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

8.11.2007

EN

Official Journal of the European Union

C 266/7

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

(2007/C 266/05)

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 January-30 June 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List of withdrawn marketing authorisations

ANNEX V

List of suspended marketing authorisations

C 266/8

EN

Official Journal of the European Union

8.11.2007

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
2006:

EU-Number

Product

Country

Date of authorisation

EU/1/01/183/020-029

HBVAXPRO

Liechtenstein

28.2.2006

EU/1/01/187/001

DepoCyte

Liechtenstein

31.1.2006

EU/1/03/258/015-022

Avandamet

Liechtenstein

28.2.2006

EU/1/03/262/001-006

EU/1/03/265/003-004

EU/1/03/266/001-002

EU/1/04/307/005-010

EU/1/05/322/001

EU/1/05/322/001/IS

EU/1/05/322/001/NO

Emend

Bonviva

Bondenza

Zonegran

Yttriga

Yttriga

Yttriga

EU/1/05/323/001/NO-011/NO

ProQuad

EU/1/05/323/001-011

EU/1/05/323/001-011/IS

EU/1/05/324/001

EU/1/05/324/001/IS

EU/1/05/324/01/NO

EU/1/05/325/001

EU/1/05/325/001/IS

EU/1/05/325/001/NO

EU/1/05/326/001

EU/1/05/326/001/IS

EU/1/05/326/001/NO

ProQuad

ProQuad

Naglazyme

Naglazyme

Naglazyme

Macugen

Macugen

Macugen

Ionsys

Ionsys

Ionsys

EU/1/05/327/001/NO-017/NO

Exubera

EU/1/05/327/001-017

EU/1/05/327/001-017/IS

Exubera

Exubera

EU/1/05/328/001/NO-002/NO

Cubicin

EU/1/05/328/001-002

EU/1/05/328/001-002/IS

Cubicin

Cubicin

EU/1/05/329/001/NO-005/NO

Kiovig

Liechtenstein

31.1.2006

Liechtenstein

31.1.2006

Liechtenstein

28.2.2006

Liechtenstein

31.1.2006

Liechtenstein

31.1.2006

Iceland

Norway

Norway

17.2.2006

10.2.2006

24.4.2006

Liechtenstein

30.4.2006

Iceland

25.4.2006

Liechtenstein

31.1.2006

Iceland

Norway

22.6.2006

23.2.2006

Liechtenstein

28.2.2006

Iceland

Norway

10.3.2006

2.3.2006

Liechtenstein

31.1.2006

Iceland

Norway

Norway

22.2.2006

16.2.2006

16.2.2006

Liechtenstein

31.1.2006

Iceland

Norway

22.3.2006

16.2.2006

Liechtenstein

28.2.2006

Iceland

Norway

13.2.2006

27.1.2006

EU/1/05/329/001-005

Kiovig

Liechtenstein

31.1.2006

8.11.2007

EN

Official Journal of the European Union

C 266/9

EU-Number

Product

Country

Date of authorisation

EU/1/05/329/001-005/IS

Kiovig

EU/1/05/330/001/NO-004/NO

Rotarix

EU/1/05/330/001-004

EU/1/05/330/001-004/IS

Rotarix

Rotarix

EU/1/05/331/001/NO-013/NO

Neupro

EU/1/05/331/001-013

EU/1/05/331/001-013/IS

Neupro

Neupro

EU/1/06/332/001/NO-003/NO

Omnitrope

Iceland

Norway

10.2.2006

8.3.2006

Liechtenstein

28.2.2006

Iceland

Norway

27.4.2006

17.3.2006

Liechtenstein

28.2.2006

Iceland

Norway

10.4.2006

5.5.2006

EU/1/06/332/001-003

Omnitrope

Liechtenstein

30.4.2006

EU/1/06/332/001-003/IS

Omnitrope

EU/1/06/333/001/NO-003/NO

Myozyme

Iceland

Norway

11.5.2006

8.5.2006

EU/1/06/333/001-003

Myozyme

Liechtenstein

30.4.2006

EU/1/06/334/001/NO-004/NO

Evoltra

EU/1/06/334/001-004/IS

Evoltra

EU/1/06/335/001

EU/1/06/335/001/IS

EU/1/06/335/001/NO

EU/1/06/336/001

EU/1/06/336/001/IS

EU/1/06/336/001/NO

Valtropin

Valtropin

Valtropin

Tygacil

Tygacil

Tygacil

EU/1/06/337/001/NO-013/NO

M-M-Rvaxpro

Norway

Iceland

27.6.2006

26.6.2006

Liechtenstein

30.6.2006

Iceland

Norway

12.5.2006

24.5.2006

Liechtenstein

30.6.2006

Iceland

Norway

Norway

1.6.2006

24.5.2006

19.5.2006

EU/1/06/337/001-013

M-M-Rvaxpro

Liechtenstein

30.6.2006

EU/1/06/337/001-013/IS

M-M-Rvaxpro

EU/1/06/338/001/NO-003/NO

DuoTrav

EU/1/06/338/001-003

EU/1/06/338/001-003/IS

DuoTrav

DuoTrav

EU/1/06/339/001/NO-002/NO

Preotact

EU/1/06/339/001-002

EU/1/06/339/001-002/IS

Preotact

Preotact

EU/1/06/340/001/NO-002/NO

Ganfort

EU/1/06/340/001-002

EU/1/06/340/001-002/IS

Ganfort

Ganfort

EU/1/06/341/001/NO-013/NO

Zostavax

EU/1/06/341/001-013

EU/1/06/341/001-013/IS

Zostavax

Zostavax

Iceland

Norway

13.6.2006

10.5.2006

Liechtenstein

30.6.2006

Iceland

Norway

12.5.2006

19.5.2006

Liechtenstein

30.6.2006

Iceland

Norway

18.5.2006

1.6.2006

Liechtenstein

30.6.2006

Iceland

Norway

15.6.2006

6.6.2006

Liechtenstein

30.6.2006

Iceland

19.6.2006

C 266/10

EN

Official Journal of the European Union

8.11.2007

EU-Number

Product

Country

Date of authorisation

EU/1/06/344/001/NO-009/NO

Acomplia

Norway

30.6.2006

EU/1/06/344/001-009

Acomplia

Liechtenstein

30.6.2006

EU/1/06/345/001/NO-009/NO

Zimulti

Norway

30.6.2006

EU/1/06/345/001-009

EU/1/96/022/019-022

EU/1/97/043/003

EU/1/97/044/007-008

EU/1/97/046/031-033

EU/1/97/049/031-033

EU/1/97/055/003

EU/1/98/063/007

EU/2/00/025/001-004

EU/2/03/037/005

EU/2/03/038/005

EU/2/04/043/001

EU/2/04/044/001

EU/2/04/044/002-005

Zimulti

Zyprexa

Revasc

Tasmar

Aprovel

Karvea

Viramune

Rebif

Advasure

ProteqFlu

ProteqFlu Te

Equilis StrepE

Aivlosin

Aivlosin

Liechtenstein

30.6.2006

Liechtenstein

31.1.2006

Liechtenstein

31.1.2006

Liechtenstein

28.2.2006

Liechtenstein

31.1.2006

Liechtenstein

31.1.2006

Liechtenstein

31.1.2006

Liechtenstein

31.1.2006

Liechtenstein

28.2.2006

Liechtenstein

28.2.2006

Liechtenstein

28.2.2006

Liechtenstein

31.1.2006

Liechtenstein

31.1.2006

Liechtenstein

28.2.2006

EU/2/06/058/001/NO-003/NO

Flexicam

Norway

3.5.2006

EU/2/06/058/001-003

EU/2/06/058/001-003/IS

EU/2/06/059/001

EU/2/97/004/014-015

Flexicam

Flexicam

Convenia

Metacam

Liechtenstein

30.4.2006

Iceland

22.4.2006

Liechtenstein

30.6.2006

Liechtenstein

28.2.2006

8.11.2007

EN

Official Journal of the European Union

C 266/11

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
2006:

EU-Number

Product

Country

Date of renewal

EU/1/00/154/001/NO-002/NO

EU/1/00/154/001-002

EU/1/00/154/001-002/IS

EU/1/00/155/001/NO-006/NO

EU/1/00/155/001-006

EU/1/00/155/001-006/IS

EU/1/00/156/002/NO-003/NO

EU/1/00/156/002-003

EU/1/00/157/001-034

EU/1/00/160/001-034

EU/1/00/161/001-034

EU/1/00/163/001/NO

EU/1/00/163/001-002

EU/1/00/163/001-002/IS

EU/1/00/163/002/NO

Neospect

NeoSpect

NeoSpect

Luveris

Luveris

Luveris

Trizivir

Trizivir

Azomyr

Aerius

Norway

27.2.2006

Liechtenstein

28.2.2006

Iceland

Norway

22.2.2006

27.2.2006

Liechtenstein

31.1.2006

Iceland

Norway

25.4.2006

27.4.2006

Liechtenstein

30.4.2006

Liechtenstein

28.2.2006

Liechtenstein

28.2.2006

Neoclarityn

Liechtenstein

28.2.2006

Xeloda

Xeloda

Xeloda

Xeloda

Norway

3.3.2006

Liechtenstein

28.2.2006

Iceland

Norway

Norway

7.3.2006

3.3.2006

20.4.2006

EU/1/00/164/003/NO-006/NO

NutropinAq

EU/1/00/164/003-005

NutropinAq

Liechtenstein

30.4.2006

EU/1/00/164/003-005/IS

NutropinAq

EU/1/00/165/001/NO-007/NO

EU/1/00/165/001-007

EU/1/00/165/007/IS

EU/1/00/166/001/NO-003/NO

EU/1/00/166/001-003

EU/1/00/166/001-003/IS

EU/1/00/167/001/NO-007/NO

EU/1/00/167/001-007

EU/1/00/167/001-007/IS

EU/1/00/169/002/NO-004/NO

EU/1/00/169/004-006

EU/1/00/169/004-006/IS

Ovitrelle

Ovitrelle

Ovitrelle

NeuroBloc

NeuroBloc

NeuroBloc

Prevenar

Prevenar

Prevenar

Metalyse

Metalyse

Metalyse

Iceland

Norway

18.5.2006

2.3.2006

Liechtenstein

28.2.2006

Iceland

Norway

11.4.2006

3.5.2006

Liechtenstein

30.4.2006

Iceland

Norway

9.6.2006

3.5.2006

Liechtenstein

30.4.2006

Iceland

Norway

30.5.2006

14.3.2006

Liechtenstein

30.4.2006

Iceland

11.4.2006

C 266/12

EN

Official Journal of the European Union

8.11.2007

EU-Number

Product

Country

Date of renewal

EU/1/00/170/001/NO-002/NO

EU/1/00/170/001-002

EU/1/00/170/001-002(IS

Fasturtec

Fasturtec

Fasturtec

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

Rapamune

EU/1/01/171/001/NO, 007/NO-012/NO

Rapamune

EU/1/01/172/001/NO-003/NO

EU/1/01/172/001-003

EU/1/01/172/001-003/IS

EU/1/01/173/001/NO-003/NO

EU/1/01/173/001-003

EU/1/01/173/001-003/IS

EU/1/01/174/001/NO-007/NO

EU/1/01/174/001-021

EU/1/01/174/001-021/IS

EU/1/01/175/001, 004-007, 008, 011-014, 015,
018-021/IS

Kaletra

Kaletra

Kaletra

Vaniqa

Vaniqa

Vaniqa

Starlix

Starlix

Starlix

Trazec

Norway

27.2.2006

Liechtenstein

28.2.2006

Iceland

Iceland

Norway

Norway

7.3.2006

8.6.2006

5.5.2006

26.4.2006

Liechtenstein

30.4.2006

Iceland

Norway

23.5.2006

9.5.2006

Liechtenstein

30.4.2006

Iceland

Norway

7.6.2006

23.5.2006

Liechtenstein

30.6.2006

Iceland

Iceland

7.6.2006

7.6.2006

EU/1/01/175/001, 004-008, 011-015, 018-021

Trazec

Liechtenstein

30.6.2006

EU/1/01/175/001/NO, 004/NO-007/NO, 008/NO,
011/NO-014/NO, 015/NO, 018/NO-021/NO

Trazec

Norway

23.5.2006

EU/1/01/176/001/NO-003/NO

EU/1/01/176/001-006

EU/1/01/176/001-006/IS

EU/1/01/177/001/NO-002/NO

EU/1/01/177/001-002

EU/1/01/177/002/IS

EU/1/01/178/001/IS

EU/1/01/178/001/NO

EU/1/01/179/001

EU/1/01/179/001/NO

EU/1/01/184/001/NO-056/NO

EU/1/01/184/001-056

EU/1/01/185/001/NO-056/NO

EU/1/01/185/001-056

EU/1/01/187/001

EU/1/01/195/001/NO-015 /NO

Zometa

Zometa

Zometa

SonoVue

SonoVue

SonoVue

Targretin

Targretin

Osigraft

Osigraft

Nespo

Nespo

Aranesp

Aranesp

DepoCyte

Liprolog

Norway

2.5.2006

Liechtenstein

30.6.2006

Iceland

Norway

22.5.2006

4.5.2006

Liechtenstein

30.4.2006

Iceland

Iceland

8.6.2006

9.6.2006

Norway

16.5.2006

Liechtenstein

30.6.2006

Norway

Norway

30.5.2006

26.6.2006

Liechtenstein

30.6.2006

Norway

26.6.2006

Liechtenstein

30.6.2006

Liechtenstein

30.6.2006

Norway

14.3.2006

8.11.2007

EN

Official Journal of the European Union

C 266/13

EU-Number

Product

Country

Date of renewal

EU/1/01/195/001-015

EU/1/01/195/001-015/IS

EU/1/03/262/007-008/IS

EU/1/95/001/001, 003-005, 009, 012, 021-022,
025-028, 031-035

EU/1/95/002/001/NO-002/NO

EU/1/95/002/001-002

EU/1/95/002/001-002/IS

EU/1/95/003/003/NO-004/NO

EU/1/95/003/003-004

EU/1/95/003/003-004/IS

EU/1/96/004/001/NO-002/NO

EU/1/96/004/001-002

EU/1/96/005/001/NO-006/NO

EU/1/96/005/001-006

EU/1/96/005/001-006/IS

EU/1/96/006/001/NO-003/NO

EU/1/96/006/001-003

EU/1/96/006/001-003/IS

Liprolog

Liprolog

Emend

Gonal-f

Taxotere

Taxotere

Taxotere

Betaferon

Betaferon

Betaferon

Fareston

Fareston

CellCept

CellCept

CellCept

Novoseven

NovoSeven

NovoSeven

EU/1/96/007/002, 004-006, 008, 010-011, 015-
021, 023-030

Humalog

Liechtenstein

28.2.2006

Iceland

Iceland

13.3.2006

19.6.2006

Liechtenstein

31.1.2006

Norway

23.2.2006

Liechtenstein

31.1.2006

Iceland

Norway

23.2.2006

2.3.2006

Liechtenstein

28.2.2006

Iceland

Norway

10.4.2006

1.3.2006

Liechtenstein

28.2.2006

Norway

6.4.2006

Liechtenstein

30.4.2006

Iceland

Norway

5.5.2006

3.3.2006

Liechtenstein

28.2.2006

Iceland

10.4.2006

Liechtenstein

30.4.2006

EU/1/96/007/002, 004-006, 008, 010-011, 015-
021, 023-030/IS

Humalog

Iceland

13.3.2006

EU/1/96/007/002/NO, 004/NO-006/NO, 008/NO,
010/NO-011/NO, 015/NO-021/NO, 023/NO-030/
NO

Humalog

Norway

3.3.2006

EU/1/96/008/001/NO-040/NO

EU/1/96/008/001-041

EU/1/96/009/001/NO-002/NO

EU/1/96/009/001-009

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

EU/1/96/011/001/NO-004/NO

EU/1/96/011/001-004

EU/1/96/011/001-004/IS

EU/1/98/093/002/IS

EU/1/98/093/002/NO

EU/2/00/019/001-003/IS

Puregon

Puregon

Zerit

Zerit

Zerit

Caelyx

Caelyx

Caelyx

Forcaltonin

Forcaltonin

Purevax FeLV

Norway

26.6.2006

Liechtenstein

30.6.2006

Norway

2.5.2006

Liechtenstein

30.4.2006

Iceland

Norway

24.5.2006

26.5.2006

Liechtenstein

30.6.2006

Iceland

Iceland

Norway

Iceland

16.6.2006

31.5.2006

21.6.2006

9.3.2006

C 266/14

EN

Official Journal of the European Union

8.11.2007

EU-Number

Product

Country

Date of renewal

EU/2/00/025/001/NO-004/NO

Advasure

EU/2/00/026/001/NO-004/NO

Porcilis AR-T DF

Norway

Norway

15.3.2006

10.3.2006

EU/2/00/026/001-004

Porcilis AR-T DF

Liechtenstein

28.2.2006

EU/2/00/026/001-004/IS

Porcilis AR-T DF

EU/2/00/027/001/NO-003/NO

EU/2/00/027/001-003

EU/2/00/028/002/NO-008 /NO

EU/2/00/028/002-008

EU/2/00/028/002-008/IS

Pirsue

Pirsue

Zubrin

Zubrin

Zubrin

EU/2/01/029/001/NO-003/NO

Eurican Herpes

Iceland

Norway

8.3.2006

10.3.2006

Liechtenstein

28.2.2006

Norway

7.4.2006

Liechtenstein

30.4.2006

Iceland

Norway

11.4.2006

18.5.2006

EU/2/01/029/001-003

Eurican Herpes

Liechtenstein

30.4.2006

EU/2/01/029/001-003/IS

Eurican Herpes

Iceland

8.6.2006

EU/2/96/001/001-010

Porcilis Porcoli

Liechtenstein

30.4.2006

EU/2/96/001/NO-010/NO

Porcilis Porcoli

Norway

5.5.2006

8.11.2007

EN

Official Journal of the European Union

C 266/15

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
2006:

EU-Number

Product

Country

Date of extention

EU/1/00/137/013-018

Avandia

Liechtenstein

30.6.2006

EU/1/00/146/030

EU/1/00/146/030/IS

EU/1/00/146/030/NO

EU/1/00/150/016-024

EU/1/00/151/014-022

EU/1/00/162/019-021

EU/1/03/255/004-005

Keppra

Keppra

Keppra

Actos

Glustin

Prandin

Ventavis

Liechtenstein

30.4.2006

Iceland

Norway

7.4.2006

28.4.2006

Liechtenstein

30.4.2006

Liechtenstein

30.4.2006

Liechtenstein

30.6.2006

Liechtenstein

30.6.2006

EU/1/03/262/007/NO-008/NO

Emend

Norway

28.6.2006

EU/1/03/262/007-008

EU/1/03/262/007-008/IS

Emend

Emend

EU/1/03/265/005/NO-006/NO

Bonviva

EU/1/03/265/005-006/IS

Bonviva

EU/1/03/266/005/NO-006/NO

Bondenza

EU/1/04/279/033/NO-035/NO

EU/1/04/279/033-035

EU/1/04/296/007

EU/1/04/296/008

EU/1/04/297/007

EU/1/04/297/008

EU/1/04/302/004

EU/1/04/302/004/IS

EU/1/04/302/004/NO

EU/1/05/319/003-004

Lyrica

Lyrica

Cymbalta

Cymbalta

Xeristar

Xeristar

Prialt

Prialt

Prialt

Xolair

Liechtenstein

30.6.2006

Iceland

Norway

Iceland

Norway

Norway

19.6.2006

2.5.2006

12.6.2006

8.5.2006

19.6.2006

Liechtenstein

30.6.2006

Liechtenstein

30.4.2006

Liechtenstein

30.6.2006

Liechtenstein

30.4.2006

Liechtenstein

30.6.2006

Liechtenstein

30.4.2006

Iceland

Norway

22.4.2006

29.3.2006

Liechtenstein

30.6.2006

EU/1/96/007/029-030

Humalog

Liechtenstein

30.4.2006

EU/1/98/063/007/IS

EU/1/98/063/007/NO

Rebif

Rebif

Iceland

Norway

30.5.2006

16.2.2006

EU/1/98/076/022-024

NovoNorm

Liechtenstein

30.6.2006

EU/1/98/089/017-019

EU/1/99/107/005

Pritor

Rebetol

Liechtenstein

30.4.2006

Liechtenstein

30.4.2006

C 266/16

EN

Official Journal of the European Union

8.11.2007

EU-Number

Product

EU/2/00/019/005-007/IS

Purevax FeL V

EU/2/02/035/007

EU/2/03/037/005/NO

SevoFlo

Proteqflu

EU/2/03/038/005/NO

Proteqflu-Te

EU/2/04/044/002/NO

EU/2/04/044/003-005/IS

Aivlosin

Aivlosin

EU/2/97/004/016/NO-023/NO

Metacam

EU/2/97/004/016-023

EU/2/97/004/016-023/IS

Metacam

Metacam

Country

Iceland

Date of extention

9.3.2006

Liechtenstein

30.4.2006

Norway

Norway

Norway

Iceland

Norway

15.3.2006

15.3.2006

4.3.2006

22.3.2006

22.4.2006

Liechtenstein

30.4.2006

Iceland

7.4.2006

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
2006:

EU-Number

Product

Country

Date of withdrawal

EU/1/00/137/001

Avandia

Liechtenstein

30.6.2006

EU/1/01/183/002-003, 006, 009-010,
012, 014, 016-17

HBVAXPRO

Liechtenstein

28.2.2006

EU/1/02/245/001

EU/1/02/245/001/IS

EU/1/06/024/006, 009

EU/1/96/022/001, 003, 005, 007, 013,
015

Theryttrex

Theryttrex

Crixivan

Zyprexa

EU/1/97/052/001/NO-006/NO,
NO-010/NO

009/

Daquiran

Liechtenstein

28.2.2006

Iceland

10.2.2006

Liechstenstein

31.1.2006

Liechstenstein

31.1.2006

Norway

22.2.2006

EU/1/97/052/001-006, 009-010

Daquiran

Liechtenstein

28.2.2006

EU/1/97/052/001-010/IS

EU/1/98/075/001-002

Daquiran

Fortovase

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

Fortovase- Saquinavir

EU/1/98/087/001/NO-003/NO

Infergen

EU/1/98/087/001-003

EU/1/98/087/001-003/IS

EU/2/00/028/001

EU/2/98/010/001-003, 015-016, 019-
020

Infergen

Infergen

Zubrin

Econor

Iceland

10.2.2006

Liechtenstein

30.6.2006

Iceland

Norway

26.6.2006

30.5.2006

Liechtenstein

30.6.2006

Iceland

16.6.2006

Liechtenstein

28.2.2006

Liechtenstein

31.1.2006

8.11.2007

EN

Official Journal of the European Union

C 266/17

ANNEX V

List of suspended marketing authorisations

The following marketing authorisations have been suspended in the EEA EFTA States during the period 1 January-30 June
2006:

EU-Number

Product

Country

Date of suspention

EU/1/02/239/001-030

Bextra

Liechtenstein

31.1.2006