# Euroopa Liidu C 359/2010

| | ISSN 1725-5171
  doi:10.3000/17255171.C_2010.359.est |
| --- | --- |
| Euroopa Liidu
  Teataja | C 359 |
| | |
| Eestikeelne väljaanne | Teave ja teatised | 53. köide31. detsember 2010 |

ISSN 1725-5171

doi:10.3000/17255171.C_2010.359.est

Euroopa Liidu

Teataja

C 359

Eestikeelne väljaanne

Teave ja teatised

53. köide31. detsember 2010

---

| Teatis nr | Sisukord | Lehekülg |
| --- | --- | --- |
| | IV   Teave |
| | TEAVE EUROOPA LIIDU INSTITUTSIOONIDELT, ORGANITELT JA ASUTUSTELT |
| | Euroopa Komisjon |
| 2010/C 359/01 | Ravimite müügilubasid käsitlevate Euroopa Liidu otsuste kokkuvõte alates 1. septembrist 2010 kuni 31. oktoobrini 2010(Avaldatud vastavalt Euroopa Parlamendi ja nõukogu määruse (EÜ) nr 726/2004 artiklile 13 või 38
  ) | 1 |
| 2010/C 359/02 | Ravimite müügilubasid käsitlevate Euroopa Liidu otsuste kokkuvõte alates 1. juulist 2010 kuni 31. augustini 2010(Direktiivi 2001/83/EÜ artikli 34
  või direktiivi 2001/82/EÜ artikli 38
  kohaselt vastu võetud otsused) | 17 |
| 2010/C 359/03 | Ravimite müügilubasid käsitlevate Euroopa Liidu otsuste kokkuvõte alates 1. septembrist 2010 kuni 31. oktoobrini 2010(Direktiivi 2001/83/EÜ artikli 34
  või direktiivi 2001/82/EÜ artikli 38
  kohaselt vastu võetud otsused) | 18 |

Teatis nr

Sisukord

Lehekülg

IV   Teave

TEAVE EUROOPA LIIDU INSTITUTSIOONIDELT, ORGANITELT JA ASUTUSTELT

Euroopa Komisjon

2010/C 359/01

Ravimite müügilubasid käsitlevate Euroopa Liidu otsuste kokkuvõte alates 1. septembrist 2010 kuni 31. oktoobrini 2010(Avaldatud vastavalt Euroopa Parlamendi ja nõukogu määruse (EÜ) nr 726/2004 artiklile 13 või 38
  )

(Avaldatud vastavalt Euroopa Parlamendi ja nõukogu määruse (EÜ) nr 726/2004 artiklile 13 või 38

)

1

2010/C 359/02

Ravimite müügilubasid käsitlevate Euroopa Liidu otsuste kokkuvõte alates 1. juulist 2010 kuni 31. augustini 2010(Direktiivi 2001/83/EÜ artikli 34
  või direktiivi 2001/82/EÜ artikli 38
  kohaselt vastu võetud otsused)

(Direktiivi 2001/83/EÜ artikli 34

või direktiivi 2001/82/EÜ artikli 38

kohaselt vastu võetud otsused)

17

2010/C 359/03

Ravimite müügilubasid käsitlevate Euroopa Liidu otsuste kokkuvõte alates 1. septembrist 2010 kuni 31. oktoobrini 2010(Direktiivi 2001/83/EÜ artikli 34
  või direktiivi 2001/82/EÜ artikli 38
  kohaselt vastu võetud otsused)

(Direktiivi 2001/83/EÜ artikli 34

või direktiivi 2001/82/EÜ artikli 38

kohaselt vastu võetud otsused)

18

| ET | |
| --- | --- |

ET

---

IV Teave

TEAVE EUROOPA LIIDU INSTITUTSIOONIDELT, ORGANITELT JA ASUTUSTELT

Euroopa Komisjon

| 31.12.2010 | ET | Euroopa Liidu Teataja | C 359/1 |
| --- | --- | --- | --- |

31.12.2010

ET

Euroopa Liidu Teataja

C 359/1

---

Ravimite müügilubasid käsitlevate Euroopa Liidu otsuste kokkuvõte alates 1. septembrist 2010 kuni 31. oktoobrini 2010

(Avaldatud vastavalt Euroopa Parlamendi ja nõukogu määruse (EÜ) nr 726/2004 artiklile 13 või 38
   (1)
  )

2010/C 359/01

—   Müügiloa väljaandmine (Euroopa Parlamendi ja nõukogu määruse (EÜ) nr 726/2004 artikkel 13): Heaks kiidetud

| Otsuse tegemise kuupäev | Ravimi nimetus | Rahvusvaheline mittekaubanduslik nimetus (INN) | Müügiloa omanik | Kande number ühenduse registris | Ravimivorm | ATC-kood (anatoomilis-terapeutiline keemiline kood) | Teatamise kuupäev |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 1.9.2010 | Brinavess | vernakalantvesinikkloriid | Merck Sharp & Dohme Limited |
| Hertford Road, |
| Hodderson, |
| Hertfordshire |
| EN11 9BU, |
| United Kingdom |

Otsuse tegemise kuupäev

Ravimi nimetus

Rahvusvaheline mittekaubanduslik nimetus (INN)

Müügiloa omanik

Kande number ühenduse registris

Ravimivorm

ATC-kood (anatoomilis-terapeutiline keemiline kood)

Teatamise kuupäev

1.9.2010

Brinavess

vernakalantvesinikkloriid

Merck Sharp & Dohme Limited

Hertford Road,

Hodderson,

Hertfordshire

EN11 9BU,

United Kingdom

EU/1/10/645/001-002

Kontsentraat infusioonilahuse valmistamiseks

C01BG11

6.9.2010

1.9.2010

Sycrest

asenapiin

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

N.V. Organon

Kloosterstraat 6,

5349 AB Oss,

Nederland

EU/1/10/640/001-006

Keelealused tabletid

N05AH05

6.9.2010

6.9.2010

Rapiscan

regadenosoon

| Gilead Sciences International Limited |
| --- |
| Cambridge |
| CB21 6GT |
| United Kingdom |

Gilead Sciences International Limited

Cambridge

CB21 6GT

United Kingdom

EU/1/10/643/001

Süstelahus

C01EB21

8.9.2010

17.9.2010

Ibandronic Acid Teva

ibandroonhape

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

Teva Pharma B.V.

Computerweg 10,

3542 DR Utrecht,

Nederland

EU/1/10/642/001-004

Õhukese polümeerikattega tablett

M05BA06

21.9.2010

30.9.2010

Telmisartan Actavis

telmisartanum

| Actavis Group PTC ehf. |
| --- |
| Reykjavíkurvegi 76-78, |
| 220 Hafnarfjörður, |
| Iceland |

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78,

220 Hafnarfjörður,

Iceland

EU/1/10/639/001-030

Tablett

C09CA07

5.10.2010

7.10.2010

Myclausen

mükofenolaatmofetiil

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

Herbert J. Passauer GmbH & Co. KG

Stubenrauchstrasse 33,

14167 Berlin,

Deutschland

EU/1/10/647/001-002

Õhukese polümeerikattega tablett

L04AA06

11.10.2010

7.10.2010

Twynsta

telmisartaan/amlodipiin

| 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/1/10/648/001-028

Tablett

C09DB04

11.10.2010

28.10.2010

Clopidogrel HCS

klopidogreel

| HCS bvba |
| --- |
| H. Kennisstraat 53, |
| B 2650 Edegem, |
| Belgïe |

HCS bvba

H. Kennisstraat 53,

B 2650 Edegem,

Belgïe

EU/1/10/651/001-015

Õhukese polümeerikattega tablett

B01AC04

2.11.2010

28.10.2010

Clopidogrel Teva Generics B.V.

klopidogreel

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

Teva Generics B.V.

Computerweg 10,

3542 DR Utrecht,

Nederland

EU/1/10/650/001-015

Õhukese polümeerikattega tablett

B01AC04

4.11.2010

28.10.2010

Ruconest

alfakonestaat

| Pharming Group N.V. |
| --- |
| Darwinweg 24, |
| NL-2333 CR Leiden, |
| Nederland |

Pharming Group N.V.

Darwinweg 24,

NL-2333 CR Leiden,

Nederland

EU/1/10/641/001

Süstelahuse pulber

Pending

4.11.2010

—   Müügiloa väljaandmine (Euroopa Parlamendi ja nõukogu määruse (EÜ) nr 726/2004 artikkel 13): Tagasi lükatud

| Otsuse tegemise kuupäev | Ravimi nimetus | Müügiloa omanik | Kande number ühenduse registris | Teatamise kuupäev |
| --- | --- | --- | --- | --- |
| 16.9.2010 | Zeftera | Janssen-Cilag International NV |
| Turnhoutseweg 30, |
| B-2340 Beerse, |
| België |

Otsuse tegemise kuupäev

Ravimi nimetus

Müügiloa omanik

Kande number ühenduse registris

Teatamise kuupäev

16.9.2010

Zeftera

Janssen-Cilag International NV

Turnhoutseweg 30,

B-2340 Beerse,

België

20.9.2010

—   Müügiloa muutmine (Euroopa Parlamendi ja nõukogu määruse (EÜ) nr 726/2004 artikkel 13): Heaks kiidetud

| Otsuse tegemise kuupäev | Ravimi nimetus | Müügiloa omanik | Kande number ühenduse registris | Teatamise kuupäev |
| --- | --- | --- | --- | --- |
| 1.9.2010 | Altargo | Glaxo Group Limited |
| Glaxo Wellcome House, |
| Berkeley Avenue, |
| Greenford, |
| Middlesex UB6 0NN, |
| United Kingdom |

Otsuse tegemise kuupäev

Ravimi nimetus

Müügiloa omanik

Kande number ühenduse registris

Teatamise kuupäev

1.9.2010

Altargo

Glaxo Group Limited

Glaxo Wellcome House,

Berkeley Avenue,

Greenford,

Middlesex UB6 0NN,

United Kingdom

EU/1/07/390/001-004

8.9.2010

1.9.2010

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

6.9.2010

1.9.2010

Keppra

| 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/1/00/146/001-032

6.9.2010

1.9.2010

Levitra

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

Bayer Schering Pharma AG

13342 Berlin,

Deutschland

EU/1/03/248/001-015

6.9.2010

1.9.2010

Prevenar 13

| Wyeth Lederle Vaccines S.A. |
| --- |
| Rue du Bosquet, 15 |
| B-1348 Louvain-la-Neuve, |
| Belgique |

Wyeth Lederle Vaccines S.A.

Rue du Bosquet, 15

B-1348 Louvain-la-Neuve,

Belgique

EU/1/09/590/001-006

6.9.2010

1.9.2010

Regranex

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

Janssen-Cilag International NV

Turnhoutseweg, 30 - 2340 Beerse - België

EU/1/99/101/001

6.9.2010

1.9.2010

Relistor

| Wyeth Europa Limited |
| --- |
| Huntercombe Lane South, Taplow, |
| Maidenhead, |
| Berkshire, SL6 0PH, |
| United Kingdom |

Wyeth Europa Limited

Huntercombe Lane South, Taplow,

Maidenhead,

Berkshire, SL6 0PH,

United Kingdom

EU/1/08/463/001-003

6.9.2010

1.9.2010

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

6.9.2010

1.9.2010

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

6.9.2010

6.9.2010

Abraxane

| Abraxis BioScience Limited |
| --- |
| Rosanne House, Parkway, |
| Welwyn Garden City, |
| Herts, AL8 6HG, |
| United Kingdom |

Abraxis BioScience Limited

Rosanne House, Parkway,

Welwyn Garden City,

Herts, AL8 6HG,

United Kingdom

EU/1/07/428/001

9.9.2010

6.9.2010

Apidra

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

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main,

Deutschland

EU/1/04/285/001-036

9.9.2010

6.9.2010

Cialis

| 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/1/02/237/001-009

9.9.2010

6.9.2010

Clopidogrel Winthrop

| Sanofi-Aventis |
| --- |
| 174, avenue de France, |
| F-75013 Paris, |
| France |

Sanofi-Aventis

174, avenue de France,

F-75013 Paris,

France

EU/1/08/465/001-020

9.9.2010

6.9.2010

Cymbalta

| 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/1/04/296/001-009

8.9.2010

6.9.2010

Dynastat

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

Pfizer Ltd

Ramsgate Road,

Sandwich,

Kent CT 13 9NJ,

United Kingdom

EU/1/02/209/001-008

8.9.2010

6.9.2010

Emadine

| 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/1/98/095/001-004

9.9.2010

6.9.2010

Insuman

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

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main,

Deutschland

EU/1/97/030/028-195

9.9.2010

6.9.2010

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

9.9.2010

6.9.2010

M-M-RVAXPRO

| Sanofi Pasteur MSD, SNC |
| --- |
| 8, rue Jonas Salk, |
| 69007 Lyon, |
| France |

Sanofi Pasteur MSD, SNC

8, rue Jonas Salk,

69007 Lyon,

France

EU/1/06/337/001-013

9.9.2010

6.9.2010

Onglyza

| Bristol Myers Squibb/AstraZeneca EEIG |
| --- |
| Bristol Myers Squibb House, Uxbridge Business Park, |
| Sanderson Road, |
| Uxbridge, |
| Middlesex UB8 1DH, |
| United Kingdom |

Bristol Myers Squibb/AstraZeneca EEIG

Bristol Myers Squibb House, Uxbridge Business Park,

Sanderson Road,

Uxbridge,

Middlesex UB8 1DH,

United Kingdom

EU/1/09/545/001-010

9.9.2010

6.9.2010

Oslif Breezhaler

| 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/1/09/586/001-010

9.9.2010

6.9.2010

ProQuad

| Sanofi Pasteur MSD, SNC |
| --- |
| 8, rue Jonas Salk, |
| 69007 Lyon, |
| France |

Sanofi Pasteur MSD, SNC

8, rue Jonas Salk,

69007 Lyon,

France

EU/1/05/323/001-013

9.9.2010

6.9.2010

Relistor

| Wyeth Europa Limited |
| --- |
| Huntercombe Lane South, Taplow, |
| Maidenhead, |
| Berkshire, SL6 0PH, |
| United Kingdom |

Wyeth Europa Limited

Huntercombe Lane South, Taplow,

Maidenhead,

Berkshire, SL6 0PH,

United Kingdom

EU/1/08/463/001-011

8.9.2010

6.9.2010

Renvela

| Genzyme Europe B.V. |
| --- |
| Gooimeer 10, |
| 1411 DD Naarden, |
| Nederland |

Genzyme Europe B.V.

Gooimeer 10,

1411 DD Naarden,

Nederland

EU/1/09/521/001-007

9.9.2010

6.9.2010

Thyrogen

| Genzyme Europe B.V. |
| --- |
| Gooimeer 10, |
| NL-1411 DD Naarden, |
| Nederland |

Genzyme Europe B.V.

Gooimeer 10,

NL-1411 DD Naarden,

Nederland

EU/1/99/122/001-002

9.9.2010

6.9.2010

Vimpat

| 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/1/08/470/001-017

8.9.2010

6.9.2010

Viread

| Gilead Sciences International Limited |
| --- |
| Cambridge CB21 6GT |
| United Kingdom |

Gilead Sciences International Limited

Cambridge CB21 6GT

United Kingdom

EU/1/01/200/001-002

9.9.2010

6.9.2010

Xeristar

| 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/1/04/297/001-008

8.9.2010

6.9.2010

Xolair

| 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/1/05/319/001-010

8.9.2010

6.9.2010

Zerit

| 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/1/96/009/001-009

9.9.2010

6.9.2010

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/1/96/022/019-034

8.9.2010

6.9.2010

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/1/99/125/001-016

8.9.2010

10.9.2010

Pandemrix

| GlaxoSmithKline Biologicals S.A. |
| --- |
| rue de l'Institut 89, |
| Rixensart, |
| B-1330 Belgique |

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89,

Rixensart,

B-1330 Belgique

EU/1/08/452/001

14.9.2010

10.9.2010

Siklos

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

ADDMEDICA

101, rue Saint Lazare,

Paris 75009,

FRANCE

EU/1/07/397/001

14.9.2010

16.9.2010

Alimta

| 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/1/04/290/001

20.9.2010

16.9.2010

Tracleer

| Actelion Registration Ltd |
| --- |
| BSI Building 13th Floor, |
| 389 Chiswick High Road, |
| London W4 4AL, |
| United Kingdom |

Actelion Registration Ltd

BSI Building 13th Floor,

389 Chiswick High Road,

London W4 4AL,

United Kingdom

EU/1/02/220/001-006

20.9.2010

17.9.2010

Xyrem

| UCB Pharma Ltd. |
| --- |
| 208 Bath Road, Slough, |
| Berkshire SL1 3WE, |
| United Kingdom |

UCB Pharma Ltd.

208 Bath Road, Slough,

Berkshire SL1 3WE,

United Kingdom

EU/1/05/312/001

21.9.2010

23.9.2010

Kepivance

| Biovitrum AB (publ) |
| --- |
| SE-112 76 Stockholm, |
| Sverige |

Biovitrum AB (publ)

SE-112 76 Stockholm,

Sverige

EU/1/05/314/001

27.9.2010

23.9.2010

Levemir

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

Novo Nordisk A/S

Novo Allé,

DK-2880 Bagsvaerd,

Danmark

EU/1/04/278/001-011

27.9.2010

23.9.2010

Revatio

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

Pfizer Limited

Sandwich,

Kent, CT13 9NJ,

United Kingdom

EU/1/05/318/001-002

27.9.2010

27.9.2010

Caelyx

| Schering Plough Europe |
| --- |
| Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, |
| België |

Schering Plough Europe

Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel,

België

EU/1/96/011/001-004

29.9.2010

27.9.2010

Panretin

| Eisai Limited |
| --- |
| European Knowledge Centre, Mosquito Way, |
| Hatfield, |
| Hertfordshire, |
| AL10 9SN, United Kingdom |

Eisai Limited

European Knowledge Centre, Mosquito Way,

Hatfield,

Hertfordshire,

AL10 9SN, United Kingdom

EU/1/00/149/001

29.9.2010

30.9.2010

Clopidogrel Apotex

| Apotex Europe B.V. |
| --- |
| Darwingweg 20, |
| 2333 CR Leiden, |
| Nederland |

Apotex Europe B.V.

Darwingweg 20,

2333 CR Leiden,

Nederland

EU/1/09/568/001-018

5.10.2010

30.9.2010

Mepact

| IDM PHARMA SAS |
| --- |
| 11-15 Quai De Dion Bouton, |
| 92816 Puteaux Cedex, |
| France |

IDM PHARMA SAS

11-15 Quai De Dion Bouton,

92816 Puteaux Cedex,

France

EU/1/08/502/001

6.10.2010

30.9.2010

Noxafil

| SP Europe |
| --- |
| Rue de Stalle, 73, 1180 Bruxelles, |
| Belgique - Stallestraat, 73 - 1180 Brussel, |
| België |

SP Europe

Rue de Stalle, 73, 1180 Bruxelles,

Belgique - Stallestraat, 73 - 1180 Brussel,

België

EU/1/05/320/001

5.10.2010

30.9.2010

Rotarix

| GlaxoSmithKline Biologicals S.A. |
| --- |
| rue de l'Institut 89, |
| Rixensart, |
| B-1330 Belgique |

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89,

Rixensart,

B-1330 Belgique

EU/1/05/330/001-011

5.10.2010

30.9.2010

Sprycel

| 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/1/06/363/001-015

5.10.2010

30.9.2010

Thalidomide Celgene

| Celgene Europe Limited |
| --- |
| Riverside House, |
| Riverside Walk, |
| Windsor SL4 1NA, |
| United Kingdom |

Celgene Europe Limited

Riverside House,

Riverside Walk,

Windsor SL4 1NA,

United Kingdom

EU/1/08/443/001

5.10.2010

5.10.2010

APTIVUS

| 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/1/05/315/001-002

7.10.2010

5.10.2010

Mircera

| 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/1/07/400/001-024

7.10.2010

5.10.2010

Revlimid

| Celgene Europe Limited |
| --- |
| Riverside House, Riverside Walk, |
| Windsor, |
| Berkshire SL4 1NA, |
| United Kingdom |

Celgene Europe Limited

Riverside House, Riverside Walk,

Windsor,

Berkshire SL4 1NA,

United Kingdom

EU/1/07/391/001-004

7.10.2010

7.10.2010

Cyanokit

| Merck Santé s.a.s. |
| --- |
| 37, rue Saint-Romain, |
| 69379 Lyon Cedex 08, |
| France |

Merck Santé s.a.s.

37, rue Saint-Romain,

69379 Lyon Cedex 08,

France

EU/1/07/420/001-002

11.10.2010

7.10.2010

DuoTrav

| 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/1/06/338/001-003

11.10.2010

7.10.2010

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

11.10.2010

11.10.2010

Retacrit

| HOSPIRA Enterprises B.V. |
| --- |
| Randstad 22-11, |
| 1316 BN, Almere, |
| Nederland |

HOSPIRA Enterprises B.V.

Randstad 22-11,

1316 BN, Almere,

Nederland

EU/1/07/431/001-025

13.10.2010

14.10.2010

Alisade

| Glaxo Group Ltd |
| --- |
| Greenford, |
| Middlesex, UB6 ONN, |
| United Kingdom |

Glaxo Group Ltd

Greenford,

Middlesex, UB6 ONN,

United Kingdom

EU/1/08/474/001-003

19.10.2010

14.10.2010

Avamys

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

Glaxo Group Ltd

Greenford,

Middlesex UB6 0NN,

United Kingdom

EU/1/07/434/001-003

19.10.2010

14.10.2010

Biograstim

| CT Arzneimittel GmbH |
| --- |
| Lengeder Straße 42a, |
| D-13407 Berlin, |
| Deutschland |

CT Arzneimittel GmbH

Lengeder Straße 42a,

D-13407 Berlin,

Deutschland

EU/1/08/450/001-010

18.10.2010

14.10.2010

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

18.10.2010

14.10.2010

Multaq

| Sanofi-Aventis |
| --- |
| 174, avenue de France, |
| F-75013 Paris, |
| France |

Sanofi-Aventis

174, avenue de France,

F-75013 Paris,

France

EU/1/09/591/001-004

18.10.2010

14.10.2010

Ratiograstim

| ratiopharm GmbH |
| --- |
| Graf-Arco-Straße 3, |
| D-89079 Ulm, |
| Deutschland |

ratiopharm GmbH

Graf-Arco-Straße 3,

D-89079 Ulm,

Deutschland

EU/1/08/444/001-012

18.10.2010

14.10.2010

Vidaza

| Celgene Europe Ltd |
| --- |
| Riverside House, Riverside Walk, |
| Windsor, SL4 1NA, |
| United Kingdom |

Celgene Europe Ltd

Riverside House, Riverside Walk,

Windsor, SL4 1NA,

United Kingdom

EU/1/08/488/001

18.10.2010

14.10.2010

Xarelto

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

Bayer Schering Pharma AG

13342 Berlin,

Deutschland

EU/1/08/472/001-010

18.10.2010

15.10.2010

Riprazo

| 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/1/07/409/001-020

19.10.2010

15.10.2010

Silapo

| STADA Arzneimittel AG |
| --- |
| Stadastrasse 2-18, |
| 61118 Bad Vilbel, |
| Deutschland |

STADA Arzneimittel AG

Stadastrasse 2-18,

61118 Bad Vilbel,

Deutschland

EU/1/07/432/001-022

19.10.2010

15.10.2010

Sprimeo

| 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/1/07/407/001-020

19.10.2010

25.10.2010

Axura

| Merz Pharmaceuticals GmbH |
| --- |
| Eckenheimer Landstr. 100, |
| D-60318 Frankfurt/Main - Deutschland |

Merz Pharmaceuticals GmbH

Eckenheimer Landstr. 100,

D-60318 Frankfurt/Main - Deutschland

EU/1/02/218/001-003

EU/1/02/218/005-030

27.10.2010

25.10.2010

Azilect

| Teva Pharma GmbH |
| --- |
| Kandelstrasse 10, |
| Kirchzarten 79199, |
| Deutschland |

Teva Pharma GmbH

Kandelstrasse 10,

Kirchzarten 79199,

Deutschland

EU/1/04/304/001-007

29.10.2010

25.10.2010

Baraclude

| 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/1/06/343/001-007

27.10.2010

25.10.2010

Cerezyme

| Genzyme Europe B.V. |
| --- |
| Gooimeer 10, |
| NL-1411 DD Naarden, |
| Nederland |

Genzyme Europe B.V.

Gooimeer 10,

NL-1411 DD Naarden,

Nederland

EU/1/97/053/001-005

27.10.2010

25.10.2010

Champix

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

Pfizer Ltd

Ramsgate Road,

Sandwich, Kent CT 13 9NJ,

United Kingdom

EU/1/06/360/001-013

27.10.2010

25.10.2010

Ebixa

| H. Lundbeck A/S |
| --- |
| Ottiliavej 9, |
| DK-2500 Valby, |
| Danmark |

H. Lundbeck A/S

Ottiliavej 9,

DK-2500 Valby,

Danmark

EU/1/02/219/001-049

27.10.2010

25.10.2010

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/1/96/015/001-005

27.10.2010

25.10.2010

Faslodex

| AstraZeneca UK Limited |
| --- |
| Alderley Park, |
| Macclesfield, |
| Cheshire, SK10 4TG |
| United Kingdom |

AstraZeneca UK Limited

Alderley Park,

Macclesfield,

Cheshire, SK10 4TG

United Kingdom

EU/1/03/269/001-002

27.10.2010

25.10.2010

Forsteo

| 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/1/03/247/001-002

27.10.2010

25.10.2010

Herceptin

| 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/1/00/145/001

27.10.2010

25.10.2010

Irbesartan/Hydrochlorothiazide Teva

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

Teva Pharma B.V.

Computerweg 10,

3542 DR Utrecht,

Nederland

EU/1/09/583/001-072

27.10.2010

25.10.2010

Karvea

| 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/1/97/049/001-039

27.10.2010

25.10.2010

Mabthera

| 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/1/98/067/001-002

27.10.2010

25.10.2010

Mirapexin

| 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/1/97/051/001-006

EU/1/97/051/009-033

27.10.2010

25.10.2010

M-M-RVAXPRO

| Sanofi Pasteur MSD, SNC |
| --- |
| 8, rue Jonas Salk, |
| 69007 Lyon, |
| France |

Sanofi Pasteur MSD, SNC

8, rue Jonas Salk,

69007 Lyon,

France

EU/1/06/337/001-013

27.10.2010

25.10.2010

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/1/08/442/001-008

27.10.2010

25.10.2010

ProQuad

| Sanofi Pasteur MSD, SNC |
| --- |
| 8, rue Jonas Salk, |
| 69007 Lyon, |
| France |

Sanofi Pasteur MSD, SNC

8, rue Jonas Salk,

69007 Lyon,

France

EU/1/05/323/001-013

27.10.2010

25.10.2010

Puregon

| Organon N.V. |
| --- |
| Kloosterstraat 6, Postbus 20, |
| 5340 BH Oss, |
| Nederland |

Organon N.V.

Kloosterstraat 6, Postbus 20,

5340 BH Oss,

Nederland

EU/1/96/008/001-041

27.10.2010

25.10.2010

Revlimid

| Celgene Europe Limited |
| --- |
| Riverside House, Riverside Walk, |
| Windsor, |
| Berkshire SL4 1NA, |
| United Kingdom |

Celgene Europe Limited

Riverside House, Riverside Walk,

Windsor,

Berkshire SL4 1NA,

United Kingdom

EU/1/07/391/001-004

27.10.2010

25.10.2010

Sifrol

| 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/1/97/050/001-006

EU/1/97/050/009-033

27.10.2010

25.10.2010

Simponi

| Centocor B.V. |
| --- |
| Einsteinweg 101, |
| 2333 CB Leiden, |
| Nederland |

Centocor B.V.

Einsteinweg 101,

2333 CB Leiden,

Nederland

EU/1/09/546/001-004

27.10.2010

25.10.2010

Sprimeo

| 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/1/07/407/001-020

27.10.2010

25.10.2010

Sprycel

| 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/1/06/363/001-015

27.10.2010

25.10.2010

Toviaz

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

Pfizer Limited

Ramsgate Road, Sandwich,

Kent CT13 9NJ,

United Kingdom

EU/1/07/386/001-018

27.10.2010

25.10.2010

Vantavo

| 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/1/09/572/001-009

27.10.2010

25.10.2010

Vasovist

| TMC Pharma Services Ltd. |
| --- |
| Finchampstead, |
| Berks, RG40 4LJ, |
| UK |

TMC Pharma Services Ltd.

Finchampstead,

Berks, RG40 4LJ,

UK

EU/1/05/313/001-009

27.10.2010

25.10.2010

Vimpat

| UCB Pharma SA. |
| --- |
| Allée de la Recherche 60, |
| 1070 Bruxelles, |

UCB Pharma SA.

Allée de la Recherche 60,

1070 Bruxelles,

| Belgique/Researchdreef, 60, |
| --- |
| Brussel 1070, |
| België |

Belgique/Researchdreef, 60,

Brussel 1070,

België

EU/1/08/470/001-017

27.10.2010

25.10.2010

Zonegran

| Eisai Limited |
| --- |
| European Knowledge Centre, Mosquito Way, |
| Hatfield, |
| Hertfordshire, AL10 9SN, |
| United Kingdom |

Eisai Limited

European Knowledge Centre, Mosquito Way,

Hatfield,

Hertfordshire, AL10 9SN,

United Kingdom

EU/1/04/307/001-013

27.10.2010

25.10.2010

Zostavax

| Sanofi Pasteur MSD, SNC |
| --- |
| 8, rue Jonas Salk, |
| 69007 Lyon, |
| France |

Sanofi Pasteur MSD, SNC

8, rue Jonas Salk,

69007 Lyon,

France

EU/1/06/341/001-013

27.10.2010

28.10.2010

Ambirix

| GlaxoSmithKline Biologicals S.A. |
| --- |
| rue de l'Institut 89, |
| Rixensart, |
| B-1330 Belgique |

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89,

Rixensart,

B-1330 Belgique

EU/1/02/224/001-005

2.11.2010

28.10.2010

Aprovel

| Sanofi Pharma Bristol-Myers Squibb SNC |
| --- |
| 174 avenue de France - |
| 75013 Paris, |
| France |

Sanofi Pharma Bristol-Myers Squibb SNC

174 avenue de France -

75013 Paris,

France

EU/1/97/046/001-039

2.11.2010

28.10.2010

Fertavid

| SP Europe |
| --- |
| Rue de Stalle, 73 |
| B-1180 Bruxelles, |
| Belgique |

SP Europe

Rue de Stalle, 73

B-1180 Bruxelles,

Belgique

EU/1/09/510/001-019

2.11.2010

28.10.2010

Hycamtin

| SmithKline Beecham Ltd. |
| --- |
| 980 Great West Road, |
| Brentford, |
| Middlesex, TW8 9GS |
| United Kingdom |

SmithKline Beecham Ltd.

980 Great West Road,

Brentford,

Middlesex, TW8 9GS

United Kingdom

EU/1/96/027/001

EU/1/96/027/003-007

4.11.2010

28.10.2010

Mimpara

| Amgen Europe B.V. |
| --- |
| Minervum 7061, |
| NL-4817 ZK Breda, |
| Nederland |

Amgen Europe B.V.

Minervum 7061,

NL-4817 ZK Breda,

Nederland

EU/1/04/292/001-012

4.11.2010

28.10.2010

NovoSeven

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

Novo Nordisk A/S

Novo Allé,

DK-2880 Bagsvaerd,

Danmark

EU/1/96/006/001-007

4.11.2010

28.10.2010

Olanzapine Neopharma

| Neopharma Limited |
| --- |
| 57 High Street, Odiham, |
| Hampshire RG29 1LF, |
| United Kingdom |

Neopharma Limited

57 High Street, Odiham,

Hampshire RG29 1LF,

United Kingdom

EU/1/07/426/001-011

1.11.2010

28.10.2010

Olanzapine Teva

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

Teva Pharma B.V.

Computerweg 10,

DR Utrecht 3542,

Nederland

EU/1/07/427/001-057

1.11.2010

28.10.2010

PegIntron

| Schering Plough Europe |
| --- |
| Rue de Stalle, 73, |
| 1180 Bruxelles, |

Schering Plough Europe

Rue de Stalle, 73,

1180 Bruxelles,

| Belgique - Stallestraat, 73 - |
| --- |
| 1180 Brussel, |
| België |

Belgique - Stallestraat, 73 -

1180 Brussel,

België

EU/1/00/131/001-050

4.11.2010

28.10.2010

Travatan

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

Alcon Laboratories (UK) Ltd.

Boundary Way,

Hemel Hempstead,

Herts HP2 7UD,

United Kingdom

EU/1/01/199/001-002

4.11.2010

28.10.2010

ViraferonPeg

| Schering Plough Europe |
| --- |
| Rue de Stalle, 73, |
| 1180 Bruxelles, |

Schering Plough Europe

Rue de Stalle, 73,

1180 Bruxelles,

| Belgique - Stallestraat, 73 - |
| --- |
| 1180 Brussel, |
| België |

Belgique - Stallestraat, 73 -

1180 Brussel,

België

EU/1/00/132/001-050

4.11.2010

29.10.2010

Mycamine

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

Astellas Pharma Europe B.V.

Elisabethhof 19,

2353 EW Leiderdorp,

Nederland

EU/1/08/448/001-002

5.11.2010

—   Müügiloa tühistamine (Euroopa Parlamendi ja nõukogu määruse (EÜ) nr 726/2004 artikkel 13)

| Otsuse tegemise kuupäev | Ravimi nimetus | Müügiloa omanik | Kande number ühenduse registris | Teatamise kuupäev |
| --- | --- | --- | --- | --- |
| 6.9.2010 | ImmunoGam | Cangene Europe Limited |
| Parkshot House, |
| 5 Kew Road, |
| Richmond, |
| Surrey TW9 2PR, |
| United Kingdom |

Otsuse tegemise kuupäev

Ravimi nimetus

Müügiloa omanik

Kande number ühenduse registris

Teatamise kuupäev

6.9.2010

ImmunoGam

Cangene Europe Limited

Parkshot House,

5 Kew Road,

Richmond,

Surrey TW9 2PR,

United Kingdom

EU/1/10/613/001-002

9.9.2010

27.9.2010

Enviage

| 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/1/07/406/001-020

29.9.2010

28.10.2010

NeoSpect

| 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/1/00/154/001-002

5.11.2010

—   Müügiloa peatamine (Euroopa Parlamendi ja nõukogu määruse (EÜ) nr 726/2004 artikkel 20)

| Otsuse tegemise kuupäev | Ravimi nimetus | Müügiloa omanik | Kande number ühenduse registris | Teatamise kuupäev |
| --- | --- | --- | --- | --- |
| 16.9.2010 | Clopidogrel 1A Pharma | Acino Pharma GmbH |
| Am Windfeld 35, |
| 83714 Miesbach, |
| Deutschland |

Otsuse tegemise kuupäev

Ravimi nimetus

Müügiloa omanik

Kande number ühenduse registris

Teatamise kuupäev

16.9.2010

Clopidogrel 1A Pharma

Acino Pharma GmbH

Am Windfeld 35,

83714 Miesbach,

Deutschland

EU/1/09/542/001-007

20.9.2010

16.9.2010

Clopidogrel Acino

| Acino Pharma GmbH |
| --- |
| Am Windfeld 35, |
| 83714 Miesbach, |
| Deutschland |

Acino Pharma GmbH

Am Windfeld 35,

83714 Miesbach,

Deutschland

EU/1/09/532/001-007

20.9.2010

16.9.2010

Clopidogrel Acino Pharma

| Acino Pharma GmbH |
| --- |
| Am Windfeld 35, |
| 83714 Miesbach, |
| Deutschland |

Acino Pharma GmbH

Am Windfeld 35,

83714 Miesbach,

Deutschland

EU/1/09/549/001-007

20.9.2010

16.9.2010

Clopidogrel Acino Pharma GmbH

| Acino Pharma GmbH |
| --- |
| Am Windfeld 35, |
| 83714 Miesbach, |
| Deutschland |

Acino Pharma GmbH

Am Windfeld 35,

83714 Miesbach,

Deutschland

EU/1/09/548/001-007

20.9.2010

16.9.2010

Clopidogrel Hexal

| Acino Pharma GmbH |
| --- |
| Am Windfeld 35, |
| Miesbach 83714, |
| Deutschland |

Acino Pharma GmbH

Am Windfeld 35,

Miesbach 83714,

Deutschland

EU/1/09/534/001-007

20.9.2010

16.9.2010

Clopidogrel ratiopharm

| Acino Pharma GmbH |
| --- |
| Am Windfeld 35, |
| 83714 Miesbach, |
| Deutschland |

Acino Pharma GmbH

Am Windfeld 35,

83714 Miesbach,

Deutschland

EU/1/09/554/001-008

20.9.2010

16.9.2010

Clopidogrel ratiopharm GmbH

| Acino Pharma GmbH |
| --- |
| Am Windfeld 35, |
| 83714 Miesbach, |
| Deutschland |

Acino Pharma GmbH

Am Windfeld 35,

83714 Miesbach,

Deutschland

EU/1/09/541/001-008

20.9.2010

16.9.2010

Clopidogrel Sandoz

| Acino Pharma GmbH |
| --- |
| Am Windfeld 35, |
| 83714 Miesbach, |
| Deutschland |

Acino Pharma GmbH

Am Windfeld 35,

83714 Miesbach,

Deutschland

EU/1/09/547/001-007

20.9.2010

—   Müügiloa väljaandmine (Euroopa Parlamendi ja nõukogu määruse (EÜ) nr 726/2004 artikkel 38
   (2)
  ): Heaks kiidetud

| Otsuse tegemise kuupäev | Ravimi nimetus | Rahvusvaheline mittekaubanduslik nimetus (INN) | Müügiloa omanik | Kande number ühenduse registris | Ravimivorm | ATC-kood (anatoomilis-terapeutiline keemiline kood) | Teatamise kuupäev |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 6.9.2010 | Bovilis BTV8 | Bluetongue viiruse serotüüp 8 | Intervet International B.V. |
| Wim de Körverstraat 35, |
| NL - 5831 Boxmeer, |
| Nederland |

Otsuse tegemise kuupäev

Ravimi nimetus

Rahvusvaheline mittekaubanduslik nimetus (INN)

Müügiloa omanik

Kande number ühenduse registris

Ravimivorm

ATC-kood (anatoomilis-terapeutiline keemiline kood)

Teatamise kuupäev

6.9.2010

Bovilis BTV8

Bluetongue viiruse serotüüp 8

Intervet International B.V.

Wim de Körverstraat 35,

NL - 5831 Boxmeer,

Nederland

EU/2/10/106/001-014

Süstesuspensioon

QI02AA08(cattle)

QI04AA02(sheep)

8.9.2010

16.9.2010

Rhiniseng

vacuna inactivada frente a la rinitis atrófica en cerdos

| Laboratorios Hipra, S.A. |
| --- |
| Avda. La Selva, 135, |
| 17170- Amer (Girona), |
| España |

Laboratorios Hipra, S.A.

Avda. La Selva, 135,

17170- Amer (Girona),

España

EU/2/10/109/001-009

Süstesuspensioon

QI09AB04

21.9.2010

30.9.2010

Coxevac

Inaktiveeritud bakterit Coxiella burnetii sisaldav vaktsiin

| CEVA SANTE ANIMALE |
| --- |
| 10 avenue de la Ballastière, |
| 33500 Libourne, |
| France |

CEVA SANTE ANIMALE

10 avenue de la Ballastière,

33500 Libourne,

France

EU/2/10/110/001-002

Süstesuspensioon

QI03AB

ngi

5.10.2010

—   Müügiloa muutmine (Euroopa Parlamendi ja nõukogu määruse (EÜ) nr 726/2004 artikkel 38): Heaks kiidetud

| Otsuse tegemise kuupäev | Ravimi nimetus | Müügiloa omanik | Kande number ühenduse registris | Teatamise kuupäev |
| --- | --- | --- | --- | --- |
| 1.9.2010 | Acticam | Ecuphar NV |
| Legeweg 157-I, |
| B-8020 Oostkamp, |
| Belgïe |

Otsuse tegemise kuupäev

Ravimi nimetus

Müügiloa omanik

Kande number ühenduse registris

Teatamise kuupäev

1.9.2010

Acticam

Ecuphar NV

Legeweg 157-I,

B-8020 Oostkamp,

Belgïe

EU/2/08/088/001-004

6.9.2010

17.9.2010

Porcilis AR-T DF

| 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/2/00/026/001-004

21.9.2010

23.9.2010

Porcilis AR-T DF

| 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/2/00/026/001-006

27.9.2010

30.9.2010

Poulvac FluFend H5N3 RG

| Fort Dodge Animal Health Ltd |
| --- |
| Flanders Road, Hedge End, |
| Southampton SO30 4QH, |
| United Kingdom |

Fort Dodge Animal Health Ltd

Flanders Road, Hedge End,

Southampton SO30 4QH,

United Kingdom

EU/2/06/060/001-002

13.10.2010

30.9.2010

Prac-Tic

| Novartis Sanidad Animal S.L. |
| --- |
| Calle de la Marina, 206, |
| E - Barcelona 08013, |
| ESPANA |

Novartis Sanidad Animal S.L.

Calle de la Marina, 206,

E - Barcelona 08013,

ESPANA

EU/2/06/066/001-012

5.10.2010

5.10.2010

Nobilis Influenza H5N2

| 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/2/06/061/001-004

7.10.2010

11.10.2010

Equioxx

| MERIAL |
| --- |
| 29 avenue Tony Garnier, |
| 69007 LYON, |
| France |

MERIAL

29 avenue Tony Garnier,

69007 LYON,

France

EU/2/08/083/001-005

13.10.2010

14.10.2010

Cerenia

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

Pfizer Ltd

Ramsgate Road, Sandwich,

Kent CT 13 9NJ,

United Kingdom

EU/2/06/062/005

18.10.2010

14.10.2010

Improvac

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

Pfizer Limited

Ramsgate Road, Sandwich,

Kent CT13 9NJ,

United Kingdom

EU/2/09/095/001-006

18.10.2010

14.10.2010

Novem

| Boehringer Ingelheim Vetmedica GmbH |
| --- |
| 55216 Ingelheim am Rhein, |
| Deutschland |

Boehringer Ingelheim Vetmedica GmbH

55216 Ingelheim am Rhein,

Deutschland

EU/2/04/042/001-002

EU/2/04/042/007-010

18.10.2010

14.10.2010

Posatex

| 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/2/08/081/001-003

18.10.2010

14.10.2010

Quadrisol

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

Pfizer Limited

Ramsgate Road, Sandwich,

Kent CT13 9NJ,

United Kingdom

EU/2/97/005/001

EU/2/97/005/005

18.10.2010

28.10.2010

Trocoxil

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

Pfizer Limited

Ramsgate Road, Sandwich,

Kent CT13 9NJ

United Kingdom

EU/2/08/084/001-005

4.11.2010

28.10.2010

Zactran

| MERIAL |
| --- |
| 29 avenue Tony Garnier, |
| 69007 LYON, |
| France |

MERIAL

29 avenue Tony Garnier,

69007 LYON,

France

EU/2/08/082/001-006

4.11.2010

—   Müügiloa peatamine (Euroopa Parlamendi ja nõukogu määruse (EÜ) nr 726/2004 artikkel 45)

| Otsuse tegemise kuupäev | Ravimi nimetus | Müügiloa omanik | Kande number ühenduse registris | Teatamise kuupäev |
| --- | --- | --- | --- | --- |
| 27.9.2010 | Flexicam | Dechra Veterinary Products A/S |
| Mekuvej 9, |
| 7171 Uldum, |
| Danmark |

Otsuse tegemise kuupäev

Ravimi nimetus

Müügiloa omanik

Kande number ühenduse registris

Teatamise kuupäev

27.9.2010

Flexicam

Dechra Veterinary Products A/S

Mekuvej 9,

7171 Uldum,

Danmark

EU/2/06/058/001-003

29.9.2010

—   Müügiloa peatamise lõpetamine (Euroopa Parlamendi ja nõukogu määruse (EÜ) nr 726/2004 artikkel 45)

| Otsuse tegemise kuupäev | Ravimi nimetus | Müügiloa omanik | Kande number ühenduse registris | Teatamise kuupäev |
| --- | --- | --- | --- | --- |
| 1.9.2010 | Porcilis Pesti | Intervet International B.V. |
| Wim de Körverstraat 35, |
| 5831 AN Boxmeer, |
| Nederland |

Otsuse tegemise kuupäev

Ravimi nimetus

Müügiloa omanik

Kande number ühenduse registris

Teatamise kuupäev

1.9.2010

Porcilis Pesti

Intervet International B.V.

Wim de Körverstraat 35,

5831 AN Boxmeer,

Nederland

EU/2/99/016/001-006

6.9.2010

Kõnealuseid ravimeid käsitleva avaliku hindamisaruandega ja vastavate otsustega tutvuda soovijatel palutakse pöörduda:

| 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)  ELT L 136, 30.4.2004, lk 1.

(2)  ELT L 136, 30.4.2004, lk 1.

---

| 31.12.2010 | ET | Euroopa Liidu Teataja | C 359/17 |
| --- | --- | --- | --- |

31.12.2010

ET

Euroopa Liidu Teataja

C 359/17

---

Ravimite müügilubasid käsitlevate Euroopa Liidu otsuste kokkuvõte alates 1. juulist 2010 kuni 31. augustini 2010

(Direktiivi 2001/83/EÜ artikli 34
   (1)
  või direktiivi 2001/82/EÜ artikli 38
   (2)
  kohaselt vastu võetud otsused)

2010/C 359/02

—   Riikliku müügiloa väljaandmine, säilitamine või muutmine

| Otsuse tegemise kuupäev | Ravimi nimetus(ed) | Müügiloa omanik(ud) | Asjaomane liikmesriik | Teatamise kuupäev |
| --- | --- | --- | --- | --- |
| 31.8.2010 | PecFent | Archimedes Development Ltd, |
| Nottingham, |
| NGT7 2TN, |
| United Kingdom |

Otsuse tegemise kuupäev

Ravimi nimetus(ed)

Müügiloa omanik(ud)

Asjaomane liikmesriik

Teatamise kuupäev

31.8.2010

PecFent

Archimedes Development Ltd,

Nottingham,

NGT7 2TN,

United Kingdom

Kõnealused otsused on adresseeritud liikmesriikidele

3.9.2010

—   Riikliku müügiloa väljaandmisest keeldumine

| Otsuse tegemise kuupäev | Ravimi nimetus(ed) | Müügiloa omanik(ud) | Asjaomane liikmesriik | Teatamise kuupäev |
| --- | --- | --- | --- | --- |
| 6.8.2010 | Myderison | Vt lisa I | Vt lisa I | 10.8.2010 |

Otsuse tegemise kuupäev

Ravimi nimetus(ed)

Müügiloa omanik(ud)

Asjaomane liikmesriik

Teatamise kuupäev

6.8.2010

Myderison

Vt lisa I

Vt lisa I

10.8.2010

—   Riikliku müügiloa peatamine

| Otsuse tegemise kuupäev | Ravimi nimetus(ed) | Müügiloa omanik(ud) | Asjaomane liikmesriik | Teatamise kuupäev |
| --- | --- | --- | --- | --- |
| 10.08.2010 | Pregsure BVD and associated names | Vt lisa II | Vt lisa II | 11.08.2010 |

Otsuse tegemise kuupäev

Ravimi nimetus(ed)

Müügiloa omanik(ud)

Asjaomane liikmesriik

Teatamise kuupäev

10.08.2010

Pregsure BVD and associated names

Vt lisa II

Vt lisa II

11.08.2010

—   Riikliku müügiloa kehtetuks tunnistamine

| Otsuse tegemise kuupäev | Ravimi nimetus(ed) | Müügiloa omanik(ud) | Asjaomane liikmesriik | Teatamise kuupäev |
| --- | --- | --- | --- | --- |
| 6.8.2010 | Myderison | Vt lisa I | Vt lisa I | 10.8.2010 |

Otsuse tegemise kuupäev

Ravimi nimetus(ed)

Müügiloa omanik(ud)

Asjaomane liikmesriik

Teatamise kuupäev

6.8.2010

Myderison

Vt lisa I

Vt lisa I

10.8.2010

---

(1)  ELT L 311, 28.11.01, lk 67.

(2)  ELT L 311, 28.11.01, lk 1.

---

| 31.12.2010 | ET | Euroopa Liidu Teataja | C 359/18 |
| --- | --- | --- | --- |

31.12.2010

ET

Euroopa Liidu Teataja

C 359/18

---

Ravimite müügilubasid käsitlevate Euroopa Liidu otsuste kokkuvõte alates 1. septembrist 2010 kuni 31. oktoobrini 2010

(Direktiivi 2001/83/EÜ artikli 34
   (1)
  või direktiivi 2001/82/EÜ artikli 38
   (2)
  kohaselt vastu võetud otsused)

2010/C 359/03

—   Riikliku müügiloa väljaandmine, säilitamine või muutmine

| Otsuse tegemise kuupäev | Ravimi nimetus(ed) | Müügiloa omanik(ud) | Asjaomane liikmesriik | Teatamise kuupäev |
| --- | --- | --- | --- | --- |
| 15.10.2010 | Xalatan and associated names | Vt lisa III | Vt lisa III | 18.10.2010 |
| 5.10.2010 | Norsed Combi D and associated names | Vt lisa IV | Vt lisa IV | 6.10.2010 |
| 16.09.2010 | Atacand Plus and associated names | Vt lisa V | Vt lisa V | 20.09.2010 |
| 30.09.2010 | Daivobet | Vt lisa VI | Vt lisa VI | 4.10.2010 |
| 5.10.2010 | Fortipan Combi D and associated names | Vt lisa VII | Vt lisa VII | 6.10.2010 |
| 1.09.2010 | Brinavess | Merck Sharp & Dohme Limited, |
| Hertford Road, |
| Hodderson, |
| Hertfordshire EN11 9BU, |
| United Kingdom |

Otsuse tegemise kuupäev

Ravimi nimetus(ed)

Müügiloa omanik(ud)

Asjaomane liikmesriik

Teatamise kuupäev

15.10.2010

Xalatan and associated names

Vt lisa III

Vt lisa III

18.10.2010

5.10.2010

Norsed Combi D and associated names

Vt lisa IV

Vt lisa IV

6.10.2010

16.09.2010

Atacand Plus and associated names

Vt lisa V

Vt lisa V

20.09.2010

30.09.2010

Daivobet

Vt lisa VI

Vt lisa VI

4.10.2010

5.10.2010

Fortipan Combi D and associated names

Vt lisa VII

Vt lisa VII

6.10.2010

1.09.2010

Brinavess

Merck Sharp & Dohme Limited,

Hertford Road,

Hodderson,

Hertfordshire EN11 9BU,

United Kingdom

Kõnealused otsused on adresseeritud liikmesriikidele

3.09.2010

28.10.2010

Ruconest

| Pharming Group N.V., |
| --- |
| Darwinweg 24, |
| NL-2333 CR Leiden, |
| Nederland |

Pharming Group N.V.,

Darwinweg 24,

NL-2333 CR Leiden,

Nederland

Kõnealused otsused on adresseeritud liikmesriikidele

4.11.2010

—   Riikliku müügiloa muutmisest keeldumine

| Otsuse tegemise kuupäev | Ravimi nimetus(ed) | Müügiloa omanik(ud) | Asjaomane liikmesriik | Teatamise kuupäev |
| --- | --- | --- | --- | --- |
| 1.9.2010 | Genotropin | Vt lisa VIII | Vt lisa VIII | 2.09.2010 |

Otsuse tegemise kuupäev

Ravimi nimetus(ed)

Müügiloa omanik(ud)

Asjaomane liikmesriik

Teatamise kuupäev

1.9.2010

Genotropin

Vt lisa VIII

Vt lisa VIII

2.09.2010

—   Riikliku müügiloa peatamine

| Otsuse tegemise kuupäev | Ravimi nimetus(ed) | Müügiloa omanik(ud) | Asjaomane liikmesriik | Teatamise kuupäev |
| --- | --- | --- | --- | --- |
| 7.10.2010 | Pregsure BVD and associated names | Vt lisa IX | Vt lisa IX | 8.10.2010 |
| 4.10.2010 | Octagam | Vt lisa X | Vt lisa X | 5.10.2010 |

Otsuse tegemise kuupäev

Ravimi nimetus(ed)

Müügiloa omanik(ud)

Asjaomane liikmesriik

Teatamise kuupäev

7.10.2010

Pregsure BVD and associated names

Vt lisa IX

Vt lisa IX

8.10.2010

4.10.2010

Octagam

Vt lisa X

Vt lisa X

5.10.2010

---

(1)  ELT L 311, 28.11.01, lk 67.

(2)  ELT L 311, 28.11.01, lk 1.

---

I LISA

RAVIMI NIMETUSTE, RAVIMVORMIDE JA TUGEVUSTE, MANUSTAMISTEEDE, MÜÜGILOA TAOTLEJATE/HOIDJATE LOETELU LIIKMESRIIKIDES

| Liikmesriik EL/EMP | Müügiloa hoidja | Taotleja | Nimetus | Tugevus | Ravimvorm | Manustamisviis |
| --- | --- | --- | --- | --- | --- | --- |
| Tšehhi Vabariik | | Meditop Pharmaceutical Co. Ltd. |
| Ady Endre u. 1. Pilisborosjenő 2097 Ungari |

Liikmesriik EL/EMP

Müügiloa hoidja

Taotleja

Nimetus

Tugevus

Ravimvorm

Manustamisviis

Tšehhi Vabariik

Meditop Pharmaceutical Co. Ltd.

Ady Endre u. 1. Pilisborosjenő 2097 Ungari

Myderison

50 mg

150 mg

Õhukese polümeerkattega tablett

Suukaudne

Saksamaa

| Meditop Pharmaceutical Co. Ltd. |
| --- |
| Ady Endre u. 1. Pilisborosjenő 2097 Ungari |

Meditop Pharmaceutical Co. Ltd.

Ady Endre u. 1. Pilisborosjenő 2097 Ungari

Myderison

50 mg

150 mg

Õhukese polümeerkattega tablett

Suukaudne

Ungari

| Meditop Pharmaceutical Co. Ltd. |
| --- |
| Ady Endre u. 1. Pilisborosjenő 2097 Ungari |

Meditop Pharmaceutical Co. Ltd.

Ady Endre u. 1. Pilisborosjenő 2097 Ungari

Myderison

50 mg

150 mg

Õhukese polümeerkattega tablett

Suukaudne

Leedu

| Meditop Pharmaceutical Co. Ltd. |
| --- |
| Ady Endre u. 1. Pilisborosjenő 2097 Ungari |

Meditop Pharmaceutical Co. Ltd.

Ady Endre u. 1. Pilisborosjenő 2097 Ungari

Myderison

50 mg

150 mg

Õhukese polümeerkattega tablett

Suukaudne

Poola

| Meditop Pharmaceutical Co. Ltd. |
| --- |
| Ady Endre u. 1. Pilisborosjenő 2097 Ungari |

Meditop Pharmaceutical Co. Ltd.

Ady Endre u. 1. Pilisborosjenő 2097 Ungari

Myderison

50 mg

150 mg

Õhukese polümeerkattega tablett

Suukaudne

Rumeenia

| Meditop Pharmaceutical Co. Ltd. |
| --- |
| Ady Endre u. 1. Pilisborosjenő 2097 Ungari |

Meditop Pharmaceutical Co. Ltd.

Ady Endre u. 1. Pilisborosjenő 2097 Ungari

Myderison

50 mg

150 mg

Õhukese polümeerkattega tablett

Suukaudne

Slovaki Vabariik

| Meditop Pharmaceutical Co. Ltd. |
| --- |
| Ady Endre u. 1. Pilisborosjenő 2097 Ungari |

Meditop Pharmaceutical Co. Ltd.

Ady Endre u. 1. Pilisborosjenő 2097 Ungari

Myderison

50 mg

150 mg

Õhukese polümeerkattega tablett

Suukaudne

---

II LISA

VETERINAARRAVIMITE NIMETUSTE, RAVIMVORMIDE, TUGEVUSTE, LOOMALIIKIDE, MANUSTAMISVIISI, KEELUAJA JA MÜÜGILOA TAOTLEJATE/HOIDJATE LOETELU LIIKMESRIIKIDES

| Liikmesriik | Müügiloa taotleja/hoidja | Ravimi nimetus | Ravimvorm | Tugevus | Loomaliigid | Manustamise sagedus ja viis |
| --- | --- | --- | --- | --- | --- | --- |
| Belgia | Pfizer Animal Health |
| Rue Laid Burniat 1 |
| 1348 - Louvain-la-Neuve |
| BELGIUM |

Liikmesriik

Müügiloa taotleja/hoidja

Ravimi nimetus

Ravimvorm

Tugevus

Loomaliigid

Manustamise sagedus ja viis

Belgia

Pfizer Animal Health

Rue Laid Burniat 1

1348 - Louvain-la-Neuve

BELGIUM

PREGSURE BVD

Süsteemulsioon

mis tekitab merisigadel vähemalt 5,6 log2 geomeetrilise keskmise seroneutraliseeriva tiitri

Veised (lehmad ja mullikad)

subkutaanselt

Bulgaaria

| Pfizer Animal Health MA EEIG |
| --- |
| Ramsgate Road |
| Sandwich, Kent |
| CT13 9NJ |
| UNITED KINGDOM |

Pfizer Animal Health MA EEIG

Ramsgate Road

Sandwich, Kent

CT13 9NJ

UNITED KINGDOM

PregSure BVD

Süsteemulsioon

mis tekitab merisigadel vähemalt 5,6 log2 geomeetrilise keskmise seroneutraliseeriva tiitri

Veised (lehmad ja mullikad)

subkutaanselt

Tšehhi Vabariik

| Pfizer, spol. s r.o. |
| --- |
| Stroupežnického 17 |
| 150 00 Praha |
| CZECH REPUBLIC |

Pfizer, spol. s r.o.

Stroupežnického 17

150 00 Praha

CZECH REPUBLIC

PregSure BVD injekční emulze

Süsteemulsioon

mis tekitab merisigadel vähemalt 5,6 log2 geomeetrilise keskmise seroneutraliseeriva tiitri

Veised (lehmad ja mullikad)

subkutaanselt

Eesti

| Pfizer Animal Health |
| --- |
| Rue Laid Burniat 1 |
| 1348 - Louvain-la-Neuve |
| BELGIUM |

Pfizer Animal Health

Rue Laid Burniat 1

1348 - Louvain-la-Neuve

BELGIUM

PregSure BVD

Süsteemulsioon

mis tekitab merisigadel vähemalt 5,6 log2 geomeetrilise keskmise seroneutraliseeriva tiitri

Veised (lehmad ja mullikad)

subkutaanselt

Prantsusmaa

| PFIZER |
| --- |
| 23/25 Avenue du Docteur Lannelongue |
| 75014 Paris |
| FRANCE |

PFIZER

23/25 Avenue du Docteur Lannelongue

75014 Paris

FRANCE

PREGSURE BVD

Süsteemulsioon

mis tekitab merisigadel vähemalt 5,6 log2 geomeetrilise keskmise seroneutraliseeriva tiitri

Veised (lehmad ja mullikad)

subkutaanselt

Saksamaa

| Pfizer GmbH |
| --- |
| Linkstraße 10 |
| D-10785 Berlin |
| GERMANY |

Pfizer GmbH

Linkstraße 10

D-10785 Berlin

GERMANY

PregSure BVD

Süsteemulsioon

mis tekitab merisigadel vähemalt 5,6 log2 geomeetrilise keskmise seroneutraliseeriva tiitri

Veised (lehmad ja mullikad)

subkutaanselt

Kreeka

| PFIZER HELLAS S.A |
| --- |
| 243 Messogeion Ave. |
| Neo Psychiko |
| GR-154 51 |
| GREECE |

PFIZER HELLAS S.A

243 Messogeion Ave.

Neo Psychiko

GR-154 51

GREECE

PREGSURE BVD

Süsteemulsioon

mis tekitab merisigadel vähemalt 5,6 log2 geomeetrilise keskmise seroneutraliseeriva tiitri

Veised (lehmad ja mullikad)

subkutaanselt

Ungari

| Pfizer Kft. |
| --- |
| Alkotas u 53 |
| MOM Park „F” Épület |
| Budapest H-1123 |
| HUNGARY |

Pfizer Kft.

Alkotas u 53

MOM Park „F” Épület

Budapest H-1123

HUNGARY

PregSure BVD vakcina A.U.V.

Süsteemulsioon

mis tekitab merisigadel vähemalt 5,6 log2 geomeetrilise keskmise seroneutraliseeriva tiitri

Veised (lehmad ja mullikad)

subkutaanselt

Iirimaa

| Pfizer Healthcare Ireland trading as Pfizer Animal Health |
| --- |
| Ringaskiddy |
| County Cork |
| IRELAND |

Pfizer Healthcare Ireland trading as Pfizer Animal Health

Ringaskiddy

County Cork

IRELAND

PregSure BVD Emulsion for Injection

Süsteemulsioon

mis tekitab merisigadel vähemalt 5,6 log2 geomeetrilise keskmise seroneutraliseeriva tiitri

Veised (lehmad ja mullikad)

subkutaanselt

Itaalia

| Pfizer Italia Srl |
| --- |
| Via Isonzo 71 |
| 04100 – Latina |
| ITALY |

Pfizer Italia Srl

Via Isonzo 71

04100 – Latina

ITALY

Pregsure BVD

Süsteemulsioon

mis tekitab merisigadel vähemalt 5,6 log2 geomeetrilise keskmise seroneutraliseeriva tiitri

Veised (lehmad ja mullikad)

subkutaanselt

Leedu

| Pfizer Animal Health S.A. |
| --- |
| Rue Laid Burniat 1 |
| B-1348 - Louvain-la-Neuve |
| BELGIUM |

Pfizer Animal Health S.A.

Rue Laid Burniat 1

B-1348 - Louvain-la-Neuve

BELGIUM

PREGSURE BVD, injekcinė emulsija

Süsteemulsioon

mis tekitab merisigadel vähemalt 5,6 log2 geomeetrilise keskmise seroneutraliseeriva tiitri

Veised (lehmad ja mullikad)

subkutaanselt

Läti

| Pfizer Ltd |
| --- |
| Ramsgate Road |
| Sandwich, Kent |
| CT13 9NJ |
| UNITED KINGDOM |

Pfizer Ltd

Ramsgate Road

Sandwich, Kent

CT13 9NJ

UNITED KINGDOM

PregSure BVD

Süsteemulsioon

mis tekitab merisigadel vähemalt 5,6 log2 geomeetrilise keskmise seroneutraliseeriva tiitri

Veised (lehmad ja mullikad)

subkutaanselt

Poola

| Pfizer Trading Polska Sp. z o.o. |
| --- |
| ul. Rzymowskiego 34 |
| 02-697 Warszawa |
| POLAND |

Pfizer Trading Polska Sp. z o.o.

ul. Rzymowskiego 34

02-697 Warszawa

POLAND

PregSure BVD emulsja do wstrzykiwań

Süsteemulsioon

mis tekitab merisigadel vähemalt 5,6 log2 geomeetrilise keskmise seroneutraliseeriva tiitri

Veised (lehmad ja mullikad)

subkutaanselt

Portugal

| Laboratórios Pfizer Lda |
| --- |
| Lagoas Park – Edifício 10 |
| 2740-244 Porto Salvo |
| PORTUGAL |

Laboratórios Pfizer Lda

Lagoas Park – Edifício 10

2740-244 Porto Salvo

PORTUGAL

Pregsure BVD

Süsteemulsioon

mis tekitab merisigadel vähemalt 5,6 log2 geomeetrilise keskmise seroneutraliseeriva tiitri

Veised (lehmad ja mullikad)

subkutaanselt

Rumeenia

| Pfizer Animal Health MA EEIG |
| --- |
| Ramsgate Road, Sandwich, Kent |
| CT 13 9NJ |
| UNITED KINGDOM |

Pfizer Animal Health MA EEIG

Ramsgate Road, Sandwich, Kent

CT 13 9NJ

UNITED KINGDOM

Pregsure BVD

Süsteemulsioon

mis tekitab merisigadel vähemalt 5,6 log2 geomeetrilise keskmise seroneutraliseeriva tiitri

Veised (lehmad ja mullikad)

subkutaanselt

Sloveenia

| Pfizer Luxembourg SARL |
| --- |
| Gran Duchy of Luxembourg |
| 51, Avenue J.F. Kennedy |
| L-1855 - Luxembourg |

Pfizer Luxembourg SARL

Gran Duchy of Luxembourg

51, Avenue J.F. Kennedy

L-1855 - Luxembourg

Pregsure BVD emulzija za injiciranje

Süsteemulsioon

mis tekitab merisigadel vähemalt 5,6 log2 geomeetrilise keskmise seroneutraliseeriva tiitri

Veised (lehmad ja mullikad)

subkutaanselt

Slovakkia

| Pfizer Luxembourg SARL o.z. |
| --- |
| Pfizer AH |
| Pribinova 25 |
| 81109 Bratislava |
| SLOVAK REPUBLIC |

Pfizer Luxembourg SARL o.z.

Pfizer AH

Pribinova 25

81109 Bratislava

SLOVAK REPUBLIC

Pregsure BVD

Süsteemulsioon

mis tekitab merisigadel vähemalt 5,6 log2 geomeetrilise keskmise seroneutraliseeriva tiitri

Veised (lehmad ja mullikad)

subkutaanselt

Hispaania

| Pfizer SA |
| --- |
| Avda. De Europa, 20 B |
| Parque Empresarial la Moraleja (Alcobendas) |
| 28108 |
| SPAIN |

Pfizer SA

Avda. De Europa, 20 B

Parque Empresarial la Moraleja (Alcobendas)

28108

SPAIN

PREGSURE BVD

Süsteemulsioon

mis tekitab merisigadel vähemalt 5,6 log2 geomeetrilise keskmise seroneutraliseeriva tiitri

Veised (lehmad ja mullikad)

subkutaanselt

Madalmaad

| Pfizer Animal Health BV |
| --- |
| Rivium Westlaan 142 |
| 2909 LD Capelle a/d Ijssel |
| P.O. Box 37 |
| 2900 AA Capelle a/d Ijssel |
| THE NETHERLANDS |

Pfizer Animal Health BV

Rivium Westlaan 142

2909 LD Capelle a/d Ijssel

P.O. Box 37

2900 AA Capelle a/d Ijssel

THE NETHERLANDS

PREGSURE BVD

Süsteemulsioon

mis tekitab merisigadel vähemalt 5,6 log2 geomeetrilise keskmise seroneutraliseeriva tiitri

Veised (lehmad ja mullikad)

subkutaanselt

Ühendkuningriik

| Pfizer Ltd |
| --- |
| Ramsgate Road |
| Sandwich, Kent |
| CT13 9NJ |
| UNITED KINGDOM |

Pfizer Ltd

Ramsgate Road

Sandwich, Kent

CT13 9NJ

UNITED KINGDOM

Pregsure BVD Emulsion for Injection

Süsteemulsioon

mis tekitab merisigadel vähemalt 5,6 log2 geomeetrilise keskmise seroneutraliseeriva tiitri

Veised (lehmad ja mullikad)

subkutaanselt

---

III LISA

RAVIMITE NIMETUSTE, RAVIMVORMIDE, TUGEVUSTE, MANUSTAMISVIISIDE, MÜÜGILOA HOIDJATE LOETELU LIIKMESRIIKIDES

| Liikmesriik EU/EEA | Müügiloa hoidja | Ravimi väljamõeldud nimetus | Tugevus | Ravimvorm | Manustamisviis | Pakendi sisu (kontsentratsioon) |
| --- | --- | --- | --- | --- | --- | --- |
| Austria | Pfizer Corporation Austria Ges.m.b.H. |
| Floridsdorfer Hauptstrasse 1 |
| A - 1210 Wien, Austria |

Liikmesriik EU/EEA

Müügiloa hoidja

Ravimi väljamõeldud nimetus

Tugevus

Ravimvorm

Manustamisviis

Pakendi sisu (kontsentratsioon)

Austria

Pfizer Corporation Austria Ges.m.b.H.

Floridsdorfer Hauptstrasse 1

A - 1210 Wien, Austria

Xalatan

0,005 % w/v

Silmatilgad, lahus

Okulaarne

2,5 ml

Belgia

| Pfizer SA |
| --- |
| Boulevard de la Plaine 17 |
| B-1050 Brussels, Belgia |

Pfizer SA

Boulevard de la Plaine 17

B-1050 Brussels, Belgia

Xalatan

0,005 %

Silmatilgad, lahus

Okulaarne

2,5 ml

Bulgaaria

Pfizer Enterprises SARL, Rond-point du Kirchberg, 51, Avenue J.F. Kennedy, L-1855 Luxembourg, G. D. of Luxembourg

Xalatan

50 micrograms/ ml

Silmatilgad, lahus

Lokaalne

2,5 ml

Tšehhi Vabariik

Pfizer. s r.o., Stroupežnického 17, 150 00 Prague 5, Tšehhi Vabariik

Xalatan

0,005 % w/v

Silmatilgad, lahus

Lokaalne

2,5 ml

Taani

Pfizer ApS, Lautrupvang 8, 2750 Ballerup, Taani

Xalatan

50 microg/ ml

Silmatilgad, lahus

Lokaalne

2,5 ml

Eesti

| Pfizer Enterprises SARL |
| --- |
| 51, Avenue J.F. Kennedy |
| Rond-Point du Kirchberg |
| L-1855 Luxembourg |

Pfizer Enterprises SARL

51, Avenue J.F. Kennedy

Rond-Point du Kirchberg

L-1855 Luxembourg

Xalatan

50 micrograms / ml

Silmatilgad, lahus

Okulaarne

2,5 ml

Soome

Pfizer Oy, Tietokuja 4, 00330 Helsinki, Soome

Xalatan

50 microg/ml

Silmatilgad, lahus

Lokaalne

2,5 ml

Prantsusmaa

| Pfizer Holding France |
| --- |
| 23-25 Avenue du Docteur Lannelongue |
| 75014 Paris |
| Prantsusmaa |

Pfizer Holding France

23-25 Avenue du Docteur Lannelongue

75014 Paris

Prantsusmaa

Xalatan

0,005 % w/v

Silmatilgad, lahus

Lokaalne

2,5 ml

Saksamaa

Pharmacia GmbH Linkstraße 10 10785 Berlin, Saksamaa

Xalatan

0,005 % w/v

Silmatilgad, lahus

Okulaarne

2,5 ml

Saksamaa

Pharmacia GmbH, Linkstraße 10 10785 Berlin, Saksamaa

Latanoprost Pharmacia & Upjohn

0,005 % w/v

Silmatilgad, lahus

Okulaarne

2,5 ml

Kreeka

| Pfizer Hellas A. E. |
| --- |
| 243, Messoghion Ave., |
| 154 51 Νeo Psychiko, Athens, Kreeka |

Pfizer Hellas A. E.

243, Messoghion Ave.,

154 51 Νeo Psychiko, Athens, Kreeka

Xalatan

50 mcg/ ml

Silmatilgad, lahus

Lokaalne

2,5 ml

Ungari

| Pfizer KFT, |
| --- |
| 1123 Budapest, |
| Alkotás u. 53. MOM Park „F” Ép., |
| Ungari |

Pfizer KFT,

1123 Budapest,

Alkotás u. 53. MOM Park „F” Ép.,

Ungari

Xalatan

0,05 mg/ml

Silmatilgad, lahus

Lokaalne

2,5 ml

Island

Pfizer ApS, Lautrupvang 8, 2750 Ballerup, Taani

Xalatan

50 microg/ ml

Silmatilgad, lahus

Lokaalne

2,5 ml

Iirimaa

| Pharmacia Ireland Limited |
| --- |
| 9 Riverwalk |
| National Digital Park |
| Citywest Business Campus |
| Dublin 24 |
| Iirimaa |

Pharmacia Ireland Limited

9 Riverwalk

National Digital Park

Citywest Business Campus

Dublin 24

Iirimaa

Xalatan

0,005 % w/v

Silmatilgad, lahus

Lokaalne

2,5 ml

Itaalia

| Pfizer Italia S.r.l. |
| --- |
| Via Isonzo, 71 |
| 04100 Latina - Itaalia |

Pfizer Italia S.r.l.

Via Isonzo, 71

04100 Latina - Itaalia

Xalatan

0,005

Silmatilgad, lahus

Lokaalne

2,5 ml

Läti

| Pfizer Europe MA EEIG, Ramsgate Road, |
| --- |
| Sandwich, |
| Kent, CT13 9NJ, |
| Ühendkuningriik |

Pfizer Europe MA EEIG, Ramsgate Road,

Sandwich,

Kent, CT13 9NJ,

Ühendkuningriik

Xalatan

0,005 % w/v

Silmatilgad, lahus

Lokaalne

2,5 ml

Leedu

| Pfizer Europe MA EEIG |
| --- |
| Ramsgate Road |
| Sandwich, Kent CT13 9NJ |
| Ühendkuningriik |

Pfizer Europe MA EEIG

Ramsgate Road

Sandwich, Kent CT13 9NJ

Ühendkuningriik

Xalatan

0,005 % w/v

Silmatilgad, lahus

Okulaarne

2,5 ml

Luxemburg

| Pfizer SA |
| --- |
| Boulevard de la Plaine 17 |
| B-1050 Brussels, Belgia |

Pfizer SA

Boulevard de la Plaine 17

B-1050 Brussels, Belgia

Xalatan

0,005 %

Silmatilgad, lahus

Okulaarne

2,5 ml

Malta

| Pfizer Hellas S.A. |
| --- |
| 243, Messoghion Ave., |
| 154 51 Νeo Psychiko, Athens, Kreeka |

Pfizer Hellas S.A.

243, Messoghion Ave.,

154 51 Νeo Psychiko, Athens, Kreeka

Xalatan

0,005 % w/v

Silmatilgad, lahus

Lokaalne

2,5 ml

Holland

| Pfizer bv |
| --- |
| Rivium Westlaan 142 |
| 2909 LD Capelle a/d IJssel |
| Holland |

Pfizer bv

Rivium Westlaan 142

2909 LD Capelle a/d IJssel

Holland

Xalatan

50 microgram/ml

Silmatilgad, lahus

Lokaalne

2,5 ml

Norra

| Pfizer AS |
| --- |
| Pb. 3 |
| 1324 Lysaker |
| Norra |

Pfizer AS

Pb. 3

1324 Lysaker

Norra

Xalatan

0,005 % w/v

Silmatilgad, lahus

Lokaalne

2,5 ml

Poola

| Pfizer Europe MA EEIG, Ramsgate Road, |
| --- |
| Sandwich, |
| Kent, CT13 9NJ, |
| Ühendkuningriik |

Pfizer Europe MA EEIG, Ramsgate Road,

Sandwich,

Kent, CT13 9NJ,

Ühendkuningriik

Xalatan

0,005 % w/v

Silmatilgad, lahus

Okulaarne

2,5 ml

Portugal

Laboratorios Pfizer, Lda., Lagoas Park, Edifício 10, 2740-271 Porto Salvo, Portugal

Xalatan

0,005 % w/v

Silmatilgad, lahus

Lokaalne

2,5 ml

Rumeenia

| Pfizer Europe MA EEIG, Ramsgate Road, |
| --- |
| Sandwich, |
| Kent, CT13 9NJ, |
| Ühendkuningriik |

Pfizer Europe MA EEIG, Ramsgate Road,

Sandwich,

Kent, CT13 9NJ,

Ühendkuningriik

Xalatan

0,005 % w/v

Silmatilgad, lahus

Okulaarne

2,5 ml

Slovakkia

| Pfizer Europe MA EEIG, Ramsgate Road, |
| --- |
| Sandwich, |
| Kent, CT13 9NJ, |
| Ühendkuningriik |

Pfizer Europe MA EEIG, Ramsgate Road,

Sandwich,

Kent, CT13 9NJ,

Ühendkuningriik

Xalatan

0,005 % w/v

Silmatilgad, lahus

Lokaalne

2,5 ml

Sloveenia

Pfizer Luxembourg SARL, 51, Avenue J. F. Kennedy, L-1855 Luxembourg, Luxembourg

Xalatan 50 mikrogramov/ml kapljice za oko, raztopina

0,005 % w/v

Silmatilgad, lahus

Lokaalne

2,5 ml

Hispaania

| Pfizer, S.A. |
| --- |
| Avda. de Europa 20B |
| Parque Empresarial la Moraleja |
| 28108 Alcobendas, (Madrid) |
| Hispaania |

Pfizer, S.A.

Avda. de Europa 20B

Parque Empresarial la Moraleja

28108 Alcobendas, (Madrid)

Hispaania

Xalatan

0,005 % w/v

Silmatilgad, lahus

Okulaarne

2,5 ml

Rootsi

| Pfizer AB |
| --- |
| Vetenskapsvagen 10, |
| SE 191 90 Sollentuna |
| Rootsi |

Pfizer AB

Vetenskapsvagen 10,

SE 191 90 Sollentuna

Rootsi

Xalatan

0,005 % w/v

Silmatilgad, lahus

Lokaalne

2,5 ml

Ühendkuningriik

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

Pfizer Limited

Ramsgate Road

Sandwich, Kent

CT13 9NJ

Ühendkuningriik

Xalatan

0,005 % w/v

Silmatilgad, lahus

Lokaalne

2,5 ml

---

IV LISA

RAVIMI(TE) NIMETUSTE, RAVIMVORMI(DE), TUGEVUS(T)E, MANUSTAMISVIISI(DE), TAOTLEJA(TE), MÜÜGILOA HOIDJA(TE) LOETELU LIIKMESRIIKIDES

| Liikmesriik EL/EMP | Müügiloa hoidja | Taotleja | (Ravimi väljamõeldud) nimetus | Tugevus | Ravimvorm | Manustamisviis |
| --- | --- | --- | --- | --- | --- | --- |
| Bulgaaria | | Sanofi-Aventis Bulgaria EOOD |
| 103, blvd Alexander Stamboliiski |
| 1303 Sofia |
| Bulgaaria |

Liikmesriik EL/EMP

Müügiloa hoidja

Taotleja

(Ravimi väljamõeldud) nimetus

Tugevus

Ravimvorm

Manustamisviis

Bulgaaria

Sanofi-Aventis Bulgaria EOOD

103, blvd Alexander Stamboliiski

1303 Sofia

Bulgaaria

Actonel Combi D

35 mg +

1 000 mg/880 IU

Õhukese polümeerikattega tabletid + kihisevad graanulid

Suukaudne

Prantsusmaa

| Procter & Gamble Pharmaceuticals France |
| --- |
| 163-165 Quai Aulagnier |
| 92600 Asnières-sur-Seine |
| Prantsusmaa |

Procter & Gamble Pharmaceuticals France

163-165 Quai Aulagnier

92600 Asnières-sur-Seine

Prantsusmaa

Norsedcombi

35 mg +

1 000 mg/880 IU

Õhukese polümeerikattega tabletid + kihisevad graanulid

Suukaudne

Saksamaa

| Warner Chilcott Deutschland GmbH |
| --- |
| Dr.-Otto-Röhm-Strasse 2-4 |
| 64331 Weiterstadt |
| Saksamaa |

Warner Chilcott Deutschland GmbH

Dr.-Otto-Röhm-Strasse 2-4

64331 Weiterstadt

Saksamaa

Norsed plus Calcium D

35 mg +

1 000 mg/880 IU

Õhukese polümeerikattega tabletid + kihisevad graanulid

Suukaudne

Iirimaa

| Warner Chilcott UK Limited, |
| --- |
| Old Belfast Road, Millbrook, Larne, County Antrim, |
| BT40 2SH |
| Ühendkuningriik |

Warner Chilcott UK Limited,

Old Belfast Road, Millbrook, Larne, County Antrim,

BT40 2SH

Ühendkuningriik

Optinate Plus Ca &D

35 mg +

1 000 mg/880 IU

Õhukese polümeerikattega tabletid + kihisevad graanulid

Suukaudne

Itaalia

| sanofi-aventis S.p.A. |
| --- |
| viale Luigi Bodio, 37/B |
| 20158 Milan |
| Itaalia |

sanofi-aventis S.p.A.

viale Luigi Bodio, 37/B

20158 Milan

Itaalia

Opticalcio D3

35 mg +

1 000 mg/880 IU

Õhukese polümeerikattega tabletid + kihisevad graanulid

Suukaudne

Rootsi

| sanofi-aventis S.p.A. |
| --- |
| Viale Luigi Bodio, 37/b |
| 20158 Milano |
| Itaalia |

sanofi-aventis S.p.A.

Viale Luigi Bodio, 37/b

20158 Milano

Itaalia

Norsed Combi D

35 mg +

1 000 mg/880 IU

Õhukese polümeerikattega tabletid + kihisevad graanulid

Suukaudne

---

V LISA

RAVIMITE NIMETUSTE, RAVIMVORMIDE, TUGEVUSTE, MANUSTAMISVIISIDE, MÜÜGILOA HOIDJATE LOETELU LIIKMESRIIKIDES

| Liikmesriik EL/EMP | Müügiloa hoidja | Nimi | Tugevus | Ravimvorm | Manustamisviis |
| --- | --- | --- | --- | --- | --- |
| Austria | AstraZeneca Österreich GmbH., |
| Schwarzenbergplatz 7, |
| A-1037 Wien, |
| Austria |

Liikmesriik EL/EMP

Müügiloa hoidja

Nimi

Tugevus

Ravimvorm

Manustamisviis

Austria

AstraZeneca Österreich GmbH.,

Schwarzenbergplatz 7,

A-1037 Wien,

Austria

Atacand plus mite 8 mg/12,5 mg Tabletten

8 mg / 12,5 mg

Tablett

Suukaudne

Austria

| AstraZeneca Österreich GmbH., |
| --- |
| Schwarzenbergplatz 7, |
| A-1037 Wien, |
| Austria |

AstraZeneca Österreich GmbH.,

Schwarzenbergplatz 7,

A-1037 Wien,

Austria

Atacand plus

16 mg/12,5 mg Tabletten

16 mg / 12,5 mg

Tablett

Suukaudne

Austria

| AstraZeneca Österreich GmbH., |
| --- |
| Schwarzenbergplatz 7, |
| A-1037 Wien, |
| Austria |

AstraZeneca Österreich GmbH.,

Schwarzenbergplatz 7,

A-1037 Wien,

Austria

Atacand Plus

32 mg/12,5 mg Tabletten

32 mg / 12,5 mg

Tablett

Suukaudne

Austria

| AstraZeneca Österreich GmbH., |
| --- |
| Schwarzenbergplatz 7, |
| A-1037 Wien, |
| Austria |

AstraZeneca Österreich GmbH.,

Schwarzenbergplatz 7,

A-1037 Wien,

Austria

Atacand Plus

32 mg/25 mg Tabletten

32 mg / 25 mg

Tablett

Suukaudne

Austria

| Takeda Pharma Ges.m.b.H., |
| --- |
| Seidengasse 33-35, |
| 1070 Wien, |
| Austria |

Takeda Pharma Ges.m.b.H.,

Seidengasse 33-35,

1070 Wien,

Austria

Blopress Plus 8mg/12,5mg - Tabletten

8 mg / 12,5 mg

Tablett

Suukaudne

Austria

| Takeda Pharma Ges.m.b.H., |
| --- |
| Seidengasse 33-35, |
| 1070 Wien, |
| Austria |

Takeda Pharma Ges.m.b.H.,

Seidengasse 33-35,

1070 Wien,

Austria

Blopress Plus 16mg/12,5mg - Tabletten

16 mg / 12,5 mg

Tablett

Suukaudne

Austria

| Takeda Pharma Ges.m.b.H., |
| --- |
| Seidengasse 33-35, |
| 1070 Wien, |
| Austria |

Takeda Pharma Ges.m.b.H.,

Seidengasse 33-35,

1070 Wien,

Austria

Blopress Plus 32mg/ 12,5mg - Tabletten

32 mg / 12,5 mg

Tablett

Suukaudne

Austria

| Takeda Pharma Ges.m.b.H., |
| --- |
| Seidengasse 33-35, |
| 1070 Wien, |
| Austria |

Takeda Pharma Ges.m.b.H.,

Seidengasse 33-35,

1070 Wien,

Austria

Blopress Plus 32mg/ 25mg - Tabletten

32 mg / 25 mg

Tablett

Suukaudne

Belgia

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussels |
| Belgia |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussels

Belgia

Atacand Plus

8 mg / 12,5 mg

Tablett

Suukaudne

Belgia

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussels |
| Belgia |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussels

Belgia

Atacand Plus

16 mg / 12,5 mg

Tablett

Suukaudne

Belgia

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussels |
| Belgia |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussels

Belgia

Atacand Plus

32 mg / 12,5 mg

Tablett

Suukaudne

Belgia

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussels |
| Belgia |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussels

Belgia

Atacand Plus

32 mg / 25 mg

Tablett

Suukaudne

Küpros

| AstraZeneca AB, S-151 85 Södertälje, |
| --- |
| Rootsi |

AstraZeneca AB, S-151 85 Södertälje,

Rootsi

Atacand Plus

16 mg / 12,5 mg

Tablett

Suukaudne

Tšehhi Vabariik

| AstraZeneca UK Ltd., |
| --- |
| Macclesfield, |
| Cheshire, |
| Ühendkuningriik |

AstraZeneca UK Ltd.,

Macclesfield,

Cheshire,

Ühendkuningriik

Atacand Plus

16 + 12,5 mg

16 mg / 12,5 mg

Tablett

Suukaudne

Taani

| AstraZeneca A/S |
| --- |
| Roskildevej 22 |
| DK-2620 Albertslund, |
| Taani |

AstraZeneca A/S

Roskildevej 22

DK-2620 Albertslund,

Taani

Atacand Zid

8 mg / 12,5 mg

8 mg / 12,5 mg

Tablett

Suukaudne

Taani

| AstraZeneca A/S |
| --- |
| Roskildevej 22 |
| DK-2620 Albertslund, |
| Taani |

AstraZeneca A/S

Roskildevej 22

DK-2620 Albertslund,

Taani

Atacand Zid 16mg / 12,5 mg

16 mg / 12,5 mg

Tablett

Suukaudne

Taani

| AstraZeneca A/S |
| --- |
| Roskildevej 22 |
| DK-2620 Albertslund, |
| Taani |

AstraZeneca A/S

Roskildevej 22

DK-2620 Albertslund,

Taani

Atacand Zid

32 mg / 12,5 mg

32 mg / 12,5 mg

Tablett

Suukaudne

Taani

| AstraZeneca A/S |
| --- |
| Roskildevej 22 |
| DK-2620 Albertslund, |
| Taani |

AstraZeneca A/S

Roskildevej 22

DK-2620 Albertslund,

Taani

Atacand Zid

32 mg / 25 mg

32 mg / 25 mg

Tablett

Suukaudne

Eesti

| AstraZeneca AB, |
| --- |
| Strängnäsvägen 44, |
| S-151 85 Södertälje, |
| Rootsi |

AstraZeneca AB,

Strängnäsvägen 44,

S-151 85 Södertälje,

Rootsi

ATACAND PLUS

16 mg / 12,5 mg

Tablett

Suukaudne

Eesti

| AstraZeneca AB, |
| --- |
| Strängnäsvägen 44, |
| S-151 85 Södertälje, |
| Rootsi |

AstraZeneca AB,

Strängnäsvägen 44,

S-151 85 Södertälje,

Rootsi

ATACAND PLUS

32 mg / 12,5 mg

Tablett

Suukaudne

Eesti

| AstraZeneca AB, Strängnäsvägen 44, |
| --- |
| S-151 85 Södertälje, |
| Rootsi |

AstraZeneca AB, Strängnäsvägen 44,

S-151 85 Södertälje,

Rootsi

ATACAND PLUS

32 mg / 25 mg

Tablett

Suukaudne

Soome

| AstraZeneca Oy |
| --- |
| Luomanportti 3 |
| FI-02200 Espoo |
| Soome |

AstraZeneca Oy

Luomanportti 3

FI-02200 Espoo

Soome

Atacand Plus

8 mg / 12,5 mg

Tablett

Suukaudne

Soome

| AstraZeneca Oy |
| --- |
| Luomanportti 3 |
| FI-02200 Espoo |
| Soome |

AstraZeneca Oy

Luomanportti 3

FI-02200 Espoo

Soome

Atacand Plus

16 mg / 12,5 mg

Tablett

Suukaudne

Soome

| AstraZeneca Oy |
| --- |
| Luomanportti 3 |
| FI-02200 Espoo |
| Soome |

AstraZeneca Oy

Luomanportti 3

FI-02200 Espoo

Soome

Atacand Plus

32 mg / 12,5 mg

Tablett

Suukaudne

Soome

| AstraZeneca Oy |
| --- |
| Luomanportti 3 |
| FI-02200 Espoo |
| Soome |

AstraZeneca Oy

Luomanportti 3

FI-02200 Espoo

Soome

Atacand Plus

32 mg / 25 mg

Tablett

Suukaudne

Prantsusmaa

| AstraZeneca |
| --- |
| 1, Place Renault |
| 92844 Rueil-Malmaison Cedex |
| Prantsusmaa |

AstraZeneca

1, Place Renault

92844 Rueil-Malmaison Cedex

Prantsusmaa

Hytacand

8 mg/12,5 mg comprimé

8 mg / 12,5 mg

Tablett

Suukaudne

Prantsusmaa

| AstraZeneca |
| --- |
| 1, Place Renault |
| 92844 Rueil-Malmaison Cedex |
| Prantsusmaa |

AstraZeneca

1, Place Renault

92844 Rueil-Malmaison Cedex

Prantsusmaa

Hytacand

16 mg/12,5 mg comprimé

16 mg / 12,5 mg

Tablett

Suukaudne

Prantsusmaa

| Laboratoires Takeda, |
| --- |
| 11-15, quai de Dion Bouton, |
| 92816 Puteaux Cedex, |
| Prantsusmaa |

Laboratoires Takeda,

11-15, quai de Dion Bouton,

92816 Puteaux Cedex,

Prantsusmaa

CoKenzen 8mg/12,5mg comprimé

8 mg / 12,5 mg

Tablett

Suukaudne

Prantsusmaa

| Laboratoires Takeda, |
| --- |
| 11-15, quai de Dion Bouton, |
| 92816 Puteaux Cedex, |
| Prantsusmaa |

Laboratoires Takeda,

11-15, quai de Dion Bouton,

92816 Puteaux Cedex,

Prantsusmaa

CoKenzen 16mg/12,5mg comprimé

16 mg / 12,5 mg

Tablett

Suukaudne

Saksamaa

| AstraZeneca GmbH |
| --- |
| 22876 Wedel, |
| Saksamaa |

AstraZeneca GmbH

22876 Wedel,

Saksamaa

Atacand Plus 8/12,5 mg

8 mg / 12,5 mg

Tablett

Suukaudne

Saksamaa

| AstraZeneca GmbH |
| --- |
| 22876 Wedel, |
| Saksamaa |

AstraZeneca GmbH

22876 Wedel,

Saksamaa

Atacand Plus 16/12,5 mg

16 mg / 12,5 mg

Tablett

Suukaudne

Saksamaa

| AstraZeneca GmbH |
| --- |
| 22876 Wedel, |
| Saksamaa |

AstraZeneca GmbH

22876 Wedel,

Saksamaa

Atacand Plus 32/12,5 mg Tabletten

32 mg / 12,5 mg

Tablett

Suukaudne

Saksamaa

| AstraZeneca GmbH |
| --- |
| 22876 Wedel, |
| Saksamaa |

AstraZeneca GmbH

22876 Wedel,

Saksamaa

Atacand Plus forte 32/25 mg Tabletten

32 mg / 25 mg

Tablett

Suukaudne

Saksamaa

| Takeda Pharma GmbH, |
| --- |
| Viktoriaallee 3-5, |
| 52066 Aachen, |
| Saksamaa |

Takeda Pharma GmbH,

Viktoriaallee 3-5,

52066 Aachen,

Saksamaa

Blopress 8 mg Plus 12,5 mg tabletten.

8 mg / 12,5 mg

Tablett

Suukaudne

Saksamaa

| Takeda Pharma GmbH, |
| --- |
| Viktoriaallee 3-5, |
| 52066 Aachen, |
| Saksamaa |

Takeda Pharma GmbH,

Viktoriaallee 3-5,

52066 Aachen,

Saksamaa

Blopress 16 mg Plus12,5 mg tabletten

16 mg / 12,5 mg

Tablett

Suukaudne

Saksamaa

| Takeda Pharma GmbH, |
| --- |
| Viktoriaallee 3-5, |
| 52066 Aachen, |
| Saksamaa |

Takeda Pharma GmbH,

Viktoriaallee 3-5,

52066 Aachen,

Saksamaa

Blopress 32mg Plus 12,5 mg tabletten

32 mg / 12,5 mg

Tablett

Suukaudne

Saksamaa

| Takeda Pharma GmbH, |
| --- |
| Viktoriaallee 3-5, |
| 52066 Aachen, |
| Saksamaa |

Takeda Pharma GmbH,

Viktoriaallee 3-5,

52066 Aachen,

Saksamaa

Blopress forte 32 mg Plus 25 mg tabletten

32 mg / 25 mg

Tablett

Suukaudne

Kreeka

| AstraZeneca SA |
| --- |
| Theotokopoulou 4 & Astronafton |
| 151 25 Maroussi |
| Kreeka |

AstraZeneca SA

Theotokopoulou 4 & Astronafton

151 25 Maroussi

Kreeka

Atacand Plus

8 mg / 12,5 mg

Tablett

Suukaudne

Kreeka

| AstraZeneca SA |
| --- |
| Theotokopoulou 4 & Astronafton |
| 151 25 Maroussi |
| Kreeka |

AstraZeneca SA

Theotokopoulou 4 & Astronafton

151 25 Maroussi

Kreeka

Atacand Plus

16 mg / 12,5 mg

Tablett

Suukaudne

Kreeka

| AstraZeneca SA |
| --- |
| Theotokopoulou 4 & Astronafton |
| 151 25 Maroussi |
| Kreeka |

AstraZeneca SA

Theotokopoulou 4 & Astronafton

151 25 Maroussi

Kreeka

Atacand Plus

32 mg / 12,5 mg

Tablett

Suukaudne

Kreeka

| AstraZeneca SA |
| --- |
| Theotokopoulou 4 & Astronafton |
| 151 25 Maroussi |
| Kreeka |

AstraZeneca SA

Theotokopoulou 4 & Astronafton

151 25 Maroussi

Kreeka

Atacand Plus

32 mg / 25 mg

Tablett

Suukaudne

Ungari

| AstraZeneca Kft. |
| --- |
| 1113 Budapest, Bocskai út 134-146 |
| Ungari |

AstraZeneca Kft.

1113 Budapest, Bocskai út 134-146

Ungari

Atacand Plus

16 mg / 12,5 mg

Tablett

Suukaudne

Island

| AstraZeneca A/S Roskildevej 22, |
| --- |
| DK-2620 Albertslund, |
| Taani |

AstraZeneca A/S Roskildevej 22,

DK-2620 Albertslund,

Taani

Atacand Plus

16 mg / 12,5 mg

Tablett

Suukaudne

Island

| AstraZeneca A/S Roskildevej 22, |
| --- |
| DK-2620 Albertslund, |
| Taani |

AstraZeneca A/S Roskildevej 22,

DK-2620 Albertslund,

Taani

Atacand Plus

32 mg / 12,5 mg

Tablett

Suukaudne

Island

| AstraZeneca A/S Roskildevej 22, |
| --- |
| DK-2620 Albertslund, |
| Taani |

AstraZeneca A/S Roskildevej 22,

DK-2620 Albertslund,

Taani

Atacand Plus

32 mg / 25 mg

Tablett

Suukaudne

Iirimaa

| AstraZeneca UK Limited, |
| --- |
| 600 Capability Green, |
| Luton, |
| LU1 3LU, |
| Ühendkuningriik |

AstraZeneca UK Limited,

600 Capability Green,

Luton,

LU1 3LU,

Ühendkuningriik

Atacand Plus 8/12,5 mg

8 mg / 12,5 mg

Tablett

Suukaudne

Iirimaa

| AstraZeneca UK Limited, |
| --- |
| 600 Capability Green, |
| Luton, |
| LU1 3LU, |
| Ühendkuningriik |

AstraZeneca UK Limited,

600 Capability Green,

Luton,

LU1 3LU,

Ühendkuningriik

Atacand Plus 16/12,5 mg

16 mg / 12,5 mg

Tablett

Suukaudne

Iirimaa

| Takeda UK Limited, |
| --- |
| Takeda House, |
| Mercury Park, |
| Wycombe Lane, |
| Wooburn Green, |
| High Wycombe, |
| Buckinghamshire |
| HP10 OHH |
| Ühendkuningriik |

Takeda UK Limited,

Takeda House,

Mercury Park,

Wycombe Lane,

Wooburn Green,

High Wycombe,

Buckinghamshire

HP10 OHH

Ühendkuningriik

Blopress Plus 8 mg/12,5 mg tablets

8 mg / 12,5 mg

Tablett

Suukaudne

Iirimaa

| Takeda UK Limited, |
| --- |
| Takeda House, |
| Mercury Park, |
| Wycombe Lane, |
| Wooburn Green, |
| High Wycombe, |
| Buckinghamshire |
| HP10 OHH |
| Ühendkuningriik |

Takeda UK Limited,

Takeda House,

Mercury Park,

Wycombe Lane,

Wooburn Green,

High Wycombe,

Buckinghamshire

HP10 OHH

Ühendkuningriik

Blopress Plus 16 mg/12,5 mg tablets

16 mg / 12,5 mg

Tablett

Suukaudne

Iirimaa

| Takeda UK Limited, |
| --- |
| Takeda House, |
| Mercury Park, |
| Wycombe Lane, |
| Wooburn Green, |
| High Wycombe, |
| Buckinghamshire |
| HP10 OHH |
| Ühendkuningriik |

Takeda UK Limited,

Takeda House,

Mercury Park,

Wycombe Lane,

Wooburn Green,

High Wycombe,

Buckinghamshire

HP10 OHH

Ühendkuningriik

Blopress Plus 32 mg/12,5 mg tablets

32 mg / 12,5 mg

Tablett

Suukaudne

Iirimaa

| Takeda UK Limited, |
| --- |
| Takeda House, |
| Mercury Park, |
| Wycombe Lane, |
| Wooburn Green, |
| High Wycombe, |
| Buckinghamshire |
| HP10 OHH |
| Ühendkuningriik |

Takeda UK Limited,

Takeda House,

Mercury Park,

Wycombe Lane,

Wooburn Green,

High Wycombe,

Buckinghamshire

HP10 OHH

Ühendkuningriik

Blopress Plus

32 mg/25 mg tablets

32 mg / 25 mg

Tablett

Suukaudne

Itaalia

| AstraZeneca SpA |
| --- |
| Palazzo Volta-via F Sforza – 20080 Basiglio (MI) - |
| Itaalia |

AstraZeneca SpA

Palazzo Volta-via F Sforza – 20080 Basiglio (MI) -

Itaalia

Ratacand Plus

8 mg / 12,5 mg

Tablett

Suukaudne

Itaalia

| AstraZeneca SpA |
| --- |
| Palazzo Volta-via F Sforza – 20080 Basiglio (MI) - |
| Itaalia |

AstraZeneca SpA

Palazzo Volta-via F Sforza – 20080 Basiglio (MI) -

Itaalia

Ratacand Plus

16 mg / 12,5 mg

Tablett

Suukaudne

Itaalia

| AstraZeneca SpA |
| --- |
| Palazzo Volta-via F Sforza – 20080 Basiglio (MI) - |
| Itaalia |

AstraZeneca SpA

Palazzo Volta-via F Sforza – 20080 Basiglio (MI) -

Itaalia

Ratacand Plus

32 mg / 12,5 mg

Tablett

Suukaudne

Itaalia

| AstraZeneca SpA |
| --- |
| Palazzo Volta-via F Sforza – 20080 Basiglio (MI) - |
| Itaalia |

AstraZeneca SpA

Palazzo Volta-via F Sforza – 20080 Basiglio (MI) -

Itaalia

Ratacand Plus

32 mg / 25 mg

Tablett

Suukaudne

Itaalia

| Takeda Italia Farmaceutici S.p.A., |
| --- |
| Via Elio Vittorini, 129 |
| 00144 Roma |
| Itaalia |

Takeda Italia Farmaceutici S.p.A.,

Via Elio Vittorini, 129

00144 Roma

Itaalia

Blopresid 8/12,5 mg compresse

8 mg / 12,5 mg

Tablett

Suukaudne

Itaalia

| Takeda Italia Farmaceutici S.p.A., |
| --- |
| Via Elio Vittorini, 129 |
| 00144 Roma |
| Itaalia |

Takeda Italia Farmaceutici S.p.A.,

Via Elio Vittorini, 129

00144 Roma

Itaalia

Blopresid 16/12,5 mg compresse

16 mg / 12,5 mg

Tablett

Suukaudne

Itaalia

| Takeda Italia Farmaceutici S.p.A., |
| --- |
| Via Elio Vittorini, 129 |
| 00144 Roma |
| Itaalia |

Takeda Italia Farmaceutici S.p.A.,

Via Elio Vittorini, 129

00144 Roma

Itaalia

Blopresid 32mg/12,5 mg compresse

32 mg / 12,5 mg

Tablett

Suukaudne

Itaalia

| Takeda Italia Farmaceutici S.p.A., |
| --- |
| Via Elio Vittorini, 129 |
| 00144 Roma |
| Itaalia |

Takeda Italia Farmaceutici S.p.A.,

Via Elio Vittorini, 129

00144 Roma

Itaalia

Blopresid 32mg/25 mg compresse

32mg/25mg

Tablett

Suukaudne

Luxembourg

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussels |
| Belgia |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussels

Belgia

Atacand Plus

8 mg / 12,5 mg

Tablett

Suukaudne

Luxembourg

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussels |
| Belgia |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussels

Belgia

Atacand Plus

16 mg / 12,5 mg

Tablett

Suukaudne

Luxembourg

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussels |
| Belgia |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussels

Belgia

Atacand Plus

32 mg / 12,5 mg

Tablett

Suukaudne

Luxembourg

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussels |
| Belgia |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussels

Belgia

Atacand Plus

32 mg / 25 mg

Tablett

Suukaudne

Holland

| AstraZeneca BV |
| --- |
| Louis Pasteurlaan 5 |
| 2719 EE Zoetermeer |
| Holland |

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

Holland

Atacand Plus 8/12,5

8 mg / 12,5 mg

Tablett

Suukaudne

Holland

| AstraZeneca BV |
| --- |
| Louis Pasteurlaan 5 |
| 2719 EE Zoetermeer |
| Holland |

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

Holland

Atacand Plus 16/12,5

16 mg / 12,5 mg

Tablett

Suukaudne

Norra

| AstraZeneca AS |
| --- |
| Boks 200 Vinderen |
| NO-0319 Oslo, |
| Norra |

AstraZeneca AS

Boks 200 Vinderen

NO-0319 Oslo,

Norra

Atacand Plus Mite

8 mg / 12,5 mg

Tablett

Suukaudne

Norra

| AstraZeneca AS |
| --- |
| Boks 200 Vinderen |
| NO-0319 Oslo, |
| Norra |

AstraZeneca AS

Boks 200 Vinderen

NO-0319 Oslo,

Norra

Atacand Plus

16 mg / 12,5 mg

Tablett

Suukaudne

Norra

| AstraZeneca AS |
| --- |
| Boks 200 Vinderen |
| NO-0319 Oslo, |
| Norra |

AstraZeneca AS

Boks 200 Vinderen

NO-0319 Oslo,

Norra

Atacand Plus

32 mg / 12,5 mg

Tablett

Suukaudne

Norra

| AstraZeneca AS |
| --- |
| Boks 200 Vinderen |
| NO-0319 Oslo, |
| Norra |

AstraZeneca AS

Boks 200 Vinderen

NO-0319 Oslo,

Norra

Atacand Plus

32 mg / 25 mg

Tablett

Suukaudne

Portugal

| AstraZeneca Produtos Farmacêuticos, Lda. |
| --- |
| Rua Humberto Madeira, 7, |
| Queluz de Baixo 2730-097 Barcarena, |
| Portugal |

AstraZeneca Produtos Farmacêuticos, Lda.

Rua Humberto Madeira, 7,

Queluz de Baixo 2730-097 Barcarena,

Portugal

Hytacand

8 mg / 12,5 mg

Tablett

Suukaudne

Portugal

| AstraZeneca Produtos Farmacêuticos, Lda. |
| --- |
| Rua Humberto Madeira, 7, |
| Queluz de Baixo 2730-097 Barcarena, |
| Portugal |

AstraZeneca Produtos Farmacêuticos, Lda.

Rua Humberto Madeira, 7,

Queluz de Baixo 2730-097 Barcarena,

Portugal

Hytacand 16 mg

16 mg / 12,5 mg

Tablett

Suukaudne

Portugal

| AstraZeneca Produtos Farmacêuticos, Lda. |
| --- |
| Rua Humberto Madeira, 7, |
| Queluz de Baixo 2730-097 Barcarena, |
| Portugal |

AstraZeneca Produtos Farmacêuticos, Lda.

Rua Humberto Madeira, 7,

Queluz de Baixo 2730-097 Barcarena,

Portugal

Hytacand

32 mg / 12,5 mg

Tablett

Suukaudne

Portugal

| AstraZeneca Produtos Farmacêuticos, Lda. |
| --- |
| Rua Humberto Madeira, 7, |
| Queluz de Baixo 2730-097 Barcarena, |
| Portugal |

AstraZeneca Produtos Farmacêuticos, Lda.

Rua Humberto Madeira, 7,

Queluz de Baixo 2730-097 Barcarena,

Portugal

Hytacand

32 mg / 25 mg

Tablett

Suukaudne

Portugal

| Lusomedicamenta - Sociedade Técnica Farmacêutica, S.A., |
| --- |
| Estrada Consiglieri Pedroso, 69 B - Queluz de Baixo |
| 2730-055 Barcarena, |
| Portugal |

Lusomedicamenta - Sociedade Técnica Farmacêutica, S.A.,

Estrada Consiglieri Pedroso, 69 B - Queluz de Baixo

2730-055 Barcarena,

Portugal

Blopress

8 mg / 12,5 mg

Tablett

Suukaudne

Portugal

| Lusomedicamenta - Sociedade Técnica Farmacêutica, S.A., |
| --- |
| Estrada Consiglieri Pedroso, 69 B - Queluz de Baixo |
| 2730-055 Barcarena, |
| Portugal |

Lusomedicamenta - Sociedade Técnica Farmacêutica, S.A.,

Estrada Consiglieri Pedroso, 69 B - Queluz de Baixo

2730-055 Barcarena,

Portugal

Blopress

16 mg / 12,5 mg

Tablett

Suukaudne

Portugal

| Lusomedicamenta - Sociedade Técnica Farmacêutica, S.A. |
| --- |
| Estrada Consiglieri Pedroso, 69 B - Queluz de Baixo |
| 2730-055 Barcarena, |
| Portugal |

Lusomedicamenta - Sociedade Técnica Farmacêutica, S.A.

Estrada Consiglieri Pedroso, 69 B - Queluz de Baixo

2730-055 Barcarena,

Portugal

Blopress

32 mg / 12,5 mg

Tablett

Suukaudne

Portugal

| Lusomedicamenta - Sociedade Técnica Farmacêutica, S.A., |
| --- |
| Estrada Consiglieri Pedroso, 69 B - Queluz de Baixo |
| 2730-055 Barcarena, |
| Portugal |

Lusomedicamenta - Sociedade Técnica Farmacêutica, S.A.,

Estrada Consiglieri Pedroso, 69 B - Queluz de Baixo

2730-055 Barcarena,

Portugal

Blopress

32 mg / 25 mg

Tablett

Suukaudne

Slovakkia

| AstraZeneca AB, S-151 85 Södertälje, |
| --- |
| Rootsi |

AstraZeneca AB, S-151 85 Södertälje,

Rootsi

Atacand Plus 16/12,5 mg

16 mg / 12,5 mg

Tablett

Suukaudne

Slovakkia

| AstraZeneca AB, S-151 85 Södertälje, |
| --- |
| Rootsi |

AstraZeneca AB, S-151 85 Södertälje,

Rootsi

Atacand Plus

32 mg / 12,5 mg

Tablett

Suukaudne

Slovakkia

| AstraZeneca AB, S-151 85 Södertälje, |
| --- |
| Rootsi |

AstraZeneca AB, S-151 85 Södertälje,

Rootsi

Atacand Plus

32 mg / 25 mg

Tablett

Suukaudne

Sloveenia

| AstraZeneca UK Limited |
| --- |
| 15 Stanhope Gate |
| London W1K 1LN |
| Ühendkuningriik |

AstraZeneca UK Limited

15 Stanhope Gate

London W1K 1LN

Ühendkuningriik

Atacand Plus 16/12,5 mg

16 mg / 12,5 mg

Tablett

Suukaudne

Hispaania

| AstraZeneca Farmacéutica Spain, S.A. |
| --- |
| Parque Norte.Edificio Roble. |
| C/ Serrano Galvache 56 |
| 28033 Madrid, |
| Hispaania |

AstraZeneca Farmacéutica Spain, S.A.

Parque Norte.Edificio Roble.

C/ Serrano Galvache 56

28033 Madrid,

Hispaania

Atacand Plus 16 mg/12,5 mg

16 mg / 12,5 mg

Tablett

Suukaudne

Hispaania

| AstraZeneca Farmacéutica Spain, S.A. |
| --- |
| Parque Norte.Edificio Roble. |
| C/ Serrano Galvache 56 |
| 28033 Madrid, |
| Hispaania |

AstraZeneca Farmacéutica Spain, S.A.

Parque Norte.Edificio Roble.

C/ Serrano Galvache 56

28033 Madrid,

Hispaania

Atacand Plus

32 mg/12,5 mg

32 mg / 12,5 mg

Tablett

Suukaudne

Hispaania

| AstraZeneca Farmacéutica Spain, S.A. |
| --- |
| Parque Norte.Edificio Roble. |
| C/ Serrano Galvache 56 |
| 28033 Madrid, |
| Hispaania |

AstraZeneca Farmacéutica Spain, S.A.

Parque Norte.Edificio Roble.

C/ Serrano Galvache 56

28033 Madrid,

Hispaania

Atacand Plus Forte

32 mg/25 mg

32 mg / 25 mg

Tablett

Suukaudne

Hispaania

| Takeda Global Research and Development Centre (Europe) Ltd, |
| --- |
| 61 Aldwych, |
| London, |
| WC2B 4AE, |
| Ühendkuningriik |

Takeda Global Research and Development Centre (Europe) Ltd,

61 Aldwych,

London,

WC2B 4AE,

Ühendkuningriik

Blopress Plus 8/12,5mg comprimidos

8 mg / 12,5 mg

Tablett

Suukaudne

Hispaania

| Takeda Global Research and Development Centre (Europe) Ltd, |
| --- |
| 61 Aldwych, |
| London, |
| WC2B 4AE, |
| Ühendkuningriik |

Takeda Global Research and Development Centre (Europe) Ltd,

61 Aldwych,

London,

WC2B 4AE,

Ühendkuningriik

Blopress Plus 16/12,5mg comprimidos

16 mg / 12,5 mg

Tablett

Suukaudne

Hispaania

| Takeda Global Research and Development Centre (Europe) Ltd, |
| --- |
| 61 Aldwych, |
| London, |
| WC2B 4AE, |
| Ühendkuningriik |

Takeda Global Research and Development Centre (Europe) Ltd,

61 Aldwych,

London,

WC2B 4AE,

Ühendkuningriik

Blopress Plus 32 mg/12,5mg comprimidos

32 mg / 12,5 mg

Tablett

Suukaudne

Hispaania

| Takeda Global Research and Development Centre (Europe) Ltd, |
| --- |
| 61 Aldwych, |
| London, |
| WC2B 4AE, |
| Ühendkuningriik |

Takeda Global Research and Development Centre (Europe) Ltd,

61 Aldwych,

London,

WC2B 4AE,

Ühendkuningriik

Blopress Forte 32 mg/25mg comprimidos

32 mg / 25 mg

Tablett

Suukaudne

Hispaania

| Almirall S.A., |
| --- |
| Ronda General Mitre, |
| 151 08022 Barcelona, |
| Hispaania |

Almirall S.A.,

Ronda General Mitre,

151 08022 Barcelona,

Hispaania

Parapres Plus 16 mg/12,5mg comprimidos

16 mg / 12,5 mg

Tablett

Suukaudne

Hispaania

| Almirall S.A., |
| --- |
| Ronda General Mitre, |
| 151 08022 Barcelona, |
| Hispaania |

Almirall S.A.,

Ronda General Mitre,

151 08022 Barcelona,

Hispaania

Parapres Plus 32mg/12,5mg comprimidos

32 mg / 12,5 mg

Tablett

Suukaudne

Hispaania

| Almirall S.A., |
| --- |
| Ronda General Mitre, |
| 151 08022 Barcelona, |
| Hispaania |

Almirall S.A.,

Ronda General Mitre,

151 08022 Barcelona,

Hispaania

Parapres Plus Forte 32mg/25mg comprimidos

32 mg / 25 mg

Tablett

Suukaudne

Rootsi

| AstraZeneca AB |
| --- |
| 151 85 Södertälje, |
| Rootsi |

AstraZeneca AB

151 85 Södertälje,

Rootsi

Atacand Plus

8 mg / 12,5 mg

Tablett

Suukaudne

Rootsi

| AstraZeneca AB |
| --- |
| 151 85 Södertälje, |
| Rootsi |

AstraZeneca AB

151 85 Södertälje,

Rootsi

Atacand Plus

16 mg / 12,5 mg

Tablett

Suukaudne

Rootsi

| AstraZeneca AB |
| --- |
| 151 85 Södertälje, |
| Rootsi |

AstraZeneca AB

151 85 Södertälje,

Rootsi

Atacand Plus

32 mg / 12,5 mg

Tablett

Suukaudne

Rootsi

| AstraZeneca AB |
| --- |
| 151 85 Södertälje, |
| Rootsi |

AstraZeneca AB

151 85 Södertälje,

Rootsi

Atacand Plus

32 mg / 25 mg

Tablett

Suukaudne

Rootsi

| Takeda Global Research and Development Centre (Europe) Ltd, |
| --- |
| 61 Aldwych, |
| London, |
| WC2B 4AE, |
| Ühendkuningriik |

Takeda Global Research and Development Centre (Europe) Ltd,

61 Aldwych,

London,

WC2B 4AE,

Ühendkuningriik

Blopress Comp

8 mg / 12,5 mg

Tablett

Suukaudne

Rootsi

| Takeda Global Research and Development Centre (Europe) Ltd, |
| --- |
| 61 Aldwych, |
| London, |
| WC2B 4AE, |
| Ühendkuningriik |

Takeda Global Research and Development Centre (Europe) Ltd,

61 Aldwych,

London,

WC2B 4AE,

Ühendkuningriik

Blopress Comp

16 mg / 12,5 mg

Tablett

Suukaudne

Rootsi

| Takeda Global Research and Development Centre (Europe) Ltd, |
| --- |
| 61 Aldwych, |
| London, |
| WC2B 4AE, |
| Ühendkuningriik |

Takeda Global Research and Development Centre (Europe) Ltd,

61 Aldwych,

London,

WC2B 4AE,

Ühendkuningriik

Blopress Comp

32 mg / 12,5 mg

Tablett

Suukaudne

Rootsi

| Takeda Global Research and Development Centre (Europe) Ltd, |
| --- |
| 61 Aldwych, |
| London, |
| WC2B 4AE, |
| Ühendkuningriik |

Takeda Global Research and Development Centre (Europe) Ltd,

61 Aldwych,

London,

WC2B 4AE,

Ühendkuningriik

Blopress Comp

32 mg / 25 mg

Tablett

Suukaudne

Rootsi

| Takeda Global Research and Development Centre (Europe) Ltd, |
| --- |
| 61 Aldwych, |
| London, |
| WC2B 4AE, |
| Ühendkuningriik |

Takeda Global Research and Development Centre (Europe) Ltd,

61 Aldwych,

London,

WC2B 4AE,

Ühendkuningriik

Parapres Comp Forte

16 mg / 12,5 mg

Tablett

Suukaudne

Rootsi

| Takeda Global Research and Development Centre (Europe) Ltd, |
| --- |
| 61 Aldwych, |
| London, |
| WC2B 4AE, |
| Ühendkuningriik |

Takeda Global Research and Development Centre (Europe) Ltd,

61 Aldwych,

London,

WC2B 4AE,

Ühendkuningriik

Parapres Comp

32 mg / 12,5 mg

Tablett

Suukaudne

Rootsi

| Takeda Global Research and Development Centre (Europe) Ltd, |
| --- |
| 61 Aldwych, |
| London, |
| WC2B 4AE, |
| Ühendkuningriik |

Takeda Global Research and Development Centre (Europe) Ltd,

61 Aldwych,

London,

WC2B 4AE,

Ühendkuningriik

Parapres Comp

32 mg / 25 mg

Tablett

Suukaudne

---

VI LISA

RAVIMI(TE) NIMETUSTE, RAVIMVORMI(DE), TUGEVUS(T)E, MANUSTAMISVIISI(DE), TAOTLEJA(TE), MÜÜGILOA HOIDJA(TE) LOETELU LIIKMESRIIKIDES

| Liikmesriik | Müügiloa hoidja | Ravimi väljamõeldud nimetus | Tugevus | Ravimvorm | Manustamisviis |
| --- | --- | --- | --- | --- | --- |
| Belgia | LEO Pharmaceutical Products Ltd. A/S |
| (LEO Pharma A/S) |
| Industriparken 55 |
| DK-2750 Ballerup |
| Taani |

Liikmesriik

Müügiloa hoidja

Ravimi väljamõeldud nimetus

Tugevus

Ravimvorm

Manustamisviis

Belgia

LEO Pharmaceutical Products Ltd. A/S

(LEO Pharma A/S)

Industriparken 55

DK-2750 Ballerup

Taani

Dovobet 50 microgram/0,5 mg/g gel

50 μg/g + 0,5 mg/g

Geel

Kasutamiseks nahal

Belgia

| LEO Pharmaceutical Products Ltd. A/S |
| --- |
| (LEO Pharma A/S) |
| Industriparken 55 |
| DK-2750 Ballerup |
| Taani |

LEO Pharmaceutical Products Ltd. A/S

(LEO Pharma A/S)

Industriparken 55

DK-2750 Ballerup

Taani

Dovobet 50 microgram/g + 0,5 mg/g, zalf

50 μg/g + 0,5 mg/g

Salv

Kasutamiseks nahal

Bulgaaria

| LEO Pharmaceutical Products Ltd. A/S |
| --- |
| (LEO Pharma A/S) |
| Industriparken 55 |
| DK-2750 Ballerup |
| Taani |

LEO Pharmaceutical Products Ltd. A/S

(LEO Pharma A/S)

Industriparken 55

DK-2750 Ballerup

Taani

Daivobet®

50 μg/g + 0,5 mg/g

Salv

Kasutamiseks nahal

Küpros

| LEO Pharmaceutical Products Ltd. A/S |
| --- |
| (LEO Pharma A/S) |
| Industriparken 55 |
| DK-2750 Ballerup |
| Taani |

LEO Pharmaceutical Products Ltd. A/S

(LEO Pharma A/S)

Industriparken 55

DK-2750 Ballerup

Taani

Dovobet® 50 microgram/g + 0,5 mg/g ointment

50 μg/g + 0,5 mg/g

Salv

Kasutamiseks nahal

Tšehhi Vabariik

| LEO Pharmaceutical Products Ltd. A/S |
| --- |
| (LEO Pharma A/S) |
| Industriparken 55 |
| DK-2750 Ballerup |
| Taani |

LEO Pharmaceutical Products Ltd. A/S

(LEO Pharma A/S)

Industriparken 55

DK-2750 Ballerup

Taani

Daivobet mast

50 μg/g + 0,5 mg/g

Salv

Kasutamiseks nahal

Taani

| LEO Pharmaceutical Products Ltd. A/S |
| --- |
| (LEO Pharma A/S) |
| Industriparken 55 |
| DK-2750 Ballerup |
| Taani |

LEO Pharmaceutical Products Ltd. A/S

(LEO Pharma A/S)

Industriparken 55

DK-2750 Ballerup

Taani

Daivobet

50 μg/g + 0,5 mg/g

Geel

Kasutamiseks nahal

Taani

| LEO Pharmaceutical Products Ltd. A/S |
| --- |
| (LEO Pharma A/S) |
| Industriparken 55 |
| DK-2750 Ballerup |
| Taani |

LEO Pharmaceutical Products Ltd. A/S

(LEO Pharma A/S)

Industriparken 55

DK-2750 Ballerup

Taani

Daivobet

50 μg/g + 0,5 mg/g

Salv

Kasutamiseks nahal

Eesti

| LEO Pharmaceutical Products |
| --- |
| Industriparken 55 |
| DK-2750 Ballerup |
| Taani |

LEO Pharmaceutical Products

Industriparken 55

DK-2750 Ballerup

Taani

DAIVOBET

50 μg/g + 0,5 mg/g

Salv

Kasutamiseks nahal

Soome

| LEO Pharmaceutical Products Ltd. A/S |
| --- |
| (LEO Pharma A/S) |
| Industriparken 55 |
| DK-2750 Ballerup |
| Taani |

LEO Pharmaceutical Products Ltd. A/S

(LEO Pharma A/S)

Industriparken 55

DK-2750 Ballerup

Taani

Daivobet 50 mikrogram/g + 0,5 mg/g geeli

50 μg/g + 0,5 mg/g

Geel

Kasutamiseks nahal

Soome

| LEO Pharmaceutical Products Ltd. A/S |
| --- |
| (LEO Pharma A/S) |
| Industriparken 55 |
| DK-2750 Ballerup |
| Taani |

LEO Pharmaceutical Products Ltd. A/S

(LEO Pharma A/S)

Industriparken 55

DK-2750 Ballerup

Taani

Daivobet 50/500 mikrog/g voide

50 μg/g + 0,5 mg/g

Salv

Kasutamiseks nahal

Prantsusmaa

| LEO Pharmaceutical Products Ltd. A/S |
| --- |
| (LEO Pharma A/S) |
| Industriparken 55 |
| DK-2750 Ballerup |
| Taani |

LEO Pharmaceutical Products Ltd. A/S

(LEO Pharma A/S)

Industriparken 55

DK-2750 Ballerup

Taani

DAIVOBET 50 microgrammes/0,5 mg/g, gel

50 μg/g + 0,5 mg/g

Geel

Kasutamiseks nahal

Prantsusmaa

| LEO Pharmaceutical Products Ltd. A/S |
| --- |
| (LEO Pharma A/S) |
| Industriparken 55 |
| DK-2750 Ballerup |
| Taani |

LEO Pharmaceutical Products Ltd. A/S

(LEO Pharma A/S)

Industriparken 55

DK-2750 Ballerup

Taani

DAIVOBET 50 microgrammes/0,5 mg/g, pommade

50 μg/g + 0,5 mg/g

Salv

Kasutamiseks nahal

Saksamaa

| LEO Pharmaceutical Products Ltd. A/S |
| --- |
| (LEO Pharma A/S) |
| Industriparken 55 |
| DK-2750 Ballerup |
| Taani |

LEO Pharmaceutical Products Ltd. A/S

(LEO Pharma A/S)

Industriparken 55

DK-2750 Ballerup

Taani

Daivobet 50 Mikrogramm/g + 0,5 mg/g Gel

50 μg/g + 0,5 mg/g

Geel

Kasutamiseks nahal

Saksamaa

| LEO Pharmaceutical Products Ltd. A/S |
| --- |
| (LEO Pharma A/S) |
| Industriparken 55 |
| DK-2750 Ballerup |
| Taani |

LEO Pharmaceutical Products Ltd. A/S

(LEO Pharma A/S)

Industriparken 55

DK-2750 Ballerup

Taani

Daivobet® 50 Mikrogramm/g + 0,5 mg/g Salbe

50 μg/g + 0,5 mg/g

Salv

Kasutamiseks nahal

Kreeka

| LEO Pharmaceutical Products Ltd. A/S |
| --- |
| (LEO Pharma A/S) |
| Industriparken 55 |
| DK-2750 Ballerup |
| Taani |

LEO Pharmaceutical Products Ltd. A/S

(LEO Pharma A/S)

Industriparken 55

DK-2750 Ballerup

Taani

Dovobet 50 microgram/ 0,5 mg/g gel

50 μg/g + 0,5 mg/g

Geel

Kasutamiseks nahal

Kreeka

| LEO Pharmaceutical Products Ltd. A/S |
| --- |
| (LEO Pharma A/S) |
| Industriparken 55 |
| DK-2750 Ballerup |
| Taani |

LEO Pharmaceutical Products Ltd. A/S

(LEO Pharma A/S)

Industriparken 55

DK-2750 Ballerup

Taani

Dovobet 50 microgram/g + 0,5 mg/g

50 μg/g + 0,5 mg/g

Salv

Kasutamiseks nahal

Ungari

| LEO Pharmaceutical Products Ltd. A/S |
| --- |
| (LEO Pharma A/S) |
| Industriparken 55 |
| DK-2750 Ballerup |
| Taani |

LEO Pharmaceutical Products Ltd. A/S

(LEO Pharma A/S)

Industriparken 55

DK-2750 Ballerup

Taani

Daivobet salv

50 μg/g + 0,5 mg/g

Salv

Kasutamiseks nahal

Island

| LEO Pharmaceutical Products Ltd. A/S |
| --- |
| (LEO Pharma A/S) |
| Industriparken 55 |
| DK-2750 Ballerup |
| Taani |

LEO Pharmaceutical Products Ltd. A/S

(LEO Pharma A/S)

Industriparken 55

DK-2750 Ballerup

Taani

Daivobet 50 míkrógrömm/0,5 mg/g hlaup

50 μg/g + 0,5 mg/g

Geel

Kasutamiseks nahal

Island

| LEO Pharmaceutical Products Ltd. A/S |
| --- |
| (LEO Pharma A/S) |
| Industriparken 55 |
| DK-2750 Ballerup |
| Taani |

LEO Pharmaceutical Products Ltd. A/S

(LEO Pharma A/S)

Industriparken 55

DK-2750 Ballerup

Taani

Daivobet 50 míkróg/g + 0,5 mg/g smyrsli

50 μg/g + 0,5 mg/g

Salv

Kasutamiseks nahal

Iirimaa

| LEO Pharmaceutical Products Ltd. A/S |
| --- |
| (LEO Pharma A/S) |
| Industriparken 55 |
| DK-2750 Ballerup |
| Taani |

LEO Pharmaceutical Products Ltd. A/S

(LEO Pharma A/S)

Industriparken 55

DK-2750 Ballerup

Taani

Dovobet 50 microgram/g + 0,5 mg/g gel

50 μg/g + 0,5 mg/g

Geel

Kasutamiseks nahal

Iirimaa

| LEO Pharmaceutical Products Ltd. A/S |
| --- |
| (LEO Pharma A/S) |
| Industriparken 55 |
| DK-2750 Ballerup |
| Taani |

LEO Pharmaceutical Products Ltd. A/S

(LEO Pharma A/S)

Industriparken 55

DK-2750 Ballerup

Taani

Dovobet 50 microgram/g + 0,5 mg/g ointment

50 μg/g + 0,5 mg/g

Salv

Kasutamiseks nahal

Itaalia

| LEO Pharmaceutical Products Ltd. A/S |
| --- |
| (LEO Pharma A/S) |
| Industriparken 55 |
| DK-2750 Ballerup |
| Taani |

LEO Pharmaceutical Products Ltd. A/S

(LEO Pharma A/S)

Industriparken 55

DK-2750 Ballerup

Taani

Dovobet

50 μg/g + 0,5 mg/g

Geel

Kasutamiseks nahal

Itaalia

| LEO Pharmaceutical Products Ltd. A/S |
| --- |
| (LEO Pharma A/S) |
| Industriparken 55 |
| DK-2750 Ballerup |
| Taani |

LEO Pharmaceutical Products Ltd. A/S

(LEO Pharma A/S)

Industriparken 55

DK-2750 Ballerup

Taani

Dovobet

50 μg/g + 0,5 mg/g

Salv

Kasutamiseks nahal

Läti

| LEO Pharmaceutical Products Ltd. A/S |
| --- |
| (LEO Pharma A/S) |
| Industriparken 55 |
| DK-2750 Ballerup |
| Taani |

LEO Pharmaceutical Products Ltd. A/S

(LEO Pharma A/S)

Industriparken 55

DK-2750 Ballerup

Taani

Daivobet® 50 μg/g + 0,5 mg/g ziede

50 μg/g + 0,5 mg/g

Salv

Kasutamiseks nahal

Leedu

| LEO Pharmaceutical Products |
| --- |
| Industriparken 55 |
| DK-2750 Ballerup |
| Taani |

LEO Pharmaceutical Products

Industriparken 55

DK-2750 Ballerup

Taani

Daivobet

50 μg/g + 0,5 mg/g

Salv

Kasutamiseks nahal

Luksemburg

| LEO Pharmaceutical Products Ltd. A/S |
| --- |
| (LEO Pharma A/S) |
| Industriparken 55 |
| DK-2750 Ballerup |
| Taani |

LEO Pharmaceutical Products Ltd. A/S

(LEO Pharma A/S)

Industriparken 55

DK-2750 Ballerup

Taani

Dovobet Scalp 50 microgram/0,5 mg/g gel

50 μg/g + 0,5 mg/g

Geel

Kasutamiseks nahal

Luksemburg

| LEO Pharmaceutical Products Ltd. A/S |
| --- |
| (LEO Pharma A/S) |
| Industriparken 55 |
| DK-2750 Ballerup |
| Taani |

LEO Pharmaceutical Products Ltd. A/S

(LEO Pharma A/S)

Industriparken 55

DK-2750 Ballerup

Taani

Dovobet 50 microgrammes/g + 0,5 mg/g, onguent

50 μg/g + 0,5 mg/g

Salv

Kasutamiseks nahal

Malta

| LEO Pharmaceutical Products Ltd. A/S |
| --- |
| (LEO Pharma A/S) |
| Industriparken 55 |
| DK-2750 Ballerup |
| Taani |

LEO Pharmaceutical Products Ltd. A/S

(LEO Pharma A/S)

Industriparken 55

DK-2750 Ballerup

Taani

Daivobet® 50 micrograms/g + 0,5 mg/g ointment

50 μg/g + 0,5 mg/g

Salv

Kasutamiseks nahal

Holland

| LEO Pharmaceutical Products Ltd. A/S |
| --- |
| (LEO Pharma A/S) |
| Industriparken 55 |
| DK-2750 Ballerup |
| Taani |

LEO Pharmaceutical Products Ltd. A/S

(LEO Pharma A/S)

Industriparken 55

DK-2750 Ballerup

Taani

Dovobet gel 50 microgram/0,5 mg/g gel

50 μg/g + 0,5 mg/g

Geel

Kasutamiseks nahal

Holland

| LEO Pharmaceutical Products Ltd. A/S |
| --- |
| (LEO Pharma A/S) |
| Industriparken 55 |
| DK-2750 Ballerup |
| Taani |

LEO Pharmaceutical Products Ltd. A/S

(LEO Pharma A/S)

Industriparken 55

DK-2750 Ballerup

Taani

Dovobet zalf 50 microgram/g + 0,5 mg/g

50 μg/g + 0,5 mg/g

Salv

Kasutamiseks nahal

Norra

| LEO Pharmaceutical Products Ltd. A/S |
| --- |
| (LEO Pharma A/S) |
| Industriparken 55 |
| DK-2750 Ballerup |
| Taani |

LEO Pharmaceutical Products Ltd. A/S

(LEO Pharma A/S)

Industriparken 55

DK-2750 Ballerup

Taani

Daivobet 50 mikrogram/g + 0,5 mg/g gel

50 μg/g + 0,5 mg/g

Geel

Kasutamiseks nahal

Norra

| LEO Pharmaceutical Products Ltd. A/S |
| --- |
| (LEO Pharma A/S) |
| Industriparken 55 |
| DK-2750 Ballerup |
| Taani |

LEO Pharmaceutical Products Ltd. A/S

(LEO Pharma A/S)

Industriparken 55

DK-2750 Ballerup

Taani

Daivobet 50 mikrogram/g + 0,5 mg/g salve

50 μg/g + 0,5 mg/g

Salv

Kasutamiseks nahal

Poola

| LEO Pharmaceutical Products Ltd. A/S |
| --- |
| Industriparken 55 |
| DK-2750 Ballerup |
| Taani |

LEO Pharmaceutical Products Ltd. A/S

Industriparken 55

DK-2750 Ballerup

Taani

DAIVOBET

(50 μg + 0,5 mg)/g

Salv

Kasutamiseks nahal

Portugal

| LEO Pharmaceutical Products Ltd. A/S |
| --- |
| (LEO Pharma A/S) |
| Industriparken 55 |
| DK-2750 Ballerup |
| Taani |

LEO Pharmaceutical Products Ltd. A/S

(LEO Pharma A/S)

Industriparken 55

DK-2750 Ballerup

Taani

Daivobet

50 μg/g + 0,5 mg/g

Geel

Kasutamiseks nahal

Portugal

| LEO Pharmaceutical Products Ltd. A/S |
| --- |
| (LEO Pharma A/S) |
| Industriparken 55 |
| DK-2750 Ballerup |
| Taani |

LEO Pharmaceutical Products Ltd. A/S

(LEO Pharma A/S)

Industriparken 55

DK-2750 Ballerup

Taani

Daivobet

50 μg/g + 0,5 mg/g

Salv

Kasutamiseks nahal

Rumeenia

| LEO Pharmaceutical Products Ltd. A/S |
| --- |
| (LEO Pharma A/S) |
| Industriparken 55 |
| DK-2750 Ballerup |
| Taani |

LEO Pharmaceutical Products Ltd. A/S

(LEO Pharma A/S)

Industriparken 55

DK-2750 Ballerup

Taani

DAIVOBET® UNGUENT

50 μg/g + 0,5 mg/g

Salv

Kasutamiseks nahal

Sloveenia

| Pharmagan, d.o.o. |
| --- |
| Vodopivceva 9 |
| SI-4000 Kranj |
| Sloveenia |

Pharmagan, d.o.o.

Vodopivceva 9

SI-4000 Kranj

Sloveenia

Daivobet 50 mikrogramov/500 mikrogramov v 1 g mazilo

50 μg/g + 0,5 mg/g

Salv

Kasutamiseks nahal

Hispaania

| LEO Pharmaceutical Products Ltd. A/S |
| --- |
| (LEO Pharma A/S) |
| Industriparken 55 |
| DK-2750 Ballerup |
| Taani |

LEO Pharmaceutical Products Ltd. A/S

(LEO Pharma A/S)

Industriparken 55

DK-2750 Ballerup

Taani

Daivobet 50 microgramos/g + 0,5 mg/g gel

50 μg/g + 0,5 mg/g

Geel

Kasutamiseks nahal

Hispaania

| LEO Pharmaceutical Products Ltd. A/S |
| --- |
| (LEO Pharma A/S) |
| Industriparken 55 |
| DK-2750 Ballerup |
| Taani |

LEO Pharmaceutical Products Ltd. A/S

(LEO Pharma A/S)

Industriparken 55

DK-2750 Ballerup

Taani

Daivobet 50 microgramos/g + 0,5 mg/g pomada

50 μg/g + 0,5 mg/g

Salv

Kasutamiseks nahal

Rootsi

| LEO Pharmaceutical Products Ltd. A/S |
| --- |
| (LEO Pharma A/S) |
| Industriparken 55 |
| DK-2750 Ballerup |
| Taani |

LEO Pharmaceutical Products Ltd. A/S

(LEO Pharma A/S)

Industriparken 55

DK-2750 Ballerup

Taani

Daivobet

50 μg/g + 0,5 mg/g

Geel

Kasutamiseks nahal

Rootsi

| LEO Pharmaceutical Products Ltd. A/S |
| --- |
| (LEO Pharma A/S) |
| Industriparken 55 |
| DK-2750 Ballerup |
| Taani |

LEO Pharmaceutical Products Ltd. A/S

(LEO Pharma A/S)

Industriparken 55

DK-2750 Ballerup

Taani

Daivobet

50 μg/g + 0,5 mg/g

Salv

Kasutamiseks nahal

Ühendkuningriik

| LEO Pharmaceutical Products Ltd. A/S |
| --- |
| (LEO Pharma A/S) |
| Industriparken 55 |
| DK-2750 Ballerup |
| Taani |

LEO Pharmaceutical Products Ltd. A/S

(LEO Pharma A/S)

Industriparken 55

DK-2750 Ballerup

Taani

Dovobet 50 microgram/g + 0,5 mg/g gel

50 μg/g + 0,5 mg/g

Geel

Kasutamiseks nahal

Ühendkuningriik

| LEO Pharmaceutical Products Ltd. A/S |
| --- |
| (LEO Pharma A/S) |
| Industriparken 55 |
| DK-2750 Ballerup |
| Taani |

LEO Pharmaceutical Products Ltd. A/S

(LEO Pharma A/S)

Industriparken 55

DK-2750 Ballerup

Taani

Dovobet® 50 microgram/g + 0,5 mg/g ointment

50 μg/g + 0,5 mg/g

Salv

Kasutamiseks nahal

---

VII LISA

RAVIMI(TE) NIMETUSTE, RAVIMVORMI(DE), TUGEVUS(T)E, MANUSTAMISVIISI(DE), TAOTLEJA(TE), MÜÜGILOA HOIDJA(TE) LOETELU LIIKMESRIIKIDES

| Liikmesriik EL/EMP | Müügiloa hoidja | Taotleja | (Ravimi väljamõeldud) nimetus | Tugevus | Ravimvorm | Manustamisviis |
| --- | --- | --- | --- | --- | --- | --- |
| Itaalia | | Warner Chilcott UK Limited, |
| Old Belfast Road, Millbrook, Larne, County Antrim, |
| BT40 2SH |
| Ühendkuningriik |

Liikmesriik EL/EMP

Müügiloa hoidja

Taotleja

(Ravimi väljamõeldud) nimetus

Tugevus

Ravimvorm

Manustamisviis

Itaalia

Warner Chilcott UK Limited,

Old Belfast Road, Millbrook, Larne, County Antrim,

BT40 2SH

Ühendkuningriik

Actocalcio D3

35 mg +

1 000 mg/880 IU

Õhukese polümeerikattega tabletid + kihisevad graanulid

Suukaudne

Hispaania

| PROCTER AND GAMBLE PHARMACEUTICALS IBERIA, S.L. |
| --- |
| WTC Almeda Park, Ed. 1, 2a pl. |
| Plaça de la Pau s/n |
| 08940 Cornellà de Llobregat (Barcelona) |
| Hispaania |

PROCTER AND GAMBLE PHARMACEUTICALS IBERIA, S.L.

WTC Almeda Park, Ed. 1, 2a pl.

Plaça de la Pau s/n

08940 Cornellà de Llobregat (Barcelona)

Hispaania

Acrelcombi

35 mg +

1 000 mg/880 IU

Õhukese polümeerikattega tabletid + kihisevad graanulid

Suukaudne

Rootsi

| Warner Chilcott UK Limited, |
| --- |
| Old Belfast Road, Millbrook, Larne, County Antrim, |
| BT40 2SH |
| Ühendkuningriik |

Warner Chilcott UK Limited,

Old Belfast Road, Millbrook, Larne, County Antrim,

BT40 2SH

Ühendkuningriik

Fortipan Combi D

35 mg +

1 000 mg/880 IU

Õhukese polümeerikattega tabletid + kihisevad graanulid

Suukaudne

---

VIII LISA

RAVIMITE NIMETUSTE, RAVIMVORMIDE, TUGEVUSTE, MANUSTAMISVIISIDE, MÜÜGILOA HOIDJATE LOETELU LIIKMESRIIKIDES

| Liikmesriik EL/EMP | Müügiloa hoidja | Nimi | Tugevus | Ravimvorm | Manustamisviis |
| --- | --- | --- | --- | --- | --- |
| Austria | Pfizer Corporation Austria GmbH |
| Floridsdorfer Hauptstraße 1 |
| A-1210 Wien |
| Austria |

Liikmesriik EL/EMP

Müügiloa hoidja

Nimi

Tugevus

Ravimvorm

Manustamisviis

Austria

Pfizer Corporation Austria GmbH

Floridsdorfer Hauptstraße 1

A-1210 Wien

Austria

Genotropin 12 mg - Pulver und Lösungsmittel zur Herstellung einer Injektionslösung

12 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Austria

| Pfizer Corporation Austria |
| --- |
| GmbH |
| Floridsdorfer Hauptstraße 1 |
| A-1210 Wien |
| Austria |

Pfizer Corporation Austria

GmbH

Floridsdorfer Hauptstraße 1

A-1210 Wien

Austria

Genotropin 5,3 mg - Pulver und Lösungsmittel zur Herstellung einer Injektionslösung

5,3 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Austria

| Pfizer Corpoation Austria |
| --- |
| GmbH |
| Floridsdorfer Hauptstraße 1 |
| A-1210 Wien |
| Austria |

Pfizer Corpoation Austria

GmbH

Floridsdorfer Hauptstraße 1

A-1210 Wien

Austria

Genotropin MiniQuick 0,2 mg - Pulver und Lösungsmittel zur Herstellung einer Injektionslösung

0,2 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Belgia

| PFIZER S.A. |
| --- |
| Boulevard de la Plaine, 17 |
| 1050 Brussels |
| Belgium |

PFIZER S.A.

Boulevard de la Plaine, 17

1050 Brussels

Belgium

Genotonorm

1,3 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Belgia

| PFIZER S.A. |
| --- |
| Boulevard de la Plaine, 17 |
| 1050 Brussels |
| Belgium |

PFIZER S.A.

Boulevard de la Plaine, 17

1050 Brussels

Belgium

Genotonorm

5,0 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Belgia

| PFIZER S.A. |
| --- |
| Boulevard de la Plaine, 17 |
| 1050 Brussels |
| Belgium |

PFIZER S.A.

Boulevard de la Plaine, 17

1050 Brussels

Belgium

Genotonorm

5,3 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Belgia

| PFIZER S.A. |
| --- |
| Boulevard de la Plaine, 17 |
| 1050 Brussels |
| Belgium |

PFIZER S.A.

Boulevard de la Plaine, 17

1050 Brussels

Belgium

Genotonorm

12 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Belgia

| PFIZER S.A. |
| --- |
| Boulevard de la Plaine, 17 |
| 1050 Brussels |
| Belgium |

PFIZER S.A.

Boulevard de la Plaine, 17

1050 Brussels

Belgium

Genotonorm MiniQuick

0,2 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Belgia

| PFIZER S.A. |
| --- |
| Boulevard de la Plaine, 17 |
| 1050 Brussels |
| Belgium |

PFIZER S.A.

Boulevard de la Plaine, 17

1050 Brussels

Belgium

Genotonorm MiniQuick

0,4 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Belgia

| PFIZER S.A. |
| --- |
| Boulevard de la Plaine, 17 |
| 1050 Brussels |
| Belgium |

PFIZER S.A.

Boulevard de la Plaine, 17

1050 Brussels

Belgium

Genotonorm MiniQuick

0,6 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Belgia

| PFIZER S.A. |
| --- |
| Boulevard de la Plaine, 17 |
| 1050 Brussels |
| Belgium |

PFIZER S.A.

Boulevard de la Plaine, 17

1050 Brussels

Belgium

Genotonorm MiniQuick

0,8 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Belgia

| PFIZER S.A. |
| --- |
| Boulevard de la Plaine, 17 |
| 1050 Brussels |
| Belgium |

PFIZER S.A.

Boulevard de la Plaine, 17

1050 Brussels

Belgium

Genotonorm MiniQuick

1,0 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Belgia

| PFIZER S.A. |
| --- |
| Boulevard de la Plaine, 17 |
| 1050 Brussels |
| Belgium |

PFIZER S.A.

Boulevard de la Plaine, 17

1050 Brussels

Belgium

Genotonorm MiniQuick

1,2 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Belgia

| PFIZER S.A. |
| --- |
| Boulevard de la Plaine, 17 |
| 1050 Brussels |
| Belgium |

PFIZER S.A.

Boulevard de la Plaine, 17

1050 Brussels

Belgium

Genotonorm MiniQuick

1,4 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Belgia

| PFIZER S.A. |
| --- |
| Boulevard de la Plaine, 17 |
| 1050 Brussels |
| Belgium |

PFIZER S.A.

Boulevard de la Plaine, 17

1050 Brussels

Belgium

Genotonorm MiniQuick

1,6 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Belgia

| PFIZER S.A. |
| --- |
| Boulevard de la Plaine, 17 |
| 1050 Brussels |
| Belgium |

PFIZER S.A.

Boulevard de la Plaine, 17

1050 Brussels

Belgium

Genotonorm MiniQuick

1,8 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Belgia

| PFIZER S.A. |
| --- |
| Boulevard de la Plaine, 17 |
| 1050 Brussels |
| Belgium |

PFIZER S.A.

Boulevard de la Plaine, 17

1050 Brussels

Belgium

Genotonorm MiniQuick

2,0 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Taani

| Pfizer ApS, |
| --- |
| Lautrupvang 8, |
| DK-2750 Ballerup, |
| Denmark |

Pfizer ApS,

Lautrupvang 8,

DK-2750 Ballerup,

Denmark

Genotropin

1,3 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Taani

| Pfizer ApS, |
| --- |
| Lautrupvang 8, |
| DK-2750 Ballerup, |
| Denmark |

Pfizer ApS,

Lautrupvang 8,

DK-2750 Ballerup,

Denmark

Genotropin

5 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Taani

| Pfizer ApS, |
| --- |
| Lautrupvang 8, |
| DK-2750 Ballerup, |
| Denmark |

Pfizer ApS,

Lautrupvang 8,

DK-2750 Ballerup,

Denmark

Genotropin

5,3 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Taani

| Pfizer ApS, |
| --- |
| Lautrupvang 8, |
| DK-2750 Ballerup, |
| Denmark |

Pfizer ApS,

Lautrupvang 8,

DK-2750 Ballerup,

Denmark

Genotropin

12 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Taani

| Pfizer ApS, |
| --- |
| Lautrupvang 8, |
| DK-2750 Ballerup, |
| Denmark |

Pfizer ApS,

Lautrupvang 8,

DK-2750 Ballerup,

Denmark

Genotropin Miniquick

0,2 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Taani

| Pfizer ApS, |
| --- |
| Lautrupvang 8, |
| DK-2750 Ballerup, |
| Denmark |

Pfizer ApS,

Lautrupvang 8,

DK-2750 Ballerup,

Denmark

Genotropin Miniquick

0,4 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Taani

| Pfizer ApS, |
| --- |
| Lautrupvang 8, |
| DK-2750 Ballerup, |
| Denmark |

Pfizer ApS,

Lautrupvang 8,

DK-2750 Ballerup,

Denmark

Genotropin Miniquick

0,6 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Taani

| Pfizer ApS, |
| --- |
| Lautrupvang 8, |
| DK-2750 Ballerup, |
| Denmark |

Pfizer ApS,

Lautrupvang 8,

DK-2750 Ballerup,

Denmark

Genotropin Miniquick

0,8 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Taani

| Pfizer ApS, |
| --- |
| Lautrupvang 8, |
| DK-2750 Ballerup, |
| Denmark |

Pfizer ApS,

Lautrupvang 8,

DK-2750 Ballerup,

Denmark

Genotropin Miniquick

1,0 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Taani

| Pfizer ApS, |
| --- |
| Lautrupvang 8, |
| DK-2750 Ballerup, |
| Denmark |

Pfizer ApS,

Lautrupvang 8,

DK-2750 Ballerup,

Denmark

Genotropin Miniquick

1,2 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Taani

| Pfizer ApS, |
| --- |
| Lautrupvang 8, |
| DK-2750 Ballerup, |
| Denmark |

Pfizer ApS,

Lautrupvang 8,

DK-2750 Ballerup,

Denmark

Genotropin Miniquick

1,4 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Taani

| Pfizer ApS, |
| --- |
| Lautrupvang 8, |
| DK-2750 Ballerup, |
| Denmark |

Pfizer ApS,

Lautrupvang 8,

DK-2750 Ballerup,

Denmark

Genotropin Miniquick

1,6 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Taani

| Pfizer ApS, |
| --- |
| Lautrupvang 8, |
| DK-2750 Ballerup, |
| Denmark |

Pfizer ApS,

Lautrupvang 8,

DK-2750 Ballerup,

Denmark

Genotropin Miniquick

1,8 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Taani

| Pfizer ApS, |
| --- |
| Lautrupvang 8, |
| DK-2750 Ballerup, |
| Denmark |

Pfizer ApS,

Lautrupvang 8,

DK-2750 Ballerup,

Denmark

Genotropin Miniquick

2,0 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Soome

| Pfizer Oy, |
| --- |
| Tietokuja 4, |
| 00330 Helsinki, |
| Finland |

Pfizer Oy,

Tietokuja 4,

00330 Helsinki,

Finland

Genotropin

5 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Soome

| Pfizer Oy, |
| --- |
| Tietokuja 4, |
| 00330 Helsinki, |
| Finland |

Pfizer Oy,

Tietokuja 4,

00330 Helsinki,

Finland

Genotropin

12 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Prantsusmaa

| Pfizer Holding France, |
| --- |
| 23-25 avenue du Docteur Lannelongue, |
| 75014 Paris |
| France |

Pfizer Holding France,

23-25 avenue du Docteur Lannelongue,

75014 Paris

France

GENOTONORM 5 mg, poudre et solvant pour solution injectable

5 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Prantsusmaa

| Pfizer Holding France, |
| --- |
| 23-25 avenue du Docteur Lannelongue, |
| 75014 Paris |
| France |

Pfizer Holding France,

23-25 avenue du Docteur Lannelongue,

75014 Paris

France

GENOTONORM 5,3 mg, poudre et solvant pour solution injectable

5,3 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Prantsusmaa

| Pfizer Holding France, |
| --- |
| 23-25 avenue du Docteur Lannelongue, |
| 75014 Paris |
| France |

Pfizer Holding France,

23-25 avenue du Docteur Lannelongue,

75014 Paris

France

GENOTONORM 12 mg, poudre et solvant pour solution injectable

12 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Prantsusmaa

| Pfizer Holding France, |
| --- |
| 23-25 avenue du Docteur Lannelongue, |
| 75014 Paris |
| France |

Pfizer Holding France,

23-25 avenue du Docteur Lannelongue,

75014 Paris

France

GENOTONORM MINIQUICK 0,2 mg, poudre et solvant pour solution injectable

0,2 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Prantsusmaa

| Pfizer Holding France, |
| --- |
| 23-25 avenue du Docteur Lannelongue, |
| 75014 Paris |
| France |

Pfizer Holding France,

23-25 avenue du Docteur Lannelongue,

75014 Paris

France

GENOTONORM MINIQUICK 0,4 mg, poudre et solvant pour solution injectable

0,4 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Prantsusmaa

| Pfizer Holding France, |
| --- |
| 23-25 avenue du Docteur Lannelongue, |
| 75014 Paris |
| France |

Pfizer Holding France,

23-25 avenue du Docteur Lannelongue,

75014 Paris

France

GENOTONORM MINIQUICK 0,6 mg, poudre et solvant pour solution injectable

0,6 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Prantsusmaa

| Pfizer Holding France, |
| --- |
| 23-25 avenue du Docteur Lannelongue, |
| 75014 Paris |
| France |

Pfizer Holding France,

23-25 avenue du Docteur Lannelongue,

75014 Paris

France

GENOTONORM MINIQUICK 0,8 mg, poudre et solvant pour solution injectable

0,8 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Prantsusmaa

| Pfizer Holding France, |
| --- |
| 23-25 avenue du Docteur Lannelongue, |
| 75014 Paris |
| France |

Pfizer Holding France,

23-25 avenue du Docteur Lannelongue,

75014 Paris

France

GENOTONORM MINIQUICK 1 mg, poudre et solvant pour solution injectable

1 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Prantsusmaa

| Pfizer Holding France, |
| --- |
| 23-25 avenue du Docteur Lannelongue, |
| 75014 Paris |
| France |

Pfizer Holding France,

23-25 avenue du Docteur Lannelongue,

75014 Paris

France

GENOTONORM MINIQUICK 1,2 mg, poudre et solvant pour solution injectable

1,2 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Prantsusmaa

| Pfizer Holding France, |
| --- |
| 23-25 avenue du Docteur Lannelongue, |
| 75014 Paris |
| France |

Pfizer Holding France,

23-25 avenue du Docteur Lannelongue,

75014 Paris

France

GENOTONORM MINIQUICK 1,4 mg, poudre et solvant pour solution injectable

1,4 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Prantsusmaa

| Pfizer Holding France, |
| --- |
| 23-25 avenue du Docteur Lannelongue, |
| 75014 Paris |
| France |

Pfizer Holding France,

23-25 avenue du Docteur Lannelongue,

75014 Paris

France

GENOTONORM MINIQUICK 1,6 mg, poudre et solvant pour solution injectable

1,6 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Prantsusmaa

| Pfizer Holding France, |
| --- |
| 23-25 avenue du Docteur Lannelongue, |
| 75014 Paris |
| France |

Pfizer Holding France,

23-25 avenue du Docteur Lannelongue,

75014 Paris

France

GENOTONORM MINIQUICK 1,8 mg, poudre et solvant pour solution injectable

1,8 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Prantsusmaa

| Pfizer Holding France, |
| --- |
| 23-25 avenue du Docteur Lannelongue, |
| 75014 Paris |
| France |

Pfizer Holding France,

23-25 avenue du Docteur Lannelongue,

75014 Paris

France

GENOTONORM MINIQUICK 2 mg, poudre et solvant pour solution injectable

2 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Saksamaa

| Pharmacia GmbH |
| --- |
| Linkstr. 10 |
| D-10785 Berlin |
| Germany |

Pharmacia GmbH

Linkstr. 10

D-10785 Berlin

Germany

Genotropin 5 mg/ml

5,0 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Saksamaa

| Pharmacia GmbH |
| --- |
| Linkstr. 10 |
| D-10785 Berlin |
| Germany |

Pharmacia GmbH

Linkstr. 10

D-10785 Berlin

Germany

Genotropin 5,3 mg/ml

5,3 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Saksamaa

| Pharmacia GmbH |
| --- |
| Linkstr. 10 |
| D-10785 Berlin |
| Germany |

Pharmacia GmbH

Linkstr. 10

D-10785 Berlin

Germany

Genotropin 12 mg/ml

12,0 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Saksamaa

| Pharmacia GmbH |
| --- |
| Linkstr. 10 |
| D-10785 Berlin |
| Germany |

Pharmacia GmbH

Linkstr. 10

D-10785 Berlin

Germany

GENOTROPIN MiniQuick 0,2 mg

0,2 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Saksamaa

| Pharmacia GmbH |
| --- |
| Linkstr. 10 |
| D-10785 Berlin |
| Germany |

Pharmacia GmbH

Linkstr. 10

D-10785 Berlin

Germany

GENOTROPIN MiniQuick 0,4 mg

0,4 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Saksamaa

| Pharmacia GmbH |
| --- |
| Linkstr. 10 |
| D-10785 Berlin |
| Germany |

Pharmacia GmbH

Linkstr. 10

D-10785 Berlin

Germany

GENOTROPIN MiniQuick 0,6 mg

0,6 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Saksamaa

| Pharmacia GmbH |
| --- |
| Linkstr. 10 |
| D-10785 Berlin |
| Germany |

Pharmacia GmbH

Linkstr. 10

D-10785 Berlin

Germany

GENOTROPIN MiniQuick 0,8 mg

0,8 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Saksamaa

| Pharmacia GmbH |
| --- |
| Linkstr. 10 |
| D-10785 Berlin |
| Germany |

Pharmacia GmbH

Linkstr. 10

D-10785 Berlin

Germany

GENOTROPIN MiniQuick 1,0 mg

1,0 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Saksamaa

| Pharmacia GmbH |
| --- |
| Linkstr. 10 |
| D-10785 Berlin |
| Germany |

Pharmacia GmbH

Linkstr. 10

D-10785 Berlin

Germany

GENOTROPIN MiniQuick 1,2 mg

1,2 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Saksamaa

| Pharmacia GmbH |
| --- |
| Linkstr. 10 |
| D-10785 Berlin |
| Germany |

Pharmacia GmbH

Linkstr. 10

D-10785 Berlin

Germany

GENOTROPIN MiniQuick 1,4 mg

1,4 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Saksamaa

| Pharmacia GmbH |
| --- |
| Linkstr. 10 |
| D-10785 Berlin |
| Germany |

Pharmacia GmbH

Linkstr. 10

D-10785 Berlin

Germany

GENOTROPIN MiniQuick 1,6 mg

1,6 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Saksamaa

| Pharmacia GmbH |
| --- |
| Linkstr. 10 |
| D-10785 Berlin |

Pharmacia GmbH

Linkstr. 10

D-10785 Berlin

GENOTROPIN MiniQuick 1,8 mg

1,8 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Saksamaa

| Pharmacia GmbH |
| --- |
| Linkstr. 10 |
| D-10785 Berlin |
| Germany |

Pharmacia GmbH

Linkstr. 10

D-10785 Berlin

Germany

GENOTROPIN MiniQuick 2,0 mg

2,0 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Kreeka

| PFIZER HELLAS A.E. |
| --- |
| MESSOGHION AVE. 243 |
| 15451 NEO PSYCHIKO |
| Greece |

PFIZER HELLAS A.E.

MESSOGHION AVE. 243

15451 NEO PSYCHIKO

Greece

GENOTROPIN

1 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Kreeka

| PFIZER HELLAS A.E. |
| --- |
| MESSOGHION AVE. 243 |
| 15451 NEO PSYCHIKO |
| Greece |

PFIZER HELLAS A.E.

MESSOGHION AVE. 243

15451 NEO PSYCHIKO

Greece

GENOTROPIN

1,4 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Kreeka

| PFIZER HELLAS A.E. |
| --- |
| MESSOGHION AVE. 243 |
| 15451 NEO PSYCHIKO |
| Greece |

PFIZER HELLAS A.E.

MESSOGHION AVE. 243

15451 NEO PSYCHIKO

Greece

GENOTROPIN

2 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Kreeka

| PFIZER HELLAS A.E. |
| --- |
| MESSOGHION AVE. 243 |
| 15451 NEO PSYCHIKO |
| Greece |

PFIZER HELLAS A.E.

MESSOGHION AVE. 243

15451 NEO PSYCHIKO

Greece

GENOTROPIN

5 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Kreeka

| PFIZER HELLAS A.E. |
| --- |
| MESSOGHION AVE. 243 |
| 15451 NEO PSYCHIKO |
| Greece |

PFIZER HELLAS A.E.

MESSOGHION AVE. 243

15451 NEO PSYCHIKO

Greece

GENOTROPIN (WITH PRESERVATIVE)

5,3 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Kreeka

| PFIZER HELLAS A.E. |
| --- |
| MESSOGHION AVE. 243 |
| 15451 NEO PSYCHIKO |
| Greece |

PFIZER HELLAS A.E.

MESSOGHION AVE. 243

15451 NEO PSYCHIKO

Greece

GENOTROPIN (WITH PRESERVATIVE)

12 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Kreeka

| PFIZER HELLAS A.E. |
| --- |
| MESSOGHION AVE. 243 |
| 15451 NEO PSYCHIKO |
| Greece |

PFIZER HELLAS A.E.

MESSOGHION AVE. 243

15451 NEO PSYCHIKO

Greece

GENOTROPIN

1,3 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Iirimaa

| Pharmacia Laboratories Limited |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| United Kingdom |

Pharmacia Laboratories Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

GENOTROPIN 5,3 MG

5,3 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Iirimaa

| Pharmacia Laboratories Limited |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| United Kingdom |

Pharmacia Laboratories Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

GENOTROPIN 12 MG

12 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Iirimaa

| Pharmacia Laboratories Limited |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| United Kingdom |

Pharmacia Laboratories Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

GENOTROPIN MINIQUICK 0,2 MG

0,2 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Iirimaa

| Pharmacia Laboratories Limited |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| United Kingdom |

Pharmacia Laboratories Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

GENOTROPIN MINIQUICK 0,4 MG

0,4 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Iirimaa

| Pharmacia Laboratories Limited |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| United Kingdom |

Pharmacia Laboratories Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

GENOTROPIN MINIQUICK 0,6 MG

0,6 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Iirimaa

| Pharmacia Laboratories Limited |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| United Kingdom |

Pharmacia Laboratories Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

GENOTROPIN MINIQUICK 0,8 MG

0,8 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Iirimaa

| Pharmacia Laboratories Limited |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| United Kingdom |

Pharmacia Laboratories Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

GENOTROPIN MINIQUICK 1 MG

1 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Iirimaa

| Pharmacia Laboratories Limited |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| United Kingdom |

Pharmacia Laboratories Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

GENOTROPIN MINIQUICK 1,2 MG

1,2 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Iirimaa

| Pharmacia Laboratories Limited |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| United Kingdom |

Pharmacia Laboratories Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

GENOTROPIN MINIQUICK 1,4 MG

1,4 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Iirimaa

| Pharmacia Laboratories Limited |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| United Kingdom |

Pharmacia Laboratories Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

GENOTROPIN MINIQUICK 1,6 MG

1,6 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Iirimaa

| Pharmacia Laboratories Limited |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| United Kingdom |

Pharmacia Laboratories Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

GENOTROPIN MINIQUICK 1,8 MG

1,8 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Iirimaa

| Pharmacia Laboratories Limited |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| United Kingdom |

Pharmacia Laboratories Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

GENOTROPIN MINIQUICK 2 MG

2 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Itaalia

| Pfizer Italia S.r.l. |
| --- |
| Via Valbondione 113 |
| 00188 Rome |
| Italy |

Pfizer Italia S.r.l.

Via Valbondione 113

00188 Rome

Italy

Genotropin

5,3 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Itaalia

| Pfizer Italia S.r.l. |
| --- |
| Via Valbondione 113 |
| 00188 Rome |
| Italy |

Pfizer Italia S.r.l.

Via Valbondione 113

00188 Rome

Italy

Genotropin

12 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Itaalia

| Pfizer Italia S.r.l. |
| --- |
| Via Valbondione 113 |
| 00188 Rome |
| Italy |

Pfizer Italia S.r.l.

Via Valbondione 113

00188 Rome

Italy

Genotropin Miniquick

0,2 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Itaalia

| Pfizer Italia S.r.l. |
| --- |
| Via Valbondione 113 |
| 00188 Rome |
| Italy |

Pfizer Italia S.r.l.

Via Valbondione 113

00188 Rome

Italy

Genotropin Miniquick

0,4 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Itaalia

| Pfizer Italia S.r.l. |
| --- |
| Via Valbondione 113 |
| 00188 Rome |
| Italy |

Pfizer Italia S.r.l.

Via Valbondione 113

00188 Rome

Italy

Genotropin Miniquick

0,6 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Itaalia

| Pfizer Italia S.r.l. |
| --- |
| Via Valbondione 113 |
| 00188 Rome |
| Italy |

Pfizer Italia S.r.l.

Via Valbondione 113

00188 Rome

Italy

Genotropin Miniquick

0,8 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Itaalia

| Pfizer Italia S.r.l. |
| --- |
| Via Valbondione 113 |
| 00188 Rome |
| Italy |

Pfizer Italia S.r.l.

Via Valbondione 113

00188 Rome

Italy

Genotropin Miniquick

1 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Itaalia

| Pfizer Italia S.r.l. |
| --- |
| Via Valbondione 113 |
| 00188 Rome |
| Italy |

Pfizer Italia S.r.l.

Via Valbondione 113

00188 Rome

Italy

Genotropin Miniquick

1,2 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Itaalia

| Pfizer Italia S.r.l. |
| --- |
| Via Valbondione 113 |
| 00188 Rome |
| Italy |

Pfizer Italia S.r.l.

Via Valbondione 113

00188 Rome

Italy

Genotropin Miniquick

1,4 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Itaalia

| Pfizer Italia S.r.l. |
| --- |
| Via Valbondione 113 |
| 00188 Rome |
| Italy |

Pfizer Italia S.r.l.

Via Valbondione 113

00188 Rome

Italy

Genotropin Miniquick

1,6 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Itaalia

| Pfizer Italia S.r.l. |
| --- |
| Via Valbondione 113 |
| 00188 Rome |
| Italy |

Pfizer Italia S.r.l.

Via Valbondione 113

00188 Rome

Italy

Genotropin Miniquick

1,8 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Itaalia

| Pfizer Italia S.r.l. |
| --- |
| Via Valbondione 113 |
| 00188 Rome |
| Italy |

Pfizer Italia S.r.l.

Via Valbondione 113

00188 Rome

Italy

Genotropin Miniquick

2 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Luksemburg

| Pfizer SA |
| --- |
| 17, Boulevard de la Plaine |
| B-1050 Bruxelles |
| Belgium |

Pfizer SA

17, Boulevard de la Plaine

B-1050 Bruxelles

Belgium

Genotonorm

1,3 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Luksemburg

| Pfizer SA |
| --- |
| 17, Boulevard de la Plaine |
| B-1050 Bruxelles |
| Belgium |

Pfizer SA

17, Boulevard de la Plaine

B-1050 Bruxelles

Belgium

Genotonorm

5 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Luksemburg

| Pfizer SA |
| --- |
| 17, Boulevard de la Plaine |
| B-1050 Bruxelles |
| Belgium |

Pfizer SA

17, Boulevard de la Plaine

B-1050 Bruxelles

Belgium

Genotonorm

5,3 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Luksemburg

| Pfizer SA |
| --- |
| 17, Boulevard de la Plaine |
| B-1050 Bruxelles |
| Belgium |

Pfizer SA

17, Boulevard de la Plaine

B-1050 Bruxelles

Belgium

Genotonorm

12 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Luksemburg

| Pfizer SA |
| --- |
| 17, Boulevard de la Plaine |
| B-1050 Bruxelles |
| Belgium |

Pfizer SA

17, Boulevard de la Plaine

B-1050 Bruxelles

Belgium

Genotonorm Miniquick

0,2 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Luksemburg

| Pfizer SA |
| --- |
| 17, Boulevard de la Plaine |
| B-1050 Bruxelles |
| Belgium |

Pfizer SA

17, Boulevard de la Plaine

B-1050 Bruxelles

Belgium

Genotonorm Miniquick

0,4 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Luksemburg

| Pfizer SA |
| --- |
| 17, Boulevard de la Plaine |
| B-1050 Bruxelles |
| Belgium |

Pfizer SA

17, Boulevard de la Plaine

B-1050 Bruxelles

Belgium

Genotonorm Miniquick

0,6 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Luksemburg

| Pfizer SA |
| --- |
| 17, Boulevard de la Plaine |
| B-1050 Bruxelles |
| Belgium |

Pfizer SA

17, Boulevard de la Plaine

B-1050 Bruxelles

Belgium

Genotonorm Miniquick

0,8 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Luksemburg

| Pfizer SA |
| --- |
| 17, Boulevard de la Plaine |
| B-1050 Bruxelles |
| Belgium |

Pfizer SA

17, Boulevard de la Plaine

B-1050 Bruxelles

Belgium

Genotonorm Miniquick

1 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Luksemburg

| Pfizer SA |
| --- |
| 17, Boulevard de la Plaine |
| B-1050 Bruxelles |
| Belgium |

Pfizer SA

17, Boulevard de la Plaine

B-1050 Bruxelles

Belgium

Genotonorm Miniquick

1,2 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Luksemburg

| Pfizer SA |
| --- |
| 17, Boulevard de la Plaine |
| B-1050 Bruxelles |
| Belgium |

Pfizer SA

17, Boulevard de la Plaine

B-1050 Bruxelles

Belgium

Genotonorm Miniquick

1,4 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Luksemburg

| Pfizer SA |
| --- |
| 17, Boulevard de la Plaine |
| B-1050 Bruxelles |
| Belgium |

Pfizer SA

17, Boulevard de la Plaine

B-1050 Bruxelles

Belgium

Genotonorm Miniquick

1,6 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Luksemburg

| Pfizer SA |
| --- |
| 17, Boulevard de la Plaine |
| B-1050 Bruxelles |
| Belgium |

Pfizer SA

17, Boulevard de la Plaine

B-1050 Bruxelles

Belgium

Genotonorm Miniquick

1,8 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Luksemburg

| Pfizer SA |
| --- |
| 17, Boulevard de la Plaine |
| B-1050 Bruxelles |
| Belgium |

Pfizer SA

17, Boulevard de la Plaine

B-1050 Bruxelles

Belgium

Genotonorm Miniquick

2 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Holland

| Pfizer BV |
| --- |
| Postbus 37 |
| 2900AA Capelle aan den Ijssel |
| The Netherlands |

Pfizer BV

Postbus 37

2900AA Capelle aan den Ijssel

The Netherlands

Genotropin 5 mg, poeder en oplosmiddel voor oplossing voor injectie

5 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Holland

| Pfizer BV |
| --- |
| Postbus 37 |
| 2900AA Capelle aan den Ijssel |
| The Netherlands |

Pfizer BV

Postbus 37

2900AA Capelle aan den Ijssel

The Netherlands

Genotropin 12 mg, poeder en oplosmiddel voor oplossing voor injectie

12 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Portugal

| Laboratórios Pfizer, Lda. |
| --- |
| Lagoas Park, |
| Edifício 10 |
| 2740-271 Porto Salvo |
| Portugal |

Laboratórios Pfizer, Lda.

Lagoas Park,

Edifício 10

2740-271 Porto Salvo

Portugal

Genotropin 1,3 mg

1,3 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Portugal

| Laboratórios Pfizer, Lda. |
| --- |
| Lagoas Park, |
| Edifício 10 |
| 2740-271 Porto Salvo |
| Portugal |

Laboratórios Pfizer, Lda.

Lagoas Park,

Edifício 10

2740-271 Porto Salvo

Portugal

Genotropin 12 mg

12 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Portugal

| Laboratórios Pfizer, Lda. |
| --- |
| Lagoas Park, |
| Edifício 10 |
| 2740-271 Porto Salvo |
| Portugal |

Laboratórios Pfizer, Lda.

Lagoas Park,

Edifício 10

2740-271 Porto Salvo

Portugal

Genotropin 5,3 mg

5,3 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Portugal

| Laboratórios Pfizer, Lda. |
| --- |
| Lagoas Park, |
| Edifício 10 |
| 2740-271 Porto Salvo |
| Portugal |

Laboratórios Pfizer, Lda.

Lagoas Park,

Edifício 10

2740-271 Porto Salvo

Portugal

Genotropin Mixer

5,3 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Portugal

| Laboratórios Pfizer, Lda. |
| --- |
| Lagoas Park, |
| Edifício 10 |
| 2740-271 Porto Salvo |
| Portugal |

Laboratórios Pfizer, Lda.

Lagoas Park,

Edifício 10

2740-271 Porto Salvo

Portugal

Genotropin Miniquick

1 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Portugal

| Laboratórios Pfizer, Lda. |
| --- |
| Lagoas Park, |
| Edifício 10 |
| 2740-271 Porto Salvo |
| Portugal |

Laboratórios Pfizer, Lda.

Lagoas Park,

Edifício 10

2740-271 Porto Salvo

Portugal

Genotropin Miniquick

2 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Portugal

| Laboratórios Pfizer, Lda. |
| --- |
| Lagoas Park, |
| Edifício 10 |
| 2740-271 Porto Salvo |
| Portugal |

Laboratórios Pfizer, Lda.

Lagoas Park,

Edifício 10

2740-271 Porto Salvo

Portugal

Genotropin Miniquick

0,2 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Portugal

| Laboratórios Pfizer, Lda. |
| --- |
| Lagoas Park, |
| Edifício 10 |
| 2740-271 Porto Salvo |
| Portugal |

Laboratórios Pfizer, Lda.

Lagoas Park,

Edifício 10

2740-271 Porto Salvo

Portugal

Genotropin Miniquick

0,4 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Portugal

| Laboratórios Pfizer, Lda. |
| --- |
| Lagoas Park, |
| Edifício 10 |
| 2740-271 Porto Salvo |
| Portugal |

Laboratórios Pfizer, Lda.

Lagoas Park,

Edifício 10

2740-271 Porto Salvo

Portugal

Genotropin Miniquick

0,6 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Portugal

| Laboratórios Pfizer, Lda. |
| --- |
| Lagoas Park, |
| Edifício 10 |
| 2740-271 Porto Salvo |
| Portugal |

Laboratórios Pfizer, Lda.

Lagoas Park,

Edifício 10

2740-271 Porto Salvo

Portugal

Genotropin Miniquick

0,8 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Portugal

| Laboratórios Pfizer, Lda. |
| --- |
| Lagoas Park, |
| Edifício 10 |
| 2740-271 Porto Salvo |
| Portugal |

Laboratórios Pfizer, Lda.

Lagoas Park,

Edifício 10

2740-271 Porto Salvo

Portugal

Genotropin Miniquick

1,2 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Portugal

| Laboratórios Pfizer, Lda. |
| --- |
| Lagoas Park, |
| Edifício 10 |
| 2740-271 Porto Salvo |
| Portugal |

Laboratórios Pfizer, Lda.

Lagoas Park,

Edifício 10

2740-271 Porto Salvo

Portugal

Genotropin Miniquick

1,4 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Portugal

| Laboratórios Pfizer, Lda. |
| --- |
| Lagoas Park, |
| Edifício 10 |
| 2740-271 Porto Salvo |
| Portugal |

Laboratórios Pfizer, Lda.

Lagoas Park,

Edifício 10

2740-271 Porto Salvo

Portugal

Genotropin Miniquick

1,6 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Portugal

| Laboratórios Pfizer, Lda. |
| --- |
| Lagoas Park, |
| Edifício 10 |
| 2740-271 Porto Salvo |
| Portugal |

Laboratórios Pfizer, Lda.

Lagoas Park,

Edifício 10

2740-271 Porto Salvo

Portugal

Genotropin Miniquick

1,8 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Portugal

| Laboratórios Pfizer, Lda. |
| --- |
| Lagoas Park, |
| Edifício 10 |
| 2740-271 Porto Salvo |
| Portugal |

Laboratórios Pfizer, Lda.

Lagoas Park,

Edifício 10

2740-271 Porto Salvo

Portugal

Genotropin Mixer

1,3 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Portugal

| Laboratórios Pfizer, Lda. |
| --- |
| Lagoas Park, |
| Edifício 10 |
| 2740-271 Porto Salvo |
| Portugal |

Laboratórios Pfizer, Lda.

Lagoas Park,

Edifício 10

2740-271 Porto Salvo

Portugal

Genotropin

5 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Hispaania

| PFIZER, S.A. |
| --- |
| Avda. de Europa, |
| 20 B. Parque Empresarial La Moraleja Alcobendas |
| 28108 MADRID |
| Spain |

PFIZER, S.A.

Avda. de Europa,

20 B. Parque Empresarial La Moraleja Alcobendas

28108 MADRID

Spain

GENOTONORM KABIPEN 12 mg polvo y disolvente para solución inyectable

12 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Hispaania

| PFIZER, S.A. |
| --- |
| Avda. de Europa, |
| 20 B. Parque Empresarial La Moraleja Alcobendas |
| 28108 MADRID |
| Spain |

PFIZER, S.A.

Avda. de Europa,

20 B. Parque Empresarial La Moraleja Alcobendas

28108 MADRID

Spain

GENOTONORM KABIPEN 5,3 mg polvo y disolvente para solución inyectable

5,3 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Hispaania

| PFIZER, S.A. |
| --- |
| Avda. de Europa, |
| 20 B. Parque Empresarial La Moraleja Alcobendas |
| 28108 MADRID |
| Spain |

PFIZER, S.A.

Avda. de Europa,

20 B. Parque Empresarial La Moraleja Alcobendas

28108 MADRID

Spain

GENOTONORM MINIQUICK 0,2 mg polvo y disolvente para solución inyectable

0,2 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Hispaania

| PFIZER, S.A. |
| --- |
| Avda. de Europa, |
| 20 B. Parque Empresarial La Moraleja Alcobendas |
| 28108 MADRID |
| Spain |

PFIZER, S.A.

Avda. de Europa,

20 B. Parque Empresarial La Moraleja Alcobendas

28108 MADRID

Spain

GENOTONORM MINIQUICK 0,4 mg polvo y disolvente para solución inyectable

0,4 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Hispaania

| PFIZER, S.A. |
| --- |
| Avda. de Europa, |
| 20 B. Parque Empresarial La Moraleja Alcobendas |
| 28108 MADRID |
| Spain |

PFIZER, S.A.

Avda. de Europa,

20 B. Parque Empresarial La Moraleja Alcobendas

28108 MADRID

Spain

GENOTONORM MINIQUICK 0,6 mg polvo y disolvente para solución inyectable

0,6 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Hispaania

| PFIZER, S.A. |
| --- |
| Avda. de Europa, |
| 20 B. Parque Empresarial La Moraleja Alcobendas |
| 28108 MADRID |
| Spain |

PFIZER, S.A.

Avda. de Europa,

20 B. Parque Empresarial La Moraleja Alcobendas

28108 MADRID

Spain

GENOTONORM MINIQUICK 0,8 mg polvo y disolvente para solución inyectable

0,8 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Hispaania

| PFIZER, S.A. |
| --- |
| Avda. de Europa, |
| 20 B. Parque Empresarial La Moraleja Alcobendas |
| 28108 MADRID |
| Spain |

PFIZER, S.A.

Avda. de Europa,

20 B. Parque Empresarial La Moraleja Alcobendas

28108 MADRID

Spain

GENOTONORM MINIQUICK 1 mg polvo y disolvente para solución inyectable

1 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Hispaania

| PFIZER, S.A. |
| --- |
| Avda. de Europa, |
| 20 B. Parque Empresarial La Moraleja Alcobendas |
| 28108 MADRID |
| Spain |

PFIZER, S.A.

Avda. de Europa,

20 B. Parque Empresarial La Moraleja Alcobendas

28108 MADRID

Spain

GENOTONORM MINIQUICK 1,2 mg polvo y disolvente para solución inyectable

1,2 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Hispaania

| PFIZER, S.A. |
| --- |
| Avda. de Europa, |
| 20 B. Parque Empresarial La Moraleja Alcobendas |
| 28108 MADRID |
| Spain |

PFIZER, S.A.

Avda. de Europa,

20 B. Parque Empresarial La Moraleja Alcobendas

28108 MADRID

Spain

GENOTONORM MINIQUICK 1,4 mg polvo y disolvente para solución inyectable

1,4 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Hispaania

| PFIZER, S.A. |
| --- |
| Avda. de Europa, |
| 20 B. Parque Empresarial La Moraleja Alcobendas |
| 28108 MADRID |
| Spain |

PFIZER, S.A.

Avda. de Europa,

20 B. Parque Empresarial La Moraleja Alcobendas

28108 MADRID

Spain

GENOTONORM MINIQUICK 1,6 mg polvo y disolvente para solución inyectable

1,6 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Hispaania

| PFIZER, S.A. |
| --- |
| Avda. de Europa, |
| 20 B. Parque Empresarial La Moraleja Alcobendas |
| 28108 MADRID |
| Spain |

PFIZER, S.A.

Avda. de Europa,

20 B. Parque Empresarial La Moraleja Alcobendas

28108 MADRID

Spain

GENOTONORM MINIQUICK 1,8 mg polvo y disolvente para solución inyectable

1,8 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Hispaania

| PFIZER, S.A. |
| --- |
| Avda. de Europa, |
| 20 B. Parque Empresarial La Moraleja Alcobendas |
| 28108 MADRID |
| Spain |

PFIZER, S.A.

Avda. de Europa,

20 B. Parque Empresarial La Moraleja Alcobendas

28108 MADRID

Spain

GENOTONORM MINIQUICK 2 mg polvo y disolvente para solución inyectable

2 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Rootsi

| Pfizer AB, |
| --- |
| 191 90 Sollentuna, |
| Sverige |
| Sweden |

Pfizer AB,

191 90 Sollentuna,

Sverige

Sweden

Genotropin

5,3 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Rootsi

| Pfizer AB, |
| --- |
| 191 90 Sollentuna, |
| Sverige |
| Sweden |

Pfizer AB,

191 90 Sollentuna,

Sverige

Sweden

Genotropin

12 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Rootsi

| Pfizer AB, |
| --- |
| 191 90 Sollentuna, |
| Sverige |
| Sweden |

Pfizer AB,

191 90 Sollentuna,

Sverige

Sweden

Genotropin

5 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Rootsi

| Pfizer AB, |
| --- |
| 191 90 Sollentuna, |
| Sverige |
| Sweden |

Pfizer AB,

191 90 Sollentuna,

Sverige

Sweden

Genotropin Mini Quick

0,2 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Rootsi

| Pfizer AB, |
| --- |
| 191 90 Sollentuna, |
| Sverige |
| Sweden |

Pfizer AB,

191 90 Sollentuna,

Sverige

Sweden

Genotropin Mini Quick

0,4 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Rootsi

| Pfizer AB, |
| --- |
| 191 90 Sollentuna, |
| Sverige |
| Sweden |

Pfizer AB,

191 90 Sollentuna,

Sverige

Sweden

Genotropin Mini Quick

0,6 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Rootsi

| Pfizer AB, |
| --- |
| 191 90 Sollentuna, |
| Sverige |
| Sweden |

Pfizer AB,

191 90 Sollentuna,

Sverige

Sweden

Genotropin Mini Quick

0,8 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Rootsi

| Pfizer AB, |
| --- |
| 191 90 Sollentuna, |
| Sverige |
| Sweden |

Pfizer AB,

191 90 Sollentuna,

Sverige

Sweden

Genotropin Mini Quick

1 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Rootsi

| Pfizer AB, |
| --- |
| 191 90 Sollentuna, |
| Sverige |
| Sweden |

Pfizer AB,

191 90 Sollentuna,

Sverige

Sweden

Genotropin Mini Quick

1,2 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Rootsi

| Pfizer AB, |
| --- |
| 191 90 Sollentuna, |
| Sverige |
| Sweden |

Pfizer AB,

191 90 Sollentuna,

Sverige

Sweden

Genotropin Mini Quick

1,4 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Rootsi

| Pfizer AB, |
| --- |
| 191 90 Sollentuna, |
| Sverige |
| Sweden |

Pfizer AB,

191 90 Sollentuna,

Sverige

Sweden

Genotropin Mini Quick

1,6 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Rootsi

| Pfizer AB, |
| --- |
| 191 90 Sollentuna, |
| Sverige |
| Sweden |

Pfizer AB,

191 90 Sollentuna,

Sverige

Sweden

Genotropin Mini Quick

1,8 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Rootsi

| Pfizer AB, |
| --- |
| 191 90 Sollentuna, |
| Sverige |
| Sweden |

Pfizer AB,

191 90 Sollentuna,

Sverige

Sweden

Genotropin Mini Quick

2 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Ühendkuningriik

| Pharmacia Laboratories Limited |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| United Kingdom |

Pharmacia Laboratories Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

GENOTROPIN 5,3 MG

5,3 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Ühendkuningriik

| Pharmacia Laboratories Limited |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| United Kingdom |

Pharmacia Laboratories Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

GENOTROPIN 12 MG

12 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Ühendkuningriik

| Pharmacia Laboratories Limited |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| United Kingdom |

Pharmacia Laboratories Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

GENOTROPIN MINIQUICK 0,2 MG

0,2 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Ühendkuningriik

| Pharmacia Laboratories Limited |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| United Kingdom |

Pharmacia Laboratories Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

GENOTROPIN MINIQUICK 0,4 MG

0,4 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Ühendkuningriik

| Pharmacia Laboratories Limited |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| United Kingdom |

Pharmacia Laboratories Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

GENOTROPIN MINIQUICK 0,6 MG

0,6 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Ühendkuningriik

| Pharmacia Laboratories Limited |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| United Kingdom |

Pharmacia Laboratories Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

GENOTROPIN MINIQUICK 0,8 MG

0,8 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Ühendkuningriik

| Pharmacia Laboratories Limited |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| United Kingdom |

Pharmacia Laboratories Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

GENOTROPIN MINIQUICK 1 MG

1 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Ühendkuningriik

| Pharmacia Laboratories Limited |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| United Kingdom |

Pharmacia Laboratories Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

GENOTROPIN MINIQUICK 1,2 MG

1,2 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Ühendkuningriik

| Pharmacia Laboratories Limited |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| United Kingdom |

Pharmacia Laboratories Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

GENOTROPIN MINIQUICK 1,4 MG

1,4 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Ühendkuningriik

| Pharmacia Laboratories Limited |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| United Kingdom |

Pharmacia Laboratories Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

GENOTROPIN MINIQUICK 1,6 MG

1,6 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Ühendkuningriik

| Pharmacia Laboratories Limited |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| United Kingdom |

Pharmacia Laboratories Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

GENOTROPIN MINIQUICK 1,8 MG

1,8 mg

Süstelahuse pulber ja lahusti

Subkutaanne

Ühendkuningriik

| Pharmacia Laboratories Limited |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| United Kingdom |

Pharmacia Laboratories Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

GENOTROPIN MINIQUICK 2 MG

2 mg

Süstelahuse pulber ja lahusti

Subkutaanne

---

IX LISA

VETERINAARRAVIMITE NIMETUSTE, RAVIMVORMIDE, TUGEVUSTE, LOOMALIIKIDE, MANUSTAMISVIISI, KEELUAJA JA MÜÜGILOA TAOTLEJATE/HOIDJATE LOETELU LIIKMESRIIKIDES

| Liikmesriik | Müügiloa taotleja/hoidja | Ravimi nimetus | Ravimvorm | Tugevus | Loomaliigid | Manustamise sagedus ja viis |
| --- | --- | --- | --- | --- | --- | --- |
| Belgia | Pfizer Animal Health |
| Rue Laid Burniat 1 |
| 1348 - Louvain-la-Neuve |
| BELGIUM |

Liikmesriik

Müügiloa taotleja/hoidja

Ravimi nimetus

Ravimvorm

Tugevus

Loomaliigid

Manustamise sagedus ja viis

Belgia

Pfizer Animal Health

Rue Laid Burniat 1

1348 - Louvain-la-Neuve

BELGIUM

PREGSURE BVD

Süsteemulsioon

mis tekitab merisigadel vähemalt 5,6 log2 geomeetrilise keskmise seroneutraliseeriva tiitri

Veised (lehmad ja mullikad)

subkutaanselt

Bulgaaria

| Pfizer Animal Health MA EEIG |
| --- |
| Ramsgate Road |
| Sandwich, Kent |
| CT13 9NJ |
| UNITED KINGDOM |

Pfizer Animal Health MA EEIG

Ramsgate Road

Sandwich, Kent

CT13 9NJ

UNITED KINGDOM

PregSure BVD

Süsteemulsioon

mis tekitab merisigadel vähemalt 5,6 log2 geomeetrilise keskmise seroneutraliseeriva tiitri

Veised (lehmad ja mullikad)

subkutaanselt

Tšehhi Vabariik

| Pfizer, spol. s r.o. |
| --- |
| Stroupežnického 17 |
| 150 00 Praha |
| CZECH REPUBLIC |

Pfizer, spol. s r.o.

Stroupežnického 17

150 00 Praha

CZECH REPUBLIC

PregSure BVD injekční emulze

Süsteemulsioon

mis tekitab merisigadel vähemalt 5,6 log2 geomeetrilise keskmise seroneutraliseeriva tiitri

Veised (lehmad ja mullikad)

subkutaanselt

Eesti

| Pfizer Animal Health |
| --- |
| Rue Laid Burniat 1 |
| 1348 - Louvain-la-Neuve |
| BELGIUM |

Pfizer Animal Health

Rue Laid Burniat 1

1348 - Louvain-la-Neuve

BELGIUM

PregSure BVD

Süsteemulsioon

mis tekitab merisigadel vähemalt 5,6 log2 geomeetrilise keskmise seroneutraliseeriva tiitri

Veised (lehmad ja mullikad)

subkutaanselt

Prantsusmaa

| PFIZER |
| --- |
| 23/25 Avenue du Docteur Lannelongue |
| 75014 Paris |
| FRANCE |

PFIZER

23/25 Avenue du Docteur Lannelongue

75014 Paris

FRANCE

PREGSURE BVD

Süsteemulsioon

mis tekitab merisigadel vähemalt 5,6 log2 geomeetrilise keskmise seroneutraliseeriva tiitri

Veised (lehmad ja mullikad)

subkutaanselt

Saksamaa

| Pfizer GmbH |
| --- |
| Linkstraße 10 |
| D-10785 Berlin |
| GERMANY |

Pfizer GmbH

Linkstraße 10

D-10785 Berlin

GERMANY

PregSure BVD

Süsteemulsioon

mis tekitab merisigadel vähemalt 5,6 log2 geomeetrilise keskmise seroneutraliseeriva tiitri

Veised (lehmad ja mullikad)

subkutaanselt

Kreeka

| PFIZER HELLAS S.A |
| --- |
| 243 Messogeion Ave. |
| Neo Psychiko |
| GR-154 51 |
| GREECE |

PFIZER HELLAS S.A

243 Messogeion Ave.

Neo Psychiko

GR-154 51

GREECE

PREGSURE BVD

Süsteemulsioon

mis tekitab merisigadel vähemalt 5,6 log2 geomeetrilise keskmise seroneutraliseeriva tiitri

Veised (lehmad ja mullikad)

subkutaanselt

Ungari

| Pfizer Kft. |
| --- |
| Alkotas u 53 |
| MOM Park „F” Épület |
| Budapest H-1123 |
| HUNGARY |

Pfizer Kft.

Alkotas u 53

MOM Park „F” Épület

Budapest H-1123

HUNGARY

PregSure BVD vakcina A.U.V.

Süsteemulsioon

mis tekitab merisigadel vähemalt 5,6 log2 geomeetrilise keskmise seroneutraliseeriva tiitri

Veised (lehmad ja mullikad)

subkutaanselt

Iirimaa

| Pfizer Healthcare Ireland trading as Pfizer Animal Health |
| --- |
| Ringaskiddy |
| County Cork |
| IRELAND |

Pfizer Healthcare Ireland trading as Pfizer Animal Health

Ringaskiddy

County Cork

IRELAND

PregSure BVD Emulsion for Injection

Süsteemulsioon

mis tekitab merisigadel vähemalt 5,6 log2 geomeetrilise keskmise seroneutraliseeriva tiitri

Veised (lehmad ja mullikad)

subkutaanselt

Itaalia

| Pfizer Italia Srl |
| --- |
| Via Isonzo 71 |
| 04100 – Latina |
| ITALY |

Pfizer Italia Srl

Via Isonzo 71

04100 – Latina

ITALY

Pregsure BVD

Süsteemulsioon

mis tekitab merisigadel vähemalt 5,6 log2 geomeetrilise keskmise seroneutraliseeriva tiitri

Veised (lehmad ja mullikad)

subkutaanselt

Leedu

| Pfizer Animal Health S.A. |
| --- |
| Rue Laid Burniat 1 |
| B-1348 - Louvain-la-Neuve |
| BELGIUM |

Pfizer Animal Health S.A.

Rue Laid Burniat 1

B-1348 - Louvain-la-Neuve

BELGIUM

PREGSURE BVD, injekcinė emulsija

Süsteemulsioon

mis tekitab merisigadel vähemalt 5,6 log2 geomeetrilise keskmise seroneutraliseeriva tiitri

Veised (lehmad ja mullikad)

subkutaanselt

Läti

| Pfizer Ltd |
| --- |
| Ramsgate Road |
| Sandwich, Kent |
| CT13 9NJ |
| UNITED KINGDOM |

Pfizer Ltd

Ramsgate Road

Sandwich, Kent

CT13 9NJ

UNITED KINGDOM

PregSure BVD

Süsteemulsioon

mis tekitab merisigadel vähemalt 5,6 log2 geomeetrilise keskmise seroneutraliseeriva tiitri

Veised (lehmad ja mullikad)

subkutaanselt

Poola

| Pfizer Trading Polska Sp. z o.o. |
| --- |
| ul. Rzymowskiego 34 |
| 02-697 Warszawa |
| POLAND |

Pfizer Trading Polska Sp. z o.o.

ul. Rzymowskiego 34

02-697 Warszawa

POLAND

PregSure BVD emulsja do wstrzykiwań

Süsteemulsioon

mis tekitab merisigadel vähemalt 5,6 log2 geomeetrilise keskmise seroneutraliseeriva tiitri

Veised (lehmad ja mullikad)

subkutaanselt

Portugal

| Laboratórios Pfizer Lda |
| --- |
| Lagoas Park – Edifício 10 |
| 2740-244 Porto Salvo |
| PORTUGAL |

Laboratórios Pfizer Lda

Lagoas Park – Edifício 10

2740-244 Porto Salvo

PORTUGAL

Pregsure BVD

Süsteemulsioon

mis tekitab merisigadel vähemalt 5,6 log2 geomeetrilise keskmise seroneutraliseeriva tiitri

Veised (lehmad ja mullikad)

subkutaanselt

Rumeenia

| Pfizer Animal Health MA EEIG |
| --- |
| Ramsgate Road, Sandwich, Kent |
| CT 13 9NJ |
| UNITED KINGDOM |

Pfizer Animal Health MA EEIG

Ramsgate Road, Sandwich, Kent

CT 13 9NJ

UNITED KINGDOM

Pregsure BVD

Süsteemulsioon

mis tekitab merisigadel vähemalt 5,6 log2 geomeetrilise keskmise seroneutraliseeriva tiitri

Veised (lehmad ja mullikad)

subkutaanselt

Sloveenia

| Pfizer Luxembourg SARL |
| --- |
| Gran Duchy of Luxembourg |
| 51, Avenue J.F. Kennedy |
| L-1855 - Luxembourg |

Pfizer Luxembourg SARL

Gran Duchy of Luxembourg

51, Avenue J.F. Kennedy

L-1855 - Luxembourg

Pregsure BVD emulzija za injiciranje

Süsteemulsioon

mis tekitab merisigadel vähemalt 5,6 log2 geomeetrilise keskmise seroneutraliseeriva tiitri

Veised (lehmad ja mullikad)

subkutaanselt

Slovakkia

| Pfizer Luxembourg SARL o.z. |
| --- |
| Pfizer AH |
| Pribinova 25 |
| 81109 Bratislava |
| SLOVAK REPUBLIC |

Pfizer Luxembourg SARL o.z.

Pfizer AH

Pribinova 25

81109 Bratislava

SLOVAK REPUBLIC

Pregsure BVD

Süsteemulsioon

mis tekitab merisigadel vähemalt 5,6 log2 geomeetrilise keskmise seroneutraliseeriva tiitri

Veised (lehmad ja mullikad)

subkutaanselt

Hispaania

| Pfizer SA |
| --- |
| Avda. De Europa, 20 B |
| Parque Empresarial la Moraleja (Alcobendas) |
| 28108 |
| SPAIN |

Pfizer SA

Avda. De Europa, 20 B

Parque Empresarial la Moraleja (Alcobendas)

28108

SPAIN

PREGSURE BVD

Süsteemulsioon

mis tekitab merisigadel vähemalt 5,6 log2 geomeetrilise keskmise seroneutraliseeriva tiitri

Veised (lehmad ja mullikad)

subkutaanselt

Madalmaad

| Pfizer Animal Health BV |
| --- |
| Rivium Westlaan 142 |
| 2909 LD Capelle a/d Ijssel |
| P.O. Box 37 |
| 2900 AA Capelle a/d Ijssel |
| THE NETHERLANDS |

Pfizer Animal Health BV

Rivium Westlaan 142

2909 LD Capelle a/d Ijssel

P.O. Box 37

2900 AA Capelle a/d Ijssel

THE NETHERLANDS

PREGSURE BVD

Süsteemulsioon

mis tekitab merisigadel vähemalt 5,6 log2 geomeetrilise keskmise seroneutraliseeriva tiitri

Veised (lehmad ja mullikad)

subkutaanselt

Ühendkuningriik

| Pfizer Ltd |
| --- |
| Ramsgate Road |
| Sandwich, Kent |
| CT13 9NJ |
| UNITED KINGDOM |

Pfizer Ltd

Ramsgate Road

Sandwich, Kent

CT13 9NJ

UNITED KINGDOM

Pregsure BVD Emulsion for Injection

Süsteemulsioon

mis tekitab merisigadel vähemalt 5,6 log2 geomeetrilise keskmise seroneutraliseeriva tiitri

Veised (lehmad ja mullikad)

subkutaanselt

---

X LISA

RAVIMITE NIMETUSTE, RAVIMVORMIDE, TUGEVUSTE, MANUSTAMISVIISIDE, MÜÜGILOA HOIDJATE LOETELU LIIKMESRIIKIDES

| Liikmesriik EL/EMP | Müügiloa hoidja | Ravimi väljamõeldud nimetus | Tugevus | Ravimvorm | Manustamisviis |
| --- | --- | --- | --- | --- | --- |
| AT - Austria | Octapharma Pharmazeutika |
| Produktionsgesellschaft m.b.H. |
| Oberlaaerstraße 235 |
| A-1100 Wien |
| Austria |

Liikmesriik EL/EMP

Müügiloa hoidja

Ravimi väljamõeldud nimetus

Tugevus

Ravimvorm

Manustamisviis

AT - Austria

Octapharma Pharmazeutika

Produktionsgesellschaft m.b.H.

Oberlaaerstraße 235

A-1100 Wien

Austria

Octagam 100 mg/ml Infusionslösung

100 mg/ml

Infusioonilahus

Intravenoosne

AT - Austria

| Octapharma Pharmazeutika |
| --- |
| Produktionsgesellschaft m.b.H. |
| Oberlaaerstraße 235 |
| A-1100 Wien |
| Austria |

Octapharma Pharmazeutika

Produktionsgesellschaft m.b.H.

Oberlaaerstraße 235

A-1100 Wien

Austria

Octagam 50 mg/ml Infusionslösung

50 mg/ml

Infusioonilahus

Intravenoosne

BE - Belgia

| OCTAPHARMA BENELUX SA |
| --- |
| Rue de Stalle 63 |
| 1180 Bruxelles (Brussels) |
| Belgium |

OCTAPHARMA BENELUX SA

Rue de Stalle 63

1180 Bruxelles (Brussels)

Belgium

Octagam 10 %, solution pour perfusion

10 % (100 mg/ml)

Infusioonilahus

Intravenoosne

BE - Belgia

| OCTAPHARMA BENELUX SA |
| --- |
| Rue de Stalle 63 |
| 1180 Bruxelles (Brussels) |
| Belgium |

OCTAPHARMA BENELUX SA

Rue de Stalle 63

1180 Bruxelles (Brussels)

Belgium

Octagam 50 mg/ml solution pour perfusion

50 mg/ml

Infusioonilahus

Intravenoosne

BG - Bulgaaria

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam 10 %

100 mg/ml

Infusioonilahus

Intravenoosne

CY - Küpros

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

OCTAGAM INFUSION 10 %

10 %

Infusioonilahus

Intravenoosne

CY - Küpros

| Hospitec Co Ltd |
| --- |
| 5 Thessalonikis, Block B |
| 2085 Lefkosia |
| Cyprus |

Hospitec Co Ltd

5 Thessalonikis, Block B

2085 Lefkosia

Cyprus

OCTAGAM INFUSION 5 %

5 %

Infusioonilahus

Intravenoosne

CZ - Tšehhi

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

OCTAGAM

50 mg/ml

Infusioonilahus

Intravenoosne

CZ - Tšehhi

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

OCTAGAM 10 %

100 mg/ml

Infusioonilahus

Intravenoosne

DE - Saksamaa

| OCTAPHARMA GmbH |
| --- |
| Elisabeth-Selbert-Str. 11 |
| 40764 Langenfeld |
| Germany |

OCTAPHARMA GmbH

Elisabeth-Selbert-Str. 11

40764 Langenfeld

Germany

Octagam 50 mg/ml

50 mg/ml

Infusioonilahus

Intravenoosne

DE - Saksamaa

| OCTAPHARMA GmbH |
| --- |
| Elisabeth-Selbert-Str. 11 |
| 40764 Langenfeld |
| Germany |

OCTAPHARMA GmbH

Elisabeth-Selbert-Str. 11

40764 Langenfeld

Germany

Octagam 5 %

50 mg/ml

Infusioonilahus

Intravenoosne

DE - Saksamaa

| OCTAPHARMA GmbH |
| --- |
| Elisabeth-Selbert-Str. 11 |
| 40764 Langenfeld |
| Germany |

OCTAPHARMA GmbH

Elisabeth-Selbert-Str. 11

40764 Langenfeld

Germany

Octagam 10 %

100 mg/ml

Infusioonilahus

Intravenoosne

DK - Taani

| Octapharma AB |
| --- |
| Elersvägen 40 |
| SE-112 75 Stockholm |
| Sweden |

Octapharma AB

Elersvägen 40

SE-112 75 Stockholm

Sweden

Octagam

50 mg/ml

Infusioonilahus

Intravenoosne

DK - Taani

| Octapharma AB |
| --- |
| Elersvägen 40 |
| SE-112 75 Stockholm |
| Sweden |

Octapharma AB

Elersvägen 40

SE-112 75 Stockholm

Sweden

Octagam

100 mg/ml

Infusioonilahus

Intravenoosne

EL - Kreeka

| Octapharma Hellas SA |
| --- |
| George Kalbitzer |
| 60, posidonos Ave. |
| 166 75 Glyfada Attiki |
| Greece |

Octapharma Hellas SA

George Kalbitzer

60, posidonos Ave.

166 75 Glyfada Attiki

Greece

OCTAGAM

5 % (W/V)

Infusioonilahus

Intravenoosne

EL - Kreeka

| Octapharma Hellas SA |
| --- |
| George Kalbitzer |
| 60, posidonos Ave. |
| 166 75 Glyfada Attiki |
| Greece |

Octapharma Hellas SA

George Kalbitzer

60, posidonos Ave.

166 75 Glyfada Attiki

Greece

OCTAGAM

10 % (100 MG/ML)

Infusioonilahus

Intravenoosne

ES - Hispaania

| OCTAPHARMA, S.A. |
| --- |
| C/ Velázquez, 150 |
| 28002 Madrid |
| ESPAÑA |

OCTAPHARMA, S.A.

C/ Velázquez, 150

28002 Madrid

ESPAÑA

Octagamocta 100 mg/ml solución para perfusión

100 mg/ml

Infusioonilahus

Intravenoosne

ES - Hispaania

| OCTAPHARMA, S.A. |
| --- |
| C/ Velázquez, 150 |
| 28002 Madrid |
| ESPAÑA |

OCTAPHARMA, S.A.

C/ Velázquez, 150

28002 Madrid

ESPAÑA

Octagamocta 50 mg/ml solución para perfusión

50 mg/ml

Infusioonilahus

Intravenoosne

ET - Eesti

| Octapharma AB |
| --- |
| Elersvägen 40 |
| SE-112 75 Stockholm |
| Sweden |

Octapharma AB

Elersvägen 40

SE-112 75 Stockholm

Sweden

OCTAGAM

50 mg/ml

Infusioonilahus

Intravenoosne

ET - Eesti

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

OCTAGAM 10 %

100 mg/1 ml

Infusioonilahus

Intravenoosne

FI - Soome

| OCTAPHARMA |
| --- |
| Rajatorpantie 41 C |
| 01640 Vantaa |
| FINLAND |

OCTAPHARMA

Rajatorpantie 41 C

01640 Vantaa

FINLAND

OCTAGAM

50 mg/ml

100 mg/ml

Infusioonilahus

Intravenoosne

FR - Prantsusmaa

| Octapharma France SAS |
| --- |
| Laurent de Narbonne |
| 62Bis Avenue André Morizet |
| F- 92100 Boulogne |
| Billancourt |
| France |

Octapharma France SAS

Laurent de Narbonne

62Bis Avenue André Morizet

F- 92100 Boulogne

Billancourt

France

OCTAGAM 100 mg/ml, solution pour perfusion

100 mg/ml

Infusioonilahus

Intravenoosne

FR - Prantsusmaa

| Octapharma France SAS |
| --- |
| Laurent de Narbonne |
| 62Bis Avenue André Morizet |
| F- 92100 Boulogne |
| Billancourt |
| France |

Octapharma France SAS

Laurent de Narbonne

62Bis Avenue André Morizet

F- 92100 Boulogne

Billancourt

France

OCTAGAM 50 mg/ml, solution pour perfusion

50 mg/ml

Infusioonilahus

Intravenoosne

HU - Ungari

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

OCTAGAM 50 mg/ml oldatos infúzió

50 mg/ml

Infusioonilahus

Intravenoosne

HU - Ungari

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

OCTAGAM 100 mg/ml oldatos infúzió

100 mg/ml

Infusioonilahus

Intravenoosne

IS - Island

| Octapharma AB |
| --- |
| Nordenflychtsvägen 55 |
| SE-112 75 Stockholm |
| Sweden |

Octapharma AB

Nordenflychtsvägen 55

SE-112 75 Stockholm

Sweden

Octagam 5 %

50 mg/ml

Infusioonilahus

Intravenoosne

IS - Island

| Octapharma AB |
| --- |
| Nordenflychtsvägen 55 |
| SE-112 75 Stockholm |
| Sweden |

Octapharma AB

Nordenflychtsvägen 55

SE-112 75 Stockholm

Sweden

Octagam 10 %

100 mg/ml

Infusioonilahus

Intravenoosne

IT - Itaalia

| Octapharma Ltd |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma Ltd

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

OCTAGAM

5 %

Infusioonilahus

Intravenoosne

LT - Leedu

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

octagam

100 mg/ml

Infusioonilahus

Intravenoosne

LU - Luksemburg

| OCTAPHARMA BENELUX SA |
| --- |
| Rue de Stalle 63 |
| 1180 Bruxelles (Brussels) |
| Belgium |

OCTAPHARMA BENELUX SA

Rue de Stalle 63

1180 Bruxelles (Brussels)

Belgium

Octagam

5 %

Infusioonilahus

Intravenoosne

LU - Luksemburg

| OCTAPHARMA BENELUX SA |
| --- |
| Rue de Stalle 63 |
| 1180 Bruxelles (Brussels) |
| Belgium |

OCTAPHARMA BENELUX SA

Rue de Stalle 63

1180 Bruxelles (Brussels)

Belgium

Octagam-10

10 %

Infusioonilahus

Intravenoosne

LV - Läti

| Octapharma AB |
| --- |
| Elesvagen 40 |
| Stockholm, S-112 75 |
| Sweden |

Octapharma AB

Elesvagen 40

Stockholm, S-112 75

Sweden

Octagam 50 mg/ml solution for infusion

1 g/20 ml

Infusioonilahus

Intravenoosne

LV - Läti

| Octapharma AB |
| --- |
| Elesvagen 40 |
| Stockholm, S-112 75 |
| Sweden |

Octapharma AB

Elesvagen 40

Stockholm, S-112 75

Sweden

Octagam 50 mg/ml solution for infusion

2,5 g/50 ml

Infusioonilahus

Intravenoosne

LV - Läti

| Octapharma AB |
| --- |
| Elesvagen 40 |
| Stockholm, S-112 75 |
| Sweden |

Octapharma AB

Elesvagen 40

Stockholm, S-112 75

Sweden

Octagam 50 mg/ml solution for infusion

5 g/100 ml

Infusioonilahus

Intravenoosne

LV - Läti

| Octapharma AB |
| --- |
| Elesvagen 40 |
| Stockholm, S-112 75 |
| Sweden |

Octapharma AB

Elesvagen 40

Stockholm, S-112 75

Sweden

Octagam 50 mg/ml solution for infusion

10 g/200 ml

Infusioonilahus

Intravenoosne

LV - Läti

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam 100 mg/ml šķīdums infūzijām, 2 g/20 ml

2 g/20 ml

Infusioonilahus

Intravenoosne

LV - Läti

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam 100 mg/ml šķīdums infūzijām, 5 g/50 ml

5 g/50 ml

Infusioonilahus

Intravenoosne

LV - Läti

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam 100 mg/ml šķīdums infūzijām, 10 g/100 ml

10 g/100 ml

Infusioonilahus

Intravenoosne

LV - Läti

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam 100 mg/ml šķīdums infūzijām, 20 g/200 ml

20 g/200 ml

Infusioonilahus

Intravenoosne

MT - Malta

| Octapharma (IP) Limited, |
| --- |
| The Zenith Building, |
| 26 Spring Gardens, Manchester M2 1AB, |
| United Kingdom |

Octapharma (IP) Limited,

The Zenith Building,

26 Spring Gardens, Manchester M2 1AB,

United Kingdom

OCTAGAM 10 %

1 ml contains: protein 100 mg (of which ≥ 95 % is human Immunoglobulin G), IgA ≤ 0,4 mg, IgM ≤ 0,3 mg

Infusioonilahus

Intravenoosne

NL - Holland

| Octapharma GmbH |
| --- |
| Reinhard Rettinghaus |
| Elisabeth-Selbert-Str. 11 |
| 40764 Langenfeld |
| Germany |

Octapharma GmbH

Reinhard Rettinghaus

Elisabeth-Selbert-Str. 11

40764 Langenfeld

Germany

Octagam 10 %

100 mg/ml

Infusioonilahus

Intravenoosne

NL - Holland

| Octapharma GmbH |
| --- |
| Reinhard Rettinghaus |
| Elisabeth-Selbert-Str. 11 |
| 40764 Langenfeld |
| Germany |

Octapharma GmbH

Reinhard Rettinghaus

Elisabeth-Selbert-Str. 11

40764 Langenfeld

Germany

Octagam 5 %

50 mg/ml

Infusioonilahus

Intravenoosne

NO - Norra

| Octapharma AG |
| --- |
| Kim Björnstrup |
| Seidenstraße 2 |
| CH-8853 Lachen |
| Switzerland |

Octapharma AG

Kim Björnstrup

Seidenstraße 2

CH-8853 Lachen

Switzerland

Octagam

50 mg/ml

Infusioonilahus

Intravenoosne

NO - Norra

| Octapharma AG |
| --- |
| Kim Björnstrup |
| Seidenstraße 2 |
| CH-8853 Lachen |
| Switzerland |

Octapharma AG

Kim Björnstrup

Seidenstraße 2

CH-8853 Lachen

Switzerland

Octagam

100 mg/ml

Infusioonilahus

Intravenoosne

PL - Poola

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam

2,5 g/50 ml

Infusioonilahus

Intravenoosne

PL - Poola

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam

5 g/100 ml

Infusioonilahus

Intravenoosne

PL - Poola

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam 10 %

20 g/200 ml

Infusioonilahus

Intravenoosne

PL - Poola

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam 10 %

100 mg/ml

Infusioonilahus

Intravenoosne

PT - Portugal

| Octapharma |
| --- |
| Produtos Farmaceuticos, Lda. |
| Paulo Castro |
| Rua da Graca, 14 |
| P-1170-169 Lisboa |
| Portugal |

Octapharma

Produtos Farmaceuticos, Lda.

Paulo Castro

Rua da Graca, 14

P-1170-169 Lisboa

Portugal

Octagam

50 mg/ml

Infusioonilahus

Intravenoosne

PT - Portugal

| Octapharma |
| --- |
| Produtos Farmaceuticos, Lda. |
| Paulo Castro |
| Rua da Graca, 14 |
| P-1170-169 Lisboa |
| Portugal |

Octapharma

Produtos Farmaceuticos, Lda.

Paulo Castro

Rua da Graca, 14

P-1170-169 Lisboa

Portugal

Octagam

100 mg/ml

Infusioonilahus

Intravenoosne

RO - Rumeenia

| OCTAPHARMA (IP) Ltd. |
| --- |
| The Zenith Building 26 Spring Gardens |
| Manchester, M2 1AB |
| United Kingdom |

OCTAPHARMA (IP) Ltd.

The Zenith Building 26 Spring Gardens

Manchester, M2 1AB

United Kingdom

OCTAGAM

50 mg/ml

Infusioonilahus

Intravenoosne

RO - Rumeenia

| OCTAPHARMA (IP) Ltd. |
| --- |
| The Zenith Building 26 Spring Gardens |
| Manchester, M2 1AB |
| United Kingdom |

OCTAPHARMA (IP) Ltd.

The Zenith Building 26 Spring Gardens

Manchester, M2 1AB

United Kingdom

OCTAGAM 10 %

100 mg/ml

Infusioonilahus

Intravenoosne

SE - Rootsi

| Octapharma AB |
| --- |
| Olivier Clairotte |
| Elersvägen 40 |
| SE-112 75 Stockholm |
| Sweden |

Octapharma AB

Olivier Clairotte

Elersvägen 40

SE-112 75 Stockholm

Sweden

Octagem

50 mg/ml

Infusioonilahus

Intravenoosne

SE - Rootsi

| Octapharma AB |
| --- |
| Olivier Clairotte |
| Elersvägen 40 |
| SE-112 75 Stockholm |
| Sweden |

Octapharma AB

Olivier Clairotte

Elersvägen 40

SE-112 75 Stockholm

Sweden

Octagem

100 mg/ml

Infusioonilahus

Intravenoosne

SL - Sloveenia

| Zavod Republike Slovenije za transfuzijsko medicino |
| --- |
| Šlajmerjeva 6 |
| 1000 Ljubljana |
| Slovenija |

Zavod Republike Slovenije za transfuzijsko medicino

Šlajmerjeva 6

1000 Ljubljana

Slovenija

Octagam 50 mg/ml raztopina za infundiranje

50 mg/ ml

Infusioonilahus

Intravenoosne

SL - Sloveenia

| Zavod Republike Slovenije za transfuzijsko medicino |
| --- |
| Šlajmerjeva 6 |
| 1000 Ljubljana |
| Slovenija |

Zavod Republike Slovenije za transfuzijsko medicino

Šlajmerjeva 6

1000 Ljubljana

Slovenija

Octagam 100 mg/ml raztopina za infundiranje

100 mg/ ml

Infusioonilahus

Intravenoosne

SK - Slovakkia

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam

20 ml 50 mg/ml

Infusioonilahus

Intravenoosne

SK - Slovakkia

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam

50 ml 50 mg/ml

Infusioonilahus

Intravenoosne

SK - Slovakkia

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam

100 ml 50 mg/ml

Infusioonilahus

Intravenoosne

SK - Slovakkia

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam

200 ml 50 mg/ml

Infusioonilahus

Intravenoosne

SK - Slovakkia

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam 10 %

20 ml 100 mg/ml

Infusioonilahus

Intravenoosne

SK - Slovakkia

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam 10 %

50 ml 100 mg/ml

Infusioonilahus

Intravenoosne

SK - Slovakkia

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam 10 %

100 ml 100 mg/ml

Infusioonilahus

Intravenoosne

SK - Slovakkia

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam 10 %

200 ml 100 mg/ml

Infusioonilahus

Intravenoosne

UK - Ühendkuningriik

| Octapharma Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam Infusion

5 % w/v

Infusioonilahus

Intravenoosne

UK - Ühendkuningriik

| Octapharma Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam 10 % solution for Infusion

10 % w/v

Infusioonilahus

Intravenoosne

---