# Den Europæiske Unions C 277/29.

| | ISSN 1977-0871 |
| --- | --- |
| Den Europæiske Unions
  Tidende | C 277 |
| | |
| Dansk udgave | Meddelelser og oplysninger | 59. årgang29. juli 2016 |

ISSN 1977-0871

Den Europæiske Unions

Tidende

C 277

Dansk udgave

Meddelelser og oplysninger

59. årgang29. juli 2016

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| Informationsnummer | Indhold | Side |
| --- | --- | --- |
| | IV   Oplysninger |
| | OPLYSNINGER FRA DEN EUROPÆISKE UNIONS INSTITUTIONER, ORGANER, KONTORER OG AGENTURER |
| | Europa-Kommissionen |
| 2016/C 277/01 | Oversigt over EU-afgørelser om tilladelse til markedsføring af lægemidler fra 1. juni 2016 til 30. juni 2016(Offentliggjort i henhold til artikel 13 eller artikel 38 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004) | 1 |
| 2016/C 277/02 | Oversigt over EU-afgørelser om tilladelse til markedsføring af lægemidler fra 1. juni 2016 til 30. juni 2016(Afgørelser truffet i henhold til artikel 34 i direktiv 2001/83/EF eller artikel 38 i direktiv 2001/82/EF) | 11 |

Informationsnummer

Indhold

Side

IV   Oplysninger

OPLYSNINGER FRA DEN EUROPÆISKE UNIONS INSTITUTIONER, ORGANER, KONTORER OG AGENTURER

Europa-Kommissionen

2016/C 277/01

Oversigt over EU-afgørelser om tilladelse til markedsføring af lægemidler fra 1. juni 2016 til 30. juni 2016(Offentliggjort i henhold til artikel 13 eller artikel 38 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004)

(Offentliggjort i henhold til artikel 13 eller artikel 38 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004)

1

2016/C 277/02

Oversigt over EU-afgørelser om tilladelse til markedsføring af lægemidler fra 1. juni 2016 til 30. juni 2016(Afgørelser truffet i henhold til artikel 34 i direktiv 2001/83/EF eller artikel 38 i direktiv 2001/82/EF)

(Afgørelser truffet i henhold til artikel 34 i direktiv 2001/83/EF eller artikel 38 i direktiv 2001/82/EF)

11

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| DA | |
| --- | --- |

DA

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IV Oplysninger

OPLYSNINGER FRA DEN EUROPÆISKE UNIONS INSTITUTIONER, ORGANER, KONTORER OG AGENTURER

Europa-Kommissionen

| 29.7.2016 | DA | Den Europæiske Unions Tidende | C 277/1 |
| --- | --- | --- | --- |

29.7.2016

DA

Den Europæiske Unions Tidende

C 277/1

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Oversigt over EU-afgørelser om tilladelse til markedsføring af lægemidler fra 1. juni 2016 til 30. juni 2016

(Offentliggjort i henhold til artikel 13 eller artikel 38 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004 (1))

(2016/C 277/01)

—   Udstedelse af markedsføringstilladelse (artikel 13 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004): Godkendt

| Dato for afgørelser | Lægemidlets navn | INN-navn (International Non-Proprietary Name) | Indehaver af markedsføringstilladelsen | Nummer i EF-registret | Lægemiddelform | ATC-kode (Anatomical Therapeutic Chemical Code) | Dato for notifikation |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 21.6.2016 | Odefsey | emtricitabin/rilpivirin/tenofoviralafenamid | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/16/1112 | Filmovertrukket tablet | J05AR19 | 23.6.2016 |
| 24.6.2016 | Ongentys | opicapon | Bial — Portela & Ca, SA
  À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado, Portugal | EU/1/15/1066 | Kapsler, hårde | Pending | 28.6.2016 |
| 24.6.2016 | Zavicefta | ceftazidim/avibactam | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/16/1109 | Pulver til koncentrat til infusionsvæske, opløsning | J01DD52 | 28.6.2016 |
| 29.6.2016 | Enzepi | Pancreas-pulver | APTALIS PHARMA SAS
  5/6 Place de l’Iris — La Défense 5
  92400 Courbevoie France | EU/1/16/1113 | Enterokapsler, hårde | A09AA02 | 1.7.2016 |

Dato for afgørelser

Lægemidlets navn

INN-navn (International Non-Proprietary Name)

Indehaver af markedsføringstilladelsen

Nummer i EF-registret

Lægemiddelform

ATC-kode (Anatomical Therapeutic Chemical Code)

Dato for notifikation

21.6.2016

Odefsey

emtricitabin/rilpivirin/tenofoviralafenamid

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/16/1112

Filmovertrukket tablet

J05AR19

23.6.2016

24.6.2016

Ongentys

opicapon

Bial — Portela & Ca, SA

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

EU/1/15/1066

Kapsler, hårde

Pending

28.6.2016

24.6.2016

Zavicefta

ceftazidim/avibactam

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/16/1109

Pulver til koncentrat til infusionsvæske, opløsning

J01DD52

28.6.2016

29.6.2016

Enzepi

Pancreas-pulver

APTALIS PHARMA SAS

5/6 Place de l’Iris — La Défense 5

92400 Courbevoie France

EU/1/16/1113

Enterokapsler, hårde

A09AA02

1.7.2016

—   Udstedelse af markedsføringstilladelse (artikel 13 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004): Afslået

| Dato for afgørelser | Lægemidlets navn | Indehaver af markedsføringstilladelsen | Nummer i EF-registret | Dato for notifikation |
| --- | --- | --- | --- | --- |
| 24.6.2016 | Dropcys | Lucane Pharma
  172 rue de Charonne, 75011 Paris, France | | 28.6.2016 |

Dato for afgørelser

Lægemidlets navn

Indehaver af markedsføringstilladelsen

Nummer i EF-registret

Dato for notifikation

24.6.2016

Dropcys

Lucane Pharma

172 rue de Charonne, 75011 Paris, France

28.6.2016

—   Ændring af markedsføringstilladelse (artikel 13 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004): Godkendt

| Dato for afgørelser | Lægemidlets navn | Indehaver af markedsføringstilladelsen | Nummer i EF-registret | Dato for notifikation |
| --- | --- | --- | --- | --- |
| 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 | Zoledronsyre 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 |

Dato for afgørelser

Lægemidlets navn

Indehaver af markedsføringstilladelsen

Nummer i EF-registret

Dato for notifikation

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

Zoledronsyre 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

—   Tilbagekaldelse af markedsføringstilladelse (artikel 13 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004)

| Dato for afgørelser | Lægemidlets navn | Indehaver af markedsføringstilladelsen | Nummer i EF-registret | Dato for notifikation |
| --- | --- | --- | --- | --- |
| 1.6.2016 | Clopidogrel/Acetylsalicylsyre 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 |

Dato for afgørelser

Lægemidlets navn

Indehaver af markedsføringstilladelsen

Nummer i EF-registret

Dato for notifikation

1.6.2016

Clopidogrel/Acetylsalicylsyre 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

—   Udstedelse af markedsføringstilladelse (artikel 38 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004): Godkendt

| Dato for afgørelser | Lægemidlets navn | INN-navn (International Non-Proprietary Name) | Indehaver af markedsføringstilladelsen | Nummer i EF-registret | Lægemiddelform | ATC-kode (Anatomical Therapeutic Chemical Code) | Dato for notifikation |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 21.6.2016 | Sevocalm | sevofluran | Chanelle Pharmaceuticals Manufacturing Limited
  Loughrea, Co. Galway, Ireland | EU/2/16/196 | Væske til inhalationsdamp | Pending | 24.6.2016 |

Dato for afgørelser

Lægemidlets navn

INN-navn (International Non-Proprietary Name)

Indehaver af markedsføringstilladelsen

Nummer i EF-registret

Lægemiddelform

ATC-kode (Anatomical Therapeutic Chemical Code)

Dato for notifikation

21.6.2016

Sevocalm

sevofluran

Chanelle Pharmaceuticals Manufacturing Limited

Loughrea, Co. Galway, Ireland

EU/2/16/196

Væske til inhalationsdamp

Pending

24.6.2016

—   Ændring af markedsføringstilladelse (artikel 38 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004): Godkendt

| Dato for afgørelser | Lægemidlets navn | Indehaver af markedsføringstilladelsen | Nummer i EF-registret | Dato for notifikation |
| --- | --- | --- | --- | --- |
| 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 |

Dato for afgørelser

Lægemidlets navn

Indehaver af markedsføringstilladelsen

Nummer i EF-registret

Dato for notifikation

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

Alle interesserede kan ved henvendelse på nedenstående adresse få tilsendt den offentlige evalueringsrapport om de pågældende lægemidler og de afgørelser, der er truffet vedrørende disse:

| 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)  EUT L 136 af 30.4.2004, s. 1.

---

| 29.7.2016 | DA | Den Europæiske Unions Tidende | C 277/11 |
| --- | --- | --- | --- |

29.7.2016

DA

Den Europæiske Unions Tidende

C 277/11

---

Oversigt over EU-afgørelser om tilladelse til markedsføring af lægemidler fra 1. juni 2016 til 30. juni 2016

(Afgørelser truffet i henhold til artikel 34 i direktiv 2001/83/EF (1) eller artikel 38 i direktiv 2001/82/EF (2))

(2016/C 277/02)

—   Udstedelse, videreførsel eller ændring af en national markedsføringstilladelse

| Dato for afgørelser | Lægemidlets navn/navne | INN-navn (International Non-Proprietary Name) | Indehaver/indehavere af markedsføringstilladelsen | Medlemsstat | Dato for notifikation |
| --- | --- | --- | --- | --- | --- |
| 29.6.2016 | Inhaled corticosteroids | beclomethasone, budesonide, flunisolide, fluticasone propionate, fluticasone furoate | Se bilag I | Se bilag I | 30.6.2016 |
| 10.6.2016 | CattleMarker IBR Inactivated emulsion for injec | Inactivated gE Bovine Herpes Virus type 1 (BoHv-1), strain Difivac | Se bilag II | Se bilag II | 13.6.2016 |
| 24.6.2016 | Novantrone and associated names | mitoxantrone | Se bilag III | Se bilag III | 27.6.2016 |
| 24.6.2016 | Irbesartan | Irbesartan | Ikke relevant | Ikke relevant | 27.6.2016 |
| 29.6.2016 | Zoledronic acid | Zoledronic acid | Ikke relevant | Ikke relevant | 30.6.2016 |

Dato for afgørelser

Lægemidlets navn/navne

INN-navn (International Non-Proprietary Name)

Indehaver/indehavere af markedsføringstilladelsen

Medlemsstat

Dato for notifikation

29.6.2016

Inhaled corticosteroids

beclomethasone, budesonide, flunisolide, fluticasone propionate, fluticasone furoate

Se bilag I

Se bilag I

30.6.2016

10.6.2016

CattleMarker IBR Inactivated emulsion for injec

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

Se bilag II

Se bilag II

13.6.2016

24.6.2016

Novantrone and associated names

mitoxantrone

Se bilag III

Se bilag III

27.6.2016

24.6.2016

Irbesartan

Irbesartan

Ikke relevant

Ikke relevant

27.6.2016

29.6.2016

Zoledronic acid

Zoledronic acid

Ikke relevant

Ikke relevant

30.6.2016

---

(1)  EFT L 311 af 28.11.2001, s. 67.

(2)  EFT L 311 af 28.11.2001, s. 1.

---

BILAG I

Liste over nationalt godkendte lægemidler

| Medlemsstat i EØS | Indehaver af markedsføringstilladelsen | Lægemidlets navn | Aktivt stof og styrke | Lægemiddelform |
| --- | --- | --- | --- | --- |
| Østrig | 3m Health Care Ltd | Aerocortin | Beclometason dipropionat 50 μg/50 μl | Inhalationsspray, opløsning |
| Østrig | Allen Pharmazeutika Gesellschaft M.B.H. | Fluticasonpropionat | Fluticasonpropionat 50 μg dosis | Inhalationsspray, suspension |
| Østrig | Allen Pharmazeutika Gesellschaft M.B.H. | Fluticasonpropionat Diskus Forte Allen | Fluticasonpropionat 500 μg dosis | Inhalationspulver |
| Østrig | Allen Pharmazeutika Gesellschaft M.B.H. | Fluticasonpropionat Diskus Junior Allen | Fluticasonpropionat 100 μg dosis | Inhalationspulver |
| Østrig | Allen Pharmazeutika Gesellschaft M.B.H. | Fluticasonpropionat »allen« | Fluticasonpropionat 125 μg dosis | Inhalationsspray, suspension |
| Østrig | Allen Pharmazeutika Gesellschaft M.B.H. | Fluticasonpropionat »allen« | Fluticasonpropionat 250 μg dosis | Inhalationspulver |
| Østrig | Allen Pharmazeutika Gesellschaft M.B.H. | Fluticasonpropionat »allen« | Fluticasonpropionat 250 μg dosis | Inhalationsspray, suspension |
| Østrig | Allen Pharmazeutika Gesellschaft M.B.H. | Samtoral Diskus Standard | Fluticasonpropionat 250 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Østrig | Astrazeneca österreich Gmbh | Pulmicort | Budesonid 400 μg dosis | Inhalationspulver |
| Østrig | Astrazeneca österreich Gmbh | Pulmicort Turbohaler | Budesonid 100 μg dosis | Inhalationspulver |
| Østrig | Astrazeneca österreich Gmbh | Pulmicort Turbohaler | Budesonid 200 μg dosis | Inhalationspulver |
| Østrig | Astrazeneca österreich Gmbh | Pulmicort Turbohaler | Budesonid 400 μg dosis | Inhalationspulver |
| Østrig | Astrazeneca österreich Gmbh | Symbicort Forte Turbohaler | Budesonid 320 μg dosis, formoterolfumaratdihydrat 9 μg dosis | Inhalationspulver |
| Østrig | Astrazeneca österreich Gmbh | Symbicort Turbohaler | Budesonid 160 μg dosis, formoterolfumaratdihydrat 4,5 μg dosis | Inhalationspulver |
| Østrig | Chiesi Pharmaceuticals Gmbh | Budiair | Budesonid 0,2  mg/0,05  ml | Inhalationsspray, opløsning |
| Østrig | Chiesi Pharmaceuticals Gmbh | Budiair Jet | Budesonid 0,2  mg/0,05  ml | Inhalationsspray, opløsning |
| Østrig | Chiesi Pharmaceuticals Gmbh | Foster | Beclometasondipropionat 100 μg aktivering, formoterolfumaratdihydrat 6 μg aktivering | Inhalationsspray, opløsning |
| Østrig | Elpen Pharmaceutical Co. Inc. | Salmeson | Fluticasonpropionat 250 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Østrig | Elpen Pharmaceutical Co. Inc. | Salmeson | Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Østrig | Glaxosmithkline Pharma Gmbh. | Flixotide | Fluticasonpropionat 125 μg inhalation | Inhalationsspray, suspension |
| Østrig | Glaxosmithkline Pharma Gmbh. | Flixotide | Fluticasonpropionat 250 μg dosis | Inhalationspulver, afdelt |
| Østrig | Glaxosmithkline Pharma Gmbh. | Flixotide | Fluticasonpropionat 250 μg inhalation | Inhalationsspray, suspension |
| Østrig | Glaxosmithkline Pharma Gmbh. | Flixotide Diskus Forte | Fluticasonpropionat 500 μg dosis | Inhalationspulver |
| Østrig | Glaxosmithkline Pharma Gmbh. | Flixotide Diskus Junior | Fluticasonpropionat 100 μg dosis | Inhalationspulver |
| Østrig | Glaxosmithkline Pharma Gmbh. | Flixotide Junior | Fluticasonpropionat 125 μg inhalation | Inhalationsspray, suspension |
| Østrig | Glaxosmithkline Pharma Gmbh. | Seretide Diskus | Fluticasonpropionat 500 μg dosis, salmeterolxinafoat 50 μg dosis | Inhalationspulver, afdelt |
| Østrig | Pari Pharma Gmbh | Buparid | Budesonid 0,25  mg ampul | Inhalationsvæske til nebulisator, suspension |
| Østrig | Pari Pharma Gmbh | Buparid | Budesonid 0,5  mg ampul | Inhalationsvæske til nebulisator, suspension |
| Østrig | Pari Pharma Gmbh | Buparid | Budesonid 1 mg ampul | Inhalationsvæske til nebulisator, suspension |
| Østrig | Sandoz Gmbh | Airflusal Forspiro | Fluticasonpropionat 233 μg dosis, salmeterol 45 μg dosis | Inhalationspulver |
| Østrig | Sandoz Gmbh | Airflusal Forspiro | Fluticasonpropionat 465 μg dosis, salmeterol 45 μg dosis | Inhalationspulver |
| Belgien | Chiesi Sa-Nv | Inuvair | Formoterolfumaratedihydrat 6 μg aktivering, beclometasondipropionat vandfri 100 μg aktivering | Inhalationsspray, opløsning |
| Belgien | Cipla Europe Nv | Salmeterol/Fluticasone Cipla | Salmeterol 25 μg/dosis, fluticasonpropionat 125 μg/dosis | Inhalationsspray, suspension |
| Belgien | Elpen Pharmaceutical Co. Inc. | Flusalio | Fluticasonpropionat 250 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Belgien | Elpen Pharmaceutical Co. Inc. | Flusalio | Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Belgien | Glaxosmithkline Pharmaceuticals S.A. | Flixotide | Fluticasonpropionat 0,05  mg/2 ml | Inhalationsvæske til nebulisator, opløsning |
| Belgien | Glaxosmithkline Pharmaceuticals S.A. | Flixotide | Fluticasonpropionat 250 μg inhalation | Inhalationsspray, suspension |
| Belgien | Glaxosmithkline Pharmaceuticals S.A. | Flixotide | Fluticasonpropionat 2 mg/2 ml | Inhalationsvæske til nebulisator, opløsning |
| Belgien | Glaxosmithkline Pharmaceuticals S.A. | Flixotide | Fluticasonpropionat 50 μg inhalation | Inhalationsspray, suspension |
| Belgien | Glaxosmithkline Pharmaceuticals S.A. | Flixotide Diskus | Fluticasonpropionat 100 μg dosis | Inhalationspulver |
| Belgien | Glaxosmithkline Pharmaceuticals S.A. | Flixotide Diskus | Fluticasonpropionat 250 μg dosis | Inhalationspulver |
| Belgien | Glaxosmithkline Pharmaceuticals S.A. | Flixotide Diskus | Fluticasonpropionat 500 μg dosis | Inhalationspulver |
| Belgien | Glaxosmithkline Pharmaceuticals S.A. | Seretide Diskus | Fluticasonpropionat 500 μg dosis, salmeterolxinafoat 50 μg dosis | Inhalationspulver, afdelt |
| Belgien | Nv Astrazeneca Sa | Pulmicort Turbohaler | Budesonid 200 μg dosis | Inhalationspulver |
| Belgien | Nv Astrazeneca Sa | Symbicort Forte Turbohaler | Budesonid 320 μg dosis, formoterolfumaratdihydrat 9 μg dosis | Inhalationspulver |
| Belgien | Nv Astrazeneca Sa | Symbicort Turbohaler | Budesonid 160 μg dosis, formoterolfumaratdihydrat 4,5 μg dosis | Inhalationspulver |
| Belgien | Orion Corporation | Bufomix Easyhaler | Budesonid 160 μg inhalation, formoterolfumaratdihydrat 4,5  μg inhalation | Inhalationspulver |
| Belgien | Orion Corporation | Bufomix Easyhaler | Budesonid 320 μg inhalation, , formoterolfumaratdihydrat 9 μg inhalation | Inhalationspulver |
| Belgien | Pari Pharma Gmbh | Buparid | Budesonid 0,25  mg ampul | Inhalationsvæske til nebulisator, suspension |
| Belgien | Pari Pharma Gmbh | Buparid | Budesonid 0,5  mg ampul | Inhalationsvæske til nebulisator, suspension |
| Belgien | Pari Pharma Gmbh | Buparid | Budesonid 1 mg ampul | Inhalationsvæske til nebulisator, suspension |
| Belgien | Sandoz N.V. | Airflusal Forspiro | Salmeterolxinafoat 50 μg dosis, fluticason 500 μg dosis | Inhalationspulver |
| Bulgarien | Astrazeneca Ab | Symbicort Turbuhaler | Budesonid 160 μg dosis, formoterolfumaratdihydrat 4,5 μg dosis | Inhalationspulver |
| Bulgarien | Astrazeneca Ab | Symbicort Turbuhaler | Budesonid 320 μg dosis, formoterolfumaratdihydrat 9 μg dosis | Inhalationspulver |
| Bulgarien | Chiesi Pharmaceuticals Gmbh | Foster | Formoterolfumaratedihydrat 6 μg aktivering, beclometasondipropionat vandfri 100 μg aktivering | Inhalationsspray, opløsning |
| Bulgarien | Elpen Pharmaceutical Co. Inc. | Flusamer | Fluticasonpropionat 250 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Bulgarien | Elpen Pharmaceutical Co. Inc. | Flusamer | Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Bulgarien | Glaxosmithkline Eood | Seretide Diskus | Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Bulgarien | Orion Oyj | Bufomix Easyhaler | Budesonid 160 μg inhalation, formoterolfumaratdihydrat 4,5  μg inhalation | Inhalationspulver |
| Bulgarien | Orion Oyj | Bufomix Easyhaler | Budesonid 320 μg inhalation, formoterolfumaratdihydrat 9 μg inhalation | Inhalationspulver |
| Bulgarien | Sandoz Pharmaceuticals D.D. | Airflusal Forspiro | Salmeterolxinafoat 50 μg dosis, fluticason 500 μg dosis | Inhalationspulver |
| Bulgarien | Sopharma Ad | Flixotide | Fluticasonpropionat 250 μg inhalation | Inhalationsspray, suspension |
| Kroatien | Astrazeneca D.O.O | Symbicort Turbuhaler | Budesonid 160 μg dosis, formoterolfumaratdihydrat 4,5 μg dosis | Inhalationspulver |
| Kroatien | Astrazeneca D.O.O | Symbicort Turbuhaler | Budesonid 160 μg dosis, formoterolfumaratdihydrat 4,5 μg dosis | Inhalationspulver |
| Kroatien | Clinres Farmacija D.O.O. | Dimenium | Fluticasonpropionat 100 mcg dosis, salmeterolxinafoat 50 mcg dosis | Inhalationspulver, afdelt |
| Kroatien | Clinres Farmacija D.O.O. | Dimenium | Fluticasonpropionat 250 mcg dosis, Salmeterolxinafoat 50 mcg dosis | Inhalationspulver, afdelt |
| Kroatien | Clinres Farmacija D.O.O. | Dimenium | Fluticasonpropionat 500 mcg dosis, salmeterolxinafoat 50 mcg dosis | Inhalationspulver, afdelt |
| Kroatien | Glaxosmithkline D.O.O. | Salmeterol/Flutikazonpropionat Diskus Glaxosmithkline | Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Kroatien | Glaxosmithkline D.O.O. | Seretide Diskus | Fluticasonpropionat 500 μg dosis, salmeterolxinafoat 50 μg dosis | Inhalationspulver, afdelt |
| Kroatien | Providens D.O.O. | Foster | Formoterolfumaratedihydrat 6 μg aktivering, beclometasondipropionat vandfri 100 μg aktivering | Inhalationsspray, opløsning |
| Kroatien | Salvus D.O.O. | Saldisk | Fluticasonpropionat 100 mcg dosis, salmeterolxinafoat 50 mcg dosis | Inhalationspulver, afdelt |
| Kroatien | Salvus D.O.O. | Saldisk | Fluticasonpropionat 250 mcg dosis, salmeterolxinafoat 50 mcg dosis | Inhalationspulver, afdelt |
| Kroatien | Salvus D.O.O. | Saldisk | Fluticasonpropionat 500 mcg dosis, salmeterolxinafoat 50 mcg dosis | Inhalationspulver, afdelt |
| Kroatien | Sandoz D.O.O. | Airflusal Forspiro | Fluticasonpropionat 233 μg dosis, salmeterol 45 μg dosis | Inhalationspulver, afdelt |
| Kroatien | Sandoz D.O.O. | Airflusal Forspiro | Fluticasonpropionat 465 μg dosis, salmeterol 45 μg dosis | Inhalationspulver, afdelt |
| Cypern | Astrazeneca Ab | Symbicort Turbuhaler | Budesonid 160 μg dosis, formoterolfumaratdihydrat 4,5 μg dosis | Inhalationspulver |
| Cypern | Astrazeneca Ab | Symbicort Turbuhaler | Budesonid 320 μg dosis, formoterolfumaratdihydrat 9 μg dosis | Inhalationspulver |
| Cypern | Costakis Tsisios & Co. Ltd | Fluticapen | Fluticasonpropionat 250 μg dosis | Inhalationspulver, afdelt |
| Cypern | Costakis Tsisios & Co. Ltd | Fluticapen | Fluticasonpropionat 500 μg dosis | Inhalationspulver, afdelt |
| Cypern | Costakis Tsisios & Co. Ltd | Pulmoton | Budesonid 100 μg dosis, formoterolfumaratdihydrat 6 μg dosis | Inhalationspulver, afdelt |
| Cypern | Costakis Tsisios & Co. Ltd | Pulmoton | Budesonid 200 μg dosis, formoterolfumaratdihydrat 6 μg dosis | Inhalationspulver, afdelt |
| Cypern | Costakis Tsisios & Co. Ltd | Pulmoton | Budesonid 400 μg dosis, formoterolfumaratdihydrat 12 μg dosis | Inhalationspulver, afdelt |
| Cypern | Costakis Tsisios & Co. Ltd | Rolenium | Fluticasonpropionat 100 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Cypern | Costakis Tsisios & Co. Ltd | Rolenium | Fluticasonpropionat 250 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Cypern | Costakis Tsisios & Co. Ltd | Rolenium | Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Cypern | Glaxo Group Limited | Flixotide Diskus | Fluticasonpropionat 100 μg dosis | Inhalationspulver |
| Cypern | Glaxo Group Limited | Flixotide Diskus | Fluticasonpropionat 250 μg dosis | Inhalationspulver |
| Cypern | Glaxo Group Limited | Seretide | Fluticasonpropionat 500 μg dosis, salmeterolxinafoat 50 μg dosis | Inhalationspulver, afdelt |
| Cypern | Orion Corporation | Bufomix Easyhaler | Budesonid 160 μg dosis, formoterolfumaratdihydrat Ph.Eur. 4,5  μg dosis | Inhalationspulver |
| Cypern | Orion Corporation | Bufomix Easyhaler | Budesonid 320 μg dosis, formoterolfumaratdihydrat Ph.Eur. 9 μg dosis | Inhalationspulver |
| Cypern | Orion Corporation | Orest Easyhaler | Budesonid 160 μg dosis, formoterolfumaratdihydrat Ph.Eur. 4,5  μg dosis | Inhalationspulver |
| Cypern | Orion Corporation | Orest Easyhaler | Budesonid 320 μg dosis, formoterolfumaratdihydrat Ph.Eur. 9 μg dosis | Inhalationspulver |
| Den Tjekkiske Republik | Astrazeneca Ab | Symbicort Turbuhaler | Budesonid 160 μg dosis, formoterolfumaratdihydrat 4,5 μg dosis | Inhalationspulver |
| Den Tjekkiske Republik | Astrazeneca Ab | Symbicort Turbuhaler | Budesonid 320 μg dosis, formoterolfumaratdihydrat 9 μg dosis | Inhalationspulver |
| Den Tjekkiske Republik | Chiesi Pharmaceuticals Gmbh | Combair | Formoterolfumaratdihydrat 1,08  mg, beclometasondipropionat 18 mg | Inhalationsspray, opløsning |
| Den Tjekkiske Republik | Elpen Pharmaceutical Co. Inc. | Dimenium | Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Den Tjekkiske Republik | Elpen Pharmaceutical Co. Inc. | Dimenium | Fluticasonpropionat 250 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Den Tjekkiske Republik | Glaxo Group Limited | Flixotide | Fluticasonpropionat 125 μg | Inhalationsspray, suspension |
| Den Tjekkiske Republik | Glaxo Group Limited | Flixotide | Fluticasonpropionat 250 μg | Inhalationsspray, suspension |
| Den Tjekkiske Republik | Glaxo Group Limited | Flixotide | Fluticasonpropionat 50 μg | Inhalationsspray, suspension |
| Den Tjekkiske Republik | Glaxo Group Limited | Flixotide Diskus | Fluticasonpropionat 100 μg | Inhalationspulver |
| Den Tjekkiske Republik | Glaxo Group Limited | Flixotide Diskus | Fluticasonpropionat 250 μg | Inhalationspulver |
| Den Tjekkiske Republik | Glaxo Group Limited | Flixotide Diskus | Fluticasonpropionat 500 μg | Inhalationspulver |
| Den Tjekkiske Republik | Glaxo Group Limited | Seretide Diskus | Fluticasonpropionat 500 μg, salmeterolxinafoat 72,5  μg | Inhalationspulver |
| Den Tjekkiske Republik | Sandoz S.R.O. | Airflusan Forspiro | Fluticasonpropionat 0,25  mg, salmeterolxinafoat 0,073  mg | Inhalationspulver, afdelt |
| Den Tjekkiske Republik | Sandoz S.R.O. | Airflusan Forspiro | Fluticasonpropionat 0,5  mg, salmeterolxinafoat 0,073  mg | Inhalationspulver, afdelt |
| Danmark | Astrazeneca A-S | Symbicort Forte Turbuhaler | Budesonid 320 μg dosis, formoterolfumaratdihydrat 9 μg dosis | Inhalationspulver |
| Danmark | Astrazeneca A-S | Symbicort Turbuhaler | Budesonid 160 μg dosis, formoterolfumaratdihydrat 4,5 μg dosis | Inhalationspulver |
| Danmark | Chiesi Farmaceutici S.P.A. | Innovair | Beclometasondipropionat 100 μg aktivering, formoterolfumaratdihydrat 6 μg aktivering | Inhalationsspray, opløsning |
| Danmark | Elpen Pharmaceutical Co. Inc. | Flusaterol | Fluticasonpropionat 250 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Danmark | Elpen Pharmaceutical Co. Inc. | Flusaterol | Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis, lactosemonohydrat 24,677  mg dosis | Inhalationspulver, afdelt |
| Danmark | Glaxosmithkline Pharma A-S | Seretide | Fluticasonpropionat 500 μg dosis, salmeterolxinafoat 50 μg dosis | Inhalationspulver, afdelt |
| Danmark | Orion Oyj | Bufomix Easyhaler | Budesonid 160 μg inhalation, formoterolfumaratdihydrat 4,5  μg inhalation | Inhalationspulver |
| Danmark | Orion Oyj | Bufomix Easyhaler | Budesonid 320 μg inhalation, formoterolfumaratdihydrat 9 μg inhalation | Inhalationspulver |
| Danmark | Sandoz A-S | Airflusal Forspiro | Fluticasonpropionat 233 μg dosis, salmeterol 45 μg dosis | Inhalationspulver, afdelt |
| Danmark | Sandoz A-S | Airflusal Forspiro | Fluticasonpropionat 465 μg dosis, salmeterol 45 μg dosis | Inhalationspulver, afdelt |
| Estland | Astrazeneca Ab | Symbicort Turbuhaler | Budesonid 160 μg dosis, formoterolfumaratdihydrat 4,5 μg dosis | Inhalationspulver |
| Estland | Astrazeneca Ab | Symbicort Turbuhaler | Budesonid 320 μg dosis, formoterolfumaratdihydrat 9 μg dosis | Inhalationspulver |
| Estland | Chiesi Pharmaceuticals Gmbh | Foster | Beclometasondipropionat 100 μg aktivering, formoterolfumaratdihydrat 6 μg aktivering | Inhalationsspray, opløsning |
| Estland | Elpen Pharmaceutical Co. Inc. | Flusamer | Fluticasonpropionat 250 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Estland | Elpen Pharmaceutical Co. Inc. | Flusamer | Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Estland | Glaxo Wellcome Ltd | Flixotide Diskus | Fluticasonpropionat 250 μg dosis | Inhalationspulver |
| Estland | Glaxo Wellcome Ltd | Seretide Diskus | Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Estland | Sandoz Pharmaceuticals D.D. | Airflusal Forspiro | Fluticasonpropionat 250 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Estland | Sandoz Pharmaceuticals D.D. | Airflusal Forspiro | Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Finland | Astrazeneca Oy | Symbicort Forte Turbuhaler | Budesonid 320 μg dosis, formoterolfumaratdihydrat 9 μg dosis | Inhalationspulver |
| Finland | Astrazeneca Oy | Symbicort Turbuhaler | Budesonid 160 μg dosis, formoterolfumaratdihydrat 4,5 μg dosis | Inhalationspulver |
| Finland | Chiesi Farmaceutici S.P.A. | Innovair | Beclometasondipropionat 100 μg aktivering, formoterolfumaratdihydrat 6 μg aktivering | Inhalationsspray, opløsning |
| Finland | Chiesi Farmaceutici S.P.A. | Innovair Nexthaler | Formoterolfumaratdihydrat 6 μg dosis, beclometasondipropionat vandfri 100 μg dosis | Inhalationspulver |
| Finland | Elpen Pharmaceutical Co. Inc. | Salmeson | Fluticasonpropionat 250 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Finland | Elpen Pharmaceutical Co. Inc. | Salmeson | Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Finland | Glaxosmithkline Oy | Seretide Diskus | Fluticasonpropionat 500 μg dosis, salmeterolxinafoat 50 μg dosis | Inhalationspulver, afdelt |
| Finland | Orion Oyj | Bufomix Easyhaler | Budesonid 160 μg inhalation, formoterolfumaratdihydrat 4,5  μg inhalation | Inhalationspulver |
| Finland | Orion Oyj | Bufomix Easyhaler | Budesonid 320 μg inhalation, formoterolfumaratdihydrat 9 μg inhalation | Inhalationspulver |
| Frankrig | Astrazeneca France | Symbicort Turbuhaler | Budesonid 160 μg dosis, formoterolfumaratdihydrat 4,5 μg dosis | Inhalationspulver |
| Frankrig | Astrazeneca France | Symbicort Turbuhaler | Budesonid 320 μg dosis, formoterolfumaratdihydrat 9 μg dosis | Inhalationspulver |
| Frankrig | Chiesi S.A. | Formodual | Formoterolfumaratdihydrat 6 μg dosis, beclometasondipropionat vandfri 100 μg dosis | Inhalationsspray, opløsning |
| Frankrig | Chiesi S.A. | Innovair | Formoterolfumaratdihydrat 6 μg dosis, beclometasondipropionat vandfri 100 μg dosis | Inhalationsspray, opløsning |
| Frankrig | Laboratoire Glaxosmithkline S.A.S. | Seretide Diskus | Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Tyskland | 3m Health Care Ltd | Bronchocort Novo | Beclometason dipropionat 100 μg/50 μl | Inhalationsspray, opløsning |
| Tyskland | 3m Health Care Ltd | Junik | Beclometasondipropionat 100 μg aktivering | Inhalationsspray, opløsning |
| Tyskland | Abz-Pharma Gmbh | Beclomethasone Dipropionate Ct | Beclometasondipropionat 0,05  mg/18,7  g | Inhalationsspray, opløsning |
| Tyskland | Meda Pharma Gmbh & Co. Kg | Budecort Novolizer | Budesonid, Micronised 0,2  mg aktivering | Inhalationspulver |
| Tyskland | Meda Pharma Gmbh & Co. Kg | Budecort Novolizer | Budesonid, micronised 0,4  mg aktivering | Inhalationspulver |
| Tyskland | Astrazeneca Gmbh | Pulmicort Budesonide | Budesonid 0,5  mg | Inhalationsvæske til nebulisator, suspension |
| Tyskland | Astrazeneca Gmbh | Pulmicort Budesonide | Budesonid 1,0  mg | Inhalationsvæske til nebulisator, suspension |
| Tyskland | Astrazeneca Gmbh | Pulmicort | Budesonid 400 μg dosis | Inhalationspulver |
| Tyskland | Astrazeneca Gmbh | Pulmicort Turbohaler | Budesonid 200 μg dosis | Inhalationspulver |
| Tyskland | Astrazeneca Gmbh | Symbicort Turbohaler | Budesonid 160 μg dosis, formoterolfumaratdihydrat 4,5 μg dosis | Inhalationspulver |
| Tyskland | Astrazeneca Gmbh | Symbicort Turbohaler | Budesonid 320 μg dosis, formoterolfumaratdihydrat 9 μg dosis | Inhalationspulver |
| Tyskland | Chiesi Farmaceutici S.P.A. | Kantos | Beclometasondipropionat 100 μg aktivering, formoterolfumaratdihydrat 6 μg aktivering | Inhalationsspray, opløsning |
| Tyskland | Chiesi Farmaceutici S.P.A. | Kantos Master | Beclometasondipropionat 100 μg aktivering, formoterolfumaratdihydrat 6 μg aktivering | Inhalationsspray, opløsning |
| Tyskland | Chiesi Gmbh | Budiair | Budesonide 200 μg Spray | Inhalationsspray, opløsning |
| Tyskland | Chiesi Gmbh | Foster | Beclometasondipropionat 100 μg aktivering, formoterolfumaratdihydrat 6 μg aktivering | Inhalationsspray, opløsning |
| Tyskland | Chiesi Gmbh | Ribuvent | Budesonide 200 μg Puff | Inhalationsspray, opløsning |
| Tyskland | Chiesi Gmbh | Sanasthmax | Beclometasondipropionat 250 μg/59,2  mg | Inhalationsspray, opløsning |
| Tyskland | Chiesi Gmbh | Sanasthmax Junior | Beclometasondipropionat 50 μg/59 mg | Inhalationsspray, opløsning |
| Tyskland | Elpen Pharmaceutical Co. Inc. | Flusalio | Fluticasonpropionat 250 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Tyskland | Elpen Pharmaceutical Co. Inc. | Flusalio | Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Tyskland | Elpen Pharmaceutical Co. Inc. | Rolenium | Fluticasonpropionat 250 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Tyskland | Elpen Pharmaceutical Co. Inc. | Rolenium | Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Tyskland | Glaxosmithkline Gmbh & Co. Kg | Flixotide Diskus | Fluticasonpropionat 250 μg dosis | Inhalationspulver |
| Tyskland | Glaxosmithkline Gmbh & Co. Kg | Flixotide Forte | Fluticasonpropionat 250 μg inhalation | Inhalationsspray, suspension |
| Tyskland | Glaxosmithkline Gmbh & Co. Kg | Flixotide Forte Diskus | Fluticasonpropionat 500 μg dosis | Inhalationspulver |
| Tyskland | Glaxosmithkline Gmbh & Co. Kg | Flutide Diskus | Fluticasonpropionat 250 μg dosis | Inhalationspulver, afdelt |
| Tyskland | Glaxosmithkline Gmbh & Co. Kg | Flutide Forte | Fluticasonpropionat 220 μg sug | Inhalationsspray, suspension |
| Tyskland | Glaxosmithkline Gmbh & Co. Kg | Flutide Forte Diskus | Fluticasonpropionat 500 μg dosis | Inhalationspulver, afdelt |
| Tyskland | Glaxosmithkline Gmbh & Co. Kg | Viani Forte | Fluticasonpropionat 500 μg dosis, salmeterolxinafoat 50 μg dosis | Inhalationspulver, afdelt |
| Tyskland | Heumann Pharma Gmbh & Co. Generica Kg | Budesonid | Budesonid 0,2  mg | Inhalationspulver |
| Tyskland | Hexal Ag | Airflusal Forspiro | Salmeterolxinafoat 50 μg dosis, fluticason 500 μg dosis | Inhalationspulver |
| Tyskland | Hexal Ag | Budes N | Budesonid 0,2  mg dosis | Inhalationsspray, opløsning |
| Tyskland | Janssen-Cilag Gmbh | Inuvair | Beclometasondipropionat 100 μg inhalation, formoterolfumarat 6 μg inhalation | Inhalationsspray, opløsning |
| Tyskland | Meda Pharma Gmbh & Co. Kg | Budesonid Novolizer Meda Pharma Gmbh & Co. Kg | Budesonid 400 μg inhalation | Inhalationspulver |
| Tyskland | Meda Pharma Gmbh & Co. Kg | Novopulmon Novolizer | Budesonid 200 μg dosis | Inhalationspulver |
| Tyskland | Meda Pharma Gmbh & Co. Kg | Novopulmon Novolizer | Budesonid 400 μg dosis | Inhalationspulver |
| Tyskland | Mylan Dura Gmbh | Budesonid Mylan | Budesonid 0,2  mg | Inhalationspulver |
| Tyskland | Orion Corporation | Beclomet Easyhaler | Beclometasondipropionat 0,2  mg dosis | Inhalationspulver |
| Tyskland | Pari Pharma Gmbh | Buparid | Budesonid 0,25  mg ampul | Inhalationsvæske til nebulisator, suspension |
| Tyskland | Pari Pharma Gmbh | Buparid | Budesonid 0,5  mg ampul | Inhalationsvæske til nebulisator, suspension |
| Tyskland | Pari Pharma Gmbh | Buparid | Budesonid 1 mg ampul | Inhalationsvæske til nebulisator, suspension |
| Tyskland | Pb Pharma Gmbh | Budesonid | Budesonid 0,92  mg | Inhalationspulver, hård kapsel |
| Tyskland | Pb Pharma Gmbh | Cyclocaps Beclometason | Beclometasondipropionat 100 μg enheder | Inhalationspulver, hård kapsel |
| Tyskland | Pb Pharma Gmbh | Cyclocaps Beclometason | Beclometasondipropionat 200 μg enheder | Inhalationspulver, hård kapsel |
| Tyskland | Pb Pharma Gmbh | Cyclocaps Beclometason | Beclometasondipropionat 400 μg enheder | Inhalationspulver, hård kapsel |
| Tyskland | Pb Pharma Gmbh | Cyclocaps Budesonid | Budesonid 0,8  mg kapsel | Inhalationspulver, hård kapsel |
| Tyskland | Pb Pharma Gmbh | Cyclocaps Budesonid | Budesonid 100 μg enheder | Inhalationspulver, hård kapsel |
| Tyskland | Pb Pharma Gmbh | Cyclocaps Budesonid | Budesonid 800 μg enheder | Inhalationspulver, hård kapsel |
| Tyskland | Ratiopharm Gmbh | Beclometason Ratiopharm | Beclometasondipropionat 0,25  mg/18,7  g | Inhalationsspray, opløsning |
| Tyskland | Ratiopharm Gmbh | Beclomethasone Dipropionate Ratiopharm | Beclometasondipropionat 0,05  mg/18,7  g | Inhalationsspray, opløsning |
| Tyskland | Ratiopharm Gmbh | Beclomethasone Dipropionate Ratiopharm | Beclometasondipropionat 0,1  mg/18,7  g | Inhalationsspray, opløsning |
| Tyskland | Ratiopharm Gmbh | Beclomethasone Dipropionate Ratiopharm | Beclometasondipropionat 0,2  mg/18,7  g | Inhalationsspray, opløsning |
| Tyskland | Teva Gmbh | Aerobec N | Beclometasondipropionat 100 g/5 ml | Inhalationsspray, opløsning |
| Tyskland | Teva Gmbh | Beclometason-Ct | Beclometasondipropionat 0,1  mg | Inhalationsspray, opløsning |
| Tyskland | Teva Gmbh | Beclometason-Ct | Beclometasondipropionat 0,2  mg | Inhalationsspray, opløsning |
| Tyskland | Teva Gmbh | Ventolair | Beclometasondipropionat 100 g/10ml | Inhalationsspray, opløsning |
| Tyskland | Teva Gmbh | Ventolair | Beclometasondipropionat 100 g/18,7  g | Inhalationsspray, opløsning |
| Tyskland | Teva Gmbh | Ventolair | Beclometasondipropionat 100 g/5 ml | Inhalationsspray, opløsning |
| Tyskland | Teva Gmbh | Ventolair | Beclometasondipropionat 250 g/18,7  g | Inhalationsspray, opløsning |
| Tyskland | Teva Gmbh | Ventolair | Beclometasondipropionat 250 g/78 mg | Inhalationsspray, opløsning |
| Tyskland | Teva Gmbh | Ventolair Mite | Beclometasondipropionat 50 g/18,7  g | Inhalationsspray, opløsning |
| Tyskland | Teva Gmbh | Ventolair Mite | Beclometasondipropionat 50 g/78 mg | Inhalationsspray, opløsning |
| Tyskland | Ucb Pharma Gmbh (Monheim De) | Atmadisc Forte Diskus | Fluticasonpropionat 500 μg inhalation, salmeterol 50 μg inhalation | Inhalationspulver |
| Grækenland | Anfarm Hellas Sa | Talgan | Budesonid 100 μg dosis | Inhalationspulver |
| Grækenland | Astrazeneca S.A. | Pulmicort Turbuhaler | Budesonid 100 μg dosis | Inhalationspulver |
| Grækenland | Astrazeneca S.A. | Pulmicort Turbuhaler | Budesonid 200 μg dosis | Inhalationspulver |
| Grækenland | Astrazeneca S.A. | Pulmicort Turbuhaler | Budesonid 400 μg dosis | Inhalationspulver |
| Grækenland | Astrazeneca S.A. | Symbicort Turbuhaler | Budesonid 160 μg dosis, formoterolfumaratdihydrat 4,5 μg dosis | Inhalationspulver |
| Grækenland | Astrazeneca S.A. | Symbicort Turbuhaler | Budesonid 320 μg dosis, formoterolfumaratdihydrat 9 μg dosis | Inhalationspulver |
| Grækenland | Chiesi Hellas A.E.B.E. | Foster | Beclometasondipropionat 100 μg aktivering, formoterolfumaratdihydrat 6 μg aktivering | Inhalationsspray, opløsning |
| Grækenland | Chiesi Hellas A.E.B.E. | Foster Nexthaler | Formoterolfumaratdihydrat 6 μg dosis, beclometasondipropionat vandfri 100 μg dosis | Inhalationspulver |
| Grækenland | Chiesi Hellas A.E.B.E. | Inuvair | Beclometasondipropionat 100 μg aktivering, formoterolfumaratdihydrat 6 μg aktivering | Inhalationsspray, opløsning |
| Grækenland | Chiesi Hellas A.E.B.E. | Inuvair Nexthaler | Formoterolfumaratdihydrat 6 μg dosis, beclometasondipropionat vandfri 100 μg dosis | Inhalationspulver |
| Grækenland | | Flihaler | Fluticasonpropionat 250 mcg/dosis | Inhalationsspray, suspension |
| Grækenland | Elpen Pharmaceutical Co. Inc. | Fluticapen | Fluticasonpropionat 250 μg dosis | Inhalationspulver, afdelt |
| Grækenland | Elpen Pharmaceutical Co. Inc. | Fluticapen | Fluticasonpropionat 500 μg dosis | Inhalationspulver, afdelt |
| Grækenland | Elpen Pharmaceutical Co. Inc. | Pulmoton | Budesonid 100 μg dosis, formoterolfumaratdihydrat 6 μg dosis | Inhalationspulver, afdelt |
| Grækenland | Elpen Pharmaceutical Co. Inc. | Pulmoton | Budesonid 200 μg dosis, formoterolfumaratdihydrat 6 μg dosis | Inhalationspulver, afdelt |
| Grækenland | Elpen Pharmaceutical Co. Inc. | Pulmoton | Budesonid 400 μg dosis, formoterolfumaratdihydrat 12 μg dosis | Inhalationspulver, afdelt |
| Grækenland | Elpen Pharmaceutical Co. Inc. | Rolenium | Fluticasonpropionat 250 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Grækenland | Elpen Pharmaceutical Co. Inc. | Rolenium | Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Grækenland | Glaxosmithkline Aebe | Flixotide | Fluticasonpropionat 100 μg dosis | Inhalationspulver |
| Grækenland | Glaxosmithkline Aebe | Flixotide | Fluticasonpropionat 125 μg dosis | Inhalationsspray |
| Grækenland | Glaxosmithkline Aebe | Flixotide | Fluticasonpropionat 250 μg dosis | Inhalationspulver |
| Grækenland | Glaxosmithkline Aebe | Flixotide | Fluticasonpropionat 250 μg dosis | Inhalationsspray |
| Grækenland | Glaxosmithkline Aebe | Flixotide | Fluticasonpropionat 500 μg dosis | Inhalationspulver |
| Grækenland | Glaxosmithkline Aebe | Flixotide | Fluticasonpropionat 50 μg dosis | Inhalationsspray |
| Grækenland | Glaxosmithkline Aebe | Flixotide Diskus | Fluticasonpropionat 100 μg dosis | Inhalationspulver |
| Grækenland | Glaxosmithkline Aebe | Flixotide Diskus | Fluticasonpropionat 250 μg dosis | Inhalationspulver |
| Grækenland | Glaxosmithkline Aebe | Flixotide Diskus | Fluticasonpropionat 500 μg dosis | Inhalationspulver |
| Grækenland | Glaxosmithkline Aebe | Seretide | Fluticasonpropionat 500 μg dosis, salmeterolxinafoat 50 μg dosis | Inhalationspulver, afdelt |
| Grækenland | Iasis Pharma | Olfo Haler | Budesonid 200 μg dosis | Inhalationspulver |
| Grækenland | Iasis Pharma | Olfo Haler | Budesonid 400 μg dosis | Inhalationspulver |
| Grækenland | Medicair Bioscience Laboratories S.A | Bocacort-S | Fluticasonpropionat 250 mcg/dosis | Inhalationsspray, suspension |
| Grækenland | Orion Corporation | Bufomix | Budosenid 160 mcg, formoterolfumaratdihydrat 4,5  mcg | Inhalationspulver |
| Grækenland | Orion Corporation | Bufomix | Budosenid 320 mcg, formoterolfumaratdihydrat 9 mcg | Inhalationspulver |
| Grækenland | Orion Corporation | Orest | Budosenid 160 mcg, formoterolfumaratdihydrat 4,5  mcg | Inhalationspulver |
| Grækenland | Orion Corporation | Orest | Budosenid 320 mcg, formoterolfumaratdihydrat 9 mcg | Inhalationspulver |
| Grækenland | Png Gerolymatos Medical A.E. | Asmaflex | Fluticasone Propionate 250 mgg | Inhalationsspray, suspension |
| Grækenland | Rafarm Sa. | Resata | Budesonid 200 μg dosis | Inhalationspulver, afdelt |
| Grækenland | Rafarm Sa. | Resata | Budesonid 400 μg dosis | Inhalationspulver, afdelt |
| Grækenland | Verisfield (Uk) Ltd | Flixocort | Fluticasonpropionat 50 μg dosis | Næsespray, suspension |
| Grækenland | Verisfield (Uk) Ltd | Flixocort | Fluticasonpropionat 125 μg dosis | Inhalationsspray, suspension |
| Grækenland | Verisfield (Uk) Ltd | Flixocort | Fluticasonpropionat 250 μg dosis | Inhalationsspray, suspension |
| Grækenland | Verisfield (Uk) Ltd | Pulmihal | Budesonid 200 μg dosis | Inhalationspulver, afdelt |
| Grækenland | Win Medica Ltd | Flusalair | Fluticasonpropionat 250 μg dosis, salmeterol 50 μg dosis | Inhalationspulver |
| Grækenland | Win Medica Ltd | Flusalair | Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Grækenland | Win Medica Ltd | Flutiresp | Fluticasonpropionat 250 mcg/dosis | Inhalationspulver |
| Grækenland | Win Medica Ltd | Flutiresp | Fluticasonpropionat 500 μg inhalation | Inhalationspulver |
| Grækenland | Zwitter Pharmaceuticals επε | Salenga | Fluticasonpropionat 250 μg dosis | Inhalationsspray, suspension |
| Grækenland | Pharmanel Commercial Pharmaceutical S.A. | Vernoral | Budesonid 200 μg dosis | Inhalationspulver |
| Grækenland | Pharmanel Commercial Pharmaceutical S.A. | Vernoral | Budesonid 400 μg dosis | Inhalationspulver |
| Ungarn | Astrazeneca Kft. | Symbicort Turbuhaler | Budesonid 160 μg dosis, formoterolfumaratdihydrat 4,5 μg dosis | Inhalationspulver |
| Ungarn | Astrazeneca Kft. | Symbicort Turbuhaler | Budesonid 320 μg dosis, formoterolfumaratdihydrat 9 μg dosis | Inhalationspulver |
| Ungarn | Chiesi Pharmaceuticals Gmbh | Formodual | Formoterolfumaratedihydrat 6 μg aktivering, beclometasondipropionat vandfri 100 μg aktivering | Inhalationsspray, opløsning |
| Ungarn | Chiesi Pharmaceuticals Gmbh | Foster | Beclometasondipropionat 100 μg aktivering, formoterolfumaratdihydrat 6 μg aktivering | Inhalationsspray, opløsning |
| Ungarn | Elpen Pharmaceutical Co. Inc. | Dimenio | Fluticasonpropionat 250 μg dosis, salmeterol 50 μg dosis | Inhalationspulver |
| Ungarn | Elpen Pharmaceutical Co. Inc. | Dimenio | Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis | Inhalationspulver |
| Ungarn | Elpen Pharmaceutical Co. Inc. | Flumetor | Fluticasonpropionat 250 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Ungarn | Elpen Pharmaceutical Co. Inc. | Flumetor | Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Ungarn | Glaxosmithkline Kft. | Seretide Diskus | Fluticasonpropionat 500 μg dosis, salmeterolxinafoat 50 μg dosis | Inhalationspulver, afdelt |
| Ungarn | Montrose Kft | Thoreus Diskus | Fluticasonpropionat 500 μg dosis, salmeterolxinafoat 50 μg dosis | Inhalationspulver, afdelt |
| Ungarn | Orion Oyj | Bufomix Easyhaler | Budesonid 160 μg inhalation, formoterolfumaratdihydrat 4,5  μg inhalation | Inhalationspulver |
| Ungarn | Orion Oyj | Bufomix Easyhaler | Budesonid 320 μg inhalation, formoterolfumaratdihydrat 9 μg inhalation | Inhalationspulver |
| Ungarn | Sandoz Hungária Kft | Airflusol Forspiro | Salmeterolxinafoat 50 μg dosis, fluticason 500 μg dosis | Inhalationspulver |
| Island | Astrazeneca A-S | Symbicort Forte Turbuhaler | Budesonid 320 μg dosis, formoterolfumaratdihydrat 9 μg dosis | Inhalationspulver |
| Island | Astrazeneca A-S | Symbicort Mite Turbuhaler | Budesonid 160 μg dosis, formoterolfumaratdihydrat 4,5 μg dosis | Inhalationspulver |
| Island | Elpen Pharmaceutical Co. Inc. | Relanio | Fluticasonpropionat 250 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Island | Elpen Pharmaceutical Co. Inc. | Relanio | Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Island | Glaxosmithkline Ehf. | Flixotide | Fluticasonpropionat 250 μg dosis | Inhalationsspray, suspension |
| Island | Glaxosmithkline Ehf. | Flixotide Diskus | Fluticasonpropionat 100 μg dosis | Inhalationspulver |
| Island | Glaxosmithkline Ehf. | Flixotide Diskus | Fluticasonpropionat 250 μg dosis | Inhalationspulver |
| Island | Glaxosmithkline Ehf. | Flixotide Diskus | Fluticasonpropionat 500 μg dosis | Inhalationspulver |
| Island | Glaxosmithkline Ehf. | Seretide Diskus | Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Irland | Astrazeneca Uk Limited | Pulmicort Turbohaler | Budesonid 100 μg dosis | Inhalationspulver |
| Irland | Astrazeneca Uk Limited | Pulmicort Turbohaler | Budesonid 200 μg dosis | Inhalationspulver |
| Irland | Astrazeneca Uk Limited | Pulmicort Turbohaler | Budesonid 400 μg dosis | Inhalationspulver |
| Irland | Astrazeneca Uk Limited | Symbicort Turbohaler | Budesonid 160 μg dosis, formoterolfumaratdihydrat 4,5 μg dosis | Inhalationspulver |
| Irland | Astrazeneca Uk Limited | Symbicort Turbohaler | Budesonid 320 μg dosis, formoterolfumaratdihydrat 9 μg dosis | Inhalationspulver |
| Irland | Elpen Pharmaceutical Co. Inc. | Flamerio | Fluticasonpropionat 250 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Irland | Elpen Pharmaceutical Co. Inc. | Flamerio | Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis, lactosemonohydrat 24,677  mg dosis | Inhalationspulver, afdelt |
| Irland | Glaxosmithkline (Ireland) Limited | Flixotide Diskus | Fluticasonpropionat 250 μg blister | Inhalationspulver, afdelt |
| Irland | Glaxosmithkline (Ireland) Limited | Flixotide Diskus | Fluticasonpropionat 500 μg blister | Inhalationspulver, afdelt |
| Irland | Glaxosmithkline (Ireland) Limited | Flixotide Evohaler | Fluticasonpropionat 250 μg dosis | Inhalationsspray, suspension |
| Irland | Glaxosmithkline (Ireland) Limited | Seretide Diskus | Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Irland | Glaxosmithkline (Ireland) Limited | Viani Diskus | Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Irland | Orion Oyj | Bufomix Easyhaler | Budesonid 160 μg inhalation, formoterolfumaratdihydrat 4,5  μg inhalation | Inhalationspulver |
| Irland | Orion Oyj | Bufomix Easyhaler | Budesonid 320 μg inhalation, formoterolfumaratdihydrat 9 μg inhalation | Inhalationspulver |
| Irland | Rowex Ltd | Airflusal Forspiro | Salmeterolxinafoat 50 μg dosis, fluticason 250 μg dosis | Inhalationspulver |
| Irland | Rowex Ltd | Airflusal Forspiro | Salmeterolxinafoat 50 μg dosis, fluticason 500 μg dosis | Inhalationspulver |
| Italien | Astrazeneca S.P.A | Sinestic | Budesonid 160 μg dosis, formoterolfumaratdihydrat 4,5 μg dosis | Inhalationspulver |
| Italien | Astrazeneca S.P.A | Sinestic | Budesonid 320 μg dosis, formoterolfumaratdihydrat 4,5  μg dosis | Inhalationspulver |
| Italien | Astrazeneca S.P.A | Symbicort | Budesonid 160 μg dosis, formoterolfumaratdihydrat 4,5 μg dosis | Inhalationspulver |
| Italien | Astrazeneca S.P.A | Symbicort | Budesonid 320 μg dosis, formoterolfumaratdihydrat 9 μg dosis | Inhalationspulver |
| Italien | Elpen Pharmaceutical Co. Inc. | Flamerio | Fluticasonpropionat 250 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Italien | Elpen Pharmaceutical Co. Inc. | Flamerio | Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Italien | Elpen Pharmaceutical Co. Inc. | Rolenium | Fluticasonpropionat 250 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Italien | Elpen Pharmaceutical Co. Inc. | Rolenium | Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Italien | Glaxosmithkline S.P.A. | Seretide | Fluticasonpropionat 500 μg dosis, salmeterolxinafoat 50 μg dosis | Inhalationspulver, afdelt |
| Italien | Menarini International Operations Luxembourg S.A. | Aliflus Diskus | Fluticasonpropionat 100 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Italien | Menarini International Operations Luxembourg S.A. | Aliflus Diskus | Fluticasonpropionat 250 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Italien | Menarini International Operations Luxembourg S.A. | Aliflus Diskus | Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Italien | Promedica S.R.L. | Clenil Compositum | Beclometasondipropionat 0,8  mg/2 mi, salbutamolsulfat 1,928  mg/2 mi | Inhalationsvæske til nebulisator, suspension |
| Italien | Promedica S.R.L. | Clenil Compositum | Beclometasondipropionat 50 μg aktivering, salbutamolsulfat 120 μg aktivering | Inhalationsspray, opløsning |
| Italien | Simesa S.P.A. | Assieme | Budesonid 160 μg dosis, formoterolfumaratdihydrat 4,5 μg dosis | Inhalationspulver |
| Italien | Simesa S.P.A. | Assieme | Budesonid 320 μg dosis, formoterolfumaratdihydrat 9 μg dosis | Inhalationspulver |
| Italien | Valeas S.P.A. | Plenaer | Flunisolid 25 mg flaske, salbutamol 10 mg flaske | Inhalationsspray, suspension |
| Italien | Valeas S.P.A. | Plenaer | Salbutamolsulfat 0,602  mg hætteglas, flunisolid 0,5  mg hætteglas | Inhalationsvæske til nebulisator, opløsning |
| Letland | Astrazeneca Ab | Pulmicort Turbuhaler | Budesonid 100 μg dosis | Inhalationspulver |
| Letland | Astrazeneca Ab | Pulmicort Turbuhaler | Budesonid 200 μg dosis | Inhalationspulver |
| Letland | Astrazeneca Ab | Symbicort Turbuhaler | Budesonid 160 μg dosis, formoterolfumaratdihydrat 4,5 μg dosis | Inhalationspulver |
| Letland | Astrazeneca Ab | Symbicort Turbuhaler | Budesonid 320 μg dosis, formoterolfumaratdihydrat 9 μg dosis | Inhalationspulver |
| Letland | Chiesi Pharmaceuticals Gmbh | Foster | Beclometasondipropionat 100 μg aktivering, formoterolfumaratdihydrat 6 μg aktivering | Inhalationsspray, opløsning |
| Letland | Elpen Pharmaceutical Co. Inc. | Flamerio | Fluticasonpropionat 250 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Letland | Elpen Pharmaceutical Co. Inc. | Flamerio | Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Letland | Glaxosmithkline Latvia Sia | Flixotide | Fluticasonpropionat 250 μg inhalation | Inhalationsspray, suspension |
| Letland | Glaxosmithkline Latvia Sia | Flixotide Diskus | Fluticasonpropionat 250 μg dosis | Inhalationspulver |
| Letland | Glaxosmithkline Latvia Sia | Flixotide Diskus | Fluticasonpropionat 500 μg dosis | Inhalationspulver |
| Letland | Glaxosmithkline Latvia Sia | Flosal | Fluticasonpropionat 250 μg inhalation, salmeterolxinafoat 25 μg inhalation | Inhalationsspray, suspension |
| Letland | Glaxosmithkline Latvia Sia | Flosal | Fluticasonpropionat 500 μg dosis, salmeterolxinafoat 50 μg dosis | Inhalationspulver |
| Letland | Glaxosmithkline Latvia Sia | Seretide | Fluticasonpropionat 250 μg inhalation, salmeterolxinafoat 25 μg inhalation | Inhalationsspray, suspension |
| Letland | Glaxosmithkline Latvia Sia | Seretide | Fluticasonpropionat 500 μg dosis, salmeterolxinafoat 50 μg dosis | Inhalationspulver |
| Letland | Novartis Finland Oy | Miflonide | Budesonid 200 μg | Inhalationspulver, hård kapsel |
| Letland | Novartis Finland Oy | Miflonide | Budesonid 400 μg | Inhalationspulver, hård kapsel |
| Letland | Orion Corporation | Bufomix Easyhaler | Budesonid 160 μg inhalation, formoterolfumaratdihydrat 4,5  μg inhalation | Inhalationspulver |
| Letland | Orion Corporation | Bufomix Easyhaler | Budesonid 320 μg inhalation, formoterolfumaratdihydrat 9 μg inhalation | Inhalationspulver |
| Letland | Sandoz Pharmaceuticals D.D. | Airflusal Forspiro | Fluticasonpropionat 233 μg dosis, salmeterol 45 μg dosis | Inhalationspulver, afdelt |
| Letland | Sandoz Pharmaceuticals D.D. | Airflusal Forspiro | Salmeterolxinafoat 50 μg dosis, fluticason 500 μg dosis | Inhalationspulver, afdelt |
| Litauen | Astrazeneca Ab | Symbicort Turbuhaler | Budesonid 160 μg dosis, formoterolfumaratdihydrat 4,5 μg dosis | Inhalationspulver |
| Litauen | Astrazeneca Ab | Symbicort Turbuhaler | Budesonid 320 μg dosis, formoterolfumaratdihydrat 9 μg dosis | Inhalationspulver |
| Litauen | Chiesi Pharmaceuticals Gmbh | Foster | Beclometasondipropionat 100 μg aktivering, formoterolfumaratdihydrat 6 μg aktivering | Inhalationsspray, opløsning |
| Litauen | Elpen Pharmaceutical Co. Inc. | Flamerio | Fluticasonpropionat 250 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Litauen | Elpen Pharmaceutical Co. Inc. | Flamerio | Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Litauen | Glaxosmithkline Lietuva Uab | Flixotide | Fluticasonpropionat 250 μg inhalation | Inhalationsspray, suspension |
| Litauen | Glaxosmithkline Lietuva Uab | Flixotide Diskus | Fluticasonpropionat 250 μg dosis | Inhalationspulver, afdelt |
| Litauen | Glaxosmithkline Lietuva Uab | Flixotide Diskus | Fluticasonpropionat 500 μg dosis | Inhalationspulver, afdelt |
| Litauen | Glaxosmithkline Lietuva Uab | Seretide | Fluticasonpropionat 500 μg dosis, salmeterolxinafoat 50 μg dosis | Inhalationspulver, afdelt |
| Litauen | Novartis Finland Oy | Miflonide | Budesonid 200 μg | Inhalationspulver, hård kapsel |
| Litauen | Novartis Finland Oy | Miflonide | Budesonid 400 μg | Inhalationspulver, hård kapsel |
| Litauen | Orion Oyj | Bufomix Easyhaler | Budesonid 160 μg inhalation, formoterolfumaratdihydrat 4,5  μg inhalation | Inhalationspulver |
| Litauen | Orion Oyj | Bufomix Easyhaler | Budesonide 160 μg, Formoterol Fumarate Dihydrate 4,5  μg | Inhalationspulver |
| Litauen | Orion Oyj | Bufomix Easyhaler | Budesonid 320 μg inhalation, formoterolfumaratdihydrat 9 μg inhalation | Inhalationspulver |
| Litauen | Orion Oyj | Bufomix Easyhaler | Budosenid 320 μg, formoterolfumaratdihydrat 9 μg | Inhalationspulver |
| Litauen | Sandoz Pharmaceuticals D.D. | Airflusal Forspiro | Salmeterolxinafoat 50 μg dosis, fluticason 250 μg dosis | Inhalationspulver |
| Litauen | Sandoz Pharmaceuticals D.D. | Airflusal Forspiro | Salmeterolxinafoat 50 μg dosis, fluticason 500 μg dosis | Inhalationspulver |
| Luxembourg | Chiesi Sa-Nv | Inuvair | Formoterolfumaratedihydrat 6 μg aktivering, beclometasondipropionat vandfri 100 μg aktivering | Inhalationsspray, opløsning |
| Luxembourg | Elpen Pharmaceutical Co. Inc. | Flusamer | Fluticasonpropionat 250 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Luxembourg | Elpen Pharmaceutical Co. Inc. | Flusamer | Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Luxembourg | Glaxosmithkline Pharmaceuticals S.A. | Flixotide | Fluticasonpropionat 250 μg inhalation | Inhalationsspray, suspension |
| Luxembourg | Glaxosmithkline Pharmaceuticals S.A. | Flixotide | Fluticasonpropionat 50 μg inhalation | Inhalationsspray, suspension |
| Luxembourg | Glaxosmithkline Pharmaceuticals S.A. | Flixotide Diskus | Fluticasonpropionat 100 μg dosis | Inhalationspulver |
| Luxembourg | Glaxosmithkline Pharmaceuticals S.A. | Flixotide Diskus | Fluticasonpropionat 250 μg dosis | Inhalationspulver |
| Luxembourg | Glaxosmithkline Pharmaceuticals S.A. | Flixotide Diskus | Fluticasonpropionat 500 μg dosis | Inhalationspulver |
| Luxembourg | Glaxosmithkline Pharmaceuticals S.A. | Seretide Diskus | Fluticasonpropionat 500 μg dosis, salmeterolxinafoat 50 μg dosis | Inhalationspulver |
| Luxembourg | Nv Astrazeneca Sa | Pulmicort Turbohaler | Budesonid 200 μg dosis | Inhalationspulver |
| Luxembourg | Nv Astrazeneca Sa | Symbicort Turbohaler | Budesonid 160 μg dosis, formoterolfumaratdihydrat 4,5 μg dosis | Inhalationspulver |
| Luxembourg | Nv Astrazeneca Sa | Symbicort Forte Turbohaler | Budesonid 320 μg dosis, formoterolfumaratdihydrat 9 μg dosis | Inhalationspulver |
| Luxembourg | Orion Corporation | Bufomix Easyhaler | Budesonid 160 μg dosis, formoterolfumaratdihydrat Ph.Eur. 4,5  μg dosis | Inhalationspulver |
| Luxembourg | Orion Corporation | Bufomix Easyhaler | Budesonid 320 μg dosis, formoterolfumaratdihydrat Ph.Eur. 9 μg dosis | Inhalationspulver |
| Luxembourg | Orion Corporation | Orest Easyhaler | Budesonid 160 μg dosis, formoterolfumaratdihydrat Ph.Eur. 4,5  μg dosis | Inhalationspulver |
| Luxembourg | Orion Corporation | Orest Easyhaler | Budesonid 320 μg dosis, formoterolfumaratdihydrat Ph.Eur. 9 μg dosis | Inhalationspulver |
| Μalta | Astrazeneca Ab | Pulmicort Turbuhaler | Budesonid 100 μg dosis | Inhalationspulver |
| Μalta | Astrazeneca Ab | Pulmicort Turbuhaler | Budesonid 200 μg dosis | Inhalationspulver |
| Μalta | Astrazeneca Ab | Symbicort Turbohaler | Budesonid 160 μg dosis, formoterolfumaratdihydrat 4,5 μg dosis | Inhalationspulver |
| Μalta | Astrazeneca Ab | Symbicort Turbohaler | Budesonid 320 μg dosis, formoterolfumaratdihydrat 9 μg dosis | Inhalationspulver |
| Μalta | Elpen Pharmaceutical Co. Inc. | Rolenium | Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Μalta | Elpen Pharmaceutical Co. Inc. | Rolenium | Fluticasonpropionat 250 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Μalta | Glaxosmithkline (Ireland) Limited | Flixotide Evohaler | Fluticasonpropionat 250 μg dosis | Inhalationsspray, suspension |
| Μalta | Glaxosmithkline (Ireland) Limited | Seretide Diskus | Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Μalta | Novartis Pharmaceuticals Uk Limited | Miflonide | Budesonide 200 μg Capsule | Inhalationspulver, hård kapsel |
| Μalta | Novartis Pharmaceuticals Uk Limited | Miflonide | Budesonid 400 μg | Inhalationspulver, hård kapsel |
| Μalta | Orion Oyj | Bufomix Easyhaler | Budesonid 160 μg inhalation, formoterolfumaratdihydrat 4,5  μg inhalation | Inhalationspulver |
| Μalta | Orion Oyj | Bufomix Easyhaler | Budesonid 320 μg inhalation, formoterolfumaratdihydrat 9 μg inhalation | Inhalationspulver |
| Μalta | Orion Oyj | Orest Easyhaler | Budesonid 160 μg inhalation, formoterolfumaratdihydrat 4,5  μg inhalation | Inhalationspulver |
| Μalta | Orion Oyj | Orest Easyhaler | Budesonid 320 μg inhalation, formoterolfumaratdihydrat 9 μg inhalation | Inhalationspulver |
| Nederlandene | Astrazeneca Bv | Symbicort Turbuhaler | Budesonid 160 μg dosis, formoterolfumaratdihydrat 4,5 μg dosis | Inhalationspulver |
| Nederlandene | Astrazeneca Bv | Symbicort Turbuhaler | Budesonid 320 μg dosis, formoterolfumaratdihydrat 9 μg dosis | Inhalationspulver |
| Nederlandene | Glaxosmithkline B.V. | Fluticasonpropionaat Inhalator GSK | Fluticasonpropionat 125 μg dosis | Aerosol |
| Nederlandene | Glaxosmithkline B.V. | Fluticasonpropionaat Inhalator GSK | Fluticasonpropionat 250 μg dosis | Aerosol |
| Nederlandene | Glaxosmithkline B.V. | Fluticasonpropionaat Inhalator GSK | Fluticasonpropionat 50 μg dosis | Aerosol |
| Nederlandene | Chiesi Pharmaceuticals B.V. | Formodual | Formoterolfumaratedihydrat 6 μg aktivering, beclometasondipropionat vandfri 100 μg aktivering | Inhalationsspray, opløsning |
| Nederlandene | Chiesi Pharmaceuticals B.V. | Foster | Beclometasondipropionat 100 μg aktivering, formoterolfumaratdihydrat 6 μg aktivering | Inhalationsspray, opløsning |
| Nederlandene | Elpen Pharmaceutical Co. Inc. | Salmeterol/Fluticasonpropionaat Elpen | Fluticasonpropionat 250 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Nederlandene | Elpen Pharmaceutical Co. Inc. | Salmeterol/Fluticasonpropionaat Elpen | Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Nederlandene | Glaxosmithkline B.V. | Flixotide | Fluticasonpropionat 250 μg inhalation | Inhalationsspray, suspension |
| Nederlandene | Glaxosmithkline B.V. | Flixotide Diskus | Fluticasonpropionat 500 μg dosis | Inhalationspulver, afdelt |
| Nederlandene | Glaxosmithkline B.V. | Seretide | Fluticasonpropionat 500 μg dosis, salmeterolxinafoat 50 μg dosis | Inhalationspulver, afdelt |
| Norge | Astrazeneca As | Symbicort Forte Turbuhaler | Budesonid 320 μg dosis, formoterolfumaratdihydrat 9 μg dosis | Inhalationspulver |
| Norge | Astrazeneca As | Symbicort Turbuhaler | Budesonid 160 μg dosis, formoterolfumaratdihydrat 4,5 μg dosis | Inhalationspulver |
| Norge | Chiesi Farmaceutici S.P.A. | Inuxair | Beclometasondipropionat 100 μg aktivering, formoterolfumaratdihydrat 6 μg aktivering | Inhalationsspray, opløsning |
| Norge | Elpen Pharmaceutical Co. Inc. | Salmeson | Fluticasonpropionat 250 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Norge | Elpen Pharmaceutical Co. Inc. | Salmeson | Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Norge | Glaxosmithkline As | Seretide Diskus | Fluticasonpropionat 500 μg dosis, salmeterolxinafoat 50 μg dosis | Inhalationspulver, afdelt |
| Norge | Sandoz A-S | Airflusal Forspiro | Salmeterolxinafoat 50 μg dosis, fluticasonpropionat 250 μg dosis | Inhalationspulver |
| Norge | Sandoz A-S | Airflusal Forspiro | Salmeterolxinafoat 50 μg dosis, fluticasonpropionat 500 μg dosis | Inhalationspulver |
| Polen | Adamed Sp. Z O.O. | Flutixon | Fluticasone Propionate 125 μg Capsule | Inhalationspulver, hård kapsel |
| Polen | Adamed Sp. Z O.O. | Flutixon | Fluticasonpropionat 250 μg kapsel | Inhalationspulver, hård kapsel |
| Polen | Astrazeneca Ab | Pulmicort Turbuhaler | Budesonid 100 μg dosis | Inhalationspulver |
| Polen | Astrazeneca Ab | Pulmicort Turbuhaler | Budesonid 200 μg dosis | Inhalationspulver |
| Polen | Astrazeneca Ab | Symbicort Turbuhaler | Budesonid 160 μg dosis, formoterolfumaratdihydrat 4,5 μg dosis | Inhalationspulver |
| Polen | Astrazeneca Ab | Symbicort Turbuhaler | Budesonid 320 μg dosis, formoterolfumaratdihydrat 9 μg dosis | Inhalationspulver |
| Polen | Celon Pharma S.A. | Salmex | Fluticasonpropionat 500 μg dosis, salmeterolxinafoat 50 μg dosis | Inhalationspulver |
| Polen | Chiesi Pharmaceuticals Gmbh | Formodual | Beclometasondipropionat 100 μg aktivering, formoterolfumaratdihydrat 6 μg aktivering | Inhalationsspray, opløsning |
| Polen | Chiesi Pharmaceuticals Gmbh | Fostex | Beclometasondipropionat 100 μg aktivering, formoterolfumaratdihydrat 6 μg aktivering | Inhalationsspray, opløsning |
| Polen | Elpen Pharmaceutical Co. Inc. | Salmeson | Fluticasonpropionat 250 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Polen | Elpen Pharmaceutical Co. Inc. | Salmeson | Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Polen | Glaxosmithkline Export Ltd | Flixotide | Fluticasonpropionat 250 μg dosis | Inhalationspulver, afdelt |
| Polen | Glaxosmithkline Export Ltd | Flixotide | Fluticasonpropionat 250 μg inhalation | Inhalationsspray, suspension |
| Polen | Glaxosmithkline Export Ltd | Flixotide Dysk | Fluticasonpropionat 50 μg dosis | Inhalationspulver, afdelt |
| Polen | Glaxosmithkline Export Ltd | Seretide Dysk | Fluticasonpropionat 500 μg dosis, salmeterolxinafoat 50 μg dosis | Inhalationspulver |
| Polen | Meda Pharma Gmbh & Co. Kg | Budelin Novolizer | Budesonid 200 μg dosis | Inhalationspulver |
| Polen | Novartis Poland Sp. Z O. O. | Miflonide | Budesonid 200 μg | Inhalationspulver, hård kapsel |
| Polen | Novartis Poland Sp. Z O. O. | Miflonide | Budesonid 400 μg | Inhalationspulver, hård kapsel |
| Polen | Orion Corporation | Orest Easyhaler | Budesonid 160 μg inhalation, formoterolfumaratdihydrat 4,5  μg inhalation | Inhalationspulver |
| Polen | Orion Corporation | Orest Easyhaler | Budesonid 320 μg inhalation, formoterolfumaratdihydrat 9 μg inhalation | Inhalationspulver |
| Polen | Polfarmex S.A. | Asaris | Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis | Inhalationspulver |
| Polen | Przedsiębiorstwo Farmaceutyczne Lek-Am Sp. Z O.O. | Budezonid Lek-Am | Budesonid 200 μg inhalation | Inhalationspulver, hård kapsel |
| Polen | Przedsiębiorstwo Farmaceutyczne Lek-Am Sp. Z O.O. | Budezonid Lek-Am | Budesonid 400 μg inhalation | Inhalationspulver, hård kapsel |
| Portugal | Astrazeneca Produtos Farmacêuticos, Lda. | Assieme Turbohaler | Budesonid 160 μg dosis, formoterolfumaratdihydrat 4,5 μg dosis | Inhalationspulver |
| Portugal | Astrazeneca Produtos Farmacêuticos, Lda. | Assieme Turbohaler | Budesonid 320 μg dosis, formoterolfumaratdihydrat 9 μg dosis | Inhalationspulver |
| Portugal | Astrazeneca Produtos Farmaceuticos Limitada | Pulmicort Turbohaler | Budesonid 200 μg dosis | Inhalationspulver |
| Portugal | Astrazeneca Produtos Farmaceuticos Limitada | Pulmicort Turbohaler | Budesonid 400 μg dosis | Inhalationspulver |
| Portugal | Astrazeneca Produtos Farmacêuticos, Lda. | Symbicort Turbohaler | Budesonid 160 μg dosis, formoterolfumaratdihydrat 4,5 μg dosis | Inhalationspulver |
| Portugal | Astrazeneca Produtos Farmacêuticos, Lda. | Symbicort Turbohaler | Budesonid 320 μg dosis, formoterolfumaratdihydrat 9 μg dosis | Inhalationspulver |
| Portugal | Bialfar — Produtos Farmacêuticos, Sociedade Anónima | Brisomax Diskus | Fluticasonpropionat 100 μg dosis, salmeterolxinafoat 50 μg dosis | Inhalationspulver, afdelt |
| Portugal | Bialfar — Produtos Farmacêuticos, Sociedade Anónima | Brisomax Diskus | Fluticasonpropionat 250 μg dosis, salmeterolxinafoat 50 μg dosis | Inhalationspulver, afdelt |
| Portugal | Bialfar — Produtos Farmacêuticos, Sociedade Anónima | Brisomax Diskus | Fluticasonpropionat 500 μg dosis, salmeterolxinafoat 50 μg dosis | Inhalationspulver, afdelt |
| Portugal | Elpen Pharmaceutical Co. Inc. | Dimenium | Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Portugal | Elpen Pharmaceutical Co. Inc. | Dimenium | Fluticasonpropionat 250 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Portugal | Farmoz — Sociedade Técnico Medicinal, S.A. | Budesonida Farmoz | Budesonid 200 μg dosis | Inhalationspulver |
| Portugal | Farmoz — Sociedade Técnico Medicinal, S.A. | Budesonida Farmoz | Budesonid 400 μg dosis | Inhalationspulver |
| Portugal | Glaxo Wellcome Farmacêutica, Limitada | Seretaide Diskus | Fluticasonpropionat 500 μg dosis, salmeterolxinafoat 50 μg dosis | Inhalationspulver, afdelt |
| Portugal | Glaxosmithkline — Produtos Farmacêuticos, Limitada | Maizar Diskus | Fluticasonpropionat 500 μg dosis, salmeterolxinafoat 50 μg dosis | Inhalationspulver, afdelt |
| Portugal | Orion Corporation | Bufomix Easyhaler | Budesonid 160 μg dosis, formoterolfumaratdihydrat 4,5 μg dosis | Inhalationspulver |
| Portugal | Orion Corporation | Bufomix Easyhaler | Budesonid 320 μg dosis, formoterolfumaratdihydrat 9 μg dosis | Inhalationspulver |
| Portugal | Orion Corporation | Orest Easyhaler | Budesonid 160 μg dosis, formoterolfumaratdihydrat 4,5 μg dosis | Inhalationspulver |
| Portugal | Orion Corporation | Orest Easyhaler | Budesonid 320 μg dosis, formoterolfumaratdihydrat 9 μg dosis | Inhalationspulver |
| Portugal | Pentafarma — Sociedade Tecnico-Medicinal S.A. | Budesonida Tecnicort | Budesonid 200 μg dosis | Inhalationspulver |
| Portugal | Pentafarma — Sociedade Tecnico-Medicinal S.A. | Budesonida Tecnicort | Budesonid 400 μg dosis | Inhalationspulver |
| Portugal | Sandoz Farmacêutica, Limitada | Airflusal Forspiro | Fluticasonpropionat 250 μg dosis, salmeterolxinafoat 50 μg dosis | Inhalationspulver, afdelt |
| Portugal | Sandoz Farmacêutica, Limitada | Airflusal Forspiro | Fluticasonpropionat 500 μg dosis, salmeterolxinafoat 50 μg dosis | Inhalationspulver, afdelt |
| Rumænien | Astrazeneca Ab | Symbicort Turbuhaler | Budesonid 160 μg dosis, formoterolfumaratdihydrat 4,5 μg dosis | Inhalationspulver |
| Rumænien | Astrazeneca Ab | Symbicort Turbuhaler | Budesonid 320 μg dosis, formoterolfumaratdihydrat 9 μg dosis | Inhalationspulver |
| Rumænien | Chiesi Pharmaceuticals Gmbh | Foster | Formoterolfumaratedihydrat 6 μg aktivering, beclometasondipropionat vandfri 100 μg aktivering | Inhalationsspray, opløsning |
| Rumænien | Elpen Pharmaceutical Co. Inc. | Flusamer | Fluticasonpropionat 250 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Rumænien | Elpen Pharmaceutical Co. Inc. | Flusamer | Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Rumænien | Glaxo Wellcome Ltd | Flixotide | Fluticasonpropionat 250 μg inhalation | Inhalationsspray, suspension |
| Rumænien | Glaxo Wellcome Ltd | Flixotide Diskus | Fluticasonpropionat 250 μg dosis | Inhalationspulver |
| Rumænien | Glaxo Wellcome Ltd | Flixotide Diskus | Fluticasonpropionat 500 μg dosis | Inhalationspulver |
| Rumænien | Glaxo Wellcome Ltd | Seretide | Fluticasonpropionat 500 μg dosis, salmeterolxinafoat 50 μg dosis | Inhalationspulver, afdelt |
| Rumænien | Medochemie Romania S.R.L. | Frenolyn | Budesonid, mikroniseret 200 μg dosis | Inhalationspulver |
| Rumænien | Medochemie Romania S.R.L. | Frenolyn | Budesonid, mikroniseret 400 μg dosis | Inhalationspulver |
| Rumænien | Orion Oyj | Bufomix Easyhaler | Budesonid 160 μg inhalation, formoterolfumaratdihydrat 4,5  μg inhalation | Inhalationspulver |
| Rumænien | Orion Oyj | Bufomix Easyhaler | Budesonid 320 μg inhalation, formoterolfumaratdihydrat 9 μg inhalation | Inhalationspulver |
| Rumænien | S.C. Sandoz S.R.L. | Airflusal Forspiro | Salmeterolxinafoat 50 μg dosis, fluticason 500 μg dosis | Inhalationspulver |
| Slovakiet | Astrazeneca Ab | Pulmicort Turbohaler | Budesonid 100 μg dosis | Inhalationspulver |
| Slovakiet | Astrazeneca Ab | Pulmicort Turbohaler | Budesonid 200 μg dosis | Inhalationspulver |
| Slovakiet | Astrazeneca Ab | Pulmicort Turbohaler | Budesonid 400 μg dosis | Inhalationspulver |
| Slovakiet | Astrazeneca Ab | Symbicort Turbuhaler | Budesonid 160 μg dosis, formoterolfumaratdihydrat 4,5 μg dosis | Inhalationspulver |
| Slovakiet | Astrazeneca Ab | Symbicort Turbuhaler | Budesonid 320 μg dosis, formoterolfumaratdihydrat 9 μg dosis | Inhalationspulver |
| Slovakiet | Chiesi Pharmaceuticals Gmbh | Foster | Beclometasondipropionat 100 μg aktivering, formoterolfumaratdihydrat 6 μg aktivering | Inhalationsspray, opløsning |
| Slovakiet | Elpen Pharmaceutical Co. Inc. | Dimenium | Fluticasonpropionat 250 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Slovakiet | Elpen Pharmaceutical Co. Inc. | Dimenium | Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Slovakiet | Elpen Pharmaceutical Co. Inc. | Flumetor | Fluticasonpropionat 250 μg dosis, salmeterolxinafoat 50 μg dosis | Inhalationspulver, afdelt |
| Slovakiet | Elpen Pharmaceutical Co. Inc. | Flumetor | Fluticasonpropionat 500 μg dosis, salmeterolxinafoat 50 μg dosis | Inhalationspulver, afdelt |
| Slovakiet | Glaxo Group Limited | Flixotide | Fluticasonpropionat 125 μg inhalation | Inhalationsspray, suspension |
| Slovakiet | Glaxo Group Limited | Flixotide | Fluticasonpropionat 250 μg inhalation | Inhalationsspray, suspension |
| Slovakiet | Glaxo Group Limited | Flixotide | Fluticasonpropionat 50 μg inhalation | Inhalationsspray, suspension |
| Slovakiet | Glaxo Group Limited | Seretide | Fluticasonpropionat 500 μg dosis, salmeterolxinafoat 50 μg dosis | Inhalationspulver, afdelt |
| Slovakiet | Glaxosmithkline Slovakia S.R.O. | Flixotide Diskus | Fluticasonpropionat 100 μg dosis | Inhalationspulver |
| Slovakiet | Glaxosmithkline Slovakia S.R.O. | Flixotide Diskus | Fluticasonpropionat 250 μg dosis | Inhalationspulver |
| Slovakiet | Glaxosmithkline Slovakia S.R.O. | Flixotide Diskus | Fluticasonpropionat 500 μg dosis | Inhalationspulver |
| Slovakiet | Glaxosmithkline Slovakia S.R.O. | Flixotide Diskus | Fluticasonpropionat 50 μg dosis | Inhalationspulver |
| Slovakiet | Meda Pharma Spol. S R.O. | Budelin Novolizer | Budesonid 200 μg dosis | Inhalationspulver |
| Slovakiet | Novartis, S.R.O. | Miflonid | Budesonid 200 μg | Inhalationspulver, hård kapsel |
| Slovakiet | Novartis, S.R.O. | Miflonid | Budesonid 400 μg | Inhalationspulver, hård kapsel |
| Slovakiet | Sandoz Pharmaceuticals D.D. | Airflusal Forspiro | Salmeterolxinafoat 50 μg dosis, fluticason 250 μg dosis | Inhalationspulver |
| Slovakiet | Sandoz Pharmaceuticals D.D. | Airflusal Forspiro | Salmeterolxinafoat 50 μg dosis, fluticason 500 μg dosis | Inhalationspulver |
| Slovenien | Astrazeneca Ab | Symbicort Turbuhaler | Budesonid 160 μg dosis, formoterolfumaratdihydrat 4,5 μg dosis | Inhalationspulver |
| Slovenien | Astrazeneca Ab | Symbicort Turbuhaler | Budesonid 320 μg dosis, formoterolfumaratdihydrat 9 μg dosis | Inhalationspulver |
| Slovenien | Chiesi Pharmaceuticals Gmbh | Formodual | Beclometasondipropionat 100 μg aktivering, formoterolfumaratdihydrat 6 μg aktivering | Inhalationsspray, opløsning |
| Slovenien | Chiesi Pharmaceuticals Gmbh | Foster | Beclometasondipropionat 100 μg aktivering, formoterolfumaratdihydrat 6 μg aktivering | Inhalationsspray, opløsning |
| Slovenien | Elpen Pharmaceutical Co. Inc. | Flamerio | Fluticasonpropionat 250 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Slovenien | Elpen Pharmaceutical Co. Inc. | Flamerio | Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Slovenien | Glaxosmithkline D.O.O., Ljubljana | Flixotide | Fluticasone Propionate 250 μg Spray | Inhalationsspray, suspension |
| Slovenien | Glaxosmithkline D.O.O., Ljubljana | Seretide Diskus | Fluticasonpropionat 500 μg dosis, salmeterolxinafoat 50 μg dosis | Inhalationspulver, afdelt |
| Slovenien | Lek Pharmaceuticals D.D. Ljubljana | Airflusan Forspiro | Salmeterol 50 μg Dose, Fluticasone Propionate 500 μg Dose | Inhalationspulver |
| Slovenien | Meda Pharma Gmbh & Co. Kg | Budelin Novolizer | Budesonid 200 μg dosis | Inhalationspulver, afdelt |
| Spanien | Allen Farmaceutica, S.A. | Anasma Accuhaler | Fluticasonpropionat 250 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Spanien | Almirall, S.A. | Plusvent | Fluticasonpropionat 50 μg dosis, salmeterolxinafoat 25 μg dosis | Inhalationsspray, suspension |
| Spanien | Almirall, S.A. | Plusvent | Fluticasonpropionat 250 μg dosis, salmeterolxinafoat 25 μg dosis | Inhalationsspray, suspension |
| Spanien | Almirall, S.A. | Plusvent | Fluticasonpropionat 125 μg dosis, salmeterolxinafoat 25 μg dosis | Inhalationsspray, suspension |
| Spanien | Almirall, S.A. | Plusvent | Fluticasonpropionat 100 μg dosis, salmeterolxinafoat 50 μg dosis | Inhalationspulver, afdelt |
| Spanien | Almirall, S.A. | Plusvent | Fluticasonpropionat 250 μg dosis, salmeterolxinafoat 50 μg dosis | Inhalationspulver, afdelt |
| Spanien | Almirall, S.A. | Plusvent | Fluticasonpropionat 500 μg dosis, salmeterolxinafoat 50 μg dosis | Inhalationspulver, afdelt |
| Spanien | Astrazeneca Farmacéutica Spain, S.A. | Pulmicort Turbuhaler | Budesonid 100 μg dosis | Inhalationspulver |
| Spanien | Astrazeneca Farmacéutica Spain, S.A. | Pulmicort Turbuhaler | Budesonid 200 μg dosis | Inhalationspulver |
| Spanien | Astrazeneca Farmacéutica Spain, S.A. | Pulmicort Turbuhaler | Budesonid 400 μg dosis | Inhalationspulver |
| Spanien | Astrazeneca Farmacéutica Spain, S.A. | Symbicort Turbuhaler | Budesonid 160 μg dosis, formoterolfumaratdihydrat 4,5 μg dosis | Inhalationspulver |
| Spanien | Astrazeneca Farmacéutica Spain, S.A. | Symbicort Turbuhaler | Budesonid 320 μg dosis, formoterolfumaratdihydrat 9 μg dosis | Inhalationspulver |
| Spanien | Chiesi España, S.A. | Formodual | Beclometasondipropionat 100 μg aktivering, formoterolfumaratdihydrat 6 μg aktivering | Inhalationsspray, opløsning |
| Spanien | Chiesi España, S.A. | Foster | Beclometasondipropionat 100 μg aktivering, formoterolfumaratdihydrat 6 μg dosis | Inhalationsspray, opløsning |
| Spanien | Glaxosmithkline S.A. | Brisair Accuhaler | Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Spanien | Glaxosmithkline S.A. | Brisair Accuhaler | Fluticasonpropionat 500 μg dosis, salmeterolxinafoat 50 μg dosis | Inhalationspulver, afdelt |
| Spanien | Glaxosmithkline S.A. | Flixotide | Fluticasonpropionat 125 μg inhalation | Inhalationsspray, suspension |
| Spanien | Glaxosmithkline S.A. | Flixotide | Fluticasonpropionat 250 μg inhalation | Inhalationsspray, suspension |
| Spanien | Glaxosmithkline S.A. | Flixotide | Fluticasonpropionat 50 μg inhalation | Inhalationsspray, suspension |
| Spanien | Glaxosmithkline S.A. | Flixotide Accuhaler | Fluticasonpropionat 100 μg dosis | Inhalationspulver |
| Spanien | Glaxosmithkline S.A. | Flixotide Accuhaler | Fluticasonpropionat 250 μg dosis | Inhalationspulver |
| Spanien | Glaxosmithkline S.A. | Flixotide Accuhaler | Fluticasonpropionat 500 μg dosis | Inhalationspulver |
| Spanien | Glaxosmithkline S.A. | Flusonal | Fluticasonpropionat 250 μg inhalation | Inhalationsspray, suspension |
| Spanien | Glaxosmithkline S.A. | Flusonal | Fluticasonpropionat 50 μg inhalation | Inhalationsspray, suspension |
| Spanien | Glaxosmithkline S.A. | Flusonal Accuhaler | Fluticasonpropionat 100 μg dosis | Inhalationspulver |
| Spanien | Glaxosmithkline S.A. | Flusonal Accuhaler | Fluticasonpropionat 500 μg dosis | Inhalationspulver |
| Spanien | Glaxosmithkline S.A. | Inalacor | Fluticasonpropionat 250 μg inhalation | Inhalationsspray, suspension |
| Spanien | Glaxosmithkline S.A. | Inalacor | Fluticasonpropionat 50 μg dosis | Inhalationsspray, suspension |
| Spanien | Glaxosmithkline S.A. | Inalacor Accuhaler | Fluticasonpropionat 100 μg dosis | Inhalationspulver |
| Spanien | Glaxosmithkline S.A. | Inalacor Accuhaler | Fluticasonpropionat 500 μg dosis | Inhalationspulver |
| Spanien | Glaxosmithkline S.A. | Inaladuo Accuhaler | Fluticasonpropionat 500 μg dosis, salmeterolxinafoat 50 μg dosis | Inhalationspulver, afdelt |
| Spanien | Glaxosmithkline S.A. | Seretide Accuhaler | Fluticasonpropionat 500 μg dosis, salmeterolxinafoat 50 μg dosis | Inhalationspulver, afdelt |
| Spanien | Laboratorio Tau, S.A. | Rilast Turbuhaler | Budesonid 160 μg dosis, formoterolfumaratdihydrat 4,5 μg dosis | Inhalationspulver |
| Spanien | Orion Corporation | Bufomix Easyhaler | Budesonid 160 μg inhalation, formoterolfumaratdihydrat 4,5  μg inhalation | Inhalationspulver |
| Spanien | Orion Corporation | Bufomix Easyhaler | Budesonid 320 μg inhalation, formoterolfumaratdihydrat 9 μg inhalation | Inhalationspulver |
| Spanien | Orion Corporation | Orest Easyhaler | Budesonid 160 μg inhalation, formoterolfumaratdihydrat 4,5  μg inhalation | Inhalationspulver |
| Spanien | Orion Corporation | Orest Easyhaler | Budesonid 320 μg inhalation, formoterolfumaratdihydrat 9 μg inhalation | Inhalationspulver |
| Spanien | Smithkline Beecham Farma S.A. | Trialona | Fluticasonpropionat 250 μg dosis | Inhalationsspray, suspension |
| Spanien | Smithkline Beecham Farma S.A. | Trialona | Fluticasonpropionat 50 μg dosis | Inhalationsspray, suspension |
| Spanien | Smithkline Beecham Farma S.A. | Trialona Accuhaler | Fluticasonpropionat 100 μg dosis | Inhalationspulver |
| Spanien | Smithkline Beecham Farma S.A. | Trialona Accuhaler | Fluticasonpropionat 500 μg dosis | Inhalationspulver |
| Sverige | Astrazeneca Ab | Gardette | Budesonid 160 μg dosis, formoterolfumaratdihydrat 4,5 μg dosis | Inhalationspulver |
| Sverige | Astrazeneca Ab | Gardette Forte | Budesonid 160 μg dosis, formoterolfumaratdihydrat 4,5 μg dosis | Inhalationspulver |
| Sverige | Astrazeneca Ab | Symbicort Forte Turbuhaler | Budesonid 320 μg dosis, formoterolfumaratdihydrat 9 μg dosis | Inhalationspulver |
| Sverige | Astrazeneca Ab | Symbicort Turbuhaler | Budesonid 160 μg dosis, formoterolfumaratdihydrat 4,5 μg dosis | Inhalationspulver |
| Sverige | Chiesi Farmaceutici S.P.A. | Innovair | Beclometasondipropionat 100 μg aktivering, formoterolfumaratdihydrat 6 μg aktivering | Inhalationsspray, opløsning |
| Sverige | Elpen Pharmaceutical Co. Inc. | Flusamer | Fluticasonpropionat 250 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Sverige | Elpen Pharmaceutical Co. Inc. | Flusamer | Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Sverige | Elpen Pharmaceutical Co. Inc. | Flusaterol | Fluticasonpropionat 250 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Sverige | Elpen Pharmaceutical Co. Inc. | Flusaterol | Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Sverige | Elpen Pharmaceutical Co. Inc. | Relanio | Fluticasonpropionat 250 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Sverige | Elpen Pharmaceutical Co. Inc. | Relanio | Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Sverige | Elpen Pharmaceutical Co. Inc. | Salmeson | Fluticasonpropionat 250 μg dosis, salmeterol 50 μg dosis, lactosemonohydrat 24,677  mg dosis | Inhalationspulver, afdelt |
| Sverige | Elpen Pharmaceutical Co. Inc. | Salmeson | Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Sverige | Glaxosmithkline Ab | Flutide Diskus | Fluticasonpropionat 250 μg dosis | Inhalationspulver, afdelt |
| Sverige | Glaxosmithkline Ab | Flutide Diskus | Fluticasonpropionat 500 μg dosis | Inhalationspulver, afdelt |
| Sverige | Glaxosmithkline Ab | Seretide Diskus | Fluticasonpropionat 500 μg dosis, salmeterolxinafoat 50 μg dosis | Inhalationspulver, afdelt |
| Sverige | Glaxosmithkline Ab | Viani Diskus Forte | Fluticasonpropionat 500 μg dosis, salmeterolxinafoat 50 μg dosis | Inhalationspulver, afdelt |
| Sverige | Hexal Ag | Salmeterol/Fluticasone Hexal | Salmeterolxinafoat 50 μg dosis, fluticason 500 μg dosis | Inhalationspulver |
| Sverige | Orion Corporation | Bufomix Easyhaler | Budesonid 160 μg inhalation, formoterolfumaratdihydrat 4,5  μg inhalation | Inhalationspulver |
| Sverige | Orion Corporation | Bufomix Easyhaler | Budesonid 320 μg inhalation, formoterolfumaratdihydrat 9 μg inhalation | Inhalationspulver |
| Sverige | Orion Corporation | Orest Easyhaler | Budesonid 160 μg inhalation, formoterolfumaratdihydrat 4,5  μg inhalation | Inhalationspulver |
| Sverige | Orion Corporation | Orest Easyhaler | Budesonid 320 μg inhalation, formoterolfumaratdihydrat 9 μg inhalation | Inhalationspulver |
| Sverige | Sandoz A-S | Aesalfluca Forspiro | Salmeterolxinafoat 50 μg dosis, fluticason 500 μg dosis | Inhalationspulver |
| Sverige | Sandoz A-S | Airflusal Forspiro | Fluticasonpropionat 250 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Sverige | Sandoz A-S | Airflusal Forspiro | Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis | Inhalationspulver, afdelt |
| Sverige | Sandoz A-S | Flaxxone Forspiro | Salmeterolxinafoat 50 μg dosis, fluticason 250 μg dosis | Inhalationspulver |
| Sverige | Sandoz A-S | Flaxxone Forspiro | Salmeterolxinafoat 50 μg dosis, fluticason 500 μg dosis | Inhalationspulver |
| Sverige | Sandoz A-S | Lastenol Forspiro | Fluticasonpropionat 500 mikrogram, salmeterolxinafoat 50 mikrogram | Inhalationspulver |
| Sverige | Sandoz A-S | Molduo Forspiro | Salmeterolxinafoat 50 μg dosis, fluticason 250 μg dosis | Inhalationspulver |
| Sverige | Sandoz A-S | Salmetorol/Fluticasone Sandoz | Salmeterolxinafoat 50 μg dosis, fluticason 500 μg dosis | Inhalationspulver |
| Sverige | Sandoz A-S | Setirenol | Salmeterolxinafoat 50 μg dosis, fluticason 250 μg dosis | Inhalationspulver |
| Sverige | Sandoz A-S | Setirenol | Salmeterolxinafoat 50 μg dosis, fluticason 500 μg dosis | Inhalationspulver |
| Det Forenede Kongerige | Astrazeneca Uk Limited | Symbicort Turbohaler | Budesonid 320 μg dosis, formoterolfumaratdihydrat 9 μg dosis | Inhalationspulver |
| Det Forenede Kongerige | Astrazeneca Uk Limited | Symbicort Turbohaler | Budesonid 160 μg dosis, formoterolfumaratdihydrat 4,5 μg dosis | Inhalationspulver |
| Det Forenede Kongerige | Chiesi Limited | Formodual | Beclometasondipropionat 100 μg aktivering, formoterolfumaratdihydrat 6 μg aktivering | Inhalationsspray, opløsning |
| Det Forenede Kongerige | Chiesi Limited | Fostair | Beclometasondipropionat 100 μg aktivering, formoterolfumaratdihydrat 6 μg aktivering | Inhalationsspray, opløsning |
| Det Forenede Kongerige | Glaxo Wellcome Ltd | Seretide | Fluticasonpropionat 100 μg dosis, salmeterolxinafoat 50 μg dosis | Inhalationspulver, afdelt |
| Det Forenede Kongerige | Glaxo Wellcome Ltd | Seretide | Fluticasonpropionat 250 μg dosis, salmeterolxinafoat 50 μg dosis | Inhalationspulver, afdelt |
| Det Forenede Kongerige | Glaxo Wellcome Ltd | Seretide Accuhaler | Fluticasonpropionat 500 μg dosis, salmeterolxinafoat 50 μg dosis | Inhalationspulver, afdelt |

Medlemsstat i EØS

Indehaver af markedsføringstilladelsen

Lægemidlets navn

Aktivt stof og styrke

Lægemiddelform

Østrig

3m Health Care Ltd

Aerocortin

Beclometason dipropionat 50 μg/50 μl

Inhalationsspray, opløsning

Østrig

Allen Pharmazeutika Gesellschaft M.B.H.

Fluticasonpropionat

Fluticasonpropionat 50 μg dosis

Inhalationsspray, suspension

Østrig

Allen Pharmazeutika Gesellschaft M.B.H.

Fluticasonpropionat Diskus Forte Allen

Fluticasonpropionat 500 μg dosis

Inhalationspulver

Østrig

Allen Pharmazeutika Gesellschaft M.B.H.

Fluticasonpropionat Diskus Junior Allen

Fluticasonpropionat 100 μg dosis

Inhalationspulver

Østrig

Allen Pharmazeutika Gesellschaft M.B.H.

Fluticasonpropionat »allen«

Fluticasonpropionat 125 μg dosis

Inhalationsspray, suspension

Østrig

Allen Pharmazeutika Gesellschaft M.B.H.

Fluticasonpropionat »allen«

Fluticasonpropionat 250 μg dosis

Inhalationspulver

Østrig

Allen Pharmazeutika Gesellschaft M.B.H.

Fluticasonpropionat »allen«

Fluticasonpropionat 250 μg dosis

Inhalationsspray, suspension

Østrig

Allen Pharmazeutika Gesellschaft M.B.H.

Samtoral Diskus Standard

Fluticasonpropionat 250 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Østrig

Astrazeneca österreich Gmbh

Pulmicort

Budesonid 400 μg dosis

Inhalationspulver

Østrig

Astrazeneca österreich Gmbh

Pulmicort Turbohaler

Budesonid 100 μg dosis

Inhalationspulver

Østrig

Astrazeneca österreich Gmbh

Pulmicort Turbohaler

Budesonid 200 μg dosis

Inhalationspulver

Østrig

Astrazeneca österreich Gmbh

Pulmicort Turbohaler

Budesonid 400 μg dosis

Inhalationspulver

Østrig

Astrazeneca österreich Gmbh

Symbicort Forte Turbohaler

Budesonid 320 μg dosis, formoterolfumaratdihydrat 9 μg dosis

Inhalationspulver

Østrig

Astrazeneca österreich Gmbh

Symbicort Turbohaler

Budesonid 160 μg dosis, formoterolfumaratdihydrat 4,5 μg dosis

Inhalationspulver

Østrig

Chiesi Pharmaceuticals Gmbh

Budiair

Budesonid 0,2  mg/0,05  ml

Inhalationsspray, opløsning

Østrig

Chiesi Pharmaceuticals Gmbh

Budiair Jet

Budesonid 0,2  mg/0,05  ml

Inhalationsspray, opløsning

Østrig

Chiesi Pharmaceuticals Gmbh

Foster

Beclometasondipropionat 100 μg aktivering, formoterolfumaratdihydrat 6 μg aktivering

Inhalationsspray, opløsning

Østrig

Elpen Pharmaceutical Co. Inc.

Salmeson

Fluticasonpropionat 250 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Østrig

Elpen Pharmaceutical Co. Inc.

Salmeson

Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Østrig

Glaxosmithkline Pharma Gmbh.

Flixotide

Fluticasonpropionat 125 μg inhalation

Inhalationsspray, suspension

Østrig

Glaxosmithkline Pharma Gmbh.

Flixotide

Fluticasonpropionat 250 μg dosis

Inhalationspulver, afdelt

Østrig

Glaxosmithkline Pharma Gmbh.

Flixotide

Fluticasonpropionat 250 μg inhalation

Inhalationsspray, suspension

Østrig

Glaxosmithkline Pharma Gmbh.

Flixotide Diskus Forte

Fluticasonpropionat 500 μg dosis

Inhalationspulver

Østrig

Glaxosmithkline Pharma Gmbh.

Flixotide Diskus Junior

Fluticasonpropionat 100 μg dosis

Inhalationspulver

Østrig

Glaxosmithkline Pharma Gmbh.

Flixotide Junior

Fluticasonpropionat 125 μg inhalation

Inhalationsspray, suspension

Østrig

Glaxosmithkline Pharma Gmbh.

Seretide Diskus

Fluticasonpropionat 500 μg dosis, salmeterolxinafoat 50 μg dosis

Inhalationspulver, afdelt

Østrig

Pari Pharma Gmbh

Buparid

Budesonid 0,25  mg ampul

Inhalationsvæske til nebulisator, suspension

Østrig

Pari Pharma Gmbh

Buparid

Budesonid 0,5  mg ampul

Inhalationsvæske til nebulisator, suspension

Østrig

Pari Pharma Gmbh

Buparid

Budesonid 1 mg ampul

Inhalationsvæske til nebulisator, suspension

Østrig

Sandoz Gmbh

Airflusal Forspiro

Fluticasonpropionat 233 μg dosis, salmeterol 45 μg dosis

Inhalationspulver

Østrig

Sandoz Gmbh

Airflusal Forspiro

Fluticasonpropionat 465 μg dosis, salmeterol 45 μg dosis

Inhalationspulver

Belgien

Chiesi Sa-Nv

Inuvair

Formoterolfumaratedihydrat 6 μg aktivering, beclometasondipropionat vandfri 100 μg aktivering

Inhalationsspray, opløsning

Belgien

Cipla Europe Nv

Salmeterol/Fluticasone Cipla

Salmeterol 25 μg/dosis, fluticasonpropionat 125 μg/dosis

Inhalationsspray, suspension

Belgien

Elpen Pharmaceutical Co. Inc.

Flusalio

Fluticasonpropionat 250 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Belgien

Elpen Pharmaceutical Co. Inc.

Flusalio

Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Belgien

Glaxosmithkline Pharmaceuticals S.A.

Flixotide

Fluticasonpropionat 0,05  mg/2 ml

Inhalationsvæske til nebulisator, opløsning

Belgien

Glaxosmithkline Pharmaceuticals S.A.

Flixotide

Fluticasonpropionat 250 μg inhalation

Inhalationsspray, suspension

Belgien

Glaxosmithkline Pharmaceuticals S.A.

Flixotide

Fluticasonpropionat 2 mg/2 ml

Inhalationsvæske til nebulisator, opløsning

Belgien

Glaxosmithkline Pharmaceuticals S.A.

Flixotide

Fluticasonpropionat 50 μg inhalation

Inhalationsspray, suspension

Belgien

Glaxosmithkline Pharmaceuticals S.A.

Flixotide Diskus

Fluticasonpropionat 100 μg dosis

Inhalationspulver

Belgien

Glaxosmithkline Pharmaceuticals S.A.

Flixotide Diskus

Fluticasonpropionat 250 μg dosis

Inhalationspulver

Belgien

Glaxosmithkline Pharmaceuticals S.A.

Flixotide Diskus

Fluticasonpropionat 500 μg dosis

Inhalationspulver

Belgien

Glaxosmithkline Pharmaceuticals S.A.

Seretide Diskus

Fluticasonpropionat 500 μg dosis, salmeterolxinafoat 50 μg dosis

Inhalationspulver, afdelt

Belgien

Nv Astrazeneca Sa

Pulmicort Turbohaler

Budesonid 200 μg dosis

Inhalationspulver

Belgien

Nv Astrazeneca Sa

Symbicort Forte Turbohaler

Budesonid 320 μg dosis, formoterolfumaratdihydrat 9 μg dosis

Inhalationspulver

Belgien

Nv Astrazeneca Sa

Symbicort Turbohaler

Budesonid 160 μg dosis, formoterolfumaratdihydrat 4,5 μg dosis

Inhalationspulver

Belgien

Orion Corporation

Bufomix Easyhaler

Budesonid 160 μg inhalation, formoterolfumaratdihydrat 4,5  μg inhalation

Inhalationspulver

Belgien

Orion Corporation

Bufomix Easyhaler

Budesonid 320 μg inhalation, , formoterolfumaratdihydrat 9 μg inhalation

Inhalationspulver

Belgien

Pari Pharma Gmbh

Buparid

Budesonid 0,25  mg ampul

Inhalationsvæske til nebulisator, suspension

Belgien

Pari Pharma Gmbh

Buparid

Budesonid 0,5  mg ampul

Inhalationsvæske til nebulisator, suspension

Belgien

Pari Pharma Gmbh

Buparid

Budesonid 1 mg ampul

Inhalationsvæske til nebulisator, suspension

Belgien

Sandoz N.V.

Airflusal Forspiro

Salmeterolxinafoat 50 μg dosis, fluticason 500 μg dosis

Inhalationspulver

Bulgarien

Astrazeneca Ab

Symbicort Turbuhaler

Budesonid 160 μg dosis, formoterolfumaratdihydrat 4,5 μg dosis

Inhalationspulver

Bulgarien

Astrazeneca Ab

Symbicort Turbuhaler

Budesonid 320 μg dosis, formoterolfumaratdihydrat 9 μg dosis

Inhalationspulver

Bulgarien

Chiesi Pharmaceuticals Gmbh

Foster

Formoterolfumaratedihydrat 6 μg aktivering, beclometasondipropionat vandfri 100 μg aktivering

Inhalationsspray, opløsning

Bulgarien

Elpen Pharmaceutical Co. Inc.

Flusamer

Fluticasonpropionat 250 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Bulgarien

Elpen Pharmaceutical Co. Inc.

Flusamer

Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Bulgarien

Glaxosmithkline Eood

Seretide Diskus

Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Bulgarien

Orion Oyj

Bufomix Easyhaler

Budesonid 160 μg inhalation, formoterolfumaratdihydrat 4,5  μg inhalation

Inhalationspulver

Bulgarien

Orion Oyj

Bufomix Easyhaler

Budesonid 320 μg inhalation, formoterolfumaratdihydrat 9 μg inhalation

Inhalationspulver

Bulgarien

Sandoz Pharmaceuticals D.D.

Airflusal Forspiro

Salmeterolxinafoat 50 μg dosis, fluticason 500 μg dosis

Inhalationspulver

Bulgarien

Sopharma Ad

Flixotide

Fluticasonpropionat 250 μg inhalation

Inhalationsspray, suspension

Kroatien

Astrazeneca D.O.O

Symbicort Turbuhaler

Budesonid 160 μg dosis, formoterolfumaratdihydrat 4,5 μg dosis

Inhalationspulver

Kroatien

Astrazeneca D.O.O

Symbicort Turbuhaler

Budesonid 160 μg dosis, formoterolfumaratdihydrat 4,5 μg dosis

Inhalationspulver

Kroatien

Clinres Farmacija D.O.O.

Dimenium

Fluticasonpropionat 100 mcg dosis, salmeterolxinafoat 50 mcg dosis

Inhalationspulver, afdelt

Kroatien

Clinres Farmacija D.O.O.

Dimenium

Fluticasonpropionat 250 mcg dosis, Salmeterolxinafoat 50 mcg dosis

Inhalationspulver, afdelt

Kroatien

Clinres Farmacija D.O.O.

Dimenium

Fluticasonpropionat 500 mcg dosis, salmeterolxinafoat 50 mcg dosis

Inhalationspulver, afdelt

Kroatien

Glaxosmithkline D.O.O.

Salmeterol/Flutikazonpropionat Diskus Glaxosmithkline

Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Kroatien

Glaxosmithkline D.O.O.

Seretide Diskus

Fluticasonpropionat 500 μg dosis, salmeterolxinafoat 50 μg dosis

Inhalationspulver, afdelt

Kroatien

Providens D.O.O.

Foster

Formoterolfumaratedihydrat 6 μg aktivering, beclometasondipropionat vandfri 100 μg aktivering

Inhalationsspray, opløsning

Kroatien

Salvus D.O.O.

Saldisk

Fluticasonpropionat 100 mcg dosis, salmeterolxinafoat 50 mcg dosis

Inhalationspulver, afdelt

Kroatien

Salvus D.O.O.

Saldisk

Fluticasonpropionat 250 mcg dosis, salmeterolxinafoat 50 mcg dosis

Inhalationspulver, afdelt

Kroatien

Salvus D.O.O.

Saldisk

Fluticasonpropionat 500 mcg dosis, salmeterolxinafoat 50 mcg dosis

Inhalationspulver, afdelt

Kroatien

Sandoz D.O.O.

Airflusal Forspiro

Fluticasonpropionat 233 μg dosis, salmeterol 45 μg dosis

Inhalationspulver, afdelt

Kroatien

Sandoz D.O.O.

Airflusal Forspiro

Fluticasonpropionat 465 μg dosis, salmeterol 45 μg dosis

Inhalationspulver, afdelt

Cypern

Astrazeneca Ab

Symbicort Turbuhaler

Budesonid 160 μg dosis, formoterolfumaratdihydrat 4,5 μg dosis

Inhalationspulver

Cypern

Astrazeneca Ab

Symbicort Turbuhaler

Budesonid 320 μg dosis, formoterolfumaratdihydrat 9 μg dosis

Inhalationspulver

Cypern

Costakis Tsisios & Co. Ltd

Fluticapen

Fluticasonpropionat 250 μg dosis

Inhalationspulver, afdelt

Cypern

Costakis Tsisios & Co. Ltd

Fluticapen

Fluticasonpropionat 500 μg dosis

Inhalationspulver, afdelt

Cypern

Costakis Tsisios & Co. Ltd

Pulmoton

Budesonid 100 μg dosis, formoterolfumaratdihydrat 6 μg dosis

Inhalationspulver, afdelt

Cypern

Costakis Tsisios & Co. Ltd

Pulmoton

Budesonid 200 μg dosis, formoterolfumaratdihydrat 6 μg dosis

Inhalationspulver, afdelt

Cypern

Costakis Tsisios & Co. Ltd

Pulmoton

Budesonid 400 μg dosis, formoterolfumaratdihydrat 12 μg dosis

Inhalationspulver, afdelt

Cypern

Costakis Tsisios & Co. Ltd

Rolenium

Fluticasonpropionat 100 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Cypern

Costakis Tsisios & Co. Ltd

Rolenium

Fluticasonpropionat 250 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Cypern

Costakis Tsisios & Co. Ltd

Rolenium

Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Cypern

Glaxo Group Limited

Flixotide Diskus

Fluticasonpropionat 100 μg dosis

Inhalationspulver

Cypern

Glaxo Group Limited

Flixotide Diskus

Fluticasonpropionat 250 μg dosis

Inhalationspulver

Cypern

Glaxo Group Limited

Seretide

Fluticasonpropionat 500 μg dosis, salmeterolxinafoat 50 μg dosis

Inhalationspulver, afdelt

Cypern

Orion Corporation

Bufomix Easyhaler

Budesonid 160 μg dosis, formoterolfumaratdihydrat Ph.Eur. 4,5  μg dosis

Inhalationspulver

Cypern

Orion Corporation

Bufomix Easyhaler

Budesonid 320 μg dosis, formoterolfumaratdihydrat Ph.Eur. 9 μg dosis

Inhalationspulver

Cypern

Orion Corporation

Orest Easyhaler

Budesonid 160 μg dosis, formoterolfumaratdihydrat Ph.Eur. 4,5  μg dosis

Inhalationspulver

Cypern

Orion Corporation

Orest Easyhaler

Budesonid 320 μg dosis, formoterolfumaratdihydrat Ph.Eur. 9 μg dosis

Inhalationspulver

Den Tjekkiske Republik

Astrazeneca Ab

Symbicort Turbuhaler

Budesonid 160 μg dosis, formoterolfumaratdihydrat 4,5 μg dosis

Inhalationspulver

Den Tjekkiske Republik

Astrazeneca Ab

Symbicort Turbuhaler

Budesonid 320 μg dosis, formoterolfumaratdihydrat 9 μg dosis

Inhalationspulver

Den Tjekkiske Republik

Chiesi Pharmaceuticals Gmbh

Combair

Formoterolfumaratdihydrat 1,08  mg, beclometasondipropionat 18 mg

Inhalationsspray, opløsning

Den Tjekkiske Republik

Elpen Pharmaceutical Co. Inc.

Dimenium

Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Den Tjekkiske Republik

Elpen Pharmaceutical Co. Inc.

Dimenium

Fluticasonpropionat 250 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Den Tjekkiske Republik

Glaxo Group Limited

Flixotide

Fluticasonpropionat 125 μg

Inhalationsspray, suspension

Den Tjekkiske Republik

Glaxo Group Limited

Flixotide

Fluticasonpropionat 250 μg

Inhalationsspray, suspension

Den Tjekkiske Republik

Glaxo Group Limited

Flixotide

Fluticasonpropionat 50 μg

Inhalationsspray, suspension

Den Tjekkiske Republik

Glaxo Group Limited

Flixotide Diskus

Fluticasonpropionat 100 μg

Inhalationspulver

Den Tjekkiske Republik

Glaxo Group Limited

Flixotide Diskus

Fluticasonpropionat 250 μg

Inhalationspulver

Den Tjekkiske Republik

Glaxo Group Limited

Flixotide Diskus

Fluticasonpropionat 500 μg

Inhalationspulver

Den Tjekkiske Republik

Glaxo Group Limited

Seretide Diskus

Fluticasonpropionat 500 μg, salmeterolxinafoat 72,5  μg

Inhalationspulver

Den Tjekkiske Republik

Sandoz S.R.O.

Airflusan Forspiro

Fluticasonpropionat 0,25  mg, salmeterolxinafoat 0,073  mg

Inhalationspulver, afdelt

Den Tjekkiske Republik

Sandoz S.R.O.

Airflusan Forspiro

Fluticasonpropionat 0,5  mg, salmeterolxinafoat 0,073  mg

Inhalationspulver, afdelt

Danmark

Astrazeneca A-S

Symbicort Forte Turbuhaler

Budesonid 320 μg dosis, formoterolfumaratdihydrat 9 μg dosis

Inhalationspulver

Danmark

Astrazeneca A-S

Symbicort Turbuhaler

Budesonid 160 μg dosis, formoterolfumaratdihydrat 4,5 μg dosis

Inhalationspulver

Danmark

Chiesi Farmaceutici S.P.A.

Innovair

Beclometasondipropionat 100 μg aktivering, formoterolfumaratdihydrat 6 μg aktivering

Inhalationsspray, opløsning

Danmark

Elpen Pharmaceutical Co. Inc.

Flusaterol

Fluticasonpropionat 250 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Danmark

Elpen Pharmaceutical Co. Inc.

Flusaterol

Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis, lactosemonohydrat 24,677  mg dosis

Inhalationspulver, afdelt

Danmark

Glaxosmithkline Pharma A-S

Seretide

Fluticasonpropionat 500 μg dosis, salmeterolxinafoat 50 μg dosis

Inhalationspulver, afdelt

Danmark

Orion Oyj

Bufomix Easyhaler

Budesonid 160 μg inhalation, formoterolfumaratdihydrat 4,5  μg inhalation

Inhalationspulver

Danmark

Orion Oyj

Bufomix Easyhaler

Budesonid 320 μg inhalation, formoterolfumaratdihydrat 9 μg inhalation

Inhalationspulver

Danmark

Sandoz A-S

Airflusal Forspiro

Fluticasonpropionat 233 μg dosis, salmeterol 45 μg dosis

Inhalationspulver, afdelt

Danmark

Sandoz A-S

Airflusal Forspiro

Fluticasonpropionat 465 μg dosis, salmeterol 45 μg dosis

Inhalationspulver, afdelt

Estland

Astrazeneca Ab

Symbicort Turbuhaler

Budesonid 160 μg dosis, formoterolfumaratdihydrat 4,5 μg dosis

Inhalationspulver

Estland

Astrazeneca Ab

Symbicort Turbuhaler

Budesonid 320 μg dosis, formoterolfumaratdihydrat 9 μg dosis

Inhalationspulver

Estland

Chiesi Pharmaceuticals Gmbh

Foster

Beclometasondipropionat 100 μg aktivering, formoterolfumaratdihydrat 6 μg aktivering

Inhalationsspray, opløsning

Estland

Elpen Pharmaceutical Co. Inc.

Flusamer

Fluticasonpropionat 250 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Estland

Elpen Pharmaceutical Co. Inc.

Flusamer

Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Estland

Glaxo Wellcome Ltd

Flixotide Diskus

Fluticasonpropionat 250 μg dosis

Inhalationspulver

Estland

Glaxo Wellcome Ltd

Seretide Diskus

Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Estland

Sandoz Pharmaceuticals D.D.

Airflusal Forspiro

Fluticasonpropionat 250 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Estland

Sandoz Pharmaceuticals D.D.

Airflusal Forspiro

Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Finland

Astrazeneca Oy

Symbicort Forte Turbuhaler

Budesonid 320 μg dosis, formoterolfumaratdihydrat 9 μg dosis

Inhalationspulver

Finland

Astrazeneca Oy

Symbicort Turbuhaler

Budesonid 160 μg dosis, formoterolfumaratdihydrat 4,5 μg dosis

Inhalationspulver

Finland

Chiesi Farmaceutici S.P.A.

Innovair

Beclometasondipropionat 100 μg aktivering, formoterolfumaratdihydrat 6 μg aktivering

Inhalationsspray, opløsning

Finland

Chiesi Farmaceutici S.P.A.

Innovair Nexthaler

Formoterolfumaratdihydrat 6 μg dosis, beclometasondipropionat vandfri 100 μg dosis

Inhalationspulver

Finland

Elpen Pharmaceutical Co. Inc.

Salmeson

Fluticasonpropionat 250 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Finland

Elpen Pharmaceutical Co. Inc.

Salmeson

Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Finland

Glaxosmithkline Oy

Seretide Diskus

Fluticasonpropionat 500 μg dosis, salmeterolxinafoat 50 μg dosis

Inhalationspulver, afdelt

Finland

Orion Oyj

Bufomix Easyhaler

Budesonid 160 μg inhalation, formoterolfumaratdihydrat 4,5  μg inhalation

Inhalationspulver

Finland

Orion Oyj

Bufomix Easyhaler

Budesonid 320 μg inhalation, formoterolfumaratdihydrat 9 μg inhalation

Inhalationspulver

Frankrig

Astrazeneca France

Symbicort Turbuhaler

Budesonid 160 μg dosis, formoterolfumaratdihydrat 4,5 μg dosis

Inhalationspulver

Frankrig

Astrazeneca France

Symbicort Turbuhaler

Budesonid 320 μg dosis, formoterolfumaratdihydrat 9 μg dosis

Inhalationspulver

Frankrig

Chiesi S.A.

Formodual

Formoterolfumaratdihydrat 6 μg dosis, beclometasondipropionat vandfri 100 μg dosis

Inhalationsspray, opløsning

Frankrig

Chiesi S.A.

Innovair

Formoterolfumaratdihydrat 6 μg dosis, beclometasondipropionat vandfri 100 μg dosis

Inhalationsspray, opløsning

Frankrig

Laboratoire Glaxosmithkline S.A.S.

Seretide Diskus

Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Tyskland

3m Health Care Ltd

Bronchocort Novo

Beclometason dipropionat 100 μg/50 μl

Inhalationsspray, opløsning

Tyskland

3m Health Care Ltd

Junik

Beclometasondipropionat 100 μg aktivering

Inhalationsspray, opløsning

Tyskland

Abz-Pharma Gmbh

Beclomethasone Dipropionate Ct

Beclometasondipropionat 0,05  mg/18,7  g

Inhalationsspray, opløsning

Tyskland

Meda Pharma Gmbh & Co. Kg

Budecort Novolizer

Budesonid, Micronised 0,2  mg aktivering

Inhalationspulver

Tyskland

Meda Pharma Gmbh & Co. Kg

Budecort Novolizer

Budesonid, micronised 0,4  mg aktivering

Inhalationspulver

Tyskland

Astrazeneca Gmbh

Pulmicort Budesonide

Budesonid 0,5  mg

Inhalationsvæske til nebulisator, suspension

Tyskland

Astrazeneca Gmbh

Pulmicort Budesonide

Budesonid 1,0  mg

Inhalationsvæske til nebulisator, suspension

Tyskland

Astrazeneca Gmbh

Pulmicort

Budesonid 400 μg dosis

Inhalationspulver

Tyskland

Astrazeneca Gmbh

Pulmicort Turbohaler

Budesonid 200 μg dosis

Inhalationspulver

Tyskland

Astrazeneca Gmbh

Symbicort Turbohaler

Budesonid 160 μg dosis, formoterolfumaratdihydrat 4,5 μg dosis

Inhalationspulver

Tyskland

Astrazeneca Gmbh

Symbicort Turbohaler

Budesonid 320 μg dosis, formoterolfumaratdihydrat 9 μg dosis

Inhalationspulver

Tyskland

Chiesi Farmaceutici S.P.A.

Kantos

Beclometasondipropionat 100 μg aktivering, formoterolfumaratdihydrat 6 μg aktivering

Inhalationsspray, opløsning

Tyskland

Chiesi Farmaceutici S.P.A.

Kantos Master

Beclometasondipropionat 100 μg aktivering, formoterolfumaratdihydrat 6 μg aktivering

Inhalationsspray, opløsning

Tyskland

Chiesi Gmbh

Budiair

Budesonide 200 μg Spray

Inhalationsspray, opløsning

Tyskland

Chiesi Gmbh

Foster

Beclometasondipropionat 100 μg aktivering, formoterolfumaratdihydrat 6 μg aktivering

Inhalationsspray, opløsning

Tyskland

Chiesi Gmbh

Ribuvent

Budesonide 200 μg Puff

Inhalationsspray, opløsning

Tyskland

Chiesi Gmbh

Sanasthmax

Beclometasondipropionat 250 μg/59,2  mg

Inhalationsspray, opløsning

Tyskland

Chiesi Gmbh

Sanasthmax Junior

Beclometasondipropionat 50 μg/59 mg

Inhalationsspray, opløsning

Tyskland

Elpen Pharmaceutical Co. Inc.

Flusalio

Fluticasonpropionat 250 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Tyskland

Elpen Pharmaceutical Co. Inc.

Flusalio

Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Tyskland

Elpen Pharmaceutical Co. Inc.

Rolenium

Fluticasonpropionat 250 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Tyskland

Elpen Pharmaceutical Co. Inc.

Rolenium

Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Tyskland

Glaxosmithkline Gmbh & Co. Kg

Flixotide Diskus

Fluticasonpropionat 250 μg dosis

Inhalationspulver

Tyskland

Glaxosmithkline Gmbh & Co. Kg

Flixotide Forte

Fluticasonpropionat 250 μg inhalation

Inhalationsspray, suspension

Tyskland

Glaxosmithkline Gmbh & Co. Kg

Flixotide Forte Diskus

Fluticasonpropionat 500 μg dosis

Inhalationspulver

Tyskland

Glaxosmithkline Gmbh & Co. Kg

Flutide Diskus

Fluticasonpropionat 250 μg dosis

Inhalationspulver, afdelt

Tyskland

Glaxosmithkline Gmbh & Co. Kg

Flutide Forte

Fluticasonpropionat 220 μg sug

Inhalationsspray, suspension

Tyskland

Glaxosmithkline Gmbh & Co. Kg

Flutide Forte Diskus

Fluticasonpropionat 500 μg dosis

Inhalationspulver, afdelt

Tyskland

Glaxosmithkline Gmbh & Co. Kg

Viani Forte

Fluticasonpropionat 500 μg dosis, salmeterolxinafoat 50 μg dosis

Inhalationspulver, afdelt

Tyskland

Heumann Pharma Gmbh & Co. Generica Kg

Budesonid

Budesonid 0,2  mg

Inhalationspulver

Tyskland

Hexal Ag

Airflusal Forspiro

Salmeterolxinafoat 50 μg dosis, fluticason 500 μg dosis

Inhalationspulver

Tyskland

Hexal Ag

Budes N

Budesonid 0,2  mg dosis

Inhalationsspray, opløsning

Tyskland

Janssen-Cilag Gmbh

Inuvair

Beclometasondipropionat 100 μg inhalation, formoterolfumarat 6 μg inhalation

Inhalationsspray, opløsning

Tyskland

Meda Pharma Gmbh & Co. Kg

Budesonid Novolizer Meda Pharma Gmbh & Co. Kg

Budesonid 400 μg inhalation

Inhalationspulver

Tyskland

Meda Pharma Gmbh & Co. Kg

Novopulmon Novolizer

Budesonid 200 μg dosis

Inhalationspulver

Tyskland

Meda Pharma Gmbh & Co. Kg

Novopulmon Novolizer

Budesonid 400 μg dosis

Inhalationspulver

Tyskland

Mylan Dura Gmbh

Budesonid Mylan

Budesonid 0,2  mg

Inhalationspulver

Tyskland

Orion Corporation

Beclomet Easyhaler

Beclometasondipropionat 0,2  mg dosis

Inhalationspulver

Tyskland

Pari Pharma Gmbh

Buparid

Budesonid 0,25  mg ampul

Inhalationsvæske til nebulisator, suspension

Tyskland

Pari Pharma Gmbh

Buparid

Budesonid 0,5  mg ampul

Inhalationsvæske til nebulisator, suspension

Tyskland

Pari Pharma Gmbh

Buparid

Budesonid 1 mg ampul

Inhalationsvæske til nebulisator, suspension

Tyskland

Pb Pharma Gmbh

Budesonid

Budesonid 0,92  mg

Inhalationspulver, hård kapsel

Tyskland

Pb Pharma Gmbh

Cyclocaps Beclometason

Beclometasondipropionat 100 μg enheder

Inhalationspulver, hård kapsel

Tyskland

Pb Pharma Gmbh

Cyclocaps Beclometason

Beclometasondipropionat 200 μg enheder

Inhalationspulver, hård kapsel

Tyskland

Pb Pharma Gmbh

Cyclocaps Beclometason

Beclometasondipropionat 400 μg enheder

Inhalationspulver, hård kapsel

Tyskland

Pb Pharma Gmbh

Cyclocaps Budesonid

Budesonid 0,8  mg kapsel

Inhalationspulver, hård kapsel

Tyskland

Pb Pharma Gmbh

Cyclocaps Budesonid

Budesonid 100 μg enheder

Inhalationspulver, hård kapsel

Tyskland

Pb Pharma Gmbh

Cyclocaps Budesonid

Budesonid 800 μg enheder

Inhalationspulver, hård kapsel

Tyskland

Ratiopharm Gmbh

Beclometason Ratiopharm

Beclometasondipropionat 0,25  mg/18,7  g

Inhalationsspray, opløsning

Tyskland

Ratiopharm Gmbh

Beclomethasone Dipropionate Ratiopharm

Beclometasondipropionat 0,05  mg/18,7  g

Inhalationsspray, opløsning

Tyskland

Ratiopharm Gmbh

Beclomethasone Dipropionate Ratiopharm

Beclometasondipropionat 0,1  mg/18,7  g

Inhalationsspray, opløsning

Tyskland

Ratiopharm Gmbh

Beclomethasone Dipropionate Ratiopharm

Beclometasondipropionat 0,2  mg/18,7  g

Inhalationsspray, opløsning

Tyskland

Teva Gmbh

Aerobec N

Beclometasondipropionat 100 g/5 ml

Inhalationsspray, opløsning

Tyskland

Teva Gmbh

Beclometason-Ct

Beclometasondipropionat 0,1  mg

Inhalationsspray, opløsning

Tyskland

Teva Gmbh

Beclometason-Ct

Beclometasondipropionat 0,2  mg

Inhalationsspray, opløsning

Tyskland

Teva Gmbh

Ventolair

Beclometasondipropionat 100 g/10ml

Inhalationsspray, opløsning

Tyskland

Teva Gmbh

Ventolair

Beclometasondipropionat 100 g/18,7  g

Inhalationsspray, opløsning

Tyskland

Teva Gmbh

Ventolair

Beclometasondipropionat 100 g/5 ml

Inhalationsspray, opløsning

Tyskland

Teva Gmbh

Ventolair

Beclometasondipropionat 250 g/18,7  g

Inhalationsspray, opløsning

Tyskland

Teva Gmbh

Ventolair

Beclometasondipropionat 250 g/78 mg

Inhalationsspray, opløsning

Tyskland

Teva Gmbh

Ventolair Mite

Beclometasondipropionat 50 g/18,7  g

Inhalationsspray, opløsning

Tyskland

Teva Gmbh

Ventolair Mite

Beclometasondipropionat 50 g/78 mg

Inhalationsspray, opløsning

Tyskland

Ucb Pharma Gmbh (Monheim De)

Atmadisc Forte Diskus

Fluticasonpropionat 500 μg inhalation, salmeterol 50 μg inhalation

Inhalationspulver

Grækenland

Anfarm Hellas Sa

Talgan

Budesonid 100 μg dosis

Inhalationspulver

Grækenland

Astrazeneca S.A.

Pulmicort Turbuhaler

Budesonid 100 μg dosis

Inhalationspulver

Grækenland

Astrazeneca S.A.

Pulmicort Turbuhaler

Budesonid 200 μg dosis

Inhalationspulver

Grækenland

Astrazeneca S.A.

Pulmicort Turbuhaler

Budesonid 400 μg dosis

Inhalationspulver

Grækenland

Astrazeneca S.A.

Symbicort Turbuhaler

Budesonid 160 μg dosis, formoterolfumaratdihydrat 4,5 μg dosis

Inhalationspulver

Grækenland

Astrazeneca S.A.

Symbicort Turbuhaler

Budesonid 320 μg dosis, formoterolfumaratdihydrat 9 μg dosis

Inhalationspulver

Grækenland

Chiesi Hellas A.E.B.E.

Foster

Beclometasondipropionat 100 μg aktivering, formoterolfumaratdihydrat 6 μg aktivering

Inhalationsspray, opløsning

Grækenland

Chiesi Hellas A.E.B.E.

Foster Nexthaler

Formoterolfumaratdihydrat 6 μg dosis, beclometasondipropionat vandfri 100 μg dosis

Inhalationspulver

Grækenland

Chiesi Hellas A.E.B.E.

Inuvair

Beclometasondipropionat 100 μg aktivering, formoterolfumaratdihydrat 6 μg aktivering

Inhalationsspray, opløsning

Grækenland

Chiesi Hellas A.E.B.E.

Inuvair Nexthaler

Formoterolfumaratdihydrat 6 μg dosis, beclometasondipropionat vandfri 100 μg dosis

Inhalationspulver

Grækenland

Flihaler

Fluticasonpropionat 250 mcg/dosis

Inhalationsspray, suspension

Grækenland

Elpen Pharmaceutical Co. Inc.

Fluticapen

Fluticasonpropionat 250 μg dosis

Inhalationspulver, afdelt

Grækenland

Elpen Pharmaceutical Co. Inc.

Fluticapen

Fluticasonpropionat 500 μg dosis

Inhalationspulver, afdelt

Grækenland

Elpen Pharmaceutical Co. Inc.

Pulmoton

Budesonid 100 μg dosis, formoterolfumaratdihydrat 6 μg dosis

Inhalationspulver, afdelt

Grækenland

Elpen Pharmaceutical Co. Inc.

Pulmoton

Budesonid 200 μg dosis, formoterolfumaratdihydrat 6 μg dosis

Inhalationspulver, afdelt

Grækenland

Elpen Pharmaceutical Co. Inc.

Pulmoton

Budesonid 400 μg dosis, formoterolfumaratdihydrat 12 μg dosis

Inhalationspulver, afdelt

Grækenland

Elpen Pharmaceutical Co. Inc.

Rolenium

Fluticasonpropionat 250 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Grækenland

Elpen Pharmaceutical Co. Inc.

Rolenium

Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Grækenland

Glaxosmithkline Aebe

Flixotide

Fluticasonpropionat 100 μg dosis

Inhalationspulver

Grækenland

Glaxosmithkline Aebe

Flixotide

Fluticasonpropionat 125 μg dosis

Inhalationsspray

Grækenland

Glaxosmithkline Aebe

Flixotide

Fluticasonpropionat 250 μg dosis

Inhalationspulver

Grækenland

Glaxosmithkline Aebe

Flixotide

Fluticasonpropionat 250 μg dosis

Inhalationsspray

Grækenland

Glaxosmithkline Aebe

Flixotide

Fluticasonpropionat 500 μg dosis

Inhalationspulver

Grækenland

Glaxosmithkline Aebe

Flixotide

Fluticasonpropionat 50 μg dosis

Inhalationsspray

Grækenland

Glaxosmithkline Aebe

Flixotide Diskus

Fluticasonpropionat 100 μg dosis

Inhalationspulver

Grækenland

Glaxosmithkline Aebe

Flixotide Diskus

Fluticasonpropionat 250 μg dosis

Inhalationspulver

Grækenland

Glaxosmithkline Aebe

Flixotide Diskus

Fluticasonpropionat 500 μg dosis

Inhalationspulver

Grækenland

Glaxosmithkline Aebe

Seretide

Fluticasonpropionat 500 μg dosis, salmeterolxinafoat 50 μg dosis

Inhalationspulver, afdelt

Grækenland

Iasis Pharma

Olfo Haler

Budesonid 200 μg dosis

Inhalationspulver

Grækenland

Iasis Pharma

Olfo Haler

Budesonid 400 μg dosis

Inhalationspulver

Grækenland

Medicair Bioscience Laboratories S.A

Bocacort-S

Fluticasonpropionat 250 mcg/dosis

Inhalationsspray, suspension

Grækenland

Orion Corporation

Bufomix

Budosenid 160 mcg, formoterolfumaratdihydrat 4,5  mcg

Inhalationspulver

Grækenland

Orion Corporation

Bufomix

Budosenid 320 mcg, formoterolfumaratdihydrat 9 mcg

Inhalationspulver

Grækenland

Orion Corporation

Orest

Budosenid 160 mcg, formoterolfumaratdihydrat 4,5  mcg

Inhalationspulver

Grækenland

Orion Corporation

Orest

Budosenid 320 mcg, formoterolfumaratdihydrat 9 mcg

Inhalationspulver

Grækenland

Png Gerolymatos Medical A.E.

Asmaflex

Fluticasone Propionate 250 mgg

Inhalationsspray, suspension

Grækenland

Rafarm Sa.

Resata

Budesonid 200 μg dosis

Inhalationspulver, afdelt

Grækenland

Rafarm Sa.

Resata

Budesonid 400 μg dosis

Inhalationspulver, afdelt

Grækenland

Verisfield (Uk) Ltd

Flixocort

Fluticasonpropionat 50 μg dosis

Næsespray, suspension

Grækenland

Verisfield (Uk) Ltd

Flixocort

Fluticasonpropionat 125 μg dosis

Inhalationsspray, suspension

Grækenland

Verisfield (Uk) Ltd

Flixocort

Fluticasonpropionat 250 μg dosis

Inhalationsspray, suspension

Grækenland

Verisfield (Uk) Ltd

Pulmihal

Budesonid 200 μg dosis

Inhalationspulver, afdelt

Grækenland

Win Medica Ltd

Flusalair

Fluticasonpropionat 250 μg dosis, salmeterol 50 μg dosis

Inhalationspulver

Grækenland

Win Medica Ltd

Flusalair

Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Grækenland

Win Medica Ltd

Flutiresp

Fluticasonpropionat 250 mcg/dosis

Inhalationspulver

Grækenland

Win Medica Ltd

Flutiresp

Fluticasonpropionat 500 μg inhalation

Inhalationspulver

Grækenland

Zwitter Pharmaceuticals επε

Salenga

Fluticasonpropionat 250 μg dosis

Inhalationsspray, suspension

Grækenland

Pharmanel Commercial Pharmaceutical S.A.

Vernoral

Budesonid 200 μg dosis

Inhalationspulver

Grækenland

Pharmanel Commercial Pharmaceutical S.A.

Vernoral

Budesonid 400 μg dosis

Inhalationspulver

Ungarn

Astrazeneca Kft.

Symbicort Turbuhaler

Budesonid 160 μg dosis, formoterolfumaratdihydrat 4,5 μg dosis

Inhalationspulver

Ungarn

Astrazeneca Kft.

Symbicort Turbuhaler

Budesonid 320 μg dosis, formoterolfumaratdihydrat 9 μg dosis

Inhalationspulver

Ungarn

Chiesi Pharmaceuticals Gmbh

Formodual

Formoterolfumaratedihydrat 6 μg aktivering, beclometasondipropionat vandfri 100 μg aktivering

Inhalationsspray, opløsning

Ungarn

Chiesi Pharmaceuticals Gmbh

Foster

Beclometasondipropionat 100 μg aktivering, formoterolfumaratdihydrat 6 μg aktivering

Inhalationsspray, opløsning

Ungarn

Elpen Pharmaceutical Co. Inc.

Dimenio

Fluticasonpropionat 250 μg dosis, salmeterol 50 μg dosis

Inhalationspulver

Ungarn

Elpen Pharmaceutical Co. Inc.

Dimenio

Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis

Inhalationspulver

Ungarn

Elpen Pharmaceutical Co. Inc.

Flumetor

Fluticasonpropionat 250 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Ungarn

Elpen Pharmaceutical Co. Inc.

Flumetor

Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Ungarn

Glaxosmithkline Kft.

Seretide Diskus

Fluticasonpropionat 500 μg dosis, salmeterolxinafoat 50 μg dosis

Inhalationspulver, afdelt

Ungarn

Montrose Kft

Thoreus Diskus

Fluticasonpropionat 500 μg dosis, salmeterolxinafoat 50 μg dosis

Inhalationspulver, afdelt

Ungarn

Orion Oyj

Bufomix Easyhaler

Budesonid 160 μg inhalation, formoterolfumaratdihydrat 4,5  μg inhalation

Inhalationspulver

Ungarn

Orion Oyj

Bufomix Easyhaler

Budesonid 320 μg inhalation, formoterolfumaratdihydrat 9 μg inhalation

Inhalationspulver

Ungarn

Sandoz Hungária Kft

Airflusol Forspiro

Salmeterolxinafoat 50 μg dosis, fluticason 500 μg dosis

Inhalationspulver

Island

Astrazeneca A-S

Symbicort Forte Turbuhaler

Budesonid 320 μg dosis, formoterolfumaratdihydrat 9 μg dosis

Inhalationspulver

Island

Astrazeneca A-S

Symbicort Mite Turbuhaler

Budesonid 160 μg dosis, formoterolfumaratdihydrat 4,5 μg dosis

Inhalationspulver

Island

Elpen Pharmaceutical Co. Inc.

Relanio

Fluticasonpropionat 250 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Island

Elpen Pharmaceutical Co. Inc.

Relanio

Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Island

Glaxosmithkline Ehf.

Flixotide

Fluticasonpropionat 250 μg dosis

Inhalationsspray, suspension

Island

Glaxosmithkline Ehf.

Flixotide Diskus

Fluticasonpropionat 100 μg dosis

Inhalationspulver

Island

Glaxosmithkline Ehf.

Flixotide Diskus

Fluticasonpropionat 250 μg dosis

Inhalationspulver

Island

Glaxosmithkline Ehf.

Flixotide Diskus

Fluticasonpropionat 500 μg dosis

Inhalationspulver

Island

Glaxosmithkline Ehf.

Seretide Diskus

Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Irland

Astrazeneca Uk Limited

Pulmicort Turbohaler

Budesonid 100 μg dosis

Inhalationspulver

Irland

Astrazeneca Uk Limited

Pulmicort Turbohaler

Budesonid 200 μg dosis

Inhalationspulver

Irland

Astrazeneca Uk Limited

Pulmicort Turbohaler

Budesonid 400 μg dosis

Inhalationspulver

Irland

Astrazeneca Uk Limited

Symbicort Turbohaler

Budesonid 160 μg dosis, formoterolfumaratdihydrat 4,5 μg dosis

Inhalationspulver

Irland

Astrazeneca Uk Limited

Symbicort Turbohaler

Budesonid 320 μg dosis, formoterolfumaratdihydrat 9 μg dosis

Inhalationspulver

Irland

Elpen Pharmaceutical Co. Inc.

Flamerio

Fluticasonpropionat 250 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Irland

Elpen Pharmaceutical Co. Inc.

Flamerio

Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis, lactosemonohydrat 24,677  mg dosis

Inhalationspulver, afdelt

Irland

Glaxosmithkline (Ireland) Limited

Flixotide Diskus

Fluticasonpropionat 250 μg blister

Inhalationspulver, afdelt

Irland

Glaxosmithkline (Ireland) Limited

Flixotide Diskus

Fluticasonpropionat 500 μg blister

Inhalationspulver, afdelt

Irland

Glaxosmithkline (Ireland) Limited

Flixotide Evohaler

Fluticasonpropionat 250 μg dosis

Inhalationsspray, suspension

Irland

Glaxosmithkline (Ireland) Limited

Seretide Diskus

Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Irland

Glaxosmithkline (Ireland) Limited

Viani Diskus

Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Irland

Orion Oyj

Bufomix Easyhaler

Budesonid 160 μg inhalation, formoterolfumaratdihydrat 4,5  μg inhalation

Inhalationspulver

Irland

Orion Oyj

Bufomix Easyhaler

Budesonid 320 μg inhalation, formoterolfumaratdihydrat 9 μg inhalation

Inhalationspulver

Irland

Rowex Ltd

Airflusal Forspiro

Salmeterolxinafoat 50 μg dosis, fluticason 250 μg dosis

Inhalationspulver

Irland

Rowex Ltd

Airflusal Forspiro

Salmeterolxinafoat 50 μg dosis, fluticason 500 μg dosis

Inhalationspulver

Italien

Astrazeneca S.P.A

Sinestic

Budesonid 160 μg dosis, formoterolfumaratdihydrat 4,5 μg dosis

Inhalationspulver

Italien

Astrazeneca S.P.A

Sinestic

Budesonid 320 μg dosis, formoterolfumaratdihydrat 4,5  μg dosis

Inhalationspulver

Italien

Astrazeneca S.P.A

Symbicort

Budesonid 160 μg dosis, formoterolfumaratdihydrat 4,5 μg dosis

Inhalationspulver

Italien

Astrazeneca S.P.A

Symbicort

Budesonid 320 μg dosis, formoterolfumaratdihydrat 9 μg dosis

Inhalationspulver

Italien

Elpen Pharmaceutical Co. Inc.

Flamerio

Fluticasonpropionat 250 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Italien

Elpen Pharmaceutical Co. Inc.

Flamerio

Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Italien

Elpen Pharmaceutical Co. Inc.

Rolenium

Fluticasonpropionat 250 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Italien

Elpen Pharmaceutical Co. Inc.

Rolenium

Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Italien

Glaxosmithkline S.P.A.

Seretide

Fluticasonpropionat 500 μg dosis, salmeterolxinafoat 50 μg dosis

Inhalationspulver, afdelt

Italien

Menarini International Operations Luxembourg S.A.

Aliflus Diskus

Fluticasonpropionat 100 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Italien

Menarini International Operations Luxembourg S.A.

Aliflus Diskus

Fluticasonpropionat 250 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Italien

Menarini International Operations Luxembourg S.A.

Aliflus Diskus

Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Italien

Promedica S.R.L.

Clenil Compositum

Beclometasondipropionat 0,8  mg/2 mi, salbutamolsulfat 1,928  mg/2 mi

Inhalationsvæske til nebulisator, suspension

Italien

Promedica S.R.L.

Clenil Compositum

Beclometasondipropionat 50 μg aktivering, salbutamolsulfat 120 μg aktivering

Inhalationsspray, opløsning

Italien

Simesa S.P.A.

Assieme

Budesonid 160 μg dosis, formoterolfumaratdihydrat 4,5 μg dosis

Inhalationspulver

Italien

Simesa S.P.A.

Assieme

Budesonid 320 μg dosis, formoterolfumaratdihydrat 9 μg dosis

Inhalationspulver

Italien

Valeas S.P.A.

Plenaer

Flunisolid 25 mg flaske, salbutamol 10 mg flaske

Inhalationsspray, suspension

Italien

Valeas S.P.A.

Plenaer

Salbutamolsulfat 0,602  mg hætteglas, flunisolid 0,5  mg hætteglas

Inhalationsvæske til nebulisator, opløsning

Letland

Astrazeneca Ab

Pulmicort Turbuhaler

Budesonid 100 μg dosis

Inhalationspulver

Letland

Astrazeneca Ab

Pulmicort Turbuhaler

Budesonid 200 μg dosis

Inhalationspulver

Letland

Astrazeneca Ab

Symbicort Turbuhaler

Budesonid 160 μg dosis, formoterolfumaratdihydrat 4,5 μg dosis

Inhalationspulver

Letland

Astrazeneca Ab

Symbicort Turbuhaler

Budesonid 320 μg dosis, formoterolfumaratdihydrat 9 μg dosis

Inhalationspulver

Letland

Chiesi Pharmaceuticals Gmbh

Foster

Beclometasondipropionat 100 μg aktivering, formoterolfumaratdihydrat 6 μg aktivering

Inhalationsspray, opløsning

Letland

Elpen Pharmaceutical Co. Inc.

Flamerio

Fluticasonpropionat 250 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Letland

Elpen Pharmaceutical Co. Inc.

Flamerio

Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Letland

Glaxosmithkline Latvia Sia

Flixotide

Fluticasonpropionat 250 μg inhalation

Inhalationsspray, suspension

Letland

Glaxosmithkline Latvia Sia

Flixotide Diskus

Fluticasonpropionat 250 μg dosis

Inhalationspulver

Letland

Glaxosmithkline Latvia Sia

Flixotide Diskus

Fluticasonpropionat 500 μg dosis

Inhalationspulver

Letland

Glaxosmithkline Latvia Sia

Flosal

Fluticasonpropionat 250 μg inhalation, salmeterolxinafoat 25 μg inhalation

Inhalationsspray, suspension

Letland

Glaxosmithkline Latvia Sia

Flosal

Fluticasonpropionat 500 μg dosis, salmeterolxinafoat 50 μg dosis

Inhalationspulver

Letland

Glaxosmithkline Latvia Sia

Seretide

Fluticasonpropionat 250 μg inhalation, salmeterolxinafoat 25 μg inhalation

Inhalationsspray, suspension

Letland

Glaxosmithkline Latvia Sia

Seretide

Fluticasonpropionat 500 μg dosis, salmeterolxinafoat 50 μg dosis

Inhalationspulver

Letland

Novartis Finland Oy

Miflonide

Budesonid 200 μg

Inhalationspulver, hård kapsel

Letland

Novartis Finland Oy

Miflonide

Budesonid 400 μg

Inhalationspulver, hård kapsel

Letland

Orion Corporation

Bufomix Easyhaler

Budesonid 160 μg inhalation, formoterolfumaratdihydrat 4,5  μg inhalation

Inhalationspulver

Letland

Orion Corporation

Bufomix Easyhaler

Budesonid 320 μg inhalation, formoterolfumaratdihydrat 9 μg inhalation

Inhalationspulver

Letland

Sandoz Pharmaceuticals D.D.

Airflusal Forspiro

Fluticasonpropionat 233 μg dosis, salmeterol 45 μg dosis

Inhalationspulver, afdelt

Letland

Sandoz Pharmaceuticals D.D.

Airflusal Forspiro

Salmeterolxinafoat 50 μg dosis, fluticason 500 μg dosis

Inhalationspulver, afdelt

Litauen

Astrazeneca Ab

Symbicort Turbuhaler

Budesonid 160 μg dosis, formoterolfumaratdihydrat 4,5 μg dosis

Inhalationspulver

Litauen

Astrazeneca Ab

Symbicort Turbuhaler

Budesonid 320 μg dosis, formoterolfumaratdihydrat 9 μg dosis

Inhalationspulver

Litauen

Chiesi Pharmaceuticals Gmbh

Foster

Beclometasondipropionat 100 μg aktivering, formoterolfumaratdihydrat 6 μg aktivering

Inhalationsspray, opløsning

Litauen

Elpen Pharmaceutical Co. Inc.

Flamerio

Fluticasonpropionat 250 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Litauen

Elpen Pharmaceutical Co. Inc.

Flamerio

Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Litauen

Glaxosmithkline Lietuva Uab

Flixotide

Fluticasonpropionat 250 μg inhalation

Inhalationsspray, suspension

Litauen

Glaxosmithkline Lietuva Uab

Flixotide Diskus

Fluticasonpropionat 250 μg dosis

Inhalationspulver, afdelt

Litauen

Glaxosmithkline Lietuva Uab

Flixotide Diskus

Fluticasonpropionat 500 μg dosis

Inhalationspulver, afdelt

Litauen

Glaxosmithkline Lietuva Uab

Seretide

Fluticasonpropionat 500 μg dosis, salmeterolxinafoat 50 μg dosis

Inhalationspulver, afdelt

Litauen

Novartis Finland Oy

Miflonide

Budesonid 200 μg

Inhalationspulver, hård kapsel

Litauen

Novartis Finland Oy

Miflonide

Budesonid 400 μg

Inhalationspulver, hård kapsel

Litauen

Orion Oyj

Bufomix Easyhaler

Budesonid 160 μg inhalation, formoterolfumaratdihydrat 4,5  μg inhalation

Inhalationspulver

Litauen

Orion Oyj

Bufomix Easyhaler

Budesonide 160 μg, Formoterol Fumarate Dihydrate 4,5  μg

Inhalationspulver

Litauen

Orion Oyj

Bufomix Easyhaler

Budesonid 320 μg inhalation, formoterolfumaratdihydrat 9 μg inhalation

Inhalationspulver

Litauen

Orion Oyj

Bufomix Easyhaler

Budosenid 320 μg, formoterolfumaratdihydrat 9 μg

Inhalationspulver

Litauen

Sandoz Pharmaceuticals D.D.

Airflusal Forspiro

Salmeterolxinafoat 50 μg dosis, fluticason 250 μg dosis

Inhalationspulver

Litauen

Sandoz Pharmaceuticals D.D.

Airflusal Forspiro

Salmeterolxinafoat 50 μg dosis, fluticason 500 μg dosis

Inhalationspulver

Luxembourg

Chiesi Sa-Nv

Inuvair

Formoterolfumaratedihydrat 6 μg aktivering, beclometasondipropionat vandfri 100 μg aktivering

Inhalationsspray, opløsning

Luxembourg

Elpen Pharmaceutical Co. Inc.

Flusamer

Fluticasonpropionat 250 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Luxembourg

Elpen Pharmaceutical Co. Inc.

Flusamer

Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Luxembourg

Glaxosmithkline Pharmaceuticals S.A.

Flixotide

Fluticasonpropionat 250 μg inhalation

Inhalationsspray, suspension

Luxembourg

Glaxosmithkline Pharmaceuticals S.A.

Flixotide

Fluticasonpropionat 50 μg inhalation

Inhalationsspray, suspension

Luxembourg

Glaxosmithkline Pharmaceuticals S.A.

Flixotide Diskus

Fluticasonpropionat 100 μg dosis

Inhalationspulver

Luxembourg

Glaxosmithkline Pharmaceuticals S.A.

Flixotide Diskus

Fluticasonpropionat 250 μg dosis

Inhalationspulver

Luxembourg

Glaxosmithkline Pharmaceuticals S.A.

Flixotide Diskus

Fluticasonpropionat 500 μg dosis

Inhalationspulver

Luxembourg

Glaxosmithkline Pharmaceuticals S.A.

Seretide Diskus

Fluticasonpropionat 500 μg dosis, salmeterolxinafoat 50 μg dosis

Inhalationspulver

Luxembourg

Nv Astrazeneca Sa

Pulmicort Turbohaler

Budesonid 200 μg dosis

Inhalationspulver

Luxembourg

Nv Astrazeneca Sa

Symbicort Turbohaler

Budesonid 160 μg dosis, formoterolfumaratdihydrat 4,5 μg dosis

Inhalationspulver

Luxembourg

Nv Astrazeneca Sa

Symbicort Forte Turbohaler

Budesonid 320 μg dosis, formoterolfumaratdihydrat 9 μg dosis

Inhalationspulver

Luxembourg

Orion Corporation

Bufomix Easyhaler

Budesonid 160 μg dosis, formoterolfumaratdihydrat Ph.Eur. 4,5  μg dosis

Inhalationspulver

Luxembourg

Orion Corporation

Bufomix Easyhaler

Budesonid 320 μg dosis, formoterolfumaratdihydrat Ph.Eur. 9 μg dosis

Inhalationspulver

Luxembourg

Orion Corporation

Orest Easyhaler

Budesonid 160 μg dosis, formoterolfumaratdihydrat Ph.Eur. 4,5  μg dosis

Inhalationspulver

Luxembourg

Orion Corporation

Orest Easyhaler

Budesonid 320 μg dosis, formoterolfumaratdihydrat Ph.Eur. 9 μg dosis

Inhalationspulver

Μalta

Astrazeneca Ab

Pulmicort Turbuhaler

Budesonid 100 μg dosis

Inhalationspulver

Μalta

Astrazeneca Ab

Pulmicort Turbuhaler

Budesonid 200 μg dosis

Inhalationspulver

Μalta

Astrazeneca Ab

Symbicort Turbohaler

Budesonid 160 μg dosis, formoterolfumaratdihydrat 4,5 μg dosis

Inhalationspulver

Μalta

Astrazeneca Ab

Symbicort Turbohaler

Budesonid 320 μg dosis, formoterolfumaratdihydrat 9 μg dosis

Inhalationspulver

Μalta

Elpen Pharmaceutical Co. Inc.

Rolenium

Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Μalta

Elpen Pharmaceutical Co. Inc.

Rolenium

Fluticasonpropionat 250 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Μalta

Glaxosmithkline (Ireland) Limited

Flixotide Evohaler

Fluticasonpropionat 250 μg dosis

Inhalationsspray, suspension

Μalta

Glaxosmithkline (Ireland) Limited

Seretide Diskus

Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Μalta

Novartis Pharmaceuticals Uk Limited

Miflonide

Budesonide 200 μg Capsule

Inhalationspulver, hård kapsel

Μalta

Novartis Pharmaceuticals Uk Limited

Miflonide

Budesonid 400 μg

Inhalationspulver, hård kapsel

Μalta

Orion Oyj

Bufomix Easyhaler

Budesonid 160 μg inhalation, formoterolfumaratdihydrat 4,5  μg inhalation

Inhalationspulver

Μalta

Orion Oyj

Bufomix Easyhaler

Budesonid 320 μg inhalation, formoterolfumaratdihydrat 9 μg inhalation

Inhalationspulver

Μalta

Orion Oyj

Orest Easyhaler

Budesonid 160 μg inhalation, formoterolfumaratdihydrat 4,5  μg inhalation

Inhalationspulver

Μalta

Orion Oyj

Orest Easyhaler

Budesonid 320 μg inhalation, formoterolfumaratdihydrat 9 μg inhalation

Inhalationspulver

Nederlandene

Astrazeneca Bv

Symbicort Turbuhaler

Budesonid 160 μg dosis, formoterolfumaratdihydrat 4,5 μg dosis

Inhalationspulver

Nederlandene

Astrazeneca Bv

Symbicort Turbuhaler

Budesonid 320 μg dosis, formoterolfumaratdihydrat 9 μg dosis

Inhalationspulver

Nederlandene

Glaxosmithkline B.V.

Fluticasonpropionaat Inhalator GSK

Fluticasonpropionat 125 μg dosis

Aerosol

Nederlandene

Glaxosmithkline B.V.

Fluticasonpropionaat Inhalator GSK

Fluticasonpropionat 250 μg dosis

Aerosol

Nederlandene

Glaxosmithkline B.V.

Fluticasonpropionaat Inhalator GSK

Fluticasonpropionat 50 μg dosis

Aerosol

Nederlandene

Chiesi Pharmaceuticals B.V.

Formodual

Formoterolfumaratedihydrat 6 μg aktivering, beclometasondipropionat vandfri 100 μg aktivering

Inhalationsspray, opløsning

Nederlandene

Chiesi Pharmaceuticals B.V.

Foster

Beclometasondipropionat 100 μg aktivering, formoterolfumaratdihydrat 6 μg aktivering

Inhalationsspray, opløsning

Nederlandene

Elpen Pharmaceutical Co. Inc.

Salmeterol/Fluticasonpropionaat Elpen

Fluticasonpropionat 250 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Nederlandene

Elpen Pharmaceutical Co. Inc.

Salmeterol/Fluticasonpropionaat Elpen

Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Nederlandene

Glaxosmithkline B.V.

Flixotide

Fluticasonpropionat 250 μg inhalation

Inhalationsspray, suspension

Nederlandene

Glaxosmithkline B.V.

Flixotide Diskus

Fluticasonpropionat 500 μg dosis

Inhalationspulver, afdelt

Nederlandene

Glaxosmithkline B.V.

Seretide

Fluticasonpropionat 500 μg dosis, salmeterolxinafoat 50 μg dosis

Inhalationspulver, afdelt

Norge

Astrazeneca As

Symbicort Forte Turbuhaler

Budesonid 320 μg dosis, formoterolfumaratdihydrat 9 μg dosis

Inhalationspulver

Norge

Astrazeneca As

Symbicort Turbuhaler

Budesonid 160 μg dosis, formoterolfumaratdihydrat 4,5 μg dosis

Inhalationspulver

Norge

Chiesi Farmaceutici S.P.A.

Inuxair

Beclometasondipropionat 100 μg aktivering, formoterolfumaratdihydrat 6 μg aktivering

Inhalationsspray, opløsning

Norge

Elpen Pharmaceutical Co. Inc.

Salmeson

Fluticasonpropionat 250 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Norge

Elpen Pharmaceutical Co. Inc.

Salmeson

Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Norge

Glaxosmithkline As

Seretide Diskus

Fluticasonpropionat 500 μg dosis, salmeterolxinafoat 50 μg dosis

Inhalationspulver, afdelt

Norge

Sandoz A-S

Airflusal Forspiro

Salmeterolxinafoat 50 μg dosis, fluticasonpropionat 250 μg dosis

Inhalationspulver

Norge

Sandoz A-S

Airflusal Forspiro

Salmeterolxinafoat 50 μg dosis, fluticasonpropionat 500 μg dosis

Inhalationspulver

Polen

Adamed Sp. Z O.O.

Flutixon

Fluticasone Propionate 125 μg Capsule

Inhalationspulver, hård kapsel

Polen

Adamed Sp. Z O.O.

Flutixon

Fluticasonpropionat 250 μg kapsel

Inhalationspulver, hård kapsel

Polen

Astrazeneca Ab

Pulmicort Turbuhaler

Budesonid 100 μg dosis

Inhalationspulver

Polen

Astrazeneca Ab

Pulmicort Turbuhaler

Budesonid 200 μg dosis

Inhalationspulver

Polen

Astrazeneca Ab

Symbicort Turbuhaler

Budesonid 160 μg dosis, formoterolfumaratdihydrat 4,5 μg dosis

Inhalationspulver

Polen

Astrazeneca Ab

Symbicort Turbuhaler

Budesonid 320 μg dosis, formoterolfumaratdihydrat 9 μg dosis

Inhalationspulver

Polen

Celon Pharma S.A.

Salmex

Fluticasonpropionat 500 μg dosis, salmeterolxinafoat 50 μg dosis

Inhalationspulver

Polen

Chiesi Pharmaceuticals Gmbh

Formodual

Beclometasondipropionat 100 μg aktivering, formoterolfumaratdihydrat 6 μg aktivering

Inhalationsspray, opløsning

Polen

Chiesi Pharmaceuticals Gmbh

Fostex

Beclometasondipropionat 100 μg aktivering, formoterolfumaratdihydrat 6 μg aktivering

Inhalationsspray, opløsning

Polen

Elpen Pharmaceutical Co. Inc.

Salmeson

Fluticasonpropionat 250 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Polen

Elpen Pharmaceutical Co. Inc.

Salmeson

Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Polen

Glaxosmithkline Export Ltd

Flixotide

Fluticasonpropionat 250 μg dosis

Inhalationspulver, afdelt

Polen

Glaxosmithkline Export Ltd

Flixotide

Fluticasonpropionat 250 μg inhalation

Inhalationsspray, suspension

Polen

Glaxosmithkline Export Ltd

Flixotide Dysk

Fluticasonpropionat 50 μg dosis

Inhalationspulver, afdelt

Polen

Glaxosmithkline Export Ltd

Seretide Dysk

Fluticasonpropionat 500 μg dosis, salmeterolxinafoat 50 μg dosis

Inhalationspulver

Polen

Meda Pharma Gmbh & Co. Kg

Budelin Novolizer

Budesonid 200 μg dosis

Inhalationspulver

Polen

Novartis Poland Sp. Z O. O.

Miflonide

Budesonid 200 μg

Inhalationspulver, hård kapsel

Polen

Novartis Poland Sp. Z O. O.

Miflonide

Budesonid 400 μg

Inhalationspulver, hård kapsel

Polen

Orion Corporation

Orest Easyhaler

Budesonid 160 μg inhalation, formoterolfumaratdihydrat 4,5  μg inhalation

Inhalationspulver

Polen

Orion Corporation

Orest Easyhaler

Budesonid 320 μg inhalation, formoterolfumaratdihydrat 9 μg inhalation

Inhalationspulver

Polen

Polfarmex S.A.

Asaris

Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis

Inhalationspulver

Polen

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

Budezonid Lek-Am

Budesonid 200 μg inhalation

Inhalationspulver, hård kapsel

Polen

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

Budezonid Lek-Am

Budesonid 400 μg inhalation

Inhalationspulver, hård kapsel

Portugal

Astrazeneca Produtos Farmacêuticos, Lda.

Assieme Turbohaler

Budesonid 160 μg dosis, formoterolfumaratdihydrat 4,5 μg dosis

Inhalationspulver

Portugal

Astrazeneca Produtos Farmacêuticos, Lda.

Assieme Turbohaler

Budesonid 320 μg dosis, formoterolfumaratdihydrat 9 μg dosis

Inhalationspulver

Portugal

Astrazeneca Produtos Farmaceuticos Limitada

Pulmicort Turbohaler

Budesonid 200 μg dosis

Inhalationspulver

Portugal

Astrazeneca Produtos Farmaceuticos Limitada

Pulmicort Turbohaler

Budesonid 400 μg dosis

Inhalationspulver

Portugal

Astrazeneca Produtos Farmacêuticos, Lda.

Symbicort Turbohaler

Budesonid 160 μg dosis, formoterolfumaratdihydrat 4,5 μg dosis

Inhalationspulver

Portugal

Astrazeneca Produtos Farmacêuticos, Lda.

Symbicort Turbohaler

Budesonid 320 μg dosis, formoterolfumaratdihydrat 9 μg dosis

Inhalationspulver

Portugal

Bialfar — Produtos Farmacêuticos, Sociedade Anónima

Brisomax Diskus

Fluticasonpropionat 100 μg dosis, salmeterolxinafoat 50 μg dosis

Inhalationspulver, afdelt

Portugal

Bialfar — Produtos Farmacêuticos, Sociedade Anónima

Brisomax Diskus

Fluticasonpropionat 250 μg dosis, salmeterolxinafoat 50 μg dosis

Inhalationspulver, afdelt

Portugal

Bialfar — Produtos Farmacêuticos, Sociedade Anónima

Brisomax Diskus

Fluticasonpropionat 500 μg dosis, salmeterolxinafoat 50 μg dosis

Inhalationspulver, afdelt

Portugal

Elpen Pharmaceutical Co. Inc.

Dimenium

Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Portugal

Elpen Pharmaceutical Co. Inc.

Dimenium

Fluticasonpropionat 250 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Portugal

Farmoz — Sociedade Técnico Medicinal, S.A.

Budesonida Farmoz

Budesonid 200 μg dosis

Inhalationspulver

Portugal

Farmoz — Sociedade Técnico Medicinal, S.A.

Budesonida Farmoz

Budesonid 400 μg dosis

Inhalationspulver

Portugal

Glaxo Wellcome Farmacêutica, Limitada

Seretaide Diskus

Fluticasonpropionat 500 μg dosis, salmeterolxinafoat 50 μg dosis

Inhalationspulver, afdelt

Portugal

Glaxosmithkline — Produtos Farmacêuticos, Limitada

Maizar Diskus

Fluticasonpropionat 500 μg dosis, salmeterolxinafoat 50 μg dosis

Inhalationspulver, afdelt

Portugal

Orion Corporation

Bufomix Easyhaler

Budesonid 160 μg dosis, formoterolfumaratdihydrat 4,5 μg dosis

Inhalationspulver

Portugal

Orion Corporation

Bufomix Easyhaler

Budesonid 320 μg dosis, formoterolfumaratdihydrat 9 μg dosis

Inhalationspulver

Portugal

Orion Corporation

Orest Easyhaler

Budesonid 160 μg dosis, formoterolfumaratdihydrat 4,5 μg dosis

Inhalationspulver

Portugal

Orion Corporation

Orest Easyhaler

Budesonid 320 μg dosis, formoterolfumaratdihydrat 9 μg dosis

Inhalationspulver

Portugal

Pentafarma — Sociedade Tecnico-Medicinal S.A.

Budesonida Tecnicort

Budesonid 200 μg dosis

Inhalationspulver

Portugal

Pentafarma — Sociedade Tecnico-Medicinal S.A.

Budesonida Tecnicort

Budesonid 400 μg dosis

Inhalationspulver

Portugal

Sandoz Farmacêutica, Limitada

Airflusal Forspiro

Fluticasonpropionat 250 μg dosis, salmeterolxinafoat 50 μg dosis

Inhalationspulver, afdelt

Portugal

Sandoz Farmacêutica, Limitada

Airflusal Forspiro

Fluticasonpropionat 500 μg dosis, salmeterolxinafoat 50 μg dosis

Inhalationspulver, afdelt

Rumænien

Astrazeneca Ab

Symbicort Turbuhaler

Budesonid 160 μg dosis, formoterolfumaratdihydrat 4,5 μg dosis

Inhalationspulver

Rumænien

Astrazeneca Ab

Symbicort Turbuhaler

Budesonid 320 μg dosis, formoterolfumaratdihydrat 9 μg dosis

Inhalationspulver

Rumænien

Chiesi Pharmaceuticals Gmbh

Foster

Formoterolfumaratedihydrat 6 μg aktivering, beclometasondipropionat vandfri 100 μg aktivering

Inhalationsspray, opløsning

Rumænien

Elpen Pharmaceutical Co. Inc.

Flusamer

Fluticasonpropionat 250 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Rumænien

Elpen Pharmaceutical Co. Inc.

Flusamer

Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Rumænien

Glaxo Wellcome Ltd

Flixotide

Fluticasonpropionat 250 μg inhalation

Inhalationsspray, suspension

Rumænien

Glaxo Wellcome Ltd

Flixotide Diskus

Fluticasonpropionat 250 μg dosis

Inhalationspulver

Rumænien

Glaxo Wellcome Ltd

Flixotide Diskus

Fluticasonpropionat 500 μg dosis

Inhalationspulver

Rumænien

Glaxo Wellcome Ltd

Seretide

Fluticasonpropionat 500 μg dosis, salmeterolxinafoat 50 μg dosis

Inhalationspulver, afdelt

Rumænien

Medochemie Romania S.R.L.

Frenolyn

Budesonid, mikroniseret 200 μg dosis

Inhalationspulver

Rumænien

Medochemie Romania S.R.L.

Frenolyn

Budesonid, mikroniseret 400 μg dosis

Inhalationspulver

Rumænien

Orion Oyj

Bufomix Easyhaler

Budesonid 160 μg inhalation, formoterolfumaratdihydrat 4,5  μg inhalation

Inhalationspulver

Rumænien

Orion Oyj

Bufomix Easyhaler

Budesonid 320 μg inhalation, formoterolfumaratdihydrat 9 μg inhalation

Inhalationspulver

Rumænien

S.C. Sandoz S.R.L.

Airflusal Forspiro

Salmeterolxinafoat 50 μg dosis, fluticason 500 μg dosis

Inhalationspulver

Slovakiet

Astrazeneca Ab

Pulmicort Turbohaler

Budesonid 100 μg dosis

Inhalationspulver

Slovakiet

Astrazeneca Ab

Pulmicort Turbohaler

Budesonid 200 μg dosis

Inhalationspulver

Slovakiet

Astrazeneca Ab

Pulmicort Turbohaler

Budesonid 400 μg dosis

Inhalationspulver

Slovakiet

Astrazeneca Ab

Symbicort Turbuhaler

Budesonid 160 μg dosis, formoterolfumaratdihydrat 4,5 μg dosis

Inhalationspulver

Slovakiet

Astrazeneca Ab

Symbicort Turbuhaler

Budesonid 320 μg dosis, formoterolfumaratdihydrat 9 μg dosis

Inhalationspulver

Slovakiet

Chiesi Pharmaceuticals Gmbh

Foster

Beclometasondipropionat 100 μg aktivering, formoterolfumaratdihydrat 6 μg aktivering

Inhalationsspray, opløsning

Slovakiet

Elpen Pharmaceutical Co. Inc.

Dimenium

Fluticasonpropionat 250 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Slovakiet

Elpen Pharmaceutical Co. Inc.

Dimenium

Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Slovakiet

Elpen Pharmaceutical Co. Inc.

Flumetor

Fluticasonpropionat 250 μg dosis, salmeterolxinafoat 50 μg dosis

Inhalationspulver, afdelt

Slovakiet

Elpen Pharmaceutical Co. Inc.

Flumetor

Fluticasonpropionat 500 μg dosis, salmeterolxinafoat 50 μg dosis

Inhalationspulver, afdelt

Slovakiet

Glaxo Group Limited

Flixotide

Fluticasonpropionat 125 μg inhalation

Inhalationsspray, suspension

Slovakiet

Glaxo Group Limited

Flixotide

Fluticasonpropionat 250 μg inhalation

Inhalationsspray, suspension

Slovakiet

Glaxo Group Limited

Flixotide

Fluticasonpropionat 50 μg inhalation

Inhalationsspray, suspension

Slovakiet

Glaxo Group Limited

Seretide

Fluticasonpropionat 500 μg dosis, salmeterolxinafoat 50 μg dosis

Inhalationspulver, afdelt

Slovakiet

Glaxosmithkline Slovakia S.R.O.

Flixotide Diskus

Fluticasonpropionat 100 μg dosis

Inhalationspulver

Slovakiet

Glaxosmithkline Slovakia S.R.O.

Flixotide Diskus

Fluticasonpropionat 250 μg dosis

Inhalationspulver

Slovakiet

Glaxosmithkline Slovakia S.R.O.

Flixotide Diskus

Fluticasonpropionat 500 μg dosis

Inhalationspulver

Slovakiet

Glaxosmithkline Slovakia S.R.O.

Flixotide Diskus

Fluticasonpropionat 50 μg dosis

Inhalationspulver

Slovakiet

Meda Pharma Spol. S R.O.

Budelin Novolizer

Budesonid 200 μg dosis

Inhalationspulver

Slovakiet

Novartis, S.R.O.

Miflonid

Budesonid 200 μg

Inhalationspulver, hård kapsel

Slovakiet

Novartis, S.R.O.

Miflonid

Budesonid 400 μg

Inhalationspulver, hård kapsel

Slovakiet

Sandoz Pharmaceuticals D.D.

Airflusal Forspiro

Salmeterolxinafoat 50 μg dosis, fluticason 250 μg dosis

Inhalationspulver

Slovakiet

Sandoz Pharmaceuticals D.D.

Airflusal Forspiro

Salmeterolxinafoat 50 μg dosis, fluticason 500 μg dosis

Inhalationspulver

Slovenien

Astrazeneca Ab

Symbicort Turbuhaler

Budesonid 160 μg dosis, formoterolfumaratdihydrat 4,5 μg dosis

Inhalationspulver

Slovenien

Astrazeneca Ab

Symbicort Turbuhaler

Budesonid 320 μg dosis, formoterolfumaratdihydrat 9 μg dosis

Inhalationspulver

Slovenien

Chiesi Pharmaceuticals Gmbh

Formodual

Beclometasondipropionat 100 μg aktivering, formoterolfumaratdihydrat 6 μg aktivering

Inhalationsspray, opløsning

Slovenien

Chiesi Pharmaceuticals Gmbh

Foster

Beclometasondipropionat 100 μg aktivering, formoterolfumaratdihydrat 6 μg aktivering

Inhalationsspray, opløsning

Slovenien

Elpen Pharmaceutical Co. Inc.

Flamerio

Fluticasonpropionat 250 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Slovenien

Elpen Pharmaceutical Co. Inc.

Flamerio

Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Slovenien

Glaxosmithkline D.O.O., Ljubljana

Flixotide

Fluticasone Propionate 250 μg Spray

Inhalationsspray, suspension

Slovenien

Glaxosmithkline D.O.O., Ljubljana

Seretide Diskus

Fluticasonpropionat 500 μg dosis, salmeterolxinafoat 50 μg dosis

Inhalationspulver, afdelt

Slovenien

Lek Pharmaceuticals D.D. Ljubljana

Airflusan Forspiro

Salmeterol 50 μg Dose, Fluticasone Propionate 500 μg Dose

Inhalationspulver

Slovenien

Meda Pharma Gmbh & Co. Kg

Budelin Novolizer

Budesonid 200 μg dosis

Inhalationspulver, afdelt

Spanien

Allen Farmaceutica, S.A.

Anasma Accuhaler

Fluticasonpropionat 250 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Spanien

Almirall, S.A.

Plusvent

Fluticasonpropionat 50 μg dosis, salmeterolxinafoat 25 μg dosis

Inhalationsspray, suspension

Spanien

Almirall, S.A.

Plusvent

Fluticasonpropionat 250 μg dosis, salmeterolxinafoat 25 μg dosis

Inhalationsspray, suspension

Spanien

Almirall, S.A.

Plusvent

Fluticasonpropionat 125 μg dosis, salmeterolxinafoat 25 μg dosis

Inhalationsspray, suspension

Spanien

Almirall, S.A.

Plusvent

Fluticasonpropionat 100 μg dosis, salmeterolxinafoat 50 μg dosis

Inhalationspulver, afdelt

Spanien

Almirall, S.A.

Plusvent

Fluticasonpropionat 250 μg dosis, salmeterolxinafoat 50 μg dosis

Inhalationspulver, afdelt

Spanien

Almirall, S.A.

Plusvent

Fluticasonpropionat 500 μg dosis, salmeterolxinafoat 50 μg dosis

Inhalationspulver, afdelt

Spanien

Astrazeneca Farmacéutica Spain, S.A.

Pulmicort Turbuhaler

Budesonid 100 μg dosis

Inhalationspulver

Spanien

Astrazeneca Farmacéutica Spain, S.A.

Pulmicort Turbuhaler

Budesonid 200 μg dosis

Inhalationspulver

Spanien

Astrazeneca Farmacéutica Spain, S.A.

Pulmicort Turbuhaler

Budesonid 400 μg dosis

Inhalationspulver

Spanien

Astrazeneca Farmacéutica Spain, S.A.

Symbicort Turbuhaler

Budesonid 160 μg dosis, formoterolfumaratdihydrat 4,5 μg dosis

Inhalationspulver

Spanien

Astrazeneca Farmacéutica Spain, S.A.

Symbicort Turbuhaler

Budesonid 320 μg dosis, formoterolfumaratdihydrat 9 μg dosis

Inhalationspulver

Spanien

Chiesi España, S.A.

Formodual

Beclometasondipropionat 100 μg aktivering, formoterolfumaratdihydrat 6 μg aktivering

Inhalationsspray, opløsning

Spanien

Chiesi España, S.A.

Foster

Beclometasondipropionat 100 μg aktivering, formoterolfumaratdihydrat 6 μg dosis

Inhalationsspray, opløsning

Spanien

Glaxosmithkline S.A.

Brisair Accuhaler

Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Spanien

Glaxosmithkline S.A.

Brisair Accuhaler

Fluticasonpropionat 500 μg dosis, salmeterolxinafoat 50 μg dosis

Inhalationspulver, afdelt

Spanien

Glaxosmithkline S.A.

Flixotide

Fluticasonpropionat 125 μg inhalation

Inhalationsspray, suspension

Spanien

Glaxosmithkline S.A.

Flixotide

Fluticasonpropionat 250 μg inhalation

Inhalationsspray, suspension

Spanien

Glaxosmithkline S.A.

Flixotide

Fluticasonpropionat 50 μg inhalation

Inhalationsspray, suspension

Spanien

Glaxosmithkline S.A.

Flixotide Accuhaler

Fluticasonpropionat 100 μg dosis

Inhalationspulver

Spanien

Glaxosmithkline S.A.

Flixotide Accuhaler

Fluticasonpropionat 250 μg dosis

Inhalationspulver

Spanien

Glaxosmithkline S.A.

Flixotide Accuhaler

Fluticasonpropionat 500 μg dosis

Inhalationspulver

Spanien

Glaxosmithkline S.A.

Flusonal

Fluticasonpropionat 250 μg inhalation

Inhalationsspray, suspension

Spanien

Glaxosmithkline S.A.

Flusonal

Fluticasonpropionat 50 μg inhalation

Inhalationsspray, suspension

Spanien

Glaxosmithkline S.A.

Flusonal Accuhaler

Fluticasonpropionat 100 μg dosis

Inhalationspulver

Spanien

Glaxosmithkline S.A.

Flusonal Accuhaler

Fluticasonpropionat 500 μg dosis

Inhalationspulver

Spanien

Glaxosmithkline S.A.

Inalacor

Fluticasonpropionat 250 μg inhalation

Inhalationsspray, suspension

Spanien

Glaxosmithkline S.A.

Inalacor

Fluticasonpropionat 50 μg dosis

Inhalationsspray, suspension

Spanien

Glaxosmithkline S.A.

Inalacor Accuhaler

Fluticasonpropionat 100 μg dosis

Inhalationspulver

Spanien

Glaxosmithkline S.A.

Inalacor Accuhaler

Fluticasonpropionat 500 μg dosis

Inhalationspulver

Spanien

Glaxosmithkline S.A.

Inaladuo Accuhaler

Fluticasonpropionat 500 μg dosis, salmeterolxinafoat 50 μg dosis

Inhalationspulver, afdelt

Spanien

Glaxosmithkline S.A.

Seretide Accuhaler

Fluticasonpropionat 500 μg dosis, salmeterolxinafoat 50 μg dosis

Inhalationspulver, afdelt

Spanien

Laboratorio Tau, S.A.

Rilast Turbuhaler

Budesonid 160 μg dosis, formoterolfumaratdihydrat 4,5 μg dosis

Inhalationspulver

Spanien

Orion Corporation

Bufomix Easyhaler

Budesonid 160 μg inhalation, formoterolfumaratdihydrat 4,5  μg inhalation

Inhalationspulver

Spanien

Orion Corporation

Bufomix Easyhaler

Budesonid 320 μg inhalation, formoterolfumaratdihydrat 9 μg inhalation

Inhalationspulver

Spanien

Orion Corporation

Orest Easyhaler

Budesonid 160 μg inhalation, formoterolfumaratdihydrat 4,5  μg inhalation

Inhalationspulver

Spanien

Orion Corporation

Orest Easyhaler

Budesonid 320 μg inhalation, formoterolfumaratdihydrat 9 μg inhalation

Inhalationspulver

Spanien

Smithkline Beecham Farma S.A.

Trialona

Fluticasonpropionat 250 μg dosis

Inhalationsspray, suspension

Spanien

Smithkline Beecham Farma S.A.

Trialona

Fluticasonpropionat 50 μg dosis

Inhalationsspray, suspension

Spanien

Smithkline Beecham Farma S.A.

Trialona Accuhaler

Fluticasonpropionat 100 μg dosis

Inhalationspulver

Spanien

Smithkline Beecham Farma S.A.

Trialona Accuhaler

Fluticasonpropionat 500 μg dosis

Inhalationspulver

Sverige

Astrazeneca Ab

Gardette

Budesonid 160 μg dosis, formoterolfumaratdihydrat 4,5 μg dosis

Inhalationspulver

Sverige

Astrazeneca Ab

Gardette Forte

Budesonid 160 μg dosis, formoterolfumaratdihydrat 4,5 μg dosis

Inhalationspulver

Sverige

Astrazeneca Ab

Symbicort Forte Turbuhaler

Budesonid 320 μg dosis, formoterolfumaratdihydrat 9 μg dosis

Inhalationspulver

Sverige

Astrazeneca Ab

Symbicort Turbuhaler

Budesonid 160 μg dosis, formoterolfumaratdihydrat 4,5 μg dosis

Inhalationspulver

Sverige

Chiesi Farmaceutici S.P.A.

Innovair

Beclometasondipropionat 100 μg aktivering, formoterolfumaratdihydrat 6 μg aktivering

Inhalationsspray, opløsning

Sverige

Elpen Pharmaceutical Co. Inc.

Flusamer

Fluticasonpropionat 250 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Sverige

Elpen Pharmaceutical Co. Inc.

Flusamer

Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Sverige

Elpen Pharmaceutical Co. Inc.

Flusaterol

Fluticasonpropionat 250 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Sverige

Elpen Pharmaceutical Co. Inc.

Flusaterol

Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Sverige

Elpen Pharmaceutical Co. Inc.

Relanio

Fluticasonpropionat 250 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Sverige

Elpen Pharmaceutical Co. Inc.

Relanio

Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Sverige

Elpen Pharmaceutical Co. Inc.

Salmeson

Fluticasonpropionat 250 μg dosis, salmeterol 50 μg dosis, lactosemonohydrat 24,677  mg dosis

Inhalationspulver, afdelt

Sverige

Elpen Pharmaceutical Co. Inc.

Salmeson

Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Sverige

Glaxosmithkline Ab

Flutide Diskus

Fluticasonpropionat 250 μg dosis

Inhalationspulver, afdelt

Sverige

Glaxosmithkline Ab

Flutide Diskus

Fluticasonpropionat 500 μg dosis

Inhalationspulver, afdelt

Sverige

Glaxosmithkline Ab

Seretide Diskus

Fluticasonpropionat 500 μg dosis, salmeterolxinafoat 50 μg dosis

Inhalationspulver, afdelt

Sverige

Glaxosmithkline Ab

Viani Diskus Forte

Fluticasonpropionat 500 μg dosis, salmeterolxinafoat 50 μg dosis

Inhalationspulver, afdelt

Sverige

Hexal Ag

Salmeterol/Fluticasone Hexal

Salmeterolxinafoat 50 μg dosis, fluticason 500 μg dosis

Inhalationspulver

Sverige

Orion Corporation

Bufomix Easyhaler

Budesonid 160 μg inhalation, formoterolfumaratdihydrat 4,5  μg inhalation

Inhalationspulver

Sverige

Orion Corporation

Bufomix Easyhaler

Budesonid 320 μg inhalation, formoterolfumaratdihydrat 9 μg inhalation

Inhalationspulver

Sverige

Orion Corporation

Orest Easyhaler

Budesonid 160 μg inhalation, formoterolfumaratdihydrat 4,5  μg inhalation

Inhalationspulver

Sverige

Orion Corporation

Orest Easyhaler

Budesonid 320 μg inhalation, formoterolfumaratdihydrat 9 μg inhalation

Inhalationspulver

Sverige

Sandoz A-S

Aesalfluca Forspiro

Salmeterolxinafoat 50 μg dosis, fluticason 500 μg dosis

Inhalationspulver

Sverige

Sandoz A-S

Airflusal Forspiro

Fluticasonpropionat 250 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Sverige

Sandoz A-S

Airflusal Forspiro

Fluticasonpropionat 500 μg dosis, salmeterol 50 μg dosis

Inhalationspulver, afdelt

Sverige

Sandoz A-S

Flaxxone Forspiro

Salmeterolxinafoat 50 μg dosis, fluticason 250 μg dosis

Inhalationspulver

Sverige

Sandoz A-S

Flaxxone Forspiro

Salmeterolxinafoat 50 μg dosis, fluticason 500 μg dosis

Inhalationspulver

Sverige

Sandoz A-S

Lastenol Forspiro

Fluticasonpropionat 500 mikrogram, salmeterolxinafoat 50 mikrogram

Inhalationspulver

Sverige

Sandoz A-S

Molduo Forspiro

Salmeterolxinafoat 50 μg dosis, fluticason 250 μg dosis

Inhalationspulver

Sverige

Sandoz A-S

Salmetorol/Fluticasone Sandoz

Salmeterolxinafoat 50 μg dosis, fluticason 500 μg dosis

Inhalationspulver

Sverige

Sandoz A-S

Setirenol

Salmeterolxinafoat 50 μg dosis, fluticason 250 μg dosis

Inhalationspulver

Sverige

Sandoz A-S

Setirenol

Salmeterolxinafoat 50 μg dosis, fluticason 500 μg dosis

Inhalationspulver

Det Forenede Kongerige

Astrazeneca Uk Limited

Symbicort Turbohaler

Budesonid 320 μg dosis, formoterolfumaratdihydrat 9 μg dosis

Inhalationspulver

Det Forenede Kongerige

Astrazeneca Uk Limited

Symbicort Turbohaler

Budesonid 160 μg dosis, formoterolfumaratdihydrat 4,5 μg dosis

Inhalationspulver

Det Forenede Kongerige

Chiesi Limited

Formodual

Beclometasondipropionat 100 μg aktivering, formoterolfumaratdihydrat 6 μg aktivering

Inhalationsspray, opløsning

Det Forenede Kongerige

Chiesi Limited

Fostair

Beclometasondipropionat 100 μg aktivering, formoterolfumaratdihydrat 6 μg aktivering

Inhalationsspray, opløsning

Det Forenede Kongerige

Glaxo Wellcome Ltd

Seretide

Fluticasonpropionat 100 μg dosis, salmeterolxinafoat 50 μg dosis

Inhalationspulver, afdelt

Det Forenede Kongerige

Glaxo Wellcome Ltd

Seretide

Fluticasonpropionat 250 μg dosis, salmeterolxinafoat 50 μg dosis

Inhalationspulver, afdelt

Det Forenede Kongerige

Glaxo Wellcome Ltd

Seretide Accuhaler

Fluticasonpropionat 500 μg dosis, salmeterolxinafoat 50 μg dosis

Inhalationspulver, afdelt

---

BILAG II

Liste med navne, lægemiddelform, styrke at det veterinære lægemiddel, dyreart, indgivelsesvej, ansøger/indehaver af markedsføringstilladelse i medlemsstaterne

| EU/EØS medlemsstat | Ansøger/markedsføringstilladelsens indehaver | Navn | Styrke | Lægemiddelform | Dyreart | Indgivelsesvej |
| --- | --- | --- | --- | --- | --- | --- |
| Belgien | Zoetis Belgium SA
  Rue Laid Burniat 1
  1348 Louvain-la-Neuve
  Belgien | CattleMarker IBR Inactivated emulsion for injection for cattle | Hver 2 ml dosis indeholder:
  Inaktiveret gE bovin herpesvirus type 1 (BoHV-1), Difivac stamme, for at inducere en geometrisk gennemsnitlig seroneutraliserende titer ≥ 5,5  log2 | Emulsion til injektion | Kvæg | Subkutan brug |
| Bulgarien | Zoetis Belgium SA
  Rue Laid Burniat 1
  1348 Louvain-la-Neuve
  Belgien | CattleMarker IBR Inactivated emulsion for injection for cattle | Hver 2 ml dosis indeholder:
  Inaktiveret gE bovin herpesvirus type 1 (BoHV-1), Difivac stamme, for at inducere en geometrisk gennemsnitlig seroneutraliserende titer ≥ 5,5  log2 | Emulsion til injektion | Kvæg | Subkutan brug |
| Kroatien | Zoetis Belgium SA
  Rue Laid Burniat 1
  1348 Louvain-la-Neuve
  Belgien | CattleMarker IBR Inactivated emulsion for injection for cattle | Hver 2 ml dosis indeholder:
  Inaktiveret gE bovin herpesvirus type 1 (BoHV-1), Difivac stamme, for at inducere en geometrisk gennemsnitlig seroneutraliserende titer ≥ 5,5  log2 | Emulsion til injektion | Kvæg | Subkutan brug |
| Frankrig | Zoetis Belgium SA
  Rue Laid Burniat 1
  1348 Louvain-la-Neuve
  Belgien | CattleMarker IBR Inactivated emulsion for injection for cattle | Hver 2 ml dosis indeholder:
  Inaktiveret gE bovin herpesvirus type 1 (BoHV-1), Difivac stamme, for at inducere en geometrisk gennemsnitlig seroneutraliserende titer ≥ 5,5  log2 | Emulsion til injektion | Kvæg | Subkutan brug |
| Tyskland | Zoetis Belgium SA
  Rue Laid Burniat 1
  1348 Louvain-la-Neuve
  Belgien | CattleMarker IBR Inactivated emulsion for injection for cattle | Hver 2 ml dosis indeholder:
  Inaktiveret gE bovin herpesvirus type 1 (BoHV-1), Difivac stamme, for at inducere en geometrisk gennemsnitlig seroneutraliserende titer ≥ 5,5  log2 | Emulsion til injektion | Kvæg | Subkutan brug |
| Irland | Zoetis Belgium SA
  Rue Laid Burniat 1
  1348 Louvain-la-Neuve
  Belgien | CattleMarker IBR Inactivated emulsion for injection for cattle | Hver 2 ml dosis indeholder:
  Inaktiveret gE bovin herpesvirus type 1 (BoHV-1), Difivac stamme, for at inducere en geometrisk gennemsnitlig seroneutraliserende titer ≥ 5,5  log2 | Emulsion til injektion | Kvæg | Subkutan brug |
| Italien | Zoetis Belgium SA
  Rue Laid Burniat 1
  1348 Louvain-la-Neuve
  Belgien | CattleMarker IBR Inactivated emulsion for injection for cattle | Hver 2 ml dosis indeholder:
  Inaktiveret gE bovin herpesvirus type 1 (BoHV-1), Difivac stamme, for at inducere en geometrisk gennemsnitlig seroneutraliserende titer ≥ 5,5  log2 | Emulsion til injektion | Kvæg | Subkutan brug |
| Holland | Zoetis Belgium SA
  Rue Laid Burniat 1
  1348 Louvain-la-Neuve
  Belgien | CattleMarker IBR Inactivated emulsion for injection for cattle | Hver 2 ml dosis indeholder:
  Inaktiveret gE bovin herpesvirus type 1 (BoHV-1), Difivac stamme, for at inducere en geometrisk gennemsnitlig seroneutraliserende titer ≥ 5,5  log2 | Emulsion til injektion | Kvæg | Subkutan brug |
| Polen | Zoetis Belgium SA
  Rue Laid Burniat 1
  1348 Louvain-la-Neuve
  Belgien | CattleMarker IBR Inactivated emulsion for injection for cattle | Hver 2 ml dosis indeholder:
  Inaktiveret gE bovin herpesvirus type 1 (BoHV-1), Difivac stamme, for at inducere en geometrisk gennemsnitlig seroneutraliserende titer ≥ 5,5  log2 | Emulsion til injektion | Kvæg | Subkutan brug |
| Portugal | Zoetis Belgium SA
  Rue Laid Burniat 1
  1348 Louvain-la-Neuve
  Belgien | CattleMarker IBR Inactivated emulsion for injection for cattle | Hver 2 ml dosis indeholder:
  Inaktiveret gE bovin herpesvirus type 1 (BoHV-1), Difivac stamme, for at inducere en geometrisk gennemsnitlig seroneutraliserende titer ≥ 5,5  log2 | Emulsion til injektion | Kvæg | Subkutan brug |
| Rumænien | Zoetis Belgium SA
  Rue Laid Burniat 1
  1348 Louvain-la-Neuve
  Belgien | CattleMarker IBR Inactivated emulsion for injection for cattle | Hver 2 ml dosis indeholder:
  Inaktiveret gE bovin herpesvirus type 1 (BoHV-1), Difivac stamme, for at inducere en geometrisk gennemsnitlig seroneutraliserende titer ≥ 5,5  log2 | Emulsion til injektion | Kvæg | Subkutan brug |
| Slovenien | Zoetis Belgium SA
  Rue Laid Burniat 1
  1348 Louvain-la-Neuve
  Belgien | CattleMarker IBR Inactivated emulsion for injection for cattle | Hver 2 ml dosis indeholder:
  Inaktiveret gE bovin herpesvirus type 1 (BoHV-1), Difivac stamme, for at inducere en geometrisk gennemsnitlig seroneutraliserende titer ≥ 5,5  log2 | Emulsion til injektion | Kvæg | Subkutan brug |
| Spanien | Zoetis Belgium SA
  Rue Laid Burniat 1
  1348 Louvain-la-Neuve
  Belgien | CattleMarker IBR Inactivated emulsion for injection for cattle | Hver 2 ml dosis indeholder:
  Inaktiveret gE bovin herpesvirus type 1 (BoHV-1), Difivac stamme, for at inducere en geometrisk gennemsnitlig seroneutraliserende titer ≥ 5,5  log2 | Emulsion til injektion | Kvæg | Subkutan brug |
| Storbritannien | Zoetis Belgium SA
  Rue Laid Burniat 1
  1348 Louvain-la-Neuve
  Belgien | CattleMarker IBR Inactivated emulsion for injection for cattle | Hver 2 ml dosis indeholder:
  Inaktiveret gE bovin herpesvirus type 1 (BoHV-1), Difivac stamme, for at inducere en geometrisk gennemsnitlig seroneutraliserende titer ≥ 5,5  log2 | Emulsion til injektion | Kvæg | Subkutan brug |

EU/EØS medlemsstat

Ansøger/markedsføringstilladelsens indehaver

Navn

Styrke

Lægemiddelform

Dyreart

Indgivelsesvej

Belgien

Zoetis Belgium SA

Rue Laid Burniat 1

1348 Louvain-la-Neuve

Belgien

CattleMarker IBR Inactivated emulsion for injection for cattle

Hver 2 ml dosis indeholder:

Inaktiveret gE bovin herpesvirus type 1 (BoHV-1), Difivac stamme, for at inducere en geometrisk gennemsnitlig seroneutraliserende titer ≥ 5,5  log2

Emulsion til injektion

Kvæg

Subkutan brug

Bulgarien

Zoetis Belgium SA

Rue Laid Burniat 1

1348 Louvain-la-Neuve

Belgien

CattleMarker IBR Inactivated emulsion for injection for cattle

Hver 2 ml dosis indeholder:

Inaktiveret gE bovin herpesvirus type 1 (BoHV-1), Difivac stamme, for at inducere en geometrisk gennemsnitlig seroneutraliserende titer ≥ 5,5  log2

Emulsion til injektion

Kvæg

Subkutan brug

Kroatien

Zoetis Belgium SA

Rue Laid Burniat 1

1348 Louvain-la-Neuve

Belgien

CattleMarker IBR Inactivated emulsion for injection for cattle

Hver 2 ml dosis indeholder:

Inaktiveret gE bovin herpesvirus type 1 (BoHV-1), Difivac stamme, for at inducere en geometrisk gennemsnitlig seroneutraliserende titer ≥ 5,5  log2

Emulsion til injektion

Kvæg

Subkutan brug

Frankrig

Zoetis Belgium SA

Rue Laid Burniat 1

1348 Louvain-la-Neuve

Belgien

CattleMarker IBR Inactivated emulsion for injection for cattle

Hver 2 ml dosis indeholder:

Inaktiveret gE bovin herpesvirus type 1 (BoHV-1), Difivac stamme, for at inducere en geometrisk gennemsnitlig seroneutraliserende titer ≥ 5,5  log2

Emulsion til injektion

Kvæg

Subkutan brug

Tyskland

Zoetis Belgium SA

Rue Laid Burniat 1

1348 Louvain-la-Neuve

Belgien

CattleMarker IBR Inactivated emulsion for injection for cattle

Hver 2 ml dosis indeholder:

Inaktiveret gE bovin herpesvirus type 1 (BoHV-1), Difivac stamme, for at inducere en geometrisk gennemsnitlig seroneutraliserende titer ≥ 5,5  log2

Emulsion til injektion

Kvæg

Subkutan brug

Irland

Zoetis Belgium SA

Rue Laid Burniat 1

1348 Louvain-la-Neuve

Belgien

CattleMarker IBR Inactivated emulsion for injection for cattle

Hver 2 ml dosis indeholder:

Inaktiveret gE bovin herpesvirus type 1 (BoHV-1), Difivac stamme, for at inducere en geometrisk gennemsnitlig seroneutraliserende titer ≥ 5,5  log2

Emulsion til injektion

Kvæg

Subkutan brug

Italien

Zoetis Belgium SA

Rue Laid Burniat 1

1348 Louvain-la-Neuve

Belgien

CattleMarker IBR Inactivated emulsion for injection for cattle

Hver 2 ml dosis indeholder:

Inaktiveret gE bovin herpesvirus type 1 (BoHV-1), Difivac stamme, for at inducere en geometrisk gennemsnitlig seroneutraliserende titer ≥ 5,5  log2

Emulsion til injektion

Kvæg

Subkutan brug

Holland

Zoetis Belgium SA

Rue Laid Burniat 1

1348 Louvain-la-Neuve

Belgien

CattleMarker IBR Inactivated emulsion for injection for cattle

Hver 2 ml dosis indeholder:

Inaktiveret gE bovin herpesvirus type 1 (BoHV-1), Difivac stamme, for at inducere en geometrisk gennemsnitlig seroneutraliserende titer ≥ 5,5  log2

Emulsion til injektion

Kvæg

Subkutan brug

Polen

Zoetis Belgium SA

Rue Laid Burniat 1

1348 Louvain-la-Neuve

Belgien

CattleMarker IBR Inactivated emulsion for injection for cattle

Hver 2 ml dosis indeholder:

Inaktiveret gE bovin herpesvirus type 1 (BoHV-1), Difivac stamme, for at inducere en geometrisk gennemsnitlig seroneutraliserende titer ≥ 5,5  log2

Emulsion til injektion

Kvæg

Subkutan brug

Portugal

Zoetis Belgium SA

Rue Laid Burniat 1

1348 Louvain-la-Neuve

Belgien

CattleMarker IBR Inactivated emulsion for injection for cattle

Hver 2 ml dosis indeholder:

Inaktiveret gE bovin herpesvirus type 1 (BoHV-1), Difivac stamme, for at inducere en geometrisk gennemsnitlig seroneutraliserende titer ≥ 5,5  log2

Emulsion til injektion

Kvæg

Subkutan brug

Rumænien

Zoetis Belgium SA

Rue Laid Burniat 1

1348 Louvain-la-Neuve

Belgien

CattleMarker IBR Inactivated emulsion for injection for cattle

Hver 2 ml dosis indeholder:

Inaktiveret gE bovin herpesvirus type 1 (BoHV-1), Difivac stamme, for at inducere en geometrisk gennemsnitlig seroneutraliserende titer ≥ 5,5  log2

Emulsion til injektion

Kvæg

Subkutan brug

Slovenien

Zoetis Belgium SA

Rue Laid Burniat 1

1348 Louvain-la-Neuve

Belgien

CattleMarker IBR Inactivated emulsion for injection for cattle

Hver 2 ml dosis indeholder:

Inaktiveret gE bovin herpesvirus type 1 (BoHV-1), Difivac stamme, for at inducere en geometrisk gennemsnitlig seroneutraliserende titer ≥ 5,5  log2

Emulsion til injektion

Kvæg

Subkutan brug

Spanien

Zoetis Belgium SA

Rue Laid Burniat 1

1348 Louvain-la-Neuve

Belgien

CattleMarker IBR Inactivated emulsion for injection for cattle

Hver 2 ml dosis indeholder:

Inaktiveret gE bovin herpesvirus type 1 (BoHV-1), Difivac stamme, for at inducere en geometrisk gennemsnitlig seroneutraliserende titer ≥ 5,5  log2

Emulsion til injektion

Kvæg

Subkutan brug

Storbritannien

Zoetis Belgium SA

Rue Laid Burniat 1

1348 Louvain-la-Neuve

Belgien

CattleMarker IBR Inactivated emulsion for injection for cattle

Hver 2 ml dosis indeholder:

Inaktiveret gE bovin herpesvirus type 1 (BoHV-1), Difivac stamme, for at inducere en geometrisk gennemsnitlig seroneutraliserende titer ≥ 5,5  log2

Emulsion til injektion

Kvæg

Subkutan brug

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BILAG III

Liste over navne, lægemiddelformer, lægemiddelstyrker, administrationsveje, indehavere af markedføringstilladelser i medlemsstaterne

| Medlemsstat i EØS | Indehaver af markedsføringstilladelsen | Handelsnavn | Styrke | Lægemiddelform | Administrationsvej | Indhold (koncentration) |
| --- | --- | --- | --- | --- | --- | --- |
| Cypern | MEDA Pharmaceuticals S.A.
  3, Evritanias Str.
  GR-15231
  Chalandri-Attiki
  Greece | Novantrone | 2 mg/ml | Koncentrat til infusionsvæske, opløsning | Intravenøs anvendelse | 20 mg/10 ml |
| Finland | MEDA Oy
  Vaisalantie 4
  FIN-02130
  Espoo
  Finland | Novantrone | 2 mg/ml | Koncentrat til infusionsvæske, opløsning | Intravenøs anvendelse | 20 mg/10 ml |
| Finland | MEDA Oy
  Vaisalantie 4
  FIN-02130
  Espoo
  Finland | Novantrone | 2 mg/ml | Koncentrat til infusionsvæske, opløsning | Intravenøs anvendelse | 10 mg/5 ml |
| Frankrig | 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 | Koncentrat til infusionsvæske, opløsning | Intravenøs anvendelse | 20 mg/10 ml |
| Frankrig | 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 | Koncentrat til infusionsvæske, opløsning | Intravenøs anvendelse | 20 mg/10 ml |
| Frankrig | 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 | Koncentrat til infusionsvæske, opløsning | Intravenøs anvendelse | 20 mg/10 ml |
| Tyskland | MEDA Pharma GmbH & Co. KG
  Benzstraße 1
  D-61352 Bad Homburg
  Germany | Novantrone 10 mg/5 ml | 2 mg/ml | Koncentrat til infusionsvæske, opløsning, eller opløsning til intrapleural eller intraperitoneal anvendelse | Intravenøs anvendelse, intrapleural anvendelse
  Intraperitoneal anvendelse | 10 mg/5 ml |
| Tyskland | MEDA Pharma GmbH & Co. KG
  Benzstraße 1
  D-61352 Bad Homburg
  Germany | Novantrone 20 mg/10 ml | 2 mg/ml | Koncentrat til infusionsvæske, opløsning, eller opløsning til intrapleural eller intraperitoneal anvendelse | Intravenøs anvendelse, intrapleural anvendelse
  Intraperitoneal anvendelse | 20 mg/10 ml |
| Tyskland | MEDA Pharma GmbH & Co. KG
  Benzstraße 1
  D-61352 Bad Homburg
  Germany | Ralenova 2 mg/ml | 2 mg/ml | Koncentrat til infusionsvæske, opløsning | Intravenøs anvendelse | 20 mg/10 ml |
| Tyskland | MEDA Pharma GmbH & Co. KG
  Benzstraße 1
  D-61352 Bad Homburg
  Germany | Ralenova 2 mg/ml | 2 mg/ml | Koncentrat til infusionsvæske, opløsning | Intravenøs anvendelse | 10 mg/5 ml |
| Grækenland | MEDA Pharmaceuticals S.A.
  3, Evritanias Str.
  GR-15231
  Chalandri-Attiki
  Greece | Novantrone | 2 mg/ml | Koncentrat til infusionsvæske, opløsning | Intravenøs anvendelse | 20 mg/10 ml |
| Island | MEDA AB
  Pipers väg 2A, Box 906
  SE-170 09
  Solna
  Sweden | Novantrone | 2 mg/ml | Koncentrat til infusionsvæske, opløsning | Intravenøs anvendelse | 20 mg/10 ml |
| Island | MEDA AB
  Pipers väg 2A, Box 906
  SE-170 09
  Solna
  Sweden | Novantrone | 2 mg/ml | Koncentrat til infusionsvæske, opløsning | Intravenøs anvendelse | 10 mg/5 ml |
| Italien | MEDA Pharma S.p.A.
  Felice Casati, 20
  IT-20124
  Milano
  Italy | Novantrone | 2 mg/ml | Koncentrat til infusionsvæske, opløsning | Intravenøs anvendelse | 10 mg/5 ml |
| Italien | MEDA Pharma S.p.A.
  Felice Casati, 20
  IT-20124
  Milano
  Italy | Novantrone | 2 mg/ml | Koncentrat til infusionsvæske, opløsning | Intravenøs anvendelse | 20 mg/10 ml |
| Norge | MEDA A/S
  Askerveien 61
  NO-1384
  Asker
  Norway | Novantrone | 2 mg/ml | Koncentrat til infusionsvæske, opløsning | Intravenøs anvendelse | 10 mg/5 ml |
| Rumænien | MEDA Pharma GmbH & Co. KG
  Benzstraße 1
  D-61352 Bad Homburg
  Germany | Novantrone | 2 mg/ml | Koncentrat til infusionsvæske, opløsning | Intravenøs anvendelse | 20 mg/10 ml |
| Slovenien | MEDA Pharma GmbH & Co. KG
  Benzstraße 1
  D-61352 Bad Homburg
  Germany | Novantrone | 2 mg/ml | Koncentrat til infusionsvæske, opløsning | Intravenøs anvendelse | 20 mg/10 ml |
| Spanien | 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 | Koncentrat til infusionsvæske, opløsning | Intravenøs anvendelse | 20 mg/10 ml |
| Sverige | MEDA AB
  Pipers väg 2A, Box 906
  SE-170 09
  Solna
  Sweden | Novantrone | 2 mg/ml | Koncentrat til infusionsvæske, opløsning | Intravenøs anvendelse | 20 mg/10 ml |
| Sverige | MEDA AB
  Pipers väg 2A, Box 906
  SE-170 09
  Solna
  Sweden | Novantrone | 2 mg/ml | Koncentrat til infusionsvæske, opløsning | Intravenøs anvendelse | 10 mg/5 ml |

Medlemsstat i EØS

Indehaver af markedsføringstilladelsen

Handelsnavn

Styrke

Lægemiddelform

Administrationsvej

Indhold (koncentration)

Cypern

MEDA Pharmaceuticals S.A.

3, Evritanias Str.

GR-15231

Chalandri-Attiki

Greece

Novantrone

2 mg/ml

Koncentrat til infusionsvæske, opløsning

Intravenøs anvendelse

20 mg/10 ml

Finland

MEDA Oy

Vaisalantie 4

FIN-02130

Espoo

Finland

Novantrone

2 mg/ml

Koncentrat til infusionsvæske, opløsning

Intravenøs anvendelse

20 mg/10 ml

Finland

MEDA Oy

Vaisalantie 4

FIN-02130

Espoo

Finland

Novantrone

2 mg/ml

Koncentrat til infusionsvæske, opløsning

Intravenøs anvendelse

10 mg/5 ml

Frankrig

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

Koncentrat til infusionsvæske, opløsning

Intravenøs anvendelse

20 mg/10 ml

Frankrig

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

Koncentrat til infusionsvæske, opløsning

Intravenøs anvendelse

20 mg/10 ml

Frankrig

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

Koncentrat til infusionsvæske, opløsning

Intravenøs anvendelse

20 mg/10 ml

Tyskland

MEDA Pharma GmbH & Co. KG

Benzstraße 1

D-61352 Bad Homburg

Germany

Novantrone 10 mg/5 ml

2 mg/ml

Koncentrat til infusionsvæske, opløsning, eller opløsning til intrapleural eller intraperitoneal anvendelse

Intravenøs anvendelse, intrapleural anvendelse

Intraperitoneal anvendelse

10 mg/5 ml

Tyskland

MEDA Pharma GmbH & Co. KG

Benzstraße 1

D-61352 Bad Homburg

Germany

Novantrone 20 mg/10 ml

2 mg/ml

Koncentrat til infusionsvæske, opløsning, eller opløsning til intrapleural eller intraperitoneal anvendelse

Intravenøs anvendelse, intrapleural anvendelse

Intraperitoneal anvendelse

20 mg/10 ml

Tyskland

MEDA Pharma GmbH & Co. KG

Benzstraße 1

D-61352 Bad Homburg

Germany

Ralenova 2 mg/ml

2 mg/ml

Koncentrat til infusionsvæske, opløsning

Intravenøs anvendelse

20 mg/10 ml

Tyskland

MEDA Pharma GmbH & Co. KG

Benzstraße 1

D-61352 Bad Homburg

Germany

Ralenova 2 mg/ml

2 mg/ml

Koncentrat til infusionsvæske, opløsning

Intravenøs anvendelse

10 mg/5 ml

Grækenland

MEDA Pharmaceuticals S.A.

3, Evritanias Str.

GR-15231

Chalandri-Attiki

Greece

Novantrone

2 mg/ml

Koncentrat til infusionsvæske, opløsning

Intravenøs anvendelse

20 mg/10 ml

Island

MEDA AB

Pipers väg 2A, Box 906

SE-170 09

Solna

Sweden

Novantrone

2 mg/ml

Koncentrat til infusionsvæske, opløsning

Intravenøs anvendelse

20 mg/10 ml

Island

MEDA AB

Pipers väg 2A, Box 906

SE-170 09

Solna

Sweden

Novantrone

2 mg/ml

Koncentrat til infusionsvæske, opløsning

Intravenøs anvendelse

10 mg/5 ml

Italien

MEDA Pharma S.p.A.

Felice Casati, 20

IT-20124

Milano

Italy

Novantrone

2 mg/ml

Koncentrat til infusionsvæske, opløsning

Intravenøs anvendelse

10 mg/5 ml

Italien

MEDA Pharma S.p.A.

Felice Casati, 20

IT-20124

Milano

Italy

Novantrone

2 mg/ml

Koncentrat til infusionsvæske, opløsning

Intravenøs anvendelse

20 mg/10 ml

Norge

MEDA A/S

Askerveien 61

NO-1384

Asker

Norway

Novantrone

2 mg/ml

Koncentrat til infusionsvæske, opløsning

Intravenøs anvendelse

10 mg/5 ml

Rumænien

MEDA Pharma GmbH & Co. KG

Benzstraße 1

D-61352 Bad Homburg

Germany

Novantrone

2 mg/ml

Koncentrat til infusionsvæske, opløsning

Intravenøs anvendelse

20 mg/10 ml

Slovenien

MEDA Pharma GmbH & Co. KG

Benzstraße 1

D-61352 Bad Homburg

Germany

Novantrone

2 mg/ml

Koncentrat til infusionsvæske, opløsning

Intravenøs anvendelse

20 mg/10 ml

Spanien

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

Koncentrat til infusionsvæske, opløsning

Intravenøs anvendelse

20 mg/10 ml

Sverige

MEDA AB

Pipers väg 2A, Box 906

SE-170 09

Solna

Sweden

Novantrone

2 mg/ml

Koncentrat til infusionsvæske, opløsning

Intravenøs anvendelse

20 mg/10 ml

Sverige

MEDA AB

Pipers väg 2A, Box 906

SE-170 09

Solna

Sweden

Novantrone

2 mg/ml

Koncentrat til infusionsvæske, opløsning

Intravenøs anvendelse

10 mg/5 ml

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