Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the second half of 2006
Date: 2007-11-08
Institutions: EFTA Surveillance Authority
Subjects: EFTA countries, European Economic Area, market approval, medicinal product, withdrawal from the market

C 266/18

EN

Official Journal of the European Union

8.11.2007

Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the
second half of 2006

(2007/C 266/06)

Subcommittee I — On the free movement of goods

With reference to EEA Joint Committee Decision No 74/1999 of 28 May 1999, the EEA Joint Committee is
invited to note, at the meeting on 8 December 2006, the following lists concerning marketing authorisations
for medicinal products for the period 1 July-31 December 2006:

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List of withdrawn marketing authorisations

8.11.2007

EN

Official Journal of the European Union

C 266/19

ANNEX I

List of new marketing authorisations

The following marketing authorisations have been granted in the EEA EFTA States during the period 1 July-31 December
2006:

EU-Number

Product

Country

Date of authorisation

EU/1/06/333/001-003/IS

Myozyme

Iceland

10.8.2006

EU/1/06/342/001

EU/1/06/342/001/IS

EU/1/06/342/001/NO

Nexavar

Nexavar

Nexavar

EU/1/06/343/001/NO-005/NO

Baraclude

EU/1/06/343/001-006/IS

Baraclude

EU/1/06/344/001-009/IS

Acomplia

EU/1/06/345/001-009/IS

EU/1/06/346/001

EU/1/06/346/001/IS

EU/1/06/346/001/NO

Zimulti

Tysabri

Tysabri

Tysabri

EU/1/06/347/001/NO-003/NO

Sutent

EU/1/06/347/001-003

EU/1/06/347/001-003/IS

Sutent

Sutent

EU/1/06/348/001/NO-002/NO

RotaTeq

EU/1/06/348/001-002

EU/1/06/348/001-002/IS

RotaTeq

RotaTeq

EU/1/06/349/001/NO-008/NO

Avaglim

EU/1/06/349/001-008

EU/1/06/349/001-008/IS

EU/1/06/350/001

EU/1/06/350/001/IS

EU/1/06/350/001/NO

Avaglim

Avaglim

Savene

Savene

Savene

EU/1/06/351/001/NO-003/NO

Livensa

EU/1/06/351/001-003

EU/1/06/351/001-003/IS

Livensa

Livensa

EU/1/06/352/001/NO-003/NO

Intrinsa

Liechtenstein

31.8.2006

Iceland

Norway

Norway

Iceland

Iceland

Iceland

4.8.2006

28.7.2006

25.7.2006

24.7.2006

19.7.2006

19.7.2006

Liechtenstein

31.8.2006

Iceland

Norway

Norway

24.7.2006

13.7.2006

27.7.2006

Liechtenstein

31.8.2006

Iceland

Norway

3.8.2006

12.7.2006

Liechtenstein

31.8.2006

Iceland

Norway

26.7.2006

13.7.2006

Liechtenstein

31.8.2006

Iceland

25.7.2006

Liechtenstein

31.8.2006

Iceland

Norway

Norway

18.8.2006

16.8.2006

6.9.2006

Liechtenstein

31.8.2006

Iceland

Norway

28.8.2006

25.8.2006

C 266/20

EN

Official Journal of the European Union

8.11.2007

EU-Number

Product

Country

Date of authorisation

EU/1/06/352/001-003

Intrinsa

Liechtenstein

31.8.2006

EU/1/06/352/001-003/IS

Intrinsa

EU/1/06/353/001/NO-005/NO

Thelin

EU/1/06/353/001-005

EU/1/06/353/001-005/IS

Thelin

Thelin

EU/1/06/354/001/NO-009/NO

Competact

Iceland

Norway

18.8.2006

1.9.2006

Liechtenstein

31.10.2006

Iceland

Norway

8.9.2006

22.8.2006

EU/1/06/354/001-009

Competact

Liechtenstein

31.8.2006

EU/1/06/354/001-009/IS

Competact

EU/1/06/355/001/NO-003/NO

Atryn

EU/1/06/355/001-003

EU/1/06/355/001-003/IS

Atryn

Atryn

EU/1/06/356/001/NO-006/NO

Exjade

EU/1/06/356/001-006

EU/1/06/356/001-006/IS

Exjade

Exjade

EU/1/06/357/001/NO-017/NO

Gardasil

Iceland

Norway

28.8.2006

21.8.2006

Liechtenstein

31.8.2006

Iceland

Norway

17.8.2006

20.9.2006

Liechtenstein

31.10.2006

Iceland

Norway

21.9.2006

28.9.2006

EU/1/06/357/001-017

Gardasil

Liechtenstein

31.10.2006

EU/1/06/357/001-017/IS

Gardasil

EU/1/06/358/001/NO-017/NO

Silgard

EU/1/06/358/001-017

EU/1/06/358/001-017/IS

Silgard

Silgard

EU/1/06/359/001/NO-004/NO

Suboxone

Iceland

Norway

17.10.2006

29.9.2006

Liechtenstein

31.10.2006

Iceland

Norway

19.10.2006

26.10.2006

EU/1/06/359/001-004

Suboxone

Liechtenstein

31.10.2006

EU/1/06/359/001-004/IS

Suboxone

EU/1/06/360/001/NO-010/NO

Champix

EU/1/06/360/001-010/IS

Champix

EU/1/06/361/001/IS

Luminity

EU/1/06/362/001/NO-004/NO

Byetta

Iceland

Norway

Iceland

Iceland

Norway

24.10.2006

20.10.2006

24.10.2006

20.10.2006

13.12.2006

8.11.2007

EN

Official Journal of the European Union

C 266/21

EU-Number

Product

Country

Date of authorisation

EU/1/06/362/001-004

EU/1/06/362/001-004/IS

Byetta

Byetta

EU/1/06/363/001/NO-009/NO

Sprycel

EU/1/06/363/001-009/IS

Sprycel

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

Nobilis OR inac

EU/2/06/059/001/IS

EU/2/06/059/001/NO

Convenia

Convenia

EU/2/06/060/001/NO-002/NO

Poulvac FluFend H5N3

Liechtenstein

Iceland

Norway

Iceland

Iceland

Iceland

Norway

Norway

EU/2/06/060/001-002

Poulvac Flufend H5N3 RG

Liechtenstein

EU/2/06/060/001-002/IS

Poulvac Flufend H5N3 RG

EU/2/06/061/001/NO-004/NO

Nobilis Influenza H5N2

Iceland

Norway

31.12.2006

19.12.2006

20.12.2006

15.12.2006

3.8.2006

19.7.2006

6.7.2006

2.10.2006

31.10.2006

18.10.2006

2.10.2006

EU/2/06/061/001-004

Nobilis Influenza H5N2

Liechtenstein

31.10.2006

EU/2/06/061/001-004/IS

Nobilis Influenza

EU/2/06/062/001/NO-005/NO

Cerenia

EU/2/06/062/001-005

EU/2/06/062/001-005/IS

Cerenia

Cerenia

EU/2/06/063/001/NO-003/NO

Yarvitan

EU/2/06/063/001-003

EU/2/06/063/001-003/IS

Yarvitan

Yarvitan

Iceland

Norway

Liechtenstein

Iceland

Norway

Liechtenstein

Iceland

19.9.2006

31.10.2006

31.10.2006

19.10.2006

14.12.2006

31.12.2006

7.12.2006

C 266/22

EN

Official Journal of the European Union

8.11.2007

ANNEX II

List of renewed marketing authorisations

The following marketing authorisations have been renewed in the EEA EFTA States during the period 1 July-31 December
2006:

EU-Number

Product

Country

Date of renewal

EU/1/00/156/002-003/IS

Trizivir

Iceland

17.7.2006

EU/1/01/171/001, 007-012

Rapamune

Liechtenstein

31.8.2006

EU/1/01/179/001/IS

Osigraft

Iceland

4.9.2006

EU/1/01/183/001, 004-005, 007-008, 011,
013, 015, 018-029

EU/1/01/183/001/NO, 004/NO-005/NO, 007/
NO-008/NO, 011/NO, 013/NO, 015/NO, 018/
NO-029/NO

HBVAXPRO

Liechtenstein

31.8.2006

HBVAXPRO

Norway

1.9.2006

EU/1/01/184/001-056/IS

EU/1/01/185/001-056/IS

EU/1/01/186/001/NO-002/NO

EU/1/01/186/001-002

EU/1/01/186/001-002/IS

EU/1/01/187/001/IS

EU/1/01/188/001/NO-006/NO

EU/1/01/188/001-003/IS

Nespo

Aranesp

Nonafact

Nonafact

Nonafact

Depocyte

Fabrazyme

Fabrazyme

Iceland

Iceland

Norway

17.7.2006

13.7.2006

21.8.2006

Liechtenstein

31.8.2006

Iceland

Iceland

Norway

Iceland

29.8.2006

1.9.2006

28.8.2006

28.8.2006

EU/1/01/188/004-006

Fabrazyme

Liechtenstein

31.8.2006

EU/1/01/189/001-006

EU/1/01/189/001/IS

EU/1/01/189/001/NO-006/NO

EU/1/01/190/001/NO-002/NO

EU/1/01/190/001-002

EU/1/01/190/001-002/IS

EU/1/01/191/001/NO-005/NO

EU/1/01/191/001-005

EU/1/01/191/001-005/IS

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

EU/1/01/192/001-005

EU/1/01/192/001-005/IS

Replagal

Replagal

Replagal

Ceprotin

Ceprotin

Ceprotin

Ketek

Ketek

Ketek

Levviax

Levviax

Levviax

EU/1/01/193/001/NO-002/NO

MabCampath

Liechtenstein

31.8.2006

Iceland

Norway

Norway

28.8.2006

28.8.2006

22.8.2006

Liechtenstein

31.8.2006

Iceland

Norway

21.9.2006

16.10.2006

Liechtenstein

31.10.2006

Iceland

Norway

18.9.2006

16.10.2006

Liechtenstein

31.10.2006

Iceland

Norway

18.9.2006

10.8.2006

8.11.2007

EN

Official Journal of the European Union

C 266/23

EU-Number

Product

Country

Date of renewal

EU/1/01/193/001-002

MabCampath

Liechtenstein

31.8.2006

EU/1/01/193/001-002/IS

MabCampath

EU/1/01/194/001/NO-002/NO

EU/1/01/194/001-002

EU/1/01/194/001-002/IS

EU/1/01/196/001/NO-003/NO

EU/1/01/196/001-003

EU/1/01/196/001-003/IS

EU/1/01/197/001/NO-002/NO

EU/1/01/197/001-002

EU/1/01/197/001-002/IS

EU/1/01/198/001/NO-013/NO

EU/1/01/198/001-013

EU/1/01/198/001-013/IS

EU/1/01/199/001/NO-002/NO

EU/1/01/199/001-002

EU/1/01/199/001-002/IS

EU/1/02/201/001/NO-006/NO

EU/1/02/201/001-006

EU/1/02/202/001/NO-006/NO

EU/1/02/202/001-006

EU/1/06/015/001/NO-005/NO

EU/1/96/004/001-002/IS

EU/1/96/008/001-041/IS

EU/1/96/010/001

EU/1/96/010/001/IS

EU/1/96/010/001/NO

EU/1/96/012/001-013/IS

EU/1/96/012/004, 009-013

EU/1/96/012/004/NO, 009/NO-010/NO, 011/
NO-013/NO

INOmax

INOmax

INOmax

Cancidas

Cancidas

Cancidas

Foscan

Foscan

Foscan

Glivec

Glivec

Glivec

Travatan

Travatan

Travatan

Protopic

Protopic

Protopy

Protopy

Epivir

Fareston

Puregon

Rilutek

Rilutek

Rilutek

Bondronat

Bondronat

Bondronat

Iceland

Norway

28.8.2006

28.8.2006

Liechtenstein

31.8.2006

Iceland

Norway

8.11.2006

1.12.2006

Liechtenstein

31.10.2006

Iceland

Norway

13.10.2006

11.12.2006

Liechtenstein

31.12.2006

Iceland

Norway

1.12.2006

16.10.2006

Liechtenstein

31.10.2006

Iceland

Norway

16.10.2006

30.10.2006

Liechtenstein

31.10.2006

Iceland

Norway

9.11.2006

5.12.2006

Liechtenstein

31.12.2006

Norway

5.12.2006

Liechtenstein

31.12.2006

Norway

Iceland

Iceland

17.8.2006

18.9.2006

30.8.2006

Liechtenstein

31.8.2006

Iceland

Norway

Iceland

4.9.2006

4.9.2006

28.8.2006

Liechtenstein

31.8.2006

Norway

24.7.2006

EU/1/96/014/001/NO-003/NO

Tritanrix HepB

Norway

21.8.2006

EU/1/96/014/001-003

Tritanrix HepB

Liechtenstein

31.8.2006

EU/1/96/015/001-005

Epivir

Liechtenstein

31.8.2006

C 266/24

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Official Journal of the European Union

8.11.2007

EU-Number

Product

Country

Date of renewal

EU/1/96/015/001-005/IS

EU/1/96/016/001, 003

EU/1/96/016/001, 003/IS

EU/1/96/016/001/NO, 003/NO

EU/1/96/018/001

EU/1/96/018/001/IS

EU/1/96/018/001/NO

Epivir

Norvir

Norvir

Norvir

Rapilysin

Rapilysin

Rapilysin

EU/1/96/020/001/NO-009/NO

Twinrix Adult

Iceland

Liechtenstein

Iceland

Norway

Liechtenstein

Iceland

Norway

Norway

EU/1/96/020/001-009

Twinrix Adult

Liechtenstein

EU/1/96/020/001-009/IS

Twinrix Adult

Iceland

EU/1/96/022/002, 004, 006, 008-012, 014,
016-017, 019-022

Zyprexa

EU/1/96/022/002, 004, 006, 008-012, 014,
016-017, 019-022/IS

Zyprexa

EU/1/96/022/002/NO, 004/NO, 006/NO, 008/
NO-012/NO, 014/NO, 016/NO-017/NO, 019/
NO-022/NO

Zyprexa

EU/1/96/024/001/NO-005/NO, 007/NO-008/
NO, 010/NO

Crixivan

EU/1/96/024/001-005, 007-008, 010

EU/1/96/024/001-005, 007-008, 010/IS

EU/1/96/026/001/NO-002/NO

EU/1/96/026/001-002

EU/1/96/026/001-002/IS

EU/1/96/027/001, 003-005

EU/1/96/027/001/NO-005/NO

Crixivan

Crixivan

Invirase

Invirase

Invirase

Hycamtin

Hycamtin

Liechtenstein

Iceland

Norway

Iceland

Norway

Liechtenstein

Iceland

Liechtenstein

Norway

EU/1/97/029/001/NO-010/NO

Twinrix Paediatric

Norway

EU/1/97/029/001-0010/IS

Twinrix Paediatric

Iceland

EU/1/97/029/001-010

Twinrix Paediatric

Liechtenstein

EU/1/99/125/001/NO-008/NO

Zyprexa Velotab

Norway

EU/1/99/125/001-008

Zyprexa Velotab

Liechtenstein

EU/1/99/125/001-008/IS

Zyprexa Velotab

EU/2/00/023/001-004/IS

EU/2/00/027/001-003/IS

Advasure

Pirsue

Iceland

Iceland

Iceland

22.9.2006

31.12.2006

29.11.2006

6.12.2006

31.8.2006

4.9.2006

6.9.2006

25.9.2006

31.10.2006

16.10.2006

31.10.2006

29.9.2006

26.10.2006

1.12.2006

12.12.2006

31.12.2006

19.12.2006

31.12.2006

4.12.2006

25.9.2006

16.10.2006

31.10.2006

26.10.2006

31.10.2006

29.9.2006

7.11.2006

7.11.2006

Norway

7.12.2006

Liechtenstein

31.12.2006

EU/2/01/030/001-004

Virbagen Omega

Liechtenstein

31.12.2006

EU/2/01/030/001-004/IS

Virbagen Omega

EU/2/96/001/001-002, 009-010/IS

Porcilis Porcoli

Iceland

Iceland

4.12.2006

3.10.2006

8.11.2007

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Official Journal of the European Union

C 266/25

ANNEX III

List of extended marketing authorisations

The following marketing authorisations have been extended in the EEA EFTA States during the period 1 July-31 December
2006:

EU-Number

Product

Country

Date of extention

EU/02/215/011-012

EU/1/00/143/007-009

PritorPlus

Kogenate

Liechtenstein

31.12.2006

Liechtenstein

31.8.2006

EU/1/00/160/035-036

Aerius

Liechtenstein

31.10.2006

EU/1/01/172/004/NO-005/NO

Kaletra

Norway

11.7.2006

EU/1/01/172/004-005

EU/1/01/172/004-005/IS

EU/1/01/184/057-068

Kaletra

Kaletra

Nespo

Liechtenstein

31.8.2006

Iceland

12.7.2006

Liechtenstein

31.12.2006

EU/1/01/185/057-068

Aranesp

Liechtenstein

31.12.2006

EU/1/01/188/001-003

Fabrazyme

Liechtenstein

31.8.2006

EU/1/02/206/018-020

EU/1/02/207/018-020

Arixtra

Quixidar

Liechtenstein

31.10.2006

Liechtenstein

31.10.2006

EU/1/02/213/011-012

MicardisPlus

Liechtenstein

31.8.2006

EU/1/02/219/014-015

EU/1/03/256/007-010

EU/1/03/257/007-010

EU/1/03/260/013-015

Ebixa

Humira

Trudexa

Stalevo

Liechtenstein

31.12.2006

Liechtenstein

31.12.2006

Liechtenstein

31.12.2006

Liechtenstein

31.8.2006

EU/1/03/266/005-006/IS

Bondenza

Iceland

25.8.2006

EU/1/04/276/036

EU/1/04/276/036/NO

Abilify

Abilify

EU/1/04/279/033-035/IS

LYRICA

EU/1/04/285/029-036

EU/1/05/308/002

EU/1/05/323/012-013

EU/1/95/003/005-006

EU/1/98/082/005

Apidra

Aclasta

ProQuad

Betaferon

Comtess

Liechtenstein

31.10.2006

Norway

Iceland

21.12.2006

21.7.2006

Liechtenstein

31.10.2006

Liechtenstein

31.10.2006

Liechtenstein

31.10.2006

Liechtenstein

31.10.2006

Liechtenstein

31.8.2006

EU/1/98/085/023/NO-028/NO

Karvezide

Norway

22.9.2006

EU/1/98/085/023-028

Karvezide

Liechtenstein

31.10.2006

EU/1/98/085/023-028/IS

Karvezide

EU/1/98/086/023/NO-028/NO

CoAprovel

Iceland

Norway

18.9.2006

22.9.2006

C 266/26

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Official Journal of the European Union

8.11.2007

EU-Number

Product

Country

Date of extention

EU/1/98/086/023-028

EU/1/98/086/023-028/IS

EU/1/98/090/015-016

EU/1/99/111/010-011

EU/1/99/111/010-011/IS

EU/1/99/126/012

EU/1/99/126/012/NO

EU/1/99/126/012-18/IS

EU/1/99/126/013/NO-018/NO

EU/1/99/126/013-018

EU/2/05/053/002

CoAprovel

CoAprovel

Micardis

Stocrin

Stocrin

Enbrel

Enbrel

Enbrel

Enbrel

Enbrel

Naxcel

EU/2/05/056/003-004

Equilis Prequenza

EU/2/05/057/003-004

Equilis Prequenza Te

Liechtenstein

31.10.2006

Iceland

Liechtenstein

Liechtenstein

Iceland

Liechtenstein

Norway

Iceland

Norway

Liechtenstein

Liechtenstein

Liechtenstein

Liechtenstein

18.9.2006

31.8.2006

31.12.2006

15.12.2006

31.8.2006

23.8.2006

11.10.2006

23.10.2006

31.10.2006

31.10.2006

31.8.2006

31.8.2006

ANNEX IV

List of withdrawn marketing authorisations

following marketing authorisations have been withdrawn in the EEA EFTA States during the period

The
1 July-31 December 2006:

EU-Number

Product

Country

Date of withdrawal

EU/1/02/235/001-004

EU/1/02/235/001-004/IS

EU/1/02/235/001-004/NO

EU/1/02/236/001-004

EU/1/02/236/001-004/IS

EU/1/02/236/001-004/NO

Monotard

Monotard

Monotard

Ultratard

Ultratard

Ultratard

EU/1/98/075/001/NO-002/NO

Fortovase

EU/1/98/075/001-002/IS

Fortovase

Liechtenstein

Iceland

Norway

Liechtenstein

Iceland

Norway

Norway

Iceland

31.12.2006

16.11.2006

20.12.2006

31.12.2006

20.11.2006

13.12.2006

6.7.2006

4.7.2006