# Amtsblatt C 224/2012

| | ISSN 1977-088X
  doi:10.3000/1977088X.C_2012.224.deu |
| --- | --- |
| Amtsblatt
  der Europäischen Union | C 224 |
| | |
| Ausgabe in deutscher Sprache | Mitteilungen und Bekanntmachungen | 55. Jahrgang27. Juli 2012 |

ISSN 1977-088X

doi:10.3000/1977088X.C_2012.224.deu

Amtsblatt

der Europäischen Union

C 224

Ausgabe in deutscher Sprache

Mitteilungen und Bekanntmachungen

55. Jahrgang27. Juli 2012

---

| Informationsnummer | Inhalt | Seite |
| --- | --- | --- |
| | IV   Informationen |
| | INFORMATIONEN DER ORGANE, EINRICHTUNGEN UND SONSTIGEN STELLEN DER EUROPÄISCHEN UNION |
| 2012/C 224/01 | Verzeichnis der Beschlüsse der Europäischen Union über die Zulassung von Arzneimitteln vom 1. Juni 2012 bis 30. Juni 2012(Veröffentlichung gemäß Artikel 13 bzw. Artikel 38 der Verordnung (EG) Nr. 726/2004 des Europäischen Parlaments und des Rates
  ) | 1 |
| 2012/C 224/02 | Verzeichnis der Beschlüsse der Europäischen Union über die Zulassung von Arzneimitteln vom 1. Juni 2012 bis 30. Juni 2012(Beschlüsse gemäß Artikel 34 der Richtlinie 2001/83/EG oder Artikel 38 der Richtlinie 2001/82/EG) | 16 |

Informationsnummer

Inhalt

Seite

IV   Informationen

INFORMATIONEN DER ORGANE, EINRICHTUNGEN UND SONSTIGEN STELLEN DER EUROPÄISCHEN UNION

2012/C 224/01

Verzeichnis der Beschlüsse der Europäischen Union über die Zulassung von Arzneimitteln vom 1. Juni 2012 bis 30. Juni 2012(Veröffentlichung gemäß Artikel 13 bzw. Artikel 38 der Verordnung (EG) Nr. 726/2004 des Europäischen Parlaments und des Rates
  )

(Veröffentlichung gemäß Artikel 13 bzw. Artikel 38 der Verordnung (EG) Nr. 726/2004 des Europäischen Parlaments und des Rates

)

1

2012/C 224/02

Verzeichnis der Beschlüsse der Europäischen Union über die Zulassung von Arzneimitteln vom 1. Juni 2012 bis 30. Juni 2012(Beschlüsse gemäß Artikel 34 der Richtlinie 2001/83/EG oder Artikel 38 der Richtlinie 2001/82/EG)

(Beschlüsse gemäß Artikel 34 der Richtlinie 2001/83/EG oder Artikel 38 der Richtlinie 2001/82/EG)

16

| DE | |
| --- | --- |

DE

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IV Informationen

INFORMATIONEN DER ORGANE, EINRICHTUNGEN UND SONSTIGEN STELLEN DER EUROPÄISCHEN UNION

| 27.7.2012 | DE | Amtsblatt der Europäischen Union | C 224/1 |
| --- | --- | --- | --- |

27.7.2012

DE

Amtsblatt der Europäischen Union

C 224/1

---

Verzeichnis der Beschlüsse der Europäischen Union über die Zulassung von Arzneimitteln vom 1. Juni 2012 bis 30. Juni 2012

(Veröffentlichung gemäß Artikel 13 bzw. Artikel 38 der Verordnung (EG) Nr. 726/2004 des Europäischen Parlaments und des Rates
   (1)
  )

2012/C 224/01

—   Erteilung einer Zulassung (Artikel 13 der Verordnung (EG) Nr. 726/2004 des Europäischen Parlaments und des Rates): Genehmigt

| Datum des Beschlusses | Bezeichnung des Arzneimittels | INN (internationaler Freiname) | Zulassungsinhaber | Registriernummer im Gemeinschaftsverzeichnis | Darreichungsform | ATC-Code (anatomisch-therapeutisch-chemischer Code) | Datum der Mitteilung |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 15.06.2012 | Rienso | Ferumoxytol | Takeda Global Research and Development Centre (Europe) Ltd |
| 61 Aldwych, |
| London WC2B 4AE, |
| United Kingdom |

Datum des Beschlusses

Bezeichnung des Arzneimittels

INN (internationaler Freiname)

Zulassungsinhaber

Registriernummer im Gemeinschaftsverzeichnis

Darreichungsform

ATC-Code (anatomisch-therapeutisch-chemischer Code)

Datum der Mitteilung

15.06.2012

Rienso

Ferumoxytol

Takeda Global Research and Development Centre (Europe) Ltd

61 Aldwych,

London WC2B 4AE,

United Kingdom

EU/1/12/774/001-002

Injektionslösung

Pending

20.06.2012

—   Erteilung einer Zulassung (Artikel 13 der Verordnung (EG) Nr. 726/2004 des Europäischen Parlaments und des Rates): Versagt

| Datum des Beschlusses | Bezeichnung des Arzneimittels | Zulassungsinhaber | Registriernummer im Gemeinschaftsverzeichnis | Datum der Mitteilung |
| --- | --- | --- | --- | --- |
| 21.06.2012 | Folotyn | Allos Therapeutics Limited |
| 71 Knowl Piece, |
| Wilbury Way, |
| Hitchin, Hertfordshire SG4 0TY, |
| United Kingdom |

Datum des Beschlusses

Bezeichnung des Arzneimittels

Zulassungsinhaber

Registriernummer im Gemeinschaftsverzeichnis

Datum der Mitteilung

21.06.2012

Folotyn

Allos Therapeutics Limited

71 Knowl Piece,

Wilbury Way,

Hitchin, Hertfordshire SG4 0TY,

United Kingdom

—

25.06.2012

—   Änderung einer Zulassung (Artikel 13 der Verordnung (EG) Nr. 726/2004 des Europäischen Parlaments und des Rates): Genehmigt

| Datum des Beschlusses | Bezeichnung des Arzneimittels | Zulassungsinhaber | Registriernummer im Gemeinschaftsverzeichnis | Datum der Mitteilung |
| --- | --- | --- | --- | --- |
| 01.06.2012 | Osigraft | Olympus Biotech International Limited |
| Raheen Business Park, |
| Limerick, |
| Ireland |

Datum des Beschlusses

Bezeichnung des Arzneimittels

Zulassungsinhaber

Registriernummer im Gemeinschaftsverzeichnis

Datum der Mitteilung

01.06.2012

Osigraft

Olympus Biotech International Limited

Raheen Business Park,

Limerick,

Ireland

EU/1/01/179/001

05.06.2012

11.06.2012

Levetiracetam Teva

| Teva Pharma B.V. |
| --- |
| Computerweg 10, |
| 3542 DR Utrecht, |
| Nederland |

Teva Pharma B.V.

Computerweg 10,

3542 DR Utrecht,

Nederland

EU/1/11/701/001-032

13.06.2012

11.06.2012

Mycophenolate mofetil Teva

| Teva Pharma B.V. |
| --- |
| Computerweg 10, |
| DR Utrecht 3542, |
| Nederland |

Teva Pharma B.V.

Computerweg 10,

DR Utrecht 3542,

Nederland

EU/1/07/439/001-006

13.06.2012

11.06.2012

Myfenax

| Teva Pharma B.V. |
| --- |
| Computerweg 10, |
| DR Utrecht 3542, |
| Nederland |

Teva Pharma B.V.

Computerweg 10,

DR Utrecht 3542,

Nederland

EU/1/07/438/001-006

13.06.2012

14.06.2012

Nivestim

| Hospira UK Limited Queensway, |
| --- |
| Royal Leamington Spa, |
| Warwickshire CV31 3RW, |
| United Kingdom |

Hospira UK Limited Queensway,

Royal Leamington Spa,

Warwickshire CV31 3RW,

United Kingdom

EU/1/10/631/001-009

18.06.2012

14.06.2012

Quadramet

| CIS bio international Boite Postale |
| --- |
| 32 - F-91192 Gif-sur-Yvette - |
| France |

CIS bio international Boite Postale

32 - F-91192 Gif-sur-Yvette -

France

EU/1/97/057/001

18.06.2012

15.06.2012

Abseamed

| Medice Arzneimittel Pütter GmbH & Co KG |
| --- |
| Kuhloweg 37, |
| D-58638 Iserlohn, |
| Deutschland |

Medice Arzneimittel Pütter GmbH & Co KG

Kuhloweg 37,

D-58638 Iserlohn,

Deutschland

EU/1/07/412/001-052

19.06.2012

15.06.2012

Azopt

| Alcon Laboratories (UK) Ltd. |
| --- |
| Pentagon Park, |
| Boundary Way, |
| Hemel Hempstead, |
| Herts HP2 7UD, |
| United Kingdom |

Alcon Laboratories (UK) Ltd.

Pentagon Park,

Boundary Way,

Hemel Hempstead,

Herts HP2 7UD,

United Kingdom

EU/1/00/129/001-003

20.06.2012

15.06.2012

Epivir

| ViiV Healthcare UK Ltd |
| --- |
| 980 Great West Road, |
| Brentford, |
| Middlesex, |
| TW8 9GS, |
| United Kingdom |

ViiV Healthcare UK Ltd

980 Great West Road,

Brentford,

Middlesex,

TW8 9GS,

United Kingdom

EU/1/96/015/002

20.06.2012

15.06.2012

Evra

| Janssen-Cilag International NV Turnhoutseweg, |
| --- |
| 30 - 2340 Beerse - |
| België |

Janssen-Cilag International NV Turnhoutseweg,

30 - 2340 Beerse -

België

EU/1/02/223/001-003

19.06.2012

15.06.2012

Optimark

| Covidien Deutschland GmbH |
| --- |
| Gewerbepark 1, |
| Neustadt/Donau 93333, |
| Deutschland |

Covidien Deutschland GmbH

Gewerbepark 1,

Neustadt/Donau 93333,

Deutschland

EU/1/07/398/001-014

19.06.2012

15.06.2012

Prevenar

| Wyeth-Lederle Vaccines S.A. |
| --- |
| Pleainlaan 17 Boulevard de la Plaine, |
| 1050 Brussels - Bruxelles, |
| Belgium |

Wyeth-Lederle Vaccines S.A.

Pleainlaan 17 Boulevard de la Plaine,

1050 Brussels - Bruxelles,

Belgium

EU/1/00/167/001-008

20.06.2012

15.06.2012

Temozolomide HEXAL

| HEXAL AG |
| --- |
| Industriestrasse 25, |
| D-83607 Holzkirchen, |
| Deutschland |

HEXAL AG

Industriestrasse 25,

D-83607 Holzkirchen,

Deutschland

EU/1/10/616/001-036

20.06.2012

15.06.2012

Temozolomide Sandoz

| Sandoz Pharmaceuticals GmbH |
| --- |
| Raiffeisenstraße 11, |
| 83607 Holzkirchen, |
| Deutschland |

Sandoz Pharmaceuticals GmbH

Raiffeisenstraße 11,

83607 Holzkirchen,

Deutschland

EU/1/10/617/001-002

EU/1/10/617/005-006

EU/1/10/617/009-010

EU/1/10/617/013-014

EU/1/10/617/017-018

EU/1/10/617/021-022

EU/1/10/617/025-036

20.06.2012

18.06.2012

Atriance

| Glaxo Group Limited |
| --- |
| Berkeley Avenue, Greenford, |
| Middlesex UB6 0NN, |
| United Kingdom |

Glaxo Group Limited

Berkeley Avenue, Greenford,

Middlesex UB6 0NN,

United Kingdom

EU/1/07/403/001

21.06.2012

18.06.2012

Binocrit

| Sandoz GmbH |
| --- |
| Biochemiestrasse 10, |
| Kundl 6250, |
| Österreich |

Sandoz GmbH

Biochemiestrasse 10,

Kundl 6250,

Österreich

EU/1/07/410/001-052

21.06.2012

18.06.2012

Epoetin alfa Hexal

| Hexal AG. |
| --- |
| Industriestrasse 25, |
| D-83607 Holzkirchen, |
| Deutschland |

Hexal AG.

Industriestrasse 25,

D-83607 Holzkirchen,

Deutschland

EU/1/07/411/001-052

21.06.2012

18.06.2012

GILENYA

| Novartis Europharm Ltd |
| --- |
| Wimblehurst Road, |
| Horsham, |
| West Sussex RH12 5AB, |
| United Kingdom |

Novartis Europharm Ltd

Wimblehurst Road,

Horsham,

West Sussex RH12 5AB,

United Kingdom

EU/1/11/677/001-005

20.06.2012

18.06.2012

GILENYA

| Novartis Europharm Ltd |
| --- |
| Wimblehurst Road, |
| Horsham, West Sussex RH12 5AB, |
| United Kingdom |

Novartis Europharm Ltd

Wimblehurst Road,

Horsham, West Sussex RH12 5AB,

United Kingdom

EU/1/11/677/001-005

22.06.2012

18.06.2012

Soliris

| Alexion Europe S.A.S. |
| --- |
| 25, boulevard |
| de l'Amiral Bruix, |
| 75016 Paris, |
| France |

Alexion Europe S.A.S.

25, boulevard

de l'Amiral Bruix,

75016 Paris,

France

EU/1/07/393/001

20.06.2012

18.06.2012

Soliris

| Alexion Europe S.A.S. |
| --- |
| 25, boulevard |
| de l'Amiral Bruix, |
| 75016 Paris, |
| France |

Alexion Europe S.A.S.

25, boulevard

de l'Amiral Bruix,

75016 Paris,

France

EU/1/07/393/001

20.06.2012

21.06.2012

alli

| Glaxo Group Limited |
| --- |
| Glaxo Wellcome House, Berkeley Avenue, |
| Greenford, Middlesex UB6 0NN, |
| United Kingdom |

Glaxo Group Limited

Glaxo Wellcome House, Berkeley Avenue,

Greenford, Middlesex UB6 0NN,

United Kingdom

EU/1/07/401/007-016

25.06.2012

21.06.2012

Cimzia

| UCB Pharma SA. |
| --- |
| Allée de la Recherche 60, |
| 1070 Bruxelles, |
| Belgique/Researchdreef, |
| 60, Brussel 1070, |
| België |

UCB Pharma SA.

Allée de la Recherche 60,

1070 Bruxelles,

Belgique/Researchdreef,

60, Brussel 1070,

België

EU/1/09/544/001-002

20.06.2012

21.06.2012

Ketek

| Aventis Pharma S.A. |
| --- |
| 20 avenue Raymond Aron, |
| F-92160 Antony, |
| France |

Aventis Pharma S.A.

20 avenue Raymond Aron,

F-92160 Antony,

France

EU/1/01/191/001-005

25.06.2012

21.06.2012

Tarceva

| Roche Registration Limited |
| --- |
| 6 Falcon Way, |
| Shire Park, |
| Welwyn Garden City, |
| AL7 1TW, |
| United Kingdom |

Roche Registration Limited

6 Falcon Way,

Shire Park,

Welwyn Garden City,

AL7 1TW,

United Kingdom

EU/1/05/311/001-003

25.06.2012

21.06.2012

Yervoy

| Bristol-Myers Squibb Pharma EEIG |
| --- |
| Uxbridge Business Park, |
| Sanderson Road, |
| Uxbridge UB8 1DH, |
| United Kingdom |

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park,

Sanderson Road,

Uxbridge UB8 1DH,

United Kingdom

EU/1/11/698/001-002

25.06.2012

27.06.2012

Abraxane

| Celgene Europe Limited |
| --- |
| 1 Longwalk Road, |
| Stockley Park, Uxbridge, |
| Middlesex, UB11 1DB, |
| United Kingdom |

Celgene Europe Limited

1 Longwalk Road,

Stockley Park, Uxbridge,

Middlesex, UB11 1DB,

United Kingdom

EU/1/07/428/001

02.07.2012

27.06.2012

Actraphane

| Novo Nordisk A/S |
| --- |
| Novo Allé, |
| DK-2880 Bagsvaerd, |
| Danmark |

Novo Nordisk A/S

Novo Allé,

DK-2880 Bagsvaerd,

Danmark

EU/1/02/229/001-004

EU/1/02/229/036-037

29.06.2012

27.06.2012

Actrapid

| Novo Nordisk A/S |
| --- |
| Novo Allé, |
| DK-2880 Bagsvaerd, |
| Danmark |

Novo Nordisk A/S

Novo Allé,

DK-2880 Bagsvaerd,

Danmark

EU/1/02/230/001-004

EU/1/02/230/016-017

29.06.2012

27.06.2012

Avastin

| Roche Registration Limited |
| --- |
| 6 Falcon Way, |
| Shire Park, |
| Welwyn Garden City, |
| AL7 1TW, |
| United Kingdom |

Roche Registration Limited

6 Falcon Way,

Shire Park,

Welwyn Garden City,

AL7 1TW,

United Kingdom

EU/1/04/300/001-002

02.07.2012

27.06.2012

Cimzia

| UCB Pharma SA. |
| --- |
| Allée de la Recherche 60, |
| 1070 Bruxelles, |
| Belgique/Researchdreef, |
| 60, Brussel 1070, |
| België |

UCB Pharma SA.

Allée de la Recherche 60,

1070 Bruxelles,

Belgique/Researchdreef,

60, Brussel 1070,

België

EU/1/09/544/001-002

29.06.2012

27.06.2012

Dificlir

| Astellas Pharma Europe B.V. |
| --- |
| Elisabethhof 19, |
| 2353 EW Leiderdorp, |
| Nederland |

Astellas Pharma Europe B.V.

Elisabethhof 19,

2353 EW Leiderdorp,

Nederland

EU/1/11/733/001-004

29.06.2012

27.06.2012

Humira

| Abbott Laboratories Ltd |
| --- |
| Abbott House, |
| Vanwall Business Park, |
| Vanwall Road, |
| Maidenhead, |
| Berkshire SL6 4XE, |
| United Kingdom |

Abbott Laboratories Ltd

Abbott House,

Vanwall Business Park,

Vanwall Road,

Maidenhead,

Berkshire SL6 4XE,

United Kingdom

EU/1/03/256/001-010

02.07.2012

27.06.2012

Insulatard

| Novo Nordisk A/S |
| --- |
| Novo Allé, |
| DK-2880 Bagsvaerd, |
| Danmark |

Novo Nordisk A/S

Novo Allé,

DK-2880 Bagsvaerd,

Danmark

EU/1/02/233/003-004

EU/1/02/233/017

02.07.2012

27.06.2012

Invanz

| Merck Sharp & Dohme Ltd |
| --- |
| Hertford Road, |
| Hoddesdon, |
| Hertfordshire EN11 9BU, |
| United Kingdom |

Merck Sharp & Dohme Ltd

Hertford Road,

Hoddesdon,

Hertfordshire EN11 9BU,

United Kingdom

EU/1/02/216/001-002

29.06.2012

27.06.2012

Invega

| Janssen-Cilag International NV |
| --- |
| Turnhoutseweg, 30 - |
| 2340 Beerse - |
| België |

Janssen-Cilag International NV

Turnhoutseweg, 30 -

2340 Beerse -

België

EU/1/07/395/001-095

02.07.2012

27.06.2012

Invirase

| Roche Registration Limited |
| --- |
| 6 Falcon Way, |
| Shire Park, |
| Welwyn Garden City, |
| AL7 1TW, |
| United Kingdom |

Roche Registration Limited

6 Falcon Way,

Shire Park,

Welwyn Garden City,

AL7 1TW,

United Kingdom

EU/1/96/026/001-002

29.06.2012

27.06.2012

Irbesartan HCT Zentiva (Ex-Winthrop)

| Sanofi |
| --- |
| 54, rue La Boétie, |
| 75008 Paris, |
| France |

Sanofi

54, rue La Boétie,

75008 Paris,

France

EU/1/06/377/001-034

03.07.2012

27.06.2012

Javlor

| Pierre Fabre Médicament |
| --- |
| 45, place Abel Gance, |
| F-92100 Boulogne, |
| France |

Pierre Fabre Médicament

45, place Abel Gance,

F-92100 Boulogne,

France

EU/1/09/550/001-012

02.07.2012

27.06.2012

Karvezide

| Bristol-Myers Squibb Pharma EEIG |
| --- |
| Uxbridge Business Park, |
| Sanderson Road, |
| Uxbridge UB8 1DH, |
| United Kingdom |

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park,

Sanderson Road,

Uxbridge UB8 1DH,

United Kingdom

EU/1/98/085/001-034

29.06.2012

27.06.2012

Lucentis

| Novartis Europharm Ltd |
| --- |
| Wimblehurst Road, |
| Horsham, |
| West Sussex RH12 5AB, |
| United Kingdom |

Novartis Europharm Ltd

Wimblehurst Road,

Horsham,

West Sussex RH12 5AB,

United Kingdom

EU/1/06/374/001

29.06.2012

27.06.2012

Menveo

| Novartis Vaccines and Diagnostics S.r.l. |
| --- |
| Via Fiorentina, 1, |
| 53100 Siena, |
| Italia |

Novartis Vaccines and Diagnostics S.r.l.

Via Fiorentina, 1,

53100 Siena,

Italia

EU/1/10/614/001-003

29.06.2012

27.06.2012

Mixtard

| Novo Nordisk A/S |
| --- |
| Novo Allé, |
| DK-2880 Bagsvaerd, |
| Danmark |

Novo Nordisk A/S

Novo Allé,

DK-2880 Bagsvaerd,

Danmark

EU/1/02/231/001-004

EU/1/02/231/036-037

02.07.2012

27.06.2012

Nexavar

| Bayer Pharma AG |
| --- |
| 13342 Berlin, |
| Deutschland |

Bayer Pharma AG

13342 Berlin,

Deutschland

EU/1/06/342/001

02.07.2012

27.06.2012

Osseor

| Les Laboratoires Servier |
| --- |
| 50, rue Carnot, |
| 92284 Suresnes cedex, |
| France |

Les Laboratoires Servier

50, rue Carnot,

92284 Suresnes cedex,

France

EU/1/04/287/001-006

02.07.2012

27.06.2012

PREZISTA

| Janssen-Cilag International NV |
| --- |
| Turnhoutseweg, 30 - |
| 2340 Beerse - |
| België |

Janssen-Cilag International NV

Turnhoutseweg, 30 -

2340 Beerse -

België

EU/1/06/380/001-005

02.07.2012

27.06.2012

Protaphane

| Novo Nordisk A/S |
| --- |
| Novo Allé, |
| DK-2880 Bagsvaerd, |
| Danmark |

Novo Nordisk A/S

Novo Allé,

DK-2880 Bagsvaerd,

Danmark

EU/1/02/234/003-004

EU/1/02/234/017

02.07.2012

27.06.2012

Protelos

| Les Laboratoires Servier |
| --- |
| 50, rue Carnot, |
| 92284 Suresnes cedex, |
| France |

Les Laboratoires Servier

50, rue Carnot,

92284 Suresnes cedex,

France

EU/1/04/288/001-006

02.07.2012

27.06.2012

Rebif

| Merck Serono Europe Limited |
| --- |
| 56, Marsh Wall, |
| London E14 9TP, |
| United Kingdom |

Merck Serono Europe Limited

56, Marsh Wall,

London E14 9TP,

United Kingdom

EU/1/98/063/001-019

29.06.2012

27.06.2012

Revolade

| GlaxoSmithKline Trading Services Limited |
| --- |
| 6900 Cork Airport Business Park, |
| Kinsale Road, |
| Cork, |
| Ireland |

GlaxoSmithKline Trading Services Limited

6900 Cork Airport Business Park,

Kinsale Road,

Cork,

Ireland

EU/1/10/612/001-006

02.07.2012

27.06.2012

Stocrin

| Merck Sharp & Dohme Ltd |
| --- |
| Hertford Road, |
| Hoddesdon, |
| Hertfordshire EN11 9BU, |
| United Kingdom |

Merck Sharp & Dohme Ltd

Hertford Road,

Hoddesdon,

Hertfordshire EN11 9BU,

United Kingdom

EU/1/99/111/001-005

EU/1/99/111/008

EU/1/99/111/010-011

02.07.2012

27.06.2012

Sustiva

| Bristol-Myers Squibb Pharma EEIG |
| --- |
| Uxbridge Business Park, |
| Sanderson Road, |
| Uxbridge UB8 1DH, |
| United Kingdom |

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park,

Sanderson Road,

Uxbridge UB8 1DH,

United Kingdom

EU/1/99/110/001-005

EU/1/99/110/008-010

02.07.2012

27.06.2012

Sycrest

| N.V. Organon |
| --- |
| Kloosterstraat 6, 5349 AB Oss, |
| Nederland |

N.V. Organon

Kloosterstraat 6, 5349 AB Oss,

Nederland

EU/1/10/640/001-006

02.07.2012

27.06.2012

Synagis

| Abbott Laboratories Ltd |
| --- |
| Abbott House, |
| Vanwall Business Park, |
| Vanwall Road, |
| Maidenhead, |
| Berkshire SL6 4XE, |
| United Kingdom |

Abbott Laboratories Ltd

Abbott House,

Vanwall Business Park,

Vanwall Road,

Maidenhead,

Berkshire SL6 4XE,

United Kingdom

EU/1/99/117/001-002

29.06.2012

27.06.2012

Tasigna

| Novartis Europharm Ltd |
| --- |
| Wimblehurst Road, |
| Horsham, |
| West Sussex RH12 5AB, |
| United Kingdom |

Novartis Europharm Ltd

Wimblehurst Road,

Horsham,

West Sussex RH12 5AB,

United Kingdom

EU/1/07/422/001-012

02.07.2012

27.06.2012

Temodal

| Merck Sharp & Dohme Limited |
| --- |
| Hertford Road, |
| Hoddesdon, |
| Hertfordshire, EN11 9BU, |
| United Kingdom |

Merck Sharp & Dohme Limited

Hertford Road,

Hoddesdon,

Hertfordshire, EN11 9BU,

United Kingdom

EU/1/98/096/001-025

02.07.2012

27.06.2012

Trisenox

| Cephalon Europe |
| --- |
| 5 Rue Charles Martigny, |
| 94700 Maisons Alfort, |
| Cedex, |
| France |

Cephalon Europe

5 Rue Charles Martigny,

94700 Maisons Alfort,

Cedex,

France

EU/1/02/204/001

02.07.2012

27.06.2012

Viracept

| Roche Registration Limited |
| --- |
| 6 Falcon Way, |
| Shire Park, |
| Welwyn Garden City, |
| AL7 1TW, |
| United Kingdom |

Roche Registration Limited

6 Falcon Way,

Shire Park,

Welwyn Garden City,

AL7 1TW,

United Kingdom

EU/1/97/054/001

EU/1/97/054/004-005

29.06.2012

27.06.2012

VPRIV

| Shire Pharmaceuticals Ireland Limited |
| --- |
| 5 Riverwalk, |
| Citywest Business Campus, |
| Dublin 24, |
| Ireland |

Shire Pharmaceuticals Ireland Limited

5 Riverwalk,

Citywest Business Campus,

Dublin 24,

Ireland

EU/1/10/646/001-006

02.07.2012

27.06.2012

Xeplion

| Janssen-Cilag International NV |
| --- |
| Turnhoutseweg 30, |
| B-2340 Beerse, |
| België |

Janssen-Cilag International NV

Turnhoutseweg 30,

B-2340 Beerse,

België

EU/1/11/672/001-006

02.07.2012

27.06.2012

Zeffix

| Glaxo Group Ltd. |
| --- |
| Greenford Road, |
| Greenford, |
| Middlesex UB6 0NN, |
| United Kingdom |

Glaxo Group Ltd.

Greenford Road,

Greenford,

Middlesex UB6 0NN,

United Kingdom

EU/1/99/114/003

02.07.2012

27.06.2012

Zypadhera

| Eli Lilly Nederland B.V. |
| --- |
| Grootslag 1-5, |
| NL-3991 RA Houten, |
| Nederland |

Eli Lilly Nederland B.V.

Grootslag 1-5,

NL-3991 RA Houten,

Nederland

EU/1/08/479/001-003

29.06.2012

27.06.2012

Zyprexa

| Eli Lilly Nederland B.V. |
| --- |
| Grootslag 1-5, |
| 3991 RA Houten, |
| Nederland |

Eli Lilly Nederland B.V.

Grootslag 1-5,

3991 RA Houten,

Nederland

EU/1/96/022/002

EU/1/96/022/004

EU/1/96/022/006

EU/1/96/022/009-012

EU/1/96/022/014

EU/1/96/022/016-017

EU/1/96/022/019-040

29.06.2012

27.06.2012

Zyprexa Velotab

| Eli Lilly Nederland B.V. |
| --- |
| Grootslag 1-5, |
| 3991 RA Houten, |
| Nederland |

Eli Lilly Nederland B.V.

Grootslag 1-5,

3991 RA Houten,

Nederland

EU/1/99/125/001-020

29.06.2012

28.06.2012

CoAprovel

| Sanofi Pharma Bristol-Myers Squibb SNC |
| --- |
| 54, rue La Boétie, |
| 75008 Paris, |
| France |

Sanofi Pharma Bristol-Myers Squibb SNC

54, rue La Boétie,

75008 Paris,

France

EU/1/98/086/001-034

03.07.2012

28.06.2012

Copalia HCT

| Novartis Europharm Ltd |
| --- |
| Wimblehurst Road, |
| Horsham, |
| West Sussex RH12 5AB, |
| United Kingdom |

Novartis Europharm Ltd

Wimblehurst Road,

Horsham,

West Sussex RH12 5AB,

United Kingdom

EU/1/09/575/001-060

03.07.2012

28.06.2012

Dafiro HCT

| Novartis Europharm Ltd |
| --- |
| Wimblehurst Road, |
| Horsham, |
| West Sussex RH12 5AB, |
| United Kingdom |

Novartis Europharm Ltd

Wimblehurst Road,

Horsham,

West Sussex RH12 5AB,

United Kingdom

EU/1/09/574/001-060

03.07.2012

28.06.2012

Ecalta

| Pfizer Limited |
| --- |
| Ramsgate Road, |
| Sandwich, |
| Kent CT13 9NJ, |
| United Kingdom |

Pfizer Limited

Ramsgate Road,

Sandwich,

Kent CT13 9NJ,

United Kingdom

EU/1/07/416/001-002

03.07.2012

28.06.2012

ellaOne

| Laboratoire HRA Pharma |
| --- |
| 15, rue Béranger, |
| 75003 Paris, |
| France |

Laboratoire HRA Pharma

15, rue Béranger,

75003 Paris,

France

EU/1/09/522/001

03.07.2012

28.06.2012

Exforge

| Novartis Europharm Ltd |
| --- |
| Wimblehurst Road, |
| Horsham, |
| West Sussex RH12 5AB, |
| United Kingdom |

Novartis Europharm Ltd

Wimblehurst Road,

Horsham,

West Sussex RH12 5AB,

United Kingdom

EU/1/06/370/001-039

03.07.2012

28.06.2012

Firmagon

| Ferring Pharmaceuticals A/S |
| --- |
| Kay Fiskers Plads 11, |
| Copenhagen S 2300, |
| Danmark |

Ferring Pharmaceuticals A/S

Kay Fiskers Plads 11,

Copenhagen S 2300,

Danmark

EU/1/08/504/001-003

07.07.2012

28.06.2012

GONAL-f

| Merck Serono Europe Ltd. |
| --- |
| 56, Marsh Wall, |
| London E14 9TP, |
| United Kingdom |

Merck Serono Europe Ltd.

56, Marsh Wall,

London E14 9TP,

United Kingdom

EU/1/95/001/001

EU/1/95/001/003-005

EU/1/95/001/009

EU/1/95/001/012

EU/1/95/001/021-022

EU/1/95/001/025-028

EU/1/95/001/031-035

03.07.2012

28.06.2012

Icandra

| Novartis Europharm Ltd |
| --- |
| Wimblehurst Road, |
| Horsham, |
| West Sussex RH12 5AB, |
| United Kingdom |

Novartis Europharm Ltd

Wimblehurst Road,

Horsham,

West Sussex RH12 5AB,

United Kingdom

EU/1/08/484/001-018

03.07.2012

28.06.2012

Imprida

| Novartis Europharm Ltd |
| --- |
| Wimblehurst Road, |
| Horsham, |
| West Sussex RH12 5AB, |
| United Kingdom |

Novartis Europharm Ltd

Wimblehurst Road,

Horsham,

West Sussex RH12 5AB,

United Kingdom

EU/1/06/373/001-039

03.07.2012

28.06.2012

Insulin Human Winthrop

| Sanofi-Aventis Deutschland GmbH |
| --- |
| D-65926 Frankfurt am Main, |
| Deutschland |

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main,

Deutschland

EU/1/06/368/001-015

EU/1/06/368/020-024

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

04.07.2012

28.06.2012

Jalra

| Novartis Europharm Ltd |
| --- |
| Wimblehurst Road, |
| Horsham, |
| West Sussex RH12 5AB, |
| United Kingdom |

Novartis Europharm Ltd

Wimblehurst Road,

Horsham,

West Sussex RH12 5AB,

United Kingdom

EU/1/08/485/001-011

03.07.2012

28.06.2012

Lamivudine Teva Pharma B.V.

| Teva Pharma B.V. |
| --- |
| Computerweg 10, |
| 3542 DR Utrecht, |
| Nederland |

Teva Pharma B.V.

Computerweg 10,

3542 DR Utrecht,

Nederland

EU/1/09/596/001-014

03.07.2012

28.06.2012

Myclausen

| Herbert J. Passauer GmbH & Co. KG |
| --- |
| Stubenrauchstrasse 33, |
| 14167 Berlin, |
| Deutschland |

Herbert J. Passauer GmbH & Co. KG

Stubenrauchstrasse 33,

14167 Berlin,

Deutschland

EU/1/10/647/001-004

03.07.2012

28.06.2012

Pradaxa

| Boehringer Ingelheim International GmbH |
| --- |
| Binger Strasse 173, |
| D-55216 Ingelheim am Rhein, |
| Deutschland |

Boehringer Ingelheim International GmbH

Binger Strasse 173,

D-55216 Ingelheim am Rhein,

Deutschland

EU/1/08/442/001-014

03.07.2012

28.06.2012

PritorPlus

| Bayer Pharma AG |
| --- |
| 13342 Berlin, |
| Deutschland |

Bayer Pharma AG

13342 Berlin,

Deutschland

EU/1/02/215/001-021

04.07.2012

28.06.2012

Rasilez HCT

| Novartis Europharm Ltd |
| --- |
| Wimblehurst Road, |
| Horsham, |
| West Sussex RH12 5AB, |
| United Kingdom |

Novartis Europharm Ltd

Wimblehurst Road,

Horsham,

West Sussex RH12 5AB,

United Kingdom

EU/1/08/491/001-080

03.07.2012

28.06.2012

Rilonacept Regeneron

| Regeneron UK Limited |
| --- |
| 40 Bank Street, |
| E14 5DS London, |
| United Kingdom |

Regeneron UK Limited

40 Bank Street,

E14 5DS London,

United Kingdom

EU/1/09/582/001

04.07.2012

28.06.2012

Riprazo HCT

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, |
| Horsham, |
| West Sussex, RH12 5AB, |
| United Kingdom |

Novartis Europharm Limited

Wimblehurst Road,

Horsham,

West Sussex, RH12 5AB,

United Kingdom

EU/1/11/680/001-080

03.07.2012

28.06.2012

Siklos

| ADDMEDICA |
| --- |
| 101, rue Saint Lazare, |
| Paris 75009, |
| France |

ADDMEDICA

101, rue Saint Lazare,

Paris 75009,

France

EU/1/07/397/001-004

03.07.2012

28.06.2012

Siklos

| ADDMEDICA |
| --- |
| 101, rue Saint Lazare, |
| Paris 75009, |
| France |

ADDMEDICA

101, rue Saint Lazare,

Paris 75009,

France

EU/1/07/397/001-004

03.07.2012

28.06.2012

Sprimeo HCT

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, |
| Horsham, |
| West Sussex, RH12 5AB, |
| United Kingdom |

Novartis Europharm Limited

Wimblehurst Road,

Horsham,

West Sussex, RH12 5AB,

United Kingdom

EU/1/11/683/001-080

02.07.2012

28.06.2012

Vfend

| Pfizer Ltd |
| --- |
| Ramsgate Road, |
| Sandwich, |
| Kent CT 13 9NJ, |
| United Kingdom |

Pfizer Ltd

Ramsgate Road,

Sandwich,

Kent CT 13 9NJ,

United Kingdom

EU/1/02/212/001-026

03.07.2012

28.06.2012

Votubia

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, |
| Horsham, |
| West Sussex, RH12 5AB, |
| United Kingdom |

Novartis Europharm Limited

Wimblehurst Road,

Horsham,

West Sussex, RH12 5AB,

United Kingdom

EU/1/11/710/001-007

04.07.2012

28.06.2012

Votubia

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, |
| Horsham, |
| West Sussex, RH12 5AB, |
| United Kingdom |

Novartis Europharm Limited

Wimblehurst Road,

Horsham,

West Sussex, RH12 5AB,

United Kingdom

EU/1/11/710/001-007

04.07.2012

28.06.2012

Vyndaqel

| Pfizer Specialty UK Limited |
| --- |
| Ramsgate Road, |
| Sandwich, |
| Kent CT13 9NJ, |
| United Kingdom |

Pfizer Specialty UK Limited

Ramsgate Road,

Sandwich,

Kent CT13 9NJ,

United Kingdom

EU/1/11/717/001

04.07.2012

28.06.2012

Xiliarx

| Novartis Europharm Ltd |
| --- |
| Wimblehurst Road, |
| Horsham, |
| West Sussex, RH12 5AB, |
| United Kingdom |

Novartis Europharm Ltd

Wimblehurst Road,

Horsham,

West Sussex, RH12 5AB,

United Kingdom

EU/1/08/486/001-011

03.07.2012

28.06.2012

Zomarist

| Novartis Europharm Ltd |
| --- |
| Wimblehurst Road, |
| Horsham, |
| West Sussex, RH12 5AB, |
| United Kingdom |

Novartis Europharm Ltd

Wimblehurst Road,

Horsham,

West Sussex, RH12 5AB,

United Kingdom

EU/1/08/483/001-018

03.07.2012

—   Rücknahme einer Zulassung (Artikel 13 der Verordnung (EG) Nr. 726/2004 des Europäischen Parlaments und des Rates)

| Datum des Beschlusses | Bezeichnung des Arzneimittels | Zulassungsinhaber | Registriernummer im Gemeinschaftsverzeichnis | Datum der Mitteilung |
| --- | --- | --- | --- | --- |
| 28.06.2012 | Hexavac | Aventis Pasteur MSD |
| 8, rue Jonas Salk, |
| 69007 Lyon, |
| France |

Datum des Beschlusses

Bezeichnung des Arzneimittels

Zulassungsinhaber

Registriernummer im Gemeinschaftsverzeichnis

Datum der Mitteilung

28.06.2012

Hexavac

Aventis Pasteur MSD

8, rue Jonas Salk,

69007 Lyon,

France

EU/1/00/147/001-012

04.07.2012

—   Erteilung einer Zulassung (Artikel 38 der Verordnung (EG) Nr. 726/2004 des Europäischen Parlaments und des Rates
   (2)): Genehmigt

| Datum des Beschlusses | Bezeichnung des Arzneimittels | INN (internationaler Freiname) | Zulassungsinhaber | Registriernummer im Gemeinschaftsverzeichnis | Darreichungsform | ATC-Code (anatomisch-therapeutisch-chemischer Code) | Datum der Mitteilung |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 14.06.2012 | Porcilis ColiClos | — | Intervet International B.V. |
| Wim de Körverstraat 35, |
| 5831 AN Boxmeer, |
| Nederland |

Datum des Beschlusses

Bezeichnung des Arzneimittels

INN (internationaler Freiname)

Zulassungsinhaber

Registriernummer im Gemeinschaftsverzeichnis

Darreichungsform

ATC-Code (anatomisch-therapeutisch-chemischer Code)

Datum der Mitteilung

14.06.2012

Porcilis ColiClos

—

Intervet International B.V.

Wim de Körverstraat 35,

5831 AN Boxmeer,

Nederland

EU/2/12/141/001-009

Injektions-suspension

QI09AB08

17.06.2012

15.06.2012

Poulvac E. coli

—

| Pfizer Limited |
| --- |
| Ramsgate Road, |
| Sandwich, Kent, |
| CT13 9NJ, |
| United Kingdom |

Pfizer Limited

Ramsgate Road,

Sandwich, Kent,

CT13 9NJ,

United Kingdom

EU/2/12/140/001-008

Lyophilisat zur Herstellung einer Suspension zur Impfung von Hühnern durch Sprühapplikation

QI01AE04

20.06.2012

—   Änderung einer Zulassung (Artikel 38 der Verordnung (EG) Nr. 726/2004 des Europäischen Parlaments und des Rates): Genehmigt

| Datum des Beschlusses | Bezeichnung des Arzneimittels | Zulassungsinhaber | Registriernummer im Gemeinschaftsverzeichnis | Datum der Mitteilung |
| --- | --- | --- | --- | --- |
| 11.06.2012 | Activyl | Intervet International B.V. |
| Wim de Körverstraat 35, |
| 5831 AN Boxmeer, |
| Nederland |

Datum des Beschlusses

Bezeichnung des Arzneimittels

Zulassungsinhaber

Registriernummer im Gemeinschaftsverzeichnis

Datum der Mitteilung

11.06.2012

Activyl

Intervet International B.V.

Wim de Körverstraat 35,

5831 AN Boxmeer,

Nederland

EU/2/10/118/001-021

13.06.2012

14.06.2012

Emdocam

| Emdoka bvba |
| --- |
| J. Lijsenstraat 16, |
| B-2321 Hoogstraten, |
| Belgïe |

Emdoka bvba

J. Lijsenstraat 16,

B-2321 Hoogstraten,

Belgïe

EU/2/11/128/001-003

18.06.2012

27.06.2012

Bovilis BTV8

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35, |
| 5831 AN Boxmeer, |
| Nederland |

Intervet International B.V.

Wim de Körverstraat 35,

5831 AN Boxmeer,

Nederland

EU/2/10/106/001-014

02.07.2012

28.06.2012

Nobilis IB 4-91

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35, |
| 5831 AN Boxmeer, |
| Nederland |

Intervet International B.V.

Wim de Körverstraat 35,

5831 AN Boxmeer,

Nederland

EU/2/98/006/001-010

04.07.2012

28.06.2012

Oxyglobin

| OPK Biotech Netherlands BV |
| --- |
| Teleportboulevard 140, |
| 1043EJ Amsterdam, |
| Nederland |

OPK Biotech Netherlands BV

Teleportboulevard 140,

1043EJ Amsterdam,

Nederland

EU/2/99/015/001-002

04.07.2012

Jeder Interessent erhält auf Anfrage den Beurteilungsbericht zu den betreffenden Arzneimitteln sowie die entsprechenden Beschlüsse. Anfragen sind an folgende Adresse zu richten:

| The European Medicines Agency |
| --- |
| 7, Westferry Circus, |
| Canary Wharf |
| UK - LONDON E14 4H |

The European Medicines Agency

7, Westferry Circus,

Canary Wharf

UK - LONDON E14 4H

---

(1)  ABl. L 136 vom 30.4.04, S. 1.

(2)  ABl. L 136 vom 30.4.04, S. 1.

---

| 27.7.2012 | DE | Amtsblatt der Europäischen Union | C 224/16 |
| --- | --- | --- | --- |

27.7.2012

DE

Amtsblatt der Europäischen Union

C 224/16

---

Verzeichnis der Beschlüsse der Europäischen Union über die Zulassung von Arzneimitteln vom 1. Juni 2012 bis 30. Juni 2012

(Beschlüsse gemäß Artikel 34 der Richtlinie 2001/83/EG
   (1)
  oder Artikel 38 der Richtlinie 2001/82/EG
   (2)
  )

2012/C 224/02

—   Erteilung, Aufrechterhaltung oder Änderung einer nationalen Zulassung

| Datum des Beschlusses | Bezeichnung(en) des Arzneimittels | Zulassungsinhaber | betreffender Mitgliedstaat | Datum der Mitteilung |
| --- | --- | --- | --- | --- |
| 14/6/2012 | Tilmicosin | Siehe Anhang I | Siehe Anhang I | 18/6/2012 |
| 18/6/2012 | Milaxyn plus and associated names | Siehe Anhang II | Siehe Anhang II | 20/6/2012 |
| 28/6/2012 | Flutiform and associated names | Siehe Anhang III | Siehe Anhang III | 3/7/2012 |
| 28/6/2012 | Iffeza and associated names | Siehe Anhang IV | Siehe Anhang IV | 3/7/2012 |

Datum des Beschlusses

Bezeichnung(en) des Arzneimittels

Zulassungsinhaber

betreffender Mitgliedstaat

Datum der Mitteilung

14/6/2012

Tilmicosin

Siehe Anhang I

Siehe Anhang I

18/6/2012

18/6/2012

Milaxyn plus and associated names

Siehe Anhang II

Siehe Anhang II

20/6/2012

28/6/2012

Flutiform and associated names

Siehe Anhang III

Siehe Anhang III

3/7/2012

28/6/2012

Iffeza and associated names

Siehe Anhang IV

Siehe Anhang IV

3/7/2012

---

(1)  ABl. L 311 vom 28.11.01, S. 67.

(2)  ABl. L 311 vom 28.11.01, S. 1.

---

ANHANG I

LISTE DER BEZEICHNUNGEN, DARREICHUNGSFORMEN, WIRKSTOFFE, STÄRKEN DER TIERARZNEIMITTEL, ZIELTIERARTEN UND INHABER DER GENEHMIGUNGEN FÜR DAS INVERKEHRBRINGEN IN DEN MITGLIEDSSTAATEN

| Mitgliedsstaat EU/EWR | Inhaber der Genehmigung für das Inverkehrbringen | Bezeichnung | INN | Stärke | Darreichungs form | Zieltierart |
| --- | --- | --- | --- | --- | --- | --- |
| Österreich | Richter Pharma AG |
| Feldgasse 19 |
| A-4600 Wels |
| ÖSTERREICH |

Mitgliedsstaat EU/EWR

Inhaber der Genehmigung für das Inverkehrbringen

Bezeichnung

INN

Stärke

Darreichungs form

Zieltierart

Österreich

Richter Pharma AG

Feldgasse 19

A-4600 Wels

ÖSTERREICH

Pulmotil G 100 g/kg Arzneimittel-Vormischung zur Herstellung von Fütterungsarzneimitteln für Schweine und Kaninchen

Tilmicosin (as phosphate)

100 g Tilmicosin pro kg Vormischung

Vormischung für Fütterungsarzneimittel

Schweine, Kaninchen

Österreich

| Richter Pharma AG |
| --- |
| Feldgasse 19 |
| A-4600 Wels |
| ÖSTERREICH |

Richter Pharma AG

Feldgasse 19

A-4600 Wels

ÖSTERREICH

Pulmotil G 200 g/kg Arzneimittel-Vormischung zur Herstellung von Fütterungsarzneimitteln für Schweine und Kaninchen

Tilmicosin (as phosphate)

200 g Tilmicosin pro kg Vormischung

Vormischung für Fütterungsarzneimittel

Schweine, Kaninchen

Belgien

| Eli Lilly Benelux N.V. |
| --- |
| Elanco Animal Health |
| Rue de l'Etuve 52 |
| Stoofstraat 52 |
| 1000 Brussel |
| BELGIEN |

Eli Lilly Benelux N.V.

Elanco Animal Health

Rue de l'Etuve 52

Stoofstraat 52

1000 Brussel

BELGIEN

Pulmotil 40 VET Pre-mix

Tilmicosin (as phosphate)

40 g Tilmicosin pro kg Vormischung

Vormischung für Fütterungsarzneimittel

Schweine, Kaninchen

Belgien

| Eli Lilly Benelux N.V. |
| --- |
| Elanco Animal Health |
| Rue de l'Etuve 52 |
| Stoofstraat 52 |
| 1000 Brussel |
| BELGIEN |

Eli Lilly Benelux N.V.

Elanco Animal Health

Rue de l'Etuve 52

Stoofstraat 52

1000 Brussel

BELGIEN

Pulmotil 100 VET Pre-mix

Tilmicosin (as phosphate)

100 g Tilmicosin pro kg Vormischung

Vormischung für Fütterungsarzneimittel

Schweine, Kaninchen

Belgien

| Eli Lilly Benelux N.V. |
| --- |
| Elanco Animal Health |
| Rue de l'Etuve 52 |
| Stoofstraat 52 |
| 1000 Brussel |
| BELGIEN |

Eli Lilly Benelux N.V.

Elanco Animal Health

Rue de l'Etuve 52

Stoofstraat 52

1000 Brussel

BELGIEN

Pulmotil 100 Granules

Tilmicosin (as phosphate)

100 g Tilmicosin pro kg Vormischung

Vormischung für Fütterungsarzneimittel

Schweine, Kaninchen

Belgien

| Eli Lilly Benelux N.V. |
| --- |
| Elanco Animal Health |
| Rue de l'Etuve 52 |
| Stoofstraat 52 |
| 1000 Brussel |
| BELGIEN |

Eli Lilly Benelux N.V.

Elanco Animal Health

Rue de l'Etuve 52

Stoofstraat 52

1000 Brussel

BELGIEN

Pulmotil 200 VET Pre-mix

Tilmicosin (as phosphate)

200 g Tilmicosin pro kg Vormischung

Vormischung für Fütterungsarzneimittel

Schweine, Kaninchen

Zypern

| Eli Lilly Regional Operations GmbH |
| --- |
| Elanco Animal Health |
| Kolblgasse 8-10 |
| 1030 Wien |
| ÖSTERREICH |

Eli Lilly Regional Operations GmbH

Elanco Animal Health

Kolblgasse 8-10

1030 Wien

ÖSTERREICH

Pulmotil pre-mix 200 g/kg, πρόμιγμα για φαρμακούχο ζωοτροφή, για χοίρους και κoνίκλους.

Tilmicosin (as phosphate)

200 g Tilmicosin pro kg Vormischung

Vormischung für Fütterungsarzneimittel

Schweine, Kaninchen

Tschechische Republik

| Eli Lilly Regional Operations GmbH |
| --- |
| Elanco Animal Health |
| Kolblgasse 8-10 |
| 1030 Wien |
| ÖSTERREICH |

Eli Lilly Regional Operations GmbH

Elanco Animal Health

Kolblgasse 8-10

1030 Wien

ÖSTERREICH

Pulmotil 200 mg/g pre-mix pro medikaci krmiva

Tilmicosin (as phosphate)

200 g Tilmicosin pro kg Vormischung

Vormischung für Fütterungsarzneimittel

Schweine, Kaninchen

Deutschland

| Lilly Deutschland GmbH |
| --- |
| Abt. Elanco Animal Health |
| Werner-Reimers-Str. 2-4 |
| D-61352 Bad Homburg |
| DEUTSCHLAND |

Lilly Deutschland GmbH

Abt. Elanco Animal Health

Werner-Reimers-Str. 2-4

D-61352 Bad Homburg

DEUTSCHLAND

Pulmotil G 40

Tilmicosin (as phosphate)

40 g Tilmicosin pro kg Vormischung

Vormischung für Fütterungsarzneimittel

Schweine, Kaninchen

Deutschland

| Lilly Deutschland GmbH |
| --- |
| Abt. Elanco Animal Health |
| Werner-Reimers-Str. 2-4 |
| D-61352 Bad Homburg |
| DEUTSCHLAND |

Lilly Deutschland GmbH

Abt. Elanco Animal Health

Werner-Reimers-Str. 2-4

D-61352 Bad Homburg

DEUTSCHLAND

Pulmotil G 100

Tilmicosin (as phosphate)

100 g Tilmicosin pro kg Vormischung

Vormischung für Fütterungsarzneimittel

Schweine, Kaninchen

Deutschland

| Lilly Deutschland GmbH |
| --- |
| Abt. Elanco Animal Health |
| Werner-Reimers-Str. 2-4 |
| D-61352 Bad Homburg |
| DEUTSCHLAND |

Lilly Deutschland GmbH

Abt. Elanco Animal Health

Werner-Reimers-Str. 2-4

D-61352 Bad Homburg

DEUTSCHLAND

Pulmotil G 20 % AMV

Tilmicosin (as phosphate)

200 g Tilmicosin pro kg Vormischung

Vormischung für Fütterungsarzneimittel

Schweine, Kaninchen

Dänemark

| Elanco Animal Health |
| --- |
| Eli Lilly Danmark A/S |
| Nybrovej 110 |
| DK-2800 Kongens Lyngby |
| DÄNEMARK |

Elanco Animal Health

Eli Lilly Danmark A/S

Nybrovej 110

DK-2800 Kongens Lyngby

DÄNEMARK

Pulmotil Vet.

Tilmicosin (as phosphate)

40 g Tilmicosin pro kg Vormischung

Vormischung für Fütterungsarzneimittel

Schweine, Kaninchen

Dänemark

| Elanco Animal Health |
| --- |
| Eli Lilly Danmark A/S |
| Nybrovej 110 |
| DK-2800 Kongens Lyngby |
| DÄNEMARK |

Elanco Animal Health

Eli Lilly Danmark A/S

Nybrovej 110

DK-2800 Kongens Lyngby

DÄNEMARK

Pulmotil Vet.

Tilmicosin (as phosphate)

100 g Tilmicosin pro kg Vormischung

Vormischung für Fütterungsarzneimittel

Schweine, Kaninchen

Dänemark

| Elanco Animal Health |
| --- |
| Eli Lilly Danmark A/S |
| Nybrovej 110 |
| DK-2800 Kongens Lyngby |
| DÄNEMARK |

Elanco Animal Health

Eli Lilly Danmark A/S

Nybrovej 110

DK-2800 Kongens Lyngby

DÄNEMARK

Pulmotil Vet.

Tilmicosin (as phosphate)

200 g Tilmicosin pro kg Vormischung

Vormischung für Fütterungsarzneimittel

Schweine, Kaninchen

Griechenland

| Eli Lilly Regional Operations GmbH |
| --- |
| Elanco Animal Health |
| Kolblgasse 8-10 |
| 1030 Wien |
| ÖSTERREICH |

Eli Lilly Regional Operations GmbH

Elanco Animal Health

Kolblgasse 8-10

1030 Wien

ÖSTERREICH

PULMOTIL 200

Tilmicosin (as phosphate)

200 g Tilmicosin pro kg Vormischung

Vormischung für Fütterungsarzneimittel

Schweine, Kaninchen

Spanien

| ELANCO VALQUÍMICA, S.A. |
| --- |
| Avda. de la Industria 30 |
| 28108 Alcobendas |
| Madrid |
| SPANIEN |

ELANCO VALQUÍMICA, S.A.

Avda. de la Industria 30

28108 Alcobendas

Madrid

SPANIEN

PULMOTIL G 40

Tilmicosin (as phosphate)

40 g Tilmicosin pro kg Vormischung

Vormischung für Fütterungsarzneimittel

Schweine, Kaninchen

Spanien

| ELANCO VALQUÍMICA, S.A. |
| --- |
| Avda. de la Industria 30 |
| 28108 Alcobendas |
| Madrid |
| SPANIEN |

ELANCO VALQUÍMICA, S.A.

Avda. de la Industria 30

28108 Alcobendas

Madrid

SPANIEN

PULMOTIL G 100

Tilmicosin (as phosphate)

100 g Tilmicosin pro kg Vormischung

Vormischung für Fütterungsarzneimittel

Schweine, Kaninchen

Spanien

| ELANCO VALQUÍMICA, S.A. |
| --- |
| Avda. de la Industria 30 |
| 28108 Alcobendas |
| Madrid |
| SPANIEN |

ELANCO VALQUÍMICA, S.A.

Avda. de la Industria 30

28108 Alcobendas

Madrid

SPANIEN

PULMOTIL G 200

Tilmicosin (as phosphate)

200 g Tilmicosin pro kg Vormischung

Vormischung für Fütterungsarzneimittel

Schweine, Kaninchen

Frankreich

| LILLY France |
| --- |
| 13 Rue Pages |
| 92158 Suresnes |
| Cedex |
| FRANKREICH |

LILLY France

13 Rue Pages

92158 Suresnes

Cedex

FRANKREICH

PULMOTIL TILMICOSINE 40 PORC-LAPIN

Tilmicosin (as phosphate)

40 g Tilmicosin pro kg Vormischung

Vormischung für Fütterungsarzneimittel

Schweine, Kaninchen

Frankreich

| QALIAN |
| --- |
| 34 Rue Jean Monnet |
| Zi D'Etriche |
| 49500 Serge |
| FRANKREICH |

QALIAN

34 Rue Jean Monnet

Zi D'Etriche

49500 Serge

FRANKREICH

SANTAMIX TILMICOSINE 40 PORCINS - LAPINS

Tilmicosin (as phosphate)

40 g Tilmicosin pro kg Vormischung

Vormischung für Fütterungsarzneimittel

Schweine, Kaninchen

Frankreich

| SOGEVAL |
| --- |
| 200 Route de Mayenne |
| Zi des Touches |
| 53000 Laval |
| FRANKREICH |

SOGEVAL

200 Route de Mayenne

Zi des Touches

53000 Laval

FRANKREICH

CONCENTRAT VO 08 TILMICOSINE PORCIN-LAPIN

Tilmicosin (as phosphate)

40 g Tilmicosin pro kg Vormischung

Vormischung für Fütterungsarzneimittel

Schweine, Kaninchen

Ungarn

| Eli Lilly Regional Operations GmbH |
| --- |
| Elanco Animal Health |
| Kolblgasse 8-10 |
| 1030 Wien |
| ÖSTERREICH |

Eli Lilly Regional Operations GmbH

Elanco Animal Health

Kolblgasse 8-10

1030 Wien

ÖSTERREICH

Pulmotil G 200 gyógypre-mix

Tilmicosin (as phosphate)

200 g Tilmicosin pro kg Vormischung

Vormischung für Fütterungsarzneimittel

Schweine, Kaninchen

Irland

| Eli Lilly and Company Ltd |
| --- |
| Elanco Animal Health |
| Lilly House |
| Priestly Road |
| Basingstoke |
| Hampshire RG24 9NL |
| VEREINIGTES KÖNIGREICH |

Eli Lilly and Company Ltd

Elanco Animal Health

Lilly House

Priestly Road

Basingstoke

Hampshire RG24 9NL

VEREINIGTES KÖNIGREICH

Pulmotil G40 Pre-mix for medicated feedingstuff

Tilmicosin (as phosphate)

40 g Tilmicosin pro kg Vormischung

Vormischung für Fütterungsarzneimittel

Schweine, Kaninchen

Irland

| Eli Lilly and Company Ltd |
| --- |
| Elanco Animal Health |
| Lilly House |
| Priestly Road |
| Basingstoke |
| Hampshire RG24 9NL |
| VEREINIGTES KÖNIGREICH |

Eli Lilly and Company Ltd

Elanco Animal Health

Lilly House

Priestly Road

Basingstoke

Hampshire RG24 9NL

VEREINIGTES KÖNIGREICH

Pulmotil G100 Pre-mix for medicated feedingstuff

Tilmicosin (as phosphate)

100 g Tilmicosin pro kg Vormischung

Vormischung für Fütterungsarzneimittel

Schweine, Kaninchen

Irland

| Eli Lilly and Company Ltd |
| --- |
| Elanco Animal Health |
| Lilly House |
| Priestly Road |
| Basingstoke |
| Hampshire RG24 9NL |
| VEREINIGTES KÖNIGREICH |

Eli Lilly and Company Ltd

Elanco Animal Health

Lilly House

Priestly Road

Basingstoke

Hampshire RG24 9NL

VEREINIGTES KÖNIGREICH

Pulmotil G200 Pre-mix for medicated feedingstuff

Tilmicosin (as phosphate)

200 g Tilmicosin pro kg Vormischung

Vormischung für Fütterungsarzneimittel

Schweine, Kaninchen

Italien

| ELI LILLY ITALIA SPA |
| --- |
| VIA GRAMSCI |
| 731/733 - SESTO FIORENTINO – FI |
| ITALIEN |

ELI LILLY ITALIA SPA

VIA GRAMSCI

731/733 - SESTO FIORENTINO – FI

ITALIEN

PULMOTIL G 200 PRE-MIX

Tilmicosin (as phosphate)

200 g Tilmicosin pro kg Vormischung

Vormischung für Fütterungsarzneimittel

Schweine, Kaninchen

Italien

| CEVA VETEM SpA |
| --- |
| via Colleoni |
| 15 20041 Agrate Brianza (MB) |
| ITALIEN |

CEVA VETEM SpA

via Colleoni

15 20041 Agrate Brianza (MB)

ITALIEN

MICLOZAN 200 PRE-MIX

Tilmicosin (as phosphate)

200 g Tilmicosin pro kg Vormischung

Vormischung für Fütterungsarzneimittel

Schweine, Kaninchen

Niederlande

| Eli Lilly Nederland B.V. |
| --- |
| Elanco Animal Health |
| Grootslag 1-5 |
| 3991 RA Houten |
| NIEDERLANDE |

Eli Lilly Nederland B.V.

Elanco Animal Health

Grootslag 1-5

3991 RA Houten

NIEDERLANDE

PULMOTIL® G40 pre-mix voor gemedicineerd voer voor varkens

Tilmicosin (as phosphate)

40 g Tilmicosin pro kg Vormischung

Vormischung für Fütterungsarzneimittel

Schweine, Kaninchen

Niederlande

| Eli Lilly Nederland B.V. |
| --- |
| Elanco Animal Health |
| Grootslag 1-5 |
| 3991 RA Houten |
| NIEDERLANDE |

Eli Lilly Nederland B.V.

Elanco Animal Health

Grootslag 1-5

3991 RA Houten

NIEDERLANDE

PULMOTIL® G100 pre-mix voor gemedicineerd voer voor varkens

Tilmicosin (as phosphate)

100 g Tilmicosin pro kg Vormischung

Vormischung für Fütterungsarzneimittel

Schweine, Kaninchen

Niederlande

| Eli Lilly Nederland B.V. |
| --- |
| Elanco Animal Health |
| Grootslag 1-5 |
| 3991 RA Houten |
| NIEDERLANDE |

Eli Lilly Nederland B.V.

Elanco Animal Health

Grootslag 1-5

3991 RA Houten

NIEDERLANDE

PULMOTIL® G200 pre-mix voor gemedicineerd voer voor varkens

Tilmicosin (as phosphate)

200 g Tilmicosin pro kg Vormischung

Vormischung für Fütterungsarzneimittel

Schweine, Kaninchen

Portugal

| Lilly Portugal – Produtos Farmacêuticos, Lda. |
| --- |
| Rua Cesário Verde, no5- piso 4 |
| Linda-a-Pastora |
| 2790 – 326 QUEIJAS |
| PORTUGAL |

Lilly Portugal – Produtos Farmacêuticos, Lda.

Rua Cesário Verde, no5- piso 4

Linda-a-Pastora

2790 – 326 QUEIJAS

PORTUGAL

Pulmotil G40 Pré-mistura medicamentosa para alimento medicamentoso para suínos e coelhos

Tilmicosin (as phosphate)

40 g Tilmicosin pro kg Vormischung

Vormischung für Fütterungsarzneimittel

Schweine, Kaninchen

Portugal

| Lilly Portugal – Produtos Farmacêuticos, Lda. |
| --- |
| Rua Cesário Verde, no5- piso 4 |
| Linda-a-Pastora |
| 2790 – 326 QUEIJAS |
| PORTUGAL |

Lilly Portugal – Produtos Farmacêuticos, Lda.

Rua Cesário Verde, no5- piso 4

Linda-a-Pastora

2790 – 326 QUEIJAS

PORTUGAL

Pulmotil G100 Pré-mistura medicamentosa para alimento medicamentoso para suínos e coelhos

Tilmicosin (as phosphate)

100 g Tilmicosin pro kg Vormischung

Vormischung für Fütterungsarzneimittel

Schweine, Kaninchen

Portugal

| Lilly Portugal – Produtos Farmacêuticos, Lda. |
| --- |
| Rua Cesário Verde, no5- piso 4 |
| Linda-a-Pastora |
| 2790 – 326 QUEIJAS |
| PORTUGAL |

Lilly Portugal – Produtos Farmacêuticos, Lda.

Rua Cesário Verde, no5- piso 4

Linda-a-Pastora

2790 – 326 QUEIJAS

PORTUGAL

Pulmotil G200 Pré-mistura medicamentosa para alimento medicamentoso para suínos e coelhos

Tilmicosin (as phosphate)

200 g Tilmicosin pro kg Vormischung

Vormischung für Fütterungsarzneimittel

Schweine, Kaninchen

Rumänien

| Eli Lilly Regional Operations GmbH |
| --- |
| Elanco Animal Health |
| Kolblgasse 8-10 |
| 1030 Wien |
| ÖSTERREICH |

Eli Lilly Regional Operations GmbH

Elanco Animal Health

Kolblgasse 8-10

1030 Wien

ÖSTERREICH

PULMOTIL 200 g/kg pre-mix

Tilmicosin (as phosphate)

200 g Tilmicosin pro kg Vormischung

Vormischung für Fütterungsarzneimittel

Schweine, Kaninchen

Slowakische Republik

| Elli Lilly and Company Limited |
| --- |
| Speke Operations Fleming RoadSpeke |
| Liverpool |
| L24 9LN |
| VEREINIGTES KÖNIGREICH |

Elli Lilly and Company Limited

Speke Operations Fleming RoadSpeke

Liverpool

L24 9LN

VEREINIGTES KÖNIGREICH

Pulmotil G 200 pre-mix ad us.vet.

Tilmicosin (as phosphate)

200 g Tilmicosin pro kg Vormischung

Vormischung für Fütterungsarzneimittel

Schweine, Kaninchen

Vereinigtes Königreich

| Eli Lilly and Company Ltd |
| --- |
| Elanco Animal Health |
| Lilly House |
| Priestly Road |
| Basingstoke |
| Hampshire RG24 9NL |
| VEREINIGTES KÖNIGREICH |

Eli Lilly and Company Ltd

Elanco Animal Health

Lilly House

Priestly Road

Basingstoke

Hampshire RG24 9NL

VEREINIGTES KÖNIGREICH

Pulmotil G100 Pre-mix for Medicated Feedingstuff

Tilmicosin (as phosphate)

100 g Tilmicosin pro kg Vormischung

Vormischung für Fütterungsarzneimittel

Schweine, Kaninchen

Vereinigtes Königreich

| Eli Lilly and Company Ltd |
| --- |
| Elanco Animal Health |
| Lilly House |
| Priestly Road |
| Basingstoke |
| Hampshire RG24 9NL |
| VEREINIGTES KÖNIGREICH |

Eli Lilly and Company Ltd

Elanco Animal Health

Lilly House

Priestly Road

Basingstoke

Hampshire RG24 9NL

VEREINIGTES KÖNIGREICH

Pulmotil G200 Pre-mix for Medicated Feedingstuff

Tilmicosin(as phosphate)

200 g Tilmicosin pro kg Vormischung

Vormischung für Fütterungsarzneimittel

Schweine, Kaninchen

---

ANHANG II

LISTE MIT DEN NAMEN, DARREICHUNGSFORM, STÄRKE DER TIERARZNEIMITTEL, TIERARTEN, ART DER VERABREICHUNG, ZULASSUNGSINHABER IN DEN MITGLIEDSTAATEN

| Mitgliedstaat EU/EEA | Zulassungsinhaber | Name | INN/Stärke | Darreichungsform | Tierart |
| --- | --- | --- | --- | --- | --- |
| Österreich | Chanelle Pharmaceuticals Manufacturing Ltd. |
| IE-Loughrea |
| Co. Galway |
| Irland |

Mitgliedstaat EU/EEA

Zulassungsinhaber

Name

INN/Stärke

Darreichungsform

Tierart

Österreich

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Exitel Plus Tabletten für Hunde

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Österreich

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Prazitel Plus Tabletten für Hunde

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Belgien

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Cazitel Plus Tabletten für Hunde

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Belgien

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Exitel Plus Tabletten für Hunde

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Belgien

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Prazitel Plus Tabletten für Hunde

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Bulgarien

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Cazitel Plus таблетки за кучета

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Bulgarien

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Exitel Plus таблетки за кучета

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Bulgariaen

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Prazitel Plus таблетки за кучета

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Zypern

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Exitel Plus Δισκία Για Σκύλους

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Tschechische Republik

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Cazitel Plus tablety pro psy

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Tschechische Republik

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Exitel Plus tablety pro psy

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Tschechische Republik

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Prazitel Plus tablety pro psy

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Dänemark

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Exitel Plus

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Dänemark

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Prazitel Plus

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Estland

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Cazitel Plus tabletid koertele

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Estland

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Exitel Plus tabletid koertele

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Finnland

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Cazitel Plus 50 mg/144 mg/150 mg tablet

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Finnland

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Exitel Plus 50 mg/144 mg/150 mg tablet

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Finnland

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Prazitel Plus 50 mg/144 mg/150 mg tablet

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Frankreich

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Milaxyn comprimé pour chiens

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Frankreich

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Strantel comprimé pour chiens

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Frankreich

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Prazical comprimé pour chiens

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Frankreich

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Voxical comprimé pour chiens

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Deutshcland

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Cazitel Tabletten für Hunde

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Deutshcland

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Exitel Tabletten für Hunde

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Deutshcland

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Strantel Tabletten für Hunde

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Griechenland

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Cazitel plus Δισκία Για Σκύλους

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Griechenland

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Exitel plus Δισκία Για Σκύλους

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Griechenland

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Prazitel plus Δισκία Για Σκύλους

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Ungarn

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Cazitel Plus tabletta kutyák részére A.U.V

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Ungarn

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Exitel Plus tabletta kutyák részére A.U.V

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Ungarn

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Prazitel Plus tabletta kutyák részére A.U.V

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Island

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Exitel Plus töflur fyrir hunda

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Island

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Prazitel Plus töflur fyrir hunda

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Irland

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Cazitel Plus tablets for dogs

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Irland

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Exitel Plus tablets for dogs

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Irland

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Milaxyn Plus tablets for dogs

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Irland

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Prazical Plus tablets for dogs

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Irland

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Prazitel Plus tablets for dogs

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Irland

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Strantel Plus tablets for dogs

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Irland

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Voxical Plus tablets for dogs

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Italien

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Canitel Plus compresse per cani

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Italien

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Exitel Plus compresse per cani

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Italien

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Prazitel compresse per cani

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Lettland

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Cazitel tablets Tabletes suņiem

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Lettland

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Exitel tablets Tabletes suņiem

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Lettland

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Prazitel tablets Tabletes suņiem

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Litauen

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Cazitel Plus tabletės šunims

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Litauen

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Exitel Plus tabletės šunims

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Litauen

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Prazitel Plus tabletės šunims

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Luxemburg

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Exitel Plus tabletten voor honden

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Luxemburg

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Prazitel Plus tabletten voor honden

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Niederlande

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Cazitel Plus tabletten voor honden

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Niederlande

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Exitel Plus tabletten voor honden

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Niederlande

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Prazitel Plus tabletten voor honden

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Norwegen

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Exitel Vet

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Norwegen

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Prazitel Vet

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Polen

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Cazitel Plus tabletki dla psów

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Polen

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Exitel Plus tabletki dla psów

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Polen

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Prazitel Plus tabletki dla psów

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Portugal

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Cazitel Plus Comprimidos para cães

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Portugal

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Exitel Plus Comprimidos para cães

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Portugal

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Prazitel Plus Comprimidos para cães

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Rumänien

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Cazitel Plus Comprimate pentru câini

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Rumänien

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Exitel Plus Comprimate pentru câini

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Rumänien

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Prazitel Plus Comprimate pentru câini

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Slowakei

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Cazitel Plus tablety pre psov

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Slowakei

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Exitel Plus tablety pre psov

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Slowakei

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Prazitel Plus tablety pre psov

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Slovenien

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Cazitel Plus tablete za pse

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Slovenien

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Exitel Plus tablete za pse

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Slovenien

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Prazitel Plus tablete za pse

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Spanien

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Cazitel comprimidos para perros

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Spanien

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Exitel comprimidos para perros

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Spanien

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Prazitel comprimidos para perros

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Schweden

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Exitel vet. 150 mg/144 mg/50 mg tablett för hund

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Schweden

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Strantel vet. 150 mg/144 mg/50 mg tablett för hund

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Vereinigtes Königreich

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Cazitel plus tablets for dogs

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Vereinigtes Königreich

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Easimax plus tablets for dogs

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

Vereinigtes Königreich

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| IE-Loughrea |
| Co. Galway |
| Irland |

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irland

Prazitel plus tablets for dogs

Praziquantel 50 mg

Pyrantel 50 mg (als 144 mg pyrantel embonate)

Febantel 150 mg

Tabletten

Hunde

---

ANHANG III

VERZEICHNIS DER BEZEICHNUNGEN, DARREICHUNGSFORM, STÄRKE DES ARZNEIMITTELS, ART DER ANWENDUNG, DER ANTRAGSTELLER IN DEN MITGLIEDSTAATEN

| Mitgliedstaat EU/EWR | Antragsteller | Phantasiebezeichnung | Stärke | Darreichungsform | Art der Anwendung |
| --- | --- | --- | --- | --- | --- |
| AT - Österreich | Napp Pharmaceuticals Limited |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Mitgliedstaat EU/EWR

Antragsteller

Phantasiebezeichnung

Stärke

Darreichungsform

Art der Anwendung

AT - Österreich

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Flutiform®

Flutiform 50 Mikrogramm/5 Mikrogramm pro Sprühstoß Druckgasinhalation

50 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

AT - Österreich

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Flutiform®

Flutiform 125 Mikrogramm/5 Mikrogramm pro Sprühstoß Druckgasinhalation

125 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

AT - Österreich

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Flutiform®

Flutiform 250 Mikrogramm/10 Mikrogramm pro Sprühstoß Druckgasinhalation

250 mcg/10 mcg

Druckgasinhalation, Suspension

Zur Inhalation

BE - Belgien

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Flutiform®

Flutiform 50 mcg/5 mcg, aërosol, suspensie

50 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

BE - Belgien

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Flutiform®

Flutiform 125 mcg/5 mcg, aërosol, suspensie

125 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

BE - Belgien

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Flutiform®

Flutiform 250 mcg/10 mcg, aërosol, suspensie

250 mcg/10 mcg

Druckgasinhalation, Suspension

Zur Inhalation

BG - Bulgarien

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Flutiform®

50 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

BG - Bulgarien

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Flutiform®

125 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

BG - Bulgarien

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Flutiform®

250 mcg/10 mcg

Druckgasinhalation, Suspension

Zur Inhalation

CY - Zypern

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Flutiform®

50 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

CY - Zypern

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Flutiform®

125 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

CY - Zypern

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Flutiform®

250 mcg/10 mcg

Druckgasinhalation, Suspension

Zur Inhalation

CZ - Tschechische Republik

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Flutiform®

50 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

CZ - Tschechische Republik

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Flutiform®

125 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

CZ - Tschechische Republik

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Flutiform®

250 mcg/10 mcg

Druckgasinhalation, Suspension

Zur Inhalation

DK - Dänemark

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Flutiform®

50 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

DK - Dänemark

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Flutiform®

125 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

DK - Dänemark

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Flutiform®

250 mcg/10 mcg

Druckgasinhalation, Suspension

Zur Inhalation

FI - Finnland

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Flutiform®

50 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

FI - Finnland

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Flutiform®

125 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

FI - Finnland

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Flutiform®

250 mcg/10 mcg

Druckgasinhalation, Suspension

Zur Inhalation

FR - Frankreich

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Flutiform®

50 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

FR - Frankreich

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Flutiform®

125 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

FR - Frankreich

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Flutiform®

250 mcg/10 mcg

Druckgasinhalation, Suspension

Zur Inhalation

DE - Deutschland

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Flutiform®

50 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

DE - Deutschland

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Flutiform®

125 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

DE - Deutschland

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Flutiform®

250 mcg/10 mcg

Druckgasinhalation, Suspension

Zur Inhalation

IS - Island

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Flutiform®

50 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

IS - Island

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Flutiform®

125 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

IS - Island

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Flutiform®

250 mcg/10 mcg

Druckgasinhalation, Suspension

Zur Inhalation

IE - Irland

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Flutiform®

50 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

IE - Irland

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Flutiform®

125 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

IE - Irland

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Flutiform®

250 mcg/10 mcg

Druckgasinhalation, Suspension

Zur Inhalation

IT - Italien

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Flutiformo®

50 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

IT - Italien

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Flutiformo®

125 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

IT - Italien

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Flutiformo®

250 mcg/10 mcg

Druckgasinhalation, Suspension

Zur Inhalation

LU - Luxemburg

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Flutiform®

50 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

LU - Luxemburg

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Flutiform®

125 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

LU - Luxemburg

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Flutiform®

250 mcg/10 mcg

Druckgasinhalation, Suspension

Zur Inhalation

NL - Niederlande

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Flutiform®

Flutiform 50 microgram/5 microgram/dosis aërosol, suspensie

50 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

NL - Niederlande

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Flutiform®

Flutiform 125 microgram/5 microgram/dosis aërosol, suspensie

125 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

NL - Niederlande

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Flutiform®

Flutiform 250 microgram/10 microgram/dosis aërosol, suspensie

250 mcg/10 mcg

Druckgasinhalation, Suspension

Zur Inhalation

NO - Norwegen

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Flutiform®

50 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

NO - Norwegen

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Flutiform®

125 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

NO - Norwegen

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Flutiform®

250 mcg/10 mcg

Druckgasinhalation, Suspension

Zur Inhalation

PL - Polen

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Flutiform®

50 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

PL - Polen

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Flutiform®

125 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

PL - Polen

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Flutiform®

250 mcg/10 mcg

Druckgasinhalation, Suspension

Zur Inhalation

PT - Portugal

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Flutiform

50 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

PT - Portugal

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Flutiform

125 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

PT - Portugal

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Flutiform

250 mcg/10 mcg

Druckgasinhalation, Suspension

Zur Inhalation

RO - Rumänien

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Flutiform®

Flutiform 50 micrograme/5 micrograme suspensie de inhalat presurizată

50 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

RO - Rumänien

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Flutiform®

Flutiform 125 micrograme/5 micrograme suspensie de inhalat presurizată

125 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

RO - Rumänien

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Flutiform®

Flutiform 250 micrograme/10 micrograme suspensie de inhalat presurizată

250 mcg/10 mcg

Druckgasinhalation, Suspension

Zur Inhalation

SK - Slowakei

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Flutiform® 50/5 μg

50 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

SK - Slowakei

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Flutiform® 125/5 μg

125 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

SK - Slowakei

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Flutiform® 250/10 μg

250 mcg/10 mcg

Druckgasinhalation, Suspension

Zur Inhalation

SE - Schweden

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Flutiform®

50 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

SE - Schweden

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Flutiform®

125 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

SE - Schweden

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Flutiform®

250 mcg/10 mcg

Druckgasinhalation, Suspension

Zur Inhalation

UK - Vereinigtes Königreich

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Flofera®

50 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

UK - Vereinigtes Königreich

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Flofera®

125 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

UK - Vereinigtes Königreich

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Flofera®

250 mcg/10 mcg

Druckgasinhalation, Suspension

Zur Inhalation

---

ANHANG IV

VERZEICHNIS DER BEZEICHNUNGEN, DARREICHUNGSFORM, STÄRKE DES ARZNEIMITTELS, ART DER ANWENDUNG, DER ANTRAGSTELLER IN DEN MITGLIEDSTAATEN

| Mitgliedstaat EU/EWR | Antragsteller | Phantasiebezeichnung | Stärke | Darreichungsform | Art der Anwendung |
| --- | --- | --- | --- | --- | --- |
| AT - Österreich | Napp Pharmaceuticals Limited |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Mitgliedstaat EU/EWR

Antragsteller

Phantasiebezeichnung

Stärke

Darreichungsform

Art der Anwendung

AT - Österreich

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Iffeza 50 Mikrogramm/5 Mikrogramm pro Sprühstoß Druckgasinhalation

50 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

AT - Österreich

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Iffeza 125 Mikrogramm/5 Mikrogramm pro Sprühstoß Druckgasinhalation

125 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

AT - Österreich

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Iffeza 250 Mikrogramm/10 Mikrogramm pro Sprühstoß Druckgasinhalation

250 mcg/10 mcg

Druckgasinhalation, Suspension

Zur Inhalation

BE - Belgien

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Iffeza 50 mcg/5 mcg, aërosol, suspensie

50 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

BE - Belgien

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Iffeza 125 mcg/5 mcg, aërosol, suspensie

125 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

BE - Belgien

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Iffeza 250 mcg/10 mcg, aërosol, suspensie

250 mcg/10 mcg

Druckgasinhalation, Suspension

Zur Inhalation

BG - Bulgarien

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Iffeza

50 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

BG - Bulgarien

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Iffeza

125 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

BG - Bulgarien

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Iffeza

250 mcg/10 mcg

Druckgasinhalation, Suspension

Zur Inhalation

CY - Zypern

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Iffeza

50 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

CY - Zypern

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Iffeza

125 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

CY - Zypern

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Iffeza

250 mcg/10 mcg

Druckgasinhalation, Suspension

Zur Inhalation

CZ - Tschechische Republik

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Iffeza

50 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

CZ - Tschechische Republik

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Iffeza

125 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

CZ - Tschechische Republik

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Iffeza

250 mcg/10 mcg

Druckgasinhalation, Suspension

Zur Inhalation

DK - Dänemark

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Iffeza

50 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

DK - Dänemark

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Iffeza

125 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

DK - Dänemark

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Iffeza

250 mcg/10 mcg

Druckgasinhalation, Suspension

Zur Inhalation

FI - Finnland

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Iffeza

50 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

FI - Finnland

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Iffeza

125 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

FI - Finnland

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Iffeza

250 mcg/10 mcg

Druckgasinhalation, Suspension

Zur Inhalation

FR - Frankreich

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Iffeza

50 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

FR - Frankreich

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Iffeza

125 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

FR - Frankreich

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Iffeza

250 mcg/10 mcg

Druckgasinhalation, Suspension

Zur Inhalation

DE - Deutschland

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Iffeza

50 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

DE - Deutschland

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Iffeza

125 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

DE - Deutschland

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Iffeza

250 mcg/10 mcg

Druckgasinhalation, Suspension

Zur Inhalation

IS - Island

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Iffeza®

50 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

IS - Island

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Iffeza®

125 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

IS - Island

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Iffeza®

250 mcg/10 mcg

Druckgasinhalation, Suspension

Zur Inhalation

IE - Irland

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Iffeza

50 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

IE - Irland

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Iffeza

125 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

IE - Irland

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Iffeza

250 mcg/10 mcg

Druckgasinhalation, Suspension

Zur Inhalation

IT - Italien

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Iffeza

50 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

IT - Italien

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Iffeza

125 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

IT - Italien

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Iffeza

250 mcg/10 mcg

Druckgasinhalation, Suspension

Zur Inhalation

LU - Luxemburg

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Iffeza

50 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

LU - Luxemburg

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Iffeza

125 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

LU - Luxemburg

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Iffeza

250 mcg/10 mcg

Druckgasinhalation, Suspension

Zur Inhalation

NL - Niederlande

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Iffeza 50 microgram/5 microgram/dosis aërosol, suspensie

50 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

NL - Niederlande

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Iffeza 125 microgram/5 microgram/dosis aërosol, suspensie

125 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

NL - Niederlande

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Iffeza 250 microgram/10 microgram/dosis aërosol, suspensie

250 mcg/10 mcg

Druckgasinhalation, Suspension

Zur Inhalation

NO - Norwegen

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Iffera®

50 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

NO - Norwegen

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Iffera®

125 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

NO - Norwegen

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Iffera®

250 mcg/10 mcg

Druckgasinhalation, Suspension

Zur Inhalation

PL - Polen

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Iffeza

50 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

PL - Polen

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Iffeza

125 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

PL - Polen

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Iffeza

250 mcg/10 mcg

Druckgasinhalation, Suspension

Zur Inhalation

PT - Portugal

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Iffeza

50 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

PT - Portugal

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Iffeza

125 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

PT - Portugal

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Iffeza

250 mcg/10 mcg

Druckgasinhalation, Suspension

Zur Inhalation

RO - Rumänien

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Iffeza 50 micrograme/5 micrograme suspensie de inhalat presurizată

50 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

RO - Rumänien

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Iffeza 125 micrograme/5 micrograme suspensie de inhalat presurizată

125 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

RO - Rumänien

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Iffeza 250 micrograme/10 micrograme suspensie de inhalat presurizată

250 mcg/10 mcg

Druckgasinhalation, Suspension

Zur Inhalation

SK - Slowakei

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Iffeza 50/5 μg

50 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

SK - Slowakei

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Iffeza 125/5 μg

125 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

SK - Slowakei

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Iffeza 250/10 μg

250 mcg/10 mcg

Druckgasinhalation, Suspension

Zur Inhalation

SE - Schweden

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Iffeza

50 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

SE - Schweden

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Iffeza

125 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

SE - Schweden

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Iffeza

250 mcg/10 mcg

Druckgasinhalation, Suspension

Zur Inhalation

UK - Vereinigtes Königreich

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Iffeza

50 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

UK - Vereinigtes Königreich

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Iffeza

125 mcg/5 mcg

Druckgasinhalation, Suspension

Zur Inhalation

UK - Vereinigtes Königreich

| Napp Pharmaceuticals Limited |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Iffeza

250 mcg/10 mcg

Druckgasinhalation, Suspension

Zur Inhalation

---