# Official Journal C 277/29 J

| | ISSN 1977-091X |
| --- | --- |
| Official Journal
  of the European Union | C 277 |
| | |
| English edition | Information and Notices | Volume 5929 July 2016 |

ISSN 1977-091X

Official Journal

of the European Union

C 277

English edition

Information and Notices

Volume 5929 July 2016

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| Notice No | Contents | page |
| --- | --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2016/C 277/01 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2016 to 30 June 2016(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) | 1 |
| 2016/C 277/02 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2016 to 30 June 2016(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC) | 11 |

Notice No

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2016/C 277/01

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2016 to 30 June 2016(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

1

2016/C 277/02

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2016 to 30 June 2016(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)

11

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| EN | |
| --- | --- |

EN

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IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 29.7.2016 | EN | Official Journal of the European Union | C 277/1 |
| --- | --- | --- | --- |

29.7.2016

EN

Official Journal of the European Union

C 277/1

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Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2016 to 30 June 2016

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))

(2016/C 277/01)

—   Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 21.6.2016 | Odefsey | emtricitabine/rilpivirine/tenofovir alafenamide | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/16/1112 | Film-coated tablet | J05AR19 | 23.6.2016 |
| 24.6.2016 | Ongentys | opicapone | Bial — Portela & Ca, SA
  À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado, Portugal | EU/1/15/1066 | Capsule, hard | Pending | 28.6.2016 |
| 24.6.2016 | Zavicefta | ceftazidime/avibactam | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/16/1109 | Powder for concentrate for solution for infusion | J01DD52 | 28.6.2016 |
| 29.6.2016 | Enzepi | pancreas powder | APTALIS PHARMA SAS
  5/6 Place de l’Iris — La Défense 5
  92400 Courbevoie France | EU/1/16/1113 | Capsule, hard, gastro-resistant | A09AA02 | 1.7.2016 |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorization

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

21.6.2016

Odefsey

emtricitabine/rilpivirine/tenofovir alafenamide

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/16/1112

Film-coated tablet

J05AR19

23.6.2016

24.6.2016

Ongentys

opicapone

Bial — Portela & Ca, SA

À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado, Portugal

EU/1/15/1066

Capsule, hard

Pending

28.6.2016

24.6.2016

Zavicefta

ceftazidime/avibactam

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/16/1109

Powder for concentrate for solution for infusion

J01DD52

28.6.2016

29.6.2016

Enzepi

pancreas powder

APTALIS PHARMA SAS

5/6 Place de l’Iris — La Défense 5

92400 Courbevoie France

EU/1/16/1113

Capsule, hard, gastro-resistant

A09AA02

1.7.2016

—   Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Rejected

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 24.6.2016 | Dropcys | Lucane Pharma
  172 rue de Charonne, 75011 Paris, France | | 28.6.2016 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

24.6.2016

Dropcys

Lucane Pharma

172 rue de Charonne, 75011 Paris, France

28.6.2016

—   Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 1.6.2016 | Cotellic | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/15/1048 | 3.6.2016 |
| 1.6.2016 | HyQvia | Baxalta Innovations GmbH
  Industriestrasse 67, A-1221 Wien, Österreich | EU/1/13/840 | 6.6.2016 |
| 1.6.2016 | Revlimid | Celgene Europe Limited
  1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom | EU/1/07/391 | 3.6.2016 |
| 1.6.2016 | Zinforo | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/12/785 | 3.6.2016 |
| 2.6.2016 | Adrovance | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/06/364 | 6.6.2016 |
| 2.6.2016 | Altargo | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/07/390 | 6.6.2016 |
| 2.6.2016 | Avastin | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/04/300 | 6.6.2016 |
| 2.6.2016 | Capecitabine Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/12/762 | 6.6.2016 |
| 2.6.2016 | Clopidogrel BGR | Laboratoires BIOGARAN
  15 boulevard Charles de Gaulle, 92707 Colombes Cedex, France | EU/1/09/558 | 6.6.2016 |
| 2.6.2016 | Clopidogrel Krka | Krka, d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/09/556 | 7.6.2016 |
| 2.6.2016 | Clopidogrel ratiopharm GmbH | Archie Samuel s.r.o.
  Slunná 16, CZ-61700 Brno, Česká republika | EU/1/09/541 | 6.6.2016 |
| 2.6.2016 | Imatinib Actavis | Actavis Group PTC ehf.
  Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Ísland | EU/1/13/825 | 6.6.2016 |
| 2.6.2016 | Kineret | Swedish Orphan Biovitrum AB (publ)
  SE-112 76 Stockholm, Sverige | EU/1/02/203 | 7.6.2016 |
| 2.6.2016 | Kiovig | Baxter AG
  Industriestrasse 67, A-1221 Wien, Österreich | EU/1/05/329 | 6.6.2016 |
| 2.6.2016 | Lonquex | UAB ‘Sicor Biotech’
  Molėtų pl. 5, LT-08409 Vilnius, Lietuva | EU/1/13/856 | 6.6.2016 |
| 2.6.2016 | Neuraceq | Piramal Imaging Limited
  Langstone Technology Park, Langstone Road, Havant, Hampshire, PO9 1SA, United Kingdom | EU/1/13/906 | 6.6.2016 |
| 2.6.2016 | Tasigna | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/07/422 | 6.6.2016 |
| 2.6.2016 | Temozolomide Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/10/615 | 6.6.2016 |
| 2.6.2016 | Vimpat | UCB Pharma S.A.
  Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België | EU/1/08/470 | 6.6.2016 |
| 9.6.2016 | Cubicin | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/05/328 | 13.6.2016 |
| 9.6.2016 | Telmisartan Teva Pharma | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/11/719 | 13.6.2016 |
| 9.6.2016 | VPRIV | Shire Pharmaceuticals Ireland Limited
  5 Riverwalk, Citywest Business Campus, Dublin 24, Ireland | EU/1/10/646 | 13.6.2016 |
| 9.6.2016 | Zyllt | Krka, d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/09/553 | 13.6.2016 |
| 13.6.2016 | Gazyvaro | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/14/937 | 15.6.2016 |
| 16.6.2016 | Advagraf | Astellas Pharma Europe B.V.
  Sylviusweg 62, NL-2333 BE Leiden, Nederland | EU/1/07/387 | 20.6.2016 |
| 16.6.2016 | Avonex | Biogen Idec Limited
  Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | EU/1/97/033 | 20.6.2016 |
| 16.6.2016 | Protopic | Leo Pharma A/S
  Industriparken 55, DK-2750 Ballerup, Danmark | EU/1/02/201 | 20.6.2016 |
| 16.6.2016 | Tesavel | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/07/435 | 20.6.2016 |
| 16.6.2016 | Xelevia | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/07/382 | 20.6.2016 |
| 21.6.2016 | Eurartesim | Sigma-Tau Industrie Farmaceutiche Riunite S.p.A
  Viale Shakespeare 47, 00144 Roma, Italia | EU/1/11/716 | 23.6.2016 |
| 21.6.2016 | Irbesartan Zentiva | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Paris, France | EU/1/06/376 | 23.6.2016 |
| 21.6.2016 | Karvea | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Paris, France | EU/1/97/049 | 23.6.2016 |
| 21.6.2016 | Lemtrada | Genzyme Therapeutics Ltd
  4620 Kingsgate, Cascade Way, Oxford Business Park South, Oxford OX4 2SU, United Kingdom | EU/1/13/869 | 23.6.2016 |
| 21.6.2016 | Modigraf | Astellas Pharma Europe B.V.
  Sylviusweg 62, NL-2333 BE Leiden, Nederland | EU/1/09/523 | 23.6.2016 |
| 21.6.2016 | Reyataz | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/03/267 | 23.6.2016 |
| 21.6.2016 | Zometa | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/01/176 | 23.6.2016 |
| 24.6.2016 | ADCETRIS | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/12/794 | 28.6.2016 |
| 24.6.2016 | Advate | Baxter AG
  Industriestrasse 67, A-1221 Wien, Österreich | EU/1/03/271 | 28.6.2016 |
| 24.6.2016 | Aprovel | Sanofi Clir SNC
  54 rue La Boétie, F-75008 Paris, France | EU/1/97/046 | 28.6.2016 |
| 24.6.2016 | Cubicin | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/05/328 | 28.6.2016 |
| 24.6.2016 | Daklinza | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/14/939 | 28.6.2016 |
| 24.6.2016 | Emtriva | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/03/261 | 28.6.2016 |
| 24.6.2016 | Grepid | Pharmathen S.A.
  6 Dervenakion, 15351 Pallini Attiki, Ελλάδα | EU/1/09/535 | 28.6.2016 |
| 24.6.2016 | Humira | AbbVie Ltd
  Maidenhead, SL6 4UB, United Kingdom | EU/1/03/256 | 28.6.2016 |
| 24.6.2016 | Imnovid | Celgene Europe Limited
  1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom | EU/1/13/850 | 28.6.2016 |
| 24.6.2016 | Januvia | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/07/383 | 28.6.2016 |
| 24.6.2016 | Rasilez | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/07/405 | 28.6.2016 |
| 24.6.2016 | Rasilez HCT | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/08/491 | 28.6.2016 |
| 24.6.2016 | Relvar Ellipta | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/13/886 | 28.6.2016 |
| 24.6.2016 | Revinty Ellipta | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/14/929 | 28.6.2016 |
| 24.6.2016 | Simponi | Janssen Biologics B.V.
  Einsteinweg 101, NL-2333 CB Leiden, Nederland | EU/1/09/546 | 28.6.2016 |
| 24.6.2016 | Tolura | Krka, d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/10/632 | 28.6.2016 |
| 24.6.2016 | Tysabri | Biogen Idec Limited
  Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | EU/1/06/346 | 28.6.2016 |
| 24.6.2016 | Zoledronic acid Hospira | Hospira UK Limited
  Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom | EU/1/12/800 | 28.6.2016 |
| 29.6.2016 | Champix | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/06/360 | 1.7.2016 |
| 29.6.2016 | Incivo | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/11/720 | 1.7.2016 |
| 29.6.2016 | Kivexa | ViiV Healthcare UK Limited
  980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | EU/1/04/298 | 1.7.2016 |
| 29.6.2016 | Kyprolis | Amgen Europe B.V.
  Minervum 7061, NL-4817 ZK Breda, Nederland | EU/1/15/1060 | 1.7.2016 |
| 29.6.2016 | Matever | Pharmathen S.A.
  6 Dervenakion, 15351 Pallini Attiki, Ελλάδα | EU/1/11/711 | 1.7.2016 |
| 29.6.2016 | Memantine Mylan | Generics [UK] Limited
  Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom | EU/1/13/827 | 8.7.2016 |
| 29.6.2016 | Mycamine | Astellas Pharma Europe B.V.
  Sylviusweg 62, NL-2333 BE Leiden, Nederland | EU/1/08/448 | 1.7.2016 |
| 29.6.2016 | PegIntron | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/00/131 | 1.7.2016 |
| 29.6.2016 | Revestive | NPS Pharma Holdings Limited
  5 Riverwalk, Citywest Business Campus, Dublin 24, Ireland | EU/1/12/787 | 1.7.2016 |
| 29.6.2016 | Tyverb | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/07/440 | 1.7.2016 |
| 29.6.2016 | Vidaza | Celgene Europe Limited
  1 Longwalk Road, Stockley Park, Uxbridge UB11 1DB, United Kingdom | EU/1/08/488 | 1.7.2016 |
| 29.6.2016 | ViraferonPeg | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/00/132 | 4.7.2016 |
| 29.6.2016 | Yondelis | Pharma Mar S.A.
  Avda de los Reyes 1, Polígono Industrial La Mina, E-28770 Colmenar Viejo, Madrid, España | EU/1/07/417 | 1.7.2016 |
| 29.6.2016 | Zoledronic acid medac | medac Gesellschaft für klinische Spezialpräparate mbH
  Theaterstr. 6, D-22880 Wedel, Deutschland | EU/1/12/779 | 1.7.2016 |
| 30.6.2016 | Ceplene | Meda AB
  Box 906, SE-170 09 Solna, Sverige | EU/1/08/477 | 5.7.2016 |
| 30.6.2016 | Dacogen | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/12/792 | 4.7.2016 |
| 30.6.2016 | Efficib | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/08/457 | 4.7.2016 |
| 30.6.2016 | Eylea | Bayer Pharma AG
  D-13342 Berlin, Deutschland | EU/1/12/797 | 4.7.2016 |
| 30.6.2016 | Filgrastim Hexal | Hexal AG
  Industriestrasse 25, D-83607 Holzkirchen, Deutschland | EU/1/08/496 | 4.7.2016 |
| 30.6.2016 | Hycamtin | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/96/027 | 4.7.2016 |
| 30.6.2016 | Janumet | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/08/455 | 4.7.2016 |
| 30.6.2016 | OLYSIO | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/14/924 | 4.7.2016 |
| 30.6.2016 | Ristaben | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/10/621 | 4.7.2016 |
| 30.6.2016 | Toujeo | Sanofi-Aventis Deutschland GmbH
  D-65926 Frankfurt am Main, Deutschland | EU/1/00/133 | 4.7.2016 |
| 30.6.2016 | Velmetia | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/08/456 | 4.7.2016 |
| 30.6.2016 | Yentreve | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/04/280 | 4.7.2016 |
| 30.6.2016 | Zarzio | Sandoz GmbH
  Biochemiestrasse 10, A-6250 Kundl, Österreich | EU/1/08/495 | 4.7.2016 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

1.6.2016

Cotellic

Roche Registration Limited

6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/15/1048

3.6.2016

1.6.2016

HyQvia

Baxalta Innovations GmbH

Industriestrasse 67, A-1221 Wien, Österreich

EU/1/13/840

6.6.2016

1.6.2016

Revlimid

Celgene Europe Limited

1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom

EU/1/07/391

3.6.2016

1.6.2016

Zinforo

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/12/785

3.6.2016

2.6.2016

Adrovance

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/06/364

6.6.2016

2.6.2016

Altargo

Glaxo Group Ltd

980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

EU/1/07/390

6.6.2016

2.6.2016

Avastin

Roche Registration Limited

6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/04/300

6.6.2016

2.6.2016

Capecitabine Accord

Accord Healthcare Limited

Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom

EU/1/12/762

6.6.2016

2.6.2016

Clopidogrel BGR

Laboratoires BIOGARAN

15 boulevard Charles de Gaulle, 92707 Colombes Cedex, France

EU/1/09/558

6.6.2016

2.6.2016

Clopidogrel Krka

Krka, d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/09/556

7.6.2016

2.6.2016

Clopidogrel ratiopharm GmbH

Archie Samuel s.r.o.

Slunná 16, CZ-61700 Brno, Česká republika

EU/1/09/541

6.6.2016

2.6.2016

Imatinib Actavis

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Ísland

EU/1/13/825

6.6.2016

2.6.2016

Kineret

Swedish Orphan Biovitrum AB (publ)

SE-112 76 Stockholm, Sverige

EU/1/02/203

7.6.2016

2.6.2016

Kiovig

Baxter AG

Industriestrasse 67, A-1221 Wien, Österreich

EU/1/05/329

6.6.2016

2.6.2016

Lonquex

UAB ‘Sicor Biotech’

Molėtų pl. 5, LT-08409 Vilnius, Lietuva

EU/1/13/856

6.6.2016

2.6.2016

Neuraceq

Piramal Imaging Limited

Langstone Technology Park, Langstone Road, Havant, Hampshire, PO9 1SA, United Kingdom

EU/1/13/906

6.6.2016

2.6.2016

Tasigna

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/07/422

6.6.2016

2.6.2016

Temozolomide Accord

Accord Healthcare Limited

Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom

EU/1/10/615

6.6.2016

2.6.2016

Vimpat

UCB Pharma S.A.

Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België

EU/1/08/470

6.6.2016

9.6.2016

Cubicin

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/05/328

13.6.2016

9.6.2016

Telmisartan Teva Pharma

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/11/719

13.6.2016

9.6.2016

VPRIV

Shire Pharmaceuticals Ireland Limited

5 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/10/646

13.6.2016

9.6.2016

Zyllt

Krka, d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/09/553

13.6.2016

13.6.2016

Gazyvaro

Roche Registration Limited

6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/14/937

15.6.2016

16.6.2016

Advagraf

Astellas Pharma Europe B.V.

Sylviusweg 62, NL-2333 BE Leiden, Nederland

EU/1/07/387

20.6.2016

16.6.2016

Avonex

Biogen Idec Limited

Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom

EU/1/97/033

20.6.2016

16.6.2016

Protopic

Leo Pharma A/S

Industriparken 55, DK-2750 Ballerup, Danmark

EU/1/02/201

20.6.2016

16.6.2016

Tesavel

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/07/435

20.6.2016

16.6.2016

Xelevia

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/07/382

20.6.2016

21.6.2016

Eurartesim

Sigma-Tau Industrie Farmaceutiche Riunite S.p.A

Viale Shakespeare 47, 00144 Roma, Italia

EU/1/11/716

23.6.2016

21.6.2016

Irbesartan Zentiva

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/06/376

23.6.2016

21.6.2016

Karvea

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/97/049

23.6.2016

21.6.2016

Lemtrada

Genzyme Therapeutics Ltd

4620 Kingsgate, Cascade Way, Oxford Business Park South, Oxford OX4 2SU, United Kingdom

EU/1/13/869

23.6.2016

21.6.2016

Modigraf

Astellas Pharma Europe B.V.

Sylviusweg 62, NL-2333 BE Leiden, Nederland

EU/1/09/523

23.6.2016

21.6.2016

Reyataz

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/03/267

23.6.2016

21.6.2016

Zometa

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/01/176

23.6.2016

24.6.2016

ADCETRIS

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/12/794

28.6.2016

24.6.2016

Advate

Baxter AG

Industriestrasse 67, A-1221 Wien, Österreich

EU/1/03/271

28.6.2016

24.6.2016

Aprovel

Sanofi Clir SNC

54 rue La Boétie, F-75008 Paris, France

EU/1/97/046

28.6.2016

24.6.2016

Cubicin

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/05/328

28.6.2016

24.6.2016

Daklinza

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/14/939

28.6.2016

24.6.2016

Emtriva

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/03/261

28.6.2016

24.6.2016

Grepid

Pharmathen S.A.

6 Dervenakion, 15351 Pallini Attiki, Ελλάδα

EU/1/09/535

28.6.2016

24.6.2016

Humira

AbbVie Ltd

Maidenhead, SL6 4UB, United Kingdom

EU/1/03/256

28.6.2016

24.6.2016

Imnovid

Celgene Europe Limited

1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom

EU/1/13/850

28.6.2016

24.6.2016

Januvia

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/07/383

28.6.2016

24.6.2016

Rasilez

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/07/405

28.6.2016

24.6.2016

Rasilez HCT

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/08/491

28.6.2016

24.6.2016

Relvar Ellipta

Glaxo Group Ltd

980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

EU/1/13/886

28.6.2016

24.6.2016

Revinty Ellipta

Glaxo Group Ltd

980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

EU/1/14/929

28.6.2016

24.6.2016

Simponi

Janssen Biologics B.V.

Einsteinweg 101, NL-2333 CB Leiden, Nederland

EU/1/09/546

28.6.2016

24.6.2016

Tolura

Krka, d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/10/632

28.6.2016

24.6.2016

Tysabri

Biogen Idec Limited

Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom

EU/1/06/346

28.6.2016

24.6.2016

Zoledronic acid Hospira

Hospira UK Limited

Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom

EU/1/12/800

28.6.2016

29.6.2016

Champix

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/1/06/360

1.7.2016

29.6.2016

Incivo

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/11/720

1.7.2016

29.6.2016

Kivexa

ViiV Healthcare UK Limited

980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom

EU/1/04/298

1.7.2016

29.6.2016

Kyprolis

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/15/1060

1.7.2016

29.6.2016

Matever

Pharmathen S.A.

6 Dervenakion, 15351 Pallini Attiki, Ελλάδα

EU/1/11/711

1.7.2016

29.6.2016

Memantine Mylan

Generics [UK] Limited

Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

EU/1/13/827

8.7.2016

29.6.2016

Mycamine

Astellas Pharma Europe B.V.

Sylviusweg 62, NL-2333 BE Leiden, Nederland

EU/1/08/448

1.7.2016

29.6.2016

PegIntron

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/00/131

1.7.2016

29.6.2016

Revestive

NPS Pharma Holdings Limited

5 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/12/787

1.7.2016

29.6.2016

Tyverb

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/07/440

1.7.2016

29.6.2016

Vidaza

Celgene Europe Limited

1 Longwalk Road, Stockley Park, Uxbridge UB11 1DB, United Kingdom

EU/1/08/488

1.7.2016

29.6.2016

ViraferonPeg

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/00/132

4.7.2016

29.6.2016

Yondelis

Pharma Mar S.A.

Avda de los Reyes 1, Polígono Industrial La Mina, E-28770 Colmenar Viejo, Madrid, España

EU/1/07/417

1.7.2016

29.6.2016

Zoledronic acid medac

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstr. 6, D-22880 Wedel, Deutschland

EU/1/12/779

1.7.2016

30.6.2016

Ceplene

Meda AB

Box 906, SE-170 09 Solna, Sverige

EU/1/08/477

5.7.2016

30.6.2016

Dacogen

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/12/792

4.7.2016

30.6.2016

Efficib

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/08/457

4.7.2016

30.6.2016

Eylea

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/12/797

4.7.2016

30.6.2016

Filgrastim Hexal

Hexal AG

Industriestrasse 25, D-83607 Holzkirchen, Deutschland

EU/1/08/496

4.7.2016

30.6.2016

Hycamtin

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/96/027

4.7.2016

30.6.2016

Janumet

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/08/455

4.7.2016

30.6.2016

OLYSIO

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/14/924

4.7.2016

30.6.2016

Ristaben

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/10/621

4.7.2016

30.6.2016

Toujeo

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/00/133

4.7.2016

30.6.2016

Velmetia

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/08/456

4.7.2016

30.6.2016

Yentreve

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/04/280

4.7.2016

30.6.2016

Zarzio

Sandoz GmbH

Biochemiestrasse 10, A-6250 Kundl, Österreich

EU/1/08/495

4.7.2016

—   Withdrawal of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 1.6.2016 | Clopidogrel/Acetylsalicylic acid Teva | Teva Pharma B.V.
  Swensweg 5, 2031GA Haarlem, Nederland | EU/1/14/942 | 3.6.2016 |
| 21.6.2016 | Capecitabine SUN | Sun Pharmaceutical Industries Europe BV
  Polarisavenue 87, NL-2132 JH Hoofddorp, Nederland | EU/1/13/831 | 23.6.2016 |
| 30.6.2016 | Krystexxa | Crealta Pharmaceuticals Ireland Limited
  Commercial House, Millbank Business Park, Lower Lucan Road, Lucan, Co.Dublin, Ireland | EU/1/12/810 | 4.7.2016 |
| 30.6.2016 | Opgenra | Olympus Biotech International Limited
  40 Upper Mount Street, Dublin 2, Ireland | EU/1/08/489 | 4.7.2016 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

1.6.2016

Clopidogrel/Acetylsalicylic acid Teva

Teva Pharma B.V.

Swensweg 5, 2031GA Haarlem, Nederland

EU/1/14/942

3.6.2016

21.6.2016

Capecitabine SUN

Sun Pharmaceutical Industries Europe BV

Polarisavenue 87, NL-2132 JH Hoofddorp, Nederland

EU/1/13/831

23.6.2016

30.6.2016

Krystexxa

Crealta Pharmaceuticals Ireland Limited

Commercial House, Millbank Business Park, Lower Lucan Road, Lucan, Co.Dublin, Ireland

EU/1/12/810

4.7.2016

30.6.2016

Opgenra

Olympus Biotech International Limited

40 Upper Mount Street, Dublin 2, Ireland

EU/1/08/489

4.7.2016

—   Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 21.6.2016 | Sevocalm | sevoflurane | Chanelle Pharmaceuticals Manufacturing Limited
  Loughrea, Co. Galway, Ireland | EU/2/16/196 | Inhalation vapour, liquid | Pending | 24.6.2016 |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorization

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

21.6.2016

Sevocalm

sevoflurane

Chanelle Pharmaceuticals Manufacturing Limited

Loughrea, Co. Galway, Ireland

EU/2/16/196

Inhalation vapour, liquid

Pending

24.6.2016

—   Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 3.6.2016 | Nobivac L4 | Intervet International B.V.
  Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | EU/2/12/143 | 7.6.2016 |
| 21.6.2016 | Emdocam | Emdoka bvba
  J. Lijsenstraat 16, B-2321 Hoogstraten, België | EU/2/11/128 | 23.6.2016 |
| 21.6.2016 | Metacam | Boehringer Ingelheim Vetmedica GmbH
  D-55216 Ingelheim am Rhein, Deutschland | EU/2/97/004 | 23.6.2016 |
| 22.6.2016 | Nobilis Influenza H5N2 | Intervet International B.V.
  Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | EU/2/06/061 | 24.6.2016 |
| 24.6.2016 | Loxicom | Norbrook Laboratories Ltd
  Station Works, Newry, Co. Down, BT35 6JP, United Kindgom | EU/2/08/090 | 29.6.2016 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

3.6.2016

Nobivac L4

Intervet International B.V.

Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland

EU/2/12/143

7.6.2016

21.6.2016

Emdocam

Emdoka bvba

J. Lijsenstraat 16, B-2321 Hoogstraten, België

EU/2/11/128

23.6.2016

21.6.2016

Metacam

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/97/004

23.6.2016

22.6.2016

Nobilis Influenza H5N2

Intervet International B.V.

Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland

EU/2/06/061

24.6.2016

24.6.2016

Loxicom

Norbrook Laboratories Ltd

Station Works, Newry, Co. Down, BT35 6JP, United Kindgom

EU/2/08/090

29.6.2016

Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:

| European Medicines Agency |
| --- |
| 30 Churchill Place |
| Canary Wharf |
| London E14 5EU |
| United Kingdom |

European Medicines Agency

30 Churchill Place

Canary Wharf

London E14 5EU

United Kingdom

---

(1)  OJ L 136, 30.4.2004, p. 1.

---

| 29.7.2016 | EN | Official Journal of the European Union | C 277/11 |
| --- | --- | --- | --- |

29.7.2016

EN

Official Journal of the European Union

C 277/11

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2016 to 30 June 2016

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2))

(2016/C 277/02)

—   Issuing, maintenance or modification of a national marketing authorization

| Date of the decision | Name(s) of the medicinal product | INN (International Non-Proprietary Name) | Holder(s) of the marketing authorization | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- | --- |
| 29.6.2016 | Inhaled corticosteroids | beclomethasone, budesonide, flunisolide, fluticasone propionate, fluticasone furoate | See Annex I | See Annex I | 30.6.2016 |
| 10.6.2016 | CattleMarker IBR Inactivated emulsion for injec | Inactivated gE Bovine Herpes Virus type 1 (BoHv-1), strain Difivac | See Annex II | See Annex II | 13.6.2016 |
| 24.6.2016 | Novantrone and associated names | mitoxantrone | See Annex III | See Annex III | 27.6.2016 |
| 24.6.2016 | Irbesartan | Irbesartan | Not applicable | Not applicable | 27.6.2016 |
| 29.6.2016 | Zoledronic acid | Zoledronic acid | Not applicable | Not applicable | 30.6.2016 |

Date of the decision

Name(s) of the medicinal product

INN (International Non-Proprietary Name)

Holder(s) of the marketing authorization

Member State concerned

Date of notification

29.6.2016

Inhaled corticosteroids

beclomethasone, budesonide, flunisolide, fluticasone propionate, fluticasone furoate

See Annex I

See Annex I

30.6.2016

10.6.2016

CattleMarker IBR Inactivated emulsion for injec

Inactivated gE Bovine Herpes Virus type 1 (BoHv-1), strain Difivac

See Annex II

See Annex II

13.6.2016

24.6.2016

Novantrone and associated names

mitoxantrone

See Annex III

See Annex III

27.6.2016

24.6.2016

Irbesartan

Irbesartan

Not applicable

Not applicable

27.6.2016

29.6.2016

Zoledronic acid

Zoledronic acid

Not applicable

Not applicable

30.6.2016

---

(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.

---

ANNEX I

List of nationally authorised medicinal products

| Member State in EEA | Marketing authorisaton holder | Product name | Active substance + Strength | Pharmaceutical form |
| --- | --- | --- | --- | --- |
| Austria | 3m Health Care Ltd | Aerocortin | Beclometasone Dipropionate 50 μg/50 μl | Pressurised Inhalation, Solution |
| Austria | Allen Pharmazeutika Gesellschaft M.B.H. | Fluticasonpropionat | Fluticasone Propionate 50 μg Dose | Pressurised Inhalation, Suspension |
| Austria | Allen Pharmazeutika Gesellschaft M.B.H. | Fluticasonpropionat Diskus Forte Allen | Fluticasone Propionate 500 μg Dose | Inhalation Powder |
| Austria | Allen Pharmazeutika Gesellschaft M.B.H. | Fluticasonpropionat Diskus Junior Allen | Fluticasone Propionate 100 μg Dose | Inhalation Powder |
| Austria | Allen Pharmazeutika Gesellschaft M.B.H. | Fluticasonpropionat ‘allen’ | Fluticasone Propionate 125 μg Dose | Pressurised Inhalation, Suspension |
| Austria | Allen Pharmazeutika Gesellschaft M.B.H. | Fluticasonpropionat ‘allen’ | Fluticasone Propionate 250 μg Dose | Inhalation Powder |
| Austria | Allen Pharmazeutika Gesellschaft M.B.H. | Fluticasonpropionat ‘allen’ | Fluticasone Propionate 250 μg Dose | Pressurised Inhalation, Suspension |
| Austria | Allen Pharmazeutika Gesellschaft M.B.H. | Samtoral Diskus Standard | Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Austria | Astrazeneca österreich Gmbh | Pulmicort | Budesonide 400 μg Dose | Inhalation Powder |
| Austria | Astrazeneca österreich Gmbh | Pulmicort Turbohaler | Budesonide 100 μg Dose | Inhalation Powder |
| Austria | Astrazeneca österreich Gmbh | Pulmicort Turbohaler | Budesonide 200 μg Dose | Inhalation Powder |
| Austria | Astrazeneca österreich Gmbh | Pulmicort Turbohaler | Budesonide 400 μg Dose | Inhalation Powder |
| Austria | Astrazeneca österreich Gmbh | Symbicort Forte Turbohaler | Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose | Inhalation Powder |
| Austria | Astrazeneca österreich Gmbh | Symbicort Turbohaler | Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose | Inhalation Powder |
| Austria | Chiesi Pharmaceuticals Gmbh | Budiair | Budesonide 0,2  mg/0,05 ml | Pressurised Inhalation, Solution |
| Austria | Chiesi Pharmaceuticals Gmbh | Budiair Jet | Budesonide 0,2  mg/0,05  ml | Pressurised Inhalation, Solution |
| Austria | Chiesi Pharmaceuticals Gmbh | Foster | Beclometasone Dipropionate 100 μg Actuation, Formoterol Fumarate Dihydrate 6 μg Actuation | Pressurised Inhalation, Solution |
| Austria | Elpen Pharmaceutical Co. Inc. | Salmeson | Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Austria | Elpen Pharmaceutical Co. Inc. | Salmeson | Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Austria | Glaxosmithkline Pharma Gmbh. | Flixotide | Fluticasone Propionate 125 μg Inhalation | Pressurised Inhalation, Suspension |
| Austria | Glaxosmithkline Pharma Gmbh. | Flixotide | Fluticasone Propionate 250 μg Dose | Inhalation Powder, Pre-Dispensed |
| Austria | Glaxosmithkline Pharma Gmbh. | Flixotide | Fluticasone Propionate 250 μg Inhalation | Pressurised Inhalation, Suspension |
| Austria | Glaxosmithkline Pharma Gmbh. | Flixotide Diskus Forte | Fluticasone Propionate 500 μg Dose | Inhalation Powder |
| Austria | Glaxosmithkline Pharma Gmbh. | Flixotide Diskus Junior | Fluticasone Propionate 100 μg Dose | Inhalation Powder |
| Austria | Glaxosmithkline Pharma Gmbh. | Flixotide Junior | Fluticasone Propionate 125 μg Inhalation | Pressurised Inhalation, Suspension |
| Austria | Glaxosmithkline Pharma Gmbh. | Seretide Diskus | Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Austria | Pari Pharma Gmbh | Buparid | Budesonide 0,25  mg Ampoule | Nebuliser Suspension |
| Austria | Pari Pharma Gmbh | Buparid | Budesonide 0,5  mg Ampoule | Nebuliser Suspension |
| Austria | Pari Pharma Gmbh | Buparid | Budesonide 1 mg Ampoule | Nebuliser Suspension |
| Austria | Sandoz Gmbh | Airflusal Forspiro | Fluticasone Propionate 233 μg Dose, Salmeterol 45 μg Dose | Inhalation Powder |
| Austria | Sandoz Gmbh | Airflusal Forspiro | Fluticasone Propionate 465 μg Dose, Salmeterol 45 μg Dose | Inhalation Powder |
| Belgium | Chiesi Sa-Nv | Inuvair | Formoterol Fumarate Dihydrate 6 μg Actuation, Beclometasone Dipropionate Anhydrous 100 μg Actuation | Pressurised Inhalation, Solution |
| Belgium | Cipla Europe Nv | Salmeterol/Fluticasone Cipla | Salmeterol 25 μg/Dose; Fluticasone Propionate 125 μg/Dose | Pressurised Inhalation, Suspension |
| Belgium | Elpen Pharmaceutical Co. Inc. | Flusalio | Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Belgium | Elpen Pharmaceutical Co. Inc. | Flusalio | Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Belgium | Glaxosmithkline Pharmaceuticals S.A. | Flixotide | Fluticasone Propionate 0,05  mg/2ml | Nebuliser Solution |
| Belgium | Glaxosmithkline Pharmaceuticals S.A. | Flixotide | Fluticasone Propionate 250 μg Inhalation | Pressurised Inhalation, Suspension |
| Belgium | Glaxosmithkline Pharmaceuticals S.A. | Flixotide | Fluticasone Propionate 2 mg/2ml | Nebuliser Solution |
| Belgium | Glaxosmithkline Pharmaceuticals S.A. | Flixotide | Fluticasone Propionate 50 μg Inhalation | Pressurised Inhalation, Suspension |
| Belgium | Glaxosmithkline Pharmaceuticals S.A. | Flixotide Diskus | Fluticasone Propionate 100 μg Dose | Inhalation Powder |
| Belgium | Glaxosmithkline Pharmaceuticals S.A. | Flixotide Diskus | Fluticasone Propionate 250 μg Dose | Inhalation Powder |
| Belgium | Glaxosmithkline Pharmaceuticals S.A. | Flixotide Diskus | Fluticasone Propionate 500 μg Dose | Inhalation Powder |
| Belgium | Glaxosmithkline Pharmaceuticals S.A. | Seretide Diskus | Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Belgium | Nv Astrazeneca Sa | Pulmicort Turbohaler | Budesonide 200 μg Dose | Inhalation Powder |
| Belgium | Nv Astrazeneca Sa | Symbicort Forte Turbohaler | Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose | Inhalation Powder |
| Belgium | Nv Astrazeneca Sa | Symbicort Turbohaler | Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose | Inhalation Powder |
| Belgium | Orion Corporation | Bufomix Easyhaler | Budesonide 160 μg Inhalation, Formoterol Fumarate Dihydrate 4,5  μg Inhalation | Inhalation Powder |
| Belgium | Orion Corporation | Bufomix Easyhaler | Budesonide 320 μg Inhalation, Formoterol Fumarate Dihydrate 9 μg Inhalation | Inhalation Powder |
| Belgium | Pari Pharma Gmbh | Buparid | Budesonide 0,25  mg Ampoule | Nebuliser Suspension |
| Belgium | Pari Pharma Gmbh | Buparid | Budesonide 0,5  mg Ampoule | Nebuliser Suspension |
| Belgium | Pari Pharma Gmbh | Buparid | Budesonide 1 mg Ampoule | Nebuliser Suspension |
| Belgium | Sandoz N.V. | Airflusal Forspiro | Salmeterol Xinafoate 50 μg Dose, Fluticasone 500 μg Dose | Inhalation Powder |
| Bulgaria | Astrazeneca Ab | Symbicort Turbuhaler | Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose | Inhalation Powder |
| Bulgaria | Astrazeneca Ab | Symbicort Turbuhaler | Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose | Inhalation Powder |
| Bulgaria | Chiesi Pharmaceuticals Gmbh | Foster | Formoterol Fumarate Dihydrate 6 μg Actuation, Beclometasone Dipropionate Anhydrous 100 μg Actuation | Pressurised Inhalation, Solution |
| Bulgaria | Elpen Pharmaceutical Co. Inc. | Flusamer | Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Bulgaria | Elpen Pharmaceutical Co. Inc. | Flusamer | Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Bulgaria | Glaxosmithkline Eood | Seretide Diskus | Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Bulgaria | Orion Oyj | Bufomix Easyhaler | Budesonide 160 μg Inhalation, Formoterol Fumarate Dihydrate 4,5  μg Inhalation | Inhalation Powder |
| Bulgaria | Orion Oyj | Bufomix Easyhaler | Budesonide 320 μg Inhalation, Formoterol Fumarate Dihydrate 9 μg Inhalation | Inhalation Powder |
| Bulgaria | Sandoz Pharmaceuticals D.D. | Airflusal Forspiro | Salmeterol Xinafoate 50 μg Dose, Fluticasone 500 μg Dose | Inhalation Powder |
| Bulgaria | Sopharma Ad | Flixotide | Fluticasone Propionate 250 μg Inhalation | Pressurised Inhalation, Suspension |
| Croatia | Astrazeneca D.O.O | Symbicort Turbuhaler | Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose | Inhalation Powder |
| Croatia | Astrazeneca D.O.O | Symbicort Turbuhaler | Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose | Inhalation Powder |
| Croatia | Clinres Farmacija D.O.O. | Dimenium | Fluticasone Propionate 100 Mcg Dose, Salmeterol Xinafoate 50 Mcg Dose | Inhalation Powder, Pre-Dispensed |
| Croatia | Clinres Farmacija D.O.O. | Dimenium | Fluticasone Propionate 250 Mcg Dose, Salmeterol Xinafoate 50 Mcg Dose | Inhalation Powder, Pre-Dispensed |
| Croatia | Clinres Farmacija D.O.O. | Dimenium | Fluticasone Propionate 500 Mcg Dose, Salmeterol Xinafoate 50 Mcg Dose | Inhalation Powder, Pre-Dispensed |
| Croatia | Glaxosmithkline D.O.O. | Salmeterol/Flutikazonpropionat Diskus Glaxosmithkline | Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Croatia | Glaxosmithkline D.O.O. | Seretide Diskus | Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Croatia | Providens D.O.O. | Foster | Formoterol Fumarate Dihydrate 6 μg Actuation, Beclometasone Dipropionate Anhydrous 100 μg Actuation | Pressurised Inhalation, Solution |
| Croatia | Salvus D.O.O. | Saldisk | Fluticasone Propionate 100 Mcg Dose, Salmeterol Xinafoate 50 Mcg Dose | Inhalation Powder, Pre-Dispensed |
| Croatia | Salvus D.O.O. | Saldisk | Fluticasone Propionate 250 Mcg Dose, Salmeterol Xinafoate 50 Mcg Dose | Inhalation Powder, Pre-Dispensed |
| Croatia | Salvus D.O.O. | Saldisk | Fluticasone Propionate 500 Mcg Dose, Salmeterol Xinafoate 50 Mcg Dose | Inhalation Powder, Pre-Dispensed |
| Croatia | Sandoz D.O.O. | Airflusal Forspiro | Fluticasone Propionate 233 μg Dose, Salmeterol 45 μg Dose | Inhalation Powder, Pre-Dispensed |
| Croatia | Sandoz D.O.O. | Airflusal Forspiro | Fluticasone Propionate 465 μg Dose, Salmeterol 45 μg Dose | Inhalation Powder, Pre-Dispensed |
| Cyprus | Astrazeneca Ab | Symbicort Turbuhaler | Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose | Inhalation Powder |
| Cyprus | Astrazeneca Ab | Symbicort Turbuhaler | Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose | Inhalation Powder |
| Cyprus | Costakis Tsisios & Co. Ltd | Fluticapen | Fluticasone Propionate 250 μg Dose | Inhalation Powder, Pre-Dispensed |
| Cyprus | Costakis Tsisios & Co. Ltd | Fluticapen | Fluticasone Propionate 500 μg Dose | Inhalation Powder, Pre-Dispensed |
| Cyprus | Costakis Tsisios & Co. Ltd | Pulmoton | Budesonide 100 μg Dose, Formoterol Fumarate Dihydrate 6 μg Dose | Inhalation Powder, Pre-Dispensed |
| Cyprus | Costakis Tsisios & Co. Ltd | Pulmoton | Budesonide 200 μg Dose, Formoterol Fumarate Dihydrate 6 μg Dose | Inhalation Powder, Pre-Dispensed |
| Cyprus | Costakis Tsisios & Co. Ltd | Pulmoton | Budesonide 400 μg Dose, Formoterol Fumarate Dihydrate 12 μg Dose | Inhalation Powder, Pre-Dispensed |
| Cyprus | Costakis Tsisios & Co. Ltd | Rolenium | Fluticasone Propionate 100 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Cyprus | Costakis Tsisios & Co. Ltd | Rolenium | Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Cyprus | Costakis Tsisios & Co. Ltd | Rolenium | Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Cyprus | Glaxo Group Limited | Flixotide Diskus | Fluticasone Propionate 100 μg Dose | Inhalation Powder |
| Cyprus | Glaxo Group Limited | Flixotide Diskus | Fluticasone Propionate 250 μg Dose | Inhalation Powder |
| Cyprus | Glaxo Group Limited | Seretide | Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Cyprus | Orion Corporation | Bufomix Easyhaler | Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate Ph.Eur. 4,5  μg Dose | Inhalation Powder |
| Cyprus | Orion Corporation | Bufomix Easyhaler | Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate Ph.Eur. 9 μg Dose | Inhalation Powder |
| Cyprus | Orion Corporation | Orest Easyhaler | Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate Ph.Eur. 4,5  μg Dose | Inhalation Powder |
| Cyprus | Orion Corporation | Orest Easyhaler | Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate Ph.Eur. 9 μg Dose | Inhalation Powder |
| Czech Republic | Astrazeneca Ab | Symbicort Turbuhaler | Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose | Inhalation Powder |
| Czech Republic | Astrazeneca Ab | Symbicort Turbuhaler | Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose | Inhalation Powder |
| Czech Republic | Chiesi Pharmaceuticals Gmbh | Combair | Formoterol Fumarate Dihydrate 1,08 Mg, Beclometasone Dipropionate 18 Mg | Pressurised Inhalation, Solution |
| Czech Republic | Elpen Pharmaceutical Co. Inc. | Dimenium | Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Czech Republic | Elpen Pharmaceutical Co. Inc. | Dimenium | Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Czech Republic | Glaxo Group Limited | Flixotide | Fluticasone Propionate 125 μg | Pressurised Inhalation, Suspension |
| Czech Republic | Glaxo Group Limited | Flixotide | Fluticasone Propionate 250 μg | Pressurised Inhalation, Suspension |
| Czech Republic | Glaxo Group Limited | Flixotide | Fluticasone Propionate 50 μg | Pressurised Inhalation, Suspension |
| Czech Republic | Glaxo Group Limited | Flixotide Diskus | Fluticasone Propionate 100 μg | Inhalation Powder |
| Czech Republic | Glaxo Group Limited | Flixotide Diskus | Fluticasone Propionate 250 μg | Inhalation Powder |
| Czech Republic | Glaxo Group Limited | Flixotide Diskus | Fluticasone Propionate 500 μg | Inhalation Powder |
| Czech Republic | Glaxo Group Limited | Seretide Diskus | Fluticasone Propionate 500 μg, Salmeterol Xinafoate 72,5  μg | Inhalation Powder |
| Czech Republic | Sandoz S.R.O. | Airflusan Forspiro | Fluticasone Propionate 0,25 Mg, Salmeterol Xinafoate 0,073 Mg | Inhalation Powder, Pre-Dispensed |
| Czech Republic | Sandoz S.R.O. | Airflusan Forspiro | Fluticasone Propionate 0,5 Mg, Salmeterol Xinafoate 0,073 Mg | Inhalation Powder, Pre-Dispensed |
| Denmark | Astrazeneca A-S | Symbicort Forte Turbuhaler | Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose | Inhalation Powder |
| Denmark | Astrazeneca A-S | Symbicort Turbuhaler | Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose | Inhalation Powder |
| Denmark | Chiesi Farmaceutici S.P.A. | Innovair | Beclometasone Dipropionate 100 μg Actuation, Formoterol Fumarate Dihydrate 6 μg Actuation | Pressurised Inhalation, Solution |
| Denmark | Elpen Pharmaceutical Co. Inc. | Flusaterol | Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Denmark | Elpen Pharmaceutical Co. Inc. | Flusaterol | Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose, Lactose Monohydrate 24,677  mg Dose | Inhalation Powder, Pre-Dispensed |
| Denmark | Glaxosmithkline Pharma A-S | Seretide | Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Denmark | Orion Oyj | Bufomix Easyhaler | Budesonide 160 μg Inhalation, Formoterol Fumarate Dihydrate 4,5  μg Inhalation | Inhalation Powder |
| Denmark | Orion Oyj | Bufomix Easyhaler | Budesonide 320 μg Inhalation, Formoterol Fumarate Dihydrate 9 μg Inhalation | Inhalation Powder |
| Denmark | Sandoz A-S | Airflusal Forspiro | Fluticasone Propionate 233 μg Dose, Salmeterol 45 μg Dose | Inhalation Powder, Pre-Dispensed |
| Denmark | Sandoz A-S | Airflusal Forspiro | Fluticasone Propionate 465 μg Dose, Salmeterol 45 μg Dose | Inhalation Powder, Pre-Dispensed |
| Estonia | Astrazeneca Ab | Symbicort Turbuhaler | Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose | Inhalation Powder |
| Estonia | Astrazeneca Ab | Symbicort Turbuhaler | Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose | Inhalation Powder |
| Estonia | Chiesi Pharmaceuticals Gmbh | Foster | Beclometasone Dipropionate 100 μg Actuation, Formoterol Fumarate Dihydrate 6 μg Actuation | Pressurised Inhalation, Solution |
| Estonia | Elpen Pharmaceutical Co. Inc. | Flusamer | Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Estonia | Elpen Pharmaceutical Co. Inc. | Flusamer | Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Estonia | Glaxo Wellcome Ltd | Flixotide Diskus | Fluticasone Propionate 250 μg Dose | Inhalation Powder |
| Estonia | Glaxo Wellcome Ltd | Seretide Diskus | Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Estonia | Sandoz Pharmaceuticals D.D. | Airflusal Forspiro | Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Estonia | Sandoz Pharmaceuticals D.D. | Airflusal Forspiro | Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Finland | Astrazeneca Oy | Symbicort Forte Turbuhaler | Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose | Inhalation Powder |
| Finland | Astrazeneca Oy | Symbicort Turbuhaler | Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose | Inhalation Powder |
| Finland | Chiesi Farmaceutici S.P.A. | Innovair | Beclometasone Dipropionate 100 μg Actuation, Formoterol Fumarate Dihydrate 6 μg Actuation | Pressurised Inhalation, Solution |
| Finland | Chiesi Farmaceutici S.P.A. | Innovair Nexthaler | Formoterol Fumarate Dihydrate 6 μg Dose, Beclometasone Dipropionate Anhydrous 100 μg Dose | Inhalation Powder |
| Finland | Elpen Pharmaceutical Co. Inc. | Salmeson | Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Finland | Elpen Pharmaceutical Co. Inc. | Salmeson | Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Finland | Glaxosmithkline Oy | Seretide Diskus | Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Finland | Orion Oyj | Bufomix Easyhaler | Budesonide 160 μg Inhalation, Formoterol Fumarate Dihydrate 4,5  μg Inhalation | Inhalation Powder |
| Finland | Orion Oyj | Bufomix Easyhaler | Budesonide 320 μg Inhalation, Formoterol Fumarate Dihydrate 9 μg Inhalation | Inhalation Powder |
| France | Astrazeneca France | Symbicort Turbuhaler | Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose | Inhalation Powder |
| France | Astrazeneca France | Symbicort Turbuhaler | Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose | Inhalation Powder |
| France | Chiesi S.A. | Formodual | Formoterol Fumarate Dihydrate 6 μg Dose, Beclometasone Dipropionate Anhydrous 100 μg Dose | Pressurised Inhalation, Solution |
| France | Chiesi S.A. | Innovair | Formoterol Fumarate Dihydrate 6 μg Dose, Beclometasone Dipropionate Anhydrous 100 μg Dose | Pressurised Inhalation, Solution |
| France | Laboratoire Glaxosmithkline S.A.S. | Seretide Diskus | Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Germany | 3m Health Care Ltd | Bronchocort Novo | Beclometasone Dipropionate 100 μg/50 μl | Pressurised Inhalation, Solution |
| Germany | 3m Health Care Ltd | Junik | Beclometasone Dipropionate 100 μg Actuation | Pressurised Inhalation, Solution |
| Germany | Abz-Pharma Gmbh | Beclomethasone Dipropionate Ct | Beclometasone Dipropionate 0,05  mg/18,7 G | Pressurised Inhalation, Solution |
| Germany | Meda Pharma Gmbh & Co. Kg | Budecort Novolizer | Budesonide, Micronised 0,2  mg Actuation | Inhalation Powder |
| Germany | Meda Pharma Gmbh & Co. Kg | Budecort Novolizer | Budesonide, Micronised 0,4  mg 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 400 μg Dose | Inhalation Powder |
| Germany | Astrazeneca Gmbh | Pulmicort Turbohaler | Budesonide 200 μg Dose | Inhalation Powder |
| Germany | Astrazeneca Gmbh | Symbicort Turbohaler | Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose | Inhalation Powder |
| Germany | Astrazeneca Gmbh | Symbicort Turbohaler | Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose | Inhalation Powder |
| Germany | Chiesi Farmaceutici S.P.A. | Kantos | Beclometasone Dipropionate 100 μg Actuation, Formoterol Fumarate Dihydrate 6 μg Actuation | Pressurised Inhalation, Solution |
| Germany | Chiesi Farmaceutici S.P.A. | Kantos Master | Beclometasone Dipropionate 100 μg Actuation, Formoterol Fumarate Dihydrate 6 μg Actuation | Pressurised Inhalation, Solution |
| Germany | Chiesi Gmbh | Budiair | Budesonide 200 μg Spray | Pressurised Inhalation, Solution |
| Germany | Chiesi Gmbh | Foster | Beclometasone Dipropionate 100 μg Actuation, Formoterol Fumarate Dihydrate 6 μg Actuation | Pressurised Inhalation, Solution |
| Germany | Chiesi Gmbh | Ribuvent | Budesonide 200 μg Puff | Pressurised Inhalation, Solution |
| Germany | Chiesi Gmbh | Sanasthmax | Beclometasone Dipropionate 250 μg/59,2 Mg | Pressurised Inhalation, Solution |
| Germany | Chiesi Gmbh | Sanasthmax Junior | Beclometasone Dipropionate 50 μg/59 Mg | Pressurised Inhalation, Solution |
| Germany | Elpen Pharmaceutical Co. Inc. | Flusalio | Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Germany | Elpen Pharmaceutical Co. Inc. | Flusalio | Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Germany | Elpen Pharmaceutical Co. Inc. | Rolenium | Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Germany | Elpen Pharmaceutical Co. Inc. | Rolenium | Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Germany | Glaxosmithkline Gmbh & Co. Kg | Flixotide Diskus | Fluticasone Propionate 250 μg Dose | Inhalation Powder |
| Germany | Glaxosmithkline Gmbh & Co. Kg | Flixotide Forte | Fluticasone Propionate 250 μg Inhalation | Pressurised Inhalation, Suspension |
| Germany | Glaxosmithkline Gmbh & Co. Kg | Flixotide Forte Diskus | Fluticasone Propionate 500 μg Dose | Inhalation Powder |
| Germany | Glaxosmithkline Gmbh & Co. Kg | Flutide Diskus | Fluticasone Propionate 250 μg Dose | Inhalation Powder, Pre-Dispensed |
| Germany | Glaxosmithkline Gmbh & Co. Kg | Flutide Forte | Fluticasone Propionate 220 μg Puff | Pressurised Inhalation, Suspension |
| Germany | Glaxosmithkline Gmbh & Co. Kg | Flutide Forte Diskus | Fluticasone Propionate 500 μg Dose | Inhalation Powder, Pre-Dispensed |
| Germany | Glaxosmithkline Gmbh & Co. Kg | Viani Forte | Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Germany | Heumann Pharma Gmbh & Co. Generica Kg | Budesonid | Budesonide 0,2 Mg | Inhalation Powder |
| Germany | Hexal Ag | Airflusal Forspiro | Salmeterol Xinafoate 50 μg Dose, Fluticasone 500 μg Dose | Inhalation Powder |
| Germany | Hexal Ag | Budes N | Budesonide 0,2  mg Dose | Pressurised Inhalation, Solution |
| Germany | Janssen-Cilag Gmbh | Inuvair | Beclometasone Dipropionate 100 μg Inhalation, Formoterol Fumarate 6 μg Inhalation | Pressurised Inhalation, Solution |
| Germany | Meda Pharma Gmbh & Co. Kg | Budesonid Novolizer Meda Pharma Gmbh & Co. Kg | Budesonide 400 μg Inhalation | Inhalation Powder |
| Germany | Meda Pharma Gmbh & Co. Kg | Novopulmon Novolizer | Budesonide 200 μg Dose | Inhalation Powder |
| Germany | Meda Pharma Gmbh & Co. Kg | Novopulmon Novolizer | Budesonide 400 μg Dose | Inhalation Powder |
| Germany | Mylan Dura Gmbh | Budesonid Mylan | Budesonide 0,2 Mg | Inhalation Powder |
| Germany | Orion Corporation | Beclomet Easyhaler | Beclometasone Dipropionate 0,2  mg Dose | Inhalation Powder |
| Germany | Pari Pharma Gmbh | Buparid | Budesonide 0,25  mg Ampoule | Nebuliser Suspension |
| Germany | Pari Pharma Gmbh | Buparid | Budesonide 0,5  mg Ampoule | Nebuliser Suspension |
| Germany | Pari Pharma Gmbh | Buparid | Budesonide 1 mg Ampoule | Nebuliser Suspension |
| Germany | Pb Pharma Gmbh | Budesonid | Budesonide 0,92 Mg | Inhalation Powder, Hard Capsule |
| Germany | Pb Pharma Gmbh | Cyclocaps Beclometason | Beclometasone Dipropionate 100 μg Units | Inhalation Powder, Hard Capsule |
| Germany | Pb Pharma Gmbh | Cyclocaps Beclometason | Beclometasone Dipropionate 200 μg Units | Inhalation Powder, Hard Capsule |
| Germany | Pb Pharma Gmbh | Cyclocaps Beclometason | Beclometasone Dipropionate 400 μg Units | Inhalation Powder, Hard Capsule |
| Germany | Pb Pharma Gmbh | Cyclocaps Budesonid | Budesonide 0,8  mg Capsule | Inhalation Powder, Hard Capsule |
| Germany | Pb Pharma Gmbh | Cyclocaps Budesonid | Budesonide 100 μg Units | Inhalation Powder, Hard Capsule |
| Germany | Pb Pharma Gmbh | Cyclocaps Budesonid | Budesonide 800 μg Units | Inhalation Powder, Hard Capsule |
| Germany | Ratiopharm Gmbh | Beclometason Ratiopharm | Beclometasone Dipropionate 0,25  mg/18,7  g | Pressurised Inhalation, Solution |
| Germany | Ratiopharm Gmbh | Beclomethasone Dipropionate Ratiopharm | Beclometasone Dipropionate 0,05  mg/18,7  g | Pressurised Inhalation, Solution |
| Germany | Ratiopharm Gmbh | Beclomethasone Dipropionate Ratiopharm | Beclometasone Dipropionate 0,1  mg/18,7  g | Pressurised Inhalation, Solution |
| Germany | Ratiopharm Gmbh | Beclomethasone Dipropionate Ratiopharm | Beclometasone Dipropionate 0,2  mg/18,7  g | Pressurised Inhalation, Solution |
| Germany | Teva Gmbh | Aerobec N | Beclometasone Dipropionate 100 g/5ml | Pressurised Inhalation, Solution |
| 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 100 g/10ml | Pressurised Inhalation, Solution |
| Germany | Teva Gmbh | Ventolair | Beclometasone Dipropionate 100 g/18,7  g | Pressurised Inhalation, Solution |
| Germany | Teva Gmbh | Ventolair | Beclometasone Dipropionate 100 g/5ml | Pressurised Inhalation, Solution |
| Germany | Teva Gmbh | Ventolair | Beclometasone Dipropionate 250 g/18,7  g | Pressurised Inhalation, Solution |
| Germany | Teva Gmbh | Ventolair | Beclometasone Dipropionate 250 g/78 mg | Pressurised Inhalation, Solution |
| Germany | Teva Gmbh | Ventolair Mite | Beclometasone Dipropionate 50 g/18,7  g | Pressurised Inhalation, Solution |
| Germany | Teva Gmbh | Ventolair Mite | Beclometasone Dipropionate 50 g/78 mg | Pressurised Inhalation, Solution |
| Germany | Ucb Pharma Gmbh (Monheim De) | Atmadisc Forte Diskus | Fluticasone Propionate 500 μg Inhalation, Salmeterol 50 μg Inhalation | Inhalation Powder |
| Greece | Anfarm Hellas Sa | Talgan | Budesonide 100 μg Dose | Inhalation Powder |
| Greece | Astrazeneca S.A. | Pulmicort Turbuhaler | Budesonide 100 μg Dose | Inhalation Powder |
| Greece | Astrazeneca S.A. | Pulmicort Turbuhaler | Budesonide 200 μg Dose | Inhalation Powder |
| Greece | Astrazeneca S.A. | Pulmicort Turbuhaler | Budesonide 400 μg Dose | Inhalation Powder |
| Greece | Astrazeneca S.A. | Symbicort Turbuhaler | Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose | Inhalation Powder |
| Greece | Astrazeneca S.A. | Symbicort Turbuhaler | Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose | Inhalation Powder |
| Greece | Chiesi Hellas A.E.B.E. | Foster | Beclometasone Dipropionate 100 μg Actuation, Formoterol Fumarate Dihydrate 6 μg Actuation | Pressurised Inhalation, Solution |
| Greece | Chiesi Hellas A.E.B.E. | Foster Nexthaler | Formoterol Fumarate Dihydrate 6 μg Dose, Beclometasone Dipropionate Anhydrous 100 μg Dose | Inhalation Powder |
| Greece | Chiesi Hellas A.E.B.E. | Inuvair | Beclometasone Dipropionate 100 μg Actuation, Formoterol Fumarate Dihydrate 6 μg Actuation | Pressurised Inhalation, Solution |
| Greece | Chiesi Hellas A.E.B.E. | Inuvair Nexthaler | Formoterol Fumarate Dihydrate 6 μg Dose, Beclometasone Dipropionate Anhydrous 100 μg 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 250 μg Dose | Inhalation Powder, Pre-Dispensed |
| Greece | Elpen Pharmaceutical Co. Inc. | Fluticapen | Fluticasone Propionate 500 μg Dose | Inhalation Powder, Pre-Dispensed |
| Greece | Elpen Pharmaceutical Co. Inc. | Pulmoton | Budesonide 100 μg Dose, Formoterol Fumarate Dihydrate 6 μg Dose | Inhalation Powder, Pre-Dispensed |
| Greece | Elpen Pharmaceutical Co. Inc. | Pulmoton | Budesonide 200 μg Dose, Formoterol Fumarate Dihydrate 6 μg Dose | Inhalation Powder, Pre-Dispensed |
| Greece | Elpen Pharmaceutical Co. Inc. | Pulmoton | Budesonide 400 μg Dose, Formoterol Fumarate Dihydrate 12 μg Dose | Inhalation Powder, Pre-Dispensed |
| Greece | Elpen Pharmaceutical Co. Inc. | Rolenium | Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Greece | Elpen Pharmaceutical Co. Inc. | Rolenium | Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Greece | Glaxosmithkline Aebe | Flixotide | Fluticasone Propionate 100 μg Dose | Inhalation Powder |
| Greece | Glaxosmithkline Aebe | Flixotide | Fluticasone Propionate 125 μg Dose | Pressurised Inhalation |
| Greece | Glaxosmithkline Aebe | Flixotide | Fluticasone Propionate 250 μg Dose | Inhalation Powder |
| Greece | Glaxosmithkline Aebe | Flixotide | Fluticasone Propionate 250 μg Dose | Pressurised Inhalation |
| Greece | Glaxosmithkline Aebe | Flixotide | Fluticasone Propionate 500 μg Dose | Inhalation Powder |
| Greece | Glaxosmithkline Aebe | Flixotide | Fluticasone Propionate 50 μg Dose | Pressurised Inhalation |
| Greece | Glaxosmithkline Aebe | Flixotide Diskus | Fluticasone Propionate 100 μg Dose | Inhalation Powder |
| Greece | Glaxosmithkline Aebe | Flixotide Diskus | Fluticasone Propionate 250 μg Dose | Inhalation Powder |
| Greece | Glaxosmithkline Aebe | Flixotide Diskus | Fluticasone Propionate 500 μg Dose | Inhalation Powder |
| Greece | Glaxosmithkline Aebe | Seretide | Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Greece | Iasis Pharma | Olfo Haler | Budesonide 200 μg Dose | Inhalation Powder |
| Greece | Iasis Pharma | Olfo Haler | Budesonide 400 μg 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 4,5 mcg | Inhalation Powder |
| Greece | Orion Corporation | Bufomix | Budosenide 320mcg, Formoterol Fumarate Dihydrate 9mcg | Inhalation Powder |
| Greece | Orion Corporation | Orest | Budosenide 160mcg, Formoterol Fumarate Dihydrate 4,5 mcg | 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 200 μg Dose | Inhalation Powder, Pre-Dispensed |
| Greece | Rafarm Sa. | Resata | Budesonide 400 μg Dose | Inhalation Powder, Pre-Dispensed |
| Greece | Verisfield (Uk) Ltd | Flixocort | Fluticasone Propionate 50 μg Dose | Nasal Spray, Suspension |
| Greece | Verisfield (Uk) Ltd | Flixocort | Fluticasone Propionate 125 μg Dose | Pressurised Inhalation, Suspension |
| Greece | Verisfield (Uk) Ltd | Flixocort | Fluticasone Propionate 250 μg Dose | Pressurised Inhalation, Suspension |
| Greece | Verisfield (Uk) Ltd | Pulmihal | Budesonide 200 μg Dose | Inhalation Powder, Pre-Dispensed |
| Greece | Win Medica Ltd | Flusalair | Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder |
| Greece | Win Medica Ltd | Flusalair | Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Greece | Win Medica Ltd | Flutiresp | Fluticasone Propionate 250mcg/Dose | Inhalation Powder |
| Greece | Win Medica Ltd | Flutiresp | Fluticasone Propionate 500 μg Inhalation | Inhalation Powder |
| Greece | Zwitter Pharmaceuticals επε | Salenga | Fluticasone Propionate 250 μg Dose | Pressurised Inhalation, Suspension |
| Greece | Pharmanel Commercial Pharmaceutical S.A. | Vernoral | Budesonide 200 μg Dose | Inhalation Powder |
| Greece | Pharmanel Commercial Pharmaceutical S.A. | Vernoral | Budesonide 400 μg Dose | Inhalation Powder |
| Hungary | Astrazeneca Kft. | Symbicort Turbuhaler | Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose | Inhalation Powder |
| Hungary | Astrazeneca Kft. | Symbicort Turbuhaler | Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose | Inhalation Powder |
| Hungary | Chiesi Pharmaceuticals Gmbh | Formodual | Formoterol Fumarate Dihydrate 6 μg Actuation, Beclometasone Dipropionate Anhydrous 100 μg Actuation | Pressurised Inhalation, Solution |
| Hungary | Chiesi Pharmaceuticals Gmbh | Foster | Beclometasone Dipropionate 100 μg Actuation, Formoterol Fumarate Dihydrate 6 μg Actuation | Pressurised Inhalation, Solution |
| Hungary | Elpen Pharmaceutical Co. Inc. | Dimenio | Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder |
| Hungary | Elpen Pharmaceutical Co. Inc. | Dimenio | Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder |
| Hungary | Elpen Pharmaceutical Co. Inc. | Flumetor | Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Hungary | Elpen Pharmaceutical Co. Inc. | Flumetor | Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Hungary | Glaxosmithkline Kft. | Seretide Diskus | Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Hungary | Montrose Kft | Thoreus Diskus | Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Hungary | Orion Oyj | Bufomix Easyhaler | Budesonide 160 μg Inhalation, Formoterol Fumarate Dihydrate 4,5  μg Inhalation | Inhalation Powder |
| Hungary | Orion Oyj | Bufomix Easyhaler | Budesonide 320 μg Inhalation, Formoterol Fumarate Dihydrate 9 μg Inhalation | Inhalation Powder |
| Hungary | Sandoz Hungária Kft | Airflusol Forspiro | Salmeterol Xinafoate 50 μg Dose, Fluticasone 500 μg Dose | Inhalation Powder |
| Iceland | Astrazeneca A-S | Symbicort Forte Turbuhaler | Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose | Inhalation Powder |
| Iceland | Astrazeneca A-S | Symbicort Mite Turbuhaler | Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose | Inhalation Powder |
| Iceland | Elpen Pharmaceutical Co. Inc. | Relanio | Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Iceland | Elpen Pharmaceutical Co. Inc. | Relanio | Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Iceland | Glaxosmithkline Ehf. | Flixotide | Fluticasone Propionate 250 μg Dose | Pressurised Inhalation, Suspension |
| Iceland | Glaxosmithkline Ehf. | Flixotide Diskus | Fluticasone Propionate 100 μg Dose | Inhalation Powder |
| Iceland | Glaxosmithkline Ehf. | Flixotide Diskus | Fluticasone Propionate 250 μg Dose | Inhalation Powder |
| Iceland | Glaxosmithkline Ehf. | Flixotide Diskus | Fluticasone Propionate 500 μg Dose | Inhalation Powder |
| Iceland | Glaxosmithkline Ehf. | Seretide Diskus | Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Ireland | Astrazeneca Uk Limited | Pulmicort Turbohaler | Budesonide 100 μg Dose | Inhalation Powder |
| Ireland | Astrazeneca Uk Limited | Pulmicort Turbohaler | Budesonide 200 μg Dose | Inhalation Powder |
| Ireland | Astrazeneca Uk Limited | Pulmicort Turbohaler | Budesonide 400 μg Dose | Inhalation Powder |
| Ireland | Astrazeneca Uk Limited | Symbicort Turbohaler | Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose | Inhalation Powder |
| Ireland | Astrazeneca Uk Limited | Symbicort Turbohaler | Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose | Inhalation Powder |
| Ireland | Elpen Pharmaceutical Co. Inc. | Flamerio | Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Ireland | Elpen Pharmaceutical Co. Inc. | Flamerio | Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose, Lactose Monohydrate 24,677  mg Dose | Inhalation Powder, Pre-Dispensed |
| Ireland | Glaxosmithkline (Ireland) Limited | Flixotide Diskus | Fluticasone Propionate 250 μg Blister | Inhalation Powder, Pre-Dispensed |
| Ireland | Glaxosmithkline (Ireland) Limited | Flixotide Diskus | Fluticasone Propionate 500 μg Blister | Inhalation Powder, Pre-Dispensed |
| Ireland | Glaxosmithkline (Ireland) Limited | Flixotide Evohaler | Fluticasone Propionate 250 μg Dose | Pressurised Inhalation, Suspension |
| Ireland | Glaxosmithkline (Ireland) Limited | Seretide Diskus | Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Ireland | Glaxosmithkline (Ireland) Limited | Viani Diskus | Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Ireland | Orion Oyj | Bufomix Easyhaler | Budesonide 160 μg Inhalation, Formoterol Fumarate Dihydrate 4,5  μg Inhalation | Inhalation Powder |
| Ireland | Orion Oyj | Bufomix Easyhaler | Budesonide 320 μg Inhalation, Formoterol Fumarate Dihydrate 9 μg Inhalation | Inhalation Powder |
| Ireland | Rowex Ltd | Airflusal Forspiro | Salmeterol Xinafoate 50 μg Dose, Fluticasone 250 μg Dose | Inhalation Powder |
| Ireland | Rowex Ltd | Airflusal Forspiro | Salmeterol Xinafoate 50 μg Dose, Fluticasone 500 μg Dose | Inhalation Powder |
| Italy | Astrazeneca S.P.A | Sinestic | Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose | Inhalation Powder |
| Italy | Astrazeneca S.P.A | Sinestic | Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose | Inhalation Powder |
| Italy | Astrazeneca S.P.A | Symbicort | Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose | Inhalation Powder |
| Italy | Astrazeneca S.P.A | Symbicort | Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose | Inhalation Powder |
| Italy | Elpen Pharmaceutical Co. Inc. | Flamerio | Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Italy | Elpen Pharmaceutical Co. Inc. | Flamerio | Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Italy | Elpen Pharmaceutical Co. Inc. | Rolenium | Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Italy | Elpen Pharmaceutical Co. Inc. | Rolenium | Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Italy | Glaxosmithkline S.P.A. | Seretide | Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Italy | Menarini International Operations Luxembourg S.A. | Aliflus Diskus | Fluticasone Propionate 100 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Italy | Menarini International Operations Luxembourg S.A. | Aliflus Diskus | Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Italy | Menarini International Operations Luxembourg S.A. | Aliflus Diskus | Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Italy | Promedica S.R.L. | Clenil Compositum | Beclometasone Dipropionate 0,8  mg/2 Ml, Salbutamol Sulfate 1,928  mg/2 Ml | Nebuliser Suspension |
| Italy | Promedica S.R.L. | Clenil Compositum | Beclometasone Dipropionate 50 μg Actuation, Salbutamol Sulfate 120 μg Actuation | Pressurised Inhalation, Solution |
| Italy | Simesa S.P.A. | Assieme | Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose | Inhalation Powder |
| Italy | Simesa S.P.A. | Assieme | Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose | Inhalation Powder |
| Italy | Valeas S.P.A. | Plenaer | Flunisolide 25 mg Bottle, Salbutamol 10 mg Bottle | Pressurised Inhalation, Suspension |
| Italy | Valeas S.P.A. | Plenaer | Salbutamol Sulfate 0,602  mg Vial, Flunisolide 0,5  mg Vial | Nebuliser Solution |
| Latvia | Astrazeneca Ab | Pulmicort Turbuhaler | Budesonide 100 μg Dose | Inhalation Powder |
| Latvia | Astrazeneca Ab | Pulmicort Turbuhaler | Budesonide 200 μg Dose | Inhalation Powder |
| Latvia | Astrazeneca Ab | Symbicort Turbuhaler | Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose | Inhalation Powder |
| Latvia | Astrazeneca Ab | Symbicort Turbuhaler | Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose | Inhalation Powder |
| Latvia | Chiesi Pharmaceuticals Gmbh | Foster | Beclometasone Dipropionate 100 μg Actuation, Formoterol Fumarate Dihydrate 6 μg Actuation | Pressurised Inhalation, Solution |
| Latvia | Elpen Pharmaceutical Co. Inc. | Flamerio | Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Latvia | Elpen Pharmaceutical Co. Inc. | Flamerio | Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Latvia | Glaxosmithkline Latvia Sia | Flixotide | Fluticasone Propionate 250 μg Inhalation | Pressurised Inhalation, Suspension |
| Latvia | Glaxosmithkline Latvia Sia | Flixotide Diskus | Fluticasone Propionate 250 μg Dose | Inhalation Powder |
| Latvia | Glaxosmithkline Latvia Sia | Flixotide Diskus | Fluticasone Propionate 500 μg Dose | Inhalation Powder |
| Latvia | Glaxosmithkline Latvia Sia | Flosal | Fluticasone Propionate 250 μg Inhalation, Salmeterol Xinafoate 25 μg Inhalation | Pressurised Inhalation, Suspension |
| Latvia | Glaxosmithkline Latvia Sia | Flosal | Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose | Inhalation Powder |
| Latvia | Glaxosmithkline Latvia Sia | Seretide | Fluticasone Propionate 250 μg Inhalation, Salmeterol Xinafoate 25 μg Inhalation | Pressurised Inhalation, Suspension |
| Latvia | Glaxosmithkline Latvia Sia | Seretide | Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose | Inhalation Powder |
| Latvia | Novartis Finland Oy | Miflonide | Budesonide 200 μg | Inhalation Powder, Hard Capsule |
| Latvia | Novartis Finland Oy | Miflonide | Budesonide 400 μg | Inhalation Powder, Hard Capsule |
| Latvia | Orion Corporation | Bufomix Easyhaler | Budesonide 160 μg Inhalation, Formoterol Fumarate Dihydrate 4,5  μg Inhalation | Inhalation Powder |
| Latvia | Orion Corporation | Bufomix Easyhaler | Budesonide 320 μg Inhalation, Formoterol Fumarate Dihydrate 9 μg Inhalation | Inhalation Powder |
| Latvia | Sandoz Pharmaceuticals D.D. | Airflusal Forspiro | Fluticasone Propionate 233 μg Dose, Salmeterol 45 μg Dose | Inhalation Powder, Pre-Dispensed |
| Latvia | Sandoz Pharmaceuticals D.D. | Airflusal Forspiro | Salmeterol Xinafoate 50 μg Dose, Fluticasone 500 μg Dose | Inhalation Powder, Pre-Dispensed |
| Lithuania | Astrazeneca Ab | Symbicort Turbuhaler | Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose | Inhalation Powder |
| Lithuania | Astrazeneca Ab | Symbicort Turbuhaler | Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose | Inhalation Powder |
| Lithuania | Chiesi Pharmaceuticals Gmbh | Foster | Beclometasone Dipropionate 100 μg Actuation, Formoterol Fumarate Dihydrate 6 μg Actuation | Pressurised Inhalation, Solution |
| Lithuania | Elpen Pharmaceutical Co. Inc. | Flamerio | Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Lithuania | Elpen Pharmaceutical Co. Inc. | Flamerio | Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Lithuania | Glaxosmithkline Lietuva Uab | Flixotide | Fluticasone Propionate 250 μg Inhalation | Pressurised Inhalation, Suspension |
| Lithuania | Glaxosmithkline Lietuva Uab | Flixotide Diskus | Fluticasone Propionate 250 μg Dose | Inhalation Powder, Pre-Dispensed |
| Lithuania | Glaxosmithkline Lietuva Uab | Flixotide Diskus | Fluticasone Propionate 500 μg Dose | Inhalation Powder, Pre-Dispensed |
| Lithuania | Glaxosmithkline Lietuva Uab | Seretide | Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Lithuania | Novartis Finland Oy | Miflonide | Budesonide 200 μg | Inhalation Powder, Hard Capsule |
| Lithuania | Novartis Finland Oy | Miflonide | Budesonide 400 μg | Inhalation Powder, Hard Capsule |
| Lithuania | Orion Oyj | Bufomix Easyhaler | Budesonide 160 μg Inhalation, Formoterol Fumarate Dihydrate 4,5  μg Inhalation | Inhalation Powder |
| Lithuania | Orion Oyj | Bufomix Easyhaler | Budesonide 160 μg, Formoterol Fumarate Dihydrate 4,5  μg | Inhalation Powder |
| Lithuania | Orion Oyj | Bufomix Easyhaler | Budesonide 320 μg Inhalation, Formoterol Fumarate Dihydrate 9 μg Inhalation | Inhalation Powder |
| Lithuania | Orion Oyj | Bufomix Easyhaler | Budesonide 320 μg, Formoterol Fumarate Dihydrate 9 μg | Inhalation Powder |
| Lithuania | Sandoz Pharmaceuticals D.D. | Airflusal Forspiro | Salmeterol Xinafoate 50 μg Dose, Fluticasone 250 μg Dose | Inhalation Powder |
| Lithuania | Sandoz Pharmaceuticals D.D. | Airflusal Forspiro | Salmeterol Xinafoate 50 μg Dose, Fluticasone 500 μg Dose | Inhalation Powder |
| Luxembourg | Chiesi Sa-Nv | Inuvair | Formoterol Fumarate Dihydrate 6 μg Actuation, Beclometasone Dipropionate Anhydrous 100 μg Actuation | Pressurised Inhalation, Solution |
| Luxembourg | Elpen Pharmaceutical Co. Inc. | Flusamer | Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Luxembourg | Elpen Pharmaceutical Co. Inc. | Flusamer | Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Luxembourg | Glaxosmithkline Pharmaceuticals S.A. | Flixotide | Fluticasone Propionate 250 μg Inhalation | Pressurised Inhalation, Suspension |
| Luxembourg | Glaxosmithkline Pharmaceuticals S.A. | Flixotide | Fluticasone Propionate 50 μg Inhalation | Pressurised Inhalation, Suspension |
| Luxembourg | Glaxosmithkline Pharmaceuticals S.A. | Flixotide Diskus | Fluticasone Propionate 100 μg Dose | Inhalation Powder |
| Luxembourg | Glaxosmithkline Pharmaceuticals S.A. | Flixotide Diskus | Fluticasone Propionate 250 μg Dose | Inhalation Powder |
| Luxembourg | Glaxosmithkline Pharmaceuticals S.A. | Flixotide Diskus | Fluticasone Propionate 500 μg Dose | Inhalation Powder |
| Luxembourg | Glaxosmithkline Pharmaceuticals S.A. | Seretide Diskus | Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose | Inhalation Powder |
| Luxembourg | Nv Astrazeneca Sa | Pulmicort Turbohaler | Budesonide 200 μg Dose | Inhalation Powder |
| Luxembourg | Nv Astrazeneca Sa | Symbicort Turbohaler | Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose | Inhalation Powder |
| Luxembourg | Nv Astrazeneca Sa | Symbicort Forte Turbohaler | Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose | Inhalation Powder |
| Luxembourg | Orion Corporation | Bufomix Easyhaler | Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate Ph.Eur. 4,5  μg Dose | Inhalation Powder |
| Luxembourg | Orion Corporation | Bufomix Easyhaler | Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate Ph.Eur. 9 μg Dose | Inhalation Powder |
| Luxembourg | Orion Corporation | Orest Easyhaler | Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate Ph.Eur. 4,5  μg Dose | Inhalation Powder |
| Luxembourg | Orion Corporation | Orest Easyhaler | Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate Ph.Eur. 9 μg Dose | Inhalation Powder |
| Malta | Astrazeneca Ab | Pulmicort Turbuhaler | Budesonide 100 μg Dose | Inhalation Powder |
| Malta | Astrazeneca Ab | Pulmicort Turbuhaler | Budesonide 200 μg Dose | Inhalation Powder |
| Malta | Astrazeneca Ab | Symbicort Turbohaler | Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose | Inhalation Powder |
| Malta | Astrazeneca Ab | Symbicort Turbohaler | Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose | Inhalation Powder |
| Malta | Elpen Pharmaceutical Co. Inc. | Rolenium | Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Malta | Elpen Pharmaceutical Co. Inc. | Rolenium | Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Malta | Glaxosmithkline (Ireland) Limited | Flixotide Evohaler | Fluticasone Propionate 250 μg Dose | Pressurised Inhalation, Suspension |
| Malta | Glaxosmithkline (Ireland) Limited | Seretide Diskus | Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Malta | Novartis Pharmaceuticals Uk Limited | Miflonide | Budesonide 200 μg Capsule | Inhalation Powder, Hard Capsule |
| Malta | Novartis Pharmaceuticals Uk Limited | Miflonide | Budesonide 400 μg | Inhalation Powder, Hard Capsule |
| Malta | Orion Oyj | Bufomix Easyhaler | Budesonide 160 μg Inhalation, Formoterol Fumarate Dihydrate 4,5  μg Inhalation | Inhalation Powder |
| Malta | Orion Oyj | Bufomix Easyhaler | Budesonide 320 μg Inhalation, Formoterol Fumarate Dihydrate 9 μg Inhalation | Inhalation Powder |
| Malta | Orion Oyj | Orest Easyhaler | Budesonide 160 μg Inhalation, Formoterol Fumarate Dihydrate 4,5  μg Inhalation | Inhalation Powder |
| Malta | Orion Oyj | Orest Easyhaler | Budesonide 320 μg Inhalation, Formoterol Fumarate Dihydrate 9 μg Inhalation | Inhalation Powder |
| Netherlands | Astrazeneca Bv | Symbicort Turbuhaler | Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose | Inhalation Powder |
| Netherlands | Astrazeneca Bv | Symbicort Turbuhaler | Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose | Inhalation Powder |
| Netherlands | Glaxosmithkline B.V. | Fluticasonpropionaat Inhalator GSK | Fluticasone Propionate 125 μg Dose | Aerosol |
| Netherlands | Glaxosmithkline B.V. | Fluticasonpropionaat Inhalator GSK | Fluticasone Propionate 250 μg Dose | Aerosol |
| Netherlands | Glaxosmithkline B.V. | Fluticasonpropionaat Inhalator GSK | Fluticasone Propionate 50 μg Dose | Aerosol |
| Netherlands | Chiesi Pharmaceuticals B.V. | Formodual | Formoterol Fumarate Dihydrate 6 μg Actuation, Beclometasone Dipropionate Anhydrous 100 μg Actuation | Pressurised Inhalation, Solution |
| Netherlands | Chiesi Pharmaceuticals B.V. | Foster | Beclometasone Dipropionate 100 μg Actuation, Formoterol Fumarate Dihydrate 6 μg Actuation | Pressurised Inhalation, Solution |
| Netherlands | Elpen Pharmaceutical Co. Inc. | Salmeterol/Fluticasonpropionaat Elpen | Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Netherlands | Elpen Pharmaceutical Co. Inc. | Salmeterol/Fluticasonpropionaat Elpen | Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Netherlands | Glaxosmithkline B.V. | Flixotide | Fluticasone Propionate 250 μg Inhalation | Pressurised Inhalation, Suspension |
| Netherlands | Glaxosmithkline B.V. | Flixotide Diskus | Fluticasone Propionate 500 μg Dose | Inhalation Powder, Pre-Dispensed |
| Netherlands | Glaxosmithkline B.V. | Seretide | Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Norway | Astrazeneca As | Symbicort Forte Turbuhaler | Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose | Inhalation Powder |
| Norway | Astrazeneca As | Symbicort Turbuhaler | Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose | Inhalation Powder |
| Norway | Chiesi Farmaceutici S.P.A. | Inuxair | Beclometasone Dipropionate 100 μg Actuation, Formoterol Fumarate Dihydrate 6 μg Actuation | Pressurised Inhalation, Solution |
| Norway | Elpen Pharmaceutical Co. Inc. | Salmeson | Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Norway | Elpen Pharmaceutical Co. Inc. | Salmeson | Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Norway | Glaxosmithkline As | Seretide Diskus | Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Norway | Sandoz A-S | Airflusal Forspiro | Salmeterol Xinafoate 50 μg Dose, Fluticasone Propionate 250 μg Dose | Inhalation Powder |
| Norway | Sandoz A-S | Airflusal Forspiro | Salmeterol Xinafoate 50 μg Dose, Fluticasone Propionate 500 μg Dose | Inhalation Powder |
| Poland | Adamed Sp. Z O.O. | Flutixon | Fluticasone Propionate 125 μg Capsule | Inhalation Powder, Hard Capsule |
| Poland | Adamed Sp. Z O.O. | Flutixon | Fluticasone Propionate 250 μg Capsule | Inhalation Powder, Hard Capsule |
| Poland | Astrazeneca Ab | Pulmicort Turbuhaler | Budesonide 100 μg Dose | Inhalation Powder |
| Poland | Astrazeneca Ab | Pulmicort Turbuhaler | Budesonide 200 μg Dose | Inhalation Powder |
| Poland | Astrazeneca Ab | Symbicort Turbuhaler | Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose | Inhalation Powder |
| Poland | Astrazeneca Ab | Symbicort Turbuhaler | Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose | Inhalation Powder |
| Poland | Celon Pharma S.A. | Salmex | Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose | Inhalation Powder |
| Poland | Chiesi Pharmaceuticals Gmbh | Formodual | Beclometasone Dipropionate 100 μg Actuation, Formoterol Fumarate Dihydrate 6 μg Actuation | Pressurised Inhalation, Solution |
| Poland | Chiesi Pharmaceuticals Gmbh | Fostex | Beclometasone Dipropionate 100 μg Actuation, Formoterol Fumarate Dihydrate 6 μg Actuation | Pressurised Inhalation, Solution |
| Poland | Elpen Pharmaceutical Co. Inc. | Salmeson | Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Poland | Elpen Pharmaceutical Co. Inc. | Salmeson | Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Poland | Glaxosmithkline Export Ltd | Flixotide | Fluticasone Propionate 250 μg Dose | Inhalation Powder, Pre-Dispensed |
| Poland | Glaxosmithkline Export Ltd | Flixotide | Fluticasone Propionate 250 μg Inhalation | Pressurised Inhalation, Suspension |
| Poland | Glaxosmithkline Export Ltd | Flixotide Dysk | Fluticasone Propionate 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Poland | Glaxosmithkline Export Ltd | Seretide Dysk | Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose | Inhalation Powder |
| Poland | Meda Pharma Gmbh & Co. Kg | Budelin Novolizer | Budesonide 200 μg Dose | Inhalation Powder |
| Poland | Novartis Poland Sp. Z O. O. | Miflonide | Budesonide 200 μg | Inhalation Powder, Hard Capsule |
| Poland | Novartis Poland Sp. Z O. O. | Miflonide | Budesonide 400 μg | Inhalation Powder, Hard Capsule |
| Poland | Orion Corporation | Orest Easyhaler | Budesonide 160 μg Inhalation, Formoterol Fumarate Dihydrate 4,5  μg Inhalation | Inhalation Powder |
| Poland | Orion Corporation | Orest Easyhaler | Budesonide 320 μg Inhalation, Formoterol Fumarate Dihydrate 9 μg Inhalation | Inhalation Powder |
| Poland | Polfarmex S.A. | Asaris | Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder |
| Poland | Przedsiębiorstwo Farmaceutyczne Lek-Am Sp. Z O.O. | Budezonid Lek-Am | Budesonide 200 μg Inhalation | Inhalation Powder, Hard Capsule |
| Poland | Przedsiębiorstwo Farmaceutyczne Lek-Am Sp. Z O.O. | Budezonid Lek-Am | Budesonide 400 μg Inhalation | Inhalation Powder, Hard Capsule |
| Portugal | Astrazeneca Produtos Farmacêuticos, Lda. | Assieme Turbohaler | Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose | Inhalation Powder |
| Portugal | Astrazeneca Produtos Farmacêuticos, Lda. | Assieme Turbohaler | Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose | Inhalation Powder |
| Portugal | Astrazeneca Produtos Farmaceuticos Limitada | Pulmicort Turbohaler | Budesonide 200 μg Dose | Inhalation Powder |
| Portugal | Astrazeneca Produtos Farmaceuticos Limitada | Pulmicort Turbohaler | Budesonide 400 μg Dose | Inhalation Powder |
| Portugal | Astrazeneca Produtos Farmacêuticos, Lda. | Symbicort Turbohaler | Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose | Inhalation Powder |
| Portugal | Astrazeneca Produtos Farmacêuticos, Lda. | Symbicort Turbohaler | Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose | Inhalation Powder |
| Portugal | Bialfar — Produtos Farmacêuticos, Sociedade Anónima | Brisomax Diskus | Fluticasone Propionate 100 μg Dose, Salmeterol Xinafoate 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Portugal | Bialfar — Produtos Farmacêuticos, Sociedade Anónima | Brisomax Diskus | Fluticasone Propionate 250 μg Dose, Salmeterol Xinafoate 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Portugal | Bialfar — Produtos Farmacêuticos, Sociedade Anónima | Brisomax Diskus | Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Portugal | Elpen Pharmaceutical Co. Inc. | Dimenium | Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Portugal | Elpen Pharmaceutical Co. Inc. | Dimenium | Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Portugal | Farmoz — Sociedade Técnico Medicinal, S.A. | Budesonida Farmoz | Budesonide 200 μg Dose | Inhalation Powder |
| Portugal | Farmoz — Sociedade Técnico Medicinal, S.A. | Budesonida Farmoz | Budesonide 400 μg Dose | Inhalation Powder |
| Portugal | Glaxo Wellcome Farmacêutica, Limitada | Seretaide Diskus | Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Portugal | Glaxosmithkline — Produtos Farmacêuticos, Limitada | Maizar Diskus | Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Portugal | Orion Corporation | Bufomix Easyhaler | Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose | Inhalation Powder |
| Portugal | Orion Corporation | Bufomix Easyhaler | Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose | Inhalation Powder |
| Portugal | Orion Corporation | Orest Easyhaler | Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose | Inhalation Powder |
| Portugal | Orion Corporation | Orest Easyhaler | Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose | Inhalation Powder |
| Portugal | Pentafarma — Sociedade Tecnico-Medicinal S.A. | Budesonida Tecnicort | Budesonide 200 μg Dose | Inhalation Powder |
| Portugal | Pentafarma — Sociedade Tecnico-Medicinal S.A. | Budesonida Tecnicort | Budesonide 400 μg Dose | Inhalation Powder |
| Portugal | Sandoz Farmacêutica, Limitada | Airflusal Forspiro | Fluticasone Propionate 250 μg Dose, Salmeterol Xinafoate 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Portugal | Sandoz Farmacêutica, Limitada | Airflusal Forspiro | Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Romania | Astrazeneca Ab | Symbicort Turbuhaler | Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose | Inhalation Powder |
| Romania | Astrazeneca Ab | Symbicort Turbuhaler | Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose | Inhalation Powder |
| Romania | Chiesi Pharmaceuticals Gmbh | Foster | Formoterol Fumarate Dihydrate 6 μg Actuation, Beclometasone Dipropionate Anhydrous 100 μg Actuation | Pressurised Inhalation, Solution |
| Romania | Elpen Pharmaceutical Co. Inc. | Flusamer | Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Romania | Elpen Pharmaceutical Co. Inc. | Flusamer | Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Romania | Glaxo Wellcome Ltd | Flixotide | Fluticasone Propionate 250 μg Inhalation | Pressurised Inhalation, Suspension |
| Romania | Glaxo Wellcome Ltd | Flixotide Diskus | Fluticasone Propionate 250 μg Dose | Inhalation Powder |
| Romania | Glaxo Wellcome Ltd | Flixotide Diskus | Fluticasone Propionate 500 μg Dose | Inhalation Powder |
| Romania | Glaxo Wellcome Ltd | Seretide | Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Romania | Medochemie Romania S.R.L. | Frenolyn | Budesonide, Micronised 200 μg Dose | Inhalation Powder |
| Romania | Medochemie Romania S.R.L. | Frenolyn | Budesonide, Micronised 400 μg Dose | Inhalation Powder |
| Romania | Orion Oyj | Bufomix Easyhaler | Budesonide 160 μg Inhalation, Formoterol Fumarate Dihydrate 4,5  μg Inhalation | Inhalation Powder |
| Romania | Orion Oyj | Bufomix Easyhaler | Budesonide 320 μg Inhalation, Formoterol Fumarate Dihydrate 9 μg Inhalation | Inhalation Powder |
| Romania | S.C. Sandoz S.R.L. | Airflusal Forspiro | Salmeterol Xinafoate 50 μg Dose, Fluticasone 500 μg Dose | Inhalation Powder |
| Slovakia | Astrazeneca Ab | Pulmicort Turbohaler | Budesonide 100 μg Dose | Inhalation Powder |
| Slovakia | Astrazeneca Ab | Pulmicort Turbohaler | Budesonide 200 μg Dose | Inhalation Powder |
| Slovakia | Astrazeneca Ab | Pulmicort Turbohaler | Budesonide 400 μg Dose | Inhalation Powder |
| Slovakia | Astrazeneca Ab | Symbicort Turbuhaler | Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose | Inhalation Powder |
| Slovakia | Astrazeneca Ab | Symbicort Turbuhaler | Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose | Inhalation Powder |
| Slovakia | Chiesi Pharmaceuticals Gmbh | Foster | Beclometasone Dipropionate 100 μg Actuation, Formoterol Fumarate Dihydrate 6 μg Actuation | Pressurised Inhalation, Solution |
| Slovakia | Elpen Pharmaceutical Co. Inc. | Dimenium | Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Slovakia | Elpen Pharmaceutical Co. Inc. | Dimenium | Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Slovakia | Elpen Pharmaceutical Co. Inc. | Flumetor | Fluticasone Propionate 250 μg Dose, Salmeterol Xinafoate 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Slovakia | Elpen Pharmaceutical Co. Inc. | Flumetor | Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Slovakia | Glaxo Group Limited | Flixotide | Fluticasone Propionate 125 μg Inhalation | Pressurised Inhalation, Suspension |
| Slovakia | Glaxo Group Limited | Flixotide | Fluticasone Propionate 250 μg Inhalation | Pressurised Inhalation, Suspension |
| Slovakia | Glaxo Group Limited | Flixotide | Fluticasone Propionate 50 μg Inhalation | Pressurised Inhalation, Suspension |
| Slovakia | Glaxo Group Limited | Seretide | Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Slovakia | Glaxosmithkline Slovakia S.R.O. | Flixotide Diskus | Fluticasone Propionate 100 μg Dose | Inhalation Powder |
| Slovakia | Glaxosmithkline Slovakia S.R.O. | Flixotide Diskus | Fluticasone Propionate 250 μg Dose | Inhalation Powder |
| Slovakia | Glaxosmithkline Slovakia S.R.O. | Flixotide Diskus | Fluticasone Propionate 500 μg Dose | Inhalation Powder |
| Slovakia | Glaxosmithkline Slovakia S.R.O. | Flixotide Diskus | Fluticasone Propionate 50 μg Dose | Inhalation Powder |
| Slovakia | Meda Pharma Spol. S R.O. | Budelin Novolizer | Budesonide 200 μg Dose | Inhalation Powder |
| Slovakia | Novartis, S.R.O. | Miflonid | Budesonide 200 μg | Inhalation Powder, Hard Capsule |
| Slovakia | Novartis, S.R.O. | Miflonid | Budesonide 400 μg | Inhalation Powder, Hard Capsule |
| Slovakia | Sandoz Pharmaceuticals D.D. | Airflusal Forspiro | Salmeterol Xinafoate 50 μg Dose, Fluticasone 250 μg Dose | Inhalation Powder |
| Slovakia | Sandoz Pharmaceuticals D.D. | Airflusal Forspiro | Salmeterol Xinafoate 50 μg Dose, Fluticasone 500 μg Dose | Inhalation Powder |
| Slovenia | Astrazeneca Ab | Symbicort Turbuhaler | Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose | Inhalation Powder |
| Slovenia | Astrazeneca Ab | Symbicort Turbuhaler | Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose | Inhalation Powder |
| Slovenia | Chiesi Pharmaceuticals Gmbh | Formodual | Beclometasone Dipropionate 100 μg Actuation, Formoterol Fumarate Dihydrate 6 μg Actuation | Pressurised Inhalation, Solution |
| Slovenia | Chiesi Pharmaceuticals Gmbh | Foster | Beclometasone Dipropionate 100 μg Actuation, Formoterol Fumarate Dihydrate 6 μg Actuation | Pressurised Inhalation, Solution |
| Slovenia | Elpen Pharmaceutical Co. Inc. | Flamerio | Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Slovenia | Elpen Pharmaceutical Co. Inc. | Flamerio | Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Slovenia | Glaxosmithkline D.O.O., Ljubljana | Flixotide | Fluticasone Propionate 250 μg Spray | Pressurised Inhalation, Suspension |
| Slovenia | Glaxosmithkline D.O.O., Ljubljana | Seretide Diskus | Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Slovenia | Lek Pharmaceuticals D.D. Ljubljana | Airflusan Forspiro | Salmeterol 50 μg Dose, Fluticasone Propionate 500 μg Dose | Inhalation Powder |
| Slovenia | Meda Pharma Gmbh & Co. Kg | Budelin Novolizer | Budesonide 200 μg Dose | Inhalation Powder, Pre-Dispensed |
| Spain | Allen Farmaceutica, S.A. | Anasma Accuhaler | Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Spain | Almirall, S.A. | Plusvent | Fluticasone Propionate 50 μg Dose, Salmeterol Xinafoate 25 μg Dose | Pressurised Inhalation, Suspension |
| Spain | Almirall, S.A. | Plusvent | Fluticasone Propionate 250 μg Dose, Salmeterol Xinafoate 25 μg Dose | Pressurised Inhalation, Suspension |
| Spain | Almirall, S.A. | Plusvent | Fluticasone Propionate 125 μg Dose, Salmeterol Xinafoate 25 μg Dose | Pressurised Inhalation, Suspension |
| Spain | Almirall, S.A. | Plusvent | Fluticasone Propionate 100 μg Dose, Salmeterol Xinafoate 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Spain | Almirall, S.A. | Plusvent | Fluticasone Propionate 250 μg Dose, Salmeterol Xinafoate 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Spain | Almirall, S.A. | Plusvent | Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Spain | Astrazeneca Farmacéutica Spain, S.A. | Pulmicort Turbuhaler | Budesonide 100 μg Dose | Inhalation Powder |
| Spain | Astrazeneca Farmacéutica Spain, S.A. | Pulmicort Turbuhaler | Budesonide 200 μg Dose | Inhalation Powder |
| Spain | Astrazeneca Farmacéutica Spain, S.A. | Pulmicort Turbuhaler | Budesonide 400 μg Dose | Inhalation Powder |
| Spain | Astrazeneca Farmacéutica Spain, S.A. | Symbicort Turbuhaler | Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose | Inhalation Powder |
| Spain | Astrazeneca Farmacéutica Spain, S.A. | Symbicort Turbuhaler | Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose | Inhalation Powder |
| Spain | Chiesi España, S.A. | Formodual | Beclometasone Dipropionate 100 μg Actuation, Formoterol Fumarate Dihydrate 6 μg Actuation | Pressurised Inhalation, Solution |
| Spain | Chiesi España, S.A. | Foster | Beclometasone Dipropionate 100 μg Actuation, Formoterol Fumarate Dihydrate 6 μg Dose | Pressurised Inhalation, Solution |
| Spain | Glaxosmithkline S.A. | Brisair Accuhaler | Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Spain | Glaxosmithkline S.A. | Brisair Accuhaler | Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Spain | Glaxosmithkline S.A. | Flixotide | Fluticasone Propionate 125 μg Inhalation | Pressurised Inhalation, Suspension |
| Spain | Glaxosmithkline S.A. | Flixotide | Fluticasone Propionate 250 μg Inhalation | Pressurised Inhalation, Suspension |
| Spain | Glaxosmithkline S.A. | Flixotide | Fluticasone Propionate 50 μg Inhalation | Pressurised Inhalation, Suspension |
| Spain | Glaxosmithkline S.A. | Flixotide Accuhaler | Fluticasone Propionate 100 μg Dose | Inhalation Powder |
| Spain | Glaxosmithkline S.A. | Flixotide Accuhaler | Fluticasone Propionate 250 μg Dose | Inhalation Powder |
| Spain | Glaxosmithkline S.A. | Flixotide Accuhaler | Fluticasone Propionate 500 μg Dose | Inhalation Powder |
| Spain | Glaxosmithkline S.A. | Flusonal | Fluticasone Propionate 250 μg Inhalation | Pressurised Inhalation, Suspension |
| Spain | Glaxosmithkline S.A. | Flusonal | Fluticasone Propionate 50 μg Inhalation | Pressurised Inhalation, Suspension |
| Spain | Glaxosmithkline S.A. | Flusonal Accuhaler | Fluticasone Propionate 100 μg Dose | Inhalation Powder |
| Spain | Glaxosmithkline S.A. | Flusonal Accuhaler | Fluticasone Propionate 500 μg Dose | Inhalation Powder |
| Spain | Glaxosmithkline S.A. | Inalacor | Fluticasone Propionate 250 μg Inhalation | Pressurised Inhalation, Suspension |
| Spain | Glaxosmithkline S.A. | Inalacor | Fluticasone Propionate 50 μg Dose | Pressurised Inhalation, Suspension |
| Spain | Glaxosmithkline S.A. | Inalacor Accuhaler | Fluticasone Propionate 100 μg Dose | Inhalation Powder |
| Spain | Glaxosmithkline S.A. | Inalacor Accuhaler | Fluticasone Propionate 500 μg Dose | Inhalation Powder |
| Spain | Glaxosmithkline S.A. | Inaladuo Accuhaler | Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Spain | Glaxosmithkline S.A. | Seretide Accuhaler | Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Spain | Laboratorio Tau, S.A. | Rilast Turbuhaler | Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose | Inhalation Powder |
| Spain | Orion Corporation | Bufomix Easyhaler | Budesonide 160 μg Inhalation, Formoterol Fumarate Dihydrate 4,5  μg Inhalation | Inhalation Powder |
| Spain | Orion Corporation | Bufomix Easyhaler | Budesonide 320 μg Inhalation, Formoterol Fumarate Dihydrate 9 μg Inhalation | Inhalation Powder |
| Spain | Orion Corporation | Orest Easyhaler | Budesonide 160 μg Inhalation, Formoterol Fumarate Dihydrate 4,5  μg Inhalation | Inhalation Powder |
| Spain | Orion Corporation | Orest Easyhaler | Budesonide 320 μg Inhalation, Formoterol Fumarate Dihydrate 9 μg Inhalation | Inhalation Powder |
| Spain | Smithkline Beecham Farma S.A. | Trialona | Fluticasone Propionate 250 μg Dose | Pressurised Inhalation, Suspension |
| Spain | Smithkline Beecham Farma S.A. | Trialona | Fluticasone Propionate 50 μg Dose | Pressurised Inhalation, Suspension |
| Spain | Smithkline Beecham Farma S.A. | Trialona Accuhaler | Fluticasone Propionate 100 μg Dose | Inhalation Powder |
| Spain | Smithkline Beecham Farma S.A. | Trialona Accuhaler | Fluticasone Propionate 500 μg Dose | Inhalation Powder |
| Sweden | Astrazeneca Ab | Gardette | Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose | Inhalation Powder |
| Sweden | Astrazeneca Ab | Gardette Forte | Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose | Inhalation Powder |
| Sweden | Astrazeneca Ab | Symbicort Forte Turbuhaler | Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose | Inhalation Powder |
| Sweden | Astrazeneca Ab | Symbicort Turbuhaler | Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose | Inhalation Powder |
| Sweden | Chiesi Farmaceutici S.P.A. | Innovair | Beclometasone Dipropionate 100 μg Actuation, Formoterol Fumarate Dihydrate 6 μg Actuation | Pressurised Inhalation, Solution |
| Sweden | Elpen Pharmaceutical Co. Inc. | Flusamer | Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Sweden | Elpen Pharmaceutical Co. Inc. | Flusamer | Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Sweden | Elpen Pharmaceutical Co. Inc. | Flusaterol | Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Sweden | Elpen Pharmaceutical Co. Inc. | Flusaterol | Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Sweden | Elpen Pharmaceutical Co. Inc. | Relanio | Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Sweden | Elpen Pharmaceutical Co. Inc. | Relanio | Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Sweden | Elpen Pharmaceutical Co. Inc. | Salmeson | Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose, Lactose Monohydrate 24,677  mg Dose | Inhalation Powder, Pre-Dispensed |
| Sweden | Elpen Pharmaceutical Co. Inc. | Salmeson | Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Sweden | Glaxosmithkline Ab | Flutide Diskus | Fluticasone Propionate 250 μg Dose | Inhalation Powder, Pre-Dispensed |
| Sweden | Glaxosmithkline Ab | Flutide Diskus | Fluticasone Propionate 500 μg Dose | Inhalation Powder, Pre-Dispensed |
| Sweden | Glaxosmithkline Ab | Seretide Diskus | Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Sweden | Glaxosmithkline Ab | Viani Diskus Forte | Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Sweden | Hexal Ag | Salmeterol/Fluticasone Hexal | Salmeterol Xinafoate 50 μg Dose, Fluticasone 500 μg Dose | Inhalation Powder |
| Sweden | Orion Corporation | Bufomix Easyhaler | Budesonide 160 μg Inhalation, Formoterol Fumarate Dihydrate 4,5  μg Inhalation | Inhalation Powder |
| Sweden | Orion Corporation | Bufomix Easyhaler | Budesonide 320 μg Inhalation, Formoterol Fumarate Dihydrate 9 μg Inhalation | Inhalation Powder |
| Sweden | Orion Corporation | Orest Easyhaler | Budesonide 160 μg Inhalation, Formoterol Fumarate Dihydrate 4,5  μg Inhalation | Inhalation Powder |
| Sweden | Orion Corporation | Orest Easyhaler | Budesonide 320 μg Inhalation, Formoterol Fumarate Dihydrate 9 μg Inhalation | Inhalation Powder |
| Sweden | Sandoz A-S | Aesalfluca Forspiro | Salmeterol Xinafoate 50 μg Dose, Fluticasone 500 μg Dose | Inhalation Powder |
| Sweden | Sandoz A-S | Airflusal Forspiro | Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Sweden | Sandoz A-S | Airflusal Forspiro | Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| Sweden | Sandoz A-S | Flaxxone Forspiro | Salmeterol Xinafoate 50 μg Dose, Fluticasone 250 μg Dose | Inhalation Powder |
| Sweden | Sandoz A-S | Flaxxone Forspiro | Salmeterol Xinafoate 50 μg Dose, Fluticasone 500 μg 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 50 μg Dose, Fluticasone 250 μg Dose | Inhalation Powder |
| Sweden | Sandoz A-S | Salmetorol/Fluticasone Sandoz | Salmeterol Xinafoate 50 μg Dose, Fluticasone 500 μg Dose | Inhalation Powder |
| Sweden | Sandoz A-S | Setirenol | Salmeterol Xinafoate 50 μg Dose, Fluticasone 250 μg Dose | Inhalation Powder |
| Sweden | Sandoz A-S | Setirenol | Salmeterol Xinafoate 50 μg Dose, Fluticasone 500 μg Dose | Inhalation Powder |
| United Kingdom | Astrazeneca Uk Limited | Symbicort Turbohaler | Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose | Inhalation Powder |
| United Kingdom | Astrazeneca Uk Limited | Symbicort Turbohaler | Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose | Inhalation Powder |
| United Kingdom | Chiesi Limited | Formodual | Beclometasone Dipropionate 100 μg Actuation, Formoterol Fumarate Dihydrate 6 μg Actuation | Pressurised Inhalation, Solution |
| United Kingdom | Chiesi Limited | Fostair | Beclometasone Dipropionate 100 μg Actuation, Formoterol Fumarate Dihydrate 6 μg Actuation | Pressurised Inhalation, Solution |
| United Kingdom | Glaxo Wellcome Ltd | Seretide | Fluticasone Propionate 100 μg Dose, Salmeterol Xinafoate 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| United Kingdom | Glaxo Wellcome Ltd | Seretide | Fluticasone Propionate 250 μg Dose, Salmeterol Xinafoate 50 μg Dose | Inhalation Powder, Pre-Dispensed |
| United Kingdom | Glaxo Wellcome Ltd | Seretide Accuhaler | Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose | Inhalation Powder, Pre-Dispensed |

Member State in EEA

Marketing authorisaton holder

Product name

Active substance + Strength

Pharmaceutical form

Austria

3m Health Care Ltd

Aerocortin

Beclometasone Dipropionate 50 μg/50 μl

Pressurised Inhalation, Solution

Austria

Allen Pharmazeutika Gesellschaft M.B.H.

Fluticasonpropionat

Fluticasone Propionate 50 μg Dose

Pressurised Inhalation, Suspension

Austria

Allen Pharmazeutika Gesellschaft M.B.H.

Fluticasonpropionat Diskus Forte Allen

Fluticasone Propionate 500 μg Dose

Inhalation Powder

Austria

Allen Pharmazeutika Gesellschaft M.B.H.

Fluticasonpropionat Diskus Junior Allen

Fluticasone Propionate 100 μg Dose

Inhalation Powder

Austria

Allen Pharmazeutika Gesellschaft M.B.H.

Fluticasonpropionat ‘allen’

Fluticasone Propionate 125 μg Dose

Pressurised Inhalation, Suspension

Austria

Allen Pharmazeutika Gesellschaft M.B.H.

Fluticasonpropionat ‘allen’

Fluticasone Propionate 250 μg Dose

Inhalation Powder

Austria

Allen Pharmazeutika Gesellschaft M.B.H.

Fluticasonpropionat ‘allen’

Fluticasone Propionate 250 μg Dose

Pressurised Inhalation, Suspension

Austria

Allen Pharmazeutika Gesellschaft M.B.H.

Samtoral Diskus Standard

Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Austria

Astrazeneca österreich Gmbh

Pulmicort

Budesonide 400 μg Dose

Inhalation Powder

Austria

Astrazeneca österreich Gmbh

Pulmicort Turbohaler

Budesonide 100 μg Dose

Inhalation Powder

Austria

Astrazeneca österreich Gmbh

Pulmicort Turbohaler

Budesonide 200 μg Dose

Inhalation Powder

Austria

Astrazeneca österreich Gmbh

Pulmicort Turbohaler

Budesonide 400 μg Dose

Inhalation Powder

Austria

Astrazeneca österreich Gmbh

Symbicort Forte Turbohaler

Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose

Inhalation Powder

Austria

Astrazeneca österreich Gmbh

Symbicort Turbohaler

Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose

Inhalation Powder

Austria

Chiesi Pharmaceuticals Gmbh

Budiair

Budesonide 0,2  mg/0,05 ml

Pressurised Inhalation, Solution

Austria

Chiesi Pharmaceuticals Gmbh

Budiair Jet

Budesonide 0,2  mg/0,05  ml

Pressurised Inhalation, Solution

Austria

Chiesi Pharmaceuticals Gmbh

Foster

Beclometasone Dipropionate 100 μg Actuation, Formoterol Fumarate Dihydrate 6 μg Actuation

Pressurised Inhalation, Solution

Austria

Elpen Pharmaceutical Co. Inc.

Salmeson

Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Austria

Elpen Pharmaceutical Co. Inc.

Salmeson

Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Austria

Glaxosmithkline Pharma Gmbh.

Flixotide

Fluticasone Propionate 125 μg Inhalation

Pressurised Inhalation, Suspension

Austria

Glaxosmithkline Pharma Gmbh.

Flixotide

Fluticasone Propionate 250 μg Dose

Inhalation Powder, Pre-Dispensed

Austria

Glaxosmithkline Pharma Gmbh.

Flixotide

Fluticasone Propionate 250 μg Inhalation

Pressurised Inhalation, Suspension

Austria

Glaxosmithkline Pharma Gmbh.

Flixotide Diskus Forte

Fluticasone Propionate 500 μg Dose

Inhalation Powder

Austria

Glaxosmithkline Pharma Gmbh.

Flixotide Diskus Junior

Fluticasone Propionate 100 μg Dose

Inhalation Powder

Austria

Glaxosmithkline Pharma Gmbh.

Flixotide Junior

Fluticasone Propionate 125 μg Inhalation

Pressurised Inhalation, Suspension

Austria

Glaxosmithkline Pharma Gmbh.

Seretide Diskus

Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose

Inhalation Powder, Pre-Dispensed

Austria

Pari Pharma Gmbh

Buparid

Budesonide 0,25  mg Ampoule

Nebuliser Suspension

Austria

Pari Pharma Gmbh

Buparid

Budesonide 0,5  mg Ampoule

Nebuliser Suspension

Austria

Pari Pharma Gmbh

Buparid

Budesonide 1 mg Ampoule

Nebuliser Suspension

Austria

Sandoz Gmbh

Airflusal Forspiro

Fluticasone Propionate 233 μg Dose, Salmeterol 45 μg Dose

Inhalation Powder

Austria

Sandoz Gmbh

Airflusal Forspiro

Fluticasone Propionate 465 μg Dose, Salmeterol 45 μg Dose

Inhalation Powder

Belgium

Chiesi Sa-Nv

Inuvair

Formoterol Fumarate Dihydrate 6 μg Actuation, Beclometasone Dipropionate Anhydrous 100 μg Actuation

Pressurised Inhalation, Solution

Belgium

Cipla Europe Nv

Salmeterol/Fluticasone Cipla

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

Pressurised Inhalation, Suspension

Belgium

Elpen Pharmaceutical Co. Inc.

Flusalio

Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Belgium

Elpen Pharmaceutical Co. Inc.

Flusalio

Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Belgium

Glaxosmithkline Pharmaceuticals S.A.

Flixotide

Fluticasone Propionate 0,05  mg/2ml

Nebuliser Solution

Belgium

Glaxosmithkline Pharmaceuticals S.A.

Flixotide

Fluticasone Propionate 250 μg Inhalation

Pressurised Inhalation, Suspension

Belgium

Glaxosmithkline Pharmaceuticals S.A.

Flixotide

Fluticasone Propionate 2 mg/2ml

Nebuliser Solution

Belgium

Glaxosmithkline Pharmaceuticals S.A.

Flixotide

Fluticasone Propionate 50 μg Inhalation

Pressurised Inhalation, Suspension

Belgium

Glaxosmithkline Pharmaceuticals S.A.

Flixotide Diskus

Fluticasone Propionate 100 μg Dose

Inhalation Powder

Belgium

Glaxosmithkline Pharmaceuticals S.A.

Flixotide Diskus

Fluticasone Propionate 250 μg Dose

Inhalation Powder

Belgium

Glaxosmithkline Pharmaceuticals S.A.

Flixotide Diskus

Fluticasone Propionate 500 μg Dose

Inhalation Powder

Belgium

Glaxosmithkline Pharmaceuticals S.A.

Seretide Diskus

Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose

Inhalation Powder, Pre-Dispensed

Belgium

Nv Astrazeneca Sa

Pulmicort Turbohaler

Budesonide 200 μg Dose

Inhalation Powder

Belgium

Nv Astrazeneca Sa

Symbicort Forte Turbohaler

Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose

Inhalation Powder

Belgium

Nv Astrazeneca Sa

Symbicort Turbohaler

Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose

Inhalation Powder

Belgium

Orion Corporation

Bufomix Easyhaler

Budesonide 160 μg Inhalation, Formoterol Fumarate Dihydrate 4,5  μg Inhalation

Inhalation Powder

Belgium

Orion Corporation

Bufomix Easyhaler

Budesonide 320 μg Inhalation, Formoterol Fumarate Dihydrate 9 μg Inhalation

Inhalation Powder

Belgium

Pari Pharma Gmbh

Buparid

Budesonide 0,25  mg Ampoule

Nebuliser Suspension

Belgium

Pari Pharma Gmbh

Buparid

Budesonide 0,5  mg Ampoule

Nebuliser Suspension

Belgium

Pari Pharma Gmbh

Buparid

Budesonide 1 mg Ampoule

Nebuliser Suspension

Belgium

Sandoz N.V.

Airflusal Forspiro

Salmeterol Xinafoate 50 μg Dose, Fluticasone 500 μg Dose

Inhalation Powder

Bulgaria

Astrazeneca Ab

Symbicort Turbuhaler

Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose

Inhalation Powder

Bulgaria

Astrazeneca Ab

Symbicort Turbuhaler

Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose

Inhalation Powder

Bulgaria

Chiesi Pharmaceuticals Gmbh

Foster

Formoterol Fumarate Dihydrate 6 μg Actuation, Beclometasone Dipropionate Anhydrous 100 μg Actuation

Pressurised Inhalation, Solution

Bulgaria

Elpen Pharmaceutical Co. Inc.

Flusamer

Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Bulgaria

Elpen Pharmaceutical Co. Inc.

Flusamer

Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Bulgaria

Glaxosmithkline Eood

Seretide Diskus

Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Bulgaria

Orion Oyj

Bufomix Easyhaler

Budesonide 160 μg Inhalation, Formoterol Fumarate Dihydrate 4,5  μg Inhalation

Inhalation Powder

Bulgaria

Orion Oyj

Bufomix Easyhaler

Budesonide 320 μg Inhalation, Formoterol Fumarate Dihydrate 9 μg Inhalation

Inhalation Powder

Bulgaria

Sandoz Pharmaceuticals D.D.

Airflusal Forspiro

Salmeterol Xinafoate 50 μg Dose, Fluticasone 500 μg Dose

Inhalation Powder

Bulgaria

Sopharma Ad

Flixotide

Fluticasone Propionate 250 μg Inhalation

Pressurised Inhalation, Suspension

Croatia

Astrazeneca D.O.O

Symbicort Turbuhaler

Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose

Inhalation Powder

Croatia

Astrazeneca D.O.O

Symbicort Turbuhaler

Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose

Inhalation Powder

Croatia

Clinres Farmacija D.O.O.

Dimenium

Fluticasone Propionate 100 Mcg Dose, Salmeterol Xinafoate 50 Mcg Dose

Inhalation Powder, Pre-Dispensed

Croatia

Clinres Farmacija D.O.O.

Dimenium

Fluticasone Propionate 250 Mcg Dose, Salmeterol Xinafoate 50 Mcg Dose

Inhalation Powder, Pre-Dispensed

Croatia

Clinres Farmacija D.O.O.

Dimenium

Fluticasone Propionate 500 Mcg Dose, Salmeterol Xinafoate 50 Mcg Dose

Inhalation Powder, Pre-Dispensed

Croatia

Glaxosmithkline D.O.O.

Salmeterol/Flutikazonpropionat Diskus Glaxosmithkline

Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Croatia

Glaxosmithkline D.O.O.

Seretide Diskus

Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose

Inhalation Powder, Pre-Dispensed

Croatia

Providens D.O.O.

Foster

Formoterol Fumarate Dihydrate 6 μg Actuation, Beclometasone Dipropionate Anhydrous 100 μg Actuation

Pressurised Inhalation, Solution

Croatia

Salvus D.O.O.

Saldisk

Fluticasone Propionate 100 Mcg Dose, Salmeterol Xinafoate 50 Mcg Dose

Inhalation Powder, Pre-Dispensed

Croatia

Salvus D.O.O.

Saldisk

Fluticasone Propionate 250 Mcg Dose, Salmeterol Xinafoate 50 Mcg Dose

Inhalation Powder, Pre-Dispensed

Croatia

Salvus D.O.O.

Saldisk

Fluticasone Propionate 500 Mcg Dose, Salmeterol Xinafoate 50 Mcg Dose

Inhalation Powder, Pre-Dispensed

Croatia

Sandoz D.O.O.

Airflusal Forspiro

Fluticasone Propionate 233 μg Dose, Salmeterol 45 μg Dose

Inhalation Powder, Pre-Dispensed

Croatia

Sandoz D.O.O.

Airflusal Forspiro

Fluticasone Propionate 465 μg Dose, Salmeterol 45 μg Dose

Inhalation Powder, Pre-Dispensed

Cyprus

Astrazeneca Ab

Symbicort Turbuhaler

Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose

Inhalation Powder

Cyprus

Astrazeneca Ab

Symbicort Turbuhaler

Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose

Inhalation Powder

Cyprus

Costakis Tsisios & Co. Ltd

Fluticapen

Fluticasone Propionate 250 μg Dose

Inhalation Powder, Pre-Dispensed

Cyprus

Costakis Tsisios & Co. Ltd

Fluticapen

Fluticasone Propionate 500 μg Dose

Inhalation Powder, Pre-Dispensed

Cyprus

Costakis Tsisios & Co. Ltd

Pulmoton

Budesonide 100 μg Dose, Formoterol Fumarate Dihydrate 6 μg Dose

Inhalation Powder, Pre-Dispensed

Cyprus

Costakis Tsisios & Co. Ltd

Pulmoton

Budesonide 200 μg Dose, Formoterol Fumarate Dihydrate 6 μg Dose

Inhalation Powder, Pre-Dispensed

Cyprus

Costakis Tsisios & Co. Ltd

Pulmoton

Budesonide 400 μg Dose, Formoterol Fumarate Dihydrate 12 μg Dose

Inhalation Powder, Pre-Dispensed

Cyprus

Costakis Tsisios & Co. Ltd

Rolenium

Fluticasone Propionate 100 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Cyprus

Costakis Tsisios & Co. Ltd

Rolenium

Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Cyprus

Costakis Tsisios & Co. Ltd

Rolenium

Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Cyprus

Glaxo Group Limited

Flixotide Diskus

Fluticasone Propionate 100 μg Dose

Inhalation Powder

Cyprus

Glaxo Group Limited

Flixotide Diskus

Fluticasone Propionate 250 μg Dose

Inhalation Powder

Cyprus

Glaxo Group Limited

Seretide

Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose

Inhalation Powder, Pre-Dispensed

Cyprus

Orion Corporation

Bufomix Easyhaler

Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate Ph.Eur. 4,5  μg Dose

Inhalation Powder

Cyprus

Orion Corporation

Bufomix Easyhaler

Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate Ph.Eur. 9 μg Dose

Inhalation Powder

Cyprus

Orion Corporation

Orest Easyhaler

Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate Ph.Eur. 4,5  μg Dose

Inhalation Powder

Cyprus

Orion Corporation

Orest Easyhaler

Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate Ph.Eur. 9 μg Dose

Inhalation Powder

Czech Republic

Astrazeneca Ab

Symbicort Turbuhaler

Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose

Inhalation Powder

Czech Republic

Astrazeneca Ab

Symbicort Turbuhaler

Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose

Inhalation Powder

Czech Republic

Chiesi Pharmaceuticals Gmbh

Combair

Formoterol Fumarate Dihydrate 1,08 Mg, Beclometasone Dipropionate 18 Mg

Pressurised Inhalation, Solution

Czech Republic

Elpen Pharmaceutical Co. Inc.

Dimenium

Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Czech Republic

Elpen Pharmaceutical Co. Inc.

Dimenium

Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Czech Republic

Glaxo Group Limited

Flixotide

Fluticasone Propionate 125 μg

Pressurised Inhalation, Suspension

Czech Republic

Glaxo Group Limited

Flixotide

Fluticasone Propionate 250 μg

Pressurised Inhalation, Suspension

Czech Republic

Glaxo Group Limited

Flixotide

Fluticasone Propionate 50 μg

Pressurised Inhalation, Suspension

Czech Republic

Glaxo Group Limited

Flixotide Diskus

Fluticasone Propionate 100 μg

Inhalation Powder

Czech Republic

Glaxo Group Limited

Flixotide Diskus

Fluticasone Propionate 250 μg

Inhalation Powder

Czech Republic

Glaxo Group Limited

Flixotide Diskus

Fluticasone Propionate 500 μg

Inhalation Powder

Czech Republic

Glaxo Group Limited

Seretide Diskus

Fluticasone Propionate 500 μg, Salmeterol Xinafoate 72,5  μg

Inhalation Powder

Czech Republic

Sandoz S.R.O.

Airflusan Forspiro

Fluticasone Propionate 0,25 Mg, Salmeterol Xinafoate 0,073 Mg

Inhalation Powder, Pre-Dispensed

Czech Republic

Sandoz S.R.O.

Airflusan Forspiro

Fluticasone Propionate 0,5 Mg, Salmeterol Xinafoate 0,073 Mg

Inhalation Powder, Pre-Dispensed

Denmark

Astrazeneca A-S

Symbicort Forte Turbuhaler

Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose

Inhalation Powder

Denmark

Astrazeneca A-S

Symbicort Turbuhaler

Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose

Inhalation Powder

Denmark

Chiesi Farmaceutici S.P.A.

Innovair

Beclometasone Dipropionate 100 μg Actuation, Formoterol Fumarate Dihydrate 6 μg Actuation

Pressurised Inhalation, Solution

Denmark

Elpen Pharmaceutical Co. Inc.

Flusaterol

Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Denmark

Elpen Pharmaceutical Co. Inc.

Flusaterol

Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose, Lactose Monohydrate 24,677  mg Dose

Inhalation Powder, Pre-Dispensed

Denmark

Glaxosmithkline Pharma A-S

Seretide

Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose

Inhalation Powder, Pre-Dispensed

Denmark

Orion Oyj

Bufomix Easyhaler

Budesonide 160 μg Inhalation, Formoterol Fumarate Dihydrate 4,5  μg Inhalation

Inhalation Powder

Denmark

Orion Oyj

Bufomix Easyhaler

Budesonide 320 μg Inhalation, Formoterol Fumarate Dihydrate 9 μg Inhalation

Inhalation Powder

Denmark

Sandoz A-S

Airflusal Forspiro

Fluticasone Propionate 233 μg Dose, Salmeterol 45 μg Dose

Inhalation Powder, Pre-Dispensed

Denmark

Sandoz A-S

Airflusal Forspiro

Fluticasone Propionate 465 μg Dose, Salmeterol 45 μg Dose

Inhalation Powder, Pre-Dispensed

Estonia

Astrazeneca Ab

Symbicort Turbuhaler

Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose

Inhalation Powder

Estonia

Astrazeneca Ab

Symbicort Turbuhaler

Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose

Inhalation Powder

Estonia

Chiesi Pharmaceuticals Gmbh

Foster

Beclometasone Dipropionate 100 μg Actuation, Formoterol Fumarate Dihydrate 6 μg Actuation

Pressurised Inhalation, Solution

Estonia

Elpen Pharmaceutical Co. Inc.

Flusamer

Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Estonia

Elpen Pharmaceutical Co. Inc.

Flusamer

Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Estonia

Glaxo Wellcome Ltd

Flixotide Diskus

Fluticasone Propionate 250 μg Dose

Inhalation Powder

Estonia

Glaxo Wellcome Ltd

Seretide Diskus

Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Estonia

Sandoz Pharmaceuticals D.D.

Airflusal Forspiro

Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Estonia

Sandoz Pharmaceuticals D.D.

Airflusal Forspiro

Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Finland

Astrazeneca Oy

Symbicort Forte Turbuhaler

Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose

Inhalation Powder

Finland

Astrazeneca Oy

Symbicort Turbuhaler

Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose

Inhalation Powder

Finland

Chiesi Farmaceutici S.P.A.

Innovair

Beclometasone Dipropionate 100 μg Actuation, Formoterol Fumarate Dihydrate 6 μg Actuation

Pressurised Inhalation, Solution

Finland

Chiesi Farmaceutici S.P.A.

Innovair Nexthaler

Formoterol Fumarate Dihydrate 6 μg Dose, Beclometasone Dipropionate Anhydrous 100 μg Dose

Inhalation Powder

Finland

Elpen Pharmaceutical Co. Inc.

Salmeson

Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Finland

Elpen Pharmaceutical Co. Inc.

Salmeson

Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Finland

Glaxosmithkline Oy

Seretide Diskus

Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose

Inhalation Powder, Pre-Dispensed

Finland

Orion Oyj

Bufomix Easyhaler

Budesonide 160 μg Inhalation, Formoterol Fumarate Dihydrate 4,5  μg Inhalation

Inhalation Powder

Finland

Orion Oyj

Bufomix Easyhaler

Budesonide 320 μg Inhalation, Formoterol Fumarate Dihydrate 9 μg Inhalation

Inhalation Powder

France

Astrazeneca France

Symbicort Turbuhaler

Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose

Inhalation Powder

France

Astrazeneca France

Symbicort Turbuhaler

Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose

Inhalation Powder

France

Chiesi S.A.

Formodual

Formoterol Fumarate Dihydrate 6 μg Dose, Beclometasone Dipropionate Anhydrous 100 μg Dose

Pressurised Inhalation, Solution

France

Chiesi S.A.

Innovair

Formoterol Fumarate Dihydrate 6 μg Dose, Beclometasone Dipropionate Anhydrous 100 μg Dose

Pressurised Inhalation, Solution

France

Laboratoire Glaxosmithkline S.A.S.

Seretide Diskus

Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Germany

3m Health Care Ltd

Bronchocort Novo

Beclometasone Dipropionate 100 μg/50 μl

Pressurised Inhalation, Solution

Germany

3m Health Care Ltd

Junik

Beclometasone Dipropionate 100 μg Actuation

Pressurised Inhalation, Solution

Germany

Abz-Pharma Gmbh

Beclomethasone Dipropionate Ct

Beclometasone Dipropionate 0,05  mg/18,7 G

Pressurised Inhalation, Solution

Germany

Meda Pharma Gmbh & Co. Kg

Budecort Novolizer

Budesonide, Micronised 0,2  mg Actuation

Inhalation Powder

Germany

Meda Pharma Gmbh & Co. Kg

Budecort Novolizer

Budesonide, Micronised 0,4  mg 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 400 μg Dose

Inhalation Powder

Germany

Astrazeneca Gmbh

Pulmicort Turbohaler

Budesonide 200 μg Dose

Inhalation Powder

Germany

Astrazeneca Gmbh

Symbicort Turbohaler

Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose

Inhalation Powder

Germany

Astrazeneca Gmbh

Symbicort Turbohaler

Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose

Inhalation Powder

Germany

Chiesi Farmaceutici S.P.A.

Kantos

Beclometasone Dipropionate 100 μg Actuation, Formoterol Fumarate Dihydrate 6 μg Actuation

Pressurised Inhalation, Solution

Germany

Chiesi Farmaceutici S.P.A.

Kantos Master

Beclometasone Dipropionate 100 μg Actuation, Formoterol Fumarate Dihydrate 6 μg Actuation

Pressurised Inhalation, Solution

Germany

Chiesi Gmbh

Budiair

Budesonide 200 μg Spray

Pressurised Inhalation, Solution

Germany

Chiesi Gmbh

Foster

Beclometasone Dipropionate 100 μg Actuation, Formoterol Fumarate Dihydrate 6 μg Actuation

Pressurised Inhalation, Solution

Germany

Chiesi Gmbh

Ribuvent

Budesonide 200 μg Puff

Pressurised Inhalation, Solution

Germany

Chiesi Gmbh

Sanasthmax

Beclometasone Dipropionate 250 μg/59,2 Mg

Pressurised Inhalation, Solution

Germany

Chiesi Gmbh

Sanasthmax Junior

Beclometasone Dipropionate 50 μg/59 Mg

Pressurised Inhalation, Solution

Germany

Elpen Pharmaceutical Co. Inc.

Flusalio

Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Germany

Elpen Pharmaceutical Co. Inc.

Flusalio

Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Germany

Elpen Pharmaceutical Co. Inc.

Rolenium

Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Germany

Elpen Pharmaceutical Co. Inc.

Rolenium

Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Germany

Glaxosmithkline Gmbh & Co. Kg

Flixotide Diskus

Fluticasone Propionate 250 μg Dose

Inhalation Powder

Germany

Glaxosmithkline Gmbh & Co. Kg

Flixotide Forte

Fluticasone Propionate 250 μg Inhalation

Pressurised Inhalation, Suspension

Germany

Glaxosmithkline Gmbh & Co. Kg

Flixotide Forte Diskus

Fluticasone Propionate 500 μg Dose

Inhalation Powder

Germany

Glaxosmithkline Gmbh & Co. Kg

Flutide Diskus

Fluticasone Propionate 250 μg Dose

Inhalation Powder, Pre-Dispensed

Germany

Glaxosmithkline Gmbh & Co. Kg

Flutide Forte

Fluticasone Propionate 220 μg Puff

Pressurised Inhalation, Suspension

Germany

Glaxosmithkline Gmbh & Co. Kg

Flutide Forte Diskus

Fluticasone Propionate 500 μg Dose

Inhalation Powder, Pre-Dispensed

Germany

Glaxosmithkline Gmbh & Co. Kg

Viani Forte

Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose

Inhalation Powder, Pre-Dispensed

Germany

Heumann Pharma Gmbh & Co. Generica Kg

Budesonid

Budesonide 0,2 Mg

Inhalation Powder

Germany

Hexal Ag

Airflusal Forspiro

Salmeterol Xinafoate 50 μg Dose, Fluticasone 500 μg Dose

Inhalation Powder

Germany

Hexal Ag

Budes N

Budesonide 0,2  mg Dose

Pressurised Inhalation, Solution

Germany

Janssen-Cilag Gmbh

Inuvair

Beclometasone Dipropionate 100 μg Inhalation, Formoterol Fumarate 6 μg Inhalation

Pressurised Inhalation, Solution

Germany

Meda Pharma Gmbh & Co. Kg

Budesonid Novolizer Meda Pharma Gmbh & Co. Kg

Budesonide 400 μg Inhalation

Inhalation Powder

Germany

Meda Pharma Gmbh & Co. Kg

Novopulmon Novolizer

Budesonide 200 μg Dose

Inhalation Powder

Germany

Meda Pharma Gmbh & Co. Kg

Novopulmon Novolizer

Budesonide 400 μg Dose

Inhalation Powder

Germany

Mylan Dura Gmbh

Budesonid Mylan

Budesonide 0,2 Mg

Inhalation Powder

Germany

Orion Corporation

Beclomet Easyhaler

Beclometasone Dipropionate 0,2  mg Dose

Inhalation Powder

Germany

Pari Pharma Gmbh

Buparid

Budesonide 0,25  mg Ampoule

Nebuliser Suspension

Germany

Pari Pharma Gmbh

Buparid

Budesonide 0,5  mg Ampoule

Nebuliser Suspension

Germany

Pari Pharma Gmbh

Buparid

Budesonide 1 mg Ampoule

Nebuliser Suspension

Germany

Pb Pharma Gmbh

Budesonid

Budesonide 0,92 Mg

Inhalation Powder, Hard Capsule

Germany

Pb Pharma Gmbh

Cyclocaps Beclometason

Beclometasone Dipropionate 100 μg Units

Inhalation Powder, Hard Capsule

Germany

Pb Pharma Gmbh

Cyclocaps Beclometason

Beclometasone Dipropionate 200 μg Units

Inhalation Powder, Hard Capsule

Germany

Pb Pharma Gmbh

Cyclocaps Beclometason

Beclometasone Dipropionate 400 μg Units

Inhalation Powder, Hard Capsule

Germany

Pb Pharma Gmbh

Cyclocaps Budesonid

Budesonide 0,8  mg Capsule

Inhalation Powder, Hard Capsule

Germany

Pb Pharma Gmbh

Cyclocaps Budesonid

Budesonide 100 μg Units

Inhalation Powder, Hard Capsule

Germany

Pb Pharma Gmbh

Cyclocaps Budesonid

Budesonide 800 μg Units

Inhalation Powder, Hard Capsule

Germany

Ratiopharm Gmbh

Beclometason Ratiopharm

Beclometasone Dipropionate 0,25  mg/18,7  g

Pressurised Inhalation, Solution

Germany

Ratiopharm Gmbh

Beclomethasone Dipropionate Ratiopharm

Beclometasone Dipropionate 0,05  mg/18,7  g

Pressurised Inhalation, Solution

Germany

Ratiopharm Gmbh

Beclomethasone Dipropionate Ratiopharm

Beclometasone Dipropionate 0,1  mg/18,7  g

Pressurised Inhalation, Solution

Germany

Ratiopharm Gmbh

Beclomethasone Dipropionate Ratiopharm

Beclometasone Dipropionate 0,2  mg/18,7  g

Pressurised Inhalation, Solution

Germany

Teva Gmbh

Aerobec N

Beclometasone Dipropionate 100 g/5ml

Pressurised Inhalation, Solution

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 100 g/10ml

Pressurised Inhalation, Solution

Germany

Teva Gmbh

Ventolair

Beclometasone Dipropionate 100 g/18,7  g

Pressurised Inhalation, Solution

Germany

Teva Gmbh

Ventolair

Beclometasone Dipropionate 100 g/5ml

Pressurised Inhalation, Solution

Germany

Teva Gmbh

Ventolair

Beclometasone Dipropionate 250 g/18,7  g

Pressurised Inhalation, Solution

Germany

Teva Gmbh

Ventolair

Beclometasone Dipropionate 250 g/78 mg

Pressurised Inhalation, Solution

Germany

Teva Gmbh

Ventolair Mite

Beclometasone Dipropionate 50 g/18,7  g

Pressurised Inhalation, Solution

Germany

Teva Gmbh

Ventolair Mite

Beclometasone Dipropionate 50 g/78 mg

Pressurised Inhalation, Solution

Germany

Ucb Pharma Gmbh (Monheim De)

Atmadisc Forte Diskus

Fluticasone Propionate 500 μg Inhalation, Salmeterol 50 μg Inhalation

Inhalation Powder

Greece

Anfarm Hellas Sa

Talgan

Budesonide 100 μg Dose

Inhalation Powder

Greece

Astrazeneca S.A.

Pulmicort Turbuhaler

Budesonide 100 μg Dose

Inhalation Powder

Greece

Astrazeneca S.A.

Pulmicort Turbuhaler

Budesonide 200 μg Dose

Inhalation Powder

Greece

Astrazeneca S.A.

Pulmicort Turbuhaler

Budesonide 400 μg Dose

Inhalation Powder

Greece

Astrazeneca S.A.

Symbicort Turbuhaler

Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose

Inhalation Powder

Greece

Astrazeneca S.A.

Symbicort Turbuhaler

Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose

Inhalation Powder

Greece

Chiesi Hellas A.E.B.E.

Foster

Beclometasone Dipropionate 100 μg Actuation, Formoterol Fumarate Dihydrate 6 μg Actuation

Pressurised Inhalation, Solution

Greece

Chiesi Hellas A.E.B.E.

Foster Nexthaler

Formoterol Fumarate Dihydrate 6 μg Dose, Beclometasone Dipropionate Anhydrous 100 μg Dose

Inhalation Powder

Greece

Chiesi Hellas A.E.B.E.

Inuvair

Beclometasone Dipropionate 100 μg Actuation, Formoterol Fumarate Dihydrate 6 μg Actuation

Pressurised Inhalation, Solution

Greece

Chiesi Hellas A.E.B.E.

Inuvair Nexthaler

Formoterol Fumarate Dihydrate 6 μg Dose, Beclometasone Dipropionate Anhydrous 100 μg 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 250 μg Dose

Inhalation Powder, Pre-Dispensed

Greece

Elpen Pharmaceutical Co. Inc.

Fluticapen

Fluticasone Propionate 500 μg Dose

Inhalation Powder, Pre-Dispensed

Greece

Elpen Pharmaceutical Co. Inc.

Pulmoton

Budesonide 100 μg Dose, Formoterol Fumarate Dihydrate 6 μg Dose

Inhalation Powder, Pre-Dispensed

Greece

Elpen Pharmaceutical Co. Inc.

Pulmoton

Budesonide 200 μg Dose, Formoterol Fumarate Dihydrate 6 μg Dose

Inhalation Powder, Pre-Dispensed

Greece

Elpen Pharmaceutical Co. Inc.

Pulmoton

Budesonide 400 μg Dose, Formoterol Fumarate Dihydrate 12 μg Dose

Inhalation Powder, Pre-Dispensed

Greece

Elpen Pharmaceutical Co. Inc.

Rolenium

Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Greece

Elpen Pharmaceutical Co. Inc.

Rolenium

Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Greece

Glaxosmithkline Aebe

Flixotide

Fluticasone Propionate 100 μg Dose

Inhalation Powder

Greece

Glaxosmithkline Aebe

Flixotide

Fluticasone Propionate 125 μg Dose

Pressurised Inhalation

Greece

Glaxosmithkline Aebe

Flixotide

Fluticasone Propionate 250 μg Dose

Inhalation Powder

Greece

Glaxosmithkline Aebe

Flixotide

Fluticasone Propionate 250 μg Dose

Pressurised Inhalation

Greece

Glaxosmithkline Aebe

Flixotide

Fluticasone Propionate 500 μg Dose

Inhalation Powder

Greece

Glaxosmithkline Aebe

Flixotide

Fluticasone Propionate 50 μg Dose

Pressurised Inhalation

Greece

Glaxosmithkline Aebe

Flixotide Diskus

Fluticasone Propionate 100 μg Dose

Inhalation Powder

Greece

Glaxosmithkline Aebe

Flixotide Diskus

Fluticasone Propionate 250 μg Dose

Inhalation Powder

Greece

Glaxosmithkline Aebe

Flixotide Diskus

Fluticasone Propionate 500 μg Dose

Inhalation Powder

Greece

Glaxosmithkline Aebe

Seretide

Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose

Inhalation Powder, Pre-Dispensed

Greece

Iasis Pharma

Olfo Haler

Budesonide 200 μg Dose

Inhalation Powder

Greece

Iasis Pharma

Olfo Haler

Budesonide 400 μg 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 4,5 mcg

Inhalation Powder

Greece

Orion Corporation

Bufomix

Budosenide 320mcg, Formoterol Fumarate Dihydrate 9mcg

Inhalation Powder

Greece

Orion Corporation

Orest

Budosenide 160mcg, Formoterol Fumarate Dihydrate 4,5 mcg

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 200 μg Dose

Inhalation Powder, Pre-Dispensed

Greece

Rafarm Sa.

Resata

Budesonide 400 μg Dose

Inhalation Powder, Pre-Dispensed

Greece

Verisfield (Uk) Ltd

Flixocort

Fluticasone Propionate 50 μg Dose

Nasal Spray, Suspension

Greece

Verisfield (Uk) Ltd

Flixocort

Fluticasone Propionate 125 μg Dose

Pressurised Inhalation, Suspension

Greece

Verisfield (Uk) Ltd

Flixocort

Fluticasone Propionate 250 μg Dose

Pressurised Inhalation, Suspension

Greece

Verisfield (Uk) Ltd

Pulmihal

Budesonide 200 μg Dose

Inhalation Powder, Pre-Dispensed

Greece

Win Medica Ltd

Flusalair

Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder

Greece

Win Medica Ltd

Flusalair

Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Greece

Win Medica Ltd

Flutiresp

Fluticasone Propionate 250mcg/Dose

Inhalation Powder

Greece

Win Medica Ltd

Flutiresp

Fluticasone Propionate 500 μg Inhalation

Inhalation Powder

Greece

Zwitter Pharmaceuticals επε

Salenga

Fluticasone Propionate 250 μg Dose

Pressurised Inhalation, Suspension

Greece

Pharmanel Commercial Pharmaceutical S.A.

Vernoral

Budesonide 200 μg Dose

Inhalation Powder

Greece

Pharmanel Commercial Pharmaceutical S.A.

Vernoral

Budesonide 400 μg Dose

Inhalation Powder

Hungary

Astrazeneca Kft.

Symbicort Turbuhaler

Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose

Inhalation Powder

Hungary

Astrazeneca Kft.

Symbicort Turbuhaler

Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose

Inhalation Powder

Hungary

Chiesi Pharmaceuticals Gmbh

Formodual

Formoterol Fumarate Dihydrate 6 μg Actuation, Beclometasone Dipropionate Anhydrous 100 μg Actuation

Pressurised Inhalation, Solution

Hungary

Chiesi Pharmaceuticals Gmbh

Foster

Beclometasone Dipropionate 100 μg Actuation, Formoterol Fumarate Dihydrate 6 μg Actuation

Pressurised Inhalation, Solution

Hungary

Elpen Pharmaceutical Co. Inc.

Dimenio

Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder

Hungary

Elpen Pharmaceutical Co. Inc.

Dimenio

Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder

Hungary

Elpen Pharmaceutical Co. Inc.

Flumetor

Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Hungary

Elpen Pharmaceutical Co. Inc.

Flumetor

Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Hungary

Glaxosmithkline Kft.

Seretide Diskus

Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose

Inhalation Powder, Pre-Dispensed

Hungary

Montrose Kft

Thoreus Diskus

Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose

Inhalation Powder, Pre-Dispensed

Hungary

Orion Oyj

Bufomix Easyhaler

Budesonide 160 μg Inhalation, Formoterol Fumarate Dihydrate 4,5  μg Inhalation

Inhalation Powder

Hungary

Orion Oyj

Bufomix Easyhaler

Budesonide 320 μg Inhalation, Formoterol Fumarate Dihydrate 9 μg Inhalation

Inhalation Powder

Hungary

Sandoz Hungária Kft

Airflusol Forspiro

Salmeterol Xinafoate 50 μg Dose, Fluticasone 500 μg Dose

Inhalation Powder

Iceland

Astrazeneca A-S

Symbicort Forte Turbuhaler

Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose

Inhalation Powder

Iceland

Astrazeneca A-S

Symbicort Mite Turbuhaler

Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose

Inhalation Powder

Iceland

Elpen Pharmaceutical Co. Inc.

Relanio

Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Iceland

Elpen Pharmaceutical Co. Inc.

Relanio

Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Iceland

Glaxosmithkline Ehf.

Flixotide

Fluticasone Propionate 250 μg Dose

Pressurised Inhalation, Suspension

Iceland

Glaxosmithkline Ehf.

Flixotide Diskus

Fluticasone Propionate 100 μg Dose

Inhalation Powder

Iceland

Glaxosmithkline Ehf.

Flixotide Diskus

Fluticasone Propionate 250 μg Dose

Inhalation Powder

Iceland

Glaxosmithkline Ehf.

Flixotide Diskus

Fluticasone Propionate 500 μg Dose

Inhalation Powder

Iceland

Glaxosmithkline Ehf.

Seretide Diskus

Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Ireland

Astrazeneca Uk Limited

Pulmicort Turbohaler

Budesonide 100 μg Dose

Inhalation Powder

Ireland

Astrazeneca Uk Limited

Pulmicort Turbohaler

Budesonide 200 μg Dose

Inhalation Powder

Ireland

Astrazeneca Uk Limited

Pulmicort Turbohaler

Budesonide 400 μg Dose

Inhalation Powder

Ireland

Astrazeneca Uk Limited

Symbicort Turbohaler

Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose

Inhalation Powder

Ireland

Astrazeneca Uk Limited

Symbicort Turbohaler

Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose

Inhalation Powder

Ireland

Elpen Pharmaceutical Co. Inc.

Flamerio

Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Ireland

Elpen Pharmaceutical Co. Inc.

Flamerio

Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose, Lactose Monohydrate 24,677  mg Dose

Inhalation Powder, Pre-Dispensed

Ireland

Glaxosmithkline (Ireland) Limited

Flixotide Diskus

Fluticasone Propionate 250 μg Blister

Inhalation Powder, Pre-Dispensed

Ireland

Glaxosmithkline (Ireland) Limited

Flixotide Diskus

Fluticasone Propionate 500 μg Blister

Inhalation Powder, Pre-Dispensed

Ireland

Glaxosmithkline (Ireland) Limited

Flixotide Evohaler

Fluticasone Propionate 250 μg Dose

Pressurised Inhalation, Suspension

Ireland

Glaxosmithkline (Ireland) Limited

Seretide Diskus

Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Ireland

Glaxosmithkline (Ireland) Limited

Viani Diskus

Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Ireland

Orion Oyj

Bufomix Easyhaler

Budesonide 160 μg Inhalation, Formoterol Fumarate Dihydrate 4,5  μg Inhalation

Inhalation Powder

Ireland

Orion Oyj

Bufomix Easyhaler

Budesonide 320 μg Inhalation, Formoterol Fumarate Dihydrate 9 μg Inhalation

Inhalation Powder

Ireland

Rowex Ltd

Airflusal Forspiro

Salmeterol Xinafoate 50 μg Dose, Fluticasone 250 μg Dose

Inhalation Powder

Ireland

Rowex Ltd

Airflusal Forspiro

Salmeterol Xinafoate 50 μg Dose, Fluticasone 500 μg Dose

Inhalation Powder

Italy

Astrazeneca S.P.A

Sinestic

Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose

Inhalation Powder

Italy

Astrazeneca S.P.A

Sinestic

Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose

Inhalation Powder

Italy

Astrazeneca S.P.A

Symbicort

Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose

Inhalation Powder

Italy

Astrazeneca S.P.A

Symbicort

Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose

Inhalation Powder

Italy

Elpen Pharmaceutical Co. Inc.

Flamerio

Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Italy

Elpen Pharmaceutical Co. Inc.

Flamerio

Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Italy

Elpen Pharmaceutical Co. Inc.

Rolenium

Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Italy

Elpen Pharmaceutical Co. Inc.

Rolenium

Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Italy

Glaxosmithkline S.P.A.

Seretide

Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose

Inhalation Powder, Pre-Dispensed

Italy

Menarini International Operations Luxembourg S.A.

Aliflus Diskus

Fluticasone Propionate 100 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Italy

Menarini International Operations Luxembourg S.A.

Aliflus Diskus

Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Italy

Menarini International Operations Luxembourg S.A.

Aliflus Diskus

Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Italy

Promedica S.R.L.

Clenil Compositum

Beclometasone Dipropionate 0,8  mg/2 Ml, Salbutamol Sulfate 1,928  mg/2 Ml

Nebuliser Suspension

Italy

Promedica S.R.L.

Clenil Compositum

Beclometasone Dipropionate 50 μg Actuation, Salbutamol Sulfate 120 μg Actuation

Pressurised Inhalation, Solution

Italy

Simesa S.P.A.

Assieme

Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose

Inhalation Powder

Italy

Simesa S.P.A.

Assieme

Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose

Inhalation Powder

Italy

Valeas S.P.A.

Plenaer

Flunisolide 25 mg Bottle, Salbutamol 10 mg Bottle

Pressurised Inhalation, Suspension

Italy

Valeas S.P.A.

Plenaer

Salbutamol Sulfate 0,602  mg Vial, Flunisolide 0,5  mg Vial

Nebuliser Solution

Latvia

Astrazeneca Ab

Pulmicort Turbuhaler

Budesonide 100 μg Dose

Inhalation Powder

Latvia

Astrazeneca Ab

Pulmicort Turbuhaler

Budesonide 200 μg Dose

Inhalation Powder

Latvia

Astrazeneca Ab

Symbicort Turbuhaler

Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose

Inhalation Powder

Latvia

Astrazeneca Ab

Symbicort Turbuhaler

Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose

Inhalation Powder

Latvia

Chiesi Pharmaceuticals Gmbh

Foster

Beclometasone Dipropionate 100 μg Actuation, Formoterol Fumarate Dihydrate 6 μg Actuation

Pressurised Inhalation, Solution

Latvia

Elpen Pharmaceutical Co. Inc.

Flamerio

Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Latvia

Elpen Pharmaceutical Co. Inc.

Flamerio

Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Latvia

Glaxosmithkline Latvia Sia

Flixotide

Fluticasone Propionate 250 μg Inhalation

Pressurised Inhalation, Suspension

Latvia

Glaxosmithkline Latvia Sia

Flixotide Diskus

Fluticasone Propionate 250 μg Dose

Inhalation Powder

Latvia

Glaxosmithkline Latvia Sia

Flixotide Diskus

Fluticasone Propionate 500 μg Dose

Inhalation Powder

Latvia

Glaxosmithkline Latvia Sia

Flosal

Fluticasone Propionate 250 μg Inhalation, Salmeterol Xinafoate 25 μg Inhalation

Pressurised Inhalation, Suspension

Latvia

Glaxosmithkline Latvia Sia

Flosal

Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose

Inhalation Powder

Latvia

Glaxosmithkline Latvia Sia

Seretide

Fluticasone Propionate 250 μg Inhalation, Salmeterol Xinafoate 25 μg Inhalation

Pressurised Inhalation, Suspension

Latvia

Glaxosmithkline Latvia Sia

Seretide

Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose

Inhalation Powder

Latvia

Novartis Finland Oy

Miflonide

Budesonide 200 μg

Inhalation Powder, Hard Capsule

Latvia

Novartis Finland Oy

Miflonide

Budesonide 400 μg

Inhalation Powder, Hard Capsule

Latvia

Orion Corporation

Bufomix Easyhaler

Budesonide 160 μg Inhalation, Formoterol Fumarate Dihydrate 4,5  μg Inhalation

Inhalation Powder

Latvia

Orion Corporation

Bufomix Easyhaler

Budesonide 320 μg Inhalation, Formoterol Fumarate Dihydrate 9 μg Inhalation

Inhalation Powder

Latvia

Sandoz Pharmaceuticals D.D.

Airflusal Forspiro

Fluticasone Propionate 233 μg Dose, Salmeterol 45 μg Dose

Inhalation Powder, Pre-Dispensed

Latvia

Sandoz Pharmaceuticals D.D.

Airflusal Forspiro

Salmeterol Xinafoate 50 μg Dose, Fluticasone 500 μg Dose

Inhalation Powder, Pre-Dispensed

Lithuania

Astrazeneca Ab

Symbicort Turbuhaler

Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose

Inhalation Powder

Lithuania

Astrazeneca Ab

Symbicort Turbuhaler

Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose

Inhalation Powder

Lithuania

Chiesi Pharmaceuticals Gmbh

Foster

Beclometasone Dipropionate 100 μg Actuation, Formoterol Fumarate Dihydrate 6 μg Actuation

Pressurised Inhalation, Solution

Lithuania

Elpen Pharmaceutical Co. Inc.

Flamerio

Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Lithuania

Elpen Pharmaceutical Co. Inc.

Flamerio

Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Lithuania

Glaxosmithkline Lietuva Uab

Flixotide

Fluticasone Propionate 250 μg Inhalation

Pressurised Inhalation, Suspension

Lithuania

Glaxosmithkline Lietuva Uab

Flixotide Diskus

Fluticasone Propionate 250 μg Dose

Inhalation Powder, Pre-Dispensed

Lithuania

Glaxosmithkline Lietuva Uab

Flixotide Diskus

Fluticasone Propionate 500 μg Dose

Inhalation Powder, Pre-Dispensed

Lithuania

Glaxosmithkline Lietuva Uab

Seretide

Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose

Inhalation Powder, Pre-Dispensed

Lithuania

Novartis Finland Oy

Miflonide

Budesonide 200 μg

Inhalation Powder, Hard Capsule

Lithuania

Novartis Finland Oy

Miflonide

Budesonide 400 μg

Inhalation Powder, Hard Capsule

Lithuania

Orion Oyj

Bufomix Easyhaler

Budesonide 160 μg Inhalation, Formoterol Fumarate Dihydrate 4,5  μg Inhalation

Inhalation Powder

Lithuania

Orion Oyj

Bufomix Easyhaler

Budesonide 160 μg, Formoterol Fumarate Dihydrate 4,5  μg

Inhalation Powder

Lithuania

Orion Oyj

Bufomix Easyhaler

Budesonide 320 μg Inhalation, Formoterol Fumarate Dihydrate 9 μg Inhalation

Inhalation Powder

Lithuania

Orion Oyj

Bufomix Easyhaler

Budesonide 320 μg, Formoterol Fumarate Dihydrate 9 μg

Inhalation Powder

Lithuania

Sandoz Pharmaceuticals D.D.

Airflusal Forspiro

Salmeterol Xinafoate 50 μg Dose, Fluticasone 250 μg Dose

Inhalation Powder

Lithuania

Sandoz Pharmaceuticals D.D.

Airflusal Forspiro

Salmeterol Xinafoate 50 μg Dose, Fluticasone 500 μg Dose

Inhalation Powder

Luxembourg

Chiesi Sa-Nv

Inuvair

Formoterol Fumarate Dihydrate 6 μg Actuation, Beclometasone Dipropionate Anhydrous 100 μg Actuation

Pressurised Inhalation, Solution

Luxembourg

Elpen Pharmaceutical Co. Inc.

Flusamer

Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Luxembourg

Elpen Pharmaceutical Co. Inc.

Flusamer

Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Luxembourg

Glaxosmithkline Pharmaceuticals S.A.

Flixotide

Fluticasone Propionate 250 μg Inhalation

Pressurised Inhalation, Suspension

Luxembourg

Glaxosmithkline Pharmaceuticals S.A.

Flixotide

Fluticasone Propionate 50 μg Inhalation

Pressurised Inhalation, Suspension

Luxembourg

Glaxosmithkline Pharmaceuticals S.A.

Flixotide Diskus

Fluticasone Propionate 100 μg Dose

Inhalation Powder

Luxembourg

Glaxosmithkline Pharmaceuticals S.A.

Flixotide Diskus

Fluticasone Propionate 250 μg Dose

Inhalation Powder

Luxembourg

Glaxosmithkline Pharmaceuticals S.A.

Flixotide Diskus

Fluticasone Propionate 500 μg Dose

Inhalation Powder

Luxembourg

Glaxosmithkline Pharmaceuticals S.A.

Seretide Diskus

Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose

Inhalation Powder

Luxembourg

Nv Astrazeneca Sa

Pulmicort Turbohaler

Budesonide 200 μg Dose

Inhalation Powder

Luxembourg

Nv Astrazeneca Sa

Symbicort Turbohaler

Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose

Inhalation Powder

Luxembourg

Nv Astrazeneca Sa

Symbicort Forte Turbohaler

Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose

Inhalation Powder

Luxembourg

Orion Corporation

Bufomix Easyhaler

Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate Ph.Eur. 4,5  μg Dose

Inhalation Powder

Luxembourg

Orion Corporation

Bufomix Easyhaler

Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate Ph.Eur. 9 μg Dose

Inhalation Powder

Luxembourg

Orion Corporation

Orest Easyhaler

Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate Ph.Eur. 4,5  μg Dose

Inhalation Powder

Luxembourg

Orion Corporation

Orest Easyhaler

Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate Ph.Eur. 9 μg Dose

Inhalation Powder

Malta

Astrazeneca Ab

Pulmicort Turbuhaler

Budesonide 100 μg Dose

Inhalation Powder

Malta

Astrazeneca Ab

Pulmicort Turbuhaler

Budesonide 200 μg Dose

Inhalation Powder

Malta

Astrazeneca Ab

Symbicort Turbohaler

Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose

Inhalation Powder

Malta

Astrazeneca Ab

Symbicort Turbohaler

Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose

Inhalation Powder

Malta

Elpen Pharmaceutical Co. Inc.

Rolenium

Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Malta

Elpen Pharmaceutical Co. Inc.

Rolenium

Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Malta

Glaxosmithkline (Ireland) Limited

Flixotide Evohaler

Fluticasone Propionate 250 μg Dose

Pressurised Inhalation, Suspension

Malta

Glaxosmithkline (Ireland) Limited

Seretide Diskus

Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Malta

Novartis Pharmaceuticals Uk Limited

Miflonide

Budesonide 200 μg Capsule

Inhalation Powder, Hard Capsule

Malta

Novartis Pharmaceuticals Uk Limited

Miflonide

Budesonide 400 μg

Inhalation Powder, Hard Capsule

Malta

Orion Oyj

Bufomix Easyhaler

Budesonide 160 μg Inhalation, Formoterol Fumarate Dihydrate 4,5  μg Inhalation

Inhalation Powder

Malta

Orion Oyj

Bufomix Easyhaler

Budesonide 320 μg Inhalation, Formoterol Fumarate Dihydrate 9 μg Inhalation

Inhalation Powder

Malta

Orion Oyj

Orest Easyhaler

Budesonide 160 μg Inhalation, Formoterol Fumarate Dihydrate 4,5  μg Inhalation

Inhalation Powder

Malta

Orion Oyj

Orest Easyhaler

Budesonide 320 μg Inhalation, Formoterol Fumarate Dihydrate 9 μg Inhalation

Inhalation Powder

Netherlands

Astrazeneca Bv

Symbicort Turbuhaler

Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose

Inhalation Powder

Netherlands

Astrazeneca Bv

Symbicort Turbuhaler

Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose

Inhalation Powder

Netherlands

Glaxosmithkline B.V.

Fluticasonpropionaat Inhalator GSK

Fluticasone Propionate 125 μg Dose

Aerosol

Netherlands

Glaxosmithkline B.V.

Fluticasonpropionaat Inhalator GSK

Fluticasone Propionate 250 μg Dose

Aerosol

Netherlands

Glaxosmithkline B.V.

Fluticasonpropionaat Inhalator GSK

Fluticasone Propionate 50 μg Dose

Aerosol

Netherlands

Chiesi Pharmaceuticals B.V.

Formodual

Formoterol Fumarate Dihydrate 6 μg Actuation, Beclometasone Dipropionate Anhydrous 100 μg Actuation

Pressurised Inhalation, Solution

Netherlands

Chiesi Pharmaceuticals B.V.

Foster

Beclometasone Dipropionate 100 μg Actuation, Formoterol Fumarate Dihydrate 6 μg Actuation

Pressurised Inhalation, Solution

Netherlands

Elpen Pharmaceutical Co. Inc.

Salmeterol/Fluticasonpropionaat Elpen

Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Netherlands

Elpen Pharmaceutical Co. Inc.

Salmeterol/Fluticasonpropionaat Elpen

Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Netherlands

Glaxosmithkline B.V.

Flixotide

Fluticasone Propionate 250 μg Inhalation

Pressurised Inhalation, Suspension

Netherlands

Glaxosmithkline B.V.

Flixotide Diskus

Fluticasone Propionate 500 μg Dose

Inhalation Powder, Pre-Dispensed

Netherlands

Glaxosmithkline B.V.

Seretide

Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose

Inhalation Powder, Pre-Dispensed

Norway

Astrazeneca As

Symbicort Forte Turbuhaler

Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose

Inhalation Powder

Norway

Astrazeneca As

Symbicort Turbuhaler

Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose

Inhalation Powder

Norway

Chiesi Farmaceutici S.P.A.

Inuxair

Beclometasone Dipropionate 100 μg Actuation, Formoterol Fumarate Dihydrate 6 μg Actuation

Pressurised Inhalation, Solution

Norway

Elpen Pharmaceutical Co. Inc.

Salmeson

Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Norway

Elpen Pharmaceutical Co. Inc.

Salmeson

Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Norway

Glaxosmithkline As

Seretide Diskus

Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose

Inhalation Powder, Pre-Dispensed

Norway

Sandoz A-S

Airflusal Forspiro

Salmeterol Xinafoate 50 μg Dose, Fluticasone Propionate 250 μg Dose

Inhalation Powder

Norway

Sandoz A-S

Airflusal Forspiro

Salmeterol Xinafoate 50 μg Dose, Fluticasone Propionate 500 μg Dose

Inhalation Powder

Poland

Adamed Sp. Z O.O.

Flutixon

Fluticasone Propionate 125 μg Capsule

Inhalation Powder, Hard Capsule

Poland

Adamed Sp. Z O.O.

Flutixon

Fluticasone Propionate 250 μg Capsule

Inhalation Powder, Hard Capsule

Poland

Astrazeneca Ab

Pulmicort Turbuhaler

Budesonide 100 μg Dose

Inhalation Powder

Poland

Astrazeneca Ab

Pulmicort Turbuhaler

Budesonide 200 μg Dose

Inhalation Powder

Poland

Astrazeneca Ab

Symbicort Turbuhaler

Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose

Inhalation Powder

Poland

Astrazeneca Ab

Symbicort Turbuhaler

Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose

Inhalation Powder

Poland

Celon Pharma S.A.

Salmex

Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose

Inhalation Powder

Poland

Chiesi Pharmaceuticals Gmbh

Formodual

Beclometasone Dipropionate 100 μg Actuation, Formoterol Fumarate Dihydrate 6 μg Actuation

Pressurised Inhalation, Solution

Poland

Chiesi Pharmaceuticals Gmbh

Fostex

Beclometasone Dipropionate 100 μg Actuation, Formoterol Fumarate Dihydrate 6 μg Actuation

Pressurised Inhalation, Solution

Poland

Elpen Pharmaceutical Co. Inc.

Salmeson

Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Poland

Elpen Pharmaceutical Co. Inc.

Salmeson

Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Poland

Glaxosmithkline Export Ltd

Flixotide

Fluticasone Propionate 250 μg Dose

Inhalation Powder, Pre-Dispensed

Poland

Glaxosmithkline Export Ltd

Flixotide

Fluticasone Propionate 250 μg Inhalation

Pressurised Inhalation, Suspension

Poland

Glaxosmithkline Export Ltd

Flixotide Dysk

Fluticasone Propionate 50 μg Dose

Inhalation Powder, Pre-Dispensed

Poland

Glaxosmithkline Export Ltd

Seretide Dysk

Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose

Inhalation Powder

Poland

Meda Pharma Gmbh & Co. Kg

Budelin Novolizer

Budesonide 200 μg Dose

Inhalation Powder

Poland

Novartis Poland Sp. Z O. O.

Miflonide

Budesonide 200 μg

Inhalation Powder, Hard Capsule

Poland

Novartis Poland Sp. Z O. O.

Miflonide

Budesonide 400 μg

Inhalation Powder, Hard Capsule

Poland

Orion Corporation

Orest Easyhaler

Budesonide 160 μg Inhalation, Formoterol Fumarate Dihydrate 4,5  μg Inhalation

Inhalation Powder

Poland

Orion Corporation

Orest Easyhaler

Budesonide 320 μg Inhalation, Formoterol Fumarate Dihydrate 9 μg Inhalation

Inhalation Powder

Poland

Polfarmex S.A.

Asaris

Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder

Poland

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

Budezonid Lek-Am

Budesonide 200 μg Inhalation

Inhalation Powder, Hard Capsule

Poland

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

Budezonid Lek-Am

Budesonide 400 μg Inhalation

Inhalation Powder, Hard Capsule

Portugal

Astrazeneca Produtos Farmacêuticos, Lda.

Assieme Turbohaler

Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose

Inhalation Powder

Portugal

Astrazeneca Produtos Farmacêuticos, Lda.

Assieme Turbohaler

Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose

Inhalation Powder

Portugal

Astrazeneca Produtos Farmaceuticos Limitada

Pulmicort Turbohaler

Budesonide 200 μg Dose

Inhalation Powder

Portugal

Astrazeneca Produtos Farmaceuticos Limitada

Pulmicort Turbohaler

Budesonide 400 μg Dose

Inhalation Powder

Portugal

Astrazeneca Produtos Farmacêuticos, Lda.

Symbicort Turbohaler

Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose

Inhalation Powder

Portugal

Astrazeneca Produtos Farmacêuticos, Lda.

Symbicort Turbohaler

Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose

Inhalation Powder

Portugal

Bialfar — Produtos Farmacêuticos, Sociedade Anónima

Brisomax Diskus

Fluticasone Propionate 100 μg Dose, Salmeterol Xinafoate 50 μg Dose

Inhalation Powder, Pre-Dispensed

Portugal

Bialfar — Produtos Farmacêuticos, Sociedade Anónima

Brisomax Diskus

Fluticasone Propionate 250 μg Dose, Salmeterol Xinafoate 50 μg Dose

Inhalation Powder, Pre-Dispensed

Portugal

Bialfar — Produtos Farmacêuticos, Sociedade Anónima

Brisomax Diskus

Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose

Inhalation Powder, Pre-Dispensed

Portugal

Elpen Pharmaceutical Co. Inc.

Dimenium

Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Portugal

Elpen Pharmaceutical Co. Inc.

Dimenium

Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Portugal

Farmoz — Sociedade Técnico Medicinal, S.A.

Budesonida Farmoz

Budesonide 200 μg Dose

Inhalation Powder

Portugal

Farmoz — Sociedade Técnico Medicinal, S.A.

Budesonida Farmoz

Budesonide 400 μg Dose

Inhalation Powder

Portugal

Glaxo Wellcome Farmacêutica, Limitada

Seretaide Diskus

Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose

Inhalation Powder, Pre-Dispensed

Portugal

Glaxosmithkline — Produtos Farmacêuticos, Limitada

Maizar Diskus

Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose

Inhalation Powder, Pre-Dispensed

Portugal

Orion Corporation

Bufomix Easyhaler

Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose

Inhalation Powder

Portugal

Orion Corporation

Bufomix Easyhaler

Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose

Inhalation Powder

Portugal

Orion Corporation

Orest Easyhaler

Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose

Inhalation Powder

Portugal

Orion Corporation

Orest Easyhaler

Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose

Inhalation Powder

Portugal

Pentafarma — Sociedade Tecnico-Medicinal S.A.

Budesonida Tecnicort

Budesonide 200 μg Dose

Inhalation Powder

Portugal

Pentafarma — Sociedade Tecnico-Medicinal S.A.

Budesonida Tecnicort

Budesonide 400 μg Dose

Inhalation Powder

Portugal

Sandoz Farmacêutica, Limitada

Airflusal Forspiro

Fluticasone Propionate 250 μg Dose, Salmeterol Xinafoate 50 μg Dose

Inhalation Powder, Pre-Dispensed

Portugal

Sandoz Farmacêutica, Limitada

Airflusal Forspiro

Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose

Inhalation Powder, Pre-Dispensed

Romania

Astrazeneca Ab

Symbicort Turbuhaler

Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose

Inhalation Powder

Romania

Astrazeneca Ab

Symbicort Turbuhaler

Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose

Inhalation Powder

Romania

Chiesi Pharmaceuticals Gmbh

Foster

Formoterol Fumarate Dihydrate 6 μg Actuation, Beclometasone Dipropionate Anhydrous 100 μg Actuation

Pressurised Inhalation, Solution

Romania

Elpen Pharmaceutical Co. Inc.

Flusamer

Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Romania

Elpen Pharmaceutical Co. Inc.

Flusamer

Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Romania

Glaxo Wellcome Ltd

Flixotide

Fluticasone Propionate 250 μg Inhalation

Pressurised Inhalation, Suspension

Romania

Glaxo Wellcome Ltd

Flixotide Diskus

Fluticasone Propionate 250 μg Dose

Inhalation Powder

Romania

Glaxo Wellcome Ltd

Flixotide Diskus

Fluticasone Propionate 500 μg Dose

Inhalation Powder

Romania

Glaxo Wellcome Ltd

Seretide

Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose

Inhalation Powder, Pre-Dispensed

Romania

Medochemie Romania S.R.L.

Frenolyn

Budesonide, Micronised 200 μg Dose

Inhalation Powder

Romania

Medochemie Romania S.R.L.

Frenolyn

Budesonide, Micronised 400 μg Dose

Inhalation Powder

Romania

Orion Oyj

Bufomix Easyhaler

Budesonide 160 μg Inhalation, Formoterol Fumarate Dihydrate 4,5  μg Inhalation

Inhalation Powder

Romania

Orion Oyj

Bufomix Easyhaler

Budesonide 320 μg Inhalation, Formoterol Fumarate Dihydrate 9 μg Inhalation

Inhalation Powder

Romania

S.C. Sandoz S.R.L.

Airflusal Forspiro

Salmeterol Xinafoate 50 μg Dose, Fluticasone 500 μg Dose

Inhalation Powder

Slovakia

Astrazeneca Ab

Pulmicort Turbohaler

Budesonide 100 μg Dose

Inhalation Powder

Slovakia

Astrazeneca Ab

Pulmicort Turbohaler

Budesonide 200 μg Dose

Inhalation Powder

Slovakia

Astrazeneca Ab

Pulmicort Turbohaler

Budesonide 400 μg Dose

Inhalation Powder

Slovakia

Astrazeneca Ab

Symbicort Turbuhaler

Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose

Inhalation Powder

Slovakia

Astrazeneca Ab

Symbicort Turbuhaler

Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose

Inhalation Powder

Slovakia

Chiesi Pharmaceuticals Gmbh

Foster

Beclometasone Dipropionate 100 μg Actuation, Formoterol Fumarate Dihydrate 6 μg Actuation

Pressurised Inhalation, Solution

Slovakia

Elpen Pharmaceutical Co. Inc.

Dimenium

Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Slovakia

Elpen Pharmaceutical Co. Inc.

Dimenium

Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Slovakia

Elpen Pharmaceutical Co. Inc.

Flumetor

Fluticasone Propionate 250 μg Dose, Salmeterol Xinafoate 50 μg Dose

Inhalation Powder, Pre-Dispensed

Slovakia

Elpen Pharmaceutical Co. Inc.

Flumetor

Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose

Inhalation Powder, Pre-Dispensed

Slovakia

Glaxo Group Limited

Flixotide

Fluticasone Propionate 125 μg Inhalation

Pressurised Inhalation, Suspension

Slovakia

Glaxo Group Limited

Flixotide

Fluticasone Propionate 250 μg Inhalation

Pressurised Inhalation, Suspension

Slovakia

Glaxo Group Limited

Flixotide

Fluticasone Propionate 50 μg Inhalation

Pressurised Inhalation, Suspension

Slovakia

Glaxo Group Limited

Seretide

Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose

Inhalation Powder, Pre-Dispensed

Slovakia

Glaxosmithkline Slovakia S.R.O.

Flixotide Diskus

Fluticasone Propionate 100 μg Dose

Inhalation Powder

Slovakia

Glaxosmithkline Slovakia S.R.O.

Flixotide Diskus

Fluticasone Propionate 250 μg Dose

Inhalation Powder

Slovakia

Glaxosmithkline Slovakia S.R.O.

Flixotide Diskus

Fluticasone Propionate 500 μg Dose

Inhalation Powder

Slovakia

Glaxosmithkline Slovakia S.R.O.

Flixotide Diskus

Fluticasone Propionate 50 μg Dose

Inhalation Powder

Slovakia

Meda Pharma Spol. S R.O.

Budelin Novolizer

Budesonide 200 μg Dose

Inhalation Powder

Slovakia

Novartis, S.R.O.

Miflonid

Budesonide 200 μg

Inhalation Powder, Hard Capsule

Slovakia

Novartis, S.R.O.

Miflonid

Budesonide 400 μg

Inhalation Powder, Hard Capsule

Slovakia

Sandoz Pharmaceuticals D.D.

Airflusal Forspiro

Salmeterol Xinafoate 50 μg Dose, Fluticasone 250 μg Dose

Inhalation Powder

Slovakia

Sandoz Pharmaceuticals D.D.

Airflusal Forspiro

Salmeterol Xinafoate 50 μg Dose, Fluticasone 500 μg Dose

Inhalation Powder

Slovenia

Astrazeneca Ab

Symbicort Turbuhaler

Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose

Inhalation Powder

Slovenia

Astrazeneca Ab

Symbicort Turbuhaler

Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose

Inhalation Powder

Slovenia

Chiesi Pharmaceuticals Gmbh

Formodual

Beclometasone Dipropionate 100 μg Actuation, Formoterol Fumarate Dihydrate 6 μg Actuation

Pressurised Inhalation, Solution

Slovenia

Chiesi Pharmaceuticals Gmbh

Foster

Beclometasone Dipropionate 100 μg Actuation, Formoterol Fumarate Dihydrate 6 μg Actuation

Pressurised Inhalation, Solution

Slovenia

Elpen Pharmaceutical Co. Inc.

Flamerio

Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Slovenia

Elpen Pharmaceutical Co. Inc.

Flamerio

Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Slovenia

Glaxosmithkline D.O.O., Ljubljana

Flixotide

Fluticasone Propionate 250 μg Spray

Pressurised Inhalation, Suspension

Slovenia

Glaxosmithkline D.O.O., Ljubljana

Seretide Diskus

Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose

Inhalation Powder, Pre-Dispensed

Slovenia

Lek Pharmaceuticals D.D. Ljubljana

Airflusan Forspiro

Salmeterol 50 μg Dose, Fluticasone Propionate 500 μg Dose

Inhalation Powder

Slovenia

Meda Pharma Gmbh & Co. Kg

Budelin Novolizer

Budesonide 200 μg Dose

Inhalation Powder, Pre-Dispensed

Spain

Allen Farmaceutica, S.A.

Anasma Accuhaler

Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Spain

Almirall, S.A.

Plusvent

Fluticasone Propionate 50 μg Dose, Salmeterol Xinafoate 25 μg Dose

Pressurised Inhalation, Suspension

Spain

Almirall, S.A.

Plusvent

Fluticasone Propionate 250 μg Dose, Salmeterol Xinafoate 25 μg Dose

Pressurised Inhalation, Suspension

Spain

Almirall, S.A.

Plusvent

Fluticasone Propionate 125 μg Dose, Salmeterol Xinafoate 25 μg Dose

Pressurised Inhalation, Suspension

Spain

Almirall, S.A.

Plusvent

Fluticasone Propionate 100 μg Dose, Salmeterol Xinafoate 50 μg Dose

Inhalation Powder, Pre-Dispensed

Spain

Almirall, S.A.

Plusvent

Fluticasone Propionate 250 μg Dose, Salmeterol Xinafoate 50 μg Dose

Inhalation Powder, Pre-Dispensed

Spain

Almirall, S.A.

Plusvent

Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose

Inhalation Powder, Pre-Dispensed

Spain

Astrazeneca Farmacéutica Spain, S.A.

Pulmicort Turbuhaler

Budesonide 100 μg Dose

Inhalation Powder

Spain

Astrazeneca Farmacéutica Spain, S.A.

Pulmicort Turbuhaler

Budesonide 200 μg Dose

Inhalation Powder

Spain

Astrazeneca Farmacéutica Spain, S.A.

Pulmicort Turbuhaler

Budesonide 400 μg Dose

Inhalation Powder

Spain

Astrazeneca Farmacéutica Spain, S.A.

Symbicort Turbuhaler

Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose

Inhalation Powder

Spain

Astrazeneca Farmacéutica Spain, S.A.

Symbicort Turbuhaler

Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose

Inhalation Powder

Spain

Chiesi España, S.A.

Formodual

Beclometasone Dipropionate 100 μg Actuation, Formoterol Fumarate Dihydrate 6 μg Actuation

Pressurised Inhalation, Solution

Spain

Chiesi España, S.A.

Foster

Beclometasone Dipropionate 100 μg Actuation, Formoterol Fumarate Dihydrate 6 μg Dose

Pressurised Inhalation, Solution

Spain

Glaxosmithkline S.A.

Brisair Accuhaler

Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Spain

Glaxosmithkline S.A.

Brisair Accuhaler

Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose

Inhalation Powder, Pre-Dispensed

Spain

Glaxosmithkline S.A.

Flixotide

Fluticasone Propionate 125 μg Inhalation

Pressurised Inhalation, Suspension

Spain

Glaxosmithkline S.A.

Flixotide

Fluticasone Propionate 250 μg Inhalation

Pressurised Inhalation, Suspension

Spain

Glaxosmithkline S.A.

Flixotide

Fluticasone Propionate 50 μg Inhalation

Pressurised Inhalation, Suspension

Spain

Glaxosmithkline S.A.

Flixotide Accuhaler

Fluticasone Propionate 100 μg Dose

Inhalation Powder

Spain

Glaxosmithkline S.A.

Flixotide Accuhaler

Fluticasone Propionate 250 μg Dose

Inhalation Powder

Spain

Glaxosmithkline S.A.

Flixotide Accuhaler

Fluticasone Propionate 500 μg Dose

Inhalation Powder

Spain

Glaxosmithkline S.A.

Flusonal

Fluticasone Propionate 250 μg Inhalation

Pressurised Inhalation, Suspension

Spain

Glaxosmithkline S.A.

Flusonal

Fluticasone Propionate 50 μg Inhalation

Pressurised Inhalation, Suspension

Spain

Glaxosmithkline S.A.

Flusonal Accuhaler

Fluticasone Propionate 100 μg Dose

Inhalation Powder

Spain

Glaxosmithkline S.A.

Flusonal Accuhaler

Fluticasone Propionate 500 μg Dose

Inhalation Powder

Spain

Glaxosmithkline S.A.

Inalacor

Fluticasone Propionate 250 μg Inhalation

Pressurised Inhalation, Suspension

Spain

Glaxosmithkline S.A.

Inalacor

Fluticasone Propionate 50 μg Dose

Pressurised Inhalation, Suspension

Spain

Glaxosmithkline S.A.

Inalacor Accuhaler

Fluticasone Propionate 100 μg Dose

Inhalation Powder

Spain

Glaxosmithkline S.A.

Inalacor Accuhaler

Fluticasone Propionate 500 μg Dose

Inhalation Powder

Spain

Glaxosmithkline S.A.

Inaladuo Accuhaler

Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose

Inhalation Powder, Pre-Dispensed

Spain

Glaxosmithkline S.A.

Seretide Accuhaler

Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose

Inhalation Powder, Pre-Dispensed

Spain

Laboratorio Tau, S.A.

Rilast Turbuhaler

Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose

Inhalation Powder

Spain

Orion Corporation

Bufomix Easyhaler

Budesonide 160 μg Inhalation, Formoterol Fumarate Dihydrate 4,5  μg Inhalation

Inhalation Powder

Spain

Orion Corporation

Bufomix Easyhaler

Budesonide 320 μg Inhalation, Formoterol Fumarate Dihydrate 9 μg Inhalation

Inhalation Powder

Spain

Orion Corporation

Orest Easyhaler

Budesonide 160 μg Inhalation, Formoterol Fumarate Dihydrate 4,5  μg Inhalation

Inhalation Powder

Spain

Orion Corporation

Orest Easyhaler

Budesonide 320 μg Inhalation, Formoterol Fumarate Dihydrate 9 μg Inhalation

Inhalation Powder

Spain

Smithkline Beecham Farma S.A.

Trialona

Fluticasone Propionate 250 μg Dose

Pressurised Inhalation, Suspension

Spain

Smithkline Beecham Farma S.A.

Trialona

Fluticasone Propionate 50 μg Dose

Pressurised Inhalation, Suspension

Spain

Smithkline Beecham Farma S.A.

Trialona Accuhaler

Fluticasone Propionate 100 μg Dose

Inhalation Powder

Spain

Smithkline Beecham Farma S.A.

Trialona Accuhaler

Fluticasone Propionate 500 μg Dose

Inhalation Powder

Sweden

Astrazeneca Ab

Gardette

Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose

Inhalation Powder

Sweden

Astrazeneca Ab

Gardette Forte

Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose

Inhalation Powder

Sweden

Astrazeneca Ab

Symbicort Forte Turbuhaler

Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose

Inhalation Powder

Sweden

Astrazeneca Ab

Symbicort Turbuhaler

Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose

Inhalation Powder

Sweden

Chiesi Farmaceutici S.P.A.

Innovair

Beclometasone Dipropionate 100 μg Actuation, Formoterol Fumarate Dihydrate 6 μg Actuation

Pressurised Inhalation, Solution

Sweden

Elpen Pharmaceutical Co. Inc.

Flusamer

Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Sweden

Elpen Pharmaceutical Co. Inc.

Flusamer

Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Sweden

Elpen Pharmaceutical Co. Inc.

Flusaterol

Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Sweden

Elpen Pharmaceutical Co. Inc.

Flusaterol

Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Sweden

Elpen Pharmaceutical Co. Inc.

Relanio

Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Sweden

Elpen Pharmaceutical Co. Inc.

Relanio

Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Sweden

Elpen Pharmaceutical Co. Inc.

Salmeson

Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose, Lactose Monohydrate 24,677  mg Dose

Inhalation Powder, Pre-Dispensed

Sweden

Elpen Pharmaceutical Co. Inc.

Salmeson

Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Sweden

Glaxosmithkline Ab

Flutide Diskus

Fluticasone Propionate 250 μg Dose

Inhalation Powder, Pre-Dispensed

Sweden

Glaxosmithkline Ab

Flutide Diskus

Fluticasone Propionate 500 μg Dose

Inhalation Powder, Pre-Dispensed

Sweden

Glaxosmithkline Ab

Seretide Diskus

Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose

Inhalation Powder, Pre-Dispensed

Sweden

Glaxosmithkline Ab

Viani Diskus Forte

Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose

Inhalation Powder, Pre-Dispensed

Sweden

Hexal Ag

Salmeterol/Fluticasone Hexal

Salmeterol Xinafoate 50 μg Dose, Fluticasone 500 μg Dose

Inhalation Powder

Sweden

Orion Corporation

Bufomix Easyhaler

Budesonide 160 μg Inhalation, Formoterol Fumarate Dihydrate 4,5  μg Inhalation

Inhalation Powder

Sweden

Orion Corporation

Bufomix Easyhaler

Budesonide 320 μg Inhalation, Formoterol Fumarate Dihydrate 9 μg Inhalation

Inhalation Powder

Sweden

Orion Corporation

Orest Easyhaler

Budesonide 160 μg Inhalation, Formoterol Fumarate Dihydrate 4,5  μg Inhalation

Inhalation Powder

Sweden

Orion Corporation

Orest Easyhaler

Budesonide 320 μg Inhalation, Formoterol Fumarate Dihydrate 9 μg Inhalation

Inhalation Powder

Sweden

Sandoz A-S

Aesalfluca Forspiro

Salmeterol Xinafoate 50 μg Dose, Fluticasone 500 μg Dose

Inhalation Powder

Sweden

Sandoz A-S

Airflusal Forspiro

Fluticasone Propionate 250 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Sweden

Sandoz A-S

Airflusal Forspiro

Fluticasone Propionate 500 μg Dose, Salmeterol 50 μg Dose

Inhalation Powder, Pre-Dispensed

Sweden

Sandoz A-S

Flaxxone Forspiro

Salmeterol Xinafoate 50 μg Dose, Fluticasone 250 μg Dose

Inhalation Powder

Sweden

Sandoz A-S

Flaxxone Forspiro

Salmeterol Xinafoate 50 μg Dose, Fluticasone 500 μg 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 50 μg Dose, Fluticasone 250 μg Dose

Inhalation Powder

Sweden

Sandoz A-S

Salmetorol/Fluticasone Sandoz

Salmeterol Xinafoate 50 μg Dose, Fluticasone 500 μg Dose

Inhalation Powder

Sweden

Sandoz A-S

Setirenol

Salmeterol Xinafoate 50 μg Dose, Fluticasone 250 μg Dose

Inhalation Powder

Sweden

Sandoz A-S

Setirenol

Salmeterol Xinafoate 50 μg Dose, Fluticasone 500 μg Dose

Inhalation Powder

United Kingdom

Astrazeneca Uk Limited

Symbicort Turbohaler

Budesonide 320 μg Dose, Formoterol Fumarate Dihydrate 9 μg Dose

Inhalation Powder

United Kingdom

Astrazeneca Uk Limited

Symbicort Turbohaler

Budesonide 160 μg Dose, Formoterol Fumarate Dihydrate 4,5  μg Dose

Inhalation Powder

United Kingdom

Chiesi Limited

Formodual

Beclometasone Dipropionate 100 μg Actuation, Formoterol Fumarate Dihydrate 6 μg Actuation

Pressurised Inhalation, Solution

United Kingdom

Chiesi Limited

Fostair

Beclometasone Dipropionate 100 μg Actuation, Formoterol Fumarate Dihydrate 6 μg Actuation

Pressurised Inhalation, Solution

United Kingdom

Glaxo Wellcome Ltd

Seretide

Fluticasone Propionate 100 μg Dose, Salmeterol Xinafoate 50 μg Dose

Inhalation Powder, Pre-Dispensed

United Kingdom

Glaxo Wellcome Ltd

Seretide

Fluticasone Propionate 250 μg Dose, Salmeterol Xinafoate 50 μg Dose

Inhalation Powder, Pre-Dispensed

United Kingdom

Glaxo Wellcome Ltd

Seretide Accuhaler

Fluticasone Propionate 500 μg Dose, Salmeterol Xinafoate 50 μg Dose

Inhalation Powder, Pre-Dispensed

---

ANNEX II

List of the names, pharmaceutical form, strength of the veterinary medicinal product, animal species, route of administration, applicant/marketing authorisation holder in the Member States

| Member State EU/EEA | Applicant/marketing authorisation holder | Name | Strength | Pharmaceutical form | Animal species | Route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| Belgium | Zoetis Belgium SA
  Rue Laid Burniat 1
  1348 Louvain-la-Neuve
  Belgium | CattleMarker IBR Inactivated emulsion for injection for cattle | Each 2 ml dose contains:
  Inactivated gE Bovine Herpes Virus type 1 (BoHV-1), strain Difivac, to induce a geometric mean seroneutralising titre ≥ 5,5 log2 | Emulsion for injection | Cattle | Subcutaneous use |
| Bulgaria | Zoetis Belgium SA
  Rue Laid Burniat 1
  1348 Louvain-la-Neuve
  Belgium | CattleMarker IBR Inactivated emulsion for injection for cattle | Each 2 ml dose contains:
  Inactivated gE Bovine Herpes Virus type 1 (BoHV-1), strain Difivac, to induce a geometric mean seroneutralising titre ≥ 5,5 log2 | Emulsion for injection | Cattle | Subcutaneous use |
| Croatia | Zoetis Belgium SA
  Rue Laid Burniat 1
  1348 Louvain-la-Neuve
  Belgium | CattleMarker IBR Inactivated emulsion for injection for cattle | Each 2 ml dose contains:
  Inactivated gE Bovine Herpes Virus type 1 (BoHV-1), strain Difivac, to induce a geometric mean seroneutralising titre ≥ 5,5 log2 | Emulsion for injection | Cattle | Subcutaneous use |
| France | Zoetis Belgium SA
  Rue Laid Burniat 1
  1348 Louvain-la-Neuve
  Belgium | CattleMarker IBR Inactivated emulsion for injection for cattle | Each 2 ml dose contains:
  Inactivated gE Bovine Herpes Virus type 1 (BoHV-1), strain Difivac, to induce a geometric mean seroneutralising titre ≥ 5,5 log2 | Emulsion for injection | Cattle | Subcutaneous use |
| Germany | Zoetis Belgium SA
  Rue Laid Burniat 1
  1348 Louvain-la-Neuve
  Belgium | CattleMarker IBR Inactivated emulsion for injection for cattle | Each 2 ml dose contains:
  Inactivated gE Bovine Herpes Virus type 1 (BoHV-1), strain Difivac, to induce a geometric mean seroneutralising titre ≥ 5,5 log2 | Emulsion for injection | Cattle | Subcutaneous use |
| Ireland | Zoetis Belgium SA
  Rue Laid Burniat 1
  1348 Louvain-la-Neuve
  Belgium | CattleMarker IBR Inactivated emulsion for injection for cattle | Each 2 ml dose contains:
  Inactivated gE Bovine Herpes Virus type 1 (BoHV-1), strain Difivac, to induce a geometric mean seroneutralising titre ≥ 5,5 log2 | Emulsion for injection | Cattle | Subcutaneous use |
| Italy | Zoetis Belgium SA
  Rue Laid Burniat 1
  1348 Louvain-la-Neuve
  Belgium | CattleMarker IBR Inactivated emulsion for injection for cattle | Each 2 ml dose contains:
  Inactivated gE Bovine Herpes Virus type 1 (BoHV-1), strain Difivac, to induce a geometric mean seroneutralising titre ≥ 5,5 log2 | Emulsion for injection | Cattle | Subcutaneous use |
| The Netherlands | Zoetis Belgium SA
  Rue Laid Burniat 1
  1348 Louvain-la-Neuve
  Belgium | CattleMarker IBR Inactivated emulsion for injection for cattle | Each 2 ml dose contains:
  Inactivated gE Bovine Herpes Virus type 1 (BoHV-1), strain Difivac, to induce a geometric mean seroneutralising titre ≥ 5,5 log2 | Emulsion for injection | Cattle | Subcutaneous use |
| Poland | Zoetis Belgium SA
  Rue Laid Burniat 1
  1348 Louvain-la-Neuve
  Belgium | CattleMarker IBR Inactivated emulsion for injection for cattle | Each 2 ml dose contains:
  Inactivated gE Bovine Herpes Virus type 1 (BoHV-1), strain Difivac, to induce a geometric mean seroneutralising titre ≥ 5,5 log2 | Emulsion for injection | Cattle | Subcutaneous use |
| Portugal | Zoetis Belgium SA
  Rue Laid Burniat 1
  1348 Louvain-la-Neuve
  Belgium | CattleMarker IBR Inactivated emulsion for injection for cattle | Each 2 ml dose contains:
  Inactivated gE Bovine Herpes Virus type 1 (BoHV-1), strain Difivac, to induce a geometric mean seroneutralising titre ≥ 5,5 log2 | Emulsion for injection | Cattle | Subcutaneous use |
| Romania | Zoetis Belgium SA
  Rue Laid Burniat 1
  1348 Louvain-la-Neuve
  Belgium | CattleMarker IBR Inactivated emulsion for injection for cattle | Each 2 ml dose contains:
  Inactivated gE Bovine Herpes Virus type 1 (BoHV-1), strain Difivac, to induce a geometric mean seroneutralising titre ≥ 5,5 log2 | Emulsion for injection | Cattle | Subcutaneous use |
| Slovenia | Zoetis Belgium SA
  Rue Laid Burniat 1
  1348 Louvain-la-Neuve
  Belgium | CattleMarker IBR Inactivated emulsion for injection for cattle | Each 2 ml dose contains:
  Inactivated gE Bovine Herpes Virus type 1 (BoHV-1), strain Difivac, to induce a geometric mean seroneutralising titre ≥ 5,5 log2 | Emulsion for injection | Cattle | Subcutaneous use |
| Spain | Zoetis Belgium SA
  Rue Laid Burniat 1
  1348 Louvain-la-Neuve
  Belgium | CattleMarker IBR Inactivated emulsion for injection for cattle | Each 2 ml dose contains:
  Inactivated gE Bovine Herpes Virus type 1 (BoHV-1), strain Difivac, to induce a geometric mean seroneutralising titre ≥ 5,5 log2 | Emulsion for injection | Cattle | Subcutaneous use |
| United Kingdom | Zoetis Belgium SA
  Rue Laid Burniat 1
  1348 Louvain-la-Neuve
  Belgium | CattleMarker IBR Inactivated emulsion for injection for cattle | Each 2 ml dose contains:
  Inactivated gE Bovine Herpes Virus type 1 (BoHV-1), strain Difivac, to induce a geometric mean seroneutralising titre ≥ 5,5 log2 | Emulsion for injection | Cattle | Subcutaneous use |

Member State EU/EEA

Applicant/marketing authorisation holder

Name

Strength

Pharmaceutical form

Animal species

Route of administration

Belgium

Zoetis Belgium SA

Rue Laid Burniat 1

1348 Louvain-la-Neuve

Belgium

CattleMarker IBR Inactivated emulsion for injection for cattle

Each 2 ml dose contains:

Inactivated gE Bovine Herpes Virus type 1 (BoHV-1), strain Difivac, to induce a geometric mean seroneutralising titre ≥ 5,5 log2

Emulsion for injection

Cattle

Subcutaneous use

Bulgaria

Zoetis Belgium SA

Rue Laid Burniat 1

1348 Louvain-la-Neuve

Belgium

CattleMarker IBR Inactivated emulsion for injection for cattle

Each 2 ml dose contains:

Inactivated gE Bovine Herpes Virus type 1 (BoHV-1), strain Difivac, to induce a geometric mean seroneutralising titre ≥ 5,5 log2

Emulsion for injection

Cattle

Subcutaneous use

Croatia

Zoetis Belgium SA

Rue Laid Burniat 1

1348 Louvain-la-Neuve

Belgium

CattleMarker IBR Inactivated emulsion for injection for cattle

Each 2 ml dose contains:

Inactivated gE Bovine Herpes Virus type 1 (BoHV-1), strain Difivac, to induce a geometric mean seroneutralising titre ≥ 5,5 log2

Emulsion for injection

Cattle

Subcutaneous use

France

Zoetis Belgium SA

Rue Laid Burniat 1

1348 Louvain-la-Neuve

Belgium

CattleMarker IBR Inactivated emulsion for injection for cattle

Each 2 ml dose contains:

Inactivated gE Bovine Herpes Virus type 1 (BoHV-1), strain Difivac, to induce a geometric mean seroneutralising titre ≥ 5,5 log2

Emulsion for injection

Cattle

Subcutaneous use

Germany

Zoetis Belgium SA

Rue Laid Burniat 1

1348 Louvain-la-Neuve

Belgium

CattleMarker IBR Inactivated emulsion for injection for cattle

Each 2 ml dose contains:

Inactivated gE Bovine Herpes Virus type 1 (BoHV-1), strain Difivac, to induce a geometric mean seroneutralising titre ≥ 5,5 log2

Emulsion for injection

Cattle

Subcutaneous use

Ireland

Zoetis Belgium SA

Rue Laid Burniat 1

1348 Louvain-la-Neuve

Belgium

CattleMarker IBR Inactivated emulsion for injection for cattle

Each 2 ml dose contains:

Inactivated gE Bovine Herpes Virus type 1 (BoHV-1), strain Difivac, to induce a geometric mean seroneutralising titre ≥ 5,5 log2

Emulsion for injection

Cattle

Subcutaneous use

Italy

Zoetis Belgium SA

Rue Laid Burniat 1

1348 Louvain-la-Neuve

Belgium

CattleMarker IBR Inactivated emulsion for injection for cattle

Each 2 ml dose contains:

Inactivated gE Bovine Herpes Virus type 1 (BoHV-1), strain Difivac, to induce a geometric mean seroneutralising titre ≥ 5,5 log2

Emulsion for injection

Cattle

Subcutaneous use

The Netherlands

Zoetis Belgium SA

Rue Laid Burniat 1

1348 Louvain-la-Neuve

Belgium

CattleMarker IBR Inactivated emulsion for injection for cattle

Each 2 ml dose contains:

Inactivated gE Bovine Herpes Virus type 1 (BoHV-1), strain Difivac, to induce a geometric mean seroneutralising titre ≥ 5,5 log2

Emulsion for injection

Cattle

Subcutaneous use

Poland

Zoetis Belgium SA

Rue Laid Burniat 1

1348 Louvain-la-Neuve

Belgium

CattleMarker IBR Inactivated emulsion for injection for cattle

Each 2 ml dose contains:

Inactivated gE Bovine Herpes Virus type 1 (BoHV-1), strain Difivac, to induce a geometric mean seroneutralising titre ≥ 5,5 log2

Emulsion for injection

Cattle

Subcutaneous use

Portugal

Zoetis Belgium SA

Rue Laid Burniat 1

1348 Louvain-la-Neuve

Belgium

CattleMarker IBR Inactivated emulsion for injection for cattle

Each 2 ml dose contains:

Inactivated gE Bovine Herpes Virus type 1 (BoHV-1), strain Difivac, to induce a geometric mean seroneutralising titre ≥ 5,5 log2

Emulsion for injection

Cattle

Subcutaneous use

Romania

Zoetis Belgium SA

Rue Laid Burniat 1

1348 Louvain-la-Neuve

Belgium

CattleMarker IBR Inactivated emulsion for injection for cattle

Each 2 ml dose contains:

Inactivated gE Bovine Herpes Virus type 1 (BoHV-1), strain Difivac, to induce a geometric mean seroneutralising titre ≥ 5,5 log2

Emulsion for injection

Cattle

Subcutaneous use

Slovenia

Zoetis Belgium SA

Rue Laid Burniat 1

1348 Louvain-la-Neuve

Belgium

CattleMarker IBR Inactivated emulsion for injection for cattle

Each 2 ml dose contains:

Inactivated gE Bovine Herpes Virus type 1 (BoHV-1), strain Difivac, to induce a geometric mean seroneutralising titre ≥ 5,5 log2

Emulsion for injection

Cattle

Subcutaneous use

Spain

Zoetis Belgium SA

Rue Laid Burniat 1

1348 Louvain-la-Neuve

Belgium

CattleMarker IBR Inactivated emulsion for injection for cattle

Each 2 ml dose contains:

Inactivated gE Bovine Herpes Virus type 1 (BoHV-1), strain Difivac, to induce a geometric mean seroneutralising titre ≥ 5,5 log2

Emulsion for injection

Cattle

Subcutaneous use

United Kingdom

Zoetis Belgium SA

Rue Laid Burniat 1

1348 Louvain-la-Neuve

Belgium

CattleMarker IBR Inactivated emulsion for injection for cattle

Each 2 ml dose contains:

Inactivated gE Bovine Herpes Virus type 1 (BoHV-1), strain Difivac, to induce a geometric mean seroneutralising titre ≥ 5,5 log2

Emulsion for injection

Cattle

Subcutaneous use

---

ANNEX III

List of the names, pharmaceutical forms, strength of the medicinal products, routes of administration, Marketing Authorisation Holders in the Member States

| Member State in EEA | Marketing authorisation holder | Invented name | Strength | Pharmaceutical form | Route of administration | Content (concentration) |
| --- | --- | --- | --- | --- | --- | --- |
| Cyprus | MEDA Pharmaceuticals S.A.
  3, Evritanias Str.
  GR-15231
  Chalandri-Attiki
  Greece | Novantrone | 2 mg/ml | Concentrate for solution for infusion | Intravenous use | 20 mg/10 ml |
| Finland | MEDA Oy
  Vaisalantie 4
  FIN-02130
  Espoo
  Finland | Novantrone | 2 mg/ml | Concentrate for solution for infusion | Intravenous use | 20 mg/10 ml |
| Finland | MEDA Oy
  Vaisalantie 4
  FIN-02130
  Espoo
  Finland | Novantrone | 2 mg/ml | Concentrate for solution for infusion | Intravenous use | 10 mg/5 ml |
| France | MEDA Pharma S.A.S.
  25, Boulevard de l'Amiral Bruix
  F-75016
  Paris
  France | Novantrone 10 mg/5 ml, solution à diluer pour perfusion | 2 mg/ml | Concentrate for solution for infusion | Intravenous use | 20 mg/10 ml |
| France | MEDA Pharma S.A.S.
  25, Boulevard de l'Amiral Bruix
  F-75016
  Paris
  France | Novantrone 20 mg/10 ml, solution à diluer pour perfusion | 2 mg/ml | Concentrate for solution for infusion | Intravenous use | 20 mg/10 ml |
| France | MEDA Pharma S.A.S.
  25, Boulevard de l'Amiral Bruix
  F-75016
  Paris
  France | Elsep 2 mg/ml, solution à diluer pour perfusion | 2 mg/ml | Concentrate for solution for infusion | Intravenous use | 20 mg/10 ml |
| Germany | MEDA Pharma GmbH & Co. KG
  Benzstrasse 1
  61352 Bad Homburg
  Germany | Novantron 10 mg/5 ml | 2 mg/ml | Concentrate for solution for infusion or solution for intrapleural or intraperitoneal use | Intravenous use Intrapleural use
  Intraperitoneal use | 10 mg/5 ml |
| Germany | MEDA Pharma GmbH & Co. KG
  Benzstrasse 1
  61352 Bad Homburg
  Germany | Novantron 20 mg/10 ml | 2 mg/ml | Concentrate for solution for infusion or solution for intrapleural or intraperitoneal use | Intravenous use Intrapleural use
  Intraperitoneal use | 20 mg/10 ml |
| Germany | MEDA Pharma GmbH & Co. KG
  Benzstrasse 1
  61352 Bad Homburg
  Germany | Ralenova 2 mg/ml | 2 mg/ml | Concentrate for solution for infusion | Intravenous use | 20 mg/10 ml |
| Germany | MEDA Pharma GmbH & Co. KG
  Benzstrasse 1
  61352 Bad Homburg
  Germany | Ralenova 2 mg/ml | 2 mg/ml | Concentrate for solution for infusion | Intravenous use | 10 mg/5 ml |
| Greece | MEDA Pharmaceuticals S.A.
  3, Evritanias Str.
  GR-15231
  Chalandri-Attiki
  Greece | Novantrone | 2 mg/ml | Concentrate for solution for infusion | Intravenous use | 20 mg/10 ml |
| Iceland | MEDA AB
  Pipers vag 2A, Box 906
  SE-170 09
  Solna
  Sweden | Novantrone | 2 mg/ml | Concentrate for solution for infusion | Intravenous use | 20 mg/10 ml |
| Iceland | MEDA AB
  Pipers vag 2A, Box 906
  SE-170 09
  Solna
  Sweden | Novantrone | 2 mg/ml | Concentrate for solution for infusion | Intravenous use | 10 mg/5 ml |
| Italy | MEDA Pharma S.p.A.
  Viale Brenta 18
  IT-20139
  Milano
  Italy | Novantrone | 2 mg/ml | Concentrate for solution for infusion | Intravenous use | 10 mg/5 ml |
| Italy | MEDA Pharma S.p.A.
  Viale Brenta 18
  IT-20139
  Milano
  Italy | Novantrone | 2 mg/ml | Concentrate for solution for infusion | Intravenous use | 20 mg/10 ml |
| Norway | MEDA A/S
  Askerveien 61
  NO-1384
  Asker
  Norway | Novantrone | 2 mg/ml | Concentrate for solution for infusion | Intravenous use | 10 mg/5 ml |
| Romania | MEDA Pharma GmbH & Co. KG
  Benzstrasse 1
  61352 Bad Homburg
  Germany | Novantrone | 2 mg/ml | Concentrate for solution for infusion | Intravenous use | 20 mg/10 ml |
| Slovenia | MEDA Pharma GmbH & Co. KG
  Benzstrasse 1
  61352 Bad Homburg
  Germany | Novantrone | 2 mg/ml | Concentrate for solution for injection/infusion | Intravenous use | 20 mg/10 ml |
| Spain | MEDA Pharma S.A.U.
  Edificio Berlin — Parque Empresarial San Fernando, Avda Castilla 2, 2a planta
  E-28830
  SAN FERNANDO DE HENARES (MADRID)
  Spain | Novantrone 20 mg solución inyectable | 2 mg/ml | Concentrate for solution for infusion | Intravenous use | 20 mg/10 ml |
| Sweden | MEDA AB
  Pipers vag 2A, Box 906
  SE-170 09
  Solna
  Sweden | Novantrone | 2 mg/ml | Concentrate for solution for infusion | Intravenous use | 20 mg/10 ml |
| Sweden | MEDA AB
  Pipers vag 2A, Box 906
  SE-170 09
  Solna
  Sweden | Novantrone | 2 mg/ml | Concentrate for solution for infusion | Intravenous use | 10 mg/5 ml |

Member State in EEA

Marketing authorisation holder

Invented name

Strength

Pharmaceutical form

Route of administration

Content (concentration)

Cyprus

MEDA Pharmaceuticals S.A.

3, Evritanias Str.

GR-15231

Chalandri-Attiki

Greece

Novantrone

2 mg/ml

Concentrate for solution for infusion

Intravenous use

20 mg/10 ml

Finland

MEDA Oy

Vaisalantie 4

FIN-02130

Espoo

Finland

Novantrone

2 mg/ml

Concentrate for solution for infusion

Intravenous use

20 mg/10 ml

Finland

MEDA Oy

Vaisalantie 4

FIN-02130

Espoo

Finland

Novantrone

2 mg/ml

Concentrate for solution for infusion

Intravenous use

10 mg/5 ml

France

MEDA Pharma S.A.S.

25, Boulevard de l'Amiral Bruix

F-75016

Paris

France

Novantrone 10 mg/5 ml, solution à diluer pour perfusion

2 mg/ml

Concentrate for solution for infusion

Intravenous use

20 mg/10 ml

France

MEDA Pharma S.A.S.

25, Boulevard de l'Amiral Bruix

F-75016

Paris

France

Novantrone 20 mg/10 ml, solution à diluer pour perfusion

2 mg/ml

Concentrate for solution for infusion

Intravenous use

20 mg/10 ml

France

MEDA Pharma S.A.S.

25, Boulevard de l'Amiral Bruix

F-75016

Paris

France

Elsep 2 mg/ml, solution à diluer pour perfusion

2 mg/ml

Concentrate for solution for infusion

Intravenous use

20 mg/10 ml

Germany

MEDA Pharma GmbH & Co. KG

Benzstrasse 1

61352 Bad Homburg

Germany

Novantron 10 mg/5 ml

2 mg/ml

Concentrate for solution for infusion or solution for intrapleural or intraperitoneal use

Intravenous use Intrapleural use

Intraperitoneal use

10 mg/5 ml

Germany

MEDA Pharma GmbH & Co. KG

Benzstrasse 1

61352 Bad Homburg

Germany

Novantron 20 mg/10 ml

2 mg/ml

Concentrate for solution for infusion or solution for intrapleural or intraperitoneal use

Intravenous use Intrapleural use

Intraperitoneal use

20 mg/10 ml

Germany

MEDA Pharma GmbH & Co. KG

Benzstrasse 1

61352 Bad Homburg

Germany

Ralenova 2 mg/ml

2 mg/ml

Concentrate for solution for infusion

Intravenous use

20 mg/10 ml

Germany

MEDA Pharma GmbH & Co. KG

Benzstrasse 1

61352 Bad Homburg

Germany

Ralenova 2 mg/ml

2 mg/ml

Concentrate for solution for infusion

Intravenous use

10 mg/5 ml

Greece

MEDA Pharmaceuticals S.A.

3, Evritanias Str.

GR-15231

Chalandri-Attiki

Greece

Novantrone

2 mg/ml

Concentrate for solution for infusion

Intravenous use

20 mg/10 ml

Iceland

MEDA AB

Pipers vag 2A, Box 906

SE-170 09

Solna

Sweden

Novantrone

2 mg/ml

Concentrate for solution for infusion

Intravenous use

20 mg/10 ml

Iceland

MEDA AB

Pipers vag 2A, Box 906

SE-170 09

Solna

Sweden

Novantrone

2 mg/ml

Concentrate for solution for infusion

Intravenous use

10 mg/5 ml

Italy

MEDA Pharma S.p.A.

Viale Brenta 18

IT-20139

Milano

Italy

Novantrone

2 mg/ml

Concentrate for solution for infusion

Intravenous use

10 mg/5 ml

Italy

MEDA Pharma S.p.A.

Viale Brenta 18

IT-20139

Milano

Italy

Novantrone

2 mg/ml

Concentrate for solution for infusion

Intravenous use

20 mg/10 ml

Norway

MEDA A/S

Askerveien 61

NO-1384

Asker

Norway

Novantrone

2 mg/ml

Concentrate for solution for infusion

Intravenous use

10 mg/5 ml

Romania

MEDA Pharma GmbH & Co. KG

Benzstrasse 1

61352 Bad Homburg

Germany

Novantrone

2 mg/ml

Concentrate for solution for infusion

Intravenous use

20 mg/10 ml

Slovenia

MEDA Pharma GmbH & Co. KG

Benzstrasse 1

61352 Bad Homburg

Germany

Novantrone

2 mg/ml

Concentrate for solution for injection/infusion

Intravenous use

20 mg/10 ml

Spain

MEDA Pharma S.A.U.

Edificio Berlin — Parque Empresarial San Fernando, Avda Castilla 2, 2a planta

E-28830

SAN FERNANDO DE HENARES (MADRID)

Spain

Novantrone 20 mg solución inyectable

2 mg/ml

Concentrate for solution for infusion

Intravenous use

20 mg/10 ml

Sweden

MEDA AB

Pipers vag 2A, Box 906

SE-170 09

Solna

Sweden

Novantrone

2 mg/ml

Concentrate for solution for infusion

Intravenous use

20 mg/10 ml

Sweden

MEDA AB

Pipers vag 2A, Box 906

SE-170 09

Solna

Sweden

Novantrone

2 mg/ml

Concentrate for solution for infusion

Intravenous use

10 mg/5 ml

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