# Euroopan unionin C 250/2011

| | ISSN 1725-2490
  doi:10.3000/17252490.C_2011.250.fin |
| --- | --- |
| Euroopan unionin
  virallinen lehti | C 250 |
| | |
| Suomenkielinen laitos | Tiedonantoja ja ilmoituksia | 54. vuosikerta26. elokuu 2011 |

ISSN 1725-2490

doi:10.3000/17252490.C_2011.250.fin

Euroopan unionin

virallinen lehti

C 250

Suomenkielinen laitos

Tiedonantoja ja ilmoituksia

54. vuosikerta26. elokuu 2011

---

| Ilmoitusnumero | Sisältö | Sivu |
| --- | --- | --- |
| | IV   Tiedotteet |
| | EUROOPAN UNIONIN TOIMIELINTEN, ELINTEN, TOIMISTOJEN JA VIRASTOJEN TIEDOTTEET |
| | Euroopan komissio |
| 2011/C 250/01 | Tiivistelmä lääkkeiden myyntilupia koskevista Euroopan unionin päätöksistä ajanjaksolla 1 päivänä toukokuuta 2011–30 päivänä kesäkuuta 2011(Julkaistu Euroopan parlamentin ja neuvoston asetuksen (EY) N:o 726/2004 13 tai 38 artiklan nojalla) | 1 |
| 2011/C 250/02 | Tiivistelmä lääkkeiden myyntilupia koskevista Euroopan unionin päätöksistä ajanjaksolla 1 päivänä toukokuuta 2011–30 päivänä kesäkuuta 2011(Päätökset, jotka on tehty direktiivin 2001/83/EY 34 artiklan tai direktiivin 2001/82/EY 38 artiklan
  nojalla) | 18 |

Ilmoitusnumero

Sisältö

Sivu

IV   Tiedotteet

EUROOPAN UNIONIN TOIMIELINTEN, ELINTEN, TOIMISTOJEN JA VIRASTOJEN TIEDOTTEET

Euroopan komissio

2011/C 250/01

Tiivistelmä lääkkeiden myyntilupia koskevista Euroopan unionin päätöksistä ajanjaksolla 1 päivänä toukokuuta 2011–30 päivänä kesäkuuta 2011(Julkaistu Euroopan parlamentin ja neuvoston asetuksen (EY) N:o 726/2004 13 tai 38 artiklan nojalla)

(Julkaistu Euroopan parlamentin ja neuvoston asetuksen (EY) N:o 726/2004 13 tai 38 artiklan nojalla)

1

2011/C 250/02

Tiivistelmä lääkkeiden myyntilupia koskevista Euroopan unionin päätöksistä ajanjaksolla 1 päivänä toukokuuta 2011–30 päivänä kesäkuuta 2011(Päätökset, jotka on tehty direktiivin 2001/83/EY 34 artiklan tai direktiivin 2001/82/EY 38 artiklan
  nojalla)

(Päätökset, jotka on tehty direktiivin 2001/83/EY 34 artiklan tai direktiivin 2001/82/EY 38 artiklan

nojalla)

18

| FI | |
| --- | --- |

FI

---

IV Tiedotteet

EUROOPAN UNIONIN TOIMIELINTEN, ELINTEN, TOIMISTOJEN JA VIRASTOJEN TIEDOTTEET

Euroopan komissio

| 26.8.2011 | FI | Euroopan unionin virallinen lehti | C 250/1 |
| --- | --- | --- | --- |

26.8.2011

FI

Euroopan unionin virallinen lehti

C 250/1

---

Tiivistelmä lääkkeiden myyntilupia koskevista Euroopan unionin päätöksistä ajanjaksolla 1 päivänä toukokuuta 2011–30 päivänä kesäkuuta 2011

(Julkaistu Euroopan parlamentin ja neuvoston asetuksen (EY) N:o 726/2004 13 tai 38 artiklan nojalla
   (1)
  )

2011/C 250/01

—   Myyntiluvan myöntäminen (Euroopan parlamentin ja neuvoston asetuksen (EY) N:o 726/2004 13 artikla): Hyväksytyt

| Päätöksen päivämäärä | Lääkkeen nimi | INN-nimi (kansainvälinen yleisnimi) | Myyntiluvan haltija | Yhteisön rekisteriin merkitty numero | Lääkemuoto | ATC-koodi (anatomis-terapeuttis-kemiallinen koodi) | Ilmoituksen päivämäärä |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 6.5.2011 | Methylthioninium chloride Proveblue | Metyylitioniinikloridi | Provepharm S.A.S. |
| Technopole de Chateau Gombert, 45 rue Frederic Joliot Curie, FR-13013 Marseille |

Päätöksen päivämäärä

Lääkkeen nimi

INN-nimi (kansainvälinen yleisnimi)

Myyntiluvan haltija

Yhteisön rekisteriin merkitty numero

Lääkemuoto

ATC-koodi (anatomis-terapeuttis-kemiallinen koodi)

Ilmoituksen päivämäärä

6.5.2011

Methylthioninium chloride Proveblue

Metyylitioniinikloridi

Provepharm S.A.S.

Technopole de Chateau Gombert, 45 rue Frederic Joliot Curie, FR-13013 Marseille

EU/1/11/682/001

Injektioneste, liuos

V03AB17

12.5.2011

18.5.2011

Eliquis

apiksabaani

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

Bristol-Myers Squibb/Pfizer EEIG

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

EU/1/11/691/001-005

Kalvopäällysteinen tabletti

B01A

20.5.2011

18.5.2011

Yellox

bromfenaakkia

| Croma-Pharma GmbH |
| --- |
| Industriezeile 6, A-2100 Leobendorf, Österreich |

Croma-Pharma GmbH

Industriezeile 6, A-2100 Leobendorf, Österreich

EU/1/11/692/001

Silmätipat, liuos

S01BC11

23.5.2011

15.6.2011

Cinryze

ihmisen C1-inhibiittori

| ViroPharma SPRL-BVBA |
| --- |
| rue Montoyer 47, 1000 Bruxelles, Belgique / Montoyerstraat 47, 1000 Brussel, België |

ViroPharma SPRL-BVBA

rue Montoyer 47, 1000 Bruxelles, Belgique / Montoyerstraat 47, 1000 Brussel, België

EU/1/11/688/001

Injektiokuiva-aine ja liuotin, liuosta varten

B02AB03

20.6.2011

16.6.2011

Clopidogrel Teva Pharma B.V.

klopidogreeli

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

Teva Pharma B.V.

Computerweg 10, 3542 DR Utrecht, Nederland

EU/1/10/649/001-016

Kalvopäällysteinen tabletti

B01AC04

21.6.2011

16.6.2011

Leganto

Rotigotiini

| Schwarz Pharma Ltd |
| --- |
| Shannon, Industrial Estate, Co.Clare, Ireland |

Schwarz Pharma Ltd

Shannon, Industrial Estate, Co.Clare, Ireland

EU/1/11/695/001-055

Depotlaastari

N04BC09

22.6.2011

16.6.2011

Rivastigmine Actavis

rivastigmiini

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

Actavis Group PTC ehf.

ReykjavÍkurvegur 76-78, Hafnarfjörður 220, Iceland

EU/1/11/693/001-016

Kapseli, kova

N06DA03

21.6.2011

17.6.2011

BYDUREON

eksenatidi

| 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/1/11/696/001-002

Injektiokuiva-aine ja liuotin depotsuspensiota varten

A10BX04

23.6.2011

17.6.2011

NULOJIX

Belatasepti

| Bristol-Myers Squibb Pharma EEIG |
| --- |
| Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom |

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/11/694/001-002

Infuusiokuiva-aine, konsentraattiliuosta varten

L04AA28

23.6.2011

23.6.2011

Sprimeo HCT

aliskireenihemifumaraatti / hydroklooritiatsidia

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom

EU/1/11/683/001-080

Kalvopäällysteinen tabletti

C09XA52

28.6.2011

—   Myyntiluvan myöntäminen (Euroopan parlamentin ja neuvoston asetuksen (EY) N:o 726/2004 13 artikla): Hylätyt

| Päätöksen päivämäärä | Lääkkeen nimi | Myyntiluvan haltija | Yhteisön rekisteriin merkitty numero | Ilmoituksen päivämäärä |
| --- | --- | --- | --- | --- |
| 17.6.2011 | Movectro | Merck Serono Europe Limited |
| 56, Marsh Wall, London E14 9TP, United Kingdom |

Päätöksen päivämäärä

Lääkkeen nimi

Myyntiluvan haltija

Yhteisön rekisteriin merkitty numero

Ilmoituksen päivämäärä

17.6.2011

Movectro

Merck Serono Europe Limited

56, Marsh Wall, London E14 9TP, United Kingdom

23.6.2011

—   Myyntiluvan muuttaminen (Euroopan parlamentin ja neuvoston asetuksen (EY) N:o 726/2004 13 artikla): Hyväksytyt

| Päätöksen päivämäärä | Lääkkeen nimi | Myyntiluvan haltija | Yhteisön rekisteriin merkitty numero | Ilmoituksen päivämäärä |
| --- | --- | --- | --- | --- |
| 2.5.2011 | Combivir | ViiV Healthcare UK Ltd |
| 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |

Päätöksen päivämäärä

Lääkkeen nimi

Myyntiluvan haltija

Yhteisön rekisteriin merkitty numero

Ilmoituksen päivämäärä

2.5.2011

Combivir

ViiV Healthcare UK Ltd

980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

EU/1/98/058/001-002

4.5.2011

2.5.2011

Kepivance

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

Swedish Orphan Biovitrum AB (publ)

SE-112 76, Stockholm, Sverige

EU/1/05/314/001

4.5.2011

2.5.2011

Kinzalkomb

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

Bayer Schering Pharma AG

D-13342 Berlin, Deutschland

EU/1/02/214/001-015

4.5.2011

2.5.2011

Kinzalmono

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

Bayer Schering Pharma AG

D-13342 Berlin, Deutschland

EU/1/98/091/001-014

4.5.2011

2.5.2011

Micardis

| 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/1/98/090/001-020

4.5.2011

2.5.2011

MicardisPlus

| 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/1/02/213/001-023

4.5.2011

2.5.2011

Nexavar

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

Bayer Schering Pharma AG

13342 Berlin, Deutschland

EU/1/06/342/001

4.5.2011

2.5.2011

Osigraft

| Howmedica International S. de R.L. |
| --- |
| Division of Stryker Corporation, Raheen Industrial Estate, Raheen, Limerick, Ireland |

Howmedica International S. de R.L.

Division of Stryker Corporation, Raheen Industrial Estate, Raheen, Limerick, Ireland

EU/1/01/179/001

4.5.2011

2.5.2011

Pritor

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

Bayer Schering Pharma AG

13342 Berlin, Deutschland

EU/1/98/089/001-022

4.5.2011

2.5.2011

PritorPlus

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

Bayer Schering Pharma AG

13342 Berlin, Deutschland

EU/1/02/215/001-021

4.5.2011

2.5.2011

Revatio

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

Pfizer Limited

Sandwich, Kent, CT13 9NJ, United Kingdom

EU/1/05/318/001-002

4.5.2011

2.5.2011

Revolade

| GlaxoSmithKline Trading Services Limited |
| --- |
| 6900 Cork Airport Business Park, Kinsale Road, Cork, Ireland |

GlaxoSmithKline Trading Services Limited

6900 Cork Airport Business Park, Kinsale Road, Cork, Ireland

EU/1/10/612/001-006

4.5.2011

2.5.2011

Votrient

| Glaxo Group Limited |
| --- |
| Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom |

Glaxo Group Limited

Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom

EU/1/10/628/001-004

4.5.2011

5.5.2011

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

9.5.2011

6.5.2011

Foclivia

| 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/1/09/577/001-004

12.5.2011

6.5.2011

Kivexa

| 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/1/04/298/001-003

12.5.2011

6.5.2011

Rasilez HCT

| Novartis Europharm Ltd |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Ltd

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/08/491/001-080

12.5.2011

6.5.2011

ReFacto AF

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

Wyeth Europa Ltd.

Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom

EU/1/99/103/001-008

12.5.2011

6.5.2011

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

12.5.2011

6.5.2011

Tygacil

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

Wyeth Europa Ltd.

Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom

EU/1/06/336/001

12.5.2011

6.5.2011

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

12.5.2011

6.5.2011

Votrient

| Glaxo Group Limited |
| --- |
| Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom |

Glaxo Group Limited

Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom

EU/1/10/628/001-004

12.5.2011

6.5.2011

Xagrid

| Shire Pharmaceutical Contracts Ltd |
| --- |
| Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom |

Shire Pharmaceutical Contracts Ltd

Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom

EU/1/04/295/001

12.5.2011

12.5.2011

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

16.5.2011

12.5.2011

Extavia

| Novartis Europharm Ltd |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Ltd

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/08/454/001-002

EU/1/08/454/005-007

16.5.2011

12.5.2011

Ketek

| Aventis Pharma S.A. |
| --- |
| 20 avenue Raymond Aron, F-92160 Antony, France |

Aventis Pharma S.A.

20 avenue Raymond Aron, F-92160 Antony, France

EU/1/01/191/001-005

16.5.2011

12.5.2011

MabCampath

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

Genzyme Europe B.V.

Gooimeer 10, NL-1411 DD Naarden, Nederland

EU/1/01/193/001-002

16.5.2011

12.5.2011

Olanzapine Apotex

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

Apotex Europe B.V.

Darwingweg 20, 2333 CR Leiden, Nederland

EU/1/10/635/001-014

16.5.2011

16.5.2011

Elonva

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

N.V. Organon

Kloosterstraat 6, 5349 AB Oss, Nederland

EU/1/09/609/001-002

18.5.2011

16.5.2011

Pramipexole Teva

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

Teva Pharma B.V.

Computerweg 10, DR Utrecht 3542, Nederland

EU/1/08/490/001-024

18.5.2011

16.5.2011

Yondelis

| Pharma Mar, S.A. |
| --- |
| Avda. de los Reyes 1, Polígono Industrial La Mina, 28770 Colmenar Viejo (Madrid), Espana |

Pharma Mar, S.A.

Avda. de los Reyes 1, Polígono Industrial La Mina, 28770 Colmenar Viejo (Madrid), Espana

EU/1/07/417/001-002

18.5.2011

16.5.2011

Zavesca

| 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/1/02/238/001

18.5.2011

18.5.2011

Arixtra

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

Glaxo Group Ltd.

Greenford Road, Greenford, Middlesex UB6 0NN, United Kingdom

EU/1/02/206/001-035

20.5.2011

18.5.2011

Celvapan

| Baxter AG |
| --- |
| Industriestraße 67, A - 1221 Wien, Österreich |

Baxter AG

Industriestraße 67, A - 1221 Wien, Österreich

EU/1/08/506/001

20.5.2011

18.5.2011

DepoCyte

| Pacira Limited |
| --- |
| 3 Glory Park Avenue, Wooburn Green, High Wycombe, Buckinghamshire, HP10 0DF, United Kingdom |

Pacira Limited

3 Glory Park Avenue, Wooburn Green, High Wycombe, Buckinghamshire, HP10 0DF, United Kingdom

EU/1/01/187/001

20.5.2011

18.5.2011

Hepsera

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

Gilead Sciences International Limited

Cambridge, CB21 6GT, United Kingdom

EU/1/03/251/001-002

20.5.2011

18.5.2011

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

23.5.2011

18.5.2011

Karvezide

| Bristol-Myers Squibb Pharma EEIG |
| --- |
| Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom |

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/98/085/001-034

23.5.2011

18.5.2011

Pelzont

| 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/1/08/460/001-014

23.5.2011

18.5.2011

PREZISTA

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

Janssen-Cilag International NV

Turnhoutseweg, 30 - 2340 Beerse - België

EU/1/06/380/001-005

23.5.2011

18.5.2011

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

20.5.2011

18.5.2011

RotaTeq

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

Sanofi Pasteur MSD, SNC

8, rue Jonas Salk, Lyon 69007, France

EU/1/06/348/001-002

23.5.2011

18.5.2011

Sprimeo

| Novartis Europharm Ltd |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Ltd

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/07/407/001-020

23.5.2011

18.5.2011

Tarceva

| Roche Registration Limited |
| --- |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |

Roche Registration Limited

6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/05/311/001-003

20.5.2011

18.5.2011

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

23.5.2011

23.5.2011

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

26.5.2011

23.5.2011

CoAprovel

| 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/1/98/086/001-034

30.5.2011

23.5.2011

Emtriva

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

Gilead Sciences International Limited

Cambridge CB21 6GT United Kingdom

EU/1/03/261/001-003

26.5.2011

23.5.2011

Exalief

| BIAL - Portela & Ca, SA |
| --- |
| A Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado - Portugal |

BIAL - Portela & Ca, SA

A Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado - Portugal

EU/1/09/520/001-020

26.5.2011

23.5.2011

Exelon

| Novartis Europharm Ltd |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Ltd

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/98/066/001-026

26.5.2011

23.5.2011

Glivec

| Novartis Europharm Ltd |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Ltd

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/01/198/001-013

26.5.2011

23.5.2011

GONAL-f

| Merck Serono Europe Ltd. |
| --- |
| 56, Marsh Wall, London E14 9TP, United Kingdom |

Merck Serono Europe Ltd.

56, Marsh Wall, London E14 9TP, United Kingdom

EU/1/95/001/033-035

26.5.2011

23.5.2011

Luveris

| Merck Serono Europe Limited |
| --- |
| 56, Marsh Wall, London E14 9TP, United Kingdom |

Merck Serono Europe Limited

56, Marsh Wall, London E14 9TP, United Kingdom

EU/1/00/155/007

25.5.2011

23.5.2011

Prometax

| Novartis Europharm Ltd |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Ltd

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/98/092/001-028

25.5.2011

23.5.2011

Rapamune

| 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/1/01/171/001

EU/1/01/171/007-010

EU/1/01/171/013

26.5.2011

23.5.2011

Rasilez

| Novartis Europharm Ltd |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Ltd

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/07/405/001-040

25.5.2011

23.5.2011

Riprazo

| Novartis Europharm Ltd |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Ltd

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/07/409/001-040

26.5.2011

23.5.2011

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

26.5.2011

23.5.2011

Tasigna

| Novartis Europharm Ltd |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Ltd

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/07/422/001-006

25.5.2011

23.5.2011

Telzir

| 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/1/04/282/001-002

26.5.2011

23.5.2011

Tredaptive

| 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/1/08/459/001-014

25.5.2011

23.5.2011

Trevaclyn

| 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/1/08/458/001-014

25.5.2011

23.5.2011

Tygacil

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

Wyeth Europa Ltd.

Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom

EU/1/06/336/001

26.5.2011

23.5.2011

Tyverb

| Glaxo Group Limited |
| --- |
| Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom |

Glaxo Group Limited

Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom

EU/1/07/440/001-006

27.5.2011

23.5.2011

Vectibix

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

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/07/423/001-003

26.5.2011

27.5.2011

Avonex

| Biogen Idec Ltd |
| --- |
| Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom |

Biogen Idec Ltd

Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom

EU/1/97/033/002-006

1.6.2011

27.5.2011

Carbaglu

| Orphan Europe SARL |
| --- |
| Immeuble Le Wilson - 70 Avenue du Général de Gaulle - F 92 800 Puteaux - France |

Orphan Europe SARL

Immeuble Le Wilson - 70 Avenue du Général de Gaulle - F 92 800 Puteaux - France

EU/1/02/246/001-003

1.6.2011

27.5.2011

CellCept

| Roche Registration Limited |
| --- |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |

Roche Registration Limited

6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/96/005/001-006

31.5.2011

27.5.2011

Competact

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

Takeda Global Research and Development Centre (Europe) Ltd

61 Aldwych, London WC2B 4AE, United Kingdom

EU/1/06/354/001-012

1.6.2011

27.5.2011

Enbrel

| 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/1/99/126/001-021

31.5.2011

27.5.2011

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

1.6.2011

27.5.2011

Levemir

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

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/04/278/001-016

1.6.2011

27.5.2011

Lucentis

| Novartis Europharm Ltd |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Ltd

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/06/374/001

31.5.2011

27.5.2011

Mycophenolate mofetil Teva

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

Teva Pharma B.V.

Computerweg 10, DR Utrecht 3542, Nederland

EU/1/07/439/001-006

31.5.2011

27.5.2011

Myfenax

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

Teva Pharma B.V.

Computerweg 10, DR Utrecht 3542, Nederland

EU/1/07/438/001-006

31.5.2011

27.5.2011

Neulasta

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

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/02/227/001-002

EU/1/02/227/004

1.6.2011

27.5.2011

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

31.5.2011

27.5.2011

Simponi

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

Janssen Biologics B.V.

Einsteinweg 101, CB Leiden 2333, Nederland

EU/1/09/546/001-004

1.6.2011

27.5.2011

Temozolomide Hospira

| Hospira UK Ltd. |
| --- |
| Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom |

Hospira UK Ltd.

Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom

EU/1/10/615/001-024

31.5.2011

27.5.2011

Truvada

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

Gilead Sciences International Limited

Cambridge CB21 6GT United Kingdom

EU/1/04/305/001-002

31.5.2011

27.5.2011

Viracept

| Roche Registration Limited |
| --- |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |

Roche Registration Limited

6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/97/054/001

EU/1/97/054/004-005

1.6.2011

7.6.2011

Caelyx

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

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/96/011/001-004

9.6.2011

7.6.2011

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

9.6.2011

7.6.2011

Fabrazyme

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

Genzyme Europe B.V.

Gooimeer 10, NL-1411 DD Naarden, Nederland

EU/1/01/188/001-006

9.6.2011

7.6.2011

Irbesartan Winthrop

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

Sanofi-Aventis

174, avenue de France, F-75013 Paris, France

EU/1/06/376/001-033

9.6.2011

7.6.2011

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

9.6.2011

7.6.2011

Norvir

| Abbott Laboratories Ltd |
| --- |
| Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, United Kingdom |

Abbott Laboratories Ltd

Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, United Kingdom

EU/1/96/016/001

EU/1/96/016/003-004

EU/1/96/016/008

9.6.2011

7.6.2011

Tractocile

| 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/1/99/124/001-002

9.6.2011

7.6.2011

Trizivir

| ViiV Healthcare UK Limited |
| --- |
| 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |

ViiV Healthcare UK Limited

980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

EU/1/00/156/002-004

9.6.2011

14.6.2011

Afinitor

| Novartis Europharm Ltd |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Ltd

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/09/538/001-008

16.6.2011

14.6.2011

Doribax

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

Janssen-Cilag International NV

Turnhoutseweg, 30 - 2340 Beerse - België

EU/1/08/467/001-002

16.6.2011

14.6.2011

Ivemend

| Merck Sharp & Dohme Limited |
| --- |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/07/437/001-004

16.6.2011

14.6.2011

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

16.6.2011

14.6.2011

Opgenra

| Howmedica International S. de R. L. |
| --- |
| Raheen Business Park, Limerick, Ireland |

Howmedica International S. de R. L.

Raheen Business Park, Limerick, Ireland

EU/1/08/489/001-002

16.6.2011

14.6.2011

PecFent

| Archimedes Development Ltd |
| --- |
| Nottingham, NGT7 2TN, United Kingdom |

Archimedes Development Ltd

Nottingham, NGT7 2TN, United Kingdom

EU/1/10/644/001-006

16.6.2011

14.6.2011

Ribavirin BioPartners

| BioPartners GmbH |
| --- |
| Kaiserpassage 11 - D-72764 Reutlingen, Deutschland |

BioPartners GmbH

Kaiserpassage 11 - D-72764 Reutlingen, Deutschland

EU/1/10/626/001-004

16.6.2011

14.6.2011

Temodal

| 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/1/98/096/001-025

16.6.2011

14.6.2011

Twynsta

| 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

16.6.2011

14.6.2011

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

16.6.2011

15.6.2011

InductOs

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

Wyeth Europa Ltd.

Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom

EU/1/02/226/001

20.6.2011

15.6.2011

Infanrix hexa

| 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/1/00/152/009-018

17.6.2011

15.6.2011

PegIntron

| 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/1/00/131/001-050

17.6.2011

15.6.2011

Ziagen

| 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/1/99/112/001-002

17.6.2011

16.6.2011

INCRELEX

| Ipsen Pharma |
| --- |
| 65, quai Georges Gorse, 92100 Boulogne-Billancourt, France |

Ipsen Pharma

65, quai Georges Gorse, 92100 Boulogne-Billancourt, France

EU/1/07/402/001

21.6.2011

16.6.2011

IntronA

| 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/1/99/127/011-039

EU/1/99/127/041-044

22.6.2011

16.6.2011

Irbesartan HCT Winthrop

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

Sanofi-Aventis

174, avenue de France, F-75013 Paris, France

EU/1/06/377/001-028

21.6.2011

16.6.2011

Macugen

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

Pfizer Ltd

Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom

EU/1/05/325/002

21.6.2011

16.6.2011

Olanzapine Mylan

| Generics [UK] Limited |
| --- |
| Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom |

Generics [UK] Limited

Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

EU/1/08/475/001-034

21.6.2011

16.6.2011

Omnitrope

| Sandoz GmbH |
| --- |
| Biochemiestrasse 10, Kundl 6250, Österreich |

Sandoz GmbH

Biochemiestrasse 10, Kundl 6250, Österreich

EU/1/06/332/001-012

21.6.2011

16.6.2011

Ozurdex

| Allergan Pharmaceuticals (Ireland) Ltd, |
| --- |
| Castlebar Road, Westport, Co. Mayo, Ireland |

Allergan Pharmaceuticals (Ireland) Ltd,

Castlebar Road, Westport, Co. Mayo, Ireland

EU/1/10/638/001

21.6.2011

16.6.2011

Samsca

| Otsuka Pharmaceutical Europe Ltd |
| --- |
| Hunton House, Highbridge Business Park, Oxford Road, Uxbridge, Middlesex UB8 1HU, United Kingdom |

Otsuka Pharmaceutical Europe Ltd

Hunton House, Highbridge Business Park, Oxford Road, Uxbridge, Middlesex UB8 1HU, United Kingdom

EU/1/09/539/001-004

21.6.2011

16.6.2011

Tysabri

| Elan Pharma International Ltd. |
| --- |
| Monksland, Athlone, County Westmeath, Ireland |

Elan Pharma International Ltd.

Monksland, Athlone, County Westmeath, Ireland

EU/1/06/346/001

21.6.2011

16.6.2011

ViraferonPeg

| 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/1/00/132/001-050

24.6.2011

16.6.2011

Zebinix

| BIAL - Portela & Ca, SA |
| --- |
| A Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado - Portugal |

BIAL - Portela & Ca, SA

A Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado - Portugal

EU/1/09/514/001-020

21.6.2011

17.6.2011

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

23.6.2011

17.6.2011

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

23.6.2011

17.6.2011

INCRELEX

| Ipsen Pharma |
| --- |
| 65, quai Georges Gorse, 92100 Boulogne-Billancourt, France |

Ipsen Pharma

65, quai Georges Gorse, 92100 Boulogne-Billancourt, France

EU/1/07/402/001

23.6.2011

17.6.2011

Lyrica

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

Pfizer Ltd

Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom

EU/1/04/279/001-044

23.6.2011

17.6.2011

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

24.6.2011

17.6.2011

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/1/07/400/008-013

EU/1/07/400/017-024

23.6.2011

17.6.2011

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

23.6.2011

17.6.2011

Ranexa

| Menarini International Operations Luxembourg S.A. |
| --- |
| 1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg |

Menarini International Operations Luxembourg S.A.

1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg

EU/1/08/462/001-012

21.6.2011

17.6.2011

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

21.6.2011

17.6.2011

Remicade

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

Janssen Biologics B.V.

Einsteinweg 101, 2333 CB Leiden, Nederland

EU/1/99/116/001-005

21.6.2011

17.6.2011

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

24.6.2011

17.6.2011

Tasigna

| Novartis Europharm Ltd |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Ltd

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/07/422/001-008

23.6.2011

17.6.2011

Tygacil

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

Wyeth Europa Ltd.

Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom

EU/1/06/336/001

23.6.2011

17.6.2011

Tysabri

| Elan Pharma International Ltd. |
| --- |
| Monksland, Athlone, County Westmeath, Ireland |

Elan Pharma International Ltd.

Monksland, Athlone, County Westmeath, Ireland

EU/1/06/346/001

23.6.2011

17.6.2011

Xeloda

| 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/1/00/163/001-002

21.6.2011

17.6.2011

Xolair

| Novartis Europharm Ltd |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Ltd

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/05/319/001-010

23.6.2011

23.6.2011

BeneFIX

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

Wyeth Europa Ltd.

Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom

EU/1/97/047/001-007

28.6.2011

23.6.2011

Docefrez

| Sun Pharmaceuticals Industries Europe B.V. |
| --- |
| Polarisavenue 87, 2132 JH Hoofddorp, Nederland |

Sun Pharmaceuticals Industries Europe B.V.

Polarisavenue 87, 2132 JH Hoofddorp, Nederland

EU/1/10/630/001-002

28.6.2011

23.6.2011

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

28.6.2011

23.6.2011

Erbitux

| Merck KGaA |
| --- |
| Frankfurter Straße 250, 64271 Darmstadt, Deutschland |

Merck KGaA

Frankfurter Straße 250, 64271 Darmstadt, Deutschland

EU/1/04/281/001-005

27.6.2011

23.6.2011

Ganfort

| Allergan Pharmaceuticals Ireland |
| --- |
| Castlebar Road, Westport, Co. Mayo, Ireland |

Allergan Pharmaceuticals Ireland

Castlebar Road, Westport, Co. Mayo, Ireland

EU/1/06/340/001-002

28.7.2011

23.6.2011

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

27.6.2011

23.6.2011

Invirase

| Roche Registration Limited |
| --- |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |

Roche Registration Limited

6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/96/026/001-002

28.6.2011

23.6.2011

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

27.6.2011

23.6.2011

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

27.6.2011

23.6.2011

Orencia

| 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/1/07/389/001-003

28.6.2011

23.6.2011

Ovitrelle

| Merck Serono Europe Limited |
| --- |
| 56, Marsh Wall, London E14 9TP, United Kingdom |

Merck Serono Europe Limited

56, Marsh Wall, London E14 9TP, United Kingdom

EU/1/00/165/001-008

27.6.2011

23.6.2011

Protopic

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

Astellas Pharma Europe B.V.

Elisabethhof 19, NL-2353 EW Leiderdorp, Nederland

EU/1/02/201/001-006

27.6.2011

23.6.2011

Tamiflu

| 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/1/02/222/001-004

28.6.2011

23.6.2011

Temozolomide HEXAL

| HEXAL AG |
| --- |
| Industriestrasse 25, D-83607 Holzkirchen, Deutschland |

HEXAL AG

Industriestrasse 25, D-83607 Holzkirchen, Deutschland

EU/1/10/616/001-024

27.6.2011

23.6.2011

Temozolomide Sandoz

| Sandoz Pharmaceuticals GmbH |
| --- |
| Raiffeisenstraße 11, 83607 Holzkirchen, Deutschland |

Sandoz Pharmaceuticals GmbH

Raiffeisenstraße 11, 83607 Holzkirchen, Deutschland

EU/1/10/617/001-024

27.6.2011

23.6.2011

Tevagrastim

| Teva GmbH |
| --- |
| Wasastraße 50, 01445 Radebeul, Deutschland |

Teva GmbH

Wasastraße 50, 01445 Radebeul, Deutschland

EU/1/08/445/001-014

27.6.2011

23.6.2011

Torisel

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

Wyeth Europa Ltd

Huntercombe Lane South, Taplow, Maidenhead, Berkshire SL6 0PH, United Kingdom

EU/1/07/424/001

27.6.2011

23.6.2011

Twinrix Adult

| 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/1/96/020/001-009

27.6.2011

23.6.2011

Viramune

| 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/1/97/055/001-004

28.6.2011

29.6.2011

Abraxane

| Celgene Europe Limited |
| --- |
| 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex, UB11 1BD, United Kingdom |

Celgene Europe Limited

1 Longwalk Road, Stockley Park, Uxbridge, Middlesex, UB11 1BD, United Kingdom

EU/1/07/428/001

5.7.2011

29.6.2011

Aclasta

| Novartis Europharm Ltd |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Ltd

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/05/308/001-002

4.7.2011

29.6.2011

Adrovance

| 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/1/06/364/001-009

1.7.2011

29.6.2011

Advagraf

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

Astellas Pharma Europe B.V.

Elisabethhof 19, NL-2353 EW Leiderdorp, Nederland

EU/1/07/387/001-026

5.7.2011

29.6.2011

Advate

| Baxter AG |
| --- |
| Industriesstrasse 67, 1220 Vienna, Österreich |

Baxter AG

Industriesstrasse 67, 1220 Vienna, Österreich

EU/1/03/271/001-006

4.7.2011

29.6.2011

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

4.7.2011

29.6.2011

Avastin

| Roche Registration Limited |
| --- |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |

Roche Registration Limited

6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/04/300/001-002

4.7.2011

29.6.2011

Bondenza

| 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/1/03/266/003-006

1.7.2011

29.6.2011

Bondronat

| Roche Registration Limited |
| --- |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |

Roche Registration Limited

6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/96/012/004

EU/1/96/012/009-013

1.7.2011

29.6.2011

Bonviva

| 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/1/03/265/003-006

1.7.2011

29.6.2011

Byetta

| 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/1/06/362/001-004

5.7.2011

29.6.2011

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

1.7.2011

29.6.2011

Enbrel

| 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/1/99/126/001-022

1.7.2011

29.6.2011

Enbrel

| 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/1/99/126/001-022

5.7.2011

29.6.2011

Fosavance

| 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/1/05/310/001-009

1.7.2011

29.6.2011

Ibandronic Acid Teva

| 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

1.7.2011

29.6.2011

Instanyl

| Nycomed Danmark ApS |
| --- |
| Langebjerg 1, DK-4000 Roskilde, Danmark |

Nycomed Danmark ApS

Langebjerg 1, DK-4000 Roskilde, Danmark

EU/1/09/531/001-021

5.7.2011

29.6.2011

IntronA

| 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/1/99/127/011-039

EU/1/99/127/041-044

4.7.2011

29.6.2011

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

5.7.2011

29.6.2011

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

4.7.2011

29.6.2011

Nexavar

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

Bayer Schering Pharma AG

13342 Berlin, Deutschland

EU/1/06/342/001

5.7.2011

29.6.2011

Pegasys

| 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/1/02/221/001-016

1.7.2011

29.6.2011

PegIntron

| 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/1/00/131/001-050

1.7.2011

29.6.2011

Prevenar 13

| Wyeth Lederle Vaccines S.A. |
| --- |
| Pleainlaan 17 Boulevard de la Plaine, 1050 Brussels - Bruxelles, Belgium |

Wyeth Lederle Vaccines S.A.

Pleainlaan 17 Boulevard de la Plaine, 1050 Brussels - Bruxelles, Belgium

EU/1/09/590/001-006

5.7.2011

29.6.2011

Rasilez HCT

| Novartis Europharm Ltd |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Ltd

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/08/491/001-080

1.7.2011

29.6.2011

Rebetol

| 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/1/99/107/001-005

1.7.2011

29.6.2011

Siklos

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

ADDMEDICA

101, rue Saint Lazare, Paris 75009, France

EU/1/07/397/001-004

4.7.2011

29.6.2011

Synflorix

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

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, 1330 Rixensart, Belgique

EU/1/09/508/001-011

5.7.2011

29.6.2011

Telmisartan Teva

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

Teva Pharma B.V.

Computerweg 10, 3542 DR Utrecht, Nederland

EU/1/09/610/031-060

5.7.2011

29.6.2011

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

1.7.2011

29.6.2011

Velcade

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

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/04/274/001-002

5.7.2011

29.6.2011

VPRIV

| Shire Pharmaceuticals Ireland Limited |
| --- |
| 5 Riverside Walk, Citywest Business Campus, Dublin 24, Ireland |

Shire Pharmaceuticals Ireland Limited

5 Riverside Walk, Citywest Business Campus, Dublin 24, Ireland

EU/1/10/646/003-006

5.7.2011

29.6.2011

Zometa

| Novartis Europharm Ltd |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Ltd

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/01/176/001-006

1.7.2011

—   Myyntiluvan peruuttaminen (Euroopan parlamentin ja neuvoston asetuksen (EY) N:o 726/2004 13 artikla)

| Päätöksen päivämäärä | Lääkkeen nimi | Myyntiluvan haltija | Yhteisön rekisteriin merkitty numero | Ilmoituksen päivämäärä |
| --- | --- | --- | --- | --- |
| 14.6.2011 | Humenza | Sanofi Pasteur SA |
| 2, avenue Pont Pasteur, F-69007 Lyon, France |

Päätöksen päivämäärä

Lääkkeen nimi

Myyntiluvan haltija

Yhteisön rekisteriin merkitty numero

Ilmoituksen päivämäärä

14.6.2011

Humenza

Sanofi Pasteur SA

2, avenue Pont Pasteur, F-69007 Lyon, France

EU/1/10/629/001

16.6.2011

—   Myyntiluvan myöntäminen (Euroopan parlamentin ja neuvoston asetuksen (EY) N:o 726/2004 38 artikla
   (2)
  ): Hyväksytyt

| Päätöksen päivämäärä | Lääkkeen nimi | INN-nimi (kansainvälinen yleisnimi) | Myyntiluvan haltija | Yhteisön rekisteriin merkitty numero | Lääkemuoto | ATC-koodi (anatomis-terapeuttis-kemiallinen koodi) | Ilmoituksen päivämäärä |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 6.5.2011 | CERTIFECT | (S)-metopreeni, Fiproniili, Amitratsi | MERIAL |
| 29 avenue Tony Garnier, 69007 LYON, France |

Päätöksen päivämäärä

Lääkkeen nimi

INN-nimi (kansainvälinen yleisnimi)

Myyntiluvan haltija

Yhteisön rekisteriin merkitty numero

Lääkemuoto

ATC-koodi (anatomis-terapeuttis-kemiallinen koodi)

Ilmoituksen päivämäärä

6.5.2011

CERTIFECT

(S)-metopreeni, Fiproniili, Amitratsi

MERIAL

29 avenue Tony Garnier, 69007 LYON, France

EU/2/11/125/001-008

Paikallisvaleluliuos

QP53AX65

12.5.2011

6.5.2011

Zuprevo

Tildipirosiini

| 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/2/11/124/001-008

Injektioneste, liuos

QJ01FA96

12.5.2011

14.6.2011

MS-H vaccine

Mycoplasma synoviae -bakteerin elävää, heikennettyä, lämpöherkkää MS-H-kantaa

| Pharmsure Ltd |
| --- |
| Bewell House, Bewell St, Hereford HR4 0BA, United Kingdom |

Pharmsure Ltd

Bewell House, Bewell St, Hereford HR4 0BA, United Kingdom

EU/2/11/126/001

Silmätipat, suspensio

QI01AE03

16.6.2011

—   Myyntiluvan muuttaminen (Euroopan parlamentin ja neuvoston asetuksen (EY) N:o 726/2004 38 artikla): Hyväksytyt

| Päätöksen päivämäärä | Lääkkeen nimi | Myyntiluvan haltija | Yhteisön rekisteriin merkitty numero | Ilmoituksen päivämäärä |
| --- | --- | --- | --- | --- |
| 16.5.2011 | Rheumocam | Chanelle Pharmaceuticals Manufacturing Limited |
| Loughrea, Co. Galway, IRELAND |

Päätöksen päivämäärä

Lääkkeen nimi

Myyntiluvan haltija

Yhteisön rekisteriin merkitty numero

Ilmoituksen päivämäärä

16.5.2011

Rheumocam

Chanelle Pharmaceuticals Manufacturing Limited

Loughrea, Co. Galway, IRELAND

EU/2/07/078/001-014

18.5.2011

18.5.2011

Aivlosin

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road New Malden Surrey KT3 4QS United Kingdom |

ECO Animal Health Ltd

78 Coombe Road New Malden Surrey KT3 4QS United Kingdom

EU/2/04/044/001-006

EU/2/04/044/013

23.5.2011

18.5.2011

Previcox

| Merial |
| --- |
| 29 Avenue Tony Garnier, 69007 Lyon, France |

Merial

29 Avenue Tony Garnier, 69007 Lyon, France

EU/2/04/045/001-007

20.5.2011

18.5.2011

ProteqFlu

| Merial |
| --- |
| 29 Avenue Tony Garnier, 69007 Lyon, France |

Merial

29 Avenue Tony Garnier, 69007 Lyon, France

EU/2/03/037/005

20.5.2011

18.5.2011

ProteqFlu-Te

| Merial |
| --- |
| 29 Avenue Tony Garnier, 69007 Lyon, France |

Merial

29 Avenue Tony Garnier, 69007 Lyon, France

EU/2/03/038/005

20.5.2011

23.5.2011

Suvaxyn PCV

| 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/2/09/099/001-006

25.5.2011

7.6.2011

Fevaxyn Pentofel

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

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/2/96/002/001-003

9.6.2011

14.6.2011

Advocate

| Bayer Animal Health GmbH |
| --- |
| 51368 Leverkusen, Deutschland |

Bayer Animal Health GmbH

51368 Leverkusen, Deutschland

EU/2/03/039/031-054

16.6.2011

14.6.2011

Naxcel

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

Pfizer Ltd

Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom

EU/2/05/053/003

16.6.2011

15.6.2011

Convenia

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

Pfizer Ltd

Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom

EU/2/06/059/001

17.6.2011

23.6.2011

Metacam

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

Boehringer Ingelheim Vetmedica GmbH

55216 Ingelheim am Rhein, Deutschland

EU/2/97/004/026

EU/2/97/004/033-034

EU/2/97/004/039-040

EU/2/97/004/043-048

28.6.2011

Kyseisten lääkkeiden julkiseen arviointilausuntoon ja siihen liittyviin päätöksiin voi tutustua ottamalla yhteyttä seuraavaan osoitteeseen:

| 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)  EUVL L 136, 30.4.2004, s. 1.

(2)  EUVL L 136, 30.4.2004, s. 1.

---

| 26.8.2011 | FI | Euroopan unionin virallinen lehti | C 250/18 |
| --- | --- | --- | --- |

26.8.2011

FI

Euroopan unionin virallinen lehti

C 250/18

---

Tiivistelmä lääkkeiden myyntilupia koskevista Euroopan unionin päätöksistä ajanjaksolla 1 päivänä toukokuuta 2011–30 päivänä kesäkuuta 2011

(Päätökset, jotka on tehty direktiivin 2001/83/EY 34 artiklan
   (1)
  tai direktiivin 2001/82/EY 38 artiklan
   (2)
  nojalla)

2011/C 250/02

—   Kansallisen myyntiluvan myöntäminen, voimassapito tai muuttaminen

| Päätöksen päivämäärä | Lääkkeen nimi (nimet) | Myyntiluvan haltija(t) | Asianomainen jäsenvaltio | Ilmoituksen päivämäärä |
| --- | --- | --- | --- | --- |
| 18.5.2011 | Arimidex and associated names - Referral Art 30 (amend) | Katso liite I | Katso liite I | 20.5.2011 |
| 12.5.2011 | Dianeal, Extraneal and Nutrineal and associated names - Art. 31 (amend) | Katso liite II | Katso liite II | 13.5.2011 |
| 15.6.2011 | Cinryze | ViroPharma SPRL-BVBA, rue Montoyer 47, 1000 Bruxelles, Belgique / Montoyerstraat 47, 1000 Brussel, België | Nämä päätökset on osoitettu jäsenvaltioille. | 20.6.2011 |
| 29.6.2011 | Instanyl | Nycomed Danmark ApS, Langebjerg 1, DK-4000 Roskilde, Danmark | Nämä päätökset on osoitettu jäsenvaltioille. | 4.7.2011 |
| 6.5.2011 | ReFacto AF | Wyeth Europa Ltd., Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | Nämä päätökset on osoitettu jäsenvaltioille. | 10.5.2011 |
| 6.5.2011 | Tygacil | Wyeth Europa Ltd., Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | Nämä päätökset on osoitettu jäsenvaltioille. | 12.5.2011 |
| 27.5.2011 | Lucentis | Novartis Europharm Ltd, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Nämä päätökset on osoitettu jäsenvaltioille. | 31.5.2011 |
| 16.6.2011 | Tysabri | Elan Pharma International Ltd., Monksland, Athlone, County Westmeath, Ireland | Nämä päätökset on osoitettu jäsenvaltioille. | 20.6.2011 |
| 2.5.2011 | Revolade | GlaxoSmithKline Trading Services Limited, 6900 Cork Airport Business Park, Kinsale Road, Cork, Ireland | Nämä päätökset on osoitettu jäsenvaltioille. | 3.5.2011 |
| 16.6.2011 | Ozurdex | Allergan Pharmaceuticals (Ireland) Ltd, Castlebar Road, Westport, Co. Mayo, Ireland | Nämä päätökset on osoitettu jäsenvaltioille. | 20.6.2011 |
| 6.5.2011 | Rotarix | GlaxoSmithKline Biologicals S.A., rue de l'Institut 89, Rixensart, B-1330 Belgique | Nämä päätökset on osoitettu jäsenvaltioille. | 11.5.2011 |

Päätöksen päivämäärä

Lääkkeen nimi (nimet)

Myyntiluvan haltija(t)

Asianomainen jäsenvaltio

Ilmoituksen päivämäärä

18.5.2011

Arimidex and associated names - Referral Art 30 (amend)

Katso liite I

Katso liite I

20.5.2011

12.5.2011

Dianeal, Extraneal and Nutrineal and associated names - Art. 31 (amend)

Katso liite II

Katso liite II

13.5.2011

15.6.2011

Cinryze

ViroPharma SPRL-BVBA, rue Montoyer 47, 1000 Bruxelles, Belgique / Montoyerstraat 47, 1000 Brussel, België

Nämä päätökset on osoitettu jäsenvaltioille.

20.6.2011

29.6.2011

Instanyl

Nycomed Danmark ApS, Langebjerg 1, DK-4000 Roskilde, Danmark

Nämä päätökset on osoitettu jäsenvaltioille.

4.7.2011

6.5.2011

ReFacto AF

Wyeth Europa Ltd., Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom

Nämä päätökset on osoitettu jäsenvaltioille.

10.5.2011

6.5.2011

Tygacil

Wyeth Europa Ltd., Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom

Nämä päätökset on osoitettu jäsenvaltioille.

12.5.2011

27.5.2011

Lucentis

Novartis Europharm Ltd, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

Nämä päätökset on osoitettu jäsenvaltioille.

31.5.2011

16.6.2011

Tysabri

Elan Pharma International Ltd., Monksland, Athlone, County Westmeath, Ireland

Nämä päätökset on osoitettu jäsenvaltioille.

20.6.2011

2.5.2011

Revolade

GlaxoSmithKline Trading Services Limited, 6900 Cork Airport Business Park, Kinsale Road, Cork, Ireland

Nämä päätökset on osoitettu jäsenvaltioille.

3.5.2011

16.6.2011

Ozurdex

Allergan Pharmaceuticals (Ireland) Ltd, Castlebar Road, Westport, Co. Mayo, Ireland

Nämä päätökset on osoitettu jäsenvaltioille.

20.6.2011

6.5.2011

Rotarix

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

Nämä päätökset on osoitettu jäsenvaltioille.

11.5.2011

—   Tapaukset, joissa kansallinen myyntilupa on evätty

| Päätöksen päivämäärä | Lääkkeen nimi (nimet) | Myyntiluvan haltija(t) | Asianomainen jäsenvaltio | Ilmoituksen päivämäärä |
| --- | --- | --- | --- | --- |
| 18.5.2011 | Isotretinoin | Katso liite III | Katso liite III | 19.5.2011 |

Päätöksen päivämäärä

Lääkkeen nimi (nimet)

Myyntiluvan haltija(t)

Asianomainen jäsenvaltio

Ilmoituksen päivämäärä

18.5.2011

Isotretinoin

Katso liite III

Katso liite III

19.5.2011

—   Kansallisen myyntiluvan keskeyttäminen

| Päätöksen päivämäärä | Lääkkeen nimi (nimet) | Myyntiluvan haltija(t) | Asianomainen jäsenvaltio | Ilmoituksen päivämäärä |
| --- | --- | --- | --- | --- |
| 18.5.2011 | Isotretinoin | Katso liite III | Katso liite III | 19.5.2011 |
| 23.5.2011 | Octagam Article 107 Final measures | Katso liite IV | Katso liite IV | 25.5.2011 |

Päätöksen päivämäärä

Lääkkeen nimi (nimet)

Myyntiluvan haltija(t)

Asianomainen jäsenvaltio

Ilmoituksen päivämäärä

18.5.2011

Isotretinoin

Katso liite III

Katso liite III

19.5.2011

23.5.2011

Octagam Article 107 Final measures

Katso liite IV

Katso liite IV

25.5.2011

—   Kansallisen myyntiluvan keskeyttämisen lopettaminen

| Päätöksen päivämäärä | Lääkkeen nimi (nimet) | Myyntiluvan haltija(t) | Asianomainen jäsenvaltio | Ilmoituksen päivämäärä |
| --- | --- | --- | --- | --- |
| 30.5.2011 | Octagam Art 31 Lift of suspension | Katso liite V | Katso liite V | 31.5.2011 |

Päätöksen päivämäärä

Lääkkeen nimi (nimet)

Myyntiluvan haltija(t)

Asianomainen jäsenvaltio

Ilmoituksen päivämäärä

30.5.2011

Octagam Art 31 Lift of suspension

Katso liite V

Katso liite V

31.5.2011

---

(1)  EUVL L 311, 28.11.2001, s. 67.

(2)  EUVL L 311, 28.11.2001, s. 1.

---

LIITE I

LUETTELO LÄÄKEVALMISTEEN NIMISTÄ, LÄÄKEMUODOISTA, VAHVUUKSISTA, ANTOREITEISTÄ JA MYYNTILUVAN HALTIJOISTA JÄSENVALTIOISSA

| EU-/ETA-jäsenvaltio | Myyntiluvan haltija | (Kauppa)nimi | Vahvuus | Lääkemuoto | Antoreitti |
| --- | --- | --- | --- | --- | --- |
| Itävalta | AstraZeneca Österreich GmbH, |
| Schwarzenbergplatz 7, |
| A-1037 Wien, Austria |

EU-/ETA-jäsenvaltio

Myyntiluvan haltija

(Kauppa)nimi

Vahvuus

Lääkemuoto

Antoreitti

Itävalta

AstraZeneca Österreich GmbH,

Schwarzenbergplatz 7,

A-1037 Wien, Austria

Arimidex

1 mg

Kalvopäällystetty tabletti

Suun kautta

Belgia

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

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussels, Belgium

Arimidex

1 mg

Kalvopäällystetty tabletti

Suun kautta

Bulgaria

| AstraZeneca Pharmaceuticals AB, S-15185 Södertälje, |
| --- |
| Sweden |

AstraZeneca Pharmaceuticals AB, S-15185 Södertälje,

Sweden

Arimidex

1 mg

Kalvopäällystetty tabletti

Suun kautta

Kypros

| AstraZeneca UK Ltd |
| --- |
| Silk Road Business Park |
| Macclesfield |
| Cheshire |
| SK10 2NA |
| United Kingdom |

AstraZeneca UK Ltd

Silk Road Business Park

Macclesfield

Cheshire

SK10 2NA

United Kingdom

Arimidex

1 mg

Kalvopäällystetty tabletti

Suun kautta

Tshekki

| AstraZeneca UK Ltd |
| --- |
| Silk Road Business Park |
| Macclesfield |
| Cheshire |
| SK10 2NA |
| United Kingdom |

AstraZeneca UK Ltd

Silk Road Business Park

Macclesfield

Cheshire

SK10 2NA

United Kingdom

Arimidex

1 mg

Kalvopäällystetty tabletti

Suun kautta

Tanska

| AstraZeneca A/S |
| --- |
| Roskildevej 22 |
| 2620 Albertslund, Denmark |

AstraZeneca A/S

Roskildevej 22

2620 Albertslund, Denmark

Arimidex

1 mg

Kalvopäällystetty tabletti

Suun kautta

Viro

| AstraZeneca UK Ltd. |
| --- |
| 2 Kingdom Street, London W2 6BD, United Kingdom |

AstraZeneca UK Ltd.

2 Kingdom Street, London W2 6BD, United Kingdom

Arimidex

1 mg

Kalvopäällystetty tabletti

Suun kautta

Suomi

| AstraZeneca Oy |
| --- |
| Luomanportti 3 |
| 02200 Espoo |
| Finland |

AstraZeneca Oy

Luomanportti 3

02200 Espoo

Finland

Arimidex

1 mg

Kalvopäällystetty tabletti

Suun kautta

Ranska

| AstraZeneca |
| --- |
| 1, Place Renault |
| 92844 RUEIL-MALMAISON CEDEX |
| France |

AstraZeneca

1, Place Renault

92844 RUEIL-MALMAISON CEDEX

France

Arimidex

1 mg

Kalvopäällystetty tabletti

Suun kautta

Saksa

| AstraZeneca GmbH |
| --- |
| Tinsdaler Weg 183 |
| 22880 Wedel |
| Postanschrift 22876 Wedel |
| Germany |

AstraZeneca GmbH

Tinsdaler Weg 183

22880 Wedel

Postanschrift 22876 Wedel

Germany

Arimidex

1 mg

Kalvopäällystetty tabletti

Suun kautta

Kreikka

| AstraZeneca S.A. |
| --- |
| 4 Theotokopoulou & Astronafton str |
| 151 25 Maroussi |
| Athens, Greece |

AstraZeneca S.A.

4 Theotokopoulou & Astronafton str

151 25 Maroussi

Athens, Greece

Arimidex

1 mg

Kalvopäällystetty tabletti

Suun kautta

Unkari

| AstraZeneca Kft. |
| --- |
| 1113 Budapest, Bocskai ut 134-146 |
| Hungary |

AstraZeneca Kft.

1113 Budapest, Bocskai ut 134-146

Hungary

Arimidex

1 mg

Kalvopäällystetty tabletti

Suun kautta

Islanti

| AstraZeneca AB |
| --- |
| 151 85 Södertälje |
| Sweden |

AstraZeneca AB

151 85 Södertälje

Sweden

Arimidex

1 mg

Kalvopäällystetty tabletti

Suun kautta

Irlanti

| AstraZeneca UK Limited |
| --- |
| 600 Capability Green |
| Luton LU1 3LU |
| United Kingdom |

AstraZeneca UK Limited

600 Capability Green

Luton LU1 3LU

United Kingdom

Arimidex

1 mg

Kalvopäällystetty tabletti

Suun kautta

Italia

| AstraZeneca UK Limited |
| --- |
| 600 Capability Green |
| Luton LU1 3LU |
| United Kingdom |

AstraZeneca UK Limited

600 Capability Green

Luton LU1 3LU

United Kingdom

Arimidex

1 mg

Kalvopäällystetty tabletti

Suun kautta

Latvia

| AstraZeneca UK Limited |
| --- |
| Silk Road Business Park Macclesfield, Cheshire |
| SK 10 2NA, United Kingdom |

AstraZeneca UK Limited

Silk Road Business Park Macclesfield, Cheshire

SK 10 2NA, United Kingdom

Arimidex

1 mg

Kalvopäällystetty tabletti

Suun kautta

Liettua

| AstraZeneca UK Ltd. |
| --- |
| Silk Road Business Park |
| Macclesfield, Cheshire |
| SK10 2NA |
| United Kingdom |

AstraZeneca UK Ltd.

Silk Road Business Park

Macclesfield, Cheshire

SK10 2NA

United Kingdom

Arimidex

1 mg

Kalvopäällystetty tabletti

Suun kautta

Luxemburg

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

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussels, Belgium

Arimidex

1 mg

Kalvopäällystetty tabletti

Suun kautta

Malta

| AstraZeneca UK Ltd. |
| --- |
| Silk Road Business Park |
| Macclesfield, Cheshire |
| SK10 2NA |
| United Kingdom |

AstraZeneca UK Ltd.

Silk Road Business Park

Macclesfield, Cheshire

SK10 2NA

United Kingdom

Arimidex

1 mg

Kalvopäällystetty tabletti

Suun kautta

Alankomaat

| AstraZeneca BV |
| --- |
| Louis Pasteurlaan 5 |
| 2719 EE Zoetermeer |
| The Netherlands |

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

The Netherlands

Arimidex

1 mg

Kalvopäällystetty tabletti

Suun kautta

Norja

| AstraZeneca AS |
| --- |
| Innspurten 15, 0663 OSLO, Postboks 6050 |
| Etterstad 0601, OSLO Norway |

AstraZeneca AS

Innspurten 15, 0663 OSLO, Postboks 6050

Etterstad 0601, OSLO Norway

Arimidex

1 mg

Kalvopäällystetty tabletti

Suun kautta

Puola

| AstraZeneca UK Ltd. |
| --- |
| Silk Road Business Park |
| Macclesfield, Cheshire, SK10 2NA |
| United Kingdom |

AstraZeneca UK Ltd.

Silk Road Business Park

Macclesfield, Cheshire, SK10 2NA

United Kingdom

Arimidex

1 mg

Kalvopäällystetty tabletti

Suun kautta

Portugali

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

AstraZeneca Produtos Farmacêuticos, Lda.

Rua Humberto Madeira, n.o 7, Queluz de Baixo, 2730-097 Barcarena, Portugal

Arimidex

1 mg

Kalvopäällystetty tabletti

Suun kautta

Romania

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

AstraZeneca UK Limited

600 Capability Green

Luton, LU1 3LU

United Kingdom

Arimidex

1 mg

Kalvopäällystetty tabletti

Suun kautta

Slovakia

| AstraZeneca UK Ltd. |
| --- |
| Silk Road Business Park |
| Macclesfield, Cheshire, SK10 2NA |
| United Kingdom |

AstraZeneca UK Ltd.

Silk Road Business Park

Macclesfield, Cheshire, SK10 2NA

United Kingdom

Arimidex

1 mg

Kalvopäällystetty tabletti

Suun kautta

Slovenia

AstraZeneca UK Limited 2 Kingdom Street, London W2 6BD, United Kingdom

Arimidex 1 mg filmsko obložene tablete

1 mg

Kalvopäällystetty tabletti

Suun kautta

Espanja

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

AstraZeneca Farmacéutica Spain, S.A.

C/ Serrano Galvache, 56 Edificio Roble

28033 Madrid, Spain

Arimidex

1 mg

Kalvopäällystetty tabletti

Suun kautta

Ruotsi

| AstraZeneca AB |
| --- |
| 151 85 Södertälje |
| Sweden |

AstraZeneca AB

151 85 Södertälje

Sweden

Arimidex

1 mg

Kalvopäällystetty tabletti

Suun kautta

Iso-Britannia

| AstraZeneca UK Limited |
| --- |
| 600 Capability Green |
| Luton LU1 3LU |
| United Kingdom |

AstraZeneca UK Limited

600 Capability Green

Luton LU1 3LU

United Kingdom

Arimidex

1 mg

Kalvopäällystetty tabletti

Suun kautta

---

LIITE II

LUETTELO LÄÄKEVALMISTEEN NIMISTÄ, LÄÄKEMUODOSTA, VAHVUUDESTA, ANTOREITISTÄ JA MYYNTILUVAN HALTIJOISTA JÄSENVALTIOISSA

| Jäsenvaltio | Myyntiluvan haltija | Kauppanimi Nimi | Vahvuus | Lääkemuoto | Antoreitti |
| --- | --- | --- | --- | --- | --- |
| Itävalta | Baxter Healthcare GmbH |
| Stella-Klein-Löw-Weg 15, |
| A-1020 Wien |
| Austria |

Jäsenvaltio

Myyntiluvan haltija

Kauppanimi Nimi

Vahvuus

Lääkemuoto

Antoreitti

Itävalta

Baxter Healthcare GmbH

Stella-Klein-Löw-Weg 15,

A-1020 Wien

Austria

Dianeal PD4 Glucose 1,36 % w/v/13,6 mg/ml- Peritonealdialyselösung

Vedetön glukoosi 13,6 g/L, Natriumkloridi 5,38 g/L, Natrium-(S)-laktaatti 4,48 g/L, Kalsiumkloridi 0,184 g/L, Magnesiumkloridi 0,051 g/L

Peritoneaalidialyysineste

Vatsaonteloon

Itävalta

| Baxter Healthcare GmbH |
| --- |
| Stella-Klein-Löw-Weg 15, |
| A-1020 Wien |
| Austria |

Baxter Healthcare GmbH

Stella-Klein-Löw-Weg 15,

A-1020 Wien

Austria

Dianeal PD4 Glucose 2,27 % w/v/22,7 mg/ml- Peritonealdialyselösung

Vedetön glukoosi 22,7 g/L, Natriumkloridi 5,38 g/L, Natrium-(S)-laktaatti 4,48 g/L, Kalsiumkloridi 0,184 g/L, Magnesiumkloridi 0,051 g/L

Peritoneaalidialyysineste

Vatsaonteloon

Itävalta

| Baxter Healthcare GmbH |
| --- |
| Stella-Klein-Löw-Weg 15, |
| A-1020 Wien |
| Austria |

Baxter Healthcare GmbH

Stella-Klein-Löw-Weg 15,

A-1020 Wien

Austria

Dianeal PD4 Glucose 3,86 % w/v/38,6 mg/ml- Peritonealdialyselösung

Vedetön glukoosi 38,6 g/L, Natriumkloridi 5,38 g/L, Natrium-(S)-laktaatti 4,48 g/L, Kalsiumkloridi 0,184 g/L, Magnesiumkloridi 0,051 g/L

Peritoneaalidialyysineste

Vatsaonteloon

Itävalta

| Baxter Healthcare GmbH |
| --- |
| Stella-Klein-Löw-Weg 15, |
| A-1020 Wien |
| Austria |

Baxter Healthcare GmbH

Stella-Klein-Löw-Weg 15,

A-1020 Wien

Austria

EXTRANEAL- Peritonealdialyselösung

75 g/L

Peritoneaalidialyysineste

Vatsaonteloon

Belgia

| Baxter S.A. |
| --- |
| Boulevard R. Branquart 80 |
| 7680 Lessines |
| Belgium |

Baxter S.A.

Boulevard R. Branquart 80

7680 Lessines

Belgium

Dianeal PD4 Glucose 1,36 % (13,6 mg/ml), solution pour dialyse péritonéale

13,6 g/l Vedetön glukoosi

Peritoneaalidialyysineste

Vatsaonteloon

Belgia

| Baxter S.A. |
| --- |
| Boulevard R. Branquart 80 |
| 7680 Lessines |
| Belgium |

Baxter S.A.

Boulevard R. Branquart 80

7680 Lessines

Belgium

Dianeal PD4 Glucose 2,27 % (22,7 mg/ml). solution pour dialyse péritonéale

22,7 g/l Vedetön glukoosi

Peritoneaalidialyysineste

Vatsaonteloon

Belgia

| Baxter S.A. |
| --- |
| Boulevard R. Branquart 80 |
| 7680 Lessines |
| Belgium |

Baxter S.A.

Boulevard R. Branquart 80

7680 Lessines

Belgium

Dianeal PD4 Glucose 3,86 % (38,6 mg/ml), solution pour dialyse péritonéale

38,6 g/l Vedetön glukoosi

Peritoneaalidialyysineste

Vatsaonteloon

Belgia

| Baxter S.A. |
| --- |
| Boulevard R. Branquart 80 |
| 7680 Lessines |
| Belgium |

Baxter S.A.

Boulevard R. Branquart 80

7680 Lessines

Belgium

Extraneal 7,5 % solution pour dialyse péritonéale

75,00 g/l Ikodekstriini

Peritoneaalidialyysineste

Vatsaonteloon

Bulgaria

BAXTER d.o.o., Zelezna cesta 18, 1000 Ljubljana, Slovenia

Dianeal PD4 Glucose 1,36 % w/v/ 13,6 mg/ml

1,36 % w/v/ 13,6 mg/ml

Peritoneaalidialyysineste

Vatsaonteloon

Bulgaria

BAXTER d.o.o., Zelezna cesta 18, 1000 Ljubljana, Slovenia

Dianeal PD4 Glucose

2,27 % w/v/ 22,7 mg/ml

Peritoneaalidialyysineste

Vatsaonteloon

Bulgaria

BAXTER d.o.o., Zelezna cesta 18, 1000 Ljubljana, Slovenia

Dianeal PD4 Glucose

3,86 % w/v/ 38,6 mg/ml

Peritoneaalidialyysineste

Vatsaonteloon

Bulgaria

BAXTER d.o.o., Zelezna cesta 18, 1000 Ljubljana, Slovenia

Extraneal

7,50 %

Peritoneaalidialyysineste

Vatsaonteloon

Tšekki

Baxter Healthcare S.A. Moneen Road Castlebar, County Mayo lreland

Dianeal PD4 Glucose 1,36 % w/v/13,6 mg/ml

1,36 % w/v/13,6 mg/ml

Peritoneaalidialyysineste

Vatsaonteloon

Tšekki

Baxter Healthcare S.A. Moneen Road Castlebar, County Mayo lreland

Dianeal PD4 Glucose 2,27 % w/v/22,7 mg/ml

2,27 % w/v/22,7 mg/ml

Peritoneaalidialyysineste

Vatsaonteloon

Tšekki

Baxter Healthcare S.A. Moneen Road Castlebar, County Mayo lreland

Dianeal PD4 Glucose 3,86 % w/v/38,6 mg/ml

3,86 % w/v/38,6 mg/ml

Peritoneaalidialyysineste

Vatsaonteloon

Tšekki

Baxter Healthcare S.A. Moneen Road Castlebar, County Mayo lreland

EXTRANEAL

7,5 % 75 g/1 000 ml

Peritoneaalidialyysineste

Vatsaonteloon

Tanska

| Baxter A/S |
| --- |
| Gydevang 43 |
| 3450 Allerød |
| Denmark |

Baxter A/S

Gydevang 43

3450 Allerød

Denmark

Dianeal PD4 med Glucos

13,6 mg/ml

Peritoneaalidialyysineste

Vatsaonteloon

Tanska

| Baxter A/S |
| --- |
| Gydevang 43 |
| 3450 Allerød |
| Denmark |

Baxter A/S

Gydevang 43

3450 Allerød

Denmark

Dianeal PD4 med Glucos

22,7 mg/ml

Peritoneaalidialyysineste

Vatsaonteloon

Tanska

| Baxter A/S |
| --- |
| Gydevang 43 |
| 3450 Allerød |
| Denmark |

Baxter A/S

Gydevang 43

3450 Allerød

Denmark

Dianeal PD4 med Glucos

38,6 mg/ml

Peritoneaalidialyysineste

Vatsaonteloon

Tanska

| Baxter A/S |
| --- |
| Gydevang 43 |
| 3450 Allerød |
| Denmark |

Baxter A/S

Gydevang 43

3450 Allerød

Denmark

Extraneal

75 mg/ml

Peritoneaalidialyysineste

Vatsaonteloon

Viro

| Baxter Oy |
| --- |
| P.O. Box 270 |
| Valimotie 15A |
| 00381 Helsinski |
| Finland |

Baxter Oy

P.O. Box 270

Valimotie 15A

00381 Helsinski

Finland

EXTRANEAL

7,50 %

Peritoneaalidialyysineste

Vatsaonteloon

Suomi

Baxter Healthcare S.A. Moneen Road Castlebar, CO. Mayo lreland

Dianeal PD4 Glucose

13,6 mg/ml

Peritoneaalidialyysineste

Vatsaonteloon

Suomi

Baxter Healthcare S.A. Moneen Road Castlebar, CO. Mayo lreland

Dianeal PD4 Glucose

22,7 mg/ml

Peritoneaalidialyysineste

Vatsaonteloon

Suomi

Baxter Healthcare S.A. Moneen Road Castlebar, CO. Mayo lreland

Dianeal PD4 Glucose

38,6 mg/ml

Peritoneaalidialyysineste

Vatsaonteloon

Suomi

| Baxter Oy |
| --- |
| P.O. Box 270 |
| Valimotie 15A |
| 00381 Helsinski |
| Finland |

Baxter Oy

P.O. Box 270

Valimotie 15A

00381 Helsinski

Finland

Extraneal

7,5 %

Peritoneaalidialyysineste

Vatsaonteloon

Ranska

| Baxter S.A.S |
| --- |
| Avenue louis Pasteur 78310 |
| ZA de Coigneres |
| 78310 Maurepas |
| France |

Baxter S.A.S

Avenue louis Pasteur 78310

ZA de Coigneres

78310 Maurepas

France

DIANEAL PD4 GLUCOSE 1,36 %, solution pour dialyse péritonéale en poche

1,36 %

Peritoneaalidialyysineste

Vatsaonteloon

Ranska

| Baxter S.A.S |
| --- |
| Avenue louis Pasteur 78310 |
| ZA de Coigneres |
| 78310 Maurepas |
| France |

Baxter S.A.S

Avenue louis Pasteur 78310

ZA de Coigneres

78310 Maurepas

France

DIANEAL PD4 GLUCOSE 2,27 %, solution pour dialyse péritonéale en poche

2,27 %

Peritoneaalidialyysineste

Vatsaonteloon

Ranska

| Baxter S.A.S |
| --- |
| Avenue louis Pasteur 78310 |
| ZA de Coigneres |
| 78310 Maurepas |
| France |

Baxter S.A.S

Avenue louis Pasteur 78310

ZA de Coigneres

78310 Maurepas

France

DIANEAL PD4 GLUCOSE 3,86 %, solution pour dialyse péritonéale en poche

3,86 %

Peritoneaalidialyysineste

Vatsaonteloon

Ranska

| Baxter S.A.S |
| --- |
| Avenue louis Pasteur 78310 |
| ZA de Coigneres |
| 78310 Maurepas |
| France |

Baxter S.A.S

Avenue louis Pasteur 78310

ZA de Coigneres

78310 Maurepas

France

EXTRANEAL, solution pour dialyse péritonéale

7,50 %

Peritoneaalidialyysineste

Vatsaonteloon

Saksa

| Baxter Deutschland GmbH |
| --- |
| Edisonstr. 4 |
| D-85716 Unterschleißheim |
| Germany |

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Germany

Dianeal PD4 Glucose 1,36 % w/v

13,6 g/l

5,4 g/l

4,5 g/l

0,184 g/l

0,051 g/l

Peritoneaalidialyysineste

Vatsaonteloon

Saksa

| Baxter Deutschland GmbH |
| --- |
| Edisonstr. 4 |
| D-85716 Unterschleißheim |
| Germany |

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Germany

Dianeal PD4 Glucose 2,27 % w/v

22,7 g/l

5,4 g/l

4,5 g/l

0,184 g/l

0,051 g/l

Peritoneaalidialyysineste

Vatsaonteloon

Saksa

| Baxter Deutschland GmbH |
| --- |
| Edisonstr. 4 |
| D-85716 Unterschleißheim |
| Germany |

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Germany

Dianeal PD4 Glucose 3,86 % w/v

38,6 g/l

5,4 g/l

4,5 g/l

0,184 g/l

0,051 g/l

Peritoneaalidialyysineste

Vatsaonteloon

Saksa

| Baxter Deutschland GmbH |
| --- |
| Edisonstr. 4 |
| D-85716 Unterschleißheim |
| Germany |

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Germany

Dianeal PDG4 1,36 %

13,6 g/l

5,38 g/l

4,48 g/l

0,184 g/l

0,051 g/l

Peritoneaalidialyysineste

Vatsaonteloon

Saksa

| Baxter Deutschland GmbH |
| --- |
| Edisonstr. 4 |
| D-85716 Unterschleißheim |
| Germany |

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Germany

Dianeal PDG4 2,27 %

22,7 g/l

5,38 g/l

4,48 g/l

0,184 g/l

0,051 g/l

Peritoneaalidialyysineste

Vatsaonteloon

Saksa

| Baxter Deutschland GmbH |
| --- |
| Edisonstr. 4 |
| D-85716 Unterschleißheim |
| Germany |

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Germany

Dianeal PDG4 3,86 %

38,6 g/l

5,38 g/l

4,48 g/l

0,184 g/l

0,051 g/l

Peritoneaalidialyysineste

Vatsaonteloon

Saksa

| Baxter Deutschland GmbH |
| --- |
| Edisonstr. 4 |
| D-85716 Unterschleißheim |
| Germany |

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Germany

Extraneal

75 g/l

5,4 g/l

4,5 g/l

0,257 g/l

0,051 g/l

Peritoneaalidialyysineste

Vatsaonteloon

Kreikka

| Diophar SA |
| --- |
| Kifissias 368 |
| Halandri 15233 |
| Greece |

Diophar SA

Kifissias 368

Halandri 15233

Greece

DIANEAL PD4

1,36 %

Peritoneaalidialyysineste

Vatsaonteloon

Kreikka

| Diophar SA |
| --- |
| Kifissias 368 |
| Halandri 15233 |
| Greece |

Diophar SA

Kifissias 368

Halandri 15233

Greece

Extraneal

(7,5 + 0,54 + 0,45 + 0,0257 + 0,0051) % w/v

Peritoneaalidialyysineste

Vatsaonteloon

Unkari

| Baxter Hungary Kft. |
| --- |
| Népfürdö u. 22. |
| 1138, Budapest |
| Hungary |

Baxter Hungary Kft.

Népfürdö u. 22.

1138, Budapest

Hungary

DIANEAL PD 4 Glucose 1,36 % peritoneális dializáló oldat

1,36 %

Peritoneaalidialyysineste

Vatsaonteloon

Unkari

| Baxter Hungary Kft. |
| --- |
| Népfürdö u. 22. |
| 1138, Budapest |
| Hungary |

Baxter Hungary Kft.

Népfürdö u. 22.

1138, Budapest

Hungary

DIANEAL PD 4 Glucose 2,27 % peritoneális dializáló oldat

2,27 %

Peritoneaalidialyysineste

Vatsaonteloon

Unkari

| Baxter Hungary Kft. |
| --- |
| Népfürdö u. 22. |
| 1138, Budapest |
| Hungary |

Baxter Hungary Kft.

Népfürdö u. 22.

1138, Budapest

Hungary

DIANEAL PD 4 Glucose 3,86 % peritoneális dializáló oldat

3,86 %

Peritoneaalidialyysineste

Vatsaonteloon

Unkari

| Baxter Hungary Kft. |
| --- |
| Népfürdö u. 22. |
| 1138, Budapest |
| Hungary |

Baxter Hungary Kft.

Népfürdö u. 22.

1138, Budapest

Hungary

EXTRANEAL peritoneális dializáló oldat

7,5 % (Ikodekstriini)

Peritoneaalidialyysineste

Vatsaonteloon

Islanti

| Baxter Healthcare SA |
| --- |
| Moneen Road Castlebar, County Mayo Ireland |

Baxter Healthcare SA

Moneen Road Castlebar, County Mayo Ireland

Dianeal PD4 Glucose

13,6 mg/ml

Peritoneaalidialyysineste

Vatsaonteloon

Islanti

| Baxter Healthcare SA |
| --- |
| Moneen Road Castlebar, County Mayo Ireland |

Baxter Healthcare SA

Moneen Road Castlebar, County Mayo Ireland

Dianeal PD4 Glucose

22,7 mg/ml

Peritoneaalidialyysineste

Vatsaonteloon

Islanti

| Baxter Healthcare SA |
| --- |
| Moneen Road Castlebar, County Mayo Ireland |

Baxter Healthcare SA

Moneen Road Castlebar, County Mayo Ireland

Dianeal PD4 Glucose

38,6 mg/ml

Peritoneaalidialyysineste

Vatsaonteloon

Irlanti

| Baxter Healthcare Limited |
| --- |
| Caxton Way |
| Thetford, Norfolk, IP24 3SE |
| United Kingdom |

Baxter Healthcare Limited

Caxton Way

Thetford, Norfolk, IP24 3SE

United Kingdom

Dianeal PD4 Glucose 1,36 % w/v (13,6 mg/ml) Solution for peritoneal dialysis

1,36 % w/v (13,6 mg/ml)

Peritoneaalidialyysineste

Vatsaonteloon

Irlanti

| Baxter Healthcare Limited |
| --- |
| Caxton Way |
| Thetford, Norfolk, IP24 3SE |
| United Kingdom |

Baxter Healthcare Limited

Caxton Way

Thetford, Norfolk, IP24 3SE

United Kingdom

Dianeal PD4 Glucose 2,27 % w/v (22,7 mg/ml) Solution for peritoneal dialysis

2,27 % w/v (22,7 mg/ml)

Peritoneaalidialyysineste

Vatsaonteloon

Irlanti

| Baxter Healthcare Limited |
| --- |
| Caxton Way |
| Thetford, Norfolk, IP24 3SE |
| United Kingdom |

Baxter Healthcare Limited

Caxton Way

Thetford, Norfolk, IP24 3SE

United Kingdom

Dianeal PD4 Glucose 3,86 % w/v (38,6 mg/ml) Solution for peritoneal dialysis

3,86 % w/v (38,6 mg/ml)

Peritoneaalidialyysineste

Vatsaonteloon

Irlanti

| Baxter Healthcare Limited |
| --- |
| Caxton Way |
| Thetford, Norfolk, IP24 3SE |
| United Kingdom |

Baxter Healthcare Limited

Caxton Way

Thetford, Norfolk, IP24 3SE

United Kingdom

EXTRANEAL Solution for peritoneal dialysis

Peritoneaalidialyysineste

Vatsaonteloon

Italia

| Baxter S.p.A. |
| --- |
| Piazzale dell'Industria 20 |
| 00144 Roma |
| Italy |

Baxter S.p.A.

Piazzale dell'Industria 20

00144 Roma

Italy

EXTRANEAL

7,5 %

Peritoneaalidialyysineste

Vatsaonteloon

Italia

| Baxter S.p.A. |
| --- |
| Piazzale dell'Industria 20 |
| 00144 Roma |
| Italy |

Baxter S.p.A.

Piazzale dell'Industria 20

00144 Roma

Italy

SOLUZIONI PER DIALISI PERITONEALE BAXTER

4,95 g/l – 49,54 g/l

Peritoneaalidialyysineste

Vatsaonteloon

Latvia

Baxter Healthcare S.A. Moneen Road Castlebar, County Mayo Ireland

Dianeal PD4 Glucose 1,36 % w/v/13,6 mg/ml- solution for peritoneal dialysis

1,36 % w/v 0,538 % w/v 0,448 % w/v

0,0184 % w/v 0,0051 % w/v

Peritoneaalidialyysineste

Vatsaonteloon

Latvia

Baxter Healthcare S.A. Moneen Road Castlebar, County Mayo Ireland

Dianeal PD4 Glucose 2,27 % w/v/22,7 mg/ml- solution for peritoneal dialysis

2,27 % w/v

0,538 % w/v 0,448 % w/v

0,0184 % w/v 0,0051 % w/v

Peritoneaalidialyysineste

Vatsaonteloon

Latvia

Baxter Healthcare S.A. Moneen Road Castlebar, County Mayo Ireland

Dianeal PD4 Glucose 3,86 % w/v/38,6 mg/ml- solution for peritoneal dialysis

3,86 % w/v 0,538 % w/v 0,448 % w/v

0,0184 % w/v 0,0051 % w/v

Peritoneaalidialyysineste

Vatsaonteloon

Latvia

| Baxter Oy |
| --- |
| P.O. Box 270 |
| Valimotie 15A |
| 00381 Helsinski |
| Finland |

Baxter Oy

P.O. Box 270

Valimotie 15A

00381 Helsinski

Finland

Extraneal solution for peritoneal dialysis

75g/L 5,4g/L 4,5g/L 0,257g/L 0,051g/L

Peritoneaalidialyysineste

Vatsaonteloon

Liettua

Baxter Healthcare S.A. Moneen Road Castlebar, County Mayo Ireland

Dianeal PD4 Glucose

13,6 g + 5,38g + 4,48 g + 0,184 g + 0,051 g/l

Peritoneaalidialyysineste

Vatsaonteloon

Liettua

Baxter Healthcare S.A. Moneen Road Castlebar, County Mayo Ireland

Dianeal PD4 Glucose

22,7 g + 5,38 g + 4,48 g + 0,184 g + 0,051 g/l

Peritoneaalidialyysineste

Vatsaonteloon

Liettua

Baxter Healthcare S.A. Moneen Road Castlebar, County Mayo Ireland

Dianeal PD4 Glucose

38,6 g + 5,38 g + 4,48 g + 0,184 g + 0,051 g/l

Peritoneaalidialyysineste

Vatsaonteloon

Liettua

| Baxter Oy |
| --- |
| P.O. Box 270 |
| Valimotie 15A |
| 00381 Helsinski |
| Finland |

Baxter Oy

P.O. Box 270

Valimotie 15A

00381 Helsinski

Finland

EXTRANEAL

75 g + 5,4 g + 4,5 g + 0,257 g + 0,051 g/1 000 ml

Peritoneaalidialyysineste

Vatsaonteloon

Luxemburg

| Baxter S.A. |
| --- |
| Bd René Branquart 80 |
| B-7860 Lessines |
| Belgium |

Baxter S.A.

Bd René Branquart 80

B-7860 Lessines

Belgium

Dianeal PD4 Glucose

1,36 %/2,27 %/3,86 % Vedetön glukoosi

Peritoneaalidialyysineste

Vatsaonteloon

Luxemburg

| Baxter S.A. |
| --- |
| Bd René Branquart 80 |
| B-7860 Lessines |
| Belgium |

Baxter S.A.

Bd René Branquart 80

B-7860 Lessines

Belgium

Extraneal

75,00 g/l Ikodekstriini

Peritoneaalidialyysineste

Vatsaonteloon

Malta

| Baxter Healthcare Ltd |
| --- |
| Caxton Way |
| Thetford, |
| Norfolk, |
| IP24 3SE |
| United Kingdom |

Baxter Healthcare Ltd

Caxton Way

Thetford,

Norfolk,

IP24 3SE

United Kingdom

Dianeal PD4 Glucose 1,36 %w/v 13,6 mg/ml

1,36 %w/v 13,6 mg/ml

Peritoneaalidialyysineste

Vatsaonteloon

Malta

| Baxter Healthcare Ltd |
| --- |
| Caxton Way |
| Thetford, |
| Norfolk, |
| IP24 3SE |
| United Kingdom |

Baxter Healthcare Ltd

Caxton Way

Thetford,

Norfolk,

IP24 3SE

United Kingdom

Dianeal PD4 Glucose 2,27 %w/v 22,7 mg/ml

2,27 %w/v 22,7 mg/ml

Peritoneaalidialyysineste

Vatsaonteloon

Malta

| Baxter Healthcare Ltd |
| --- |
| Caxton Way |
| Thetford, |
| Norfolk, |
| IP24 3SE |
| United Kingdom |

Baxter Healthcare Ltd

Caxton Way

Thetford,

Norfolk,

IP24 3SE

United Kingdom

Dianeal PD4 Glucose 3,86 %w/v 38,6 mg/ml

3,86 %w/v 38,6 mg/ml

Peritoneaalidialyysineste

Vatsaonteloon

Malta

| Baxter Healthcare Ltd |
| --- |
| Caxton Way |
| Thetford, |
| Norfolk, |
| IP24 3SE |
| United Kingdom |

Baxter Healthcare Ltd

Caxton Way

Thetford,

Norfolk,

IP24 3SE

United Kingdom

Extraneal (Icodextrin 7,5 %)

N/A

Peritoneaalidialyysineste

Vatsaonteloon

Norja

| Baxter AS |
| --- |
| Gjerdrumsvei 11 |
| 0484 Oslo, Norway |

Baxter AS

Gjerdrumsvei 11

0484 Oslo, Norway

Extraneal

75 mg/ml

Peritoneaalidialyysineste

Vatsaonteloon

Puola

Baxter Polska SP. z.o.o. Kruczkowskiego 8 st., 00-380 Warszawa, Poland

Dianeal PD4 (glukoza 1,36 %). Zestaw do dializy otrzewnowej

Peritoneaalidialyysineste

Vatsaonteloon

Puola

Baxter Polska SP. z.o.o. Kruczkowskiego 8 st., 00-380 Warszawa, Poland

Dianeal PD4 (glukoza 2,27 %). Zestaw do dializy otrzewnowej

Peritoneaalidialyysineste

Vatsaonteloon

Puola

Baxter Polska SP. z.o.o. Kruczkowskiego 8 st., 00-380 Warszawa, Poland

Dianeal PD4 (glukoza 3,86 %). Zestaw do dializy otrzewnowej

Peritoneaalidialyysineste

Vatsaonteloon

Puola

Baxter Polska SP. z.o.o. Kruczkowskiego 8 st., 00-380 Warszawa, Poland

Extraneal Zestaw do dializy otrzewnowej

Peritoneaalidialyysineste

Vatsaonteloon

Portugali

| Baxter Médico Farmacêutica Lda |
| --- |
| Zona Industrial da Abrunheira, |
| Edificio 10 Sintra Business Park, |
| 2710-089 Sintra |
| Portugal |

Baxter Médico Farmacêutica Lda

Zona Industrial da Abrunheira,

Edificio 10 Sintra Business Park,

2710-089 Sintra

Portugal

Dianeal Pd4

Association

Peritoneaalidialyysineste

Vatsaonteloon

Portugalii

| Baxter Médico Farmacêutica Lda |
| --- |
| Zona Industrial da Abrunheira, |
| Edificio 10 Sintra Business Park, |
| 2710-089 Sintra |
| Portugal |

Baxter Médico Farmacêutica Lda

Zona Industrial da Abrunheira,

Edificio 10 Sintra Business Park,

2710-089 Sintra

Portugal

Dianeal Pd4

Association

Peritoneaalidialyysineste

Vatsaonteloon

Portugali

| Baxter Médico Farmacêutica Lda |
| --- |
| Zona Industrial da Abrunheira, |
| Edificio 10 Sintra Business Park, |
| 2710-089 Sintra |
| Portugal |

Baxter Médico Farmacêutica Lda

Zona Industrial da Abrunheira,

Edificio 10 Sintra Business Park,

2710-089 Sintra

Portugal

Dianeal Pd4

Association

Peritoneaalidialyysineste

Vatsaonteloon

Portugali

| Baxter Médico Farmacêutica Lda |
| --- |
| Zona Industrial da Abrunheira, |
| Edificio 10 Sintra Business Park, |
| 2710-089 Sintra |
| Portugal |

Baxter Médico Farmacêutica Lda

Zona Industrial da Abrunheira,

Edificio 10 Sintra Business Park,

2710-089 Sintra

Portugal

Extraneal

75 mg/ml

Peritoneaalidialyysineste

Vatsaonteloon

Romania

Baxter Healthcare SA, Moneen Road, Castlebar, Co. Mayo, Ireland

DIANEAL PD4 GLUCOSE 1,36 % m/v (13,6 mg/ml)

13,6 mg/ml

Peritoneaalidialyysineste

Vatsaonteloon

Romania

Baxter Healthcare SA, Moneen Road, Castlebar, Co. Mayo, Ireland

DIANEAL PD4 GLUCOSE 2,27 % m/v (22,7 mg/ml)

22,7 mg/ml

Peritoneaalidialyysineste

Vatsaonteloon

Romania

Baxter Healthcare SA, Moneen Road, Castlebar, Co. Mayo, Ireland

DIANEAL PD4 GLUCOSE 3,86 % m/v (38,6 mg/ml)

38,6 mg/ml

Peritoneaalidialyysineste

Vatsaonteloon

Romania

| Baxter Healthcare Ltd |
| --- |
| Caxton Way, |
| Thetford, Norfolk, IP24 3SE, United Kingdom |

Baxter Healthcare Ltd

Caxton Way,

Thetford, Norfolk, IP24 3SE, United Kingdom

EXTRANEAL

Peritoneaalidialyysineste

Vatsaonteloon

Slovakian tasavallan

Baxter Healthcare SA, Moneen Rd, Castlebar, Co. Mayo, Ireland

Dianeal® PD4 glucose 1,36 % w/v/13,6 mg/ml

13,6 mg/1 ml

Peritoneaalidialyysineste

Vatsaonteloon

Slovakian tasavallan

Baxter Healthcare SA, Moneen Rd, Castlebar, Co. Mayo, Ireland

Dianeal® PD4 glucose 2,27 % w/v/22,7 mg/ml

22,7 mg/1 ml

Peritoneaalidialyysineste

Vatsaonteloon

Slovakian tasavallan

Baxter Healthcare SA, Moneen Rd, Castlebar, Co. Mayo, Ireland

Dianeal® PD4 glucose 3,86 % w/v/38,6 mg/ml

38,6 mg/1 ml

Peritoneaalidialyysineste

Vatsaonteloon

Slovakian tasavallan

| Baxter Healthcare Ltd |
| --- |
| Caxton Way, |
| Thetford, Norfolk, IP24 3SE |

Baxter Healthcare Ltd

Caxton Way,

Thetford, Norfolk, IP24 3SE

EXTRANEAL

Peritoneaalidialyysineste

Vatsaonteloon

Slovenia

Baxter d.o.o., Zelezna cesta 18, Ljubljana, SI -1000, Slovenia

Dianeal PD4 13,6 mg/ml glukoze raztopina za peritonelano dializo

13,6 mg/ml

Peritoneaalidialyysineste

Vatsaonteloon

Slovenia

Baxter d.o.o., Zelezna cesta 18, Ljubljana, SI -1000, Slovenia

Dianeal PD4 22,7 mg/ml glukoze raztopina za peritonelano dializo

22,7 mg/ml

Peritoneaalidialyysineste

Vatsaonteloon

Slovenia

Baxter d.o.o., Zelezna cesta 18, Ljubljana, SI -1000, Slovenia

Dianeal PD4 38,6 mg/ml glukoze raztopina za peritonelano dializo

38,6 mg/ml

Peritoneaalidialyysineste

Vatsaonteloon

Slovenia

Baxter d.o.o., Zelezna cesta 18,Ljubljana, SI-1000, Slovenia

Extraneal 75 mg/ml ikodekstrina raztopina za peritonealno dializo

75 mg/ml

Peritoneaalidialyysineste

Vatsaonteloon

Espanja

| Baxter S.L |
| --- |
| Pouet de Camilo, 2 |
| Ribarroja del Turia (Valencia) |
| 46394 |
| Spain |

Baxter S.L

Pouet de Camilo, 2

Ribarroja del Turia (Valencia)

46394

Spain

Dianeal PD4 Glucosa 1,36 %

Peritoneaalidialyysineste

Vatsaonteloon

Espanja

| Baxter S.L |
| --- |
| Pouet de Camilo, 2 |
| Ribarroja del Turia (Valencia) |
| 46394 |
| Spain |

Baxter S.L

Pouet de Camilo, 2

Ribarroja del Turia (Valencia)

46394

Spain

Dianeal PD4 Glucosa 1,36 % con sistema de desconexión integrado

Peritoneaalidialyysineste

Vatsaonteloon

Espanja

| Baxter S.L |
| --- |
| Pouet de Camilo, 2 |
| Ribarroja del Turia (Valencia) |
| 46394 |
| Spain |

Baxter S.L

Pouet de Camilo, 2

Ribarroja del Turia (Valencia)

46394

Spain

Dianeal PD4 Glucosa 2,27 %

Peritoneaalidialyysineste

Vatsaonteloon

Espanja

| Baxter S.L |
| --- |
| Pouet de Camilo, 2 |
| Ribarroja del Turia (Valencia) |
| 46394 |
| Spain |

Baxter S.L

Pouet de Camilo, 2

Ribarroja del Turia (Valencia)

46394

Spain

Dianeal PD4 Glucosa 2,27 % con sistema de desconexión integrado

Peritoneaalidialyysineste

Vatsaonteloon

Espanja

| Baxter S.L |
| --- |
| Pouet de Camilo, 2 |
| Ribarroja del Turia (Valencia) |
| 46394 |
| Spain |

Baxter S.L

Pouet de Camilo, 2

Ribarroja del Turia (Valencia)

46394

Spain

Dianeal PD4 Glucosa 3,86 %

Peritoneaalidialyysineste

Vatsaonteloon

Espanja

| Baxter S.L |
| --- |
| Pouet de Camilo, 2 |
| Ribarroja del Turia (Valencia) |
| 46394 |
| Spain |

Baxter S.L

Pouet de Camilo, 2

Ribarroja del Turia (Valencia)

46394

Spain

Dianeal PD4 Glucosa 3,86 % con sistema de desconexión integrado

Peritoneaalidialyysineste

Vatsaonteloon

Espanja

| Baxter S.L |
| --- |
| Pouet de Camilo, 2 |
| Ribarroja del Turia (Valencia) |
| 46394 |
| Spain |

Baxter S.L

Pouet de Camilo, 2

Ribarroja del Turia (Valencia)

46394

Spain

EXTRANEAL Solución para diálisis peritoneal

Peritoneaalidialyysineste

Vatsaonteloon

Ruotsi

| Baxter Healthare SA |
| --- |
| Moneen Road |
| Castlebar |
| County Mayo |
| Irland |

Baxter Healthare SA

Moneen Road

Castlebar

County Mayo

Irland

Dianeal PD4 med glucos 13,6 mg/ml

13,6 mg/ml

Peritoneaalidialyysineste

Vatsaonteloon

Ruotsi

| Baxter Healthare SA |
| --- |
| Moneen Road |
| Castlebar |
| County Mayo |
| Irland |

Baxter Healthare SA

Moneen Road

Castlebar

County Mayo

Irland

Dianeal PD4 med glucos 22,7 mg/ml

22,7 mg/ml

Peritoneaalidialyysineste

Vatsaonteloon

Ruotsi

| Baxter Healthare SA |
| --- |
| Moneen Road |
| Castlebar |
| County Mayo |
| Irland |

Baxter Healthare SA

Moneen Road

Castlebar

County Mayo

Irland

Dianeal PD4 med glucos 38,6 mg/ml

38,6 mg/ml

Peritoneaalidialyysineste

Vatsaonteloon

Ruotsi

| Baxter AB |
| --- |
| Box 63 |
| 16494 Kista |
| Sverige |

Baxter AB

Box 63

16494 Kista

Sverige

Extraneal

7,5 %

Peritoneaalidialyysineste

Vatsaonteloon

Alankomaat

| Baxter B.V |
| --- |
| Kobaltweg 49 |
| 3542 CE Utrecht |
| The Netherlands |

Baxter B.V

Kobaltweg 49

3542 CE Utrecht

The Netherlands

Dianeal PD4 Glucose 1,36 %/13,6 mg/ml, peritoneaaldialysevloeist of

13,6 g/l Vedetön glukoosi

Peritoneaalidialyysineste

Vatsaonteloon

Alankomaat

| Baxter B.V |
| --- |
| Kobaltweg 49 |
| 3542 CE Utrecht |
| The Netherlands |

Baxter B.V

Kobaltweg 49

3542 CE Utrecht

The Netherlands

Dianeal PD4 Glucose 2,27 %/22,7 mg/ml, peritoneaaldialysevloeist of

22,7 g/l Vedetön glukoosi

Peritoneaalidialyysineste

Vatsaonteloon

Alankomaat

| Baxter B.V |
| --- |
| Kobaltweg 49 |
| 3542 CE Utrecht |
| The Netherlands |

Baxter B.V

Kobaltweg 49

3542 CE Utrecht

The Netherlands

Dianeal PD4 Glucose 3,86 %/38,6 mg/ml, peritoneaaldialysevloeist of

38,6 g/l Vedetön glukoosi

Peritoneaalidialyysineste

Vatsaonteloon

Alankomaat

| Baxter B.V |
| --- |
| Kobaltweg 49 |
| 3542 CE Utrecht |
| The Netherlands |

Baxter B.V

Kobaltweg 49

3542 CE Utrecht

The Netherlands

EXTRANEAL 7,5 %, oplossing voor peritoneale dialyse

75 g/l Ikodekstriini

Peritoneaalidialyysineste

Vatsaonteloon

Iso-Britannia

| Baxter Healthcare Limited |
| --- |
| Caxton Way, |
| Thetford IP24 3SE |
| United Kingdom |

Baxter Healthcare Limited

Caxton Way,

Thetford IP24 3SE

United Kingdom

Dianeal PD4 Glucose 1,36 % w/v/13,6 mg/ml

1,36 % w/v /13,6 mg/ml

Peritoneaalidialyysineste

Vatsaonteloon

Iso-Britannia

| Baxter Healthcare Limited |
| --- |
| Caxton Way, |
| Thetford IP24 3SE |
| United Kingdom |

Baxter Healthcare Limited

Caxton Way,

Thetford IP24 3SE

United Kingdom

Dianeal PD4 Glucose 2,27 % w/v/22,7 mg/ml

2,27 % w/v /22,7 mg/ml

Peritoneaalidialyysineste

Vatsaonteloon

Iso-Britannia

| Baxter Healthcare Limited |
| --- |
| Caxton Way, |
| Thetford IP24 3SE |
| United Kingdom |

Baxter Healthcare Limited

Caxton Way,

Thetford IP24 3SE

United Kingdom

Dianeal PD4 Glucose 3,86 % w/v/38,6 mg/ml

3,86 % w/v /38,6 mg/ml

Peritoneaalidialyysineste

Vatsaonteloon

Iso-Britannia

| Baxter Healthcare Limited |
| --- |
| Caxton Way, |
| Thetford IP24 3SE |
| United Kingdom |

Baxter Healthcare Limited

Caxton Way,

Thetford IP24 3SE

United Kingdom

Extraneal (lcodextrin 7,5 %) Solution for peritoneal dialysis

Peritoneaalidialyysineste

Vatsaonteloon

---

LIITE III

LUETTELO LÄÄKEVALMISTEEN NIMISTÄ, LÄÄKEMUODOISTA, VAHVUUKSISTA, ANTOREITEISTÄ, HAKIJASTA JA MYYNTILUVAN HALTIJASTA JÄSENVALTIOISSA

| Jäsenvaltio (EU/ETA) | Myyntiluvan haltija | Hakija | Kauppanimi | Vahvuus | Lääkemuoto | Antoreitti |
| --- | --- | --- | --- | --- | --- | --- |
| Ranska | | Ranbaxy (UK) Ltd. |
| Building 4, Chiswick Park, |
| 566 Chiswick High Road, |
| London W4 5YE, |
| United Kingdom |

Jäsenvaltio (EU/ETA)

Myyntiluvan haltija

Hakija

Kauppanimi

Vahvuus

Lääkemuoto

Antoreitti

Ranska

Ranbaxy (UK) Ltd.

Building 4, Chiswick Park,

566 Chiswick High Road,

London W4 5YE,

United Kingdom

ISOTRETINOINE RANBAXY 10 mg, capsule molle

10 mg

kapseli, pehmeä

suun kautta

Ranska

| Ranbaxy (UK) Ltd. |
| --- |
| Building 4, Chiswick Park, |
| 566 Chiswick High Road, |
| London W4 5YE, |
| United Kingdom |

Ranbaxy (UK) Ltd.

Building 4, Chiswick Park,

566 Chiswick High Road,

London W4 5YE,

United Kingdom

ISOTRETINOINE RANBAXY 20 mg, capsule molle

20 mg

kapseli, pehmeä

suun kautta

Espanja

| Ranbaxy (UK) Ltd. |
| --- |
| Building 4, Chiswick Park, |
| 566 Chiswick High Road, |
| London W4 5YE, |
| United Kingdom |

Ranbaxy (UK) Ltd.

Building 4, Chiswick Park,

566 Chiswick High Road,

London W4 5YE,

United Kingdom

ISOTRETINOINA RANBAXY 10 mg CAPSULAS BLANDAS EFG

10 mg

kapseli, pehmeä

suun kautta

Espanja

| Ranbaxy (UK) Ltd. |
| --- |
| Building 4, Chiswick Park, |
| 566 Chiswick High Road, |
| London W4 5YE, |
| United Kingdom |

Ranbaxy (UK) Ltd.

Building 4, Chiswick Park,

566 Chiswick High Road,

London W4 5YE,

United Kingdom

ISOTRETINOINA RANBAXY 20 mg CAPSULAS BLANDAS EFG

20 mg

kapseli, pehmeä

suun kautta

Yhdistynyt kuningaskunta

| Ranbaxy (UK) Ltd. |
| --- |
| Building 4, Chiswick Park, |
| 566 Chiswick High Road, |
| London W4 5YE, |
| United Kingdom |

Ranbaxy (UK) Ltd.

Building 4, Chiswick Park,

566 Chiswick High Road,

London W4 5YE,

United Kingdom

Isotretinoin 10 mg Capsules

10 mg

kapseli, pehmeä

suun kautta

Yhdistynyt kuningaskunta

| Ranbaxy (UK) Ltd. |
| --- |
| Building 4, Chiswick Park, |
| 566 Chiswick High Road, |
| London W4 5YE, |
| United Kingdom |

Ranbaxy (UK) Ltd.

Building 4, Chiswick Park,

566 Chiswick High Road,

London W4 5YE,

United Kingdom

Isotretinoin 20 mg Capsules

20 mg

kapseli, pehmeä

suun kautta

---

LIITE IV

LUETTELO LÄÄKEVALMISTEIDEN NIMISTÄ, LÄÄKEMUODOISTA, VAHVUUKSISTA, ANTOREITEISTÄ JA MYYNTILUVAN HALTIJOISTA JÄSENVALTIOISSA

| Jäsenvaltio EU/EEA | Myyntiluvan haltija | Kauppanimi Nimi | Vahvuus | Lääkemuoto | Antoreitti |
| --- | --- | --- | --- | --- | --- |
| AT - Itävalta | Octapharma Pharmazeutika |
| Produktionsgesellschaft m.b.H. |
| Oberlaaerstraße 235 |
| A-1100 Wien |
| Austria |

Jäsenvaltio EU/EEA

Myyntiluvan haltija

Kauppanimi Nimi

Vahvuus

Lääkemuoto

Antoreitti

AT - Itävalta

Octapharma Pharmazeutika

Produktionsgesellschaft m.b.H.

Oberlaaerstraße 235

A-1100 Wien

Austria

Octagam 100 mg/ml Infusionslösung

100 mg/ml

Infuusioneste, liuos

Laskimoon

AT - Itävalta

| 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

Infuusioneste, liuos

Laskimoon

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)

Infuusioneste, liuos

Laskimoon

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

Infuusioneste, liuos

Laskimoon

BG - Bulgaria

| 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

Infuusioneste, liuos

Laskimoon

CY - Kypros

| 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 %

Infuusioneste, liuos

Laskimoon

CY - Kypros

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

Hospitec Co Ltd

5 Thessalonikis, Block B

2085 Lefkosia

Cyprus

OCTAGAM INFUSION 5 %

5 %

Infuusioneste, liuos

Laskimoon

CZ - Tshekki

| 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

Infuusioneste, liuos

Laskimoon

CZ - Tshekki

| 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

Infuusioneste, liuos

Laskimoon

Saksa

| 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

Infuusioneste, liuos

Laskimoon

DE - Saksa

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

OCTAPHARMA GmbH

Elisabeth-Selbert-Str. 11

40764 Langenfeld

Germany

Octagam 5 %

50 mg/ml

Infuusioneste, liuos

Laskimoon

DE - Saksa

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

OCTAPHARMA GmbH

Elisabeth-Selbert-Str. 11

40764 Langenfeld

Germany

Octagam 10 %

100 mg/ml

Infuusioneste, liuos

Laskimoon

DK - Tanska

| Octapharma AB |
| --- |
| Elersvägen 40 |
| SE-11275 Stockholm |
| Sweden |

Octapharma AB

Elersvägen 40

SE-11275 Stockholm

Sweden

Octagam

50 mg/ml

Infuusioneste, liuos

Laskimoon

DK - Tanska

| Octapharma AB |
| --- |
| Elersvägen 40 |
| SE-11275 Stockholm |
| Sweden |

Octapharma AB

Elersvägen 40

SE-11275 Stockholm

Sweden

Octagam

100 mg/ml

Infuusioneste, liuos

Laskimoon

EL - Kreikka

| 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)

Infuusioneste, liuos

Laskimoon

EL - Kreikka

| 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)

Infuusioneste, liuos

Laskimoon

ES - Espanja

| 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

Infuusioneste, liuos

Laskimoon

ES - Espanja

| 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

Infuusioneste, liuos

Laskimoon

ES - Espanja

| Octapharma AB |
| --- |
| Elersvägen 40 |
| SE-11275 Stockholm |
| Sweden |

Octapharma AB

Elersvägen 40

SE-11275 Stockholm

Sweden

OCTAGAM

50 mg/ml

Infuusioneste, liuos

Laskimoon

ES - Espanja

| 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

Infuusioneste, liuos

Laskimoon

FI - Suomi

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

OCTAPHARMA

Rajatorpantie 41 C

01640 Vantaa

FINLAND

OCTAGAM

50 mg/ml

100 mg/ml

Infuusioneste, liuos

Laskimoon

FR - Ranska

| 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

Infuusioneste, liuos

Laskimoon

FR - Ranska

| 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

Infuusioneste, liuos

Laskimoon

HU - Unkari

| 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

Infuusioneste, liuos

Laskimoon

HU - Unkari

| 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

Infuusioneste, liuos

Laskimoon

IS - Islanti

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

Octapharma AB

Nordenflychtsvägen 55

SE-112 75 Stockholm

Sweden

Octagam 5 %

50 mg/ml

Infuusioneste, liuos

Laskimoon

IS - Islanti

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

Octapharma AB

Nordenflychtsvägen 55

SE-112 75 Stockholm

Sweden

Octagam 10 %

100 mg/ml

Infuusioneste, liuos

Laskimoon

IT - Italia

| 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 %

Infuusioneste, liuos

Laskimoon

LT - Liettua

| 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

Infuusioneste, liuos

Laskimoon

LU - Luxemburg

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

OCTAPHARMA BENELUX SA

Rue de Stalle 63

1180 Bruxelles (Brussels)

Belgium

Octagam

5 %

Infuusioneste, liuos

Laskimoon

LU - Luxemburg

| 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 %

Infuusioneste, liuos

Laskimoon

LV - Latvia

| 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

Infuusioneste, liuos

Laskimoon

LV - Latvia

| 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

Infuusioneste, liuos

Laskimoon

LV - Latvia

| 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

Infuusioneste, liuos

Laskimoon

LV - Latvia

| 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

Infuusioneste, liuos

Laskimoon

LV - Latvia

| 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

Infuusioneste, liuos

Laskimoon

LV - Latvia

| 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

Infuusioneste, liuos

Laskimoon

LV - Latvia

| 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

Infuusioneste, liuos

Laskimoon

LV - Latvia

| 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

Infuusioneste, liuos

Laskimoon

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, I gM ≤ 0,3 mg

Infuusioneste, liuos

Laskimoon

NL - Alankomaat

| 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

Infuusioneste, liuos

Laskimoon

NL - Alankomaat

| 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

Infuusioneste, liuos

Laskimoon

NO - Norja

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

Octapharma AG

Kim Björnstrup

Seidenstraße 2

CH-8853 Lachen

Switzerland

Octagam

50 mg/ml

Infuusioneste, liuos

Laskimoon

NO - Norja

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

Octapharma AG

Kim Björnstrup

Seidenstraße 2

CH-8853 Lachen

Switzerland

Octagam

100 mg/ml

Infuusioneste, liuos

Laskimoon

PL - Puola

| 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

Infuusioneste, liuos

Laskimoon

PL - Puola

| 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

Infuusioneste, liuos

Laskimoon

PL - Puola

| 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

Infuusioneste, liuos

Laskimoon

PL - Puola

| 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

Infuusioneste, liuos

Laskimoon

PT - Portugali

| 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

Infuusioneste, liuos

Laskimoon

PT - Portugali

| 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

Infuusioneste, liuos

Laskimoon

RO - Romania

| 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

Infuusioneste, liuos

Laskimoon

RO - Romania

| 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

Infuusioneste, liuos

Laskimoon

SE - Ruotsi

| Octapharma AB |
| --- |
| Olivier Clairotte |
| Elersvägen 40 |
| SE-11275 Stockholm |
| Sweden |

Octapharma AB

Olivier Clairotte

Elersvägen 40

SE-11275 Stockholm

Sweden

Octagem

50 mg/ml

Infuusioneste, liuos

Laskimoon

SE - Ruotsi

| Octapharma AB |
| --- |
| Olivier Clairotte |
| Elersvägen 40 |
| SE-11275 Stockholm |
| Sweden |

Octapharma AB

Olivier Clairotte

Elersvägen 40

SE-11275 Stockholm

Sweden

Octagem

100 mg/ml

Infuusioneste, liuos

Laskimoon

SI - Slovenia

| 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

Infuusioneste, liuos

Laskimoon

SI - Slovenia

| 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

Infuusioneste, liuos

Laskimoon

SK - Slovakia

| 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

Infuusioneste, liuos

Laskimoon

SK - Slovakia

| 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

Infuusioneste, liuos

Laskimoon

SK - Slovakia

| 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

Infuusioneste, liuos

Laskimoon

SK - Slovakia

| 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

Infuusioneste, liuos

Laskimoon

SK - Slovakia

| 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

Infuusioneste, liuos

Laskimoon

SK - Slovakia

| 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

Infuusioneste, liuos

Laskimoon

SK - Slovakia

| 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

Infuusioneste, liuos

Laskimoon

SK - Slovakia

| 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

Infuusioneste, liuos

Laskimoon

UK - Iso-Britannia

| 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

Infuusioneste, liuos

Laskimoon

UK - Iso-Britannia

| 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

Infuusioneste, liuos

Laskimoon

---

LIITE V

LUETTELO LÄÄKEVALMISTEIDEN NIMISTÄ, LÄÄKEMUODOISTA, VAHVUUKSISTA, ANTOREITEISTÄ JA MYYNTILUVAN HALTIJOISTA JÄSENVALTIOISSA

| Jäsenvaltio EU/ETA | Myyntiluvan haltija | Kauppanimi | Vahvuus | Lääkemuoto | Antoreitti |
| --- | --- | --- | --- | --- | --- |
| AT - Itävalta | Octapharma Pharmazeutika |
| Produktionsgesellschaft m.b.H. |
| Oberlaaerstraße 235 |
| A-1100 Wien |
| Itävalta |

Jäsenvaltio EU/ETA

Myyntiluvan haltija

Kauppanimi

Vahvuus

Lääkemuoto

Antoreitti

AT - Itävalta

Octapharma Pharmazeutika

Produktionsgesellschaft m.b.H.

Oberlaaerstraße 235

A-1100 Wien

Itävalta

Octagam 100 mg/ml Infusionslösung

100 mg/ml

Infuusioneste, liuos

Laskimoon.

AT - Itävalta

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

Octapharma Pharmazeutika

Produktionsgesellschaft m.b.H.

Oberlaaerstraße 235

A-1100 Wien

Itävalta

Octagam 50 mg/ml Infusionslösung

50 mg/ml

Infuusioneste, liuos

Laskimoon.

BE - Belgia

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

OCTAPHARMA BENELUX SA

Rue de Stalle 63

1180 Bruxelles (Brussels)

Belgia

Octagam 10 %, solution pour perfusion

10 % (100 mg/ml)

Infuusioneste, liuos

Laskimoon.

BE - Belgia

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

OCTAPHARMA BENELUX SA

Rue de Stalle 63

1180 Bruxelles (Brussels)

Belgia

Octagam 50 mg/ml solution pour perfusion

50 mg/ml

Infuusioneste, liuos

Laskimoon.

BG - Bulgaria

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

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

Yhdistynyt kuningaskunta

Octagam 10 %

100 mg/ml

Infuusioneste, liuos

Laskimoon.

CY - Kypros

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

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

Yhdistynyt kuningaskunta

Octagam Infusion 10 %

10 %

Infuusioneste, liuos

Laskimoon.

CY - Kypros

| Hospitec Co Ltd |
| --- |
| 5 Thessalonikis, Block B |
| 2085 Nicosia |
| Kypros |

Hospitec Co Ltd

5 Thessalonikis, Block B

2085 Nicosia

Kypros

Octagam Infusion 5 %

5 %

Infuusioneste, liuos

Laskimoon.

CZ – Tsekin tasavalta

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

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

Yhdistynyt kuningaskunta

Octagam

50 mg/ml

Infuusioneste, liuos

Laskimoon.

CZ - Tsekin tasavalta

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

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

Yhdistynyt kuningaskunta

Octagam 10 %

100 mg/ml

Infuusioneste, liuos

Laskimoon.

DE - Saksa

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

OCTAPHARMA GmbH

Elisabeth-Selbert-Str. 11

40764 Langenfeld

Saksa

Octagam 50 mg/ml

50 mg/ml

Infuusioneste, liuos

Laskimoon.

DE - Saksa

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

OCTAPHARMA GmbH

Elisabeth-Selbert-Str. 11

40764 Langenfeld

Saksa

Octagam 5 %

50 mg/ml

Infuusioneste, liuos

Laskimoon.

DE - Saksa

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

OCTAPHARMA GmbH

Elisabeth-Selbert-Str. 11

40764 Langenfeld

Saksa

Octagam 10 %

100 mg/ml

Infuusioneste, liuos

Laskimoon.

DK - Tanska

| Octapharma AB |
| --- |
| Elersvägen 40 |
| SE-11275 Stockholm |
| Ruotsi |

Octapharma AB

Elersvägen 40

SE-11275 Stockholm

Ruotsi

Octagam

50 mg/ml

Infuusioneste, liuos

Laskimoon.

DK - Tanska

| Octapharma AB |
| --- |
| Elersvägen 40 |
| SE-11275 Stockholm |
| Ruotsi |

Octapharma AB

Elersvägen 40

SE-11275 Stockholm

Ruotsi

Octagam

100 mg/ml

Infuusioneste, liuos

Laskimoon.

EL - Kreikka

| Octapharma Hellas SA |
| --- |
| 60, posidonos Ave. |
| 166 75 Glyfada Attiki |
| Kreikka |

Octapharma Hellas SA

60, posidonos Ave.

166 75 Glyfada Attiki

Kreikka

Octagam

5 % (W/V)

Infuusioneste, liuos

Laskimoon.

EL - Kreikka

| Octapharma Hellas SA |
| --- |
| 60, posidonos Ave. |
| 166 75 Glyfada Attiki |
| Kreikka |

Octapharma Hellas SA

60, posidonos Ave.

166 75 Glyfada Attiki

Kreikka

Octagam

10 % (100 MG/ML)

Infuusioneste, liuos

Laskimoon.

ES - Espanja

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

OCTAPHARMA, S.A.

C/ Velázquez, 150

28002 Madrid

Espanja

Octagamocta 100 mg/ml solución para perfusión

100 mg/ml

Infuusioneste, liuos

Laskimoon.

ES - Espanja

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

OCTAPHARMA, S.A.

C/ Velázquez, 150

28002 Madrid

Espanja

Octagamocta 50 mg/ml solución para perfusión

50 mg/ml

Infuusioneste, liuos

Laskimoon.

ET - Viro

| Octapharma AB |
| --- |
| Elersvägen 40 |
| SE-11275 Stockholm |
| Ruotsi |

Octapharma AB

Elersvägen 40

SE-11275 Stockholm

Ruotsi

Octagam

50 mg/ml

Infuusioneste, liuos

Laskimoon.

ET - Viro

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

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

Yhdistynyt kuningaskunta

Octagam 10 %

100 mg/1 ml

Infuusioneste, liuos

Laskimoon.

FI - Suomi

| Octapharma AB |
| --- |
| Elersvägen 40 |
| SE-11275 Stockholm |
| Ruotsi |

Octapharma AB

Elersvägen 40

SE-11275 Stockholm

Ruotsi

Octagam

50 mg/ml

100 mg/ml

Infuusioneste, liuos

Laskimoon.

FR - Ranska

| Octapharma France SAS |
| --- |
| 62Bis Avenue André Morizet |
| F- 92100 Boulogne |
| Billancourt |
| Ranska |

Octapharma France SAS

62Bis Avenue André Morizet

F- 92100 Boulogne

Billancourt

Ranska

Octagam 100 mg/ml, solution pour perfusion

100 mg/ml

Infuusioneste, liuos

Laskimoon.

FR - Ranska

| Octapharma France SAS |
| --- |
| 62Bis Avenue André Morizet |
| F- 92100 Boulogne |
| Billancourt |
| Ranska |

Octapharma France SAS

62Bis Avenue André Morizet

F- 92100 Boulogne

Billancourt

Ranska

Octagam 50 mg/ml, solution pour perfusion

50 mg/ml

Infuusioneste, liuos

Laskimoon.

HU - Unkari

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

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

Yhdistynyt kuningaskunta

Octagam 50 mg/ml oldatos infúzió

50 mg/ml

Infuusioneste, liuos

Laskimoon.

HU - Unkari

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

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

Yhdistynyt kuningaskunta

Octagam 100 mg/ml oldatos infúzió

100 mg/ml

Infuusioneste, liuos

Laskimoon.

IS - Islanti

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

Octapharma AB

Nordenflychtsvägen 55

SE-112 75 Stockholm

Ruotsi

Octagam 5 %

50 mg/ml

Infuusioneste, liuos

Laskimoon.

IS - Islanti

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

Octapharma AB

Nordenflychtsvägen 55

SE-112 75 Stockholm

Ruotsi

Octagam 10 %

100 mg/ml

Infuusioneste, liuos

Laskimoon.

IT - Italia

| Octapharma Ltd |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| Yhdistynyt kuningaskunta |

Octapharma Ltd

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

Yhdistynyt kuningaskunta

Octagam

5 %

Infuusioneste, liuos

Laskimoon.

IT - Italia

| Octapharma Italy S.p.A |
| --- |
| Via Cisanello 145 |
| 56100 Pisa |
| Italia |

Octapharma Italy S.p.A

Via Cisanello 145

56100 Pisa

Italia

Gamten

10 %

Infuusioneste, liuos

Laskimoon.

LT - Liettua

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

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

Yhdistynyt kuningaskunta

Octagam

100 mg/ml

Infuusioneste, liuos

Laskimoon.

LU - Luxemburg

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

OCTAPHARMA BENELUX SA

Rue de Stalle 63

1180 Bruxelles (Brussels)

Belgia

Octagam

5 %

Infuusioneste, liuos

Laskimoon.

LU - Luxemburg

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

OCTAPHARMA BENELUX SA

Rue de Stalle 63

1180 Bruxelles (Brussels)

Belgia

Octagam-10

10 %

Infuusioneste, liuos

Laskimoon.

LV - Latvia

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

Octapharma AB

Elesvagen 40

Stockholm, S-112 75

Ruotsi

Octagam 50 mg/ml solution for infusion

1 g/20 ml

Infuusioneste, liuos

Laskimoon.

LV - Latvia

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

Octapharma AB

Elesvagen 40

Stockholm, S-112 75

Ruotsi

Octagam 50 mg/ml solution for infusion

2,5 g/50 ml

Infuusioneste, liuos

Laskimoon.

LV - Latvia

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

Octapharma AB

Elesvagen 40

Stockholm, S-112 75

Ruotsi

Octagam 50 mg/ml solution for infusion

5 g/100 ml

Infuusioneste, liuos

Laskimoon.

LV - Latvia

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

Octapharma AB

Elesvagen 40

Stockholm, S-112 75

Ruotsi

Octagam 50 mg/ml solution for infusion

10 g/200 ml

Infuusioneste, liuos

Laskimoon.

LV - Latvia

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

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

Yhdistynyt kuningaskunta

Octagam 100 mg/ml solution for infusion, 2 g/20 ml

2 g/20 ml

Infuusioneste, liuos

Laskimoon.

LV - Latvia

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

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

Yhdistynyt kuningaskunta

Octagam 100 mg/ml solution for infusion, 5 g/50 ml

5 g/50 ml

Infuusioneste, liuos

Laskimoon.

LV - Latvia

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

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

Yhdistynyt kuningaskunta

Octagam 100 mg/ml solution for infusion, 10 g/100 ml

10 g/100 ml

Infuusioneste, liuos

Laskimoon.

LV - Latvia

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

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

Yhdistynyt kuningaskunta

Octagam 100 mg/ml solution for infusion, 20 g/200 ml

20 g/200 ml

Infuusioneste, liuos

Laskimoon.

MT - Malta

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

Octapharma (IP) Limited,

The Zenith Building,

26 Spring Gardens, Manchester M2 1AB,

Yhdistynyt kuningaskunta

Octagam 10 %, solution for infusion

1ml sisältää: 100 mg proteiinia (josta ≥ 95 % ihmisen immunoglobuliinia G), IgA ≤ 0,4 mg, IgM ≤ 0,3 mg

Infuusioneste, liuos

Laskimoon.

NL - Alankomaat

| Octapharma GmbH |
| --- |
| Elisabeth-Selbert-Str. 11 |
| 40764 Langenfeld |
| Saksa |

Octapharma GmbH

Elisabeth-Selbert-Str. 11

40764 Langenfeld

Saksa

Octagam 10 %

100 mg/ml

Infuusioneste, liuos

Laskimoon.

NL - Alankomaat

| Octapharma GmbH |
| --- |
| Elisabeth-Selbert-Str. 11 |
| 40764 Langenfeld |
| Saksa |

Octapharma GmbH

Elisabeth-Selbert-Str. 11

40764 Langenfeld

Saksa

Octagam 5 %

50 mg/ml

Infuusioneste, liuos

Laskimoon.

NO - Norja

| Octapharma AG |
| --- |
| Seidenstraße 2 |
| CH-8853 Lachen |
| Sveitsi |

Octapharma AG

Seidenstraße 2

CH-8853 Lachen

Sveitsi

Octagam

50 mg/ml

Infuusioneste, liuos

Laskimoon.

NO - Norja

| Octapharma AG |
| --- |
| Seidenstraße 2 |
| CH-8853 Lachen |
| Sveitsi |

Octapharma AG

Seidenstraße 2

CH-8853 Lachen

Sveitsi

Octagam

100 mg/ml

Infuusioneste, liuos

Laskimoon.

PL - Puola

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

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

Yhdistynyt kuningaskunta

Octagam

2,5 g/50 ml

Infuusioneste, liuos

Laskimoon.

PL - Puola

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

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

Yhdistynyt kuningaskunta

Octagam

5 g/100 ml

Infuusioneste, liuos

Laskimoon.

PL - Puola

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

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

Yhdistynyt kuningaskunta

Octagam

10 g/200 ml

Infuusioneste, liuos

Laskimoon.

PL - Puola

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

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

Yhdistynyt kuningaskunta

Octagam 10 %

100 mg/ml

Infuusioneste, liuos

Laskimoon.

PT - Portugali

| Octapharma |
| --- |
| Produtos Farmaceuticos, Lda. |
| Rua dos Lagares D'el Rei, 21C r/c Dto. |
| P-1170-268 Lisboa |
| Portugali |

Octapharma

Produtos Farmaceuticos, Lda.

Rua dos Lagares D'el Rei, 21C r/c Dto.

P-1170-268 Lisboa

Portugali

Octagam

50 mg/ml

Infuusioneste, liuos

Laskimoon.

PT - Portugali

| Octapharma |
| --- |
| Produtos Farmaceuticos, Lda. |
| Rua dos Lagares D'el Rei, 21C r/c Dto. |
| P-1170-268 Lisboa |
| Portugali |

Octapharma

Produtos Farmaceuticos, Lda.

Rua dos Lagares D'el Rei, 21C r/c Dto.

P-1170-268 Lisboa

Portugali

Octagam

100 mg/ml

Infuusioneste, liuos

Laskimoon.

RO - Romania

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

OCTAPHARMA (IP) Ltd.

The Zenith Building 26 Spring Gardens

Manchester, M2 1AB

Yhdistynyt kuningaskunta

Octagam

50 mg/ml

Infuusioneste, liuos

Laskimoon.

RO - Romania

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

OCTAPHARMA (IP) Ltd.

The Zenith Building 26 Spring Gardens

Manchester, M2 1AB

Yhdistynyt kuningaskunta

Octagam 10 %

100 mg/ml

Infuusioneste, liuos

Laskimoon.

SE - Ruotsi

| Octapharma AB |
| --- |
| Elersvägen 40 |
| 112 75 Stockholm |
| Ruotsi |

Octapharma AB

Elersvägen 40

112 75 Stockholm

Ruotsi

Octagam

50 mg/ml

Infuusioneste, liuos

Laskimoon.

SE - Ruotsi

| Octapharma AB |
| --- |
| Elersvägen 40 |
| 112 75 Stockholm |
| Ruotsi |

Octapharma AB

Elersvägen 40

112 75 Stockholm

Ruotsi

Octagam

100 mg/ml

Infuusioneste, liuos

Laskimoon.

SI - Slovenia

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

Zavod Republike Slovenije za transfuzijsko medicino

Šlajmerjeva 6

1000 Ljubljana

Slovenia

Octagam 50 mg/ml raztopina za infundiranje

50 mg/ ml

Infuusioneste, liuos

Laskimoon.

SI - Slovenia

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

Zavod Republike Slovenije za transfuzijsko medicino

Šlajmerjeva 6

1000 Ljubljana

Slovenia

Octagam 100 mg/ml raztopina za infundiranje

100 mg/ ml

Infuusioneste, liuos

Laskimoon.

SK - Slovakia

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

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

Yhdistynyt kuningaskunta

Octagam

50 mg/ml

Infuusioneste, liuos

Laskimoon.

SK - Slovakia

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

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

Yhdistynyt kuningaskunta

Octagam 10 %

100 mg/ml

Infuusioneste, liuos

Laskimoon.

UK - Yhdistynyt kuningaskunta

| Octapharma Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| Yhdistynyt kuningaskunta |

Octapharma Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

Yhdistynyt kuningaskunta

Octagam Infusion

5 % w/v

Infuusioneste, liuos

Laskimoon.

UK - Yhdistynyt kuningaskunta

| Octapharma Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| Yhdistynyt kuningaskunta |

Octapharma Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

Yhdistynyt kuningaskunta

Octagam 10 % solution for Infusion

10 % w/v

Infuusioneste, liuos

Laskimoon.

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