# Jornal Oficial C 224/2012

| | ISSN 1977-1010
  doi:10.3000/19771010.C_2012.224.por |
| --- | --- |
| Jornal Oficial
  da União Europeia | C 224 |
| | |
| Edição em língua portuguesa | Comunicações e Informações | 55.o ano27 de Julho de 2012 |

ISSN 1977-1010

doi:10.3000/19771010.C_2012.224.por

Jornal Oficial

da União Europeia

C 224

Edição em língua portuguesa

Comunicações e Informações

55.o ano27 de Julho de 2012

---

| Número de informação | Índice | Página |
| --- | --- | --- |
| | IV   Informações |
| | INFORMAÇÕES DAS INSTITUIÇÕES, ÓRGÃOS E ORGANISMOS DA UNIÃO EUROPEIA |
| 2012/C 224/01 | Resumo das decisões da União Europeia relativas às autorizações de introdução no mercado dos medicamentos de 1 de junho de 2012 para 30 de junho de 2012[Publicado nos termos do artigo 13.o ou do artigo 38.o do Regulamento (CE) n.o 726/2004 do Parlamento Europeu e do Conselho] | 1 |
| 2012/C 224/02 | Resumo das decisões da União Europeia relativas às autorizações de introdução no mercado dos medicamentos de 1 de junho de 2012 para 30 de junho de 2012(Decisões adoptadas nos termos do artigo 34.o da Directiva 2001/83/CE ou do artigo 38.o da Directiva 2001/82/CE) | 16 |

Número de informação

Índice

Página

IV   Informações

INFORMAÇÕES DAS INSTITUIÇÕES, ÓRGÃOS E ORGANISMOS DA UNIÃO EUROPEIA

2012/C 224/01

Resumo das decisões da União Europeia relativas às autorizações de introdução no mercado dos medicamentos de 1 de junho de 2012 para 30 de junho de 2012[Publicado nos termos do artigo 13.o ou do artigo 38.o do Regulamento (CE) n.o 726/2004 do Parlamento Europeu e do Conselho]

[Publicado nos termos do artigo 13.o

o

o

1

2012/C 224/02

Resumo das decisões da União Europeia relativas às autorizações de introdução no mercado dos medicamentos de 1 de junho de 2012 para 30 de junho de 2012(Decisões adoptadas nos termos do artigo 34.o da Directiva 2001/83/CE ou do artigo 38.o da Directiva 2001/82/CE)

(Decisões adoptadas nos termos do artigo 34.o

o

16

| PT | |
| --- | --- |

PT

---

IV Informações

INFORMAÇÕES DAS INSTITUIÇÕES, ÓRGÃOS E ORGANISMOS DA UNIÃO EUROPEIA

| 27.7.2012 | PT | Jornal Oficial da União Europeia | C 224/1 |
| --- | --- | --- | --- |

27.7.2012

PT

Jornal Oficial da União Europeia

C 224/1

---

Resumo das decisões da União Europeia relativas às autorizações de introdução no mercado dos medicamentos de 1 de junho de 2012 para 30 de junho de 2012

[Publicado nos termos do artigo 13.o ou do artigo 38.o do Regulamento (CE) n.o 726/2004 do Parlamento Europeu e do Conselho
   (1)
  ]

2012/C 224/01

—   Concessão de uma autorização de introdução no mercado (Artigo 13 do Regulamento (CE) n.o 726/2004 do Parlamento Europeu e do Conselho): Autorizado

| Data da decisão | Nome do medicamento | DCI (Denominação Comum Internacional) | Titular da autorização de introdução no mercado | Número de inscrição no Registo Comunitário | Forma farmacêutica | Código ATC (código anatómico-terapêutico-químico) | Data de notificação |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 15.06.2012 | Rienso | Ferromoxitol | Takeda Global Research and Development Centre (Europe) Ltd |
| 61 Aldwych, |
| London WC2B 4AE, |
| United Kingdom |

Data da decisão

Nome do medicamento

DCI (Denominação Comum Internacional)

Titular da autorização de introdução no mercado

Número de inscrição no Registo Comunitário

Forma farmacêutica

Código ATC (código anatómico-terapêutico-químico)

Data de notificação

15.06.2012

Rienso

Ferromoxitol

Takeda Global Research and Development Centre (Europe) Ltd

61 Aldwych,

London WC2B 4AE,

United Kingdom

EU/1/12/774/001-002

Solução injectável

Pending

20.06.2012

—   Concessão de uma autorização de introdução no mercado (Artigo 13 do Regulamento (CE) n.o 726/2004 do Parlamento Europeu e do Conselho): Recusado

| Data da decisão | Nome do medicamento | Titular da autorização de introdução no mercado | Número de inscrição no Registo Comunitário | Data de notificação |
| --- | --- | --- | --- | --- |
| 21.06.2012 | Folotyn | Allos Therapeutics Limited |
| 71 Knowl Piece, |
| Wilbury Way, |
| Hitchin, Hertfordshire SG4 0TY, |
| United Kingdom |

Data da decisão

Nome do medicamento

Titular da autorização de introdução no mercado

Número de inscrição no Registo Comunitário

Data de notificação

21.06.2012

Folotyn

Allos Therapeutics Limited

71 Knowl Piece,

Wilbury Way,

Hitchin, Hertfordshire SG4 0TY,

United Kingdom

—

25.06.2012

—   Alteração de uma autorização de introdução no mercado [Artigo 13 do Regulamento (CE) n.o 726/2004 do Parlamento Europeu e do Conselho]: Autorizado

| Data da decisão | Nome do medicamento | Titular da autorização de introdução no mercado | Número de inscrição no Registo Comunitário | Data de notificação |
| --- | --- | --- | --- | --- |
| 01.06.2012 | Osigraft | Olympus Biotech International Limited |
| Raheen Business Park, |
| Limerick, |
| Ireland |

Data da decisão

Nome do medicamento

Titular da autorização de introdução no mercado

Número de inscrição no Registo Comunitário

Data de notificação

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

—   Retirada de uma autorização de introdução no mercado (Artigo 13 do Regulamento (CE) n.o 726/2004 do Parlamento Europeu e do Conselho)

| Data da decisão | Nome do medicamento | Titular da autorização de introdução no mercado | Número de inscrição no Registo Comunitário | Data de notificação |
| --- | --- | --- | --- | --- |
| 28.06.2012 | Hexavac | Aventis Pasteur MSD |
| 8, rue Jonas Salk, |
| 69007 Lyon, |
| France |

Data da decisão

Nome do medicamento

Titular da autorização de introdução no mercado

Número de inscrição no Registo Comunitário

Data de notificação

28.06.2012

Hexavac

Aventis Pasteur MSD

8, rue Jonas Salk,

69007 Lyon,

France

EU/1/00/147/001-012

04.07.2012

—   Concessão de uma autorização de introdução no mercado (Artigo 38 do Regulamento (CE) n.o 726/2004 do Parlamento Europeu e do Conselho
   (2)
  ): Autorizado

| Data da decisão | Nome do medicamento | DCI (Denominação Comum Internacional) | Titular da autorização de introdução no mercado | Número de inscrição no Registo Comunitário | Forma farmacêutica | Código ATC (código anatómico-terapêutico-químico) | Data de notificação |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 14.06.2012 | Porcilis ColiClos | — | Intervet International B.V. |
| Wim de Körverstraat 35, |
| 5831 AN Boxmeer, |
| Nederland |

Data da decisão

Nome do medicamento

DCI (Denominação Comum Internacional)

Titular da autorização de introdução no mercado

Número de inscrição no Registo Comunitário

Forma farmacêutica

Código ATC (código anatómico-terapêutico-químico)

Data de notificação

14.06.2012

Porcilis ColiClos

—

Intervet International B.V.

Wim de Körverstraat 35,

5831 AN Boxmeer,

Nederland

EU/2/12/141/001-009

Suspensão injectável

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

Liofilizado para suspensão para administração por spray

QI01AE04

20.06.2012

—   Alteração de uma autorização de introdução no mercado (Artigo 38 do Regulamento (CE) n.o 726/2004 do Parlamento Europeu e do Conselho): Autorizado

| Data da decisão | Nome do medicamento | Titular da autorização de introdução no mercado | Número de inscrição no Registo Comunitário | Data de notificação |
| --- | --- | --- | --- | --- |
| 11.06.2012 | Activyl | Intervet International B.V. |
| Wim de Körverstraat 35, |
| 5831 AN Boxmeer, |
| Nederland |

Data da decisão

Nome do medicamento

Titular da autorização de introdução no mercado

Número de inscrição no Registo Comunitário

Data de notificação

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

Os interessados podem solicitar o acesso ao relatório público dos medicamentos em questão e das decisões correspondentes junto de:

| 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)  JO L 136 de 30.4.04, p. 1.

(2)  JO L 136 de 30.4.04, p. 1.

---

| 27.7.2012 | PT | Jornal Oficial da União Europeia | C 224/16 |
| --- | --- | --- | --- |

27.7.2012

PT

Jornal Oficial da União Europeia

C 224/16

---

Resumo das decisões da União Europeia relativas às autorizações de introdução no mercado dos medicamentos de 1 de junho de 2012 para 30 de junho de 2012

(Decisões adoptadas nos termos do artigo 34.o da Directiva 2001/83/CE
   (1)
  ou do artigo 38.o da Directiva 2001/82/CE
   (2)
  )

2012/C 224/02

—   Concessão, manutenção ou alteração de uma autorização nacional de introdução no mercado

| Data da decisão | Nome(s) do medicamento | Titular(es) da autorização de introdução no mercado | Estado-Membro considerado | Data de notificação |
| --- | --- | --- | --- | --- |
| 14/6/2012 | Tilmicosin | Ver anexo I | Ver anexo I | 18/6/2012 |
| 18/6/2012 | Milaxyn plus and associated names | Ver anexo II | Ver anexo II | 20/6/2012 |
| 28/6/2012 | Flutiform and associated names | Ver anexo III | Ver anexo III | 3/7/2012 |
| 28/6/2012 | Iffeza and associated names | Ver anexo IV | Ver anexo IV | 3/7/2012 |

Data da decisão

Nome(s) do medicamento

Titular(es) da autorização de introdução no mercado

Estado-Membro considerado

Data de notificação

14/6/2012

Tilmicosin

Ver anexo I

Ver anexo I

18/6/2012

18/6/2012

Milaxyn plus and associated names

Ver anexo II

Ver anexo II

20/6/2012

28/6/2012

Flutiform and associated names

Ver anexo III

Ver anexo III

3/7/2012

28/6/2012

Iffeza and associated names

Ver anexo IV

Ver anexo IV

3/7/2012

---

(1)  JO L 311 de 28.11.01, p. 67.

(2)  JO L 311 de 28.11.01, p. 1.

---

ANEXO I

LISTA DOS NOMES, FORMAS FARMACÊUTICAS, SUBSTÂNCIA ATIVA, DOSAGENS DOS MEDICAMENTOS VETERINÁRIOS, ESPÉCIES-ALVO E TITULARES DAS AUTORIZAÇÕES DE INTRODUÇÃO NO MERCADO NOS ESTADOS-MEMBROS

| Estado-Membro UE/EEE | Titular da Autorização de Introdução no Mercado | Nome | DCI | Dosagem | Forma farmacêutica | Espécies-alvo |
| --- | --- | --- | --- | --- | --- | --- |
| Áustria | Richter Pharma AG |
| Feldgasse 19 |
| A-4600 Wels |
| ÁUSTRIA |

Estado-Membro UE/EEE

Titular da Autorização de Introdução no Mercado

Nome

DCI

Dosagem

Forma farmacêutica

Espécies-alvo

Áustria

Richter Pharma AG

Feldgasse 19

A-4600 Wels

ÁUSTRIA

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

Tilmicosin (as phosphate)

100 g de tilmicosina por kg de pré-mistura

Pré-mistura para alimento medicamentoso

Suínos, coelhos

Áustria

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

Richter Pharma AG

Feldgasse 19

A-4600 Wels

ÁUSTRIA

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

Tilmicosin (as phosphate)

200 g de tilmicosina por kg de pré-mistura

Pré-mistura para alimento medicamentoso

Suínos, coelhos

Bélgica

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

Eli Lilly Benelux N.V.

Elanco Animal Health

Rue de l'Etuve 52

Stoofstraat 52

1000 Brussel

BÉLGICA

Pulmotil 40 VET Pre-mix

Tilmicosin (as phosphate)

40 g de tilmicosina por kg de pré-mistura

Pré-mistura para alimento medicamentoso

Suínos, coelhos

Bélgica

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

Eli Lilly Benelux N.V.

Elanco Animal Health

Rue de l'Etuve 52

Stoofstraat 52

1000 Brussel

BÉLGICA

Pulmotil 100 VET Pre-mix

Tilmicosin (as phosphate)

100 g de tilmicosina por kg de pré-mistura

Pré-mistura para alimento medicamentoso

Suínos, coelhos

Bélgica

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

Eli Lilly Benelux N.V.

Elanco Animal Health

Rue de l'Etuve 52

Stoofstraat 52

1000 Brussel

BÉLGICA

Pulmotil 100 Granules

Tilmicosin (as phosphate)

100 g de tilmicosina por kg de pré-mistura

Pré-mistura para alimento medicamentoso

Suínos, coelhos

Bélgica

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

Eli Lilly Benelux N.V.

Elanco Animal Health

Rue de l'Etuve 52

Stoofstraat 52

1000 Brussel

BÉLGICA

Pulmotil 200 VET Pre-mix

Tilmicosin (as phosphate)

200 g de tilmicosina por kg de pré-mistura

Pré-mistura para alimento medicamentoso

Suínos, coelhos

Chipre

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

Eli Lilly Regional Operations GmbH

Elanco Animal Health

Kolblgasse 8-10

1030 Wien

ÁUSTRIA

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

Tilmicosin (as phosphate)

200 g de tilmicosina por kg de pré-mistura

Pré-mistura para alimento medicamentoso

Suínos, coelhos

República Checa

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

Eli Lilly Regional Operations GmbH

Elanco Animal Health

Kolblgasse 8-10

1030 Wien

ÁUSTRIA

Pulmotil 200 mg/g pre-mix pro medikaci krmiva

Tilmicosin (as phosphate)

200 g de tilmicosina por kg de pré-mistura

Pré-mistura para alimento medicamentoso

Suínos, coelhos

Alemanha

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

Lilly Deutschland GmbH

Abt. Elanco Animal Health

Werner-Reimers-Str. 2-4

D-61352 Bad Homburg

ALEMANHA

Pulmotil G 40

Tilmicosin (as phosphate)

40 g de tilmicosina por kg de pré-mistura

Pré-mistura para alimento medicamentoso

Suínos, coelhos

Alemanha

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

Lilly Deutschland GmbH

Abt. Elanco Animal Health

Werner-Reimers-Str. 2-4

D-61352 Bad Homburg

ALEMANHA

Pulmotil G 100

Tilmicosin (as phosphate)

100 g de tilmicosina por kg de pré-mistura

Pré-mistura para alimento medicamentoso

Suínos, coelhos

Alemanha

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

Lilly Deutschland GmbH

Abt. Elanco Animal Health

Werner-Reimers-Str. 2-4

D-61352 Bad Homburg

ALEMANHA

Pulmotil G 20 % AMV

Tilmicosin (as phosphate)

200 g de tilmicosina por kg de pré-mistura

Pré-mistura para alimento medicamentoso

Suínos, coelhos

Dinamarca

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

Elanco Animal Health

Eli Lilly Danmark A/S

Nybrovej 110

DK-2800 Kongens Lyngby

DINAMARCA

Pulmotil Vet.

Tilmicosin (as phosphate)

40 g de tilmicosina por kg de pré-mistura

Pré-mistura para alimento medicamentoso

Suínos, coelhos

Dinamarca

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

Elanco Animal Health

Eli Lilly Danmark A/S

Nybrovej 110

DK-2800 Kongens Lyngby

DINAMARCA

Pulmotil Vet.

Tilmicosin (as phosphate)

100 g de tilmicosina por kg de pré-mistura

Pré-mistura para alimento medicamentoso

Suínos, coelhos

Dinamarca

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

Elanco Animal Health

Eli Lilly Danmark A/S

Nybrovej 110

DK-2800 Kongens Lyngby

DINAMARCA

Pulmotil Vet.

Tilmicosin (as phosphate)

200 g de tilmicosina por kg de pré-mistura

Pré-mistura para alimento medicamentoso

Suínos, coelhos

Grécia

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

Eli Lilly Regional Operations GmbH

Elanco Animal Health

Kolblgasse 8-10

1030 Wien

ÁUSTRIA

PULMOTIL 200

Tilmicosin (as phosphate)

200 g de tilmicosina por kg de pré-mistura

Pré-mistura para alimento medicamentoso

Suínos, coelhos

Espanha

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

ELANCO VALQUÍMICA, S.A.

Avda. de la Industria 30

28108 Alcobendas

Madrid

ESPANHA

PULMOTIL G 40

Tilmicosin (as phosphate)

40 g de tilmicosina por kg de pré-mistura

Pré-mistura para alimento medicamentoso

Suínos, coelhos

Espanha

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

ELANCO VALQUÍMICA, S.A.

Avda. de la Industria 30

28108 Alcobendas

Madrid

ESPANHA

PULMOTIL G 100

Tilmicosin (as phosphate)

100 g de tilmicosina por kg de pré-mistura

Pré-mistura para alimento medicamentoso

Suínos, coelhos

Espanha

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

ELANCO VALQUÍMICA, S.A.

Avda. de la Industria 30

28108 Alcobendas

Madrid

ESPANHA

PULMOTIL G 200

Tilmicosin (as phosphate)

200 g de tilmicosina por kg de pré-mistura

Pré-mistura para alimento medicamentoso

Suínos, coelhos

França

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

LILLY France

13 Rue Pages

92158 Suresnes

Cedex

FRANÇA

PULMOTIL TILMICOSINE 40 PORC-LAPIN

Tilmicosin (as phosphate)

40 g de tilmicosina por kg de pré-mistura

Pré-mistura para alimento medicamentoso

Suínos, coelhos

França

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

QALIAN

34 Rue Jean Monnet

Zi D'Etriche

49500 Serge

FRANÇA

SANTAMIX TILMICOSINE 40 PORCINS - LAPINS

Tilmicosin (as phosphate)

40 g de tilmicosina por kg de pré-mistura

Pré-mistura para alimento medicamentoso

Suínos, coelhos

França

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

SOGEVAL

200 Route de Mayenne

Zi des Touches

53000 Laval

FRANÇA

CONCENTRAT VO 08 TILMICOSINE PORCIN-LAPIN

Tilmicosin (as phosphate)

40 g de tilmicosina por kg de pré-mistura

Pré-mistura para alimento medicamentoso

Suínos, coelhos

Hungria

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

Eli Lilly Regional Operations GmbH

Elanco Animal Health

Kolblgasse 8-10

1030 Wien

ÁUSTRIA

Pulmotil G 200 gyógypre-mix

Tilmicosin (as phosphate)

200 g de tilmicosina por kg de pré-mistura

Pré-mistura para alimento medicamentoso

Suínos, coelhos

Irlanda

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

Eli Lilly and Company Ltd

Elanco Animal Health

Lilly House

Priestly Road

Basingstoke

Hampshire RG24 9NL

REINO UNIDO

Pulmotil G40 Pre-mix for medicated feedingstuff

Tilmicosin (as phosphate)

40 g de tilmicosina por kg de pré-mistura

Pré-mistura para alimento medicamentoso

Suínos, coelhos

Irlanda

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

Eli Lilly and Company Ltd

Elanco Animal Health

Lilly House

Priestly Road

Basingstoke

Hampshire RG24 9NL

REINO UNIDO

Pulmotil G100 Pre-mix for medicated feedingstuff

Tilmicosin (as phosphate)

100 g de tilmicosina por kg de pré-mistura

Pré-mistura para alimento medicamentoso

Suínos, coelhos

Irlanda

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

Eli Lilly and Company Ltd

Elanco Animal Health

Lilly House

Priestly Road

Basingstoke

Hampshire RG24 9NL

REINO UNIDO

Pulmotil G200 Pre-mix for medicated feedingstuff

Tilmicosin (as phosphate)

200 g de tilmicosina por kg de pré-mistura

Pré-mistura para alimento medicamentoso

Suínos, coelhos

Itália

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

ELI LILLY ITALIA SPA

VIA GRAMSCI

731/733 - SESTO FIORENTINO – FI

ITÁLIA

PULMOTIL G 200 PRE-MIX

Tilmicosin (as phosphate)

200 g de tilmicosina por kg de pré-mistura

Pré-mistura para alimento medicamentoso

Suínos, coelhos

Itália

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

CEVA VETEM SpA

via Colleoni

15 20041 Agrate Brianza (MB)

ITÁLIA

MICLOZAN 200 PRE-MIX

Tilmicosin (as phosphate)

200 g de tilmicosina por kg de pré-mistura

Pré-mistura para alimento medicamentoso

Suínos, coelhos

Países Baixos

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

Eli Lilly Nederland B.V.

Elanco Animal Health

Grootslag 1-5

3991 RA Houten

PAÍSES BAIXOS

PULMOTIL® G40 pre-mix voor gemedicineerd voer voor varkens

Tilmicosin (as phosphate)

40 g de tilmicosina por kg de pré-mistura

Pré-mistura para alimento medicamentoso

Suínos, coelhos

Países Baixos

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

Eli Lilly Nederland B.V.

Elanco Animal Health

Grootslag 1-5

3991 RA Houten

PAÍSES BAIXOS

PULMOTIL® G100 pre-mix voor gemedicineerd voer voor varkens

Tilmicosin (as phosphate)

100 g de tilmicosina por kg de pré-mistura

Pré-mistura para alimento medicamentoso

Suínos, coelhos

Países Baixos

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

Eli Lilly Nederland B.V

Elanco Animal Health

Grootslag 1-5

3991 RA Houten

PAÍSES BAIXOS

PULMOTIL® G200 pre-mix voor gemedicineerd voer voor varkens

Tilmicosin (as phosphate)

200 g de tilmicosina por kg de pré-mistura

Pré-mistura para alimento medicamentoso

Suínos, coelhos

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 de tilmicosina por kg de pré-mistura

Pré-mistura para alimento medicamentoso

Suínos, coelhos

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 de tilmicosina por kg de pré-mistura

Pré-mistura para alimento medicamentoso

Suínos, coelhos

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 de tilmicosina por kg de pré-mistura

Pré-mistura para alimento medicamentoso

Suínos, coelhos

Roménia

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

Eli Lilly Regional Operations GmbH

Elanco Animal Health

Kolblgasse 8-10

1030 Wien

ÁUSTRIA

PULMOTIL 200 g/kg pre-mix

Tilmicosin (as phosphate)

200 g de tilmicosina por kg de pré-mistura

Pré-mistura para alimento medicamentoso

Suínos, coelhos

Eslováquia

| Elli Lilly and Company Limited. |
| --- |
| Speke Operations Fleming RoadSpeke |
| Liverpool |
| L24 9LN |
| REINO UNIDO |

Elli Lilly and Company Limited.

Speke Operations Fleming RoadSpeke

Liverpool

L24 9LN

REINO UNIDO

Pulmotil G 200 pre-mix ad us.vet.

Tilmicosin (as phosphate)

200 g de tilmicosina por kg de pré-mistura

Pré-mistura para alimento medicamentoso

Suínos, coelhos

Reino Unido

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

Eli Lilly and Company Ltd

Elanco Animal Health

Lilly House

Priestly Road

Basingstoke

Hampshire RG24 9NL

REINO UNIDO

Pulmotil G100 Pre-mix for Medicated Feedingstuff

Tilmicosin (as phosphate)

100 g de tilmicosina por kg de pré-mistura

Pré-mistura para alimento medicamentoso

Suínos, coelhos

Reino Unido

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

Eli Lilly and Company Ltd

Elanco Animal Health

Lilly House

Priestly Road

Basingstoke

Hampshire RG24 9NL

REINO UNIDO

Pulmotil G200 Pre-mix for Medicated Feedingstuff

Tilmicosin (as phosphate)

200 g de tilmicosina por kg de pré-mistura

Pré-mistura para alimento medicamentoso

Suínos, coelhos

---

ANEXO II

LISTA DOS NOMES, FORMA FARMACÊUTICA, A FORÇA DOS MEDICAMENTOS VETERINÁRIOS, ESPÉCIES ANIMAIS, A VIA DE ADMINISTRAÇÃO, TITULAR DA AUTORIZAÇÃO DE INTRODUÇÃO NO MERCADO NOS ESTADOS-MEMBROS

| Estado Membro da EU/AEA | Titular da autorização de introdução no mercado | Nome | INN/Dosage | Forma farmacêutica | Espécies animais |
| --- | --- | --- | --- | --- | --- |
| Áustria | Chanelle Pharmaceuticals Manufacturing Ltd. |
| IE-Loughrea |
| Co. Galway |
| Irlanda |

Estado Membro da EU/AEA

Titular da autorização de introdução no mercado

Nome

INN/Dosage

Forma farmacêutica

Espécies animais

Áustria

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

Exitel Plus Tabletten für Hunde

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

Áustria

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

Prazitel Plus Tabletten für Hunde

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

Bélgica

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

Cazitel Plus Tabletten für Hunde

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

Bélgica

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

Exitel Plus Tabletten für Hunde

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

Bélgica

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

Prazitel Plus Tabletten für Hunde

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

Bulgária

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

Cazitel Plus таблетки за кучета

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

Bulgária

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

Exitel Plus таблетки за кучета

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

Bulgária

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

Prazitel Plus таблетки за кучета

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

Chipre

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

Exitel Plus Δισκία Για Σκύλους

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

República Checa

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

Cazitel Plus tablety pro psy

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

República Checa

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

Exitel Plus tablety pro psy

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

República Checa

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

Prazitel Plus tablety pro psy

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

Dinamarca

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

Exitel Plus

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

Dinamarca

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

Prazitel Plus

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

Estônia

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

Cazitel Plus tabletid koertele

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

Estônia

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

Exitel Plus tabletid koertele

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

Finlândia

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

Cazitel Plus 50 mg/144 mg/150 mg tablet

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

Finlândia

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

Exitel Plus 50 mg/144 mg/150 mg tablet

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

Finlândia

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

Prazitel Plus 50 mg/144 mg/150 mg tablet

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

França

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

Milaxyn comprimé pour chiens

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

França

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

Strantel comprimé pour chiens

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

França

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

Prazical comprimé pour chiens

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

França

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

Voxical comprimé pour chiens

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

Alemanha

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

Cazitel Tabletten für Hunde

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

Alemanha

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

Exitel Tabletten für Hunde

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

Alemanha

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

Strantel Tabletten für Hunde

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

Grécia

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

Cazitel plus Δισκία Για Σκύλους

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

Grécia

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

Exitel plus Δισκία Για Σκύλους

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

Grécia

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

Prazitel plus Δισκία Για Σκύλους

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

Hungria

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

Cazitel Plus tabletta kutyák részére A.U.V

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

Hungria

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

Exitel Plus tabletta kutyák részére A.U.V

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

Hungria

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

Prazitel Plus tabletta kutyák részére A.U.V

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

Islândia

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

Exitel Plus töflur fyrir hunda

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

Islândia

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

Prazitel Plus töflur fyrir hunda

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

Irlanda

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

Cazitel Plus tablets for dogs

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

Irlanda

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

Exitel Plus tablets for dogs

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

Irlanda

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

Milaxyn Plus tablets for dogs

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

Irlanda

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

Prazical Plus tablets for dogs

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

Irlanda

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

Prazitel Plus tablets for dogs

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

Irlanda

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

Strantel Plus tablets for dogs

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

Irlanda

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

Voxical Plus tablets for dogs

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

Itália

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

Canitel Plus compresse per cani

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

Itália

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

Exitel Plus compresse per cani

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

Itália

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

Prazitel compresse per cani

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

Letónia

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

Cazitel tablets Tabletes suņiem

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

Letónia

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

Exitel tablets Tabletes suņiem

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

Letónia

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

Prazitel tablets Tabletes suņiem

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

Lituânia

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

Cazitel Plus tabletės šunims

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

Lituânia

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

Exitel Plus tabletės šunims

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

Lituânia

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

Prazitel Plus tabletės šunims

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

Luxemburgo

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

Exitel Plus tabletten voor honden

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

Luxemburgo

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

Prazitel Plus tabletten voor honden

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

Holanda

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

Cazitel Plus tabletten voor honden

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

Holanda

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

Exitel Plus tabletten voor honden

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

Holanda

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

Prazitel Plus tabletten voor honden

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

Noruega

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

Exitel Vet

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

Noruega

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

Prazitel Vet

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

Polônia

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

Cazitel Plus tabletki dla psów

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

Polônia

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

Exitel Plus tabletki dla psów

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

Polônia

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

Prazitel Plus tabletki dla psów

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

Portugal

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

Cazitel Plus Comprimidos para cães

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

Portugal

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

Exitel Plus Comprimidos para cães

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

Portugal

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

Prazitel Plus Comprimidos para cães

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

Romênia

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

Cazitel Plus Comprimate pentru câini

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

Romênia

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

Exitel Plus Comprimate pentru câini

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

Romênia

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

Prazitel Plus Comprimate pentru câini

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

Eslováquia

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

Cazitel Plus tablety pre psov

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

Eslováquia

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

Exitel Plus tablety pre psov

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

Eslováquia

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

Prazitel Plus tablety pre psov

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

Eslovénia

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

Cazitel Plus tablete za pse

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

Eslovénia

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

Exitel Plus tablete za pse

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

Eslovénia

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

Prazitel Plus tablete za pse

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

Espanha

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

Cazitel comprimidos para perros

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

Espanha

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

Exitel comprimidos para perros

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

Espanha

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

Prazitel comprimidos para perros

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

Suécia

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

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

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

Suécia

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

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

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

Reino Unido

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

Cazitel plus tablets for dogs

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

Reino Unido

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

Easimax plus tablets for dogs

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

Reino Unido

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Irlanda

Prazitel plus tablets for dogs

Praziquantel 50 mg

Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)

Febantel 150 mg

Comprimidos

Cães

---

ANEXO III

LISTA DAS DENOMINAÇÕES, FORMA FARMACÊUTICA, DOSAGENS, VIA DE ADMINISTRAÇÃO DO MEDICAMENTO, DOS REQUERENTES NOS ESTADOS-MEMBROS

| Estado-Membro UE/EEE | Requerente | Nome de fantasia | Dosagem | Forma farmacêutica | Via de administração |
| --- | --- | --- | --- | --- | --- |
| AT - Áustria | Napp Pharmaceuticals Limited |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Estado-Membro UE/EEE

Requerente

Nome de fantasia

Dosagem

Forma farmacêutica

Via de administração

AT - Áustria

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

Suspensão pressurizada para inalação

Via inalatoria

AT - Áustria

| 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

Suspensão pressurizada para inalação

Via inalatoria

AT - Áustria

| 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

Suspensão pressurizada para inalação

Via inalatoria

BE - Bélgica

| 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

Suspensão pressurizada para inalação

Via inalatoria

BE - Bélgica

| 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

Suspensão pressurizada para inalação

Via inalatoria

BE - Bélgica

| 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

Suspensão pressurizada para inalação

Via inalatoria

BG - Bulgária

| 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

Suspensão pressurizada para inalação

Via inalatoria

BG - Bulgária

| 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

Suspensão pressurizada para inalação

Via inalatoria

BG - Bulgária

| 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

Suspensão pressurizada para inalação

Via inalatoria

CY - Chipre

| 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

Suspensão pressurizada para inalação

Via inalatoria

CY - Chipre

| 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

Suspensão pressurizada para inalação

Via inalatoria

CY - Chipre

| 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

Suspensão pressurizada para inalação

Via inalatoria

CZ - Républica Checa

| 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

Suspensão pressurizada para inalação

Via inalatoria

CZ - Républica Checa

| 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

Suspensão pressurizada para inalação

Via inalatoria

CZ - Républica Checa

| 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

Suspensão pressurizada para inalação

Via inalatoria

DK - Dinamarca

| 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

Suspensão pressurizada para inalação

Via inalatoria

DK - Dinamarca

| 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

Suspensão pressurizada para inalação

Via inalatoria

DK - Dinamarca

| 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

Suspensão pressurizada para inalação

Via inalatoria

FI - Finlândia

| 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

Suspensão pressurizada para inalação

Via inalatoria

FI - Finlândia

| 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

Suspensão pressurizada para inalação

Via inalatoria

FI - Finlândia

| 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

Suspensão pressurizada para inalação

Via inalatoria

FR - França

| 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

Suspensão pressurizada para inalação

Via inalatoria

FR - França

| 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

Suspensão pressurizada para inalação

Via inalatoria

FR - França

| 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

Suspensão pressurizada para inalação

Via inalatoria

DE - Alemanha

| 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

Suspensão pressurizada para inalação

Via inalatoria

DE - Alemanha

| 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

Suspensão pressurizada para inalação

Via inalatoria

DE - Alemanha

| 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

Suspensão pressurizada para inalação

Via inalatoria

IS - Islândia

| 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

Suspensão pressurizada para inalação

Via inalatoria

IS - Islândia

| 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

Suspensão pressurizada para inalação

Via inalatoria

IS - Islândia

| 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

Suspensão pressurizada para inalação

Via inalatoria

IE - Irlanda

| 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

Suspensão pressurizada para inalação

Via inalatoria

IE - Irlanda

| 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

Suspensão pressurizada para inalação

Via inalatoria

IE - Irlanda

| 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

Suspensão pressurizada para inalação

Via inalatoria

IT - Itália

| 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

Suspensão pressurizada para inalação

Via inalatoria

IT - Itália

| 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

Suspensão pressurizada para inalação

Via inalatoria

IT - Itália

| 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

Suspensão pressurizada para inalação

Via inalatoria

LU - Luxemburgo

| 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

Suspensão pressurizada para inalação

Via inalatoria

LU - Luxemburgo

| 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

Suspensão pressurizada para inalação

Via inalatoria

LU - Luxemburgo

| 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

Suspensão pressurizada para inalação

Via inalatoria

NL - Países Baixos

| 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

Suspensão pressurizada para inalação

Via inalatoria

NL - Países Baixos

| 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

Suspensão pressurizada para inalação

Via inalatoria

NL - Países Baixos

| 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

Suspensão pressurizada para inalação

Via inalatoria

NO - Noruega

| 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

Suspensão pressurizada para inalação

Via inalatoria

NO - Noruega

| 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

Suspensão pressurizada para inalação

Via inalatoria

NO - Noruega

| 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

Suspensão pressurizada para inalação

Via inalatoria

PL - Polónia

| 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

Suspensão pressurizada para inalação

Via inalatoria

PL - Polónia

| 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

Suspensão pressurizada para inalação

Via inalatoria

PL - Polónia

| 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

Suspensão pressurizada para inalação

Via inalatoria

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

Suspensão pressurizada para inalação

Via inalatoria

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

Suspensão pressurizada para inalação

Via inalatoria

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

Suspensão pressurizada para inalação

Via inalatoria

RO - Roménia

| 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

Suspensão pressurizada para inalação

Via inalatoria

RO - Roménia

| 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

Suspensão pressurizada para inalação

Via inalatoria

RO - Roménia

| 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

Suspensão pressurizada para inalação

Via inalatoria

SK - Eslováquia

| 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

Suspensão pressurizada para inalação

Via inalatoria

SK - Eslováquia

| 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

Suspensão pressurizada para inalação

Via inalatoria

SK - Eslováquia

| 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

Suspensão pressurizada para inalação

Via inalatoria

SE - Suécia

| 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

Suspensão pressurizada para inalação

Via inalatoria

SE - Suécia

| 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

Suspensão pressurizada para inalação

Via inalatoria

SE - Suécia

| 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

Suspensão pressurizada para inalação

Via inalatoria

UK - Reino Unido

| 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

Suspensão pressurizada para inalação

Via inalatoria

UK - Reino Unido

| 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

Suspensão pressurizada para inalação

Via inalatoria

UK - Reino Unido

| 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

Suspensão pressurizada para inalação

Via inalatoria

---

ANEXO IV

LISTA DAS DENOMINAÇÕES, FORMA FARMACÊUTICA, DOSAGENS, VIA DE ADMINISTRAÇÃO DO MEDICAMENTO, DOS REQUERENTES NOS ESTADOS-MEMBROS

| Estado-Membro UE/EEE | Requerente | Nome de fantasia | Dosagem | Forma farmacêutica | Via de administração |
| --- | --- | --- | --- | --- | --- |
| AT - Áustria | Napp Pharmaceuticals Limited |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Estado-Membro UE/EEE

Requerente

Nome de fantasia

Dosagem

Forma farmacêutica

Via de administração

AT - Áustria

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

Suspensão pressurizada para inalação

Via inalatoria

AT - Áustria

| 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

Suspensão pressurizada para inalação

Via inalatoria

AT - Áustria

| 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

Suspensão pressurizada para inalação

Via inalatoria

BE - Bélgica

| 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

Suspensão pressurizada para inalação

Via inalatoria

BE - Bélgica

| 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

Suspensão pressurizada para inalação

Via inalatoria

BE - Bélgica

| 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

Suspensão pressurizada para inalação

Via inalatoria

BG - Bulgária

| 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

Suspensão pressurizada para inalação

Via inalatoria

BG - Bulgária

| 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

Suspensão pressurizada para inalação

Via inalatoria

BG - Bulgária

| 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

Suspensão pressurizada para inalação

Via inalatoria

CY - Chipre

| 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

Suspensão pressurizada para inalação

Via inalatoria

CY - Chipre

| 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

Suspensão pressurizada para inalação

Via inalatoria

CY - Chipre

| 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

Suspensão pressurizada para inalação

Via inalatoria

CZ - Républica Checa

| 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

Suspensão pressurizada para inalação

Via inalatoria

CZ - Républica Checa

| 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

Suspensão pressurizada para inalação

Via inalatoria

CZ - Républica Checa

| 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

Suspensão pressurizada para inalação

Via inalatoria

DK - Dinamarca

| 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

Suspensão pressurizada para inalação

Via inalatoria

DK - Dinamarca

| 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

Suspensão pressurizada para inalação

Via inalatoria

DK - Dinamarca

| 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

Suspensão pressurizada para inalação

Via inalatoria

FI - Finlândia

| 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

Suspensão pressurizada para inalação

Via inalatoria

FI - Finlândia

| 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

Suspensão pressurizada para inalação

Via inalatoria

FI - Finlândia

| 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

Suspensão pressurizada para inalação

Via inalatoria

FR - França

| 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

Suspensão pressurizada para inalação

Via inalatoria

FR - França

| 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

Suspensão pressurizada para inalação

Via inalatoria

FR - França

| 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

Suspensão pressurizada para inalação

Via inalatoria

DE - Alemanha

| 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

Suspensão pressurizada para inalação

Via inalatoria

DE - Alemanha

| 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

Suspensão pressurizada para inalação

Via inalatoria

DE - Alemanha

| 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

Suspensão pressurizada para inalação

Via inalatoria

IS - Islândia

| 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

Suspensão pressurizada para inalação

Via inalatoria

IS - Islândia

| 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

Suspensão pressurizada para inalação

Via inalatoria

IS - Islândia

| 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

Suspensão pressurizada para inalação

Via inalatoria

IE - Irlanda

| 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

Suspensão pressurizada para inalação

Via inalatoria

IE - Irlanda

| 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

Suspensão pressurizada para inalação

Via inalatoria

IE - Irlanda

| 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

Suspensão pressurizada para inalação

Via inalatoria

IT - Itália

| 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

Suspensão pressurizada para inalação

Via inalatoria

IT - Itália

| 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

Suspensão pressurizada para inalação

Via inalatoria

IT - Itália

| 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

Suspensão pressurizada para inalação

Via inalatoria

LU - Luxemburgo

| 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

Suspensão pressurizada para inalação

Via inalatoria

LU - Luxemburgo

| 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

Suspensão pressurizada para inalação

Via inalatoria

LU - Luxemburgo

| 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

Suspensão pressurizada para inalação

Via inalatoria

NL - Países Baixos

| 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

Suspensão pressurizada para inalação

Via inalatoria

NL - Países Baixos

| 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

Suspensão pressurizada para inalação

Via inalatoria

NL - Países Baixos

| 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

Suspensão pressurizada para inalação

Via inalatoria

NO - Noruega

| 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

Suspensão pressurizada para inalação

Via inalatoria

NO - Noruega

| 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

Suspensão pressurizada para inalação

Via inalatoria

NO - Noruega

| 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

Suspensão pressurizada para inalação

Via inalatoria

PL - Polónia

| 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

Suspensão pressurizada para inalação

Via inalatoria

PL - Polónia

| 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

Suspensão pressurizada para inalação

Via inalatoria

PL - Polónia

| 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

Suspensão pressurizada para inalação

Via inalatoria

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

Suspensão pressurizada para inalação

Via inalatoria

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

Suspensão pressurizada para inalação

Via inalatoria

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

Suspensão pressurizada para inalação

Via inalatoria

RO - Roménia

| 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

Suspensão pressurizada para inalação

Via inalatoria

RO - Roménia

| 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

Suspensão pressurizada para inalação

Via inalatoria

RO - Roménia

| 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

Suspensão pressurizada para inalação

Via inalatoria

SK - Eslováquia

| 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

Suspensão pressurizada para inalação

Via inalatoria

SK - Eslováquia

| 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

Suspensão pressurizada para inalação

Via inalatoria

SK - Eslováquia

| 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

Suspensão pressurizada para inalação

Via inalatoria

SE - Suécia

| 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

Suspensão pressurizada para inalação

Via inalatoria

SE - Suécia

| 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

Suspensão pressurizada para inalação

Via inalatoria

SE - Suécia

| 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

Suspensão pressurizada para inalação

Via inalatoria

UK - Reino Unido

| 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

Suspensão pressurizada para inalação

Via inalatoria

UK - Reino Unido

| 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

Suspensão pressurizada para inalação

Via inalatoria

UK - Reino Unido

| 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

Suspensão pressurizada para inalação

Via inalatoria

---