# Úradný vestník C 224/2012

| | ISSN 1977-1037
  doi:10.3000/19771037.C_2012.224.slk |
| --- | --- |
| Úradný vestník
  Európskej únie | C 224 |
| | |
| Slovenské vydanie | Informácie a oznámenia | Zväzok 5527. júla 2012 |

ISSN 1977-1037

doi:10.3000/19771037.C_2012.224.slk

Úradný vestník

Európskej únie

C 224

Slovenské vydanie

Informácie a oznámenia

Zväzok 5527. júla 2012

---

| Číslo oznamu | Obsah | Strana |
| --- | --- | --- |
| | IV   Informácie |
| | INFORMÁCIE INŠTITÚCIÍ, ORGÁNOV, ÚRADOV A AGENTÚR EURÓPSKEJ ÚNIE |
| 2012/C 224/01 | Súhrn rozhodnutí Európskej únie o povolení na uvedenie liekov na trh od 1. jún 2012 do 30. jún 2012[Uverejnené v súlade s článkom 13 alebo 38 nariadenia Európskeho parlamentu a Rady (ES) č. 726/2004] | 1 |
| 2012/C 224/02 | Súhrn rozhodnutí Európskej únie o povolení na uvedenie liekov na trh od 1. jún 2012 do 30. jún 2012(Rozhodnutia prijaté v súlade s článkom 34 smernice 2001/83/ES alebo s článkom 38 smernice 2001/82/ES) | 16 |

Číslo oznamu

Obsah

Strana

IV   Informácie

INFORMÁCIE INŠTITÚCIÍ, ORGÁNOV, ÚRADOV A AGENTÚR EURÓPSKEJ ÚNIE

2012/C 224/01

Súhrn rozhodnutí Európskej únie o povolení na uvedenie liekov na trh od 1. jún 2012 do 30. jún 2012[Uverejnené v súlade s článkom 13 alebo 38 nariadenia Európskeho parlamentu a Rady (ES) č. 726/2004]

[Uverejnené v súlade s článkom 13 alebo 38 nariadenia Európskeho parlamentu a Rady (ES) č. 726/2004]

1

2012/C 224/02

Súhrn rozhodnutí Európskej únie o povolení na uvedenie liekov na trh od 1. jún 2012 do 30. jún 2012(Rozhodnutia prijaté v súlade s článkom 34 smernice 2001/83/ES alebo s článkom 38 smernice 2001/82/ES)

(Rozhodnutia prijaté v súlade s článkom 34 smernice 2001/83/ES alebo s článkom 38 smernice 2001/82/ES)

16

| SK | |
| --- | --- |

SK

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IV Informácie

INFORMÁCIE INŠTITÚCIÍ, ORGÁNOV, ÚRADOV A AGENTÚR EURÓPSKEJ ÚNIE

| 27.7.2012 | SK | Úradný vestník Európskej únie | C 224/1 |
| --- | --- | --- | --- |

27.7.2012

SK

Úradný vestník Európskej únie

C 224/1

---

Súhrn rozhodnutí Európskej únie o povolení na uvedenie liekov na trh od 1. jún 2012 do 30. jún 2012

[Uverejnené v súlade s článkom 13 alebo 38 nariadenia Európskeho parlamentu a Rady (ES) č. 726/2004
   (1)
  ]

2012/C 224/01

—   Udelenie povolenia na uvedenie na trh (článok 13 nariadenia Európskeho parlamentu a Rady (ES) č. 726/2004): Prijaté

| Dátum rozhodnutia | Názov lieku | INN (medzinárodný neregistrovaný názov) | Držiteľ povolenia na uvedenie na trh | Číslo záznamu v registri Spoločenstva | Lieková forma | Kód ATC (anatomicko-terapeuticko-chemický kód) | Dátum oznámenia |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 15.06.2012 | Rienso | Ferumoxytol | Takeda Global Research and Development Centre (Europe) Ltd |
| 61 Aldwych, |
| London WC2B 4AE, |
| United Kingdom |

Dátum rozhodnutia

Názov lieku

INN (medzinárodný neregistrovaný názov)

Držiteľ povolenia na uvedenie na trh

Číslo záznamu v registri Spoločenstva

Lieková forma

Kód ATC (anatomicko-terapeuticko-chemický kód)

Dátum oznámenia

15.06.2012

Rienso

Ferumoxytol

Takeda Global Research and Development Centre (Europe) Ltd

61 Aldwych,

London WC2B 4AE,

United Kingdom

EU/1/12/774/001-002

Injekčný roztok

Pending

20.06.2012

—   Udelenie povolenia na uvedenie na trh (článok 13 nariadenia Európskeho parlamentu a Rady (ES) č. 726/2004): Zamietnuté

| Dátum rozhodnutia | Názov lieku | Držiteľ povolenia na uvedenie na trh | Číslo záznamu v registri Spoločenstva | Dátum oznámenia |
| --- | --- | --- | --- | --- |
| 21.06.2012 | Folotyn | Allos Therapeutics Limited |
| 71 Knowl Piece, |
| Wilbury Way, |
| Hitchin, Hertfordshire SG4 0TY, |
| United Kingdom |

Dátum rozhodnutia

Názov lieku

Držiteľ povolenia na uvedenie na trh

Číslo záznamu v registri Spoločenstva

Dátum oznámenia

21.06.2012

Folotyn

Allos Therapeutics Limited

71 Knowl Piece,

Wilbury Way,

Hitchin, Hertfordshire SG4 0TY,

United Kingdom

—

25.06.2012

—   Zmena povolenia na uvedenie na trh (článok 13 nariadenia Európskeho parlamentu a Rady (ES) č. 726/2004): Prijaté

| Dátum rozhodnutia | Názov lieku | Držiteľ povolenia na uvedenie na trh | Číslo záznamu v registri Spoločenstva | Dátum oznámenia |
| --- | --- | --- | --- | --- |
| 01.06.2012 | Osigraft | Olympus Biotech International Limited |
| Raheen Business Park, |
| Limerick, |
| Ireland |

Dátum rozhodnutia

Názov lieku

Držiteľ povolenia na uvedenie na trh

Číslo záznamu v registri Spoločenstva

Dátum oznámenia

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

—   Odňatie povolenia na uvedenie na trh (článok 13 nariadenia Európskeho parlamentu a Rady (ES) č. 726/2004)

| Dátum rozhodnutia | Názov lieku | Držiteľ povolenia na uvedenie na trh | Číslo záznamu v registri Spoločenstva | Dátum oznámenia |
| --- | --- | --- | --- | --- |
| 28.06.2012 | Hexavac | Aventis Pasteur MSD |
| 8, rue Jonas Salk, |
| 69007 Lyon, |
| France |

Dátum rozhodnutia

Názov lieku

Držiteľ povolenia na uvedenie na trh

Číslo záznamu v registri Spoločenstva

Dátum oznámenia

28.06.2012

Hexavac

Aventis Pasteur MSD

8, rue Jonas Salk,

69007 Lyon,

France

EU/1/00/147/001-012

04.07.2012

—   Udelenie povolenia na uvedenie na trh (článok 38 nariadenia Európskeho parlamentu a Rady (ES) č. 726/2004
   (2)
  ): Prijaté

| Dátum rozhodnutia | Názov lieku | INN (medzinárodný neregistrovaný názov) | Držiteľ povolenia na uvedenie na trh | Číslo záznamu v registri Spoločenstva | Lieková forma | Kód ATC (anatomicko-terapeuticko-chemický kód) | Dátum oznámenia |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 14.06.2012 | Porcilis ColiClos | — | Intervet International B.V. |
| Wim de Körverstraat 35, |
| 5831 AN Boxmeer, |
| Nederland |

Dátum rozhodnutia

Názov lieku

INN (medzinárodný neregistrovaný názov)

Držiteľ povolenia na uvedenie na trh

Číslo záznamu v registri Spoločenstva

Lieková forma

Kód ATC (anatomicko-terapeuticko-chemický kód)

Dátum oznámenia

14.06.2012

Porcilis ColiClos

—

Intervet International B.V.

Wim de Körverstraat 35,

5831 AN Boxmeer,

Nederland

EU/2/12/141/001-009

Injekčná suspenzia

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

Prášok na prípravu aerosólu

QI01AE04

20.06.2012

—   Zmena povolenia na uvedenie na trh (článok 38 nariadenia Európskeho parlamentu a Rady (ES) č. 726/2004): Prijaté

| Dátum rozhodnutia | Názov lieku | Držiteľ povolenia na uvedenie na trh | Číslo záznamu v registri Spoločenstva | Dátum oznámenia |
| --- | --- | --- | --- | --- |
| 11.06.2012 | Activyl | Intervet International B.V. |
| Wim de Körverstraat 35, |
| 5831 AN Boxmeer, |
| Nederland |

Dátum rozhodnutia

Názov lieku

Držiteľ povolenia na uvedenie na trh

Číslo záznamu v registri Spoločenstva

Dátum oznámenia

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

Ak sa chcete oboznámiť s verejnou hodnotiacou správou o príslušných liekoch a s ňou súvisiacimi rozhodnutiami, môžete kontaktovať:

| 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)  Ú. v. EÚ L 136, 30.4.04, s. 1.

(2)  Ú. v. EÚ L 136, 30.4.04, s. 1.

---

| 27.7.2012 | SK | Úradný vestník Európskej únie | C 224/16 |
| --- | --- | --- | --- |

27.7.2012

SK

Úradný vestník Európskej únie

C 224/16

---

Súhrn rozhodnutí Európskej únie o povolení na uvedenie liekov na trh od 1. jún 2012 do 30. jún 2012

(Rozhodnutia prijaté v súlade s článkom 34 smernice 2001/83/ES
   (1)
  alebo s článkom 38 smernice 2001/82/ES
   (2)
  )

2012/C 224/02

—   Udelenie, zachovanie alebo zmena vnútroštátneho povolenia na uvedenie na trh

| Dátum rozhodnutia | Názov(-vy) lieku | Držiteľ(-lia) povolenia na uvedenie na trh | Príslušný členský štát | Dátum oznámenia |
| --- | --- | --- | --- | --- |
| 14/6/2012 | Tilmicosin | Pozri prílohu I | Pozri prílohu I | 18/6/2012 |
| 18/6/2012 | Milaxyn plus and associated names | Pozri prílohu II | Pozri prílohu II | 20/6/2012 |
| 28/6/2012 | Flutiform and associated names | Pozri prílohu III | Pozri prílohu III | 3/7/2012 |
| 28/6/2012 | Iffeza and associated names | Pozri prílohu IV | Pozri prílohu IV | 3/7/2012 |

Dátum rozhodnutia

Názov(-vy) lieku

Držiteľ(-lia) povolenia na uvedenie na trh

Príslušný členský štát

Dátum oznámenia

14/6/2012

Tilmicosin

Pozri prílohu I

Pozri prílohu I

18/6/2012

18/6/2012

Milaxyn plus and associated names

Pozri prílohu II

Pozri prílohu II

20/6/2012

28/6/2012

Flutiform and associated names

Pozri prílohu III

Pozri prílohu III

3/7/2012

28/6/2012

Iffeza and associated names

Pozri prílohu IV

Pozri prílohu IV

3/7/2012

---

(1)  Ú. v. ES L 311, 28.11.01, s. 67.

(2)  Ú. v. ES L 311, 28.11.01, s. 1.

---

PRÍLOHA I

ZOZNAM NÁZVOV, LIEKOVÉ FORMY, ÚČINNÉ LÁTKY, SILY VETERINÁRNYCH LIEKOV, DRUHY ZVIERAT, DRŽITELIA POVOLENÍ NA UVEDENIE NA TRH V ČLENSKÝCH ŠTÁTOCH

| Členský štát EÚ/EHP | Držiteľ povolenia na uvedenie na trh | Názov | Medzinárodný nechránený názov | Sila | Lieková forma | Druhy zvierat |
| --- | --- | --- | --- | --- | --- | --- |
| Rakúsko | Richter Pharma AG |
| Feldgasse 19 |
| A-4600 Wels |
| RAKÚSKO |

Členský štát EÚ/EHP

Držiteľ povolenia na uvedenie na trh

Názov

Medzinárodný nechránený názov

Sila

Lieková forma

Druhy zvierat

Rakúsko

Richter Pharma AG

Feldgasse 19

A-4600 Wels

RAKÚSKO

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

Tilmicosin (as phosphate)

100 g tilmikozínu na kg premixu

Premix na medikované krmivo

Ošípané, králiky

Rakúsko

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

Richter Pharma AG

Feldgasse 19

A-4600 Wels

RAKÚSKO

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

Tilmicosin (as phosphate)

200 g tilmikozínu na kg premixu

Premix na medikované krmivo

Ošípané, králiky

Belgicko

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

Eli Lilly Benelux N. V.

Elanco Animal Health

Rue de l'Etuve 52

Stoofstraat 52

1000 Brussel

BELGICKO

Pulmotil 40 VET Pre-mix

Tilmicosin (as phosphate)

40 g tilmikozínu na kg premixu

Premix na medikované krmivo

Ošípané, králiky

Belgicko

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

Eli Lilly Benelux N.V.

Elanco Animal Health

Rue de l'Etuve 52

Stoofstraat 52

1000 Brussel

BELGICKO

Pulmotil 100 VET Pre-mix

Tilmicosin (as phosphate)

100 g tilmikozínu na kg premixu

Premix na medikované krmivo

Ošípané, králiky

Belgicko

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

Eli Lilly Benelux N.V.

Elanco Animal Health

Rue de l'Etuve 52

Stoofstraat 52

1000 Brussel

BELGICKO

Pulmotil 100 Granules

Tilmicosin (as phosphate)

100 g tilmikozínu na kg premixu

Premix na medikované krmivo

Ošípané, králiky

Belgicko

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

Eli Lilly Benelux N.V.

Elanco Animal Health

Rue de l'Etuve 52

Stoofstraat 52

1000 Brussel

BELGICKO

Pulmotil 200 VET Pre-mix

Tilmicosin (as phosphate)

200 g tilmikozínu na kg premixu

Premix na medikované krmivo

Ošípané, králiky

Cyprus

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

Eli Lilly Regional Operations GmbH

Elanco Animal Health

Kolblgasse 8-10

1030 Wien

RAKÚSKO

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

Tilmicosin (as phosphate)

200 g tilmikozínu na kg premixu

Premix na medikované krmivo

Ošípané, králiky

Česká republika

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

Eli Lilly Regional Operations GmbH

Elanco Animal Health

Kolblgasse 8-10

1030 Wien

RAKÚSKO

Pulmotil 200 mg/g pre-mix pro medikaci krmiva

Tilmicosin (as phosphate)

200 g tilmikozínu na kg premixu

Premix na medikované krmivo

Ošípané, králiky

Nemecko

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

Lilly Deutschland GmbH

Abt. Elanco Animal Health

Werner-Reimers-Str. 2-4

D-61352 Bad Homburg

NEMECKO

Pulmotil G 40

Tilmicosin (as phosphate)

40 g tilmikozínu na kg premixu

Premix na medikované krmivo

Ošípané, králiky

Nemecko

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

Lilly Deutschland GmbH

Abt. Elanco Animal Health

Werner-Reimers-Str. 2-4

D-61352 Bad Homburg

NEMECKO

Pulmotil G 100

Tilmicosin (as phosphate)

100 g tilmikozínu na kg premixu

Premix na medikované krmivo

Ošípané, králiky

Nemecko

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

Lilly Deutschland GmbH

Abt. Elanco Animal Health

Werner-Reimers-Str. 2-4

D-61352 Bad Homburg

NEMECKO

Pulmotil G 20 % AMV

Tilmicosin (as phosphate)

200 g tilmikozínu na kg premixu

Premix na medikované krmivo

Ošípané, králiky

Dánsko

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

Elanco Animal Health

Eli Lilly Danmark A/S

Nybrovej 110

DK-2800 Kongens Lyngby

DÁNSKO

Pulmotil Vet.

Tilmicosin (as phosphate)

40 g tilmikozínu na kg premixu

Premix na medikované krmivo

Ošípané, králiky

Dánsko

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

Elanco Animal Health

Eli Lilly Danmark A/S

Nybrovej 110

DK-2800 Kongens Lyngby

DÁNSKO

Pulmotil Vet.

Tilmicosin (as phosphate)

100 g tilmikozínu na kg premixu

Premix na medikované krmivo

Ošípané, králiky

Dánsko

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

Elanco Animal Health

Eli Lilly Danmark A/S

Nybrovej 110

DK-2800 Kongens Lyngby

DÁNSKO

Pulmotil Vet.

Tilmicosin (as phosphate)

200 g tilmikozínu na kg premixu

Premix na medikované krmivo

Ošípané, králiky

Grécko

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

Eli Lilly Regional Operations GmbH

Elanco Animal Health

Kolblgasse 8-10

1030 Wien

RAKÚSKO

PULMOTIL 200

Tilmicosin (as phosphate)

200 g tilmikozínu na kg premixu

Premix na medikované krmivo

Ošípané, králiky

Španielsko

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

ELANCO VALQUÍMICA, S.A.

Avda. de la Industria 30

28108 Alcobendas

Madrid

ŠPANIELSKO

PULMOTIL G 40

Tilmicosin (as phosphate)

40 g tilmikozínu na kg premixu

Premix na medikované krmivo

Ošípané, králiky

Španielsko

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

ELANCO VALQUÍMICA, S.A.

Avda. de la Industria 30

28108 Alcobendas

Madrid

ŠPANIELSKO

PULMOTIL G 100

Tilmicosin (as phosphate)

100 g tilmikozínu na kg premixu

Premix na medikované krmivo

Ošípané, králiky

Španielsko

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

ELANCO VALQUÍMICA, S.A.

Avda. de la Industria 30

28108 Alcobendas

Madrid

ŠPANIELSKO

PULMOTIL G 200

Tilmicosin (as phosphate)

200 g tilmikozínu na kg premixu

Premix na medikované krmivo

Ošípané, králiky

Francúzsko

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

LILLY France

13 Rue Pages

92158 Suresnes

Cedex

FRANCÚZSKO

PULMOTIL TILMICOSINE 40 PORC-LAPIN

Tilmicosin (as phosphate)

40 g tilmikozínu na kg premixu

Premix na medikované krmivo

Ošípané, králiky

Francúzsko

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

QALIAN

34 Rue Jean Monnet

Zi D'Etriche

49500 Serge

FRANCÚZSKO

SANTAMIX TILMICOSINE 40 PORCINS-LAPINS

Tilmicosin (as phosphate)

40 g tilmikozínu na kg premixu

Premix na medikované krmivo

Ošípané, králiky

Francúzsko

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

SOGEVAL

200 Route de Mayenne

Zi des Touches

53000 Laval

FRANCÚZSKO

CONCENTRAT VO 08 TILMICOSINE PORCIN-LAPIN

Tilmicosin (as phosphate)

40 g tilmikozínu na kg premixu

Premix na medikované krmivo

Ošípané, králiky

Maďarsko

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

Eli Lilly Regional Operations GmbH

Elanco Animal Health

Kolblgasse 8-10

1030 Wien

RAKÚSKO

Pulmotil G 200 gyógypre-mix

Tilmicosin (as phosphate)

200 g tilmikozínu na kg premixu

Premix na medikované krmivo

Ošípané, králiky

Írsko

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

Eli Lilly and Company Ltd

Elanco Animal Health

Lilly House

Priestly Road

Basingstoke

Hampshire RG24 9NL

SPOJENÉ KRÁĽOVSTVO

Pulmotil G40 Pre-mix for medicated feedingstuff

Tilmicosin (as phosphate)

40 g tilmikozínu na kg premixu

Premix na medikované krmivo

Ošípané, králiky

Írsko

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

Eli Lilly and Company Ltd

Elanco Animal Health

Lilly House

Priestly Road

Basingstoke

Hampshire RG24 9NL

SPOJENÉ KRÁĽOVSTVO

Pulmotil G100 Pre-mix for medicated feedingstuff

Tilmicosin (as phosphate)

100 g tilmikozínu na kg premixu

Premix na medikované krmivo

Ošípané, králiky

Írsko

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

Eli Lilly and Company Ltd

Elanco Animal Health

Lilly House

Priestly Road

Basingstoke

Hampshire RG24 9NL

SPOJENÉ KRÁĽOVSTVO

Pulmotil G200 Pre-mix for medicated feedingstuff

Tilmicosin (as phosphate)

200 g tilmikozínu na kg premixu

Premix na medikované krmivo

Ošípané, králiky

Taliansko

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

ELI LILLY ITALIA SPA

VIA GRAMSCI

731/733 - SESTO FIORENTINO – FI

TALIANSKO

PULMOTIL G 200 PRE-MIX

Tilmicosin (as phosphate)

200 g tilmikozínu na kg premixu

Premix na medikované krmivo

Ošípané, králiky

Taliansko

| CEVA VETEM SpA |
| --- |
| Via Colleoni |
| 15 20041 Agrate Brianza (MB) |
| TALIANSKO |

CEVA VETEM SpA

Via Colleoni

15 20041 Agrate Brianza (MB)

TALIANSKO

MICLOZAN 200 PRE-MIX

Tilmicosin (as phosphate)

200 g tilmikozínu na kg premixu

Premix na medikované krmivo

Ošípané, králiky

Holandsko

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

Eli Lilly Nederland B.V.

Elanco Animal Health

Grootslag 1-5

3991 RA Houten

HOLANDSKO

PULMOTIL® G40 pre-mix voor gemedicineerd voer voor varkens

Tilmicosin (as phosphate)

40 g tilmikozínu na kg premixu

Premix na medikované krmivo

Ošípané, králiky

Holandsko

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

Eli Lilly Nederland B.V.

Elanco Animal Health

Grootslag 1-5

3991 RA Houten

HOLANDSKO

PULMOTIL® G100 pre-mix voor gemedicineerd voer voor varkens

Tilmicosin (as phosphate)

100 g tilmikozínu na kg premixu

Premix na medikované krmivo

Ošípané, králiky

Holandsko

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

Eli Lilly Nederland B.V.

Elanco Animal Health

Grootslag 1-5

3991 RA Houten

HOLANDSKO

PULMOTIL® G200 pre-mix voor gemedicineerd voer voor varkens

Tilmicosin (as phosphate)

200 g tilmikozínu na kg premixu

Premix na medikované krmivo

Ošípané, králiky

Portugalsko

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

Lilly Portugal – Produtos Farmacęuticos, Lda.

Rua Cesário Verde, no5- piso 4

Linda-a-Pastora

2790 – 326 QUEIJAS

PORTUGALSKO

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

Tilmicosin (as phosphate)

40 g tilmikozínu na kg premixu

Premix na medikované krmivo

Ošípané, králiky

Portugalsko

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

Lilly Portugal – Produtos Farmacęuticos, Lda.

Rua Cesário Verde, no5- piso 4

Linda-a-Pastora

2790 – 326 QUEIJAS

PORTUGALSKO

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

Tilmicosin (as phosphate)

100 g tilmikozínu na kg premixu

Premix na medikované krmivo

Ošípané, králiky

Portugalsko

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

Lilly Portugal – Produtos Farmacęuticos, Lda.

Rua Cesário Verde, no5- piso 4

Linda-a-Pastora

2790 – 326 QUEIJAS

PORTUGALSKO

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

Tilmicosin (as phosphate)

200 g tilmikozínu na kg premixu

Premix na medikované krmivo

Ošípané, králiky

Rumunsko

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

Eli Lilly Regional Operations GmbH

Elanco Animal Health

Kolblgasse 8-10

1030 Wien

RAKÚSKO

PULMOTIL 200 g/kg pre-mix

Tilmicosin (as phosphate)

200 g tilmikozínu na kg premixu

Premix na medikované krmivo

Ošípané, králiky

Slovenská republika

| Elli Lilly and Company Limited |
| --- |
| Speke Operations Fleming RoadSpeke |
| Liverpool |
| L24 9LN |
| SPOJENÉ KRÁĽOVSTVO |

Elli Lilly and Company Limited

Speke Operations Fleming RoadSpeke

Liverpool

L24 9LN

SPOJENÉ KRÁĽOVSTVO

Pulmotil G 200 pre-mix ad us.vet.

Tilmicosin (as phosphate)

200 g tilmikozínu na kg premixu

Premix na medikované krmivo

Ošípané, králiky

Spojené kráľovstvo

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

Eli Lilly and Company Ltd

Elanco Animal Health

Lilly House

Priestly Road

Basingstoke

Hampshire RG24 9NL

SPOJENÉ KRÁĽOVSTVO

Pulmotil G100 Pre-mix for Medicated Feedingstuff

Tilmicosin (as phosphate)

100 g tilmikozínu na kg premixu

Premix na medikované krmivo

Ošípané, králiky

Spojené kráľovstvo

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

Eli Lilly and Company Ltd

Elanco Animal Health

Lilly House

Priestly Road

Basingstoke

Hampshire RG24 9NL

SPOJENÉ KRÁĽOVSTVO

Pulmotil G200 Pre-mix for Medicated Feedingstuff

Tilmicosin (as phosphate)

200 g tilmikozínu na kg premixu

Premix na medikované krmivo

Ošípané, králiky

---

PRÍLOHA II

ZOZNAM MIEN, FARMACEUTICKÁ FORMA, SIL VETERINÁRNYCH LIEKOV, CIEL’OVÝCH DRUHOV ZVIERAT, CESTA PODANIA, DRŽITEĽOV ROZHODNUTIA O REGISTRÁCII V ČLENSKÝCH ŠTÁTOCH

| Členský štát EU/EEA | Držiteľ rozhodnutia o registrácii | Meno | INN/Sila | Farmaceutická forma | Živočíšnych druhov |
| --- | --- | --- | --- | --- | --- |
| Rakúsko | Chanelle Pharmaceuticals Manufacturing Ltd. |
| IE-Loughrea |
| Co. Galway |
| Írsko |

Členský štát EU/EEA

Držiteľ rozhodnutia o registrácii

Meno

INN/Sila

Farmaceutická forma

Živočíšnych druhov

Rakúsko

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

Exitel Plus Tabletten für Hunde

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Rakúsko

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

Prazitel Plus Tabletten für Hunde

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Belgicko

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

Cazitel Plus Tabletten für Hunde

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Belgicko

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

Exitel Plus Tabletten für Hunde

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Belgicko

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

Prazitel Plus Tabletten für Hunde

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Bulharsko

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

Cazitel Plus таблетки за кучета

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Bulharsko

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

Exitel Plus таблетки за кучета

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Bulharsko

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

Prazitel Plus таблетки за кучета

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Cyprus

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

Exitel Plus Δισκία Για Σκύλους

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Česká republika

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

Cazitel Plus tablety pro psy

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Česká republika

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

Exitel Plus tablety pro psy

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Česká republika

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

Prazitel Plus tablety pro psy

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Dánsko

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

Exitel Plus

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Dánsko

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

Prazitel Plus

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Estónsko

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

Cazitel Plus tabletid koertele

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Estónsko

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

Exitel Plus tabletid koertele

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Fínsko

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

Cazitel Plus 50 mg/144 mg/150 mg tablet

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Fínsko

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

Exitel Plus 50 mg/144 mg/150 mg tablet

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Fínsko

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

Prazitel Plus 50 mg/144 mg/150 mg tablet

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Francúzsko

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

Milaxyn comprimé pour chiens

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Francúzsko

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

Strantel comprimé pour chiens

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Francúzsko

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

Prazical comprimé pour chiens

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Francúzsko

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

Voxical comprimé pour chiens

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Nemecko

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

Cazitel Tabletten für Hunde

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Nemecko

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

Exitel Tabletten für Hunde

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Nemecko

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

Strantel Tabletten für Hunde

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Grécko

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

Cazitel plus Δισκία Για Σκύλους

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Grécko

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

Exitel plus Δισκία Για Σκύλους

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Grécko

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

Prazitel plus Δισκία Για Σκύλους

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Mad’arsko

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

Cazitel Plus tabletta kutyák részére A.U.V

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Mad’arsko

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

Exitel Plus tabletta kutyák részére A.U.V

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Mad’arsko

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

Prazitel Plus tabletta kutyák részére A.U.V

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Island

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

Exitel Plus töflur fyrir hunda

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Island

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

Prazitel Plus töflur fyrir hunda

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Írsko

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

Cazitel Plus tablets for dogs

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Írsko

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

Exitel Plus tablets for dogs

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Írsko

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

Milaxyn Plus tablets for dogs

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Írsko

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

Prazical Plus tablets for dogs

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Írsko

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

Prazitel Plus tablets for dogs

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Írsko

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

Strantel Plus tablets for dogs

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Írsko

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

Voxical Plus tablets for dogs

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Taliansko

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

Canitel Plus compresse per cani

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Taliansko

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

Exitel Plus compresse per cani

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Taliansko

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

Prazitel compresse per cani

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Lotyšsko

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

Cazitel tablets Tabletes suņiem

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Lotyšsko

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

Exitel tablets Tabletes suņiem

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Lotyšsko

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

Prazitel tablets Tabletes suņiem

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Litva

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

Cazitel Plus tabletės šunims

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Litva

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

Exitel Plus tabletės šunims

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Litva

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

Prazitel Plus tabletės šunims

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Luxemburg

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

Exitel Plus tabletten voor honden

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Luxemburg

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

Prazitel Plus tabletten voor honden

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Holandsko

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

Cazitel Plus tabletten voor honden

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Holandsko

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

Exitel Plus tabletten voor honden

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Holandsko

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

Prazitel Plus tabletten voor honden

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Nórsko

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

Exitel Vet

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Nórsko

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

Prazitel Vet

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Pol’sko

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

Cazitel Plus tabletki dla psów

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Pol’sko

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

Exitel Plus tabletki dla psów

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Pol’sko

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

Prazitel Plus tabletki dla psów

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Portugalsko

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

Cazitel Plus Comprimidos para cães

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Portugalsko

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

Exitel Plus Comprimidos para cães

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Portugalsko

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

Prazitel Plus Comprimidos para cães

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Rumunsko

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

Cazitel Plus Comprimate pentru câini

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Rumunsko

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

Exitel Plus Comprimate pentru câini

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Rumunsko

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

Prazitel Plus Comprimate pentru câini

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Slovensko

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

Cazitel Plus tablety pre psov

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Slovensko

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

Exitel Plus tablety pre psov

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Slovensko

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

Prazitel Plus tablety pre psov

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Slovinsko

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

Cazitel Plus tablete za pse

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Slovinsko

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

Exitel Plus tablete za pse

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Slovinsko

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

Prazitel Plus tablete za pse

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Španielsko

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

Cazitel comprimidos para perros

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Španielsko

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

Exitel comprimidos para perros

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Španielsko

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

Prazitel comprimidos para perros

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Švédsko

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

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

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Švédsko

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

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

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Veľká Británia

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

Cazitel plus tablets for dogs

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Veľká Británia

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

Easimax plus tablets for dogs

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

Veľká Británia

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Írsko

Prazitel plus tablets for dogs

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalent 144 mg pyrantel embonate)

Febantel 150 mg

Tablety

Psy

---

PRÍLOHA III

ZOZNAM NÁZVOV, FARMACEUTICKÝCH FORIEM, MNOŽSTVÁ ÚČINNÝCH LÁTOK V LIEKOCH, SPÔSOB PODÁVANIA, UCHÁDZAČI V ČLENSKÝCH ŠTÁTOCH

| Členský štát EÚ/EHP | Uchádzač | Vymyslený názov | Množstvo aktívnej látky | Farmaceutická forma | Spôsob podávania |
| --- | --- | --- | --- | --- | --- |
| AT - Rakúsko | Napp Pharmaceuticals Limited |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Členský štát EÚ/EHP

Uchádzač

Vymyslený názov

Množstvo aktívnej látky

Farmaceutická forma

Spôsob podávania

AT - Rakúsko

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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

AT - Rakúsko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

AT - Rakúsko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

BE - Belgicko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

BE - Belgicko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

BE - Belgicko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

BG - Bulharsko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

BG - Bulharsko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

BG - Bulharsko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

CY - Cyprus

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

CY - Cyprus

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

CY - Cyprus

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

CZ - Česká republika

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

CZ - Česká republika

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

CZ - Česká republika

| 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/10mc

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

DK - Dánsko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

DK - Dánsko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

DK - Dánsko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

FI - Fínsko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

FI - Fínsko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

FI - Fínsko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

FR - Francúzsko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

FR - Francúzsko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

FR - Francúzsko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

DE - Nemecko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

DE - Nemecko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

DE - Nemecko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

IS - Island

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

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Flutiform®

50 mcg/5 mcg

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

IS - Island

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

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Flutiform®

125 mcg/5 mcg

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

IS - Island

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

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Flutiform®

250 mcg/10 mcg

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

IE - Írsko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

IE - Írsko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

IE - Írsko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

IT - Taliansko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

IT - Taliansko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

IT - Taliansko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

LU - Luxembursko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

LU - Luxembursko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

LU - Luxembursko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

NL - Holandsko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

NL - Holandsko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

NL - Holandsko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

NO - Nórsko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

NO - Nórsko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

NO - Nórsko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

PL - Poľsko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

PL - Poľsko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

PL - Poľsko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

PT - Portugalsko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

PT - Portugalsko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

PT - Portugalsko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

RO - Rumunsko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

RO - Rumunsko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

RO - Rumunsko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

SK - Slovenská republika

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

SK - Slovenská republika

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

SK - Slovenská republika

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

SE - Švédsko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

SE - Švédsko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

SE - Švédsko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

UK - Veľká Británia

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

UK - Veľká Británia

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

UK - Veľká Británia

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

---

PRÍLOHA IV

ZOZNAM NÁZVOV, FARMACEUTICKÝCH FORIEM, MNOŽSTVÁ ÚČINNÝCH LÁTOK V LIEKOCH, SPÔSOB PODÁVANIA, UCHÁDZAČI V ČLENSKÝCH ŠTÁTOCH

| Členský štát EÚ/EHP | Uchádzač | Vymyslený názov | Množstvo aktívnej látky | Farmaceutická forma | Spôsob podávania |
| --- | --- | --- | --- | --- | --- |
| AT - Rakúsko | Napp Pharmaceuticals Limited |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Členský štát EÚ/EHP

Uchádzač

Vymyslený názov

Množstvo aktívnej látky

Farmaceutická forma

Spôsob podávania

AT - Rakúsko

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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

AT - Rakúsko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

AT - Rakúsko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

BE - Belgicko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

BE - Belgicko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

BE - Belgicko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

BG - Bulharsko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

BG - Bulharsko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

BG - Bulharsko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

CY - Cyprus

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

CY - Cyprus

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

CY - Cyprus

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

CZ - Česká republika

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

CZ - Česká republika

| 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 mcgg

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

CZ - Česká republika

| 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/10mc

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

DK - Dánsko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

DK - Dánsko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

DK - Dánsko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

FI - Fínsko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

FI - Fínsko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

FI - Fínsko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

FR - Francúzsko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

FR - Francúzsko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

FR - Francúzsko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

DE - Nemecko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

DE - Nemecko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

DE - Nemecko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

IS - Island

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

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Iffeza®

50 mcg/5 mcg

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

IS - Island

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

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Iffeza®

125 mcg/5 mcg

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

IS - Island

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

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Iffeza®

250 mcg/10 mcg

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

IE - Írsko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

IE - Írsko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

IE - Írsko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

IT - Taliansko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

IT - Taliansko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

IT - Taliansko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

LU - Luxembursko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

LU - Luxembursko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

LU - Luxembursko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

NL - Holandsko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

NL - Holandsko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

NL - Holandsko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

NO - Nórsko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

NO - Nórsko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

NO - Nórsko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

PL - Poľsko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

PL - Poľsko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

PL - Poľsko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

PT - Portugalsko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

PT - Portugalsko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

PT - Portugalsko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

RO - Rumunsko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

RO - Rumunsko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

RO - Rumunsko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

SK - Slovenská republika

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

SK - Slovenská republika

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

SK - Slovenská republika

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

SE - Švédsko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

SE - Švédsko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

SE - Švédsko

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

UK - Veľká Británia

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

UK - Veľká Británia

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

UK - Veľká Británia

| 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

Inhalačná suspenzia v tlakovom obale

Inhalačné použitie

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