# Europos Sąjungos C 224/2012

| | ISSN 1977-0960
  doi:10.3000/19770960.C_2012.224.lit |
| --- | --- |
| Europos Sąjungos
  oficialusis leidinys | C 224 |
| | |
| Leidimas lietuvių kalba | Informacija ir prane_imai | 55 tomas2012m. liepos 27d. |

ISSN 1977-0960

doi:10.3000/19770960.C_2012.224.lit

Europos Sąjungos

oficialusis leidinys

C 224

Leidimas lietuvių kalba

Informacija ir prane_imai

55 tomas2012m. liepos 27d.

---

| Prane_imo Nr. | Turinys | Puslapis |
| --- | --- | --- |
| | IV   Pranešimai |
| | EUROPOS SĄJUNGOS INSTITUCIJŲ, ĮSTAIGŲ IR ORGANŲ PRANEŠIMAI |
| 2012/C 224/01 | Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2012 m. birželis 1 d. iki 2012 m. birželis 30 d.(Paskelbta pagal Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004
  13 straipsnį arba 38 straipsnį) | 1 |
| 2012/C 224/02 | Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2012 m. birželis 1 d. iki 2012 m. birželis 30 d.(Sprendimai priimti pagal Direktyvos 2001/83/EB 34 straipsnį arba Direktyvos 2001/82/EB
  38 straipsnį) | 16 |

Prane_imo Nr.

Turinys

Puslapis

IV   Pranešimai

EUROPOS SĄJUNGOS INSTITUCIJŲ, ĮSTAIGŲ IR ORGANŲ PRANEŠIMAI

2012/C 224/01

Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2012 m. birželis 1 d. iki 2012 m. birželis 30 d.(Paskelbta pagal Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004
  13 straipsnį arba 38 straipsnį)

(Paskelbta pagal Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004

13 straipsnį arba 38 straipsnį)

1

2012/C 224/02

Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2012 m. birželis 1 d. iki 2012 m. birželis 30 d.(Sprendimai priimti pagal Direktyvos 2001/83/EB 34 straipsnį arba Direktyvos 2001/82/EB
  38 straipsnį)

(Sprendimai priimti pagal Direktyvos 2001/83/EB 34 straipsnį arba Direktyvos 2001/82/EB

38 straipsnį)

16

| LT | |
| --- | --- |

LT

---

IV Pranešimai

EUROPOS SĄJUNGOS INSTITUCIJŲ, ĮSTAIGŲ IR ORGANŲ PRANEŠIMAI

| 27.7.2012 | LT | Europos Sąjungos oficialusis leidinys | C 224/1 |
| --- | --- | --- | --- |

27.7.2012

LT

Europos Sąjungos oficialusis leidinys

C 224/1

---

Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2012 m. birželis 1 d. iki 2012 m. birželis 30 d.

(Paskelbta pagal Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004
   (1)
  13 straipsnį arba 38 straipsnį)

2012/C 224/01

—   Rinkodaros leidimo suteikimas (Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 13 straipsnis): Priimta

| Sprendimo data | Vaisto pavadinimas | INN (Tarptautinis nepatentuotas pavadinimas) | Rinkodaros leidimo turėtojas | Įrašo numeris Bendrijos vaistų registre | Farmacinė forma | ATC kodas (Anatominis terapinis cheminis kodas) | Pranešimo data |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 15.06.2012 | Rienso | Ferumoksitolis | Takeda Global Research and Development Centre (Europe) Ltd |
| 61 Aldwych, |
| London WC2B 4AE, |
| United Kingdom |

Sprendimo data

Vaisto pavadinimas

INN (Tarptautinis nepatentuotas pavadinimas)

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Farmacinė forma

ATC kodas (Anatominis terapinis cheminis kodas)

Pranešimo data

15.06.2012

Rienso

Ferumoksitolis

Takeda Global Research and Development Centre (Europe) Ltd

61 Aldwych,

London WC2B 4AE,

United Kingdom

EU/1/12/774/001-002

Injekcinis tirpalas

Pending

20.06.2012

—   Rinkodaros leidimo suteikimas (Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 13 straipsnis): Atmesta

| Sprendimo data | Vaisto pavadinimas | Rinkodaros leidimo turėtojas | Įrašo numeris Bendrijos vaistų registre | Pranešimo data |
| --- | --- | --- | --- | --- |
| 21.06.2012 | Folotyn | Allos Therapeutics Limited |
| 71 Knowl Piece, |
| Wilbury Way, |
| Hitchin, Hertfordshire SG4 0TY, |
| United Kingdom |

Sprendimo data

Vaisto pavadinimas

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Pranešimo data

21.06.2012

Folotyn

Allos Therapeutics Limited

71 Knowl Piece,

Wilbury Way,

Hitchin, Hertfordshire SG4 0TY,

United Kingdom

—

25.06.2012

—   Rinkodaros leidimo pakeitimas (Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 13 straipsnis): Priimta

| Sprendimo data | Vaisto pavadinimas | Rinkodaros leidimo turėtojas | Įrašo numeris Bendrijos vaistų registre | Pranešimo data |
| --- | --- | --- | --- | --- |
| 01.06.2012 | Osigraft | Olympus Biotech International Limited |
| Raheen Business Park, |
| Limerick, |
| Ireland |

Sprendimo data

Vaisto pavadinimas

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Pranešimo data

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

—   Rinkodaros leidimo atšaukimas (Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 13 straipsnis)

| Sprendimo data | Vaisto pavadinimas | Rinkodaros leidimo turėtojas | Įrašo numeris Bendrijos vaistų registre | Pranešimo data |
| --- | --- | --- | --- | --- |
| 28.06.2012 | Hexavac | Aventis Pasteur MSD |
| 8, rue Jonas Salk, |
| 69007 Lyon, |
| France |

Sprendimo data

Vaisto pavadinimas

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Pranešimo data

28.06.2012

Hexavac

Aventis Pasteur MSD

8, rue Jonas Salk,

69007 Lyon,

France

EU/1/00/147/001-012

04.07.2012

—   Rinkodaros leidimo suteikimas (Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 38 straipsnis
   (2)
  ): Priimta

| Sprendimo data | Vaisto pavadinimas | INN (Tarptautinis nepatentuotas pavadinimas) | Rinkodaros leidimo turėtojas | Įrašo numeris Bendrijos vaistų registre | Farmacinė forma | ATC kodas (Anatominis terapinis cheminis kodas) | Pranešimo data |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 14.06.2012 | Porcilis ColiClos | — | Intervet International B.V. |
| Wim de Körverstraat 35, |
| 5831 AN Boxmeer, |
| Nederland |

Sprendimo data

Vaisto pavadinimas

INN (Tarptautinis nepatentuotas pavadinimas)

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Farmacinė forma

ATC kodas (Anatominis terapinis cheminis kodas)

Pranešimo data

14.06.2012

Porcilis ColiClos

—

Intervet International B.V.

Wim de Körverstraat 35,

5831 AN Boxmeer,

Nederland

EU/2/12/141/001-009

Injekcinė suspensija

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

Liofilizatas suspensijai vakcinuoti purškiant

QI01AE04

20.06.2012

—   Rinkodaros leidimo pakeitimas (Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 38 straipsnis): Priimta

| Sprendimo data | Vaisto pavadinimas | Rinkodaros leidimo turėtojas | Įrašo numeris Bendrijos vaistų registre | Pranešimo data |
| --- | --- | --- | --- | --- |
| 11.06.2012 | Activyl | Intervet International B.V. |
| Wim de Körverstraat 35, |
| 5831 AN Boxmeer, |
| Nederland |

Sprendimo data

Vaisto pavadinimas

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Pranešimo data

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

Norintieji susipažinti su nagrinėjamųjų vaistų vieša vertinimo ataskaita ir su ja susijusiais sprendimais, gali kreiptis į:

| 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)  OL L 136, 2004 4 30, p. 1.

(2)  OL L 136, 2004 4 30, p. 1.

---

| 27.7.2012 | LT | Europos Sąjungos oficialusis leidinys | C 224/16 |
| --- | --- | --- | --- |

27.7.2012

LT

Europos Sąjungos oficialusis leidinys

C 224/16

---

Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2012 m. birželis 1 d. iki 2012 m. birželis 30 d.

(Sprendimai priimti pagal Direktyvos 2001/83/EB
   (1)
  34 straipsnį arba Direktyvos 2001/82/EB
   (2)
  38 straipsnį)

2012/C 224/02

—   Nacionalinio rinkodaros leidimo suteikimas, atnaujinimas arba pakeitimas

| Sprendimo data | Vaisto pavadinimas (-ai) | Rinkodaros leidimo turėtojas (-ai) | Susijusi valstybė narė | Pranešimo data |
| --- | --- | --- | --- | --- |
| 14/6/2012 | Tilmicosin | Žr. Priedą I | Žr. Priedą I | 18/6/2012 |
| 18/6/2012 | Milaxyn plus and associated names | Žr. Priedą II | Žr. Priedą II | 20/6/2012 |
| 28/6/2012 | Flutiform and associated names | Žr. Priedą III | Žr. Priedą III | 3/7/2012 |
| 28/6/2012 | Iffeza and associated names | Žr. Priedą IV | Žr. Priedą IV | 3/7/2012 |

Sprendimo data

Vaisto pavadinimas (-ai)

Rinkodaros leidimo turėtojas (-ai)

Susijusi valstybė narė

Pranešimo data

14/6/2012

Tilmicosin

Žr. Priedą I

Žr. Priedą I

18/6/2012

18/6/2012

Milaxyn plus and associated names

Žr. Priedą II

Žr. Priedą II

20/6/2012

28/6/2012

Flutiform and associated names

Žr. Priedą III

Žr. Priedą III

3/7/2012

28/6/2012

Iffeza and associated names

Žr. Priedą IV

Žr. Priedą IV

3/7/2012

---

(1)  OL L 311, 2001 11 28, p. 67.

(2)  OL L 311, 2001 11 28, p. 1.

---

I PRIEDAS

VETERINARINIŲ VAISTŲ PAVADINIMŲ, FARMACINIŲ FORMŲ, VEIKLIŲJŲ MEDŽIAGŲ, STIPRUMO, PASKIRTIES GYVŪNŲ RŪŠIŲ IR RINKODAROS TEISĖS TURĖTOJŲ VALSTYBĖSE NARĖSE SĄRAŠAS

| ES/EEE valstybė narė | Rinkodaros teisės turėtojas | Pavadinimas | Tarptautinis prekės ženklu neregistruotas pavadinimas (INN) | Stiprumas | Farmacinė forma | Gyvūnų rūšys |
| --- | --- | --- | --- | --- | --- | --- |
| Austrija | Richter Pharma AG |
| Feldgasse 19 |
| A-4600 Wels |
| AUSTRIJA |

ES/EEE valstybė narė

Rinkodaros teisės turėtojas

Pavadinimas

Tarptautinis prekės ženklu neregistruotas pavadinimas (INN)

Stiprumas

Farmacinė forma

Gyvūnų rūšys

Austrija

Richter Pharma AG

Feldgasse 19

A-4600 Wels

AUSTRIJA

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

Tilmicosin (as phosphate)

100 g tilmikozino/kg premikso

Vaistinis premiksas

Kiaulės, triušiai

Austrija

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

Richter Pharma AG

Feldgasse 19

A-4600 Wels

AUSTRIJA

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

Tilmicosin (as phosphate)

200 g tilmikozino/kg premikso

Vaistinis premiksas

Kiaulės, triušiai

Belgija

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

Eli Lilly Benelux N.V.

Elanco Animal Health

Rue de l'Etuve 52

Stoofstraat 52

1000 Brussel

BELGIJA

Pulmotil 40 VET Pre-mix

Tilmicosin (as phosphate)

40 g tilmikozino/kg premikso

Vaistinis premiksas

Kiaulės, triušiai

Belgija

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

Eli Lilly Benelux N.V.

Elanco Animal Health

Rue de l'Etuve 52

Stoofstraat 52

1000 Brussel

BELGIJA

Pulmotil 100 VET Pre-mix

Tilmicosin (as phosphate)

100 g tilmikozino/kg premikso

Vaistinis premiksas

Kiaulės, triušiai

Belgija

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

Eli Lilly Benelux N.V.

Elanco Animal Health

Rue de l'Etuve 52

Stoofstraat 52

1000 Brussel

BELGIJA

Pulmotil 100 Granules

Tilmicosin (as phosphate)

100 g tilmikozino/kg premikso

Vaistinis premiksas

Kiaulės, triušiai

Belgija

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

Eli Lilly Benelux N.V.

Elanco Animal Health

Rue de l'Etuve 52

Stoofstraat 52

1000 Brussel

BELGIJA

Pulmotil 200 VET Pre-mix

Tilmicosin (as phosphate)

200 g tilmikozino/kg premikso

Vaistinis premiksas

Kiaulės, triušiai

Kipras

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

Eli Lilly Regional Operations GmbH

Elanco Animal Health

Kolblgasse 8-10

1030 Wien

AUSTRIJA

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

Tilmicosin (as phosphate)

200 g tilmikozino/kg premikso

Vaistinis premiksas

Kiaulės, triušiai

Čekijos Respublika

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

Eli Lilly Regional Operations GmbH

Elanco Animal Health

Kolblgasse 8-10

1030 Wien

AUSTRIJA

Pulmotil 200 mg/g pre-mix pro medikaci krmiva

Tilmicosin (as phosphate)

200 g tilmikozino/kg premikso

Vaistinis premiksas

Kiaulės, triušiai

Vokietija

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

Lilly Deutschland GmbH

Abt. Elanco Animal Health

Werner-Reimers-Str. 2-4

D-61352 Bad Homburg

VOKIETIJA

Pulmotil G 40

Tilmicosin (as phosphate)

40 g tilmikozino/kg premikso

Vaistinis premiksas

Kiaulės, triušiai

Vokietija

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

Lilly Deutschland GmbH

Abt. Elanco Animal Health

Werner-Reimers-Str. 2-4

D-61352 Bad Homburg

VOKIETIJA

Pulmotil G 100

Tilmicosin (as phosphate)

100 g tilmikozino/kg premikso

Vaistinis premiksas

Kiaulės, triušiai

Vokietija

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

Lilly Deutschland GmbH

Abt. Elanco Animal Health

Werner-Reimers-Str. 2-4

D-61352 Bad Homburg

VOKIETIJA

Pulmotil G 20 % AMV

Tilmicosin (as phosphate)

200 g tilmikozino/kg premikso

Vaistinis premiksas

Kiaulės, triušiai

Danija

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

Elanco Animal Health

Eli Lilly Danmark A/S

Nybrovej 110

DK-2800 Kongens Lyngby

DANIJA

Pulmotil Vet.

Tilmicosin (as phosphate)

40 g tilmikozino/kg premikso

Vaistinis premiksas

Kiaulės, triušiai

Danija

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

Elanco Animal Health

Eli Lilly Danmark A/S

Nybrovej 110

DK-2800 Kongens Lyngby

DANIJA

Pulmotil Vet.

Tilmicosin (as phosphate)

100 g tilmikozino/kg premikso

Vaistinis premiksas

Kiaulės, triušiai

Danija

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

Elanco Animal Health

Eli Lilly Danmark A/S

Nybrovej 110

DK-2800 Kongens Lyngby

DANIJA

Pulmotil Vet.

Tilmicosin (as phosphate)

200 g tilmikozino/kg premikso

Vaistinis premiksas

Kiaulės, triušiai

Graikija

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

Eli Lilly Regional Operations GmbH

Elanco Animal Health

Kolblgasse 8-10

1030 Wien

AUSTRIJA

PULMOTIL 200

Tilmicosin (as phosphate)

200 g tilmikozino/kg premikso

Vaistinis premiksas

Kiaulės, triušiai

Ispanija

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

ELANCO VALQUÍMICA, S.A.

Avda. de la Industria 30

28108 Alcobendas

Madrid

ISPANIJA

PULMOTIL G 40

Tilmicosin (as phosphate)

40 g tilmikozino/kg premikso

Vaistinis premiksas

Kiaulės, triušiai

Ispanija

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

ELANCO VALQUÍMICA, S.A.

Avda. de la Industria 30

28108 Alcobendas

Madrid

ISPANIJA

PULMOTIL G 100

Tilmicosin (as phosphate)

100 g tilmikozino/kg premikso

Vaistinis premiksas

Kiaulės, triušiai

Ispanija

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

ELANCO VALQUÍMICA, S.A.

Avda. de la Industria 30

28108 Alcobendas

Madrid

ISPANIJA

PULMOTIL G 200

Tilmicosin (as phosphate)

200 g tilmikozino/kg premikso

Vaistinis premiksas

Kiaulės, triušiai

Prancūzija

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

LILLY France

13 Rue Pages

92158 Suresnes

Cedex

FPRANCŪZIJA

PULMOTIL TILMICOSINE 40 PORC-LAPIN

Tilmicosin (as phosphate)

40 g tilmikozino/kg premikso

Vaistinis premiksas

Kiaulės, triušiai

Prancūzija

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

QALIAN

34 Rue Jean Monnet

Zi D'Etriche

49500 Serge

FPRANCŪZIJA

SANTAMIX TILMICOSINE 40 PORCINS - LAPINS

Tilmicosin (as phosphate)

40 g tilmikozino/kg premikso

Vaistinis premiksas

Kiaulės, triušiai

Prancūzija

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

SOGEVAL

200 Route de Mayenne

Zi des Touches

53000 Laval

FPRANCŪZIJA

CONCENTRAT VO 08 TILMICOSINE PORCIN-LAPIN

Tilmicosin (as phosphate)

40 g tilmikozino/kg premikso

Vaistinis premiksas

Kiaulės, triušiai

Vengrija

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

Eli Lilly Regional Operations GmbH

Elanco Animal Health

Kolblgasse 8-10

1030 Wien

AUSTRIJA

Pulmotil G 200 gyógypre-mix

Tilmicosin (as phosphate)

200 g tilmikozino/kg premikso

Vaistinis premiksas

Kiaulės, triušiai

Airija

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

Eli Lilly and Company Ltd

Elanco Animal Health

Lilly House

Priestly Road

Basingstoke

Hampshire RG24 9NL

JUNGTINĖ KARALYSTĖ

Pulmotil G40 Pre-mix for medicated feedingstuff

Tilmicosin (as phosphate)

40 g tilmikozino/kg premikso

Vaistinis premiksas

Kiaulės, triušiai

Airija

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

Eli Lilly and Company Ltd

Elanco Animal Health

Lilly House

Priestly Road

Basingstoke

Hampshire RG24 9NL

JUNGTINĖ KARALYSTĖ

Pulmotil G100 Pre-mix for medicated feedingstuff

Tilmicosin (as phosphate)

100 g tilmikozino/kg premikso

Vaistinis premiksas

Kiaulės, triušiai

Airija

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

Eli Lilly and Company Ltd

Elanco Animal Health

Lilly House

Priestly Road

Basingstoke

Hampshire RG24 9NL

JUNGTINĖ KARALYSTĖ

Pulmotil G200 Pre-mix for medicated feedingstuff

Tilmicosin (as phosphate)

200 g tilmikozino/kg premikso

Vaistinis premiksas

Kiaulės, triušiai

Italija

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

ELI LILLY ITALIA SPA

VIA GRAMSCI

731/733 - SESTO FIORENTINO – FI

ITALIJA

PULMOTIL G 200 PRE-MIX

Tilmicosin (as phosphate)

200 g tilmikozino/kg premikso

Vaistinis premiksas

Kiaulės, triušiai

Italija

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

CEVA VETEM SpA

via Colleoni

15 20041 Agrate Brianza (MB)

ITALIJA

MICLOZAN 200 PRE-MIX

Tilmicosin (as phosphate)

200 g tilmikozino/kg premikso

Vaistinis premiksas

Kiaulės, triušiai

Nyderlandai

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

Eli Lilly Nederland B.V.

Elanco Animal Health

Grootslag 1-5

3991 RA Houten

NYDERLANDAI

PULMOTIL® G40 pre-mix voor gemedicineerd voer voor varkens

Tilmicosin (as phosphate)

40 g tilmikozino/kg premikso

Vaistinis premiksas

Kiaulės, triušiai

Nyderlandai

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

Eli Lilly Nederland B.V.

Elanco Animal Health

Grootslag 1-5

3991 RA Houten

NYDERLANDAI

PULMOTIL® G100 pre-mix voor gemedicineerd voer voor varkens

Tilmicosin (as phosphate)

100 g tilmikozino/kg premikso

Vaistinis premiksas

Kiaulės, triušiai

Nyderlandai

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

Eli Lilly Nederland B.V.

Elanco Animal Health

Grootslag 1-5

3991 RA Houten

NYDERLANDAI

PULMOTIL® G200 pre-mix voor gemedicineerd voer voor varkens

Tilmicosin (as phosphate)

200 g tilmikozino/kg premikso

Vaistinis premiksas

Kiaulės, triušiai

Portugalija

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

Lilly Portugal – Produtos Farmacêuticos, Lda.

Rua Cesário Verde, no5- piso 4

Linda-a-Pastora

2790 – 326 QUEIJAS

PORTUGALIJA

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

Tilmicosin (as phosphate)

40 g tilmikozino/kg premikso

Vaistinis premiksas

Kiaulės, triušiai

Portugalija

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

Lilly Portugal – Produtos Farmacêuticos, Lda.

Rua Cesário Verde, no5- piso 4

Linda-a-Pastora

2790 – 326 QUEIJAS

PORTUGALIJA

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

Tilmicosin (as phosphate)

100 g tilmikozino/kg premikso

Vaistinis premiksas

Kiaulės, triušiai

Portugalija

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

Lilly Portugal – Produtos Farmacêuticos, Lda.

Rua Cesário Verde, no5- piso 4

Linda-a-Pastora

2790 – 326 QUEIJAS

PORTUGALIJA

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

Tilmicosin (as phosphate)

200 g tilmikozino/kg premikso

Vaistinis premiksas

Kiaulės, triušiai

Rumunija

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

Eli Lilly Regional Operations GmbH

Elanco Animal Health

Kolblgasse 8-10

1030 Wien

AUSTRIJA

PULMOTIL 200 g/kg pre-mix

Tilmicosin (as phosphate)

200 g tilmikozino/kg premikso

Vaistinis premiksas

Kiaulės, triušiai

Slovakijos Respublika

| Elli Lilly and Company Limited |
| --- |
| Speke Operations Fleming RoadSpeke |
| Liverpool |
| L24 9LN |
| JUNGTINĖ KARALYSTĖ |

Elli Lilly and Company Limited

Speke Operations Fleming RoadSpeke

Liverpool

L24 9LN

JUNGTINĖ KARALYSTĖ

Pulmotil G 200 pre-mix ad us.vet.

Tilmicosin (as phosphate)

200 g tilmikozino/kg premikso

Vaistinis premiksas

Kiaulės, triušiai

Jungtinė Karalystė

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

Eli Lilly and Company Ltd

Elanco Animal Health

Lilly House

Priestly Road

Basingstoke

Hampshire RG24 9NL

JUNGTINĖ KARALYSTĖ

Pulmotil G100 Pre-mix for Medicated Feedingstuff

Tilmicosin (as phosphate)

100 g tilmikozino/kg premikso

Vaistinis premiksas

Kiaulės, triušiai

Jungtinė Karalystė

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

Eli Lilly and Company Ltd

Elanco Animal Health

Lilly House

Priestly Road

Basingstoke

Hampshire RG24 9NL

JUNGTINĖ KARALYSTĖ

Pulmotil G200 Pre-mix for Medicated Feedingstuff

Tilmicosin (as phosphate)

200 g tilmikozino/kg premikso

Vaistinis premiksas

Kiaulės, triušiai

---

II PRIEDAS

VETERINARINIŲ VAISTŲ PAVADINIMŲ, VAISTO FORMŲ, STIPRUMŲ GYVŪNŲ RŪŠIŲ, VARTOJIMO BŪDAS, RINKODAROS TEISĖS TURĖTOJŲ VALSTYBĖSE NARĖSE SĄRAŠAS

| Valstybėnarė ES/EEE | Rinkodaros teisės turėtojas | Pavadinimas | INN/Stiprumai | Vaisto formos | Gyvūnų rūšys |
| --- | --- | --- | --- | --- | --- |
| Austrija | Chanelle Pharmaceuticals Manufacturing Ltd. |
| IE-Loughrea |
| Co. Galway |
| Airija |

Valstybėnarė ES/EEE

Rinkodaros teisės turėtojas

Pavadinimas

INN/Stiprumai

Vaisto formos

Gyvūnų rūšys

Austrija

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

Exitel Plus Tabletten für Hunde

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Austrija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

Prazitel Plus Tabletten für Hunde

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Belgija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

Cazitel Plus Tabletten für Hunde

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Belgija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

Exitel Plus Tabletten für Hunde

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Belgija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

Prazitel Plus Tabletten für Hunde

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Bulgarija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

Cazitel Plus таблетки за кучета

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Bulgarija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

Exitel Plus таблетки за кучета

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Bulgarija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

Prazitel Plus таблетки за кучета

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Kipras

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

Exitel Plus Δισκία Για Σκύλους

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Čekija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

Cazitel Plus tablety pro psy

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Čekija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

Exitel Plus tablety pro psy

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Čekija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

Prazitel Plus tablety pro psy

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Danija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

Exitel Plus

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Danija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

Prazitel Plus

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Estija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

Cazitel Plus tabletid koertele

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Estija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

Exitel Plus tabletid koertele

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Suomija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

Cazitel Plus 50 mg/144 mg/150 mg tablet

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Suomija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

Exitel Plus 50 mg/144 mg/150 mg tablet

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Suomija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

Prazitel Plus 50 mg/144 mg/150 mg tablet

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Prancūzija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

Milaxyn comprimé pour chiens

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Prancūzija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

Strantel comprimé pour chiens

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Prancūzija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

Prazical comprimé pour chiens

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Prancūzija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

Voxical comprimé pour chiens

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Vokietija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

Cazitel Tabletten für Hunde

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Vokietija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

Exitel Tabletten für Hunde

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Vokietija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

Strantel Tabletten für Hunde

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Graikija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

Cazitel plus Δισκία Για Σκύλους

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Graikija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

Exitel plus Δισκία Για Σκύλους

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Graikija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

Prazitel plus Δισκία Για Σκύλους

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Vengrija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

Cazitel Plus tabletta kutyák részére A.U.V

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Vengrija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

Exitel Plus tabletta kutyák részére A.U.V

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Vengrija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

Prazitel Plus tabletta kutyák részére A.U.V

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Islandija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

Exitel Plus töflur fyrir hunda

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Islandija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

Prazitel Plus töflur fyrir hunda

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Airija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

Cazitel Plus tablets for dogs

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Airija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

Exitel Plus tablets for dogs

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Airija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

Milaxyn Plus tablets for dogs

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Airija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

Prazical Plus tablets for dogs

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Airija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

Prazitel Plus tablets for dogs

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Airija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

Strantel Plus tablets for dogs

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Airija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

Voxical Plus tablets for dogs

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Italija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

Canitel Plus compresse per cani

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Italija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

Exitel Plus compresse per cani

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Italija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

Prazitel compresse per cani

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Latvija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

Cazitel tablets Tabletes suņiem

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Latvija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

Exitel tablets Tabletes suņiem

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Latvija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

Prazitel tablets Tabletes suņiem

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Lietuva

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

Cazitel Plus tabletės šunims

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Lietuva

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

Exitel Plus tabletės šunims

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Lietuva

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

Prazitel Plus tabletės šunims

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Liuksemburgas

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

Exitel Plus tabletten voor honden

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Liuksemburgas

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

Prazitel Plus tabletten voor honden

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Nyderlandai

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

Cazitel Plus tabletten voor honden

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Nyderlandai

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

Exitel Plus tabletten voor honden

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Nyderlandai

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

Prazitel Plus tabletten voor honden

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Norvegija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

Exitel Vet

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Norvegija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

Prazitel Vet

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Lenkija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

Cazitel Plus tabletki dla psów

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Lenkija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

Exitel Plus tabletki dla psów

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Lenkija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

Prazitel Plus tabletki dla psów

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Portugalija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

Cazitel Plus Comprimidos para cães

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Portugalija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

Exitel Plus Comprimidos para cães

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Portugalija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

Prazitel Plus Comprimidos para cães

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Rumunija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

Cazitel Plus Comprimate pentru câini

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Rumunija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

Exitel Plus Comprimate pentru câini

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Rumunija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

Prazitel Plus Comprimate pentru câini

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Slovakija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

Cazitel Plus tablety pre psov

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Slovakija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

Exitel Plus tablety pre psov

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Slovakija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

Prazitel Plus tablety pre psov

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Slovėnija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

Cazitel Plus tablete za pse

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Slovėnija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

Exitel Plus tablete za pse

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Slovėnija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

Prazitel Plus tablete za pse

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Ispanija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

Cazitel comprimidos para perros

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Ispanija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

Exitel comprimidos para perros

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Ispanija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

Prazitel comprimidos para perros

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Švedija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

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

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Švedija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

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

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Jungtinė Karalystė

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

Cazitel plus tablets for dogs

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Jungtinė Karalystė

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

Easimax plus tablets for dogs

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

Jungtinė Karalystė

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Airija

Prazitel plus tablets for dogs

Praziquantel 50 mg

Pyrantel 50 mg (atitinka 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Šunys

---

III PRIEDAS

VAISTŲ PAVADINIMŲ, VAISTŲ FORMŲ, STIPRUMO, VARTOJIMO BŪDŲ, PAREIŠKĖJŲ VALSTYBĖSE NARĖSE SĄRAŠAS

| Valstybė narė ES/EEE | Pareiškėjas | Sugalvotas pavadinimas | Stiprumas | Vaisto forma | Vartojimo būdas |
| --- | --- | --- | --- | --- | --- |
| AT - Austrija | Napp Pharmaceuticals Limited |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Valstybė narė ES/EEE

Pareiškėjas

Sugalvotas pavadinimas

Stiprumas

Vaisto forma

Vartojimo būdas

AT - Austrija

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

Suslėgta inhaliacinė suspensija

Įkvėpti

AT - Austrija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

AT - Austrija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

BE - Belgija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

BE - Belgija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

BE - Belgija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

BG - Bulgarija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

BG - Bulgarija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

BG - Bulgarija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

CY - Kipras

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

CY - Kipras

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

CY - Kipras

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

CZ - Čekija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

CZ - Čekija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

CZ - Čekija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

DK - Danija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

DK - Danija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

DK - Danija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

FI - Suomija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

FI - Suomija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

FI - Suomija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

FR - Prancūzija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

FR - Prancūzija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

FR - Prancūzija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

DE - Vokietija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

DE - Vokietija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

DE - Vokietija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

IS - Islandija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

IS - Islandija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

IS - Islandija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

IE - Airija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

IE - Airija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

IE - Airija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

IT - Italija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

IT - Italija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

IT - Italija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

LU - Liuksemburgas

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

LU - Liuksemburgas

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

LU - Liuksemburgas

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

NL - Nyderlandai

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

NL - Nyderlandai

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

NL - Nyderlandai

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

NO - Norvegija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

NO - Norvegija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

NO - Norvegija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

PL - Lenkija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

PL - Lenkija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

PL - Lenkija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

PT - Portugalija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

PT - Portugalija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

PT - Portugalija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

RO - Rumunija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

RO - Rumunija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

RO - Rumunija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

SK - Slovakija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

SK - Slovakija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

SK - Slovakija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

SE - Švedija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

SE - Švedija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

SE - Švedija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

UK - Jungtinė Karalystė

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

UK - Jungtinė Karalystė

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

UK - Jungtinė Karalystė

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

---

IV PRIEDAS

VAISTŲ PAVADINIMŲ, VAISTŲ FORMŲ, STIPRUMO, VARTOJIMO BŪDŲ, PAREIŠKĖJŲ VALSTYBĖSE NARĖSE SĄRAŠAS

| Valstybė narė ES/EEE | Pareiškėjas | Sugalvotas pavadinimas | Stiprumas | Vaisto forma | Vartojimo būdas |
| --- | --- | --- | --- | --- | --- |
| AT - Austrija | Napp Pharmaceuticals Limited |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Valstybė narė ES/EEE

Pareiškėjas

Sugalvotas pavadinimas

Stiprumas

Vaisto forma

Vartojimo būdas

AT - Austrija

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

Suslėgta inhaliacinė suspensija

Įkvėpti

AT - Austrija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

AT - Austrija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

BE - Belgija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

BE - Belgija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

BE - Belgija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

BG - Bulgarija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

BG - Bulgarija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

BG - Bulgarija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

CY - Kipras

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

CY - Kipras

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

CY - Kipras

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

CZ - Čekija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

CZ - Čekija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

CZ - Čekija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

DK - Danija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

DK - Danija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

DK - Danija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

FI - Suomija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

FI - Suomija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

FI - Suomija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

FR - Prancūzija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

FR - Prancūzija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

FR - Prancūzija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

DE - Vokietija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

DE - Vokietija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

DE - Vokietija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

IS - Islandija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

IS - Islandija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

IS - Islandija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

IE - Airija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

IE - Airija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

IE - Airija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

IT - Italija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

IT - Italija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

IT - Italija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

LU - Liuksemburgas

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

LU - Liuksemburgas

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

LU - Liuksemburgas

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

NL - Nyderlandai

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

NL - Nyderlandai

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

NL - Nyderlandai

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

NO - Norvegija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

NO - Norvegija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

NO - Norvegija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

PL - Lenkija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

PL - Lenkija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

PL - Lenkija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

PT - Portugalija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

PT - Portugalija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

PT - Portugalija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

RO - Rumunija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

RO - Rumunija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

RO - Rumunija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

SK - Slovakija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

SK - Slovakija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

SK - Slovakija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

SE - Švedija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

SE - Švedija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

SE - Švedija

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

UK - Jungtinė Karalystė

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

UK - Jungtinė Karalystė

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

UK - Jungtinė Karalystė

| Napp Pharmaceuticals 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

Suslėgta inhaliacinė suspensija

Įkvėpti

---