ISSN 1977-091X

Official Journal C 224

of the European Union

Volume 55 English edition Information and Notices 27 July 2012

Notice No Contents Page

IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

2012/C 224/01 Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2012 to 30 June 2012 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) ...... 1

2012/C 224/02 Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2012 to 30 June 2012 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC) ...... 16

Price: EN EUR 3

27.7.2012 EN Official Journal of the European Union C 224/1

IV

(Notices)

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2012 to 30 June 2012 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council ( 1 )) (2012/C 224/01)

( 1 ) OJ L 136, 30.4.04, p. 1. C 224/2 EN Official Journal of the European Union 27.7.2012

Date of notification

20.06.2012 ATC code Therapeutic (Anatomical Chemical Code)

Pending

: Accepted Pharmaceutical form Pharmaceutical Solution for injection for Solution

Community Register Number of the entry in the in entry the Number of EU/1/12/774/001-002

Holder of the marketing authorization (Europe) Ltd 61 Aldwych, London WC2B 4AE, United Kingdom

Takeda Global Research and Development Centre Development and Research Global Takeda INN (International Non-Proprietary Name)

product Ferumoxytol Name of the medicinal Rienso

decision (EC) No 726/2004 (Article 13 and of the Council) of Regulation authorization European Parliament of the of a marketing Issuing Date of the 15.06.2012 — 27.7.2012 EN Official Journal of the European Union C 224/3

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

Date of the Name of the medicinal Number of the entry in the Date of Holder of the marketing authorization decision product Community Register notification

21.06.2012 Folotyn Allos Therapeutics Limited — 25.06.2012 71 Knowl Piece, Wilbury Way, Hitchin, Hertfordshire SG4 0TY, United Kingdom

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

Date of the Name of the Number of the entry in the Date of Holder of the marketing authorization decision medicinal product Community Register notification

01.06.2012 Osigraft Olympus Biotech International Limited EU/1/01/179/001 05.06.2012 Raheen Business Park, Limerick, Ireland

11.06.2012 Levetiracetam Teva Pharma B.V. EU/1/11/701/001-032 13.06.2012 Teva Computerweg 10, 3542 DR Utrecht, Nederland

11.06.2012 Mycophenolate Teva Pharma B.V. EU/1/07/439/001-006 13.06.2012 mofetil Teva Computerweg 10, DR Utrecht 3542, Nederland

11.06.2012 Myfenax Teva Pharma B.V. EU/1/07/438/001-006 13.06.2012 Computerweg 10, DR Utrecht 3542, Nederland

14.06.2012 Nivestim Hospira UK Limited Queensway, EU/1/10/631/001-009 18.06.2012 Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom

14.06.2012 Quadramet CIS bio international Boite Postale EU/1/97/057/001 18.06.2012 32 - F-91192 Gif-sur-Yvette - France

15.06.2012 Abseamed Medice Arzneimittel Pütter GmbH & Co KG EU/1/07/412/001-052 19.06.2012 Kuhloweg 37, D-58638 Iserlohn, Deutschland

15.06.2012 Azopt Alcon Laboratories (UK) Ltd. EU/1/00/129/001-003 20.06.2012 Pentagon Park, Boundary Way, Hemel Hempstead, Herts HP2 7UD, United Kingdom C 224/4 EN Official Journal of the European Union 27.7.2012

Date of the Name of the Number of the entry in the Date of Holder of the marketing authorization decision medicinal product Community Register notification

15.06.2012 Epivir ViiV Healthcare UK Ltd EU/1/96/015/002 20.06.2012 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

15.06.2012 Evra Janssen-Cilag International NV EU/1/02/223/001-003 19.06.2012 Turnhoutseweg, 30 - 2340 Beerse - België

15.06.2012 Optimark Covidien Deutschland GmbH EU/1/07/398/001-014 19.06.2012 Gewerbepark 1, Neustadt/Donau 93333, Deutschland

15.06.2012 Prevenar Wyeth-Lederle Vaccines S.A. EU/1/00/167/001-008 20.06.2012 Pleainlaan 17 Boulevard de la Plaine, 1050 Brussels - Bruxelles, Belgium

15.06.2012 Temozolomide HEXAL AG EU/1/10/616/001-036 20.06.2012 HEXAL Industriestrasse 25, D-83607 Holzkirchen, Deutschland

15.06.2012 Temozolomide Sandoz Pharmaceuticals GmbH EU/1/10/617/001-002 20.06.2012 Sandoz Raiffeisenstraße 11, EU/1/10/617/005-006 83607 Holzkirchen, EU/1/10/617/009-010 Deutschland EU/1/10/617/013-014 EU/1/10/617/017-018 EU/1/10/617/021-022 EU/1/10/617/025-036

18.06.2012 Atriance Glaxo Group Limited EU/1/07/403/001 21.06.2012 Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom

18.06.2012 Binocrit Sandoz GmbH EU/1/07/410/001-052 21.06.2012 Biochemiestrasse 10, Kundl 6250, Österreich

18.06.2012 Epoetin alfa Hexal AG. EU/1/07/411/001-052 21.06.2012 Hexal Industriestrasse 25, D-83607 Holzkirchen, Deutschland

18.06.2012 GILENYA Novartis Europharm Ltd EU/1/11/677/001-005 20.06.2012 Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom 27.7.2012 EN Official Journal of the European Union C 224/5

Date of the Name of the Number of the entry in the Date of Holder of the marketing authorization decision medicinal product Community Register notification

18.06.2012 GILENYA Novartis Europharm Ltd EU/1/11/677/001-005 22.06.2012 Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

18.06.2012 Soliris Alexion Europe S.A.S. EU/1/07/393/001 20.06.2012 25, boulevard de l'Amiral Bruix, 75016 Paris, France

18.06.2012 Soliris Alexion Europe S.A.S. EU/1/07/393/001 20.06.2012 25, boulevard de l'Amiral Bruix, 75016 Paris, France

21.06.2012 alli Glaxo Group Limited EU/1/07/401/007-016 25.06.2012 Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom

21.06.2012 Cimzia UCB Pharma SA. EU/1/09/544/001-002 20.06.2012 Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef, 60, Brussel 1070, België

21.06.2012 Ketek Aventis Pharma S.A. EU/1/01/191/001-005 25.06.2012 20 avenue Raymond Aron, F-92160 Antony, France

21.06.2012 Tarceva Roche Registration Limited EU/1/05/311/001-003 25.06.2012 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

21.06.2012 Yervoy Bristol-Myers Squibb Pharma EEIG EU/1/11/698/001-002 25.06.2012 Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

27.06.2012 Abraxane Celgene Europe Limited EU/1/07/428/001 02.07.2012 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex, UB11 1DB, United Kingdom C 224/6 EN Official Journal of the European Union 27.7.2012

Date of the Name of the Number of the entry in the Date of Holder of the marketing authorization decision medicinal product Community Register notification

27.06.2012 Actraphane Novo Nordisk A/S EU/1/02/229/001-004 29.06.2012 Novo Allé, EU/1/02/229/036-037 DK-2880 Bagsvaerd, Danmark

27.06.2012 Actrapid Novo Nordisk A/S EU/1/02/230/001-004 29.06.2012 Novo Allé, EU/1/02/230/016-017 DK-2880 Bagsvaerd, Danmark

27.06.2012 Avastin Roche Registration Limited EU/1/04/300/001-002 02.07.2012 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

27.06.2012 Cimzia UCB Pharma SA. EU/1/09/544/001-002 29.06.2012 Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef, 60, Brussel 1070, België

27.06.2012 Dificlir Astellas Pharma Europe B.V. EU/1/11/733/001-004 29.06.2012 Elisabethhof 19, 2353 EW Leiderdorp, Nederland

27.06.2012 Humira Abbott Laboratories Ltd EU/1/03/256/001-010 02.07.2012 Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, United Kingdom

27.06.2012 Insulatard Novo Nordisk A/S EU/1/02/233/003-004 02.07.2012 Novo Allé, EU/1/02/233/017 DK-2880 Bagsvaerd, Danmark

27.06.2012 Invanz Merck Sharp & Dohme Ltd EU/1/02/216/001-002 29.06.2012 Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

27.06.2012 Invega Janssen-Cilag International NV EU/1/07/395/001-095 02.07.2012 Turnhoutseweg, 30 - 2340 Beerse - België 27.7.2012 EN Official Journal of the European Union C 224/7

Date of the Name of the Number of the entry in the Date of Holder of the marketing authorization decision medicinal product Community Register notification

27.06.2012 Invirase Roche Registration Limited EU/1/96/026/001-002 29.06.2012 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

27.06.2012 Irbesartan HCT Sanofi EU/1/06/377/001-034 03.07.2012 Zentiva 54, rue La Boétie, (Ex-Winthrop) 75008 Paris, France

27.06.2012 Javlor Pierre Fabre Médicament EU/1/09/550/001-012 02.07.2012 45, place Abel Gance, F-92100 Boulogne, France

27.06.2012 Karvezide Bristol-Myers Squibb Pharma EEIG EU/1/98/085/001-034 29.06.2012 Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

27.06.2012 Lucentis Novartis Europharm Ltd EU/1/06/374/001 29.06.2012 Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

27.06.2012 Menveo Novartis Vaccines and Diagnostics S.r.l. EU/1/10/614/001-003 29.06.2012 Via Fiorentina, 1, 53100 Siena, Italia

27.06.2012 Mixtard Novo Nordisk A/S EU/1/02/231/001-004 02.07.2012 Novo Allé, EU/1/02/231/036-037 DK-2880 Bagsvaerd, Danmark

27.06.2012 Nexavar Bayer Pharma AG EU/1/06/342/001 02.07.2012 13342 Berlin, Deutschland

27.06.2012 Osseor Les Laboratoires Servier EU/1/04/287/001-006 02.07.2012 50, rue Carnot, 92284 Suresnes cedex, France C 224/8 EN Official Journal of the European Union 27.7.2012

Date of the Name of the Number of the entry in the Date of Holder of the marketing authorization decision medicinal product Community Register notification

27.06.2012 PREZISTA Janssen-Cilag International NV EU/1/06/380/001-005 02.07.2012 Turnhoutseweg, 30 - 2340 Beerse - België

27.06.2012 Protaphane Novo Nordisk A/S EU/1/02/234/003-004 02.07.2012 Novo Allé, EU/1/02/234/017 DK-2880 Bagsvaerd, Danmark

27.06.2012 Protelos Les Laboratoires Servier EU/1/04/288/001-006 02.07.2012 50, rue Carnot, 92284 Suresnes cedex, France

27.06.2012 Rebif Merck Serono Europe Limited EU/1/98/063/001-019 29.06.2012 56, Marsh Wall, London E14 9TP, United Kingdom

27.06.2012 Revolade GlaxoSmithKline Trading Services Limited EU/1/10/612/001-006 02.07.2012 6900 Cork Airport Business Park, Kinsale Road, Cork, Ireland

27.06.2012 Stocrin Merck Sharp & Dohme Ltd EU/1/99/111/001-005 02.07.2012 Hertford Road, EU/1/99/111/008 Hoddesdon, EU/1/99/111/010-011 Hertfordshire EN11 9BU, United Kingdom

27.06.2012 Sustiva Bristol-Myers Squibb Pharma EEIG EU/1/99/110/001-005 02.07.2012 Uxbridge Business Park, EU/1/99/110/008-010 Sanderson Road, Uxbridge UB8 1DH, United Kingdom

27.06.2012 Sycrest N.V. Organon EU/1/10/640/001-006 02.07.2012 Kloosterstraat 6, 5349 AB Oss, Nederland

27.06.2012 Synagis Abbott Laboratories Ltd EU/1/99/117/001-002 29.06.2012 Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, United Kingdom 27.7.2012 EN Official Journal of the European Union C 224/9

Date of the Name of the Number of the entry in the Date of Holder of the marketing authorization decision medicinal product Community Register notification

27.06.2012 Tasigna Novartis Europharm Ltd EU/1/07/422/001-012 02.07.2012 Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

27.06.2012 Temodal Merck Sharp & Dohme Limited EU/1/98/096/001-025 02.07.2012 Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU, United Kingdom

27.06.2012 Trisenox Cephalon Europe EU/1/02/204/001 02.07.2012 5 Rue Charles Martigny, 94700 Maisons Alfort, Cedex, France

27.06.2012 Viracept Roche Registration Limited EU/1/97/054/001 29.06.2012 6 Falcon Way, EU/1/97/054/004-005 Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

27.06.2012 VPRIV Shire Pharmaceuticals Ireland Limited EU/1/10/646/001-006 02.07.2012 5 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

27.06.2012 Xeplion Janssen-Cilag International NV EU/1/11/672/001-006 02.07.2012 Turnhoutseweg 30, B-2340 Beerse, België

27.06.2012 Zeffix Glaxo Group Ltd. EU/1/99/114/003 02.07.2012 Greenford Road, Greenford, Middlesex UB6 0NN, United Kingdom

27.06.2012 Zypadhera Eli Lilly Nederland B.V. EU/1/08/479/001-003 29.06.2012 Grootslag 1-5, NL-3991 RA Houten, Nederland C 224/10 EN Official Journal of the European Union 27.7.2012

Date of the Name of the Number of the entry in the Date of Holder of the marketing authorization decision medicinal product Community Register notification

27.06.2012 Zyprexa Eli Lilly Nederland B.V. EU/1/96/022/002 29.06.2012 Grootslag 1-5, EU/1/96/022/004 3991 RA Houten, EU/1/96/022/006 Nederland EU/1/96/022/009-012 EU/1/96/022/014 EU/1/96/022/016-017 EU/1/96/022/019-040

27.06.2012 Zyprexa Velotab Eli Lilly Nederland B.V. EU/1/99/125/001-020 29.06.2012 Grootslag 1-5, 3991 RA Houten, Nederland

28.06.2012 CoAprovel Sanofi Pharma Bristol-Myers Squibb SNC EU/1/98/086/001-034 03.07.2012 54, rue La Boétie, 75008 Paris, France

28.06.2012 Copalia HCT Novartis Europharm Ltd EU/1/09/575/001-060 03.07.2012 Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

28.06.2012 Dafiro HCT Novartis Europharm Ltd EU/1/09/574/001-060 03.07.2012 Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

28.06.2012 Ecalta Pfizer Limited EU/1/07/416/001-002 03.07.2012 Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

28.06.2012 ellaOne Laboratoire HRA Pharma EU/1/09/522/001 03.07.2012 15, rue Béranger, 75003 Paris, France

28.06.2012 Exforge Novartis Europharm Ltd EU/1/06/370/001-039 03.07.2012 Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom 27.7.2012 EN Official Journal of the European Union C 224/11

Date of the Name of the Number of the entry in the Date of Holder of the marketing authorization decision medicinal product Community Register notification

28.06.2012 Firmagon Ferring Pharmaceuticals A/S EU/1/08/504/001-003 07.07.2012 Kay Fiskers Plads 11, Copenhagen S 2300, Danmark

28.06.2012 GONAL-f Merck Serono Europe Ltd. EU/1/95/001/001 03.07.2012 56, Marsh Wall, EU/1/95/001/003-005 London E14 9TP, EU/1/95/001/009 United Kingdom EU/1/95/001/012 EU/1/95/001/021-022 EU/1/95/001/025-028 EU/1/95/001/031-035

28.06.2012 Icandra Novartis Europharm Ltd EU/1/08/484/001-018 03.07.2012 Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

28.06.2012 Imprida Novartis Europharm Ltd EU/1/06/373/001-039 03.07.2012 Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

28.06.2012 Insulin Human Sanofi-Aventis Deutschland GmbH EU/1/06/368/001-015 04.07.2012 Winthrop D-65926 Frankfurt am Main, EU/1/06/368/020-024 Deutschland EU/1/06/368/029-033 EU/1/06/368/037-042 EU/1/06/368/047-051 EU/1/06/368/056-057 EU/1/06/368/088-102 EU/1/06/368/113-150 EU/1/06/368/163-174

28.06.2012 Jalra Novartis Europharm Ltd EU/1/08/485/001-011 03.07.2012 Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

28.06.2012 Lamivudine Teva Teva Pharma B.V. EU/1/09/596/001-014 03.07.2012 Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland

28.06.2012 Myclausen Herbert J. Passauer GmbH & Co. KG EU/1/10/647/001-004 03.07.2012 Stubenrauchstrasse 33, 14167 Berlin, Deutschland C 224/12 EN Official Journal of the European Union 27.7.2012

Date of the Name of the Number of the entry in the Date of Holder of the marketing authorization decision medicinal product Community Register notification

28.06.2012 Pradaxa Boehringer Ingelheim International GmbH EU/1/08/442/001-014 03.07.2012 Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland

28.06.2012 PritorPlus Bayer Pharma AG EU/1/02/215/001-021 04.07.2012 13342 Berlin, Deutschland

28.06.2012 Rasilez HCT Novartis Europharm Ltd EU/1/08/491/001-080 03.07.2012 Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

28.06.2012 Rilonacept Regeneron UK Limited EU/1/09/582/001 04.07.2012 Regeneron 40 Bank Street, E14 5DS London, United Kingdom

28.06.2012 Riprazo HCT Novartis Europharm Limited EU/1/11/680/001-080 03.07.2012 Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom

28.06.2012 Siklos ADDMEDICA EU/1/07/397/001-004 03.07.2012 101, rue Saint Lazare, Paris 75009, France

28.06.2012 Siklos ADDMEDICA EU/1/07/397/001-004 03.07.2012 101, rue Saint Lazare, Paris 75009, France

28.06.2012 Sprimeo HCT Novartis Europharm Limited EU/1/11/683/001-080 02.07.2012 Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom

28.06.2012 Vfend Pfizer Ltd EU/1/02/212/001-026 03.07.2012 Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom

28.06.2012 Votubia Novartis Europharm Limited EU/1/11/710/001-007 04.07.2012 Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom 27.7.2012 EN Official Journal of the European Union C 224/13

Date of the Name of the Number of the entry in the Date of Holder of the marketing authorization decision medicinal product Community Register notification

28.06.2012 Votubia Novartis Europharm Limited EU/1/11/710/001-007 04.07.2012 Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom

28.06.2012 Vyndaqel Pfizer Specialty UK Limited EU/1/11/717/001 04.07.2012 Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom

28.06.2012 Xiliarx Novartis Europharm Ltd EU/1/08/486/001-011 03.07.2012 Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom

28.06.2012 Zomarist Novartis Europharm Ltd EU/1/08/483/001-018 03.07.2012 Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom

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

Date of the Name of the medicinal Number of the entry in the Date of Holder of the marketing authorization decision product Community Register notification

28.06.2012 Hexavac Aventis Pasteur MSD EU/1/00/147/001-012 04.07.2012 8, rue Jonas Salk, 69007 Lyon, France C 224/14 EN Official Journal of the European Union 27.7.2012

Date of notification

17.06.2012 20.06.2012

ATC code Therapeutic (Anatomical QI09AB08 QI01AE04 Chemical Code)

): Accepted )

1 (

Pharmaceutical form Pharmaceutical injection suspension for spray vaccination Suspension for Suspension for Lyophilisate

Community Register EU/2/12/140/001-008 EU/2/12/141/001-009 Number of the entry in the entry the Number of

Holder of the marketing authorization Wim de Körverstraat 35, Körverstraat Wim de Boxmeer, 5831 AN Nederland Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom

Intervet International B.V. International Intervet Limited Pfizer INN (International Non-Proprietary Name) —

— product Name of the medicinal Porcilis ColiClos Porcilis coli E. Poulvac

Décision (EC) No 726/2004 (Article 38 and of the Council of Regulation authorization European Parliament of the of a marketing Issuing Date of the ) OJ L 136, 30.4.04, p. 1. p. 30.4.04, 136, L ) OJ

1 15.06.2012 14.06.2012 — ( 27.7.2012 EN Official Journal of the European Union C 224/15

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

Date of the Name of the medicinal Number of the entry in the Date of Holder of the marketing authorization decision product Community Register notification

11.06.2012 Activyl Intervet International B.V. EU/2/10/118/001-021 13.06.2012 Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

14.06.2012 Emdocam Emdoka bvba EU/2/11/128/001-003 18.06.2012 J. Lijsenstraat 16, B-2321 Hoogstraten, Belgïe

27.06.2012 Bovilis BTV8 Intervet International B.V. EU/2/10/106/001-014 02.07.2012 Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

28.06.2012 Nobilis IB 4-91 Intervet International B.V. EU/2/98/006/001-010 04.07.2012 Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

28.06.2012 Oxyglobin OPK Biotech Netherlands BV EU/2/99/015/001-002 04.07.2012 Teleportboulevard 140, 1043EJ Amsterdam, Nederland

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

The European Medicines Agency 7, Westferry Circus, Canary Wharf UK - LONDON E14 4H C 224/16 EN Official Journal of the European Union 27.7.2012

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2012 to 30 June 2012

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC ( 1 ) or Article 38 of Directive 2001/82/EC ( 2) ) (2012/C 224/02)

— Issuing, maintenance or modification of a national marketing authorization

Date of the Holder(s) of the Member State Date of Name(s) of the medicinal product decision marketing authorization concerned notification

14/6/2012 Tilmicosin See Annex I See Annex I 18/6/2012

18/6/2012 Milaxyn plus and associated names See Annex II See Annex II 20/6/2012

28/6/2012 Flutiform and associated names See Annex III See Annex III 3/7/2012

28/6/2012 Iffeza and associated names See Annex IV See Annex IV 3/7/2012

( 1 ) OJ L 311, 28.11.01, p. 67. ( 2 ) OJ L 311, 28.11.01, p. 1. 27.7.2012 Official 27.7.2012 Official Journal of the European C Union 224/17 ANNEX I

LIST OF THE NAMES, PHARMACEUTICAL FORMS, ACTIVE SUBSTANCE, STRENGTHS OF THE VETERINARY MEDICINAL PRODUCTS, ANIMAL SPECIES, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

Member State EN

Marketing Authorisation Holder Name INN Strength Pharmaceutical form Animal species EU/EEA

Austria Richter Pharma AG Pulmotil G 100 g/kg Arzneimittel- Tilmicosin (as phosphate) 100 g tilmicosin per kg Pre-mix for medicated Pigs, Rabbits Feldgasse 19 Vormischung zur Herstellung von pre-mix feedingstuff A-4600 Wels Fütterungsarzneimitteln für Schweine AUSTRIA und Kaninchen

Austria Richter Pharma AG Pulmotil G 200 g/kg Arzneimittel- Tilmicosin (as phosphate) 200 g tilmicosin per kg Pre-mix for medicated Pigs, Rabbits Feldgasse 19 Vormischung zur Herstellung von pre-mix feedingstuff A-4600 Wels Fütterungsarzneimitteln für Schweine AUSTRIA und Kaninchen

Belgium Eli Lilly Benelux N.V. Pulmotil 40 VET Pre-mix Tilmicosin (as phosphate) 40 g tilmicosin per kg Pre-mix for medicated Pigs, Rabbits Elanco Animal Health pre-mix feedingstuff Rue de l'Etuve 52 Stoofstraat 52 1000 Brussel BELGIUM

Belgium Eli Lilly Benelux N.V. Pulmotil 100 VET Pre-mix Tilmicosin (as phosphate) 100 g tilmicosin per kg Pre-mix for medicated Pigs, Rabbits Elanco Animal Health pre-mix feedingstuff Rue de l'Etuve 52 Stoofstraat 52 1000 Brussel BELGIUM

Belgium Eli Lilly Benelux N.V. Pulmotil 100 Granules Tilmicosin (as phosphate) 100 g tilmicosin per kg Pre-mix for medicated Pigs, Rabbits Elanco Animal Health pre-mix feedingstuff Rue de l'Etuve 52 Stoofstraat 52 1000 Brussel BELGIUM

Belgium Eli Lilly Benelux N.V. Pulmotil 200 VET Pre-mix Tilmicosin (as phosphate) 200 g tilmicosin per kg Pre-mix for medicated Pigs, Rabbits Elanco Animal Health pre-mix feedingstuff Rue de l'Etuve 52 Stoofstraat 52 1000 Brussel BELGIUM 2/8 fiilJunlo h uoenUin 27.7.2012 Official Journal of the European Union C 224/18 Member State Marketing Authorisation Holder Name INN Strength Pharmaceutical form Animal species EU/EEA

Cyprus Eli Lilly Regional Operations GmbH Pulmotil pre-mix 200 g/kg ,πρόμιγμα Tilmicosin (as phosphate) 200 g tilmicosin per kg Pre-mix for medicated Pigs, Rabbits Elanco Animal Health για φαρμακούχο ζωοτροφή,για χοίρους pre-mix feedingstuff Kolblgasse 8-10 και κoνίκλους. 1030 Wien AUSTRIA EN

Czech Republic Eli Lilly Regional Operations GmbH Pulmotil 200 mg/g pre-mix pro Tilmicosin (as phosphate) 200 g tilmicosin per kg Pre-mix for medicated Pigs, Rabbits Elanco Animal Health medikaci krmiva pre-mix feedingstuff Kolblgasse 8-10 1030 Wien AUSTRIA

Germany Lilly Deutschland GmbH Pulmotil G 40 Tilmicosin (as phosphate) 40 g tilmicosin per kg Pre-mix for medicated Pigs, Rabbits Abt. Elanco Animal Health pre-mix feedingstuff Werner-Reimers-Str. 2-4 D-61352 Bad Homburg GERMANY

Germany Lilly Deutschland GmbH Pulmotil G 100 Tilmicosin (as phosphate) 100 g tilmicosin per kg Pre-mix for medicated Pigs, Rabbits Abt. Elanco Animal Health pre-mix feedingstuff Werner-Reimers-Str. 2-4 D-61352 Bad Homburg GERMANY

Germany Lilly Deutschland GmbH Pulmotil G 20 % AMV Tilmicosin (as phospate) 200 g tilmicosin per kg Pre-mix for medicated Pigs, Rabbits Abt. Elanco Animal Health pre-mix feedingstuff Werner-Reimers-Str. 2-4 D-61352 Bad Homburg GERMANY

Denmark Elanco Animal Health Pulmotil Vet. Tilmicosin (as phosphate) 40 g tilmicosin per kg Pre-mix for medicated Pigs, Rabbits Eli Lilly Danmark A/S pre-mix feedingstuff Nybrovej 110 DK-2800 Kongens Lyngby DENMARK

Denmark Elanco Animal Health Pulmotil Vet. Tilmicosin (as phosphate) 100 g tilmicosin per kg Pre-mix for medicated Pigs, Rabbits Eli Lilly Danmark A/S pre-mix feedingstuff Nybrovej 110 DK-2800 Kongens Lyngby DENMARK 27.7.2012 Official 27.7.2012 Official Journal of the European C Union 224/19 Member State Marketing Authorisation Holder Name INN Strength Pharmaceutical form Animal species EU/EEA

Denmark Elanco Animal Health Pulmotil Vet. Tilmicosin (as phosphate) 200 g tilmicosin per kg Pre-mix for medicated Pigs, Rabbits Eli Lilly Danmark A/S pre-mix feedingstuff Nybrovej 110 DK-2800 Kongens Lyngby DENMARK EN

Greece Eli Lilly Regional Operations GmbH PULMOTIL 200 Tilmicosin (as phosphate) 200 g tilmicosin per kg Pre-mix for medicated Pigs, Rabbits Elanco Animal Health pre-mix feedingstuff Kolblgasse 8-10 1030 Wien AUSTRIA

Spain ELANCO VALQUÍMICA, S.A. PULMOTIL G 40 Tilmicosin (as phosphate) 40 g tilmicosin per kg Pre-mix for medicated Pigs, Rabbits Avda. de la Industria 30 pre-mix feedingstuff 28108 Alcobendas Madrid SPAIN

Spain ELANCO VALQUÍMICA, S.A. PULMOTIL G 100 Tilmicosin (as phosphate) 100 g tilmicosin per kg Pre-mix for medicated Pigs, Rabbits Avda. de la Industria 30 pre-mix feedingstuff 28108 Alcobendas Madrid SPAIN

Spain ELANCO VALQUÍMICA, S.A. PULMOTIL G 200 Tilmicosin (as phosphate) 200 g tilmicosin per kg Pre-mix for medicated Pigs, Rabbits Avda. de la Industria 30 pre-mix feedingstuff 28108 Alcobendas Madrid SPAIN

France LILLY France PULMOTIL TILMICOSINE 40 Tilmicosin (as phosphate) 40 g tilmicosin per kg Pre-mix for medicated Pigs, Rabbits 13 Rue Pages PORC-LAPIN pre-mix feedingstuff 92158 Suresnes Cedex FRANCE

France QALIAN SANTAMIX TILMICOSINE 40 Tilmicosin (as phosphate) 40 g tilmicosin per kg Pre-mix for medicated Pigs, Rabbits 34 Rue Jean Monnet PORCINS - LAPINS pre-mix feedingstuff Zi D'Etriche 49500 Serge FRANCE 2/0 fiilJunlo h uoenUin 27.7.2012 Official Journal of the European Union C 224/20 Member State Marketing Authorisation Holder Name INN Strength Pharmaceutical form Animal species EU/EEA

France SOGEVAL CONCENTRAT VO 08 TILMICOSINE Tilmicosin (as phosphate) 40 g tilmicosin per kg Pre-mix for medicated Pigs, Rabbits 200 Route de Mayenne PORCIN-LAPIN pre-mix feedingstuff Zi des Touches 53000 Laval France EN

Hungary Eli Lilly Regional Operations GmbH Pulmotil G 200 gyógypre-mix Tilmicosin (as phosphate) 200 g tilmicosin per kg Pre-mix for medicated Pigs, Rabbits Elanco Animal Health pre-mix feedingstuff Kolblgasse 8-10 1030 Wien AUSTRIA

Ireland Eli Lilly and Company Ltd Pulmotil G40 Pre-mix for medicated Tilmicosin (as phosphate) 40 g tilmicosin per kg Pre-mix for medicated Pigs, Rabbits Elanco Animal Health feedingstuff pre-mix feedingstuff Lilly House Priestly Road Basingstoke Hampshire RG24 9NL UNITED KINGDOM

Ireland Eli Lilly and Company Ltd Pulmotil G100 Pre-mix for medicated Tilmicosin (as phosphate) 100 g tilmicosin per kg Pre-mix for medicated Pigs, Rabbits Elanco Animal Health feedingstuff pre-mix feedingstuff Lilly House Priestly Road Basingstoke Hampshire RG24 9NL UNITED KINGDOM

Ireland Eli Lilly and Company Ltd Pulmotil G200 Pre-mix for medicated Tilmicosin (as phosphate) 200 g tilmicosin per kg Pre-mix for medicated Pigs, Rabbits Elanco Animal Health feedingstuff pre-mix feedingstuff Lilly House Priestly Road Basingstoke Hampshire RG24 9NL UNITED KINGDOM

Italy ELI LILLY ITALIA SPA PULMOTIL G 200 PRE-MIX Tilmicosin (as phosphate) 200 g tilmicosin per kg Pre-mix for medicated Pigs, Rabbits VIA GRAMSCI pre-mix feedingstuff 731/733 - SESTO FIORENTINO – FI ITALY 27.7.2012 Official 27.7.2012 Official Journal of the European C Union 224/21 Member State Marketing Authorisation Holder Name INN Strength Pharmaceutical form Animal species EU/EEA

Italy CEVA VETEM SpA MICLOZAN 200 PRE-MIX Tilmicosin (as phosphate) 200 g tilmicosin per kg Pre-mix for medicated Pigs, Rabbits via Colleoni pre-mix feedingstuff 15 20041 Agrate Brianza (MB)

ITALY EN

Netherlands Eli Lilly Nederland B.V. PULMOTIL® G40 pre-mix voor Tilmicosin (as phosphate) 40 g tilmicosin per kg Pre-mix for medicated Pigs, Rabbits Elanco Animal Health gemedicineerd voer voor varkens pre-mix feedingstuff Grootslag 1-5 3991 RA Houten THE NETHERLANDS

Netherlands Eli Lilly Nederland B.V. PULMOTIL® G100 pre-mix voor Tilmicosin (as phosphate) 100 g tilmicosin per kg Pre-mix for medicated Pigs, Rabbits Elanco Animal Health gemedicineerd voer voor varkens pre-mix feedingstuff Grootslag 1-5 3991 RA Houten THE NETHERLANDS

Netherlands Eli Lilly Nederland B.V. PULMOTIL® G200 pre-mix voor Tilmicosin (as phosphate) 200 g tilmicosin per kg Pre-mix for medicated Pigs, Rabbits Elanco Animal Health gemedicineerd voer voor varkens pre-mix feedingstuff Grootslag 1-5 3991 RA Houten THE NETHERLANDS

Portugal Lilly Portugal – Produtos Pulmotil G40 Pré-mistura Tilmicosin (as phosphate) 40 g tilmicosin per kg Pre-mix for medicated Pigs, Rabbits Farmacêuticos, Lda. medicamentosa para alimento pre-mix feedingstuff Rua Cesário Verde, no5- piso 4 medicamentoso para suínos e coelhos Linda-a-Pastora 2790 – 326 QUEIJAS PORTUGAL

Portugal Lilly Portugal – Produtos Pulmotil G100 Pré-mistura Tilmicosin (as phosphate) 100 g tilmicosin per kg Pre-mix for medicated Pigs, Rabbits Farmacêuticos, Lda. medicamentosa para alimento pre-mix feedingstuff Rua Cesário Verde, no5- piso 4 medicamentoso para suínos e coelhos Linda-a-Pastora 2790 – 326 QUEIJAS PORTUGAL 2/2 fiilJunlo h uoenUin 27.7.2012 Official Journal of the European Union C 224/22 Member State Marketing Authorisation Holder Name INN Strength Pharmaceutical form Animal species EU/EEA

Portugal Lilly Portugal – Produtos Pulmotil G200 Pré-mistura Tilmicosin (as phosphate) 200 g tilmicosin per kg Pre-mix for medicated Pigs, Rabbits Farmacêuticos, Lda. medicamentosa para alimento pre-mix feedingstuff Rua Cesário Verde, no5- piso 4 medicamentoso para suínos e coelhos Linda-a-Pastora 2790 – 326 QUEIJAS EN PORTUGAL

Romania Eli Lilly Regional Operations GmbH PULMOTIL 200g/kg pre-mix Tilmicosin (as phosphate) 200 g tilmicosin per kg Pre-mix for medicated Pigs, Rabbits Elanco Animal Health pre-mix feedingstuff Kolblgasse 8-10 1030 Wien AUSTRIA

Slovak Republic Elli Lilly and Company Limited. Pulmotil G 200 pre-mix ad us.vet. Tilmicosin (as phosphate) 200 g tilmicosin per kg Pre-mix for medicated Pigs, Rabbits Speke Operations Fleming RoadSpeke pre-mix feedingstuff Liverpool L24 9LN UNITED KINGDOM

United Kingdom Eli Lilly and Company Ltd Pulmotil G100 Pre-mix for Medicated Tilmicosin (as phosphate) 100 g tilmicosin per kg Pre-mix for medicated Pigs, Rabbits Elanco Animal Health Feedingstuff pre-mix feedingstuff Lilly House Priestly Road Basingstoke Hampshire RG24 9NL UNITED KINGDOM

United Kingdom Eli Lilly and Company Ltd Pulmotil G200 Pre-mix for Medicated Tilmicosin (as phosphate) 200 g tilmicosin per kg Pre-mix for medicated Pigs, Rabbits Elanco Animal Health Feedingstuff pre-mix feedingstuff Lilly House Priestly Road Basingstoke Hampshire RG24 9NL UNITED KINGDOM 27.7.2012 Official 27.7.2012 Official Journal of the European C Union 224/23 ANNEX II

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTE OF ADMINISTRATION MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES

Mamber State EN

Marketing authorisation holder Name INN/Strength Pharmaceutical form Animal species EU/EEA

Austria Chanelle Pharmaceuticals Manufacturing Ltd. Exitel Plus Tabletten für Hunde Praziquantel 50 mg Tablet Dogs IE-Loughrea Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg

Austria Chanelle Pharmaceuticals Manufacturing Ltd. Prazitel Plus Tabletten für Hunde Praziquantel 50 mg Tablet Dogs IE-Loughrea Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg

Belgium Chanelle Pharmaceuticals Manufacturing Ltd. Cazitel Plus Tabletten für Hunde Praziquantel 50 mg Tablet Dogs IE-Loughrea Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg

Belgium Chanelle Pharmaceuticals Manufacturing Ltd. Exitel Plus Tabletten für Hunde Praziquantel 50 mg Tablet Dogs IE-Loughrea Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg

Belgium Chanelle Pharmaceuticals Manufacturing Ltd. Prazitel Plus Tabletten für Hunde Praziquantel 50 mg Tablet Dogs IE-Loughrea Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg

Bulgaria Chanelle Pharmaceuticals Manufacturing Ltd. Cazitel Plus таблетки за кучета Praziquantel 50 mg Tablet Dogs IE-Loughrea Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg

Bulgaria Chanelle Pharmaceuticals Manufacturing Ltd. Exitel Plus таблетки за кучета Praziquantel 50 mg Tablet Dogs IE-Loughrea Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg

Bulgaria Chanelle Pharmaceuticals Manufacturing Ltd. Prazitel Plus таблетки за кучета Praziquantel 50 mg Tablet Dogs IE-Loughrea Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg 2/4 fiilJunlo h uoenUin 27.7.2012 Official Journal of the European Union C 224/24 Mamber State Marketing authorisation holder Name INN/Strength Pharmaceutical form Animal species EU/EEA

Cyprus Chanelle Pharmaceuticals Manufacturing Ltd. Exitel Plus Δισκία Για Σκύλους Praziquantel 50 mg Tablet Dogs IE-Loughrea Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg EN

Czech Republic Chanelle Pharmaceuticals Manufacturing Ltd. Cazitel Plus tablety pro psy Praziquantel 50 mg Tablet Dogs IE-Loughrea Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg

Czech Republic Chanelle Pharmaceuticals Manufacturing Ltd. Exitel Plus tablety pro psy Praziquantel 50 mg Tablet Dogs IE-Loughrea Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg

Czech Republic Chanelle Pharmaceuticals Manufacturing Ltd. Prazitel Plus tablety pro psy Praziquantel 50 mg Tablet Dogs IE-Loughrea Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg

Denmark Chanelle Pharmaceuticals Manufacturing Ltd. Exitel Plus Praziquantel 50 mg Tablet Dogs IE-Loughrea Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg

Denmark Chanelle Pharmaceuticals Manufacturing Ltd. Prazitel Plus Praziquantel 50 mg Tablet Dogs IE-Loughrea Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg

Estonia Chanelle Pharmaceuticals Manufacturing Ltd. Cazitel Plus tabletid koertele Praziquantel 50 mg Tablet Dogs IE-Loughrea Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg

Estonia Chanelle Pharmaceuticals Manufacturing Ltd. Exitel Plus tabletid koertele Praziquantel 50 mg Tablet Dogs IE-Loughrea Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg

Finland Chanelle Pharmaceuticals Manufacturing Ltd. Cazitel Plus 50 mg/144 mg/ Praziquantel 50 mg Tablet Dogs IE-Loughrea 150 mg tablet Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg 27.7.2012 Official 27.7.2012 Official Journal of the European C Union 224/25 Mamber State Marketing authorisation holder Name INN/Strength Pharmaceutical form Animal species EU/EEA

Finland Chanelle Pharmaceuticals Manufacturing Ltd. Exitel Plus 50 mg/144 mg/ Praziquantel 50 mg Tablet Dogs IE-Loughrea 150 mg tablet Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg EN

Finland Chanelle Pharmaceuticals Manufacturing Ltd. Prazitel Plus 50 mg/144 mg/ Praziquantel 50 mg Tablet Dogs IE-Loughrea 150 mg tablet Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg

France Chanelle Pharmaceuticals Manufacturing Ltd. Milaxyn comprimé pour chiens Praziquantel 50 mg Tablet Dogs IE-Loughrea Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg

France Chanelle Pharmaceuticals Manufacturing Ltd. Strantel comprimé pour chiens Praziquantel 50 mg Tablet Dogs IE-Loughrea Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg

France Chanelle Pharmaceuticals Manufacturing Ltd. Prazical comprimé pour chiens Praziquantel 50 mg Tablet Dogs IE-Loughrea Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg

France Chanelle Pharmaceuticals Manufacturing Ltd. Voxical comprimé pour chiens Praziquantel 50 mg Tablet Dogs IE-Loughrea Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg

Germany Chanelle Pharmaceuticals Manufacturing Ltd. Cazitel Tabletten für Hunde Praziquantel 50 mg Tablet Dogs IE-Loughrea Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg

Germany Chanelle Pharmaceuticals Manufacturing Ltd. Exitel Tabletten für Hunde Praziquantel 50 mg Tablet Dogs IE-Loughrea Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg

Germany Chanelle Pharmaceuticals Manufacturing Ltd. Strantel Tabletten für Hunde Praziquantel 50 mg Tablet Dogs IE-Loughrea Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg 2/6 fiilJunlo h uoenUin 27.7.2012 Official Journal of the European Union C 224/26 Mamber State Marketing authorisation holder Name INN/Strength Pharmaceutical form Animal species EU/EEA

Greece Chanelle Pharmaceuticals Manufacturing Ltd. Cazitel plus Δισκία Για Σκύλους Praziquantel 50 mg Tablet Dogs IE-Loughrea Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg EN

Greece Chanelle Pharmaceuticals Manufacturing Ltd. Exitel plus Δισκία Για Σκύλους Praziquantel 50 mg Tablet Dogs IE-Loughrea Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg

Greece Chanelle Pharmaceuticals Manufacturing Ltd. Prazitel plus Δισκία Για Σκύλους Praziquantel 50 mg Tablet Dogs IE-Loughrea Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg

Hungary Chanelle Pharmaceuticals Manufacturing Ltd. Cazitel Plus tabletta kutyák Praziquantel 50 mg Tablet Dogs IE-Loughrea részére A.U.V Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg

Hungary Chanelle Pharmaceuticals Manufacturing Ltd. Exitel Plus tabletta kutyák részére Praziquantel 50 mg Tablet Dogs IE-Loughrea A.U.V Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg

Hungary Chanelle Pharmaceuticals Manufacturing Ltd. Prazitel Plus tabletta kutyák Praziquantel 50 mg Tablet Dogs IE-Loughrea részére A.U.V Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg

Iceland Chanelle Pharmaceuticals Manufacturing Ltd. Exitel Plus töflur fyrir hunda Praziquantel 50 mg Tablet Dogs IE-Loughrea Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg

Iceland Chanelle Pharmaceuticals Manufacturing Ltd. Prazitel Plus töflur fyrir hunda Praziquantel 50 mg Tablet Dogs IE-Loughrea Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg

Ireland Chanelle Pharmaceuticals Manufacturing Ltd. Cazitel Plus tablets for dogs Praziquantel 50 mg Tablet Dogs IE-Loughrea Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg 27.7.2012 Official 27.7.2012 Official Journal of the European C Union 224/27 Mamber State Marketing authorisation holder Name INN/Strength Pharmaceutical form Animal species EU/EEA

Ireland Chanelle Pharmaceuticals Manufacturing Ltd. Exitel Plus tablets for dogs Praziquantel 50 mg Tablet Dogs IE-Loughrea Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg EN

Ireland Chanelle Pharmaceuticals Manufacturing Ltd. Milaxyn Plus tablets for dogs Praziquantel 50 mg Tablet Dogs IE-Loughrea Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg

Ireland Chanelle Pharmaceuticals Manufacturing Ltd. Prazical Plus tablets for dogs Praziquantel 50 mg Tablet Dogs IE-Loughrea Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg

Ireland Chanelle Pharmaceuticals Manufacturing Ltd. Prazitel Plus tablets for dogs Praziquantel 50 mg Tablet Dogs IE-Loughrea Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg

Ireland Chanelle Pharmaceuticals Manufacturing Ltd. Strantel Plus tablets for dogs Praziquantel 50 mg Tablet Dogs IE-Loughrea Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg

Ireland Chanelle Pharmaceuticals Manufacturing Ltd. Voxical Plus tablets for dogs Praziquantel 50 mg Tablet Dogs IE-Loughrea Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg

Italy Chanelle Pharmaceuticals Manufacturing Ltd. Canitel Plus compresse per cani Praziquantel 50 mg Tablet Dogs IE-Loughrea Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg

Italy Chanelle Pharmaceuticals Manufacturing Ltd. Exitel Plus compresse per cani Praziquantel 50 mg Tablet Dogs IE-Loughrea Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg

Italy Chanelle Pharmaceuticals Manufacturing Ltd. Prazitel compresse per cani Praziquantel 50 mg Tablet Dogs IE-Loughrea Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg 2/8 fiilJunlo h uoenUin 27.7.2012 Official Journal of the European Union C 224/28 Mamber State Marketing authorisation holder Name INN/Strength Pharmaceutical form Animal species EU/EEA

Latvia Chanelle Pharmaceuticals Manufacturing Ltd. Cazitel tablets Tabletes suņiem Praziquantel 50 mg Tablet Dogs IE-Loughrea Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg EN

Latvia Chanelle Pharmaceuticals Manufacturing Ltd. Exitel tablets Tabletes suņiem Praziquantel 50 mg Tablet Dogs IE-Loughrea Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg

Latvia Chanelle Pharmaceuticals Manufacturing Ltd. Prazitel tablets Tabletes suņiem Praziquantel 50 mg Tablet Dogs IE-Loughrea Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg

Lithuania Chanelle Pharmaceuticals Manufacturing Ltd. Cazitel Plus tabletės šunims Praziquantel 50 mg Tablet Dogs IE-Loughrea Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg

Lithuania Chanelle Pharmaceuticals Manufacturing Ltd. Exitel Plus tabletės šunims Praziquantel 50 mg Tablet Dogs IE-Loughrea Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg

Lithuania Chanelle Pharmaceuticals Manufacturing Ltd. Prazitel Plus tabletės šunims Praziquantel 50 mg Tablet Dogs IE-Loughrea Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg

Luxembourg Chanelle Pharmaceuticals Manufacturing Ltd. Exitel Plus tabletten voor honden Praziquantel 50 mg Tablet Dogs IE-Loughrea Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg

Luxembourg Chanelle Pharmaceuticals Manufacturing Ltd. Prazitel Plus tabletten voor Praziquantel 50 mg Tablet Dogs IE-Loughrea honden Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg

Netherlands Chanelle Pharmaceuticals Manufacturing Ltd. Cazitel Plus tabletten voor Praziquantel 50 mg Tablet Dogs IE-Loughrea honden Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg 27.7.2012 Official 27.7.2012 Official Journal of the European C Union 224/29 Mamber State Marketing authorisation holder Name INN/Strength Pharmaceutical form Animal species EU/EEA

Netherlands Chanelle Pharmaceuticals Manufacturing Ltd. Exitel Plus tabletten voor honden Praziquantel 50 mg Tablet Dogs IE-Loughrea Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg EN

Netherlands Chanelle Pharmaceuticals Manufacturing Ltd. Prazitel Plus tabletten voor Praziquantel 50 mg Tablet Dogs IE-Loughrea honden Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg

Norway Chanelle Pharmaceuticals Manufacturing Ltd. Exitel Vet Praziquantel 50 mg Tablet Dogs IE-Loughrea Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg

Norway Chanelle Pharmaceuticals Manufacturing Ltd. Prazitel Vet Praziquantel 50 mg Tablet Dogs IE-Loughrea Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg

Poland Chanelle Pharmaceuticals Manufacturing Ltd. Cazitel Plus tabletki dla psów Praziquantel 50 mg Tablet Dogs IE-Loughrea Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg

Poland Chanelle Pharmaceuticals Manufacturing Ltd. Exitel Plus tabletki dla psów Praziquantel 50 mg Tablet Dogs IE-Loughrea Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg

Poland Chanelle Pharmaceuticals Manufacturing Ltd. Prazitel Plus tabletki dla psów Praziquantel 50 mg Tablet Dogs IE-Loughrea Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg

Portugal Chanelle Pharmaceuticals Manufacturing Ltd. Cazitel Plus Comprimidos para Praziquantel 50 mg Tablet Dogs IE-Loughrea cães Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg

Portugal Chanelle Pharmaceuticals Manufacturing Ltd. Exitel Plus Comprimidos para Praziquantel 50 mg Tablet Dogs IE-Loughrea cães Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg 2/0 fiilJunlo h uoenUin 27.7.2012 Official Journal of the European Union C 224/30 Mamber State Marketing authorisation holder Name INN/Strength Pharmaceutical form Animal species EU/EEA

Portugal Chanelle Pharmaceuticals Manufacturing Ltd. Prazitel Plus Comprimidos para Praziquantel 50 mg Tablet Dogs IE-Loughrea cães Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg EN

Romania Chanelle Pharmaceuticals Manufacturing Ltd. Cazitel Plus Comprimate pentru Praziquantel 50 mg Tablet Dogs IE-Loughrea câini Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg

Romania Chanelle Pharmaceuticals Manufacturing Ltd. Exitel Plus Comprimate pentru Praziquantel 50 mg Tablet Dogs IE-Loughrea câini Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg

Romania Chanelle Pharmaceuticals Manufacturing Ltd. Prazitel Plus Comprimate pentru Praziquantel 50 mg Tablet Dogs IE-Loughrea câini Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg

Slovakia Chanelle Pharmaceuticals Manufacturing Ltd. Cazitel Plus tablety pre psov Praziquantel 50 mg Tablet Dogs IE-Loughrea Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg

Slovakia Chanelle Pharmaceuticals Manufacturing Ltd. Exitel Plus tablety pre psov Praziquantel 50 mg Tablet Dogs IE-Loughrea Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg

Slovakia Chanelle Pharmaceuticals Manufacturing Ltd. Prazitel Plus tablety pre psov Praziquantel 50 mg Tablet Dogs IE-Loughrea Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg

Slovenia Chanelle Pharmaceuticals Manufacturing Ltd. Cazitel Plus tablete za pse Praziquantel 50 mg Tablet Dogs IE-Loughrea Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg

Slovenia Chanelle Pharmaceuticals Manufacturing Ltd. Exitel Plus tablete za pse Praziquantel 50 mg Tablet Dogs IE-Loughrea Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg 27.7.2012 Official 27.7.2012 Official Journal of the European C Union 224/31 Mamber State Marketing authorisation holder Name INN/Strength Pharmaceutical form Animal species EU/EEA

Slovenia Chanelle Pharmaceuticals Manufacturing Ltd. Prazitel Plus tablete za pse Praziquantel 50 mg Tablet Dogs IE-Loughrea Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg EN Spain Chanelle Pharmaceuticals Manufacturing Ltd. Cazitel comprimidos para perros Praziquantel 50 mg Tablet Dogs

IE-Loughrea Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg

Spain Chanelle Pharmaceuticals Manufacturing Ltd. Exitel comprimidos para perros Praziquantel 50 mg Tablet Dogs IE-Loughrea Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg

Spain Chanelle Pharmaceuticals Manufacturing Ltd. Prazitel comprimidos para perros Praziquantel 50 mg Tablet Dogs IE-Loughrea Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg

Sweden Chanelle Pharmaceuticals Manufacturing Ltd. Exitel vet. 150 mg/ Praziquantel 50 mg Tablet Dogs IE-Loughrea 144 mg/50 mg tablett för hund Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg

Sweden Chanelle Pharmaceuticals Manufacturing Ltd. Strantel vet. 150 mg/ Praziquantel 50 mg Tablet Dogs IE-Loughrea 144 mg/50 mg tablett för hund Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg

United Kingdom Chanelle Pharmaceuticals Manufacturing Ltd. Cazitel plus tablets for dogs Praziquantel 50 mg Tablet Dogs IE-Loughrea Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg

United Kingdom Chanelle Pharmaceuticals Manufacturing Ltd. Easimax plus tablets for dogs Praziquantel 50 mg Tablet Dogs IE-Loughrea Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg

United Kingdom Chanelle Pharmaceuticals Manufacturing Ltd. Prazitel plus tablets for dogs Praziquantel 50 mg Tablet Dogs IE-Loughrea Pyrantel 50 mg (equivalent to 144 mg Co. Galway pyrantel embonate) Ireland Febantel 150 mg 2/2 fiilJunlo h uoenUin 27.7.2012 Official Journal of the European Union C 224/32 ANNEX III

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANT IN THE MEMBER STATES

Member State Applicant (Invented) Name Strength Pharmaceutical form Route of administration EN EU/EEA company name, address

Austria Napp Pharmaceuticals Limited Flutiform® 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Flutiform 50 Mikrogramm/ Milton Road 5 Mikrogramm pro Sprühstoß Cambridge CB4 0GW Druckgasinhalation United Kingdom

Austria Napp Pharmaceuticals Limited Flutiform® 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Flutiform 125 Mikrogramm/ Milton Road 5 Mikrogramm pro Sprühstoß Cambridge CB4 0GW Druckgasinhalation United Kingdom

Austria Napp Pharmaceuticals Limited Flutiform® 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Flutiform 250 Mikrogramm/ Milton Road 10 Mikrogramm pro Sprühstoß Cambridge CB4 0GW Druckgasinhalation United Kingdom

Belgium Napp Pharmaceuticals Limited Flutiform® 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Flutiform 50 mcg/5 mcg, aërosol, Milton Road suspensie Cambridge CB4 0GW United Kingdom

Belgium Napp Pharmaceuticals Limited Flutiform® 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Flutiform 125 mcg/5 mcg, aërosol, Milton Road suspensie Cambridge CB4 0GW United Kingdom

Belgium Napp Pharmaceuticals Limited Flutiform® 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Flutiform 250 mcg/10 mcg, aërosol, Milton Road suspensie Cambridge CB4 0GW United Kingdom

Bulgaria Napp Pharmaceuticals Limited Flutiform® 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom 27.7.2012 Official 27.7.2012 Official Journal of the European C Union 224/33 Member State Applicant (Invented) Name Strength Pharmaceutical form Route of administration EU/EEA company name, address

Bulgaria Napp Pharmaceuticals Limited Flutiform® 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW

United Kingdom EN

Bulgaria Napp Pharmaceuticals Limited Flutiform® 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom

Cyprus Napp Pharmaceuticals Limited Flutiform® 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom

Cyprus Napp Pharmaceuticals Limited Flutiform® 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom

Cyprus Napp Pharmaceuticals Limited Flutiform® 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom

Czech Republic Napp Pharmaceuticals Limited Flutiform® 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom

Czech Republic Napp Pharmaceuticals Limited Flutiform® 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom

Czech Republic Napp Pharmaceuticals Limited Flutiform® 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom 2/4 fiilJunlo h uoenUin 27.7.2012 Official Journal of the European Union C 224/34 Member State Applicant (Invented) Name Strength Pharmaceutical form Route of administration EU/EEA company name, address

Denmark Napp Pharmaceuticals Limited Flutiform® 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW

United Kingdom EN

Denmark Napp Pharmaceuticals Limited Flutiform® 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom

Denmark Napp Pharmaceuticals Limited Flutiform® 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom

Finland Napp Pharmaceuticals Limited Flutiform® 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom

Finland Napp Pharmaceuticals Limited Flutiform® 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom

Finland Napp Pharmaceuticals Limited Flutiform® 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom

France Napp Pharmaceuticals Limited Flutiform® 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom

France Napp Pharmaceuticals Limited Flutiform® 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom 27.7.2012 Official 27.7.2012 Official Journal of the European C Union 224/35 Member State Applicant (Invented) Name Strength Pharmaceutical form Route of administration EU/EEA company name, address

France Napp Pharmaceuticals Limited Flutiform® 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW

United Kingdom EN

Germany Napp Pharmaceuticals Limited Flutiform® 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom

Germany Napp Pharmaceuticals Limited Flutiform® 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom

Germany Napp Pharmaceuticals Limited Flutiform® 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom

Iceland Napp Pharmaceuticals Limited Flutiform® 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom

Iceland Napp Pharmaceuticals Limited Flutiform® 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom

Iceland Napp Pharmaceuticals Limited Flutiform® 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom

Ireland Napp Pharmaceuticals Limited Flutiform® 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom 2/6 fiilJunlo h uoenUin 27.7.2012 Official Journal of the European Union C 224/36 Member State Applicant (Invented) Name Strength Pharmaceutical form Route of administration EU/EEA company name, address

Ireland Napp Pharmaceuticals Limited Flutiform® 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW

United Kingdom EN

Ireland Napp Pharmaceuticals Limited Flutiform® 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom

Italy Napp Pharmaceuticals Limited Flutiformo® 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom

Italy Napp Pharmaceuticals Limited Flutiformo® 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom

Italy Napp Pharmaceuticals Limited Flutiformo® 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom

Luxembourg Napp Pharmaceuticals Limited Flutiform® 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom

Luxembourg Napp Pharmaceuticals Limited Flutiform® 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom

Luxembourg Napp Pharmaceuticals Limited Flutiform® 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom 27.7.2012 Official 27.7.2012 Official Journal of the European C Union 224/37 Member State Applicant (Invented) Name Strength Pharmaceutical form Route of administration EU/EEA company name, address

Netherlands Napp Pharmaceuticals Limited Flutiform® 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Flutiform 50 microgram/ Milton Road 5 microgram/dosis aërosol, suspensie Cambridge CB4 0GW

United Kingdom EN

Netherlands Napp Pharmaceuticals Limited Flutiform® 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Flutiform 125 microgram/ Milton Road 5 microgram/dosis aërosol, suspensie Cambridge CB4 0GW United Kingdom

Netherlands Napp Pharmaceuticals Limited Flutiform® 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Flutiform 250 microgram/ Milton Road 10 microgram/dosis aërosol, suspensie Cambridge CB4 0GW United Kingdom

Norway Napp Pharmaceuticals Limited Flutiform® 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom

Norway Napp Pharmaceuticals Limited Flutiform® 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom

Norway Napp Pharmaceuticals Limited Flutiform® 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom

Poland Napp Pharmaceuticals Limited Flutiform® 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom

Poland Napp Pharmaceuticals Limited Flutiform® 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom 2/8 fiilJunlo h uoenUin 27.7.2012 Official Journal of the European Union C 224/38 Member State Applicant (Invented) Name Strength Pharmaceutical form Route of administration EU/EEA company name, address

Poland Napp Pharmaceuticals Limited Flutiform® 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW

United Kingdom EN

Portugal Napp Pharmaceuticals Limited Flutiform 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom

Portugal Napp Pharmaceuticals Limited Flutiform 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom

Portugal Napp Pharmaceuticals Limited Flutiform 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom

Romania Napp Pharmaceuticals Limited Flutiform® 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Flutiform 50 micrograme/ Milton Road 5 micrograme suspensie de inhalat Cambridge CB4 0GW presurizată United Kingdom

Romania Napp Pharmaceuticals Limited Flutiform® 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Flutiform 125 micrograme/ Milton Road 5 micrograme suspensie de inhalat Cambridge CB4 0GW presurizată United Kingdom

Romania Napp Pharmaceuticals Limited Flutiform® 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Flutiform 250 micrograme/ Milton Road 10 micrograme suspensie de inhalat Cambridge CB4 0GW presurizată United Kingdom

Slovak Republic Napp Pharmaceuticals Limited Flutiform® 50/5 μg 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom 27.7.2012 Official 27.7.2012 Official Journal of the European C Union 224/39 Member State Applicant (Invented) Name Strength Pharmaceutical form Route of administration EU/EEA company name, address

Slovak Republic Napp Pharmaceuticals Limited Flutiform® 125/5 μg 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom EN

Slovak Republic Napp Pharmaceuticals Limited Flutiform® 250/10 μg 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom

Sweden Napp Pharmaceuticals Limited Flutiform® 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom

Sweden Napp Pharmaceuticals Limited Flutiform® 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom

Sweden Napp Pharmaceuticals Limited Flutiform® 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom

United Kingdom Napp Pharmaceuticals Limited Flofera® 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom

United Kingdom Napp Pharmaceuticals Limited Flofera® 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom

United Kingdom Napp Pharmaceuticals Limited Flofera® 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom 2/0 fiilJunlo h uoenUin 27.7.2012 Official Journal of the European Union C 224/40 ANNEX IV

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANT IN THE MEMBER STATES

Member State Applicant

(Invented) Name Strengths Pharmaceutical form Route of administration EN EU/EEA company name, address

Austria Napp Pharmaceuticals Limited Iffeza 50 Mikrogramm/5 Mikrogramm pro 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Sprühstoß Druckgasinhalation Milton Road Cambridge CB4 0GW United Kingdom

Austria Napp Pharmaceuticals Limited Iffeza 125 Mikrogramm/5 Mikrogramm pro 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Sprühstoß Druckgasinhalation Milton Road Cambridge CB4 0GW United Kingdom

Austria Napp Pharmaceuticals Limited Iffeza 250 Mikrogramm/10 Mikrogramm pro 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Sprühstoß Druckgasinhalation Milton Road Cambridge CB4 0GW United Kingdom

Belgium Napp Pharmaceuticals Limited Iffeza 50 mcg/5 mcg, aërosol, suspensie 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom

Belgium Napp Pharmaceuticals Limited Iffeza 125 mcg/5 mcg, aërosol, suspensie 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom

Belgium Napp Pharmaceuticals Limited Iffeza 250 mcg/10 mcg, aërosol, suspensie 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom

Bulgaria Napp Pharmaceuticals Limited Iffeza 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom 27.7.2012 Official 27.7.2012 Official Journal of the European C Union 224/41 Member State Applicant (Invented) Name Strengths Pharmaceutical form Route of administration EU/EEA company name, address

Bulgaria Napp Pharmaceuticals Limited Iffeza 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW

United Kingdom EN

Bulgaria Napp Pharmaceuticals Limited Iffeza 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom

Cyprus Napp Pharmaceuticals Limited Iffeza 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom

Cyprus Napp Pharmaceuticals Limited Iffeza 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom

Cyprus Napp Pharmaceuticals Limited Iffeza 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom

Czech Republic Napp Pharmaceuticals Limited Iffeza 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom

Czech Republic Napp Pharmaceuticals Limited Iffeza 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom

Czech Republic Napp Pharmaceuticals Limited Iffeza 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom 2/2 fiilJunlo h uoenUin 27.7.2012 Official Journal of the European Union C 224/42 Member State Applicant (Invented) Name Strengths Pharmaceutical form Route of administration EU/EEA company name, address

Denmark Napp Pharmaceuticals Limited Iffeza 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW

United Kingdom EN

Denmark Napp Pharmaceuticals Limited Iffeza 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom

Denmark Napp Pharmaceuticals Limited Iffeza 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom

Finland Napp Pharmaceuticals Limited Iffeza 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom

Finland Napp Pharmaceuticals Limited Iffeza 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom

Finland Napp Pharmaceuticals Limited Iffeza 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom

France Napp Pharmaceuticals Limited Iffeza 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom

France Napp Pharmaceuticals Limited Iffeza 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom 27.7.2012 Official 27.7.2012 Official Journal of the European C Union 224/43 Member State Applicant (Invented) Name Strengths Pharmaceutical form Route of administration EU/EEA company name, address

France Napp Pharmaceuticals Limited Iffeza 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW

United Kingdom EN

Germany Napp Pharmaceuticals Limited Iffeza 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom

Germany Napp Pharmaceuticals Limited Iffeza 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom

Germany Napp Pharmaceuticals Limited Iffeza 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom

Iceland Napp Pharmaceuticals Limited Iffeza® 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom

Iceland Napp Pharmaceuticals Limited Iffeza® 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom

Iceland Napp Pharmaceuticals Limited Iffeza® 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom

Ireland Napp Pharmaceuticals Limited Iffeza 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom 2/4 fiilJunlo h uoenUin 27.7.2012 Official Journal of the European Union C 224/44 Member State Applicant (Invented) Name Strengths Pharmaceutical form Route of administration EU/EEA company name, address

Ireland Napp Pharmaceuticals Limited Iffeza 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW

United Kingdom EN

Ireland Napp Pharmaceuticals Limited Iffeza 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom

Italy Napp Pharmaceuticals Limited Iffeza 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom

Italy Napp Pharmaceuticals Limited Iffeza 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom

Italy Napp Pharmaceuticals Limited Iffeza 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom

Luxembourg Napp Pharmaceuticals Limited Iffeza 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom

Luxembourg Napp Pharmaceuticals Limited Iffeza 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom

Luxembourg Napp Pharmaceuticals Limited Iffeza 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom 27.7.2012 Official 27.7.2012 Official Journal of the European C Union 224/45 Member State Applicant (Invented) Name Strengths Pharmaceutical form Route of administration EU/EEA company name, address

Netherlands Napp Pharmaceuticals Limited Iffeza 50 microgram/5 microgram/dosis 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park aërosol, suspensie Milton Road Cambridge CB4 0GW

United Kingdom EN

Netherlands Napp Pharmaceuticals Limited Iffeza 125 microgram/5 microgram/dosis 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park aërosol, suspensie Milton Road Cambridge CB4 0GW United Kingdom

Netherlands Napp Pharmaceuticals Limited Iffeza 250 microgram/10 microgram/dosis 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park aërosol, suspensie Milton Road Cambridge CB4 0GW United Kingdom

Norway Napp Pharmaceuticals Limited Iffera® 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom

Norway Napp Pharmaceuticals Limited Iffera® 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom

Norway Napp Pharmaceuticals Limited Iffera® 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom

Poland Napp Pharmaceuticals Limited Iffeza 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom

Poland Napp Pharmaceuticals Limited Iffeza 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom 2/6 fiilJunlo h uoenUin 27.7.2012 Official Journal of the European Union C 224/46 Member State Applicant (Invented) Name Strengths Pharmaceutical form Route of administration EU/EEA company name, address

Poland Napp Pharmaceuticals Limited Iffeza 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW

United Kingdom EN

Portugal Napp Pharmaceuticals Limited Iffeza 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom

Portugal Napp Pharmaceuticals Limited Iffeza 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom

Portugal Napp Pharmaceuticals Limited Iffeza 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom

Romania Napp Pharmaceuticals Limited Iffeza 50 micrograme/5 micrograme suspensie 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park de inhalat presurizată Milton Road Cambridge CB4 0GW United Kingdom

Romania Napp Pharmaceuticals Limited Iffeza 125 micrograme/5 micrograme 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park suspensie de inhalat presurizată Milton Road Cambridge CB4 0GW United Kingdom

Romania Napp Pharmaceuticals Limited Iffeza 250 micrograme/10 micrograme 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park suspensie de inhalat presurizată Milton Road Cambridge CB4 0GW United Kingdom

Slovak Republic Napp Pharmaceuticals Limited Iffeza 50/5 μg 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom 27.7.2012 Official 27.7.2012 Official Journal of the European C Union 224/47 Member State Applicant (Invented) Name Strengths Pharmaceutical form Route of administration EU/EEA company name, address

Slovak Republic Napp Pharmaceuticals Limited Iffeza 125/μg 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom EN

Slovak Republic Napp Pharmaceuticals Limited Iffeza 250/10 μg 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom

Sweden Napp Pharmaceuticals Limited Iffeza 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom

Sweden Napp Pharmaceuticals Limited Iffeza 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom

Sweden Napp Pharmaceuticals Limited Iffeza 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom

United Kingdom Napp Pharmaceuticals Limited Iffeza 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom

United Kingdom Napp Pharmaceuticals Limited Iffeza 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom

United Kingdom Napp Pharmaceuticals Limited Iffeza 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom

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