Latvia Novartis Finland Oy Miflonide Budesonide 200µg Inhalation Powder, Hard Capsule

Latvia Novartis Finland Oy Miflonide Budesonide 400µg Inhalation Powder, Hard Capsule

Latvia Orion Corporation Bufomix Easyhaler Budesonide 160µg Inhalation, Formoterol Fumarate Dihydrate 4.5µg Inhalation

Inhalation Powder

Latvia Orion Corporation Bufomix Easyhaler Budesonide 320µg Inhalation, Formoterol Fumarate Dihydrate 9µg Inhalation

Inhalation Powder

26

Member State in EEA


Latvia Sandoz Pharmaceuticals D.D. Airflusal Forspiro Fluticasone Propionate 233µg Dose, Salmeterol 45µg Dose


Latvia Sandoz Pharmaceuticals D.D. Airflusal Forspiro Salmeterol Xinafoate 50µg Dose, Fluticasone 500µg Dose


Lithuania Astrazeneca Ab Symbicort Turbuhaler Budesonide 160µg Dose, Formoterol Fumarate Dihydrate 4.5µg Dose

Inhalation Powder

Lithuania Astrazeneca Ab Symbicort Turbuhaler Budesonide 320µg Dose, Formoterol Fumarate Dihydrate 9µg Dose

Inhalation Powder

Lithuania Chiesi Pharmaceuticals Gmbh Foster Beclometasone Dipropionate 100µg Actuation, Formoterol Fumarate Dihydrate 6µg Actuation


Lithuania Elpen Pharmaceutical Co. Inc. Flamerio Fluticasone Propionate 250µg Dose, Salmeterol 50µg Dose


Lithuania Elpen Pharmaceutical Co. Inc. Flamerio Fluticasone Propionate 500µg Dose, Salmeterol 50µg Dose


Lithuania Glaxosmithkline Lietuva Uab Flixotide Fluticasone Propionate 250µg Inhalation


Lithuania Glaxosmithkline Lietuva Uab Flixotide Diskus Fluticasone Propionate 250µg Dose Inhalation Powder, Pre-Dispensed

Lithuania Glaxosmithkline Lietuva Uab Flixotide Diskus Fluticasone Propionate 500µg Dose Inhalation Powder, Pre-Dispensed

Lithuania Glaxosmithkline Lietuva Uab Seretide Fluticasone Propionate 500µg Dose, Salmeterol Xinafoate 50µg Dose


Lithuania Novartis Finland Oy Miflonide Budesonide 200µg Inhalation Powder, Hard Capsule

Lithuania Novartis Finland Oy Miflonide Budesonide 400µg Inhalation Powder, Hard Capsule

Lithuania Orion Oyj Bufomix Easyhaler Budesonide 160µg Inhalation, Formoterol Fumarate Dihydrate 4.5µg Inhalation

Inhalation Powder

27

Member State in EEA


Lithuania Orion Oyj Bufomix Easyhaler Budesonide 160µg, Formoterol Fumarate Dihydrate 4.5µg

Inhalation Powder

Lithuania Orion Oyj Bufomix Easyhaler Budesonide 320µg Inhalation, Formoterol Fumarate Dihydrate 9µg Inhalation

Inhalation Powder

Lithuania Orion Oyj Bufomix Easyhaler Budesonide 320µg, Formoterol Fumarate Dihydrate 9µg

Inhalation Powder

Lithuania Sandoz Pharmaceuticals D.D. Airflusal Forspiro Salmeterol Xinafoate 50µg Dose, Fluticasone 250µg Dose

Inhalation Powder

Lithuania Sandoz Pharmaceuticals D.D. Airflusal Forspiro Salmeterol Xinafoate 50µg Dose, Fluticasone 500µg Dose

Inhalation Powder

Luxembourg Chiesi Sa-Nv Inuvair Formoterol Fumarate Dihydrate 6µg Actuation, Beclometasone Dipropionate Anhydrous 100µg Actuation


Luxembourg Elpen Pharmaceutical Co. Inc. Flusamer Fluticasone Propionate 250µg Dose, Salmeterol 50µg Dose


Luxembourg Elpen Pharmaceutical Co. Inc. Flusamer Fluticasone Propionate 500µg Dose, Salmeterol 50µg Dose


Luxembourg Glaxosmithkline Pharmaceuticals S.A.












28

Member State in EEA



Seretide Diskus Fluticasone Propionate 500µg Dose, Salmeterol Xinafoate 50µg Dose

Inhalation Powder

Luxembourg Nv Astrazeneca Sa Pulmicort Turbohaler Budesonide 200µg Dose Inhalation Powder

Luxembourg Nv Astrazeneca Sa Symbicort Turbohaler Budesonide 160µg Dose, Formoterol Fumarate Dihydrate 4.5µg Dose

Inhalation Powder

Luxembourg Nv Astrazeneca Sa Symbicort Forte Turbohaler Budesonide 320µg Dose, Formoterol Fumarate Dihydrate 9µg Dose

Inhalation Powder

Luxembourg Orion Corporation Bufomix Easyhaler Budesonide 160µg Dose, Formoterol Fumarate Dihydrate Ph.Eur. 4.5µg Dose

Inhalation Powder

Luxembourg Orion Corporation Bufomix Easyhaler Budesonide 320µg Dose, Formoterol Fumarate Dihydrate Ph.Eur. 9µg Dose

Inhalation Powder

Luxembourg Orion Corporation Orest Easyhaler Budesonide 160µg Dose, Formoterol Fumarate Dihydrate Ph.Eur. 4.5µg Dose

Inhalation Powder

Luxembourg Orion Corporation Orest Easyhaler Budesonide 320µg Dose, Formoterol Fumarate Dihydrate Ph.Eur. 9µg Dose

Inhalation Powder

Malta Astrazeneca Ab Pulmicort Turbuhaler Budesonide 100µg Dose Inhalation Powder

Malta Astrazeneca Ab Pulmicort Turbuhaler Budesonide 200µg Dose Inhalation Powder

Malta Astrazeneca Ab Symbicort Turbohaler Budesonide 160µg Dose, Formoterol Fumarate Dihydrate 4.5µg Dose

Inhalation Powder

Malta Astrazeneca Ab Symbicort Turbohaler Budesonide 320µg Dose, Formoterol Fumarate Dihydrate 9µg Dose

Inhalation Powder

Malta Elpen Pharmaceutical Co. Inc. Rolenium Fluticasone Propionate 500µg Dose, Salmeterol 50µg Dose


Malta Elpen Pharmaceutical Co. Inc. Rolenium Fluticasone Propionate 250µg Dose, Salmeterol 50µg Dose


29

Member State in EEA


Malta Glaxosmithkline (Ireland) Limited Flixotide Evohaler Fluticasone Propionate 250µg Dose Pressurised Inhalation, Suspension

Malta Glaxosmithkline (Ireland) Limited Seretide Diskus Fluticasone Propionate 500µg Dose, Salmeterol 50µg Dose


Malta Novartis Pharmaceuticals Uk Limited Miflonide Budesonide 200µg Capsule Inhalation Powder, Hard Capsule

Malta Novartis Pharmaceuticals Uk Limited Miflonide Budesonide 400µg Inhalation Powder, Hard Capsule

Malta Orion Oyj Bufomix Easyhaler Budesonide 160µg Inhalation, Formoterol Fumarate Dihydrate 4.5µg Inhalation

Inhalation Powder

Malta Orion Oyj Bufomix Easyhaler Budesonide 320µg Inhalation, Formoterol Fumarate Dihydrate 9µg Inhalation

Inhalation Powder

Malta Orion Oyj Orest Easyhaler Budesonide 160µg Inhalation, Formoterol Fumarate Dihydrate 4.5µg Inhalation

Inhalation Powder

Malta Orion Oyj Orest Easyhaler Budesonide 320µg Inhalation, Formoterol Fumarate Dihydrate 9µg Inhalation

Inhalation Powder

Netherlands Astrazeneca Bv Symbicort Turbuhaler Budesonide 160µg Dose, Formoterol Fumarate Dihydrate 4.5µg Dose

Inhalation Powder

Netherlands Astrazeneca Bv Symbicort Turbuhaler Budesonide 320µg Dose, Formoterol Fumarate Dihydrate 9µg Dose

Inhalation Powder

Netherlands Glaxosmithkline B.V. Fluticasonpropionaat Inhalator GSK

Fluticasone Propionate 125µg Dose Aerosol





30

Member State in EEA


Netherlands Chiesi Pharmaceuticals B.V. Formodual Formoterol Fumarate Dihydrate 6µg Actuation, Beclometasone Dipropionate Anhydrous 100µg Actuation


Netherlands Chiesi Pharmaceuticals B.V. Foster Beclometasone Dipropionate 100µg Actuation, Formoterol Fumarate Dihydrate 6µg Actuation


Netherlands Elpen Pharmaceutical Co. Inc. Salmeterol/ Fluticasonpropionaat Elpen



Netherlands Elpen Pharmaceutical Co. Inc. Salmeterol/ Fluticasonpropionaat Elpen



Netherlands Glaxosmithkline B.V. Flixotide Fluticasone Propionate 250µg Inhalation


Netherlands Glaxosmithkline B.V. Flixotide Diskus Fluticasone Propionate 500µg Dose Inhalation Powder, Pre-Dispensed

Netherlands Glaxosmithkline B.V. Seretide Fluticasone Propionate 500µg Dose, Salmeterol Xinafoate 50µg Dose


Norway Astrazeneca As Symbicort Forte Turbuhaler Budesonide 320µg Dose, Formoterol Fumarate Dihydrate 9µg Dose

Inhalation Powder

Norway Astrazeneca As Symbicort Turbuhaler Budesonide 160µg Dose, Formoterol Fumarate Dihydrate 4.5µg Dose

Inhalation Powder

Norway Chiesi Farmaceutici S.P.A. Inuxair Beclometasone Dipropionate 100µg Actuation, Formoterol Fumarate Dihydrate 6µg Actuation


Norway Elpen Pharmaceutical Co. Inc. Salmeson Fluticasone Propionate 250µg Dose, Salmeterol 50µg Dose


Norway Elpen Pharmaceutical Co. Inc. Salmeson Fluticasone Propionate 500µg Dose, Salmeterol 50µg Dose


Norway Glaxosmithkline As Seretide Diskus Fluticasone Propionate 500µg Dose, Salmeterol Xinafoate 50µg Dose


31

Member State in EEA


Norway Sandoz A-S Airflusal Forspiro Salmeterol Xinafoate 50µg Dose, Fluticasone Propionate 250µg Dose

Inhalation Powder

Norway Sandoz A-S Airflusal Forspiro Salmeterol Xinafoate 50µg Dose, Fluticasone Propionate 500µg Dose

Inhalation Powder

Poland Adamed Sp. Z O.O. Flutixon Fluticasone Propionate 125µg Capsule Inhalation Powder, Hard Capsule

Poland Adamed Sp. Z O.O. Flutixon Fluticasone Propionate 250µg Capsule Inhalation Powder, Hard Capsule

Poland Astrazeneca Ab Pulmicort Turbuhaler Budesonide 100µg Dose Inhalation Powder

Poland Astrazeneca Ab Pulmicort Turbuhaler Budesonide 200µg Dose Inhalation Powder

Poland Astrazeneca Ab Symbicort Turbuhaler Budesonide 160µg Dose, Formoterol Fumarate Dihydrate 4.5µg Dose

Inhalation Powder

Poland Astrazeneca Ab Symbicort Turbuhaler Budesonide 320µg Dose, Formoterol Fumarate Dihydrate 9µg Dose

Inhalation Powder

Poland Celon Pharma S.A. Salmex Fluticasone Propionate 500µg Dose, Salmeterol Xinafoate 50µg Dose

Inhalation Powder

Poland Chiesi Pharmaceuticals Gmbh Formodual Beclometasone Dipropionate 100µg Actuation, Formoterol Fumarate Dihydrate 6µg Actuation


Poland Chiesi Pharmaceuticals Gmbh Fostex Beclometasone Dipropionate 100µg Actuation, Formoterol Fumarate Dihydrate 6µg Actuation


Poland Elpen Pharmaceutical Co. Inc. Salmeson Fluticasone Propionate 250µg Dose, Salmeterol 50µg Dose


Poland Elpen Pharmaceutical Co. Inc. Salmeson Fluticasone Propionate 500µg Dose, Salmeterol 50µg Dose


Poland Glaxosmithkline Export Ltd Flixotide Fluticasone Propionate 250µg Dose Inhalation Powder, Pre-Dispensed

32

Member State in EEA


Poland Glaxosmithkline Export Ltd Flixotide Fluticasone Propionate 250µg Inhalation


Poland Glaxosmithkline Export Ltd Flixotide Dysk Fluticasone Propionate 50µg Dose Inhalation Powder, Pre-Dispensed

Poland Glaxosmithkline Export Ltd Seretide Dysk Fluticasone Propionate 500µg Dose, Salmeterol Xinafoate 50µg Dose

Inhalation Powder

Poland Meda Pharma Gmbh & Co. Kg Budelin Novolizer Budesonide 200µg Dose Inhalation Powder

Poland Novartis Poland Sp. Z O. O. Miflonide Budesonide 200µg Inhalation Powder, Hard Capsule

Poland Novartis Poland Sp. Z O. O. Miflonide Budesonide 400µg Inhalation Powder, Hard Capsule

Poland Orion Corporation Orest Easyhaler Budesonide 160µg Inhalation, Formoterol Fumarate Dihydrate 4.5µg Inhalation

Inhalation Powder

Poland Orion Corporation Orest Easyhaler Budesonide 320µg Inhalation, Formoterol Fumarate Dihydrate 9µg Inhalation

Inhalation Powder

Poland Polfarmex S.A. Asaris Fluticasone Propionate 500µg Dose, Salmeterol 50µg Dose

Inhalation Powder

Poland Przedsiębiorstwo Farmaceutyczne Lek-Am Sp. Z O.O.

Budezonid Lek-Am Budesonide 200µg Inhalation Inhalation Powder, Hard Capsule

Poland Przedsiębiorstwo Farmaceutyczne Lek-Am Sp. Z O.O.

Budezonid Lek-Am Budesonide 400µg Inhalation Inhalation Powder, Hard Capsule

Portugal Astrazeneca Produtos Farmacêuticos, Lda.

Assieme Turbohaler Budesonide 160µg Dose, Formoterol Fumarate Dihydrate 4.5µg Dose

Inhalation Powder


Assieme Turbohaler Budesonide 320µg Dose, Formoterol Fumarate Dihydrate 9µg Dose

Inhalation Powder

Portugal Astrazeneca Produtos Farmaceuticos Limitada

Pulmicort Turbohaler Budesonide 200µg Dose Inhalation Powder

33

Member State in EEA


Portugal Astrazeneca Produtos Farmaceuticos Limitada

Pulmicort Turbohaler Budesonide 400µg Dose Inhalation Powder


Symbicort Turbohaler Budesonide 160µg Dose, Formoterol Fumarate Dihydrate 4.5µg Dose

Inhalation Powder


Symbicort Turbohaler Budesonide 320µg Dose, Formoterol Fumarate Dihydrate 9µg Dose

Inhalation Powder

Portugal Bialfar - Produtos Farmacêuticos, Sociedade Anónima

Brisomax Diskus Fluticasone Propionate 100µg Dose, Salmeterol Xinafoate 50µg Dose








Portugal Elpen Pharmaceutical Co. Inc. Dimenium Fluticasone Propionate 500µg Dose, Salmeterol 50µg Dose


Portugal Elpen Pharmaceutical Co. Inc. Dimenium Fluticasone Propionate 250µg Dose, Salmeterol 50µg Dose


Portugal Farmoz - Sociedade Técnico Medicinal, S.A.

Budesonida Farmoz Budesonide 200µg Dose Inhalation Powder

Portugal Farmoz - Sociedade Técnico Medicinal, S.A.

Budesonida Farmoz Budesonide 400µg Dose Inhalation Powder

Portugal Glaxo Wellcome Farmacêutica, Limitada

Seretaide Diskus Fluticasone Propionate 500µg Dose, Salmeterol Xinafoate 50µg Dose


Portugal Glaxosmithkline - Produtos Farmacêuticos, Limitada

Maizar Diskus Fluticasone Propionate 500µg Dose, Salmeterol Xinafoate 50µg Dose


Portugal Orion Corporation Bufomix Easyhaler Budesonide 160µg Dose, Formoterol Fumarate Dihydrate 4.5µg Dose

Inhalation Powder

Portugal Orion Corporation Bufomix Easyhaler Budesonide 320µg Dose, Formoterol Fumarate Dihydrate 9µg Dose

Inhalation Powder

34

Member State in EEA


Portugal Orion Corporation Orest Easyhaler Budesonide 160µg Dose, Formoterol Fumarate Dihydrate 4.5µg Dose

Inhalation Powder

Portugal Orion Corporation Orest Easyhaler Budesonide 320µg Dose, Formoterol Fumarate Dihydrate 9µg Dose

Inhalation Powder

Portugal Pentafarma - Sociedade Tecnico-Medicinal S.A.

Budesonida Tecnicort Budesonide 200µg Dose Inhalation Powder

Portugal Pentafarma - Sociedade Tecnico-Medicinal S.A.

Budesonida Tecnicort Budesonide 400µg Dose Inhalation Powder

Portugal Sandoz Farmacêutica, Limitada Airflusal Forspiro Fluticasone Propionate 250µg Dose, Salmeterol Xinafoate 50µg Dose


Portugal Sandoz Farmacêutica, Limitada Airflusal Forspiro Fluticasone Propionate 500µg Dose, Salmeterol Xinafoate 50µg Dose


Romania Astrazeneca Ab Symbicort Turbuhaler Budesonide 160µg Dose, Formoterol Fumarate Dihydrate 4.5µg Dose

Inhalation Powder

Romania Astrazeneca Ab Symbicort Turbuhaler Budesonide 320µg Dose, Formoterol Fumarate Dihydrate 9µg Dose

Inhalation Powder

Romania Chiesi Pharmaceuticals Gmbh Foster Formoterol Fumarate Dihydrate 6µg Actuation, Beclometasone Dipropionate Anhydrous 100µg Actuation


Romania Elpen Pharmaceutical Co. Inc. Flusamer Fluticasone Propionate 250µg Dose, Salmeterol 50µg Dose


Romania Elpen Pharmaceutical Co. Inc. Flusamer Fluticasone Propionate 500µg Dose, Salmeterol 50µg Dose


Romania Glaxo Wellcome Ltd Flixotide Fluticasone Propionate 250µg Inhalation


Romania Glaxo Wellcome Ltd Flixotide Diskus Fluticasone Propionate 250µg Dose Inhalation Powder

35

Member State in EEA


Romania Glaxo Wellcome Ltd Flixotide Diskus Fluticasone Propionate 500µg Dose Inhalation Powder

Romania Glaxo Wellcome Ltd Seretide Fluticasone Propionate 500µg Dose, Salmeterol Xinafoate 50µg Dose


Romania Medochemie Romania S.R.L. Frenolyn Budesonide, Micronised 200µg Dose Inhalation Powder

Romania Medochemie Romania S.R.L. Frenolyn Budesonide, Micronised 400µg Dose Inhalation Powder

Romania Orion Oyj Bufomix Easyhaler Budesonide 160µg Inhalation, Formoterol Fumarate Dihydrate 4.5µg Inhalation

Inhalation Powder

Romania Orion Oyj Bufomix Easyhaler Budesonide 320µg Inhalation, Formoterol Fumarate Dihydrate 9µg Inhalation

Inhalation Powder

Romania S.C. Sandoz S.R.L. Airflusal Forspiro Salmeterol Xinafoate 50µg Dose, Fluticasone 500µg Dose

Inhalation Powder

Slovakia Astrazeneca Ab Pulmicort Turbohaler Budesonide 100µg Dose Inhalation Powder



Slovakia Astrazeneca Ab Symbicort Turbuhaler Budesonide 160µg Dose, Formoterol Fumarate Dihydrate 4.5µg Dose

Inhalation Powder

Slovakia Astrazeneca Ab Symbicort Turbuhaler Budesonide 320µg Dose, Formoterol Fumarate Dihydrate 9µg Dose

Inhalation Powder

Slovakia Chiesi Pharmaceuticals Gmbh Foster Beclometasone Dipropionate 100µg Actuation, Formoterol Fumarate Dihydrate 6µg Actuation


Slovakia Elpen Pharmaceutical Co. Inc. Dimenium Fluticasone Propionate 250µg Dose, Salmeterol 50µg Dose


36

Member State in EEA


Slovakia Elpen Pharmaceutical Co. Inc. Dimenium Fluticasone Propionate 500µg Dose, Salmeterol 50µg Dose


Slovakia Elpen Pharmaceutical Co. Inc. Flumetor Fluticasone Propionate 250µg Dose, Salmeterol Xinafoate 50µg Dose


Slovakia Elpen Pharmaceutical Co. Inc. Flumetor Fluticasone Propionate 500µg Dose, Salmeterol Xinafoate 50µg Dose


Slovakia Glaxo Group Limited Flixotide Fluticasone Propionate 125µg Inhalation






Slovakia Glaxo Group Limited Seretide Fluticasone Propionate 500µg Dose, Salmeterol Xinafoate 50µg Dose


Slovakia Glaxosmithkline Slovakia S.R.O. Flixotide Diskus Fluticasone Propionate 100µg Dose Inhalation Powder




Slovakia Meda Pharma Spol. S R.O. Budelin Novolizer Budesonide 200µg Dose Inhalation Powder

Slovakia Novartis, S.R.O. Miflonid Budesonide 200µg Inhalation Powder, Hard Capsule

Slovakia Novartis, S.R.O. Miflonid Budesonide 400µg Inhalation Powder, Hard Capsule

37

Member State in EEA


Slovakia Sandoz Pharmaceuticals D.D. Airflusal Forspiro Salmeterol Xinafoate 50µg Dose, Fluticasone 250µg Dose

Inhalation Powder

Slovakia Sandoz Pharmaceuticals D.D. Airflusal Forspiro Salmeterol Xinafoate 50µg Dose, Fluticasone 500µg Dose

Inhalation Powder

Slovenia Astrazeneca Ab Symbicort Turbuhaler Budesonide 160µg Dose, Formoterol Fumarate Dihydrate 4.5µg Dose

Inhalation Powder

Slovenia Astrazeneca Ab Symbicort Turbuhaler Budesonide 320µg Dose, Formoterol Fumarate Dihydrate 9µg Dose

Inhalation Powder

Slovenia Chiesi Pharmaceuticals Gmbh Formodual Beclometasone Dipropionate 100µg Actuation, Formoterol Fumarate Dihydrate 6µg Actuation


Slovenia Chiesi Pharmaceuticals Gmbh Foster Beclometasone Dipropionate 100µg Actuation, Formoterol Fumarate Dihydrate 6µg Actuation


Slovenia Elpen Pharmaceutical Co. Inc. Flamerio Fluticasone Propionate 250µg Dose, Salmeterol 50µg Dose


Slovenia Elpen Pharmaceutical Co. Inc. Flamerio Fluticasone Propionate 500µg Dose, Salmeterol 50µg Dose


Slovenia Glaxosmithkline D.O.O., Ljubljana Flixotide Fluticasone Propionate 250µg Spray Pressurised Inhalation, Suspension

Slovenia Glaxosmithkline D.O.O., Ljubljana Seretide Diskus Fluticasone Propionate 500µg Dose, Salmeterol Xinafoate 50µg Dose


Slovenia Lek Pharmaceuticals D.D. Ljubljana Airflusan Forspiro Salmeterol 50µg Dose, Fluticasone Propionate 500µg Dose

Inhalation Powder

Slovenia Meda Pharma Gmbh & Co. Kg Budelin Novolizer Budesonide 200µg Dose Inhalation Powder, Pre-Dispensed

Spain Allen Farmaceutica, S.A. Anasma Accuhaler Fluticasone Propionate 250µg Dose, Salmeterol 50µg Dose


38

Member State in EEA


Spain Almirall, S.A. Plusvent Fluticasone Propionate 50µg Dose, Salmeterol Xinafoate 25µg Dose












Spain Astrazeneca Farmacéutica Spain, S.A.

Pulmicort Turbuhaler Budesonide 100µg Dose Inhalation Powder






Symbicort Turbuhaler Budesonide 160µg Dose, Formoterol Fumarate Dihydrate 4.5µg Dose

Inhalation Powder


Symbicort Turbuhaler Budesonide 320µg Dose, Formoterol Fumarate Dihydrate 9µg Dose

Inhalation Powder

Spain Chiesi España, S.A. Formodual Beclometasone Dipropionate 100µg Actuation, Formoterol Fumarate Dihydrate 6µg Actuation


Spain Chiesi España, S.A. Foster Beclometasone Dipropionate 100µg Actuation, Formoterol Fumarate Dihydrate 6µg Dose


39

Member State in EEA


Spain Glaxosmithkline S.A. Brisair Accuhaler Fluticasone Propionate 500µg Dose, Salmeterol 50µg Dose


Spain Glaxosmithkline S.A. Brisair Accuhaler Fluticasone Propionate 500µg Dose, Salmeterol Xinafoate 50µg Dose


Spain Glaxosmithkline S.A. Flixotide Fluticasone Propionate 125µg Inhalation






Spain Glaxosmithkline S.A. Flixotide Accuhaler Fluticasone Propionate 100µg Dose Inhalation Powder



Spain Glaxosmithkline S.A. Flusonal Fluticasone Propionate 250µg Inhalation


Spain Glaxosmithkline S.A. Flusonal Fluticasone Propionate 50µg Inhalation


Spain Glaxosmithkline S.A. Flusonal Accuhaler Fluticasone Propionate 100µg Dose Inhalation Powder

Spain Glaxosmithkline S.A. Flusonal Accuhaler Fluticasone Propionate 500µg Dose Inhalation Powder

Spain Glaxosmithkline S.A. Inalacor Fluticasone Propionate 250µg Inhalation


40

Member State in EEA


Spain Glaxosmithkline S.A. Inalacor Fluticasone Propionate 50µg Dose Pressurised Inhalation, Suspension

Spain Glaxosmithkline S.A. Inalacor Accuhaler Fluticasone Propionate 100µg Dose Inhalation Powder

Spain Glaxosmithkline S.A. Inalacor Accuhaler Fluticasone Propionate 500µg Dose Inhalation Powder

Spain Glaxosmithkline S.A. Inaladuo Accuhaler Fluticasone Propionate 500µg Dose, Salmeterol Xinafoate 50µg Dose


Spain Glaxosmithkline S.A. Seretide Accuhaler Fluticasone Propionate 500µg Dose, Salmeterol Xinafoate 50µg Dose


Spain Laboratorio Tau, S.A. Rilast Turbuhaler Budesonide 160µg Dose, Formoterol Fumarate Dihydrate 4.5µg Dose

Inhalation Powder

Spain Orion Corporation Bufomix Easyhaler Budesonide 160µg Inhalation, Formoterol Fumarate Dihydrate 4.5µg Inhalation

Inhalation Powder

Spain Orion Corporation Bufomix Easyhaler Budesonide 320µg Inhalation, Formoterol Fumarate Dihydrate 9µg Inhalation

Inhalation Powder

Spain Orion Corporation Orest Easyhaler Budesonide 160µg Inhalation, Formoterol Fumarate Dihydrate 4.5µg Inhalation

Inhalation Powder

Spain Orion Corporation Orest Easyhaler Budesonide 320µg Inhalation, Formoterol Fumarate Dihydrate 9µg Inhalation

Inhalation Powder

Spain Smithkline Beecham Farma S.A. Trialona Fluticasone Propionate 250µg Dose Pressurised Inhalation, Suspension

Spain Smithkline Beecham Farma S.A. Trialona Fluticasone Propionate 50µg Dose Pressurised Inhalation, Suspension

Spain Smithkline Beecham Farma S.A. Trialona Accuhaler Fluticasone Propionate 100µg Dose Inhalation Powder

41

Member State in EEA


Spain Smithkline Beecham Farma S.A. Trialona Accuhaler Fluticasone Propionate 500µg Dose Inhalation Powder

Sweden Astrazeneca Ab Gardette Budesonide 160µg Dose, Formoterol Fumarate Dihydrate 4.5µg Dose

Inhalation Powder

Sweden Astrazeneca Ab Gardette Forte Budesonide 160µg Dose, Formoterol Fumarate Dihydrate 4.5µg Dose

Inhalation Powder

Sweden Astrazeneca Ab Symbicort Forte Turbuhaler Budesonide 320µg Dose, Formoterol Fumarate Dihydrate 9µg Dose

Inhalation Powder

Sweden Astrazeneca Ab Symbicort Turbuhaler Budesonide 160µg Dose, Formoterol Fumarate Dihydrate 4.5µg Dose

Inhalation Powder

Sweden Chiesi Farmaceutici S.P.A. Innovair Beclometasone Dipropionate 100µg Actuation, Formoterol Fumarate Dihydrate 6µg Actuation


Sweden Elpen Pharmaceutical Co. Inc. Flusamer Fluticasone Propionate 250µg Dose, Salmeterol 50µg Dose


Sweden Elpen Pharmaceutical Co. Inc. Flusamer Fluticasone Propionate 500µg Dose, Salmeterol 50µg Dose


Sweden Elpen Pharmaceutical Co. Inc. Flusaterol Fluticasone Propionate 250µg Dose, Salmeterol 50µg Dose


Sweden Elpen Pharmaceutical Co. Inc. Flusaterol Fluticasone Propionate 500µg Dose, Salmeterol 50µg Dose


Sweden Elpen Pharmaceutical Co. Inc. Relanio Fluticasone Propionate 250µg Dose, Salmeterol 50µg Dose


Sweden Elpen Pharmaceutical Co. Inc. Relanio Fluticasone Propionate 500µg Dose, Salmeterol 50µg Dose


Sweden Elpen Pharmaceutical Co. Inc. Salmeson Fluticasone Propionate 250µg Dose, Salmeterol 50µg Dose, Lactose Monohydrate 24.677mg Dose


Sweden Elpen Pharmaceutical Co. Inc. Salmeson Fluticasone Propionate 500µg Dose, Salmeterol 50µg Dose


42

Member State in EEA


Sweden Glaxosmithkline Ab Flutide Diskus Fluticasone Propionate 250µg Dose Inhalation Powder, Pre-Dispensed

Sweden Glaxosmithkline Ab Flutide Diskus Fluticasone Propionate 500µg Dose Inhalation Powder, Pre-Dispensed

Sweden Glaxosmithkline Ab Seretide Diskus Fluticasone Propionate 500µg Dose, Salmeterol Xinafoate 50µg Dose


Sweden Glaxosmithkline Ab Viani Diskus Forte Fluticasone Propionate 500µg Dose, Salmeterol Xinafoate 50µg Dose


Sweden Hexal Ag Salmeterol/Fluticasone Hexal

Salmeterol Xinafoate 50µg Dose, Fluticasone 500µg Dose

Inhalation Powder

Sweden Orion Corporation Bufomix Easyhaler Budesonide 160µg Inhalation, Formoterol Fumarate Dihydrate 4.5µg Inhalation

Inhalation Powder

Sweden Orion Corporation Bufomix Easyhaler Budesonide 320µg Inhalation, Formoterol Fumarate Dihydrate 9µg Inhalation

Inhalation Powder

Sweden Orion Corporation Orest Easyhaler Budesonide 160µg Inhalation, Formoterol Fumarate Dihydrate 4.5µg Inhalation

Inhalation Powder

Sweden Orion Corporation Orest Easyhaler Budesonide 320µg Inhalation, Formoterol Fumarate Dihydrate 9µg Inhalation

Inhalation Powder

Sweden Sandoz A-S Aesalfluca Forspiro Salmeterol Xinafoate 50µg Dose, Fluticasone 500µg Dose

Inhalation Powder

Sweden Sandoz A-S Airflusal Forspiro Fluticasone Propionate 250µg Dose, Salmeterol 50µg Dose


Sweden Sandoz A-S Airflusal Forspiro Fluticasone Propionate 500µg Dose, Salmeterol 50µg Dose


Sweden Sandoz A-S Flaxxone Forspiro Salmeterol Xinafoate 50µg Dose, Fluticasone 250µg Dose

Inhalation Powder

43

Member State in EEA


Sweden Sandoz A-S Flaxxone Forspiro Salmeterol Xinafoate 50µg Dose, Fluticasone 500µg Dose

Inhalation Powder

Sweden Sandoz A-S Lastenol Forspiro Fluticasone Propionate 500 Microgram, Salmeterol Xinafoate 50 Microgram

Inhalation Powder

Sweden Sandoz A-S Molduo Forspiro Salmeterol Xinafoate 50µg Dose, Fluticasone 250µg Dose

Inhalation Powder

Sweden Sandoz A-S Salmetorol/Fluticasone Sandoz

Salmeterol Xinafoate 50µg Dose, Fluticasone 500µg Dose

Inhalation Powder

Sweden Sandoz A-S Setirenol Salmeterol Xinafoate 50µg Dose, Fluticasone 250µg Dose

Inhalation Powder

Sweden Sandoz A-S Setirenol Salmeterol Xinafoate 50µg Dose, Fluticasone 500µg Dose

Inhalation Powder

United Kingdom

Astrazeneca Uk Limited Symbicort Turbohaler Budesonide 320µg Dose, Formoterol Fumarate Dihydrate 9µg Dose

Inhalation Powder

United Kingdom

Astrazeneca Uk Limited Symbicort Turbohaler Budesonide 160µg Dose, Formoterol Fumarate Dihydrate 4.5µg Dose

Inhalation Powder

United Kingdom

Chiesi Limited Formodual Beclometasone Dipropionate 100µg Actuation, Formoterol Fumarate Dihydrate 6µg Actuation


United Kingdom

Chiesi Limited Fostair Beclometasone Dipropionate 100µg Actuation, Formoterol Fumarate Dihydrate 6µg Actuation


United Kingdom

Glaxo Wellcome Ltd Seretide Fluticasone Propionate 100µg Dose, Salmeterol Xinafoate 50µg Dose


United Kingdom

Glaxo Wellcome Ltd Seretide Fluticasone Propionate 250µg Dose, Salmeterol Xinafoate 50µg Dose


United Kingdom

Glaxo Wellcome Ltd Seretide Accuhaler Fluticasone Propionate 500µg Dose, Salmeterol Xinafoate 50µg Dose


44

Annex II

Scientific conclusions

45

Scientific conclusions

Chronic obstructive pulmonary disease (COPD) is characterised by persistent, usually progressive, airflow limitation associated with an enhanced inflammatory response in the airways and the lungs. Exacerbations and comorbidities contribute to the overall severity in individual patients [Global Initiative for Obstructive Lung Disease (GOLD), 2015]. Symptoms of COPD include dyspnoea, chronic cough and chronic sputum production. Episodes of acute worsening of these symptoms (exacerbations) often occur.

Inhaled corticosteroid (ICS) medicinal products are widely used in the treatment of COPD, as a mono-component or in combination with a long-acting beta2 adrenergic agonist (LABA). The therapeutic effect of inhaled corticosteroids is considered to be the result of suppression of airway inflammation, but the airway effects of ICS in COPD are complex and the mechanism of action is not completely understood (Finney et al., 2014, Jen et al., 2012). However ICSs are an important therapeutic option for certain patient groups as established in some treatment guidelines (GOLD report, 2015).

ICS-containing products authorised across the EU for the treatment of COPD includes the active substances beclomethasone, fluticasone propionate, fluticasone furoate, budesonide and flunisolide. All these products are restricted to ‘prescription only’ status. Estimates based on the data provided suggest a patient exposure in the tens of millions across ICS as a class.

A signal of increased risk of pneumonia in COPD patients with ICS-containing treatments was first identified in the TORCH study (Calverley et al., 2007) a large clinical study of three years treatment duration comparing the fluticasone propionate/salmeterol combination with its component parts and placebo in COPD patients. Since then other products containing ICS have been subject to review and it was considered that data on the risk of pneumonia with these products in the COPD population should be reviewed all together, so that the risk of pneumonia in this patient population could be further characterised. On 27 April 2015 the European Commission therefore triggered a referral under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data, and requested the PRAC to assess the impact of the above concerns on the benefit-risk balance of ICS containing medicinal products indicated in the treatment of COPD and to issue a recommendation on whether the relevant marketing authorisations should be maintained, varied, suspended or revoked.

The PRAC adopted a recommendation on 17 March 2016 which was then considered by the CHMP, in accordance with Article 107k of Directive 2001/83/EC.

Overall summary of the scientific evaluation by the PRAC Since the results of the TORCH study were published in 2007, a number of large meta-analyses of pooled data have been conducted. Although a number of common criticisms can be levelled at the studies included in these meta-analyses, including difficulties with the accurate identification of pneumonia (particularly pre-TORCH studies), variations in participant populations and comparators, differential withdrawal rates, and trials not specifically powered to detect pneumonia, a consistent association between ICS use and increased risk of pneumonia in COPD patients was seen across the meta-analyses. Overall the evidence from observational studies was in agreement with the randomised clinical trials (RCT) findings and it was therefore considered that the evidence continues to support the conclusion that treatment with ICS increases the risk of pneumonia in COPD patients.

No clinical trials directly examined the risk of pneumonia with ICSs head to head, and only indirect comparison in meta-analyses/systematic reviews or from observational studies is available, mainly between budesonide and fluticasone. Results from older meta-analyses and from observational studies were also variable, with some suggesting an increased risk of pneumonia with fluticasone compared to budesonide and others finding no difference. Overall, due to the variability in the clinical data and

46

multiple uncertainties with study methodologies, there is no conclusive clinical evidence for intra-class differences in the magnitude of the risk among inhaled corticosteroid products.

The PRAC therefore concluded that pneumonia (in COPD patients) should be added as a common adverse drug reaction in the product information of all ICS-containing products and that for products with an existing Risk Management Plan, “increased risk of pneumonia in COPD patients” should be considered an Important Identified Risk.

It was acknowledged that any risk of pneumonia with ICS should be considered in context, as pneumonia is an intrinsic comorbidity to COPD with certain predisposing factors making some COPD patients more susceptible to this risk than others. Further, it was recognised that there are difficulties associated with the differential diagnosis of pneumonia or an exacerbation of COPD. To mitigate the risk of pneumonia, the PRAC considered that a warning should be included in the product information for healthcare professionals and patients to remain vigilant for the possible development of pneumonia in patients with COPD, taking into consideration the overlap of the symptoms of pneumonia with those of exacerbation of COPD.

Finally, the PRAC considered the ICS dose-response effect or the influence of LABA and other concomitant medications on the risk of pneumonia in COPD patients. Some evidence suggests an increased risk of pneumonia with increasing steroid dose. It is considered mechanistically plausible that a higher dose of corticosteroid could cause a greater degree of immunosuppression in the lung and lead to a higher risk of pneumonia, but this has not been demonstrated conclusively across all studies. It was considered that this should be reflected in the product information. Due to a paucity of data regarding the potential effects of other classes of medication prescribed for COPD, no conclusions could be drawn regarding the influence of concomitant medications on the risk of pneumonia in COPD patients.

In conclusion, the PRAC considered that the benefit-risk balance of ICS-containing products remained favourable, provided the proposed changes to the product information are implemented.

Grounds for PRAC recommendation

• The PRAC considered the procedure under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data for inhaled corticosteroids (ICS)-containing medicinal products indicated in the treatment of chronic obstructive pulmonary disease (COPD);

• The PRAC reviewed the data submitted by the marketing authorisation holders in relation to the increased risk of pneumonia in patients with COPD in association with ICS-containing medicinal products;

• The PRAC concluded that the evidence provided supports a causal association between the use of ICS-containing products and an increased risk of pneumonia in COPD patients;

• The PRAC also concluded that there is no conclusive clinical evidence for intra-class differences in the magnitude of the risk among ICS-containing products;

• The PRAC considered that some evidence of an increased risk of pneumonia with increasing steroid dose exists, although this has not been demonstrated conclusively across all studies;

• The PRAC was of the view that the increased risk of pneumonia should be included in the product information of all ICS-containing products indicated in the treatment of COPD, with a warning for healthcare professionals and patients to remain vigilant for the possible development of pneumonia in patients with COPD, taking into consideration the overlap of the symptoms of pneumonia with those of exacerbation of COPD.

47

In view of the above, the Committee considers that the benefit-risk balance of ICS-containing medicinal products remains favourable in the treatment of COPD subject to the agreed amendments to the product information.

The Committee, as a consequence, recommends the variation to the terms of the marketing authorisations for ICS-containing medicinal products indicated in the treatment of COPD.

CHMP opinion

Having reviewed the PRAC recommendation, the CHMP agrees with the PRAC overall conclusions and grounds for recommendation.

48

Annex III

Amendments to relevant sections of the product information

Note:

These amendments to the relevant sections of the product information are the outcome of the referral procedure.

The product information may be subsequently updated by the Member State competent authorities, in liaison with the reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.

49

Amendments to relevant sections of the product information

The following information should be implemented in the product information of inhaled corticosteroids with a COPD indication.

The wording should be added to or replace existing text as appropriate for each product. If the current SmPC or package leaflet includes corresponding information in any other sections, it should be deleted in order to avoid repeated or contradictory information.

Summary of product characteristics

• Section 4.4 Special warnings and precautions for use

Pneumonia in patients with COPD

An increase in the incidence of pneumonia, including pneumonia requiring hospitalisation, has been observed in patients with COPD receiving inhaled corticosteroids. There is some evidence of an increased risk of pneumonia with increasing steroid dose but this has not been demonstrated conclusively across all studies.

There is no conclusive clinical evidence for intra-class differences in the magnitude of the pneumonia risk among inhaled corticosteroid products.

Physicians should remain vigilant for the possible development of pneumonia in patients with COPD as the clinical features of such infections overlap with the symptoms of COPD exacerbations.

Risk factors for pneumonia in patients with COPD include current smoking, older age, low body mass index (BMI) and severe COPD.

• Section 4.8 Undesirable effects

Tabulated list of adverse reactions

“Pneumonia (in COPD patients)” to be listed as “Common” adverse drug reaction in the “Infections and infestations” SOC.

Package leaflet

• Section 4: Possible side effects

Pneumonia (infection of the lung) in COPD patients (common side effect)

Tell your doctor if you have any of the following while taking <active substance> they could be symptoms of a lung infection:

• fever or chills

• increased mucus production, change in mucus colour

• increased cough or increased breathing difficulties

Annex I List of nationally authorised medicinal...

Documents

Transcript of Annex I List of nationally authorised medicinal...