5.3.2009   

EN

Official Journal of the European Union

C 52/11


Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the first half of 2008

(2009/C 52/05)

Subcommittee I — On the free movement of goods

To be noted by the EEA Joint Committee

With reference to EEA Joint Committee Decision No 74/1999 of 28 May 1999, the EEA Joint Committee is invited to note the following lists concerning marketing authorisations for medicinal products for the period 1 January-30 June 2008, at their meeting on 7 November 2008:

Annex I

List of new marketing authorisations

Annex II

List of renewed marketing authorisations

Annex III

List of extended marketing authorisations

Annex IV

List of withdrawn marketing authorisations


ANNEX I

List of new marketing authorisations

The following marketing authorisations have been granted in the EEA EFTA States during the period 1 January-30 June 2008:

EU-Number

Product

Country

Date of authorisation

EU/1/05/312/001

Xyrem

Liechtenstein

30.6.2008

EU/1/06/334/001-004

Evoltra

Liechtenstein

30.6.2008

EU/1/06/370/001-024

Exforge

Liechtenstein

30.6.2008

EU/1/06/371/001-024

Dafiro

Liechtenstein

30.6.2008

EU/1/06/372/001-024

Copalia

Liechtenstein

30.6.2008

EU/1/06/373/001-024

Imprida

Liechtenstein

30.6.2008

EU/1/07/001-019/IS

Retacrit

Iceland

16.1.2008

EU/1/07/393/001

Soliris

Liechtenstein

30.6.2008

EU/1/07/400/001-016

Mircera

Liechtenstein

30.6.2008

EU/1/07/402/001/NO

Increlex

Norway

31.1.2008

EU/1/07/421/001-009/IS

Pioglitazone

Iceland

9.1.2008

EU/1/07/422/001/NO-004/NO

Tasigna

Norway

17.1.2008

EU/1/07/422/001-004

Tasigna

Liechtenstein

30.6.2008

EU/1/07/423/001/NO-003/NO

Vectibix

Norway

21.1.2008

EU/1/07/423/001-003

Vectibix

Liechtenstein

30.6.2008

EU/1/07/423/001-003/IS

Vectibix

Iceland

28.1.2008

EU/1/07/427/001/NO-037/NO

Olanzapine Teva

Norway

7.1.2008

EU/1/07/427/001-047/IS

Olanzapine Teva

Iceland

7.1.2008

EU/1/07/428/001

Abraxane

Liechtenstein

29.2.2008

EU/1/07/428/001/IS

Abraxane

Iceland

24.1.2008

EU/1/07/428/001/NO

Abraxane

Norway

21.1.2008

EU/1/07/430/001

Atripla

Liechtenstein

30.6.2008

EU/1/07/430/001/IS

Atripla

Iceland

28.1.2008

EU/1/07/430/001/NO

Atripla

Norway

29.1.2008

EU/1/07/431/001/NO-019/NO

Retacrit

Norway

17.1.2008

EU/1/07/431/001-019

Retacrit

Liechtenstein

30.6.2008

EU/1/07/432/001/NO-019/NO

Silapo

Norway

17.1.2008

EU/1/07/432/001-019

Silapo

Liechtenstein

29.2.2008

EU/1/07/432/001-019/IS

Silapo

Iceland

16.1.2008

EU/1/07/433/001/IS

Nevanac

Iceland

8.1.2008

EU/1/07/434/001/NO-003/NO

Avamys

Norway

23.1.2008

EU/1/07/434/001-003

Avamys

Liechtenstein

29.2.2008

EU/1/07/434/001-003/IS

Avamys

Iceland

25.1.2008

EU/1/07/435/001/NO-018/NO

Tesavel

Norway

24.1.2008

EU/1/07/435/001-018

Tesavel

Liechtenstein

30.4.2008

EU/1/07/435/001-018/IS

Tesavel

Iceland

24.1.2008

EU/1/07/436/001/NO-002/NO

Isentress

Norway

16.1.2008

EU/1/07/436/001-002

Isentress

Liechtenstein

29.2.2008

EU/1/07/436/001-002/IS

Isentress

Iceland

18.1.2008

EU/1/07/437/001/NO-002/NO

Ivemend

Norway

31.1.2008

EU/1/07/437/001-002

Ivemend

Liechtenstein

29.2.2008

EU/1/07/437/001-002/IS

Ivemend

Iceland

22.1.2008

EU/1/07/438/001/NO-004/NO

Myfenac

Norway

14.3.2008

EU/1/07/438/001-004

Myfenax

Liechtenstein

30.4.2008

EU/1/07/438/001-004/IS

Myfenax

Iceland

17.3.2008

EU/1/07/439/001/NO-004/NO

Mycophenolate mofetil Teva

Norway

14.3.2008

EU/1/07/439/001-004

Mycophenolate mofetil Teva

Liechtenstein

30.4.2008

EU/1/07/439/001-004/IS

Mycophenolate mofetil Teva

Iceland

17.3.2008

EU/1/07/440/001/NO-002/NO

Tyverb

Norway

17.6.2008

EU/1/07/440/001-002/IS

Tyverb

Iceland

26.6.2008

EU/1/08/441/001/NO-010/NO

Effentora

Norway

15.4.2008

EU/1/08/441/001-010

Effentora

Liechtenstein

30.4.2008

EU/1/08/441/001-010/IS

Effentora

Iceland

17.4.2008

EU/1/08/442/001/NO-008/NO

Pradaxa

Norway

14.4.2008

EU/1/08/442/001-008

Pradaxa

Liechtenstein

30.4.2008

EU/1/08/442/001-008/IS

Pradaxa

Iceland

26.3.2008

EU/1/08/443/001

Thalidomide Pharmion

Liechtenstein

30.4.2008

EU/1/08/443/001/IS

Thalidomide Pharmion

Iceland

21.4.2008

EU/1/08/443/001/NO

Thalidomide Pharmion

Norway

16.5.2008

EU/1/08/446/001/NO-003/NO

Privigen

Norway

19.5.2008

EU/1/08/446/001-003

Privigen

Liechtenstein

30.6.2008

EU/1/08/446/001-003/IS

Privigen

Iceland

23.5.2008

EU/1/08/447/001/NO-004/NO

Adenuric

Norway

24.6.2008

EU/1/08/447/001-004

Adenuric

Liechtenstein

30.4.2008

EU/1/08/447/001-004/IS

Adenuric

Iceland

16.5.2008

EU/1/08/448/001/NO-002/NO

Mycamine

Norway

21.5.2008

EU/1/08/448/001-002

Mycamine

Liechtenstein

30.4.2008

EU/1/08/448/001-002/IS

Mycamine

Iceland

28.5.2008

EU/1/08/451/001/NO-004/NO

Volibris

Norway

29.4.2008

EU/1/08/451/001-002/IS

Volibris

Iceland

21.5.2008

EU/1/08/451/001-004

Volibris

Liechtenstein

30.4.2008

EU/1/08/452/001

Pandemrix

Liechtenstein

30.6.2008

EU/1/08/452/001/IS

Pandemrix

Iceland

23.5.2008

EU/1/08/452/001/NO

Pandemrix

Norway

20.5.2008

EU/1/08/453/001

Prepandrix

Liechtenstein

30.6.2008

EU/1/08/453/001/IS

Prepandrix

Iceland

23.5.2008

EU/1/08/454/001/NO-004/NO

Extavia

Norway

3.6.2008

EU/1/08/454/001-004

Extavia

Liechtenstein

30.6.2008

EU/1/08/454/001-004/IS

Extavia

Iceland

30.5.2008

EU/2//08/081/001-003

Posatex

Liechtenstein

30.6.2008

EU/2/04/044/007/IS

Aivlosin

Iceland

19.6.2008

EU/2/07/073/001/NO-004/NO

Nobilis Influenza H7N1

Norway

4.1.2008

EU/2/07/076/001/NO-004/NO

Nobilis Influenza H5N6

Norway

13.3.2008

EU/2/07/076/001-004

Nobilis Influenza H5N6

Liechtenstein

29.2.2008

EU/2/07/077/001/NO-005/NO

Meloxivet

Norway

7.2.2008

EU/2/07/077/001-004/IS

Meloxivet

Iceland

27.6.2008

EU/2/07/078/001/NO-003/NO

Rheumocam

Norway

25.2.2008

EU/2/07/078/001-002/IS

Rheumocam

Iceland

25.1.2008

EU/2/07/078/001-003

Rheumocam

Liechtenstein

29.2.2008

EU/2/07/079/001/NO-004/NO

Ingelvac CircoFLEX

Norway

26.3.2008

EU/2/07/079/001-004

Ingelvac CircoFLEX

Liechtenstein

29.2.2008

EU/2/07/079/001-004/IS

Ingelvac CircoFLEX

Iceland

19.3.2008


ANNEX II

List of renewed marketing authorisations

The following marketing authorisations have been renewed in the EEA EFTA States during the period 1 January-30 June 2008:

EU-Number

Product

Country

Date of authorisation

EU/1/02/246/001/NO-003/NO

Carbaglu

Norway

30.5.2008

EU/1/02/246/001-003

Carbaglu

Liechtenstein

30.6.2008

EU/1/02/246/001-003/IS

Carbaglu

Iceland

29.5.2008

EU/1/03/247/001/NO-002/NO

Forsteo

Norway

1.7.2008

EU/1/03/247/001-002

Forsteo

Liechtenstein

30.6.2008

EU/1/03/247/001-002/IS

Forsteo

Iceland

21.5.2008

EU/1/03/248/001/NO-012/NO

Levitra

Norway

25.2.2008

EU/1/03/248/001-012/IS

Levitra

Iceland

19.2.2008

EU/1/03/249/001/NO-012/NO

Vivanza

Norway

25.2.2008

EU/1/03/249/001-012

Vivanza

Liechtenstein

29.2.2008

EU/1/03/249/001-012/IS

Vivanza

Iceland

19.2.2008

EU/1/03/250/001

Ytracis

Liechtenstein

29.2.2008

EU/1/03/250/001/IS

Ytracis

Iceland

28.2.2008

EU/1/03/250/001/NO

Ytracis

Norway

25.2.2008

EU/1/03/251/001/NO-002/NO

Hepsera

Norway

4.4.2008

EU/1/03/251/001-002

Hepsera

Liechtenstein

30.4.2008

EU/1/03/251/001-002/IS

Hepsera

Iceland

10.4.2008

EU/1/03/253/001/NO-003/NO

Aldurazyme

Norway

30.5.2008

EU/1/03/253/001-003

Aldurazyme

Liechtenstein

30.6.2008

EU/1/03/253/001-003/IS

Aldurazyme

Iceland

22.5.2008

EU/1/06/367/001/NO-012/NO

Diacomit

Norway

7.1.2008

EU/1/06/367/001-012

Diacomit

Liechtenstein

29.2.2008

EU/1/06/367/001-012/IS

Diacomit

Iceland

7.1.2008

EU/1/06/380/001

Prezista

Liechtenstein

29.2.2008

EU/1/06/380/001/IS

Prezista

Iceland

22.1.2008

EU/1/06/380/001/NO

Prezista

Norway

21.1.2008

EU/1/97/045/001-004

Helicobacter Test INFAI

Liechtenstein

30.4.2008

EU/1/97/045/001-004/IS

Helicobacter Test INFAI

Iceland

9.4.2008

EU/1/97/054/001&004-005/IS

Viracept

Iceland

21.1.2008

EU/1/97/054/001, 004-005

Viracept

Liechtenstein

29.2.2008

EU/1/97/054/001/NO, 004/NO-005/NO

Viracept

Norway

17.1.2008

EU/1/97/055/001/NO-003/NO

Viramune

Norway

21.1.2008

EU/1/97/055/001-003

Viramune

Liechtenstein

30.4.2008

EU/1/97/055/001-003/IS

Viramune

Iceland

22.1.2008

EU/1/97/057/001/IS

Quadramet

Iceland

7.1.2008

EU/1/97/057/001/NO

Quadramet

Norway

17.1.2008

EU/1/98/058/001/NO-002/NO

Combivir

Norway

26.2.2008

EU/1/98/058/001-002

Combivir

Liechtenstein

29.2.2008

EU/1/98/058/001-002/IS

Combivir

Iceland

12.3.2008

EU/1/98/063/001/NO-006/NO

Rebif

Norway

3.6.2008

EU/1/98/063/001-007

Rebif

Liechtenstein

30.6.2008

EU/1/98/063/001-007/IS

Rebif

Iceland

2.6.2008

EU/1/98/065/001-002

Otpison

Liechtenstein

30.6.2008

EU/1/98/066/001/NO-026/NO

Exelon

Norway

3.6.2008

EU/1/98/066/001-026

Exelon

Liechtenstein

30.6.2008

EU/1/98/066/001-026/IS

Exelon

Iceland

29.5.2008

EU/1/98/067/001/NO-002/NO

MabThera

Norway

24.6.2008

EU/1/98/067/001-002

Mabthera

Liechtenstein

30.6.2008

EU/1/98/067/001-002/IS

MabThera

Iceland

29.5.2008

EU/1/98/069/001a/NO-007a/NO;

EU/1/98/069/001b/NO-007b/NO;

EU/1/98/069/008/NO-010/NO

Plavix

Norway

2.7.2008

EU/1/98/069/001a-001b, 002a-002b, 003a-003b, -004a-004b, 005a-005b, 006a-006b, 007a-007b, 008-010

Plavix

Liechtenstein

30.6.2008

EU/1/98/069/001a-007a& 001b-007b&008-010/IS

Plavix

Iceland

27.6.2008

EU/1/98/070/001a/NO-007a/NO;

EU/1/98/070/001b/NO-007b/NO;

EU/1/98/070/008/NO-010/NO

Iscover

Norway

2.7.2008

EU/1/98/070/001a-001b, 002a-002b, 003a-003b, -004a-004b, 005a-005b, 006a-006b, 007a-007b, 008-010

Iscover

Liechtenstein

30.6.2008

EU/1/98/070/001a-007a& 001b-007b&008-010/IS

Iscover

Iceland

27.6.2008

EU/1/98/071/001-006

Xenical

Liechtenstein

30.6.2008

EU/1/98/092/001/NO-023/NO

Prometax

Norway

3.6.2008

EU/1/98/092/001-026

Prometax

Liechtenstein

30.6.2008

EU/1/98/092/001-026/IS

Prometax

Iceland

16.6.2008

EU/2/02/032/001/NO

Vaxxitek HVT + IBD

Norway

24.1.2008

EU/2/02/033/001/NO

Dexdomitor

Norway

21.1.2008

EU/2/02/034/001/NO

Nobivac Bb for cats

Norway

24.1.2008

EU/2/02/035/001/NO-007/NO

SevoFlo

Norway

17.1.2008

EU/2/02/036/001/NO-002/NO

Nobilis OR inac

Norway

26.2.2008

EU/2/02/036/001-002

Nobilis OR inac

Liechtenstein

30.4.2008

EU/2/02/036/001-002/IS

Nobilis OR inac

Iceland

21.1.2008

EU/2/03/037/005

ProteqFlu

Liechtenstein

29.2.2008

EU/2/03/037/005/IS

ProteqFlu

Iceland

21.1.2008

EU/2/03/037/005/NO

ProteqFlu

Norway

27.3.2008

EU/2/03/038/005

ProteqFlu-Te

Liechtenstein

29.2.2008

EU/2/03/038/005/IS

ProteqFlu-Te

Iceland

21.1.2008

EU/2/03/038/005/NO

ProteqFlu Te

Norway

27.3.2008

EU/2/03/039/001/NO-030/NO

Advocate

Norway

22.4.2008

EU/2/03/039/001-004&013-14&019-022/IS

Advocate for cats

Iceland

13.3.2008

EU/2/03/039/001-030

Advocate

Liechtenstein

29.2.2008

EU/2/03/039/005-012&015-018&023-030/IS

Advocate for dogs

Iceland

13.3.2008

EU/2/03/040/001-002

Gonazon

Liechtenstein

30.6.2008

EU/2/96/002/001/NO-003/NO

Fevaxyn Pentofel

Norway

12.2.2008

EU/2/97/001-018/IS

Dicural

Iceland

21.1.2008

EU/2/97/003/001/NO-018/NO

Dicural

Norway

25.2.2008

EU/2/97/003/001-018

Dicural

Liechtenstein

29.2.2008

EU/2/97/004/001&010/IS

Metacam for cattle and pigs

Iceland

4.1.2008

EU/2/97/004/003-005&012-013&016-025&029/IS

Metacam for dogs

Iceland

4.1.2008

EU/2/97/004/006&011/IS

Metacam for dogs and cats

Iceland

4.1.2008

EU/2/97/004/007-008&014-015&027-028&031-032/IS

Metacam for cattle, pigs and horses

Iceland

4.1.2008

EU/2/97/004/009&030/IS

Metacam for horses

Iceland

4.1.2008

EU/2/97/004/026/IS

Metcam for cats

Iceland

4.1.2008

EU/2/98/006/001-010

Nobilis IB 4-91

Liechtenstein

30.6.2008

EU/2/98/006/001-010/IS

Nobilis IB 4-91

Iceland

23.5.2008

EU/2/98/007/001/NO-003/NO

Clomicalm

Norway

26.5.2008

EU/2/98/007/001-003

Clomicalm

Liechtenstein

30.4.2008

EU/2/98/007/001-003/IS

Clomicalm

Iceland

21.4.2008

EU/2/98/008/001/NO-004/NO

Neocolipor

Norway

21.4.2008

EU/2/98/008/001-004

Neocolipor

Liechtenstein

30.4.2008

EU/2/98/008/001-004/IS

Neocolipor

Iceland

9.4.2008


ANNEX III

List of extended marketing authorisations

The following marketing authorisations have been extended in the EEA EFTA States during the period 1 January-30 June 2008:

EU-Number

Product

Country

Date of extention

EU/1/00/143/010/NO-011/NO

Kogenate Bayer

Norway

28.1.2008

EU/1/00/143/010-011

Kogenate Bayer

Liechtenstein

29.2.2008

EU/1/00/143/010-011/IS

Kogenate Bayer

Iceland

16.1.2008

EU/1/00/144/004

Helixate NexGen

Liechtenstein

29.2.2008

EU/1/00/144/004/IS

Helixate NexGen

Iceland

16.1.2008

EU/1/00/144/004/NO

Helixate NexGen

Norway

28.1.2008

EU/1/00/167/008

Prevenar

Liechtenstein

30.6.2008

EU/1/01/172/006

Kaletra

Liechtenstein

30.4.2008

EU/1/01/172/006/IS

Kaletra

Iceland

14.4.2008

EU/1/01/172/006/NO

Kaletra

Norway

14.4.2008

EU/1/01/195/016/NO-021/NO

Liprolog

Norway

29.1.2008

EU/1/01/195/016-021

Liprolog

Liechtenstein

29.2.2008

EU/1/01/200/002

Viread

Liechtenstein

30.4.2008

EU/1/01/200/002/NO

Viread

Norway

23.4.2008

EU/1/02/213/017-023

MicardisPlus

Liechtenstein

30.4.2008

EU/1/02/213/017/NO-023/NO

MicardisPlus

Norway

27.5.2008

EU/1/02/213/017-023/IS

MicardisPlus

Iceland

15.4.2008

EU/1/02/214/011-015

Kinzalcomb

Liechtenstein

30.4.2008

EU/1/02/215/015-021

Pritor Plus

Liechtenstein

30.4.2008

EU/1/02/218/012-029

Axura

Liechtenstein

30.6.2008

EU/1/02/218/012-029/IS

Axura

Iceland

28.5.2008

EU/1/02/218/016/NO-023/NO

Axura

Norway

27.5.2008

EU/1/02/219/016-021

Ebixa

Liechtenstein

30.4.2008

EU/1/02/219/022/NO-049/NO

Ebixa

Norway

21.5.2008

EU/1/02/219/022-049

Ebixa

Liechtenstein

30.6.2008

EU/1/02/219/022-049/IS

Ebixa

Iceland

27.5.2008

EU/1/03/260/019/NO-023/NO

Stalevo

Norway

27.5.2008

EU/1/03/260/019-023

Stalevo

Liechtenstein

30.4.2008

EU/1/03/260/019-023/IS

Stalevo

Iceland

20.5.2008

EU/1/03/267/008/NO-009/NO

Reyataz

Norway

16.5.2008

EU/1/03/267/008-009

Reyataz

Liechtenstein

30.4.2008

EU/1/03/267/008-009/IS

Reyataz

Iceland

22.4.2008

EU/1/03/268/004

Cholestagel

Liechtenstein

30.6.2008

EU/1/03/271/001-006/IS

Advate

Iceland

30.5.2008

EU/1/03/271/005/NO-006/NO

Advate

Norway

3.6.2008

EU/1/03/271/005-006

Advate

Liechtenstein

30.6.2008

EU/1/04/274/002

Velcade

Liechtenstein

30.4.2008

EU/1/04/274/002/NO

Velcade

Norway

21.4.2008

EU/1/04/279/036-043

Lyrica

Liechtenstein

29.2.2008

EU/1/04/283/008/NO-012/NO

Ariclaim

Norway

17.1.2008

EU/1/04/283/008-012/IS

Ariclaim

Iceland

15.2.2008

EU/1/04/298/003

Kivexa

Liechtenstein

30.4.2008

EU/1/04/298/003/NO

Kivexa

Norway

29.2.2008

EU/1/06/357/018-021

Gardasil

Liechtenstein

30.4.2008

EU/1/06/358/018-021

Silgard

Liechtenstein

30.4.2008

EU/1/06/366/017/NO-022/NO

Tandemact

Norway

22.4.2008

EU/1/06/366/017-022

Tandemact

Liechtenstein

30.4.2008

EU/1/06/366/017-022/IS

Tandemact

Iceland

16.4.2008

EU/1/06/368/058-087

Insulin Human Winthrop

Liechtenstein

29.2.2008

EU/1/06/370/025-033

Exforge

Liechtenstein

30.6.2008

EU/1/06/371/025-033

Dafiro

Liechtenstein

30.6.2008

EU/1/06/372/025-033

Copalia

Liechtenstein

30.6.2008

EU/1/06/373/025-033

Imprida

Liechtenstein

30.6.2008

EU/1/07/387/009/NO-010/NO

Advagraf

Norway

25.1.2008

EU/1/07/387/009-010

Advagraf

Liechtenstein

29.2.2008

EU/1/07/388/002

Sebivo

Liechtenstein

29.2.2008

EU/1/07/388/002/NO

Sebivo

Norway

28.2.2008

EU/1/96/006/004/NO-006/NO

NovoSeven

Norway

21.5.2008

EU/1/96/006/004-006

NovoSeven

Liechtenstein

30.4.2008

EU/1/96/006/004-006/IS

NovoSeven

Iceland

22.5.2008

EU/1/96/007/031/NO-038/NO

Humalog

Norway

31.1.2008

EU/1/96/007/031-038

Humalog

Liechtenstein

29.2.2008

EU/1/96/027/006/NO-007/NO

Hycamtin

Norway

9.4.2008

EU/1/96/027/006-007

Hycamtin

Liechtenstein

30.4.2008

EU/1/96/027/006-007/IS

Hycamtin

Iceland

26.3.2008

EU/1/97/030/085-139

Insuman

Liechtenstein

29.2.2008

EU/1/98/069/008/NO-010/NO

Plavix

Norway

22.4.2008

EU/1/98/069/008-010

Plavix

Liechtenstein

30.4.2008

EU/1/98/069/008-010/IS

Plavix

Iceland

17.4.2008

EU/1/98/070/008/NO-010/NO

Iscover

Norway

19.5.2008

EU/1/98/070/008-010

Iscover

Liechtenstein

30.4.2008

EU/1/98/070/008-010/IS

Iscover

Iceland

17.4.2008

EU/1/99/119/015

NovoRapid

Liechtenstein

30.4.2008

EU/1/99/119/015/NO

NovoRapid

Norway

25.2.2008

EU/2/04/044/007

Aivlosin

Liechtenstein

30.6.2008

EU/2/04/045/007/NO

Previcox

Norway

29.1.2008

EU/2/97/004/031-032

Metacam

Liechtenstein

30.6.2008


ANNEX IV

List of withdrawn marketing authorisations

The following marketing authorisations have been withdrawn in the EEA EFTA States during the period 1 January-30 June 2008:

EU-Number

Product

Country

Date of withdrawal

EU/1/01/192/001/NO-005/NO

Levviax

Norway

24.1.2008

EU/1/02/207/001-020

Quixidar

Liechtenstein

30.4.2008

EU/1/02/207/001-020/IS

Quixidar

Iceland

11.3.2008

EU/1/02/207/001-020/NO

Quixidar

Norway

2.4.2008

EU/1/99/098/001-002

Zenapax

Liechtenstein

30.6.2008

EU/2/00/025/001-004

Advasure

Liechtenstein

30.6.2008