# C_2006291EN.01006901.xml

| 30.11.2006 | EN | Official Journal of the European Union | C 291/69 |
| --- | --- | --- | --- |

30.11.2006

EN

Official Journal of the European Union

C 291/69

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List of marketing authorisations granted by the EEA EFTA States for the second half of 2005

(2006/C 291/20)

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 2 June 2006, the following lists concerning marketing authorisations for medicinal products for the period 1 June — 31 December 2005:

| 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| Annex IV | List of withdrawn marketing authorisations |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 |

Annex I

List of new marketing authorisations

new

Annex II

List of renewed marketing authorisations

renewed

Annex III

List of extended marketing authorisations

extended

Annex IV

List of withdrawn marketing authorisations

withdrawn

Annex V

List of suspended marketing authorisations

suspended

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ANNEX I

1.   New Marketing Authorisations:

The following marketing authorisations have been granted in the EEA EFTA States during the period 1 June — 31 December 2005:

| EU-Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/00/129/001-003 | Azopt | Liechtenstein | 31.7.2005 |
| EU/1/00/131/001-030 | PegIntron | Liechtenstein | 30.9.2005 |
| EU/1/00/134/008-011 | Lantus | Liechtenstein | 30.9.2005 |
| EU/1/00/135/002 | DaTSCAN | Liechtenstein | 30.9.2005 |
| EU/1/00/142/009-010 | NovoMix | Liechtenstein | 30.9.2005 |
| EU/1/00/142/011-016 | NovoMix | Liechtenstein | 30.11.2005 |
| EU/1/00/142/017-022 | NovoMix | Liechtenstein | 30.11.2005 |
| EU/1/01/198/007-010 | Glivec | Liechtenstein | 31.7.2005 |
| EU/1/02/215/001/NO-010/NO | Pritor Plus | Norway | 7.9.2005 |
| EU/1/02/227/003 | Neulasta | Liechtenstein | 30.11.2005 |
| EU/1/02/228/003 | Neupopeg | Liechtenstein | 30.11.2005 |
| EU/1/03/255/001-003 | Ventavis | Liechtenstein | 30.11.2005 |
| EU/1/03/258/013-014 | Avandamet | Liechtenstein | 30.9.2005 |
| EU/1/03/263/001-003/IS | Dukoral, Suspension of vaccine and effervescent granules for oral solution | Iceland | 6.10.2005 |
| EU/1/03/265/003-004 | Bonviva | Liechtenstein | 30.9.2005 |
| EU/1/03/266/003-004 | Bondenza | Liechtenstein | 30.9.2005 |
| EU/1/03/269/001 | Faslodex | Liechtenstein | 30.11.2005 |
| EU/1/03/270/003 | Kentera | Liechtenstein | 31.7.2005 |
| EU/1/04/276/021-032 | Abilify | Liechtenstein | 31.7.2005 |
| EU/1/04/276/033-035 | Abilify | Liechtenstein | 30.11.2005 |
| EU/1/04/279/030-032 | Lyrica | Liechtenstein | 30.9.2005 |
| EU/1/04/280/007 | Yentreve | Liechtenstein | 30.9.2005 |
| EU/1/04/283/007 | Ariclaim | Liechtenstein | 30.9.2005 |
| EU/1/04/289/002 | Angiox | Liechtenstein | 31.7.2005 |
| EU/1/04/296/005-006 | Cymbalta | Liechtenstein | 31.7.2005 |
| EU/1/04/297/005-006 | Xeristar | Liechtenstein | 31.7.2005 |
| EU/1/05/310/001/NO-005/NO | Fosavance | Norway | 6.9.2005 |
| EU/1/05/310/001-005 | Fosavance | Liechtenstein | 30.9.2005 |
| EU/1/05/310/001-005/IS | Fosavance tablets | Iceland | 20.9.2005 |
| EU/1/05/311/001/NO-003/NO | Tarceva | Norway | 26.9.2005 |
| EU/1/05/311/001-003 | Tarceva | Liechtenstein | 30.9.2005 |
| EU/1/05/311/001-003/IS | Tarceva | Iceland | 18.10.2005 |
| EU/1/05/312/001/IS | Xyrem | Iceland | 18.11.2005 |
| EU/1/05/312/001/NO | Xyrem | Norway | 18.11.2005 |
| EU/1/05/313/001/NO-009/NO | Vasovist | Norway | 14.10.2005 |
| EU/1/05/313/001-009 | Vasovist | Liechtenstein | 30.11.2005 |
| EU/1/05/313/001-009/IS | Vasovist | Iceland | 2.11.2005 |
| EU/1/05/314/001 | Kepivance | Liechtenstein | 30.11.2005 |
| EU/1/05/314/001/IS | Kepivance | Iceland | 24.11.2005 |
| EU/1/05/314/001/NO | Kepivance | Norway | 22.11.2005 |
| EU/1/05/315/001 | Aptivus | Liechtenstein | 30.11.2005 |
| EU/1/05/315/001/IS | Aptivus | Iceland | 25.11.2005 |
| EU/1/05/315/001/NO | Aptivus | Norway | 2.11.2005 |
| EU/1/05/316/001/NO-014/NO | Procoralan | Norway | 10.11.2005 |
| EU/1/05/316/001-014 | Procoralan | Liechtenstein | 30.11.2005 |
| EU/1/05/316/001-014/IS | Procoralan | Iceland | 24.11.2005 |
| EU/1/05/317/001/NO-014/NO | Corlentor | Norway | 10.11.2005 |
| EU/1/05/317/001-014 | Corlentor | Liechtenstein | 30.11.2005 |
| EU/1/05/317/001-014/IS | Corlentor | Iceland | 24.11.2005 |
| EU/1/05/318/001 | Revatio | Liechtenstein | 30.11.2005 |
| EU/1/05/318/001/IS | Revatio | Iceland | 28.11.2005 |
| EU/1/05/318/001/NO | Revatio | Norway | 11.11.2005 |
| EU/1/05/319/001/NO-002/NO | Xolair | Norway | 7.11.2005 |
| EU/1/05/319/001-002 | Xolair | Liechtenstein | 30.11.2005 |
| EU/1/05/319/001-002/IS | Xolair | Iceland | 25.11.2005 |
| EU/1/05/320/001 | Noxafil | Liechtenstein | 30.11.2005 |
| EU/1/05/320/001/IS | Noxafil | Iceland | 20.11.2005 |
| EU/1/05/320/001/NO | Noxafil | Norway | 23.11.2005 |
| EU/1/05/321/001 | Posaconazole SP | Liechtenstein | 30.11.2005 |
| EU/1/05/321/001/IS | Posaconazole SP | Iceland | 24.11.2005 |
| EU/1/05/321/001/NO | Posaconazole SP | Norway | 23.11.2005 |
| EU/2/01/030/003-004 | Virbagen Omega | Liechtenstein | 30.9.2005 |
| EU/2/04/047/001-002/IS | Purevax RCPCh Fel V, powder and solv. for susp. for injection | Iceland | 30.6.2005 |
| EU/2/04/048/001-002/IS | Purevax RCP Fel V, powder and solv. for susp. for injection | Iceland | 30.6.2005 |
| EU/2/04/049/001-002/IS | Purevax RCCh, powder and solvent for suspension for injection | Iceland | 30.6.2005 |
| EU/2/04/050/001-002/IS | Purevax RCPCh, powder and solv. for susp. for injection | Iceland | 30.6.2005 |
| EU/2/04/051/001-002/IS | Purevax RC, powder and solvent for suspension for injection | Iceland | 30.6.2005 |
| EU/2/04/052/001-002/IS | Purevax RCP, powder and solvent for suspension for injection | Iceland | 30.6.2005 |
| EU/2/05/053/001 | Naxcel | Liechtenstein | 31.7.2005 |
| EU/2/05/053/001/IS | Naxcel, suspension for injection | Iceland | 9.6.2005 |
| EU/2/05/053/001/NO | Naxcel | Norway | 17.6.2005 |
| EU/2/05/054/001/NO-017/NO | Profender | Norway | 30.8.2005 |
| EU/2/05/054/001-017 | Profender | Liechtenstein | 30.9.2005 |
| EU/2/05/054/001-017/IS | Profender Spot-on solution | Iceland | 26.8.2005 |
| EU/2/05/055/001/NO-002/NO | Equilis Te | Norway | 12.8.2005 |
| EU/2/05/055/001-002 | Equilis Te | Liechtenstein | 30.9.2005 |
| EU/2/05/055/001-002/IS | Equilis Te, susp. for injection | Iceland | 2.8.2005 |
| EU/2/05/056/001/NO-002/NO | Equilis Prequenza | Norway | 12.8.2005 |
| EU/2/05/056/001-002 | Equilis Prequenza | Liechtenstein | 30.9.2005 |
| EU/2/05/056/001-002/IS | Equilis Prequenza, susp. for injection | Iceland | 2.08.2005 |
| EU/2/05/057/001/NO-002/NO | Equilis Prequenza Te | Norway | 12.8.2005 |
| EU/2/05/057/001-002 | Equilis Prequenza Te | Liechtenstein | 30.9.2005 |
| EU/2/05/057/001-002/IS | Equilis Prequenza Te, susp. for injection | Iceland | 2.8.2005 |
| EU/2/97/004/011 | Metacam | Liechtenstein | 31.7.2005 |
| EU/2/97/004/012-013 | Metacam | Liechtenstein | 30.9.2005 |

EU-Number

Product

Country

Date of authorisation

EU/1/00/129/001-003

Azopt

Liechtenstein

31.7.2005

EU/1/00/131/001-030

PegIntron

Liechtenstein

30.9.2005

EU/1/00/134/008-011

Lantus

Liechtenstein

30.9.2005

EU/1/00/135/002

DaTSCAN

Liechtenstein

30.9.2005

EU/1/00/142/009-010

NovoMix

Liechtenstein

30.9.2005

EU/1/00/142/011-016

NovoMix

Liechtenstein

30.11.2005

EU/1/00/142/017-022

NovoMix

Liechtenstein

30.11.2005

EU/1/01/198/007-010

Glivec

Liechtenstein

31.7.2005

EU/1/02/215/001/NO-010/NO

Pritor Plus

Norway

7.9.2005

EU/1/02/227/003

Neulasta

Liechtenstein

30.11.2005

EU/1/02/228/003

Neupopeg

Liechtenstein

30.11.2005

EU/1/03/255/001-003

Ventavis

Liechtenstein

30.11.2005

EU/1/03/258/013-014

Avandamet

Liechtenstein

30.9.2005

EU/1/03/263/001-003/IS

Dukoral, Suspension of vaccine and effervescent granules for oral solution

Iceland

6.10.2005

EU/1/03/265/003-004

Bonviva

Liechtenstein

30.9.2005

EU/1/03/266/003-004

Bondenza

Liechtenstein

30.9.2005

EU/1/03/269/001

Faslodex

Liechtenstein

30.11.2005

EU/1/03/270/003

Kentera

Liechtenstein

31.7.2005

EU/1/04/276/021-032

Abilify

Liechtenstein

31.7.2005

EU/1/04/276/033-035

Abilify

Liechtenstein

30.11.2005

EU/1/04/279/030-032

Lyrica

Liechtenstein

30.9.2005

EU/1/04/280/007

Yentreve

Liechtenstein

30.9.2005

EU/1/04/283/007

Ariclaim

Liechtenstein

30.9.2005

EU/1/04/289/002

Angiox

Liechtenstein

31.7.2005

EU/1/04/296/005-006

Cymbalta

Liechtenstein

31.7.2005

EU/1/04/297/005-006

Xeristar

Liechtenstein

31.7.2005

EU/1/05/310/001/NO-005/NO

Fosavance

Norway

6.9.2005

EU/1/05/310/001-005

Fosavance

Liechtenstein

30.9.2005

EU/1/05/310/001-005/IS

Fosavance tablets

Iceland

20.9.2005

EU/1/05/311/001/NO-003/NO

Tarceva

Norway

26.9.2005

EU/1/05/311/001-003

Tarceva

Liechtenstein

30.9.2005

EU/1/05/311/001-003/IS

Tarceva

Iceland

18.10.2005

EU/1/05/312/001/IS

Xyrem

Iceland

18.11.2005

EU/1/05/312/001/NO

Xyrem

Norway

18.11.2005

EU/1/05/313/001/NO-009/NO

Vasovist

Norway

14.10.2005

EU/1/05/313/001-009

Vasovist

Liechtenstein

30.11.2005

EU/1/05/313/001-009/IS

Vasovist

Iceland

2.11.2005

EU/1/05/314/001

Kepivance

Liechtenstein

30.11.2005

EU/1/05/314/001/IS

Kepivance

Iceland

24.11.2005

EU/1/05/314/001/NO

Kepivance

Norway

22.11.2005

EU/1/05/315/001

Aptivus

Liechtenstein

30.11.2005

EU/1/05/315/001/IS

Aptivus

Iceland

25.11.2005

EU/1/05/315/001/NO

Aptivus

Norway

2.11.2005

EU/1/05/316/001/NO-014/NO

Procoralan

Norway

10.11.2005

EU/1/05/316/001-014

Procoralan

Liechtenstein

30.11.2005

EU/1/05/316/001-014/IS

Procoralan

Iceland

24.11.2005

EU/1/05/317/001/NO-014/NO

Corlentor

Norway

10.11.2005

EU/1/05/317/001-014

Corlentor

Liechtenstein

30.11.2005

EU/1/05/317/001-014/IS

Corlentor

Iceland

24.11.2005

EU/1/05/318/001

Revatio

Liechtenstein

30.11.2005

EU/1/05/318/001/IS

Revatio

Iceland

28.11.2005

EU/1/05/318/001/NO

Revatio

Norway

11.11.2005

EU/1/05/319/001/NO-002/NO

Xolair

Norway

7.11.2005

EU/1/05/319/001-002

Xolair

Liechtenstein

30.11.2005

EU/1/05/319/001-002/IS

Xolair

Iceland

25.11.2005

EU/1/05/320/001

Noxafil

Liechtenstein

30.11.2005

EU/1/05/320/001/IS

Noxafil

Iceland

20.11.2005

EU/1/05/320/001/NO

Noxafil

Norway

23.11.2005

EU/1/05/321/001

Posaconazole SP

Liechtenstein

30.11.2005

EU/1/05/321/001/IS

Posaconazole SP

Iceland

24.11.2005

EU/1/05/321/001/NO

Posaconazole SP

Norway

23.11.2005

EU/2/01/030/003-004

Virbagen Omega

Liechtenstein

30.9.2005

EU/2/04/047/001-002/IS

Purevax RCPCh Fel V, powder and solv. for susp. for injection

Iceland

30.6.2005

EU/2/04/048/001-002/IS

Purevax RCP Fel V, powder and solv. for susp. for injection

Iceland

30.6.2005

EU/2/04/049/001-002/IS

Purevax RCCh, powder and solvent for suspension for injection

Iceland

30.6.2005

EU/2/04/050/001-002/IS

Purevax RCPCh, powder and solv. for susp. for injection

Iceland

30.6.2005

EU/2/04/051/001-002/IS

Purevax RC, powder and solvent for suspension for injection

Iceland

30.6.2005

EU/2/04/052/001-002/IS

Purevax RCP, powder and solvent for suspension for injection

Iceland

30.6.2005

EU/2/05/053/001

Naxcel

Liechtenstein

31.7.2005

EU/2/05/053/001/IS

Naxcel, suspension for injection

Iceland

9.6.2005

EU/2/05/053/001/NO

Naxcel

Norway

17.6.2005

EU/2/05/054/001/NO-017/NO

Profender

Norway

30.8.2005

EU/2/05/054/001-017

Profender

Liechtenstein

30.9.2005

EU/2/05/054/001-017/IS

Profender Spot-on solution

Iceland

26.8.2005

EU/2/05/055/001/NO-002/NO

Equilis Te

Norway

12.8.2005

EU/2/05/055/001-002

Equilis Te

Liechtenstein

30.9.2005

EU/2/05/055/001-002/IS

Equilis Te, susp. for injection

Iceland

2.8.2005

EU/2/05/056/001/NO-002/NO

Equilis Prequenza

Norway

12.8.2005

EU/2/05/056/001-002

Equilis Prequenza

Liechtenstein

30.9.2005

EU/2/05/056/001-002/IS

Equilis Prequenza, susp. for injection

Iceland

2.08.2005

EU/2/05/057/001/NO-002/NO

Equilis Prequenza Te

Norway

12.8.2005

EU/2/05/057/001-002

Equilis Prequenza Te

Liechtenstein

30.9.2005

EU/2/05/057/001-002/IS

Equilis Prequenza Te, susp. for injection

Iceland

2.8.2005

EU/2/97/004/011

Metacam

Liechtenstein

31.7.2005

EU/2/97/004/012-013

Metacam

Liechtenstein

30.9.2005

---

ANNEX II

2.   Renewed Marketing Authorisations

The following marketing authorisations have been renewed in the EEA EFTA States during the period 1 June — 31 December 2005:

| EU-Number | Product | Country | Date of renewal |
| --- | --- | --- | --- |
| EU/1/00/129/001/NO-003/NO | Azopt | Norway | 30.6.2005 |
| EU/1/00/129/001-003/IS | Azopt, eye drops, suspension, 1% | Iceland | 30.6.2005 |
| EU/1/05/131/001/NO-005/NO | PegIntron | Norway | 24.06.2005 |
| EU/1/00/131/001-050/IS | PegIntron | Iceland | 28.6.2005 |
| EU/1/00/131/031-050 | PegIntron | Liechtenstein | 30.9.2005 |
| EU/1/05/132/001/NO-005/NO | ViraferonPeg | Norway | 24.6.2005 |
| EU/1/00/132/001-050 | ViraferonPeg | Liechtenstein | 31.7.2005 |
| EU/1/00/132/001-050/IS | ViraferonPeg | Iceland | 28.6.2005 |
| EU/1/00/133/001/NO-008/NO | Optisulin | Norway | 27.7.2005 |
| EU/1/00/133/001-008 | Optisulin | Liechtenstein | 30.9.2005 |
| EU/1/00/133/001-008/IS | Optisulin | Iceland | 29.8.2005 |
| EU/1/00/134/001/NO-029/NO | Lantus | Norway | 27.7.2005 |
| EU/1/00/134/001-007, 012-029 | Lantus | Liechtenstein | 30.9.2005 |
| EU/1/00/134/001-029/IS | Lantus | Iceland | 29.8.2005 |
| EU/1/00/135/001 | DaTSCAN | Liechtenstein | 30.9.2005 |
| EU/1/00/135/001/NO-002/NO | DaTSCAN | Norway | 20.9.2005 |
| EU/1/00/135/001-002/IS | DaTSCAN | Iceland | 11.10.2005 |
| EU/1/00/137/001/NO-012/NO | Avandia | Norway | 27.7.2005 |
| EU/1/00/137/001-012 | Avandia | Liechtenstein | 30.9.2005 |
| EU/1/00/137/001-012/IS | Avandia | Iceland | 16.9.2005 |
| EU/1/00/140/001 | Visudyne | Liechtenstein | 31.7.2005 |
| EU/1/00/140/001/IS | Visudyne 15 mg Powder for solution for injection | Iceland | 14.7.2005 |
| EU/1/00/140/001/NO | Visudyne | Norway | 27.7.2005 |
| EU/1/00/141/001 | Myocet | Liechtenstein | 30.9.2005 |
| EU/1/00/141/001/IS | Myocet | Iceland | 13.10.2005 |
| EU/1/00/141/001/NO | Myocet | Norway | 28.9.2005 |
| EU/1/00/142/004/NO-005/NO | NovoMix Penfill | Norway | 13.10.2005 |
| EU/1/00/142/004-005 | NovoMix | Liechtenstein | 30.9.2005 |
| EU/1/00/142/004-005/IS | NovoMix 30 Penfill | Iceland | 21.10.2005 |
| EU/1/00/142/009/NO-010/NO | NovoMix Flexpen | Norway | 13.10.2005 |
| EU/1/00/142/009-010/IS | NovoMix 30 FlexPen | Iceland | 21.10.2005 |
| EU/1/00/143/001/NO-006/NO | Kogenate Bayer | Norway | 7.9.2005 |
| EU/1/00/143/001-006 | Kogenate | Liechtenstein | 30.9.2005 |
| EU/1/00/143/001-006/IS | Kogenate Bayer | Iceland | 7.10.2005 |
| EU/1/00/144/001/NO-003/NO | Helixate NexGen | Norway | 7.9.2005 |
| EU/1/00/144/001-003 | Helixate | Liechtenstein | 30.9.2005 |
| EU/1/00/144/001-003/IS | Helixate NexGen | Iceland | 7.10.2005 |
| EU/1/00/145/001 | Herceptin | Liechtenstein | 30.9.2005 |
| EU/1/00/145/001/IS | Herceptin | Iceland | 28.11.2005 |
| EU/1/00/145/001/NO | Herceptin | Norway | 23.9.2005 |
| EU/1/00/146/001/NO-029/NO | Keppra | Norway | 08.8.2005 |
| EU/1/00/146/001-029 | Keppra | Liechtenstein | 30.9.2005 |
| EU/1/00/146/001-029/IS | Keppra | Iceland | 12.9.2005 |
| EU/1/00/148/001/NO-004/NO | Agenerase | Norway | 12.12.2005 |
| EU/1/00/148/001-004 | Agenerase | Liechtenstein | 30.11.2005 |
| EU/1/00/148/001-004/IS | Agenerase | Iceland | 16.12.2005 |
| EU/1/00/149/001 | Panretin | Liechtenstein | 30.11.2005 |
| EU/1/00/149/001/IS | Panretin | Iceland | 16.12.2005 |
| EU/1/00/149/001/NO | Panretin | Norway | 9.12.2005 |
| EU/1/00/150/001/NO-015/NO | Actos | Norway | 2.11.2005 |
| EU/1/00/150/001-015 | Actos | Liechtenstein | 30.11.2005 |
| EU/1/00/150/001-015/IS | Actos | Iceland | 11.11.2005 |
| EU/1/00/151/001/NO-013/NO | Glustin | Norway | 2.11.2005 |
| EU/1/00/151/001-013 | Glustin | Liechtenstein | 30.11.2005 |
| EU/1/00/151/001-013/IS | Glustin | Iceland | 11.11.2005 |
| EU/1/00/152/001-018 | Infanrix hexa | Liechtenstein | 30.11.2005 |
| EU/1/00/153/001-010 | Infanrix penta | Liechtenstein | 30.11.2005 |
| EU/1/00/153/001-010/IS | Infanrix penta | Iceland | 16.12.2005 |
| EU/1/00/153/001-010/NO | Infanrix penta | Norway | 7.12.2005 |
| EU/1/00152/001-018/NO | Infanrix hexa | Norway | 7.12.2005 |
| EU/1/95/001/001, 003-005, 009, 012, 021-022, 025-028, 031-035/IS | Gonal-F | Iceland | 15.11.2005 |
| EU/1/95/001/001/NO | Gonal-F | Norway | 11.11.2005 |
| EU/1/95/001/003/NO-006/NO | Gonal-F | Norway | 11.11.2005 |
| EU/1/95/001/009/NO | Gonal-F | Norway | 11.11.2005 |
| EU/1/95/001/012/NO | Gonal-F | Norway | 11.11.2005 |
| EU/1/95/001/021/NO-022/NO | Gonal-F | Norway | 11.11.2005 |
| EU/1/95/001/025/NO-028/NO | Gonal-F | Norway | 11.11.2005 |
| EU/1/95/001/031/NO-035/NO | Gonal-F | Norway | 11.11.2005 |
| EU/1/98/093/002 | Forcaltonin | Liechtenstein | 31.7.2005 |
| EU/1/99/127/001/NO-044/NO | IntronA | Norway | 20.6.2005 |
| EU/1/99/127/001-044 | IntronA | Liechtenstein | 31.7.2005 |
| EU/1/99/127/001-044/IS | IntronA | Iceland | 27.6.2005 |
| EU/1/99/128/001/NO-037/NO | Viraferon | Norway | 20.6.2005 |
| EU/1/99/128/001-037 | Viraferon | Liechtenstein | 31.7.2005 |
| EU/1/99/128/001-037/IS | Viraferon | Iceland | 27.6.2005 |
| EU/2/00/018/001 | Incurin | Liechtenstein | 31.7.2005 |
| EU/2/00/018/001/NO | Incurin | Norway | 16.6.2005 |
| EU/2/00/022//002b-03a | Ibaflin | Liechtenstein | 30.9.2005 |
| EU/2/00/022/001/NO-017/NO | Ibaflin | Norway | 31.8.2005 |
| EU/2/00/022/001-017/IS | Ibaflin | Iceland | 15.07.2005 |
| EU/2/00/022/001a | Ibaflin | Liechtenstein | 30.9.2005 |
| EU/2/00/022/001b-02a | Ibaflin | Liechtenstein | 30.9.2005 |
| EU/2/00/022/003b-04a | Ibaflin | Liechtenstein | 30.9.2005 |
| EU/2/00/022/004b | Ibaflin | Liechtenstein | 30.9.2005 |
| EU/2/00/022/005-017 | Ibaflin | Liechtenstein | 30.9.2005 |
| EU/2/00/024/001/IS | Pruban | Iceland | 16.12.2005 |
| EU/2/99/016/001/NO-006/NO | Porcilis Pesti | Norway | 18.7.2005 |
| EU/2/99/016/001-006 | Porcilis Pesti | Liechtenstein | 31.7.2005 |
| EU/2/99/016/001-006/IS | Porcilis Pesti | Iceland | 13.7.2005 |
| EU/2/99/017/001/NO-006/NO | Ibraxion | Norway | 2.6.2005 |

EU-Number

Product

Country

Date of renewal

EU/1/00/129/001/NO-003/NO

Azopt

Norway

30.6.2005

EU/1/00/129/001-003/IS

Azopt, eye drops, suspension, 1%

Iceland

30.6.2005

EU/1/05/131/001/NO-005/NO

PegIntron

Norway

24.06.2005

EU/1/00/131/001-050/IS

PegIntron

Iceland

28.6.2005

EU/1/00/131/031-050

PegIntron

Liechtenstein

30.9.2005

EU/1/05/132/001/NO-005/NO

ViraferonPeg

Norway

24.6.2005

EU/1/00/132/001-050

ViraferonPeg

Liechtenstein

31.7.2005

EU/1/00/132/001-050/IS

ViraferonPeg

Iceland

28.6.2005

EU/1/00/133/001/NO-008/NO

Optisulin

Norway

27.7.2005

EU/1/00/133/001-008

Optisulin

Liechtenstein

30.9.2005

EU/1/00/133/001-008/IS

Optisulin

Iceland

29.8.2005

EU/1/00/134/001/NO-029/NO

Lantus

Norway

27.7.2005

EU/1/00/134/001-007, 012-029

Lantus

Liechtenstein

30.9.2005

EU/1/00/134/001-029/IS

Lantus

Iceland

29.8.2005

EU/1/00/135/001

DaTSCAN

Liechtenstein

30.9.2005

EU/1/00/135/001/NO-002/NO

DaTSCAN

Norway

20.9.2005

EU/1/00/135/001-002/IS

DaTSCAN

Iceland

11.10.2005

EU/1/00/137/001/NO-012/NO

Avandia

Norway

27.7.2005

EU/1/00/137/001-012

Avandia

Liechtenstein

30.9.2005

EU/1/00/137/001-012/IS

Avandia

Iceland

16.9.2005

EU/1/00/140/001

Visudyne

Liechtenstein

31.7.2005

EU/1/00/140/001/IS

Visudyne 15 mg Powder for solution for injection

Iceland

14.7.2005

EU/1/00/140/001/NO

Visudyne

Norway

27.7.2005

EU/1/00/141/001

Myocet

Liechtenstein

30.9.2005

EU/1/00/141/001/IS

Myocet

Iceland

13.10.2005

EU/1/00/141/001/NO

Myocet

Norway

28.9.2005

EU/1/00/142/004/NO-005/NO

NovoMix Penfill

Norway

13.10.2005

EU/1/00/142/004-005

NovoMix

Liechtenstein

30.9.2005

EU/1/00/142/004-005/IS

NovoMix 30 Penfill

Iceland

21.10.2005

EU/1/00/142/009/NO-010/NO

NovoMix Flexpen

Norway

13.10.2005

EU/1/00/142/009-010/IS

NovoMix 30 FlexPen

Iceland

21.10.2005

EU/1/00/143/001/NO-006/NO

Kogenate Bayer

Norway

7.9.2005

EU/1/00/143/001-006

Kogenate

Liechtenstein

30.9.2005

EU/1/00/143/001-006/IS

Kogenate Bayer

Iceland

7.10.2005

EU/1/00/144/001/NO-003/NO

Helixate NexGen

Norway

7.9.2005

EU/1/00/144/001-003

Helixate

Liechtenstein

30.9.2005

EU/1/00/144/001-003/IS

Helixate NexGen

Iceland

7.10.2005

EU/1/00/145/001

Herceptin

Liechtenstein

30.9.2005

EU/1/00/145/001/IS

Herceptin

Iceland

28.11.2005

EU/1/00/145/001/NO

Herceptin

Norway

23.9.2005

EU/1/00/146/001/NO-029/NO

Keppra

Norway

08.8.2005

EU/1/00/146/001-029

Keppra

Liechtenstein

30.9.2005

EU/1/00/146/001-029/IS

Keppra

Iceland

12.9.2005

EU/1/00/148/001/NO-004/NO

Agenerase

Norway

12.12.2005

EU/1/00/148/001-004

Agenerase

Liechtenstein

30.11.2005

EU/1/00/148/001-004/IS

Agenerase

Iceland

16.12.2005

EU/1/00/149/001

Panretin

Liechtenstein

30.11.2005

EU/1/00/149/001/IS

Panretin

Iceland

16.12.2005

EU/1/00/149/001/NO

Panretin

Norway

9.12.2005

EU/1/00/150/001/NO-015/NO

Actos

Norway

2.11.2005

EU/1/00/150/001-015

Actos

Liechtenstein

30.11.2005

EU/1/00/150/001-015/IS

Actos

Iceland

11.11.2005

EU/1/00/151/001/NO-013/NO

Glustin

Norway

2.11.2005

EU/1/00/151/001-013

Glustin

Liechtenstein

30.11.2005

EU/1/00/151/001-013/IS

Glustin

Iceland

11.11.2005

EU/1/00/152/001-018

Infanrix hexa

Liechtenstein

30.11.2005

EU/1/00/153/001-010

Infanrix penta

Liechtenstein

30.11.2005

EU/1/00/153/001-010/IS

Infanrix penta

Iceland

16.12.2005

EU/1/00/153/001-010/NO

Infanrix penta

Norway

7.12.2005

EU/1/00152/001-018/NO

Infanrix hexa

Norway

7.12.2005

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

Gonal-F

Iceland

15.11.2005

EU/1/95/001/001/NO

Gonal-F

Norway

11.11.2005

EU/1/95/001/003/NO-006/NO

Gonal-F

Norway

11.11.2005

EU/1/95/001/009/NO

Gonal-F

Norway

11.11.2005

EU/1/95/001/012/NO

Gonal-F

Norway

11.11.2005

EU/1/95/001/021/NO-022/NO

Gonal-F

Norway

11.11.2005

EU/1/95/001/025/NO-028/NO

Gonal-F

Norway

11.11.2005

EU/1/95/001/031/NO-035/NO

Gonal-F

Norway

11.11.2005

EU/1/98/093/002

Forcaltonin

Liechtenstein

31.7.2005

EU/1/99/127/001/NO-044/NO

IntronA

Norway

20.6.2005

EU/1/99/127/001-044

IntronA

Liechtenstein

31.7.2005

EU/1/99/127/001-044/IS

IntronA

Iceland

27.6.2005

EU/1/99/128/001/NO-037/NO

Viraferon

Norway

20.6.2005

EU/1/99/128/001-037

Viraferon

Liechtenstein

31.7.2005

EU/1/99/128/001-037/IS

Viraferon

Iceland

27.6.2005

EU/2/00/018/001

Incurin

Liechtenstein

31.7.2005

EU/2/00/018/001/NO

Incurin

Norway

16.6.2005

EU/2/00/022//002b-03a

Ibaflin

Liechtenstein

30.9.2005

EU/2/00/022/001/NO-017/NO

Ibaflin

Norway

31.8.2005

EU/2/00/022/001-017/IS

Ibaflin

Iceland

15.07.2005

EU/2/00/022/001a

Ibaflin

Liechtenstein

30.9.2005

EU/2/00/022/001b-02a

Ibaflin

Liechtenstein

30.9.2005

EU/2/00/022/003b-04a

Ibaflin

Liechtenstein

30.9.2005

EU/2/00/022/004b

Ibaflin

Liechtenstein

30.9.2005

EU/2/00/022/005-017

Ibaflin

Liechtenstein

30.9.2005

EU/2/00/024/001/IS

Pruban

Iceland

16.12.2005

EU/2/99/016/001/NO-006/NO

Porcilis Pesti

Norway

18.7.2005

EU/2/99/016/001-006

Porcilis Pesti

Liechtenstein

31.7.2005

EU/2/99/016/001-006/IS

Porcilis Pesti

Iceland

13.7.2005

EU/2/99/017/001/NO-006/NO

Ibraxion

Norway

2.6.2005

---

ANNEX III

3.   Extended Marketing Authorisations

The following marketing authorisations have been extended in the EEA EFTA States during the period 1 June — 31 December 2005:

| EU-Number | Product | Country | Date of extention |
| --- | --- | --- | --- |
| EU/1/00/142/011/NO-013/NO | NovoMix Penfill 50 | Norway | 1.11.2005 |
| EU/1/00/142/001-013/IS | NovoMix 50 Penfill suspension for injection | Iceland | 5.10.2005 |
| EU/1/00/142/014/NO-016/NO | NovoMix Flexpen 50 | Norway | 1.11.2005 |
| EU/1/00/142/014-016/IS | NovoMix 50 FlexPen suspension for injection | Iceland | 5.10.2005 |
| EU/1/00/142/017/NO-019/NO | NovoMix Penfill 70 | Norway | 1.11.2005 |
| EU/1/00/142/017-019/IS | NovoMix 70 Penfill suspension for injection | Iceland | 5.10.2005 |
| EU/1/00/142/020/NO-022/NO | NovoMix Flexpen 70 | Norway | 1.11.2005 |
| EU/1/00/142/020-022/IS | NovoMix 70 FlexPen suspension for injection | Iceland | 5.10.2005 |
| EU/1/03/265/003/NO-004/NO | Bonviva, film-coated tablets | Norway | 28.9.2005 |
| EU/1/03/265/003-004/IS | Bonviva, film-coated tablets | Iceland | 25.10.2005 |
| EU/1/03/266/003/NO-004/NO | Bondenza, film-coated tablets | Norway | 28.9.2005 |
| EU/1/03/266/003-004/IS | Bondenza, film-coated tablets | Iceland | 21.10.2005 |
| EU/1/04/276/021/NO-023/NO | Abilify, orodispersible tablet 5 mg | Norway | 18.7.2005 |
| EU/1/04/276/021-023/IS | Abilify, orodispersible tablet 5 mg | Iceland | 14.7.2005 |
| EU/1/04/276/024/NO-026/NO | Abilify, orodispersible tablet 10 mg | Norway | 18.7.2005 |
| EU/1/04/276/024-026/IS | Abilify, orodispersible tablet 10 mg | Iceland | 14.7.2005 |
| EU/1/04/276/027/NO-029/NO | Abilify, orodispersible tablet 15 mg | Norway | 18.7.2005 |
| EU/1/04/276/027-029/IS | Abilify, orodispersible tablet 15 mg | Iceland | 14.7.2005 |
| EU/1/04/276/030/NO-032/NO | Abilify, orodispersible tablet 30 mg | Norway | 18.7.2005 |
| EU/1/04/276/030-032/IS | Abilify, orodispersible tablet 30 mg | Iceland | 14.7.2005 |
| EU/1/04/276/033/NO-035/NO | Abilify 1mg/ml, oral solution | Norway | 9.11.2005 |
| EU/1/04/276/033-035/IS | Abilify 1 mg/ml, oral solution | Iceland | 1.12.2005 |
| EU/1/96/026/002/IS | Invirase, filmcoated tablet 500 mg | Iceland | 19.7.2005 |
| EU/1/96/026/002/NO | Invirase | Norway | 9.6.2005 |
| EU/2/97/004/012/NO-013/NO | Metacam, 0,5 mg/ml oral suspension for dogs | Norway | 5.9.2005 |
| EU/2/97/004/012-013/IS | Metacam, 0,5 mg/ml oral suspension for dogs | Iceland | 2.9.2005 |

EU-Number

Product

Country

Date of extention

EU/1/00/142/011/NO-013/NO

NovoMix Penfill 50

Norway

1.11.2005

EU/1/00/142/001-013/IS

NovoMix 50 Penfill suspension for injection

Iceland

5.10.2005

EU/1/00/142/014/NO-016/NO

NovoMix Flexpen 50

Norway

1.11.2005

EU/1/00/142/014-016/IS

NovoMix 50 FlexPen suspension for injection

Iceland

5.10.2005

EU/1/00/142/017/NO-019/NO

NovoMix Penfill 70

Norway

1.11.2005

EU/1/00/142/017-019/IS

NovoMix 70 Penfill suspension for injection

Iceland

5.10.2005

EU/1/00/142/020/NO-022/NO

NovoMix Flexpen 70

Norway

1.11.2005

EU/1/00/142/020-022/IS

NovoMix 70 FlexPen suspension for injection

Iceland

5.10.2005

EU/1/03/265/003/NO-004/NO

Bonviva, film-coated tablets

Norway

28.9.2005

EU/1/03/265/003-004/IS

Bonviva, film-coated tablets

Iceland

25.10.2005

EU/1/03/266/003/NO-004/NO

Bondenza, film-coated tablets

Norway

28.9.2005

EU/1/03/266/003-004/IS

Bondenza, film-coated tablets

Iceland

21.10.2005

EU/1/04/276/021/NO-023/NO

Abilify, orodispersible tablet 5 mg

Norway

18.7.2005

EU/1/04/276/021-023/IS

Abilify, orodispersible tablet 5 mg

Iceland

14.7.2005

EU/1/04/276/024/NO-026/NO

Abilify, orodispersible tablet 10 mg

Norway

18.7.2005

EU/1/04/276/024-026/IS

Abilify, orodispersible tablet 10 mg

Iceland

14.7.2005

EU/1/04/276/027/NO-029/NO

Abilify, orodispersible tablet 15 mg

Norway

18.7.2005

EU/1/04/276/027-029/IS

Abilify, orodispersible tablet 15 mg

Iceland

14.7.2005

EU/1/04/276/030/NO-032/NO

Abilify, orodispersible tablet 30 mg

Norway

18.7.2005

EU/1/04/276/030-032/IS

Abilify, orodispersible tablet 30 mg

Iceland

14.7.2005

EU/1/04/276/033/NO-035/NO

Abilify 1mg/ml, oral solution

Norway

9.11.2005

EU/1/04/276/033-035/IS

Abilify 1 mg/ml, oral solution

Iceland

1.12.2005

EU/1/96/026/002/IS

Invirase, filmcoated tablet 500 mg

Iceland

19.7.2005

EU/1/96/026/002/NO

Invirase

Norway

9.6.2005

EU/2/97/004/012/NO-013/NO

Metacam, 0,5 mg/ml oral suspension for dogs

Norway

5.9.2005

EU/2/97/004/012-013/IS

Metacam, 0,5 mg/ml oral suspension for dogs

Iceland

2.9.2005

---

ANNEX IV

4.   Withdrawn Marketing Authorisations

The following marketing authorisations have been withdrawn in the EEA EFTA States during the period 1 June — 31 December 2005:

| EU-Number | Product | Country | Date of withdrawal |
| --- | --- | --- | --- |
| EU/1/00/158/001-034/IS | Opulis | Iceland | 9.9.2005 |
| EU/1/00/168/001/NO-006/NO | Tenecteplase | Norway | 9.8.2005 |
| EU/1/00/168/001-006 | Tenecteplase | Liechtenstein | 30.9.2005 |
| EU/1/02/208/001-008/IS | Xapit | Iceland | 9.9.2005 |
| EU/1/02/210/001/NO-008/NO | Rayzon | Norway | 22.7.2005 |
| EU/1/02/210/001-008 | Rayzon | Liechtenstein | 31.7.2005 |
| EU/1/02/210/001-008/IS | Rayzon | Iceland | 5.7.2005 |
| EU/1/02/242/001-024 | Valdyn | Liechtenstein | 30.9.2005 |
| EU/1/02/242/001-024/IS | Valdyn, filmcoated tablets | Iceland | 5.07.2005 |
| EU/1/02/244/001/NO-024/NO | Valdyn | Norway | 22.7.2005 |
| EU/1/02/244/001-024/IS | Valdyn | Liechtenstein | 31.7.2005 |
| EU/1/96/009/010/NO-017/NO | Zerit | Norway | 30.9.2005 |
| EU/1/96/009/010-017/IS | Zerit prolonged-release capsules | Iceland | 29.11.2005 |
| EU/1/96/023/001 | Cea-Scan | Liechtenstein | 30.11.2005 |
| EU/1/96/023/001/IS | CEA-Scan | Iceland | 9.11.2005 |
| EU/1/97/048/001-014/IS | Infanrix HepB, suspension for injection | Iceland | 15.6.2005 |
| EU/2/00/023/001-003 | Pulsaflox | Liechtenstein | 30.11.2005 |

EU-Number

Product

Country

Date of withdrawal

EU/1/00/158/001-034/IS

Opulis

Iceland

9.9.2005

EU/1/00/168/001/NO-006/NO

Tenecteplase

Norway

9.8.2005

EU/1/00/168/001-006

Tenecteplase

Liechtenstein

30.9.2005

EU/1/02/208/001-008/IS

Xapit

Iceland

9.9.2005

EU/1/02/210/001/NO-008/NO

Rayzon

Norway

22.7.2005

EU/1/02/210/001-008

Rayzon

Liechtenstein

31.7.2005

EU/1/02/210/001-008/IS

Rayzon

Iceland

5.7.2005

EU/1/02/242/001-024

Valdyn

Liechtenstein

30.9.2005

EU/1/02/242/001-024/IS

Valdyn, filmcoated tablets

Iceland

5.07.2005

EU/1/02/244/001/NO-024/NO

Valdyn

Norway

22.7.2005

EU/1/02/244/001-024/IS

Valdyn

Liechtenstein

31.7.2005

EU/1/96/009/010/NO-017/NO

Zerit

Norway

30.9.2005

EU/1/96/009/010-017/IS

Zerit prolonged-release capsules

Iceland

29.11.2005

EU/1/96/023/001

Cea-Scan

Liechtenstein

30.11.2005

EU/1/96/023/001/IS

CEA-Scan

Iceland

9.11.2005

EU/1/97/048/001-014/IS

Infanrix HepB, suspension for injection

Iceland

15.6.2005

EU/2/00/023/001-003

Pulsaflox

Liechtenstein

30.11.2005

---

ANNEX V

5.   Suspended Marketing Authorisations

The following marketing authorisations have been suspended in the EEA EFTA States during the period 1 June — 31 December 2005:

| EU-Number | Product | Country | Date of suspension |
| --- | --- | --- | --- |
| EU/1/00/147/001/NO-012/NO | Hexavac | Norway | 17.11.2005 |
| EU/1/00/147/001-008 | Hexavac | Liechtenstein | 30.11.2005 |
| EU/1/00/147/001-008/IS | Hexavac | Iceland | 17.11.2005 |

EU-Number

Product

Country

Date of suspension

EU/1/00/147/001/NO-012/NO

Hexavac

Norway

17.11.2005

EU/1/00/147/001-008

Hexavac

Liechtenstein

30.11.2005

EU/1/00/147/001-008/IS

Hexavac

Iceland

17.11.2005

---