# Eiropas Savienības C 224/2012

| | ISSN 1977-0952
  doi:10.3000/19770952.C_2012.224.lav |
| --- | --- |
| Eiropas Savienības
  Oficiālais Vēstnesis | C 224 |
| | |
| Izdevums latviešu valodā | Informācija un paziņojumi | 55. sējums2012. gada 27. jūlijs |

ISSN 1977-0952

doi:10.3000/19770952.C_2012.224.lav

Eiropas Savienības

Oficiālais Vēstnesis

C 224

Izdevums latviešu valodā

Informācija un paziņojumi

55. sējums2012. gada 27. jūlijs

---

| Paziņojums Nr. | Saturs | Lappuse |
| --- | --- | --- |
| | IV   Paziņojumi |
| | EIROPAS SAVIENĪBAS IESTĀŽU UN STRUKTŪRU SNIEGTI PAZIŅOJUMI |
| 2012/C 224/01 | Eiropas Savienības lēmumu kopsavilkums par zāļu tirdzniecības atļaujām no 2012. gada 1. jūnijs līdz 2012. gada 30. jūnijs(publicēts saskaņā ar 13. vai 38. pantu Eiropas Parlamenta un Padomes Regulā (EK) Nr. 726/2004
  ) | 1 |
| 2012/C 224/02 | Eiropas Savienības lēmumu kopsavilkums par zāļu tirdzniecības atļaujām no 2012. gada 1. jūnijs līdz 2012. gada 30. jūnijs(lēmumi pieņemti saskaņā ar 34. pantu Direktīvā 2001/83/EK vai 38. pantu Direktīvā 2001/82/EK) | 16 |

Paziņojums Nr.

Saturs

Lappuse

IV   Paziņojumi

EIROPAS SAVIENĪBAS IESTĀŽU UN STRUKTŪRU SNIEGTI PAZIŅOJUMI

2012/C 224/01

Eiropas Savienības lēmumu kopsavilkums par zāļu tirdzniecības atļaujām no 2012. gada 1. jūnijs līdz 2012. gada 30. jūnijs(publicēts saskaņā ar 13. vai 38. pantu Eiropas Parlamenta un Padomes Regulā (EK) Nr. 726/2004
  )

(publicēts saskaņā ar 13. vai 38. pantu Eiropas Parlamenta un Padomes Regulā (EK) Nr. 726/2004

)

1

2012/C 224/02

Eiropas Savienības lēmumu kopsavilkums par zāļu tirdzniecības atļaujām no 2012. gada 1. jūnijs līdz 2012. gada 30. jūnijs(lēmumi pieņemti saskaņā ar 34. pantu Direktīvā 2001/83/EK vai 38. pantu Direktīvā 2001/82/EK)

(lēmumi pieņemti saskaņā ar 34. pantu Direktīvā 2001/83/EK vai 38. pantu Direktīvā 2001/82/EK)

16

| LV | |
| --- | --- |

LV

---

IV Paziņojumi

EIROPAS SAVIENĪBAS IESTĀŽU UN STRUKTŪRU SNIEGTI PAZIŅOJUMI

| 27.7.2012 | LV | Eiropas Savienības Oficiālais Vēstnesis | C 224/1 |
| --- | --- | --- | --- |

27.7.2012

LV

Eiropas Savienības Oficiālais Vēstnesis

C 224/1

---

Eiropas Savienības lēmumu kopsavilkums par zāļu tirdzniecības atļaujām no 2012. gada 1. jūnijs līdz 2012. gada 30. jūnijs

(publicēts saskaņā ar 13. vai 38. pantu Eiropas Parlamenta un Padomes Regulā (EK) Nr. 726/2004
   (1)
  )

2012/C 224/01

—   Tirdzniecības atļaujas izsniegšana (13. pants Eiropas Parlamenta un Padomes Regulā (EK) Nr. 726/2004): Pieņemtas

| Lēmuma datums | Zāļu nosaukums | INN (starptautiskais nepatentētais nosaukums) | Tirdzniecības atļaujas turētājs | Ieraksta numurs Kopienas reģistrā | Farmaceitiskā forma | AĶT kods (Anatomiski ķīmiski terapeitiskais kods) | Paziņojuma datums |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 15.06.2012 | Rienso | Ferumoksitols | Takeda Global Research and Development Centre (Europe) Ltd |
| 61 Aldwych, |
| London WC2B 4AE, |
| United Kingdom |

Lēmuma datums

Zāļu nosaukums

INN (starptautiskais nepatentētais nosaukums)

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Farmaceitiskā forma

AĶT kods (Anatomiski ķīmiski terapeitiskais kods)

Paziņojuma datums

15.06.2012

Rienso

Ferumoksitols

Takeda Global Research and Development Centre (Europe) Ltd

61 Aldwych,

London WC2B 4AE,

United Kingdom

EU/1/12/774/001-002

Šķīdums injekcijai

Pending

20.06.2012

—   Tirdzniecības atļaujas izsniegšana (13. pants Eiropas Parlamenta un Padomes Regulā (EK) Nr. 726/2004): Noraidītas

| Lēmuma datums | Zāļu nosaukums | Tirdzniecības atļaujas turētājs | Ieraksta numurs Kopienas reģistrā | Paziņojuma datums |
| --- | --- | --- | --- | --- |
| 21.06.2012 | Folotyn | Allos Therapeutics Limited |
| 71 Knowl Piece, |
| Wilbury Way, |
| Hitchin, Hertfordshire SG4 0TY, |
| United Kingdom |

Lēmuma datums

Zāļu nosaukums

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Paziņojuma datums

21.06.2012

Folotyn

Allos Therapeutics Limited

71 Knowl Piece,

Wilbury Way,

Hitchin, Hertfordshire SG4 0TY,

United Kingdom

—

25.06.2012

—   Tirdzniecības atļaujas grozīšana (13. pants Eiropas Parlamenta un Padomes Regulā (EK) Nr. 726/2004): Pieņemtas

| Lēmuma datums | Zāļu nosaukums | Tirdzniecības atļaujas turētājs | Ieraksta numurs Kopienas reģistrā | Paziņojuma datums |
| --- | --- | --- | --- | --- |
| 01.06.2012 | Osigraft | Olympus Biotech International Limited |
| Raheen Business Park, |
| Limerick, |
| Ireland |

Lēmuma datums

Zāļu nosaukums

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Paziņojuma datums

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

—   Tirdzniecības atļaujas izņemšana no aprites (13. pants Eiropas Parlamenta un Padomes Regulā (EK) Nr. 726/2004)

| Lēmuma datums | Zāļu nosaukums | Tirdzniecības atļaujas turētājs | Ieraksta numurs Kopienas reģistrā | Paziņojuma datums |
| --- | --- | --- | --- | --- |
| 28.06.2012 | Hexavac | Aventis Pasteur MSD |
| 8, rue Jonas Salk, |
| 69007 Lyon, |
| France |

Lēmuma datums

Zāļu nosaukums

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Paziņojuma datums

28.06.2012

Hexavac

Aventis Pasteur MSD

8, rue Jonas Salk,

69007 Lyon,

France

EU/1/00/147/001-012

04.07.2012

—   Tirdzniecības atļaujas izsniegšana (38. pants Eiropas Parlamenta un Padomes Regulā (EK) Nr. 726/2004
   (2)
  ): Pieņemtas

| Lēmuma datums | Zāļu nosaukums | INN (starptautiskais nepatentētais nosaukums) | Tirdzniecības atļaujas turētājs | Ieraksta numurs Kopienas reģistrā | Farmaceitiskā forma | AĶT kods (Anatomiski ķīmiski terapeitiskais kods) | Paziņojuma datums |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 14.06.2012 | Porcilis ColiClos | - | Intervet International B.V. |
| Wim de Körverstraat 35, |
| 5831 AN Boxmeer, |
| Nederland |

Lēmuma datums

Zāļu nosaukums

INN (starptautiskais nepatentētais nosaukums)

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Farmaceitiskā forma

AĶT kods (Anatomiski ķīmiski terapeitiskais kods)

Paziņojuma datums

14.06.2012

Porcilis ColiClos

-

Intervet International B.V.

Wim de Körverstraat 35,

5831 AN Boxmeer,

Nederland

EU/2/12/141/001-009

Suspensija injekcijai

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

Liofilizāts izsmidzināmas vakcīnas suspensijas pagatavošanai

QI01AE04

20.06.2012

—   Tirdzniecības atļaujas grozīšana (38. pants Eiropas Parlamenta un Padomes Regulā (EK) Nr. 726/2004): Pieņemtas

| Lēmuma datums | Zāļu nosaukums | Tirdzniecības atļaujas turētājs | Ieraksta numurs Kopienas reģistrā | Paziņojuma datums |
| --- | --- | --- | --- | --- |
| 11.06.2012 | Activyl | Intervet International B.V. |
| Wim de Körverstraat 35, |
| 5831 AN Boxmeer, |
| Nederland |

Lēmuma datums

Zāļu nosaukums

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Paziņojuma datums

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

Ikvienam, kurš vēlas apskatīt publisko novērtējuma ziņojumu par attiecīgajām zālēm un ar tām saistītos lēmumus, jāsazinās ar:

| 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)  OV L 136, 30.4.04, 1. lpp.

(2)  OV L 136, 30.4.04, 1. lpp.

---

| 27.7.2012 | LV | Eiropas Savienības Oficiālais Vēstnesis | C 224/16 |
| --- | --- | --- | --- |

27.7.2012

LV

Eiropas Savienības Oficiālais Vēstnesis

C 224/16

---

Eiropas Savienības lēmumu kopsavilkums par zāļu tirdzniecības atļaujām no 2012. gada 1. jūnijs līdz 2012. gada 30. jūnijs

(lēmumi pieņemti saskaņā ar 34. pantu Direktīvā 2001/83/EK
   (1)
  vai 38. pantu Direktīvā 2001/82/EK
   (2)
  )

2012/C 224/02

—   Valsts tirdzniecības atļaujas izsniegšana, uzturēšana vai grozīšana

| Lēmuma datums | Zāļu nosaukums(-i) | Tirdzniecības atļaujas turētājs(-i) | Attiecīgā dalībvalsts | Paziņojuma datums |
| --- | --- | --- | --- | --- |
| 14/6/2012 | Tilmicosin | Skatīt pielikumu I | Skatīt pielikumu I | 18/6/2012 |
| 18/6/2012 | Milaxyn plus and associated names | Skatīt pielikumu II | Skatīt pielikumu II | 20/6/2012 |
| 28/6/2012 | Flutiform and associated names | Skatīt pielikumu III | Skatīt pielikumu III | 3/7/2012 |
| 28/6/2012 | Iffeza and associated names | Skatīt pielikumu IV | Skatīt pielikumu IV | 3/7/2012 |

Lēmuma datums

Zāļu nosaukums(-i)

Tirdzniecības atļaujas turētājs(-i)

Attiecīgā dalībvalsts

Paziņojuma datums

14/6/2012

Tilmicosin

Skatīt pielikumu I

Skatīt pielikumu I

18/6/2012

18/6/2012

Milaxyn plus and associated names

Skatīt pielikumu II

Skatīt pielikumu II

20/6/2012

28/6/2012

Flutiform and associated names

Skatīt pielikumu III

Skatīt pielikumu III

3/7/2012

28/6/2012

Iffeza and associated names

Skatīt pielikumu IV

Skatīt pielikumu IV

3/7/2012

---

(1)  OV L 311, 28.11.01, 67. lpp.

(2)  OV L 311, 28.11.01, 1. lpp.

---

I PIELIKUMS

VETERINĀRO ZĀĻU NOSAUKUMU, ZĀĻU FORMU, AKTĪVO VIELU, STIPRUMU, DZĪVNIEKU SUGU, REĢISTRĀCIJAS APLIECĪBAS ĪPAŠNIEKU SARAKTS DALĪBVALSTĪS

| ES un EEZ dalībvalsts | Reģistrācijas apliecības īpašnieks | Nosaukums | SNN | Stiprums | Zāļu forma | Dzīvnieku sugas |
| --- | --- | --- | --- | --- | --- | --- |
| Austrija | Richter Pharma AG |
| Feldgasse 19 |
| A-4600 Wels |
| AUSTRIJA |

ES un EEZ dalībvalsts

Reģistrācijas apliecības īpašnieks

Nosaukums

SNN

Stiprums

Zāļu forma

Dzīvnieku sugas

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 tilmikozīna uz kg premiksa

Premikss ārstnieciskajai dzīvnieku barībai

Cūkas, truši

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 tilmikozīna uz kg premiksa

Premikss ārstnieciskajai dzīvnieku barībai

Cūkas, truši

Beļģija

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

Eli Lilly Benelux N.V.

Elanco Animal Health

Rue de l'Etuve 52

Stoofstraat 52

1000 Brussel

BEĻĢIJA

Pulmotil 40 VET Pre-mix

Tilmicosin (as phosphate)

40 g tilmikozīna uz kg premiksa

Premikss ārstnieciskajai dzīvnieku barībai

Cūkas, truši

Beļģija

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

Eli Lilly Benelux N.V.

Elanco Animal Health

Rue de l'Etuve 52

Stoofstraat 52

1000 Brussel

BEĻĢIJA

Pulmotil 100 VET Pre-mix

Tilmicosin (as phosphate)

100 g tilmikozīna uz kg premiksa

Premikss ārstnieciskajai dzīvnieku barībai

Cūkas, truši

Beļģija

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

Eli Lilly Benelux N.V.

Elanco Animal Health

Rue de l'Etuve 52

Stoofstraat 52

1000 Brussel

BEĻĢIJA

Pulmotil 100 Granules

Tilmicosin (as phosphate)

100 g tilmikozīna uz kg premiksa

Premikss ārstnieciskajai dzīvnieku barībai

Cūkas, truši

Beļģija

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

Eli Lilly Benelux N.V.

Elanco Animal Health

Rue de l'Etuve 52

Stoofstraat 52

1000 Brussel

BEĻĢIJA

Pulmotil 200 VET Pre-mix

Tilmicosin (as phosphate)

200 g tilmikozīna uz kg premiksa

Premikss ārstnieciskajai dzīvnieku barībai

Cūkas, truši

Kipra

| 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 tilmikozīna uz kg premiksa

Premikss ārstnieciskajai dzīvnieku barībai

Cūkas, truši

Čehijas Republika

| 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 tilmikozīna uz kg premiksa

Premikss ārstnieciskajai dzīvnieku barībai

Cūkas, truši

Vācija

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

Lilly Deutschland GmbH

Abt. Elanco Animal Health

Werner-Reimers-Str. 2-4

D-61352 Bad Homburg

VĀCIJA

Pulmotil G 40

Tilmicosin (as phosphate)

40 g tilmikozīna uz kg premiksa

Premikss ārstnieciskajai dzīvnieku barībai

Cūkas, truši

Vācija

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

Lilly Deutschland GmbH

Abt. Elanco Animal Health

Werner-Reimers-Str. 2-4

D-61352 Bad Homburg

VĀCIJA

Pulmotil G 100

Tilmicosin (as phosphate)

100 g tilmikozīna uz kg premiksa

Premikss ārstnieciskajai dzīvnieku barībai

Cūkas, truši

Vācija

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

Lilly Deutschland GmbH

Abt. Elanco Animal Health

Werner-Reimers-Str. 2-4

D-61352 Bad Homburg

VĀCIJA

Pulmotil G 20 % AMV

Tilmicosin (as phosphate)

200 g tilmikozīna uz kg premiksa

Premikss ārstnieciskajai dzīvnieku barībai

Cūkas, truši

Dānija

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

Elanco Animal Health

Eli Lilly Danmark A/S

Nybrovej 110

DK-2800 Kongens Lyngby

DĀNIJA

Pulmotil Vet.

Tilmicosin (as phosphate)

40 g tilmikozīna uz kg premiksa

Premikss ārstnieciskajai dzīvnieku barībai

Cūkas, truši

Dānija

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

Elanco Animal Health

Eli Lilly Danmark A/S

Nybrovej 110

DK-2800 Kongens Lyngby

DĀNIJA

Pulmotil Vet.

Tilmicosin (as phosphate)

100 g tilmikozīna uz kg premiksa

Premikss ārstnieciskajai dzīvnieku barībai

Cūkas, truši

Dānija

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

Elanco Animal Health

Eli Lilly Danmark A/S

Nybrovej 110

DK-2800 Kongens Lyngby

DĀNIJA

Pulmotil Vet.

Tilmicosin (as phosphate)

200 g tilmikozīna uz kg premiksa

Premikss ārstnieciskajai dzīvnieku barībai

Cūkas, truši

Grieķija

| 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 tilmikozīna uz kg premiksa

Premikss ārstnieciskajai dzīvnieku barībai

Cūkas, truši

Spānija

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

ELANCO VALQUÍMICA, S.A.

Avda. de la Industria 30

28108 Alcobendas

Madrid

SPĀNIJA

PULMOTIL G 40

Tilmicosin (as phosphate)

40 g tilmikozīna uz kg premiksa

Premikss ārstnieciskajai dzīvnieku barībai

Cūkas, truši

Spānija

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

ELANCO VALQUÍMICA, S.A.

Avda. de la Industria 30

28108 Alcobendas

Madrid

SPĀNIJA

PULMOTIL G 100

Tilmicosin (as phosphate)

100 g tilmikozīna uz kg premiksa

Premikss ārstnieciskajai dzīvnieku barībai

Cūkas, truši

Spānija

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

ELANCO VALQUÍMICA, S.A.

Avda. de la Industria 30

28108 Alcobendas

Madrid

SPĀNIJA

PULMOTIL G 200

Tilmicosin (as phosphate)

200 g tilmikozīna uz kg premiksa

Premikss ārstnieciskajai dzīvnieku barībai

Cūkas, truši

Francija

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

LILLY France

13 Rue Pages

92158 Suresnes

Cedex

FRANCIJA

PULMOTIL TILMICOSINE 40 PORC-LAPIN

Tilmicosin (as phosphate)

40 g tilmikozīna uz kg premiksa

Premikss ārstnieciskajai dzīvnieku barībai

Cūkas, truši

Francija

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

QALIAN

34 Rue Jean Monnet

Zi D'Etriche

49500 Serge

FRANCIJA

SANTAMIX TILMICOSINE 40 PORCINS - LAPINS

Tilmicosin (as phosphate)

40 g tilmikozīna uz kg premiksa

Premikss ārstnieciskajai dzīvnieku barībai

Cūkas, truši

Francija

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

SOGEVAL

200 Route de Mayenne

Zi des Touches

53000 Laval

FRANCIJA

CONCENTRAT VO 08 TILMICOSINE PORCIN-LAPIN

Tilmicosin (as phosphate)

40 g tilmikozīna uz kg premiksa

Premikss ārstnieciskajai dzīvnieku barībai

Cūkas, truši

Ungārija

| 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 tilmikozīna uz kg premiksa

Premikss ārstnieciskajai dzīvnieku barībai

Cūkas, truši

Īrija

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

Eli Lilly and Company Ltd

Elanco Animal Health

Lilly House

Priestly Road

Basingstoke

Hampshire RG24 9NL

APVIENOTĀ KARALISTE

Pulmotil G40 Pre-mix for medicated feedingstuff

Tilmicosin (as phosphate)

40 g tilmikozīna uz kg premiksa

Premikss ārstnieciskajai dzīvnieku barībai

Cūkas, truši

Īrija

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

Eli Lilly and Company Ltd

Elanco Animal Health

Lilly House

Priestly Road

Basingstoke

Hampshire RG24 9NL

APVIENOTĀ KARALISTE

Pulmotil G100 Pre-mix for medicated feedingstuff

Tilmicosin (as phosphate)

100 g tilmikozīna uz kg premiksa

Premikss ārstnieciskajai dzīvnieku barībai

Cūkas, truši

Īrija

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

Eli Lilly and Company Ltd

Elanco Animal Health

Lilly House

Priestly Road

Basingstoke

Hampshire RG24 9NL

APVIENOTĀ KARALISTE

Pulmotil G200 Pre-mix for medicated feedingstuff

Tilmicosin (as phosphate)

200 g tilmikozīna uz kg premiksa

Premikss ārstnieciskajai dzīvnieku barībai

Cūkas, truši

Itālija

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

ELI LILLY ITALIA SPA

VIA GRAMSCI

731/733 - SESTO FIORENTINO – FI

ITĀLIJA

PULMOTIL G 200 PRE-MIX

Tilmicosin (as phosphate)

200 g tilmikozīna uz kg premiksa

Premikss ārstnieciskajai dzīvnieku barībai

Cūkas, truši

Itālija

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

CEVA VETEM SpA

via Colleoni

15 20041 Agrate Brianza (MB)

ITĀLIJA

MICLOZAN 200 PRE-MIX

Tilmicosin (as phosphate)

200 g tilmikozīna uz kg premiksa

Premikss ārstnieciskajai dzīvnieku barībai

Cūkas, truši

Nīderlande

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

Eli Lilly Nederland B.V.

Elanco Animal Health

Grootslag 1-5

3991 RA Houten

NĪDERLANDE

PULMOTIL® G40 pre-mix voor gemedicineerd voer voor varkens

Tilmicosin (as phosphate)

40 g tilmikozīna uz kg premiksa

Premikss ārstnieciskajai dzīvnieku barībai

Cūkas, truši

Nīderlande

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

Eli Lilly Nederland B.V.

Elanco Animal Health

Grootslag 1-5

3991 RA Houten

NĪDERLANDE

PULMOTIL® G100 pre-mix voor gemedicineerd voer voor varkens

Tilmicosin (as phosphate)

100 g tilmikozīna uz kg premiksa

Premikss ārstnieciskajai dzīvnieku barībai

Cūkas, truši

Nīderlande

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

Eli Lilly Nederland B.V.

Elanco Animal Health

Grootslag 1-5

3991 RA Houten

NĪDERLANDE

PULMOTIL® G200 pre-mix voor gemedicineerd voer voor varkens

Tilmicosin (as phosphate)

200 g tilmikozīna uz kg premiksa

Premikss ārstnieciskajai dzīvnieku barībai

Cūkas, truši

Portugāle

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

Lilly Portugal – Produtos Farmacźuticos, Lda.

Rua Cesário Verde, no5- piso 4

Linda-a-Pastora

2790 – 326 QUEIJAS

PORTUGĀLE

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

Tilmicosin (as phosphate)

40 g tilmikozīna uz kg premiksa

Premikss ārstnieciskajai dzīvnieku barībai

Cūkas, truši

Portugāle

| Lilly Portugal – Produtos Farmacźuticos, Lda. |
| --- |
| Rua Cesįrio Verde, nŗ5- piso 4 |
| Linda-a-Pastora |
| 2790 – 326 QUEIJAS |
| PORTUGĀLE |

Lilly Portugal – Produtos Farmacźuticos, Lda.

Rua Cesįrio Verde, nŗ5- piso 4

Linda-a-Pastora

2790 – 326 QUEIJAS

PORTUGĀLE

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

Tilmicosin (as phosphate)

100 g tilmikozīna uz kg premiksa

Premikss ārstnieciskajai dzīvnieku barībai

Cūkas, truši

Portugāle

| Lilly Portugal – Produtos Farmacźuticos, Lda. |
| --- |
| Rua Cesįrio Verde, nŗ5- piso 4 |
| Linda-a-Pastora |
| 2790 – 326 QUEIJAS |
| PORTUGĀLE |

Lilly Portugal – Produtos Farmacźuticos, Lda.

Rua Cesįrio Verde, nŗ5- piso 4

Linda-a-Pastora

2790 – 326 QUEIJAS

PORTUGĀLE

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

Tilmicosin (as phosphate)

200 g tilmikozīna uz kg premiksa

Premikss ārstnieciskajai dzīvnieku barībai

Cūkas, truši

Rumānija

| 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 tilmikozīna uz kg premiksa

Premikss ārstnieciskajai dzīvnieku barībai

Cūkas, truši

Slovākija

| Elli Lilly and Company Limited |
| --- |
| Speke Operations Fleming RoadSpeke |
| Liverpool |
| L24 9LN |
| APVIENOTĀ KARALISTE |

Elli Lilly and Company Limited

Speke Operations Fleming RoadSpeke

Liverpool

L24 9LN

APVIENOTĀ KARALISTE

Pulmotil G 200 pre-mix ad us.vet.

Tilmicosin (as phosphate)

200 g tilmikozīna uz kg premiksa

Premikss ārstnieciskajai dzīvnieku barībai

Cūkas, truši

Apvienotā Karaliste

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

Eli Lilly and Company Ltd

Elanco Animal Health

Lilly House

Priestly Road

Basingstoke

Hampshire RG24 9NL

APVIENOTĀ KARALISTE

Pulmotil G100 Pre-mix for Medicated Feedingstuff

Tilmicosin (as phosphate)

100 g tilmikozīna uz kg premiksa

Premikss ārstnieciskajai dzīvnieku barībai

Cūkas, truši

Apvienotā Karaliste

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

Eli Lilly and Company Ltd

Elanco Animal Health

Lilly House

Priestly Road

Basingstoke

Hampshire RG24 9NL

APVIENOTĀ KARALISTE

Pulmotil G200 Pre-mix for Medicated Feedingstuff

Tilmicosin (as phosphate)

200 g tilmikozīna uz kg premiksa

Premikss ārstnieciskajai dzīvnieku barībai

Cūkas, truši

---

II PIELIKUMS

VETERINĀRO ZĀĻU NOSAUKUMU, FARMACEITISKĀS FORMAS, STIPRUMU, DZĪVNIEKU SUGU, IEVADĪŠANAS VEIDS, REĢISTRĀCIJAS APLIECĪBU ĪPAŠNIEKU DALĪBVALSTĪS SARAKSTS

| Dalībvalsts ES/EEZ | Reģistrācijas apliecības īpašnieks | Nosaukums | INN/Stiprumi | Faemaceitiskas formas | Dzīvnieku sugus |
| --- | --- | --- | --- | --- | --- |
| Austrija | Chanelle Pharmaceuticals Manufacturing Ltd. |
| IE-Loughrea |
| Co. Galway |
| Īrija |

Dalībvalsts ES/EEZ

Reģistrācijas apliecības īpašnieks

Nosaukums

INN/Stiprumi

Faemaceitiskas formas

Dzīvnieku sugus

Austrija

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

Exitel Plus Tabletten für Hunde

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Austrija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

Prazitel Plus Tabletten für Hunde

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Beļģija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

Cazitel Plus Tabletten für Hunde

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Beļģija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

Exitel Plus Tabletten für Hunde

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Beļģija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

Prazitel Plus Tabletten für Hunde

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Bulgārija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

Cazitel Plus таблетки за кучета

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Bulgārija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

Exitel Plus таблетки за кучета

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Bulgārija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

Prazitel Plus таблетки за кучета

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Kipra

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

Exitel Plus Δισκία Για Σκύλους

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Čehija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

Cazitel Plus tablety pro psy

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Čehija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

Exitel Plus tablety pro psy

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Čehija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

Prazitel Plus tablety pro psy

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Dānija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

Exitel Plus

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Dānija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

Prazitel Plus

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Igaunija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

Cazitel Plus tabletid koertele

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Igaunija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

Exitel Plus tabletid koertele

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Somija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

Cazitel Plus 50 mg/144 mg/150 mg tablet

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Somija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

Exitel Plus 50 mg/144 mg/150 mg tablet

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Somija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

Prazitel Plus 50 mg/144 mg/150 mg tablet

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Francija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

Milaxyn comprimé pour chiens

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Francija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

Strantel comprimé pour chiens

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Francija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

Prazical comprimé pour chiens

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Francija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

Voxical comprimé pour chiens

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Vācija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

Cazitel Tabletten für Hunde

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Vācija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

Exitel Tabletten für Hunde

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Vācija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

Strantel Tabletten für Hunde

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Grieķija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

Cazitel plus Δισκία Για Σκύλους

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Grieķija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

Exitel plus Δισκία Για Σκύλους

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Grieķija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

Prazitel plus Δισκία Για Σκύλους

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Ungārija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

Cazitel Plus tabletta kutyák részére A.U.V

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Ungārija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

Exitel Plus tabletta kutyák részére A.U.V

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Ungārija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

Prazitel Plus tabletta kutyák részére A.U.V

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Islande

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

Exitel Plus töflur fyrir hunda

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Islande

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

Prazitel Plus töflur fyrir hunda

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Īrija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

Cazitel Plus tablets for dogs

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Īrija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

Exitel Plus tablets for dogs

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Īrija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

Milaxyn Plus tablets for dogs

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Īrija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

Prazical Plus tablets for dogs

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Īrija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

Prazitel Plus tablets for dogs

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Īrija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

Strantel Plus tablets for dogs

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Īrija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

Voxical Plus tablets for dogs

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Itālija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

Canitel Plus compresse per cani

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Itālija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

Exitel Plus compresse per cani

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Itālija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

Prazitel compresse per cani

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Latvija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

Cazitel tablets Tabletes suņiem

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Latvija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

Exitel tablets Tabletes suņiem

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Latvija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

Prazitel tablets Tabletes suņiem

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Lietuva

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

Cazitel Plus tabletės šunims

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Lietuva

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

Exitel Plus tabletės šunims

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Lietuva

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

Prazitel Plus tabletės šunims

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Luksemburga

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

Exitel Plus tabletten voor honden

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Luksemburga

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

Prazitel Plus tabletten voor honden

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Nīderlande

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

Cazitel Plus tabletten voor honden

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Nīderlande

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

Exitel Plus tabletten voor honden

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Nīderlande

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

Prazitel Plus tabletten voor honden

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Norvēģija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

Exitel Vet

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Norvēģija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

Prazitel Vet

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Polija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

Cazitel Plus tabletki dla psów

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Polija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

Exitel Plus tabletki dla psów

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Polija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

Prazitel Plus tabletki dla psów

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Portugāle

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

Cazitel Plus Comprimidos para cães

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Portugāle

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

Exitel Plus Comprimidos para cães

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Portugāle

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

Prazitel Plus Comprimidos para cães

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Rumānija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

Cazitel Plus Comprimate pentru câini

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Rumānija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

Exitel Plus Comprimate pentru câini

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Rumānija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

Prazitel Plus Comprimate pentru câini

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Slovākija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

Cazitel Plus tablety pre psov

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Slovākija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

Exitel Plus tablety pre psov

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Slovākija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

Prazitel Plus tablety pre psov

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Slovena

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

Cazitel Plus tablete za pse

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Slovena

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

Exitel Plus tablete za pse

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Slovena

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

Prazitel Plus tablete za pse

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Spānija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

Cazitel comprimidos para perros

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Spānija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

Exitel comprimidos para perros

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Spānija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

Prazitel comprimidos para perros

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Zviedrija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

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

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Zviedrija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

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

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Lielbritānija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

Cazitel plus tablets for dogs

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Lielbritānija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

Easimax plus tablets for dogs

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

Lielbritānija

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

Chanelle Pharmaceuticals Manufacturing Ltd.

IE-Loughrea

Co. Galway

Īrija

Prazitel plus tablets for dogs

Praziquantel 50 mg

Pyrantel 50 mg (ekvivalents 144 mg pyrantel embonate)

Febantel 150 mg

Tabletes

Suņi

---

III PIELIKUMS

ZĀĻU NOSAUKUMI, ZĀĻU FORMA, STIPRUMS, LIETOŠANAS VEIDS, PIETEIKUMA IESNIEDZĒJI DALĪBVALSTĪS

| Dalībvalsts ES/EEA | Pieteikuma iesniedzējs | Piešķirtais nosaukums | Stiprums | Zāļu forma | Lietošanas veids |
| --- | --- | --- | --- | --- | --- |
| AT - Austrija | Napp Pharmaceuticals Limited |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Dalībvalsts ES/EEA

Pieteikuma iesniedzējs

Piešķirtais nosaukums

Stiprums

Zāļu forma

Lietošanas veids

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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

BE - Beļģija

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

BE - Beļģija

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

BE - Beļģija

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

BG - Bulgārija

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

BG - Bulgārija

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

BG - Bulgārija

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

CY - Kipra

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

CY - Kipra

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

CY - Kipra

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

CZ - Čehijas Republika

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

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Flutiform®

50 mcg/5 mcg

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

CZ - Čehijas Republika

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

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Flutiform®

125 mcg/5 mcg

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

CZ - Čehijas Republika

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

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Flutiform®

250 mcg/10 mcg

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

DK - Dānija

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

DK - Dānija

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

DK - Dānija

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

FI - Somija

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

FI - Somija

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

FI - Somija

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

FR - Francija

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

FR - Francija

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

FR - Francija

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

DE - Vācija

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

DE - Vācija

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

DE - Vācija

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

IS - Islande

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

IS - Islande

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

IS - Islande

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

IE - Īrija

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

IE - Īrija

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

IE - Īrija

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

IT - Itālija

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

IT - Itālija

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

IT - Itālija

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

LU - Luksemburga

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

LU - Luksemburga

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

LU - Luksemburga

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

NL - Nīderlande

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

NL - Nīderlande

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

NL - Nīderlande

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

NO - Norvēģija

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

NO - Norvēģija

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

NO - Norvēģija

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

PL - Polija

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

PL - Polija

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

PL - Polija

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

PT - Portugāle

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

PT - Portugāle

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

PT - Portugāle

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

RO - Rumānija

| Napp Pharmaceuticals 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 micrògrame/5 micrograme suspensie de inhalat presurizată

50 mcg/5 mcg

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

RO - Rumānija

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

RO - Rumānija

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

SK - Slovākijas Republika

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

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Flutiform® 50/5 μg

50 mcg/5 mcg

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

SK - Slovākijas Republika

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

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Flutiform® 125/5 μg

125 mcg/5 mcg

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

SK - Slovākijas Republika

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

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Flutiform® 250/10 μg

250 mcg/10 mcg

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

SE - Zviedrija

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

SE - Zviedrija

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

SE - Zviedrija

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

UK - Lielbritānija

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

UK - Lielbritānija

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

UK - Lielbritānija

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

---

IV PIELIKUMS

ZĀĻU NOSAUKUMI, ZĀĻU FORMA, STIPRUMS, LIETOŠANAS VEIDS, PIETEIKUMA IESNIEDZĒJI DALĪBVALSTĪS

| Dalībvalsts ES/EEA | Pieteikuma iesniedzējs | Piešķirtais nosaukums | Stiprums | Zāļu forma | Lietošanas veids |
| --- | --- | --- | --- | --- | --- |
| AT - Austrija | Napp Pharmaceuticals Limited |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0GW |
| United Kingdom |

Dalībvalsts ES/EEA

Pieteikuma iesniedzējs

Piešķirtais nosaukums

Stiprums

Zāļu forma

Lietošanas veids

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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

BE - Beļģija

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

BE - Beļģija

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

BE - Beļģija

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

BG - Bulgārija

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

BG - Bulgārija

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

BG - Bulgārija

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

CY - Kipra

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

CY - Kipra

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

CY - Kipra

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

CZ - Čehijas Republika

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

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Iffeza

50 mcg/5 mcg

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

CZ - Čehijas Republika

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

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Iffeza

125 mcg/5 mcg

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

CZ - Čehijas Republika

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

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Iffeza

250 mcg/10 mcg

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

DK - Dānija

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

DK - Dānija

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

DK - Dānija

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

FI - Somija

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

FI - Somija

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

FI - Somija

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

FR - Francija

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

FR - Francija

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

FR - Francija

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

DE - Vācija

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

DE - Vācija

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

DE - Vācija

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

IS - Islande

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

IS - Islande

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

IS - Islande

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

IE - Īrija

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

IE - Īrija

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

IE - Īrija

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

IT - Itālija

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

IT - Itālija

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

IT - Itālija

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

LU - Luksemburga

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

LU - Luksemburga

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

LU - Luksemburga

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

NL - Nīderlande

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

NL - Nīderlande

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

NL - Nīderlande

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

NO - Norvēģija

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

NO - Norvēģija

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

NO - Norvēģija

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

PL - Polija

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

PL - Polija

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

PL - Polija

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

PT - Portugāle

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

PT - Portugāle

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

PT - Portugāle

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

RO - Rumānija

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

RO - Rumānija

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

RO - Rumānija

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

SK - Slovākijas Republika

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

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Iffeza 50/5 μg

50 mcg/5 mcg

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

SK - Slovākijas Republika

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

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Iffeza 125/5 μg

125 mcg/5 mcg

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

SK - Slovākijas Republika

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

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Iffeza 250/10 μg

250 mcg/10 mcg

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

SE - Zviedrija

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

SE - Zviedrija

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

SE - Zviedrija

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

UK - Lielbritānija

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

UK - Lielbritānija

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

UK - Lielbritānija

| Napp Pharmaceuticals 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

Aerosols inhalācijām, zem spiediena, suspensija

Inhalācijām

---