# C_2011302EN.01002201.xml

| 13.10.2011 | EN | Official Journal of the European Union | C 302/22 |
| --- | --- | --- | --- |

13.10.2011

EN

Official Journal of the European Union

C 302/22

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Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the second half of 2010

2011/C 302/06

Subcommittee I on the free movement of goods

Subcommittee I on the free movement of goods

To be noted by the EEA Joint Committee

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 July-31 December 2010, at their meeting on 1 April 2011:

| 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| Annex IV | List of withdrawn marketing authorisations |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

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List of withdrawn marketing authorisations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

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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 2010:

| EU-Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/09/605/001/NO-012/NO | Temomedac | Norway | 8.7.2010 |
| EU/1/10/626/001-004 | Ribavirin BioPartners | Liechtenstein | 31.8.2010 |
| EU/1/10/629/001/NO | Humenza | Norway | 17.8.2010 |
| EU/1/10/631/001/NO-009/NO | Nivestim | Norway | 15.9.2010 |
| EU/1/10/631/001-009/IS | Nivestim | Iceland | 27.8.2010 |
| EU/1/10/632/001/NO-021/NO | Tolura | Norway | 26.8.2010 |
| EU/1/10/632/001-021/IS | Tolura | Iceland | 2.7.2010 |
| EU/1/10/633/001-002/IS | Topotecan Hospira | Iceland | 1.9.2010 |
| EU/1/10/634/001/NO-004/NO | Ribavirin Three Rivers | Norway | 19.8.2010 |
| EU/1/10/636/001/NO-003/NO | Daxas | Norway | 12.8.2010 |
| EU/1/10/636/001-003 | Daxas | Liechtenstein | 31.8.2010 |
| EU/1/10/636/001-003/IS | Daxas | Iceland | 3.8.2010 |
| EU/1/10/637/001/NO-009/NO | Leflunomide medac | Norway | 25.8.2010 |
| EU/1/10/637/001-009 | Leflunomide medac | Liechtenstein | 31.10.2010 |
| EU/1/10/637/001-009/IS | Leflunomide medac | Iceland | 26.8.2010 |
| EU/1/10/638/001 | Ozurdex | Liechtenstein | 31.8.2010 |
| EU/1/10/638/001/IS | Ozurdex | Iceland | 26.8.2010 |
| EU/1/10/638/001/NO | Ozurdex | Norway | 8.10.2010 |
| EU/1/10/639/001-030 | Telmisartan Actavis | Liechtenstein | 31.12.2010 |
| EU/1/10/639/001-030/IS | Telmisartan Actavis | Iceland | 15.12.2010 |
| EU/1/10/640/001/NO-006/NO | Sycrest | Norway | 15.11.2010 |
| EU/1/10/640/001-006 | Sycrest | Liechtenstein | 31.10.2010 |
| EU/1/10/640/001-006/IS | Sycrest | Iceland | 23.9.2010 |
| EU/1/10/641/001/NO | Ruconest | Norway | 2.12.2010 |
| EU/1/10/642/001-004 | Ibandronic acid | Liechtenstein | 31.10.2010 |
| EU/1/10/643/001 | Rapiscan | Liechtenstein | 31.10.2010 |
| EU/1/10/643/001/IS | Rapiscan | Iceland | 26.10.2010 |
| EU/1/10/643/001/NO | Rapiscan | Norway | 27.9.2010 |
| EU/1/10/644/001/NO-004/NO | PecFent | Norway | 15.9.2010 |
| EU/1/10/644/001-004 | PecFent | Liechtenstein | 31.10.2010 |
| EU/1/10/644/001-004/IS | PecFent | Iceland | 29.9.2010 |
| EU/1/10/645/001/NO-002/NO | Brinavess | Norway | 28.9.2010 |
| EU/1/10/645/001-002 | Brinavess | Liechtenstein | 31.10.2010 |
| EU/1/10/645/001-002/IS | Brinavess | Iceland | 23.9.2010 |
| EU/1/10/646/001/NO-002/NO | VPRIV | Norway | 2.11.2010 |
| EU/1/10/646/001-002 | VPRIV | Liechtenstein | 31.10.2010 |
| EU/1/10/646/001-002/IS | VPRIV | Iceland | 17.9.2010 |
| EU/1/10/647/001/NO-002/NO | Myclausen | Norway | 17.11.2010 |
| EU/1/10/647/001-002 | Myclausen | Liechtenstein | 31.10.2010 |
| EU/1/10/648/001/NO-028/NO | Twynsta | Norway | 29.11.2010 |
| EU/1/10/648/001-028 | Twynsta | Liechtenstein | 31.10.2010 |
| EU/1/10/650/001/NO-015/NO | Clopidogrel Teva Generics B.V. | Norway | 26.11.2010 |
| EU/1/10/650/001-015 | Clopidogrel Teva Generics B.V. | Liechtenstein | 31.12.2010 |
| EU/1/10/651/001/NO-015/NO | Clopidogrel HCS | Norway | 26.11.2010 |
| EU/1/10/651/001-015 | Clopidogrel HCS | Liechtenstein | 31.12.2010 |
| EU/1/10/654/001-004 | Leflunomide Ratiopharm | Liechtenstein | 31.12.2010 |
| EU/1/10/655/001/NO-006/NO | Brilique | Norway | 16.12.2010 |
| EU/1/10/655/001-006 | Brilique | Liechtenstein | 31.12.2010 |
| EU/1/10/655/001-006/IS | Brilique | Iceland | 10.12.2010 |
| EU/1/10/656/001-006 | Possia | Liechtenstein | 31.12.2010 |
| EU/1/10/657/001-002 | Präpandemischer Influenzaimpfstoff (H5N1) | Liechtenstein | 31.12.2010 |
| EU/1/10/658/001-002 | Aflunov | Liechtenstein | 31.12.2010 |
| EU/2/10/106/001/NO-014/NO | Bovilis BTV8 | Norway | 5.10.2010 |
| EU/2/10/106/001-014 | Bovilis BTV8 | Liechtenstein | 31.10.2010 |
| EU/2/10/106/001-014/IS | Bovilis BTV8 | Iceland | 20.10.2010 |
| EU/2/10/108/001/NO-005/NO | BTVPUR Alsap 2-4 | Norway | 22.11.2010 |
| EU/2/10/108/001-005 | BTVPUR Alsap 2-4 | Liechtenstein | 31.12.2010 |
| EU/2/10/109/001-009 | Rhiniseng | Liechtenstein | 31.10.2010 |
| EU/2/10/109/001-009/IS | Rhiniseng | Iceland | 10.12.2010 |
| EU/2/10/110/001-002 | Coxevac | Liechtenstein | 31.10.2010 |
| EU/2/10/111/001-004 | Meloxoral | Liechtenstein | 31.12.2010 |

EU-Number

Product

Country

Date of authorisation

EU/1/09/605/001/NO-012/NO

Temomedac

Norway

8.7.2010

EU/1/10/626/001-004

Ribavirin BioPartners

Liechtenstein

31.8.2010

EU/1/10/629/001/NO

Humenza

Norway

17.8.2010

EU/1/10/631/001/NO-009/NO

Nivestim

Norway

15.9.2010

EU/1/10/631/001-009/IS

Nivestim

Iceland

27.8.2010

EU/1/10/632/001/NO-021/NO

Tolura

Norway

26.8.2010

EU/1/10/632/001-021/IS

Tolura

Iceland

2.7.2010

EU/1/10/633/001-002/IS

Topotecan Hospira

Iceland

1.9.2010

EU/1/10/634/001/NO-004/NO

Ribavirin Three Rivers

Norway

19.8.2010

EU/1/10/636/001/NO-003/NO

Daxas

Norway

12.8.2010

EU/1/10/636/001-003

Daxas

Liechtenstein

31.8.2010

EU/1/10/636/001-003/IS

Daxas

Iceland

3.8.2010

EU/1/10/637/001/NO-009/NO

Leflunomide medac

Norway

25.8.2010

EU/1/10/637/001-009

Leflunomide medac

Liechtenstein

31.10.2010

EU/1/10/637/001-009/IS

Leflunomide medac

Iceland

26.8.2010

EU/1/10/638/001

Ozurdex

Liechtenstein

31.8.2010

EU/1/10/638/001/IS

Ozurdex

Iceland

26.8.2010

EU/1/10/638/001/NO

Ozurdex

Norway

8.10.2010

EU/1/10/639/001-030

Telmisartan Actavis

Liechtenstein

31.12.2010

EU/1/10/639/001-030/IS

Telmisartan Actavis

Iceland

15.12.2010

EU/1/10/640/001/NO-006/NO

Sycrest

Norway

15.11.2010

EU/1/10/640/001-006

Sycrest

Liechtenstein

31.10.2010

EU/1/10/640/001-006/IS

Sycrest

Iceland

23.9.2010

EU/1/10/641/001/NO

Ruconest

Norway

2.12.2010

EU/1/10/642/001-004

Ibandronic acid

Liechtenstein

31.10.2010

EU/1/10/643/001

Rapiscan

Liechtenstein

31.10.2010

EU/1/10/643/001/IS

Rapiscan

Iceland

26.10.2010

EU/1/10/643/001/NO

Rapiscan

Norway

27.9.2010

EU/1/10/644/001/NO-004/NO

PecFent

Norway

15.9.2010

EU/1/10/644/001-004

PecFent

Liechtenstein

31.10.2010

EU/1/10/644/001-004/IS

PecFent

Iceland

29.9.2010

EU/1/10/645/001/NO-002/NO

Brinavess

Norway

28.9.2010

EU/1/10/645/001-002

Brinavess

Liechtenstein

31.10.2010

EU/1/10/645/001-002/IS

Brinavess

Iceland

23.9.2010

EU/1/10/646/001/NO-002/NO

VPRIV

Norway

2.11.2010

EU/1/10/646/001-002

VPRIV

Liechtenstein

31.10.2010

EU/1/10/646/001-002/IS

VPRIV

Iceland

17.9.2010

EU/1/10/647/001/NO-002/NO

Myclausen

Norway

17.11.2010

EU/1/10/647/001-002

Myclausen

Liechtenstein

31.10.2010

EU/1/10/648/001/NO-028/NO

Twynsta

Norway

29.11.2010

EU/1/10/648/001-028

Twynsta

Liechtenstein

31.10.2010

EU/1/10/650/001/NO-015/NO

Clopidogrel Teva Generics B.V.

Norway

26.11.2010

EU/1/10/650/001-015

Clopidogrel Teva Generics B.V.

Liechtenstein

31.12.2010

EU/1/10/651/001/NO-015/NO

Clopidogrel HCS

Norway

26.11.2010

EU/1/10/651/001-015

Clopidogrel HCS

Liechtenstein

31.12.2010

EU/1/10/654/001-004

Leflunomide Ratiopharm

Liechtenstein

31.12.2010

EU/1/10/655/001/NO-006/NO

Brilique

Norway

16.12.2010

EU/1/10/655/001-006

Brilique

Liechtenstein

31.12.2010

EU/1/10/655/001-006/IS

Brilique

Iceland

10.12.2010

EU/1/10/656/001-006

Possia

Liechtenstein

31.12.2010

EU/1/10/657/001-002

Präpandemischer Influenzaimpfstoff (H5N1)

Liechtenstein

31.12.2010

EU/1/10/658/001-002

Aflunov

Liechtenstein

31.12.2010

EU/2/10/106/001/NO-014/NO

Bovilis BTV8

Norway

5.10.2010

EU/2/10/106/001-014

Bovilis BTV8

Liechtenstein

31.10.2010

EU/2/10/106/001-014/IS

Bovilis BTV8

Iceland

20.10.2010

EU/2/10/108/001/NO-005/NO

BTVPUR Alsap 2-4

Norway

22.11.2010

EU/2/10/108/001-005

BTVPUR Alsap 2-4

Liechtenstein

31.12.2010

EU/2/10/109/001-009

Rhiniseng

Liechtenstein

31.10.2010

EU/2/10/109/001-009/IS

Rhiniseng

Iceland

10.12.2010

EU/2/10/110/001-002

Coxevac

Liechtenstein

31.10.2010

EU/2/10/111/001-004

Meloxoral

Liechtenstein

31.12.2010

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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 2010:

| EU-Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/00/135/001/NO-002/NO | DaTSCAN | Norway | 6.9.2010 |
| EU/1/00/135/001-002 | DaTSCAN | Liechtenstein | 31.8.2010 |
| EU/1/00/141/001/NO | Myocet | Norway | 3.8.2010 |
| EU/1/00/141/001 | Myocet | Liechtenstein | 31.8.2010 |
| EU/1/00/141/001/IS | Myocet | Iceland | 30.8.2010 |
| EU/1/00/142/004/NO-005/NO, 009/NO-022/NO | NovoMix | Norway | 4.8.2010 |
| EU/1/00/142/004-005, 009-022 | NovoMix | Liechtenstein | 31.8.2010 |
| EU/1/00/142/004-005, 009-022/IS | NovoMix | Iceland | 31.8.2010 |
| EU/1/00/143/001/NO-011/NO | Kogenate Bayer | Norway | 26.8.2010 |
| EU/1/00/143/001-011 | Kogenate Bayer | Liechtenstein | 31.8.2010 |
| EU/1/00/143/004-011/IS | Kogenate Bayer | Iceland | 8.9.2010 |
| EU/1/00/144/001/NO-004/NO | Helixate NexGen | Norway | 25.8.2010 |
| EU/1/00/144/001-004 | Helixate NexGen | Liechtenstein | 31.8.2010 |
| EU/1/00/144/001-004/IS | Helixate NexGen | Iceland | 29.9.2010 |
| EU/1/00/145/001 | Herceptin | Liechtenstein | 31.8.2010 |
| EU/1/00/145/001/IS | Herceptin | Iceland | 6.9.2010 |
| EU/1/00/145/001/NO | Herceptin | Norway | 24.8.2010 |
| EU/1/00/146/001/NO-032/NO | Keppra | Norway | 1.11.2010 |
| EU/1/00/146/001-032 | Keppra | Liechtenstein | 31.10.2010 |
| EU/1/00/146/001-032/IS | Keppra | Iceland | 2.9.2010 |
| EU/1/00/149/001 | Panretin | Liechtenstein | 31.10.2010 |
| EU/1/00/149/001/NO | Panretin | Norway | 22.10.2010 |
| EU/1/00/150/001/NO-024/NO | Actos | Norway | 19.10.2010 |
| EU/1/00/150/001-030 | Actos | Liechtenstein | 31.10.2010 |
| EU/1/00/150/001-030/IS | Actos | Iceland | 22.9.2010 |
| EU/1/00/151/001/NO-024/NO | Glustin | Norway | 19.10.2010 |
| EU/1/00/151/001-024 | Glustin | Liechtenstein | 31.10.2010 |
| EU/1/00/151/001-024/IS | Glustin | Iceland | 23.9.2010 |
| EU/1/00/152/001/NO-020/NO | Infanrix Hexa | Norway | 6.12.2010 |
| EU/1/00/152/001-020 | Infanrix Hexa | Liechtenstein | 31.10.2010 |
| EU/1/00/152/001-020/IS | Infanrix Hexa | Iceland | 22.9.2010 |
| EU/1/00/153/001/NO-010/NO | Infanrix Penta | Norway | 3.12.2010 |
| EU/1/00/153/001-010 | Infanrix Penta | Liechtenstein | 31.10.2010 |
| EU/1/00/153/001-010/IS | Infanrix Penta | Iceland | 22.9.2010 |
| EU/1/00/156/002/NO-004/NO | Trizivir | Norway | 13.12.2010 |
| EU/1/00/156/002-004 | Trizivir | Liechtenstein | 31.12.2010 |
| EU/1/00/166/001-003 | NeuroBloc | Liechtenstein | 31.12.2010 |
| EU/1/05/310/001/NO-009/NO | Fosavance | Norway | 13.9.2010 |
| EU/1/05/310/001-009 | Fosavance | Liechtenstein | 31.8.2010 |
| EU/1/05/310/001-009/IS | Fosavance | Iceland | 13.9.2010 |
| EU/1/05/311/001/NO-003/NO | Tarceva | Norway | 24.8.2010 |
| EU/1/05/311/001-003 | Tarceva | Liechtenstein | 31.8.2010 |
| EU/1/05/311/001-003/IS | Tarceva | Iceland | 19.8.2010 |
| EU/1/05/312/001 | Xyrem | Liechtenstein | 31.10.2010 |
| EU/1/05/312/001/NO | Xyrem | Norway | 16.11.2010 |
| EU/1/05/313/001/NO-009/NO | Vasovist | Norway | 22.12.2010 |
| EU/1/05/313/001-009 | Vasovist | Liechtenstein | 31.10.2010 |
| EU/1/05/314/001 | Kepivance | Liechtenstein | 31.12.2010 |
| EU/1/05/315/001/NO-002/NO | Aptivus | Norway | 13.12.2010 |
| EU/1/05/315/001-002 | Aptivus | Liechtenstein | 31.10.2010 |
| EU/1/05/316/001/NO-014/NO | Procoralan | Norway | 28.9.2010 |
| EU/1/05/316/001-014 | Procoralan | Liechtenstein | 31.10.2010 |
| EU/1/05/316/001-014/IS | Procoralan | Iceland | 21.9.2010 |
| EU/1/05/317/001/NO-014/NO | Corlentor | Norway | 28.9.2010 |
| EU/1/05/317/001-014 | Corlentor | Liechtenstein | 31.10.2010 |
| EU/1/05/317/001-014/IS | Corlentor | Iceland | 21.9.2010 |
| EU/1/05/318/001/NO-002/NO | Revatio | Norway | 6.10.2010 |
| EU/1/05/318/001-002 | Revatio | Liechtenstein | 31.10.2010 |
| EU/1/05/318/001-002/IS | Revatio | Iceland | 20.12.2010 |
| EU/1/05/319/001/NO-010/NO | Xolair | Norway | 19.10.2010 |
| EU/1/05/319/001-010 | Xolair | Liechtenstein | 31.10.2010 |
| EU/1/05/319/001-010/IS | Xolair | Iceland | 15.12.2010 |
| EU/1/05/320/001/NO | Noxafil | Norway | 13.12.2010 |
| EU/1/05/328/001-004 | Cubicin | Liechtenstein | 31.12.2010 |
| EU/1/05/331/001-055 | Neupro | Liechtenstein | 31.12.2010 |
| EU/1/06/338/001/NO-003/NO | Duo Trav | Norway | 18.11.2010 |
| EU/1/06/338/001-003 | Duo Trav | Liechtenstein | 31.10.2010 |
| EU/1/07/423/001-003 | Vectibix | Liechtenstein | 31.12.2010 |
| EU/1/07/440/001-002 | Tyverb | Liechtenstein | 31.10.2010 |
| EU/1/08/468/001 | Intelence | Liechtenstein | 31.8.2010 |
| EU/1/08/468/001/IS | Intelence | Iceland | 30.8.2010 |
| EU/1/08/468/001/NO | Intelence | Norway | 19.8.2010 |
| EU/1/09/543/001 | Cayston | Liechtenstein | 31.10.2010 |
| EU/1/09/543/001/NO | Cayston | Norway | 28.9.2010 |
| EU/1/09/543/001-002/IS | Cayston | Iceland | 16.9.2010 |
| EU/1/95/001/001, 003-005, 009, 012, 021-022, 025-028, 031-035/IS | Gonal-f | Iceland | 26.8.2010 |
| EU/1/95/001/005, 021, 025-027, 031-033, 035 | Gonal-f | Liechtenstein | 31.8.2010 |
| EU/1/95/001/005/NO, EU/1/95/001/025/NO-027/NO, EU/1/95/001/031/NO-035/NO | Gonal-f | Norway | 9.9.2010 |
| EU/2/00/018/001 | Incurin | Liechtenstein | 31.8.2010 |
| EU/2/05/053/001-003/IS | Naxcel | Iceland | 15.12.2010 |
| EU/2/05/054/001/NO-031/NO | Profender | Norway | 4.10.2010 |
| EU/2/05/054/001-031 | Profender | Liechtenstein | 31.8.2010 |
| EU/2/05/054/001-031/IS | Profender | Iceland | 1.9.2010 |
| EU/2/05/055/001/NO-002/NO | Equilis Te | Norway | 3.9.2010 |
| EU/2/05/055/001-002/IS | Equilis Te | Iceland | 6.9.2010 |
| EU/2/05/056/001/NO-004/NO | Equilis Prequenza | Norway | 6.9.2010 |
| EU/2/05/056/001-004/IS | Equilis Prequenza | Iceland | 6.9.2010 |
| EU/2/05/057/001/NO-004/NO | Equilis Prequenza Te | Norway | 6.9.2010 |
| EU/2/05/057/001-004 | Equilis Prequenza Te | Liechtenstein | 31.8.2010 |
| EU/2/05/057/001-004/IS | Equilis Prequenza Te | Iceland | 6.9.2010 |
| EU/2/055/001-002 | Equilis Te | Liechtenstein | 31.8.2010 |

EU-Number

Product

Country

Date of authorisation

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

DaTSCAN

Norway

6.9.2010

EU/1/00/135/001-002

DaTSCAN

Liechtenstein

31.8.2010

EU/1/00/141/001/NO

Myocet

Norway

3.8.2010

EU/1/00/141/001

Myocet

Liechtenstein

31.8.2010

EU/1/00/141/001/IS

Myocet

Iceland

30.8.2010

EU/1/00/142/004/NO-005/NO, 009/NO-022/NO

NovoMix

Norway

4.8.2010

EU/1/00/142/004-005, 009-022

NovoMix

Liechtenstein

31.8.2010

EU/1/00/142/004-005, 009-022/IS

NovoMix

Iceland

31.8.2010

EU/1/00/143/001/NO-011/NO

Kogenate Bayer

Norway

26.8.2010

EU/1/00/143/001-011

Kogenate Bayer

Liechtenstein

31.8.2010

EU/1/00/143/004-011/IS

Kogenate Bayer

Iceland

8.9.2010

EU/1/00/144/001/NO-004/NO

Helixate NexGen

Norway

25.8.2010

EU/1/00/144/001-004

Helixate NexGen

Liechtenstein

31.8.2010

EU/1/00/144/001-004/IS

Helixate NexGen

Iceland

29.9.2010

EU/1/00/145/001

Herceptin

Liechtenstein

31.8.2010

EU/1/00/145/001/IS

Herceptin

Iceland

6.9.2010

EU/1/00/145/001/NO

Herceptin

Norway

24.8.2010

EU/1/00/146/001/NO-032/NO

Keppra

Norway

1.11.2010

EU/1/00/146/001-032

Keppra

Liechtenstein

31.10.2010

EU/1/00/146/001-032/IS

Keppra

Iceland

2.9.2010

EU/1/00/149/001

Panretin

Liechtenstein

31.10.2010

EU/1/00/149/001/NO

Panretin

Norway

22.10.2010

EU/1/00/150/001/NO-024/NO

Actos

Norway

19.10.2010

EU/1/00/150/001-030

Actos

Liechtenstein

31.10.2010

EU/1/00/150/001-030/IS

Actos

Iceland

22.9.2010

EU/1/00/151/001/NO-024/NO

Glustin

Norway

19.10.2010

EU/1/00/151/001-024

Glustin

Liechtenstein

31.10.2010

EU/1/00/151/001-024/IS

Glustin

Iceland

23.9.2010

EU/1/00/152/001/NO-020/NO

Infanrix Hexa

Norway

6.12.2010

EU/1/00/152/001-020

Infanrix Hexa

Liechtenstein

31.10.2010

EU/1/00/152/001-020/IS

Infanrix Hexa

Iceland

22.9.2010

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

Infanrix Penta

Norway

3.12.2010

EU/1/00/153/001-010

Infanrix Penta

Liechtenstein

31.10.2010

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

Infanrix Penta

Iceland

22.9.2010

EU/1/00/156/002/NO-004/NO

Trizivir

Norway

13.12.2010

EU/1/00/156/002-004

Trizivir

Liechtenstein

31.12.2010

EU/1/00/166/001-003

NeuroBloc

Liechtenstein

31.12.2010

EU/1/05/310/001/NO-009/NO

Fosavance

Norway

13.9.2010

EU/1/05/310/001-009

Fosavance

Liechtenstein

31.8.2010

EU/1/05/310/001-009/IS

Fosavance

Iceland

13.9.2010

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

Tarceva

Norway

24.8.2010

EU/1/05/311/001-003

Tarceva

Liechtenstein

31.8.2010

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

Tarceva

Iceland

19.8.2010

EU/1/05/312/001

Xyrem

Liechtenstein

31.10.2010

EU/1/05/312/001/NO

Xyrem

Norway

16.11.2010

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

Vasovist

Norway

22.12.2010

EU/1/05/313/001-009

Vasovist

Liechtenstein

31.10.2010

EU/1/05/314/001

Kepivance

Liechtenstein

31.12.2010

EU/1/05/315/001/NO-002/NO

Aptivus

Norway

13.12.2010

EU/1/05/315/001-002

Aptivus

Liechtenstein

31.10.2010

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

Procoralan

Norway

28.9.2010

EU/1/05/316/001-014

Procoralan

Liechtenstein

31.10.2010

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

Procoralan

Iceland

21.9.2010

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

Corlentor

Norway

28.9.2010

EU/1/05/317/001-014

Corlentor

Liechtenstein

31.10.2010

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

Corlentor

Iceland

21.9.2010

EU/1/05/318/001/NO-002/NO

Revatio

Norway

6.10.2010

EU/1/05/318/001-002

Revatio

Liechtenstein

31.10.2010

EU/1/05/318/001-002/IS

Revatio

Iceland

20.12.2010

EU/1/05/319/001/NO-010/NO

Xolair

Norway

19.10.2010

EU/1/05/319/001-010

Xolair

Liechtenstein

31.10.2010

EU/1/05/319/001-010/IS

Xolair

Iceland

15.12.2010

EU/1/05/320/001/NO

Noxafil

Norway

13.12.2010

EU/1/05/328/001-004

Cubicin

Liechtenstein

31.12.2010

EU/1/05/331/001-055

Neupro

Liechtenstein

31.12.2010

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

Duo Trav

Norway

18.11.2010

EU/1/06/338/001-003

Duo Trav

Liechtenstein

31.10.2010

EU/1/07/423/001-003

Vectibix

Liechtenstein

31.12.2010

EU/1/07/440/001-002

Tyverb

Liechtenstein

31.10.2010

EU/1/08/468/001

Intelence

Liechtenstein

31.8.2010

EU/1/08/468/001/IS

Intelence

Iceland

30.8.2010

EU/1/08/468/001/NO

Intelence

Norway

19.8.2010

EU/1/09/543/001

Cayston

Liechtenstein

31.10.2010

EU/1/09/543/001/NO

Cayston

Norway

28.9.2010

EU/1/09/543/001-002/IS

Cayston

Iceland

16.9.2010

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

Gonal-f

Iceland

26.8.2010

EU/1/95/001/005, 021, 025-027, 031-033, 035

Gonal-f

Liechtenstein

31.8.2010

EU/1/95/001/005/NO, EU/1/95/001/025/NO-027/NO, EU/1/95/001/031/NO-035/NO

Gonal-f

Norway

9.9.2010

EU/2/00/018/001

Incurin

Liechtenstein

31.8.2010

EU/2/05/053/001-003/IS

Naxcel

Iceland

15.12.2010

EU/2/05/054/001/NO-031/NO

Profender

Norway

4.10.2010

EU/2/05/054/001-031

Profender

Liechtenstein

31.8.2010

EU/2/05/054/001-031/IS

Profender

Iceland

1.9.2010

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

Equilis Te

Norway

3.9.2010

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

Equilis Te

Iceland

6.9.2010

EU/2/05/056/001/NO-004/NO

Equilis Prequenza

Norway

6.9.2010

EU/2/05/056/001-004/IS

Equilis Prequenza

Iceland

6.9.2010

EU/2/05/057/001/NO-004/NO

Equilis Prequenza Te

Norway

6.9.2010

EU/2/05/057/001-004

Equilis Prequenza Te

Liechtenstein

31.8.2010

EU/2/05/057/001-004/IS

Equilis Prequenza Te

Iceland

6.9.2010

EU/2/055/001-002

Equilis Te

Liechtenstein

31.8.2010

---

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 2010:

| EU-Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/00/143/012/NO-013/NO | Kogenate Bayer | Norway | 26.8.2010 |
| EU/1/00/143/012-013 | Kogenate Bayer | Liechtenstein | 31.8.2010 |
| EU/1/00/143/012-013/IS | Kogenate Bayer | Iceland | 8.9.2010 |
| EU/1/00/144/005 | Helixate NexGen | Liechtenstein | 31.8.2010 |
| EU/1/00/144/005/IS | Helixate NexGen | Iceland | 29.9.2010 |
| EU/1/00/152/019-020/IS | Infanrix Hexa | Iceland | 7.7.2010 |
| EU/1/00/152/019/NO-020/NO | Infanrix Hexa | Norway | 6.12.2010 |
| EU/1/01/171/013/NO-014/NO | Rapamune | Norway | 18.8.2010 |
| EU/1/01/171/013-014/IS | Rapamune | Iceland | 6.7.2010 |
| EU/1/01/171013-014 | Rapamune | Liechtenstein | 31.8.2010 |
| EU/1/01/172/008 | Kaletra | Liechtenstein | 31.10.2010 |
| EU/1/02/218/030 | Axura | Liechtenstein | 31.12.2010 |
| EU/1/02/237/009 | Cialis | Liechtenstein | 31.10.2010 |
| EU/1/03/248/013/NO-015/NO | Levitra | Norway | 24.9.2010 |
| EU/1/03/248/013-015/IS | Levitra | Iceland | 24.9.2010 |
| EU/1/03/269/002 | Faslodex | Liechtenstein | 31.12.2010 |
| EU/1/04/179/044/NO | Lyrica | Norway | 2.9.2010 |
| EU/1/04/279/044/IS | Lyrica | Iceland | 19.8.2010 |
| EU/1/04/307/014/NO-021/NO | Zonegran | Norway | 26.8.2010 |
| EU/1/04/307/014-021 | Zonegran | Liechtenstein | 31.8.2010 |
| EU/1/04/307/014-021/IS | Zonegran | Iceland | 27.7.2010 |
| EU/1/05/328/003-004 | Cubicin | Liechtenstein | 31.10.2010 |
| EU/1/06/363/012/NO-015/NO | Sprycel | Norway | 26.10.2010 |
| EU/1/06/363/012-015 | Sprycel | Liechtenstein | 31.10.2010 |
| EU/1/06/363/012-015/IS | Sprycel | Iceland | 22.11.2010 |
| EU/1/07/401/012-015 | Alli | Liechtenstein | 31.12.2010 |
| EU/1/07/420/002 | Cyanokit | Liechtenstein | 31.10.2010 |
| EU/1/07/437/003/NO-004/NO | Ivemend | Norway | 28.9.2010 |
| EU/1/07/437/003-004 | Ivemend | Liechtenstein | 31.10.2010 |
| EU/1/07/437/003-004/IS | Ivemend | Iceland | 23.9.2010 |
| EU/1/070/401/011 | Alli | Liechtenstein | 31.8.2010 |
| EU/1/08/447/005-012 | Adenuric | Liechtenstein | 31.10.2010 |
| EU/1/08/454/006-007 | Extavia | Liechtenstein | 31.8.2010 |
| EU/1/08/463/004/NO-011/NO | Relistor | Norway | 26.10.2010 |
| EU/1/08/463/004-0011/IS | Relistor | Iceland | 16.9.2010 |
| EU/1/08/472/009-010 | Xarelto | Liechtenstein | 31.10.2010 |
| EU/1/08/495/009-016 | Zarzio | Liechtenstein | 31.12.2010 |
| EU/1/08/496/009-016 | Filgrastim Hexal | Liechtenstein | 31.12.2010 |
| EU/1/08/504/003 | Firmagon | Liechtenstein | 31.12.2010 |
| EU/1/09/535/015-016 | Grepid | Liechtenstein | 31.8.2010 |
| EU/1/09/543/002 | Cayston | Liechtenstein | 31.10.2010 |
| EU/1/09/580/019-021 | Enyglid | Liechtenstein | 31.12.2010 |
| EU/1/10/619/015 | DuoPlavin | Liechtenstein | 31.8.2010 |
| EU/1/10/623/015 | DuoCover | Liechtenstein | 31.8.2010 |
| EU/1/96/006/007 | NovoSeven | Liechtenstein | 31.12.2010 |
| EU/1/96/016/007 | Norvir | Liechtenstein | 31.12.2010 |
| EU/1/97/050/028/NO-033/NO | Sifrol | Norway | 10.8.2010 |
| EU/1/97/050/028-033/IS | Sifrol | Iceland | 18.8.2010 |
| EU/1/97/051/028/NO-033/NO | Mirapexin | Norway | 30.8.2010 |
| EU/1/97/051/028-033/IS | Mirapexin | Iceland | 18.8.2010 |
| EU/1/99/108/004/NO-006/NO | Ferriprox | Norway | 10.9.2010 |
| EU/1/99/108/004-006 | Ferriprox | Liechtenstein | 31.8.2010 |
| EU/1/99/108/004-006/IS | Ferriprox | Iceland | 2.9.2010 |
| EU/2/97/004/039-040 | Metacam | Liechtenstein | 31.8.2010 |
| EU/2/00/026/005-006 | Porcilis AR | Liechtenstein | 31.10.2010 |
| EU/2/06/070/005-008/IS | Meloxidyl | Iceland | 15.9.2010 |
| EU/2/06/070/008 | Meloxidyl | Liechtenstein | 31.10.2010 |
| EU/2/06/070/008/NO | Meloxidyl | Norway | 5.10.2010 |
| EU/2/07/072/003/NO-004/NO | Suprelorin | Norway | 5.10.2010 |
| EU/2/07/072/003-004 | Suprelorin | Liechtenstein | 31.8.2010 |
| EU/2/07/072/003-004/IS | Suprelorin | Iceland | 24.8.2010 |
| EU/2/08/083/004-005 | Equioxx | Liechtenstein | 31.10.2010 |
| EU/2/09/095/004-006 | Improvac | Liechtenstein | 31.10.2010 |
| EU/2/97/004/039/NO-040/NO | Metacam | Norway | 8.9.2010 |
| EU/2/97/004/039-042/IS | Metacam | Iceland | 6.7.2010 |
| EU/2/97/004/041/NO-042/NO | Metacam | Norway | 8.9.2010 |

EU-Number

Product

Country

Date of authorisation

EU/1/00/143/012/NO-013/NO

Kogenate Bayer

Norway

26.8.2010

EU/1/00/143/012-013

Kogenate Bayer

Liechtenstein

31.8.2010

EU/1/00/143/012-013/IS

Kogenate Bayer

Iceland

8.9.2010

EU/1/00/144/005

Helixate NexGen

Liechtenstein

31.8.2010

EU/1/00/144/005/IS

Helixate NexGen

Iceland

29.9.2010

EU/1/00/152/019-020/IS

Infanrix Hexa

Iceland

7.7.2010

EU/1/00/152/019/NO-020/NO

Infanrix Hexa

Norway

6.12.2010

EU/1/01/171/013/NO-014/NO

Rapamune

Norway

18.8.2010

EU/1/01/171/013-014/IS

Rapamune

Iceland

6.7.2010

EU/1/01/171013-014

Rapamune

Liechtenstein

31.8.2010

EU/1/01/172/008

Kaletra

Liechtenstein

31.10.2010

EU/1/02/218/030

Axura

Liechtenstein

31.12.2010

EU/1/02/237/009

Cialis

Liechtenstein

31.10.2010

EU/1/03/248/013/NO-015/NO

Levitra

Norway

24.9.2010

EU/1/03/248/013-015/IS

Levitra

Iceland

24.9.2010

EU/1/03/269/002

Faslodex

Liechtenstein

31.12.2010

EU/1/04/179/044/NO

Lyrica

Norway

2.9.2010

EU/1/04/279/044/IS

Lyrica

Iceland

19.8.2010

EU/1/04/307/014/NO-021/NO

Zonegran

Norway

26.8.2010

EU/1/04/307/014-021

Zonegran

Liechtenstein

31.8.2010

EU/1/04/307/014-021/IS

Zonegran

Iceland

27.7.2010

EU/1/05/328/003-004

Cubicin

Liechtenstein

31.10.2010

EU/1/06/363/012/NO-015/NO

Sprycel

Norway

26.10.2010

EU/1/06/363/012-015

Sprycel

Liechtenstein

31.10.2010

EU/1/06/363/012-015/IS

Sprycel

Iceland

22.11.2010

EU/1/07/401/012-015

Alli

Liechtenstein

31.12.2010

EU/1/07/420/002

Cyanokit

Liechtenstein

31.10.2010

EU/1/07/437/003/NO-004/NO

Ivemend

Norway

28.9.2010

EU/1/07/437/003-004

Ivemend

Liechtenstein

31.10.2010

EU/1/07/437/003-004/IS

Ivemend

Iceland

23.9.2010

EU/1/070/401/011

Alli

Liechtenstein

31.8.2010

EU/1/08/447/005-012

Adenuric

Liechtenstein

31.10.2010

EU/1/08/454/006-007

Extavia

Liechtenstein

31.8.2010

EU/1/08/463/004/NO-011/NO

Relistor

Norway

26.10.2010

EU/1/08/463/004-0011/IS

Relistor

Iceland

16.9.2010

EU/1/08/472/009-010

Xarelto

Liechtenstein

31.10.2010

EU/1/08/495/009-016

Zarzio

Liechtenstein

31.12.2010

EU/1/08/496/009-016

Filgrastim Hexal

Liechtenstein

31.12.2010

EU/1/08/504/003

Firmagon

Liechtenstein

31.12.2010

EU/1/09/535/015-016

Grepid

Liechtenstein

31.8.2010

EU/1/09/543/002

Cayston

Liechtenstein

31.10.2010

EU/1/09/580/019-021

Enyglid

Liechtenstein

31.12.2010

EU/1/10/619/015

DuoPlavin

Liechtenstein

31.8.2010

EU/1/10/623/015

DuoCover

Liechtenstein

31.8.2010

EU/1/96/006/007

NovoSeven

Liechtenstein

31.12.2010

EU/1/96/016/007

Norvir

Liechtenstein

31.12.2010

EU/1/97/050/028/NO-033/NO

Sifrol

Norway

10.8.2010

EU/1/97/050/028-033/IS

Sifrol

Iceland

18.8.2010

EU/1/97/051/028/NO-033/NO

Mirapexin

Norway

30.8.2010

EU/1/97/051/028-033/IS

Mirapexin

Iceland

18.8.2010

EU/1/99/108/004/NO-006/NO

Ferriprox

Norway

10.9.2010

EU/1/99/108/004-006

Ferriprox

Liechtenstein

31.8.2010

EU/1/99/108/004-006/IS

Ferriprox

Iceland

2.9.2010

EU/2/97/004/039-040

Metacam

Liechtenstein

31.8.2010

EU/2/00/026/005-006

Porcilis AR

Liechtenstein

31.10.2010

EU/2/06/070/005-008/IS

Meloxidyl

Iceland

15.9.2010

EU/2/06/070/008

Meloxidyl

Liechtenstein

31.10.2010

EU/2/06/070/008/NO

Meloxidyl

Norway

5.10.2010

EU/2/07/072/003/NO-004/NO

Suprelorin

Norway

5.10.2010

EU/2/07/072/003-004

Suprelorin

Liechtenstein

31.8.2010

EU/2/07/072/003-004/IS

Suprelorin

Iceland

24.8.2010

EU/2/08/083/004-005

Equioxx

Liechtenstein

31.10.2010

EU/2/09/095/004-006

Improvac

Liechtenstein

31.10.2010

EU/2/97/004/039/NO-040/NO

Metacam

Norway

8.9.2010

EU/2/97/004/039-042/IS

Metacam

Iceland

6.7.2010

EU/2/97/004/041/NO-042/NO

Metacam

Norway

8.9.2010

---

ANNEX IV

List of withdrawn marketing authorisations

The following marketing authorisations have been withdrawn in the EEA EFTA States during the period 1 July-31 December 2010:

| EU-Number | Product | Country | Date of withdrawal |
| --- | --- | --- | --- |
| EU/1/00/148/001/NO-004/NO | Agenerase | Norway | 14.9.2010 |
| EU/1/00/154/001/NO-002/NO | NeoSpect | Norway | 8.12.2010 |
| EU/1/00/154/001-002 | NeoSpect | Liechtenstein | 31.12.2010 |
| EU/1/02/239/001-030/IS | Bextra | Iceland | 31.8.2010 |
| EU/1/02/244/001-020/IS | Valdyn | Iceland | 31.8.2010 |
| EU/1/07/406/001-020 | Enviage | Liechtenstein | 31.10.2010 |
| EU/1/10/613/001-002 | ImmunoGam | Liechtenstein | 31.10.2010 |
| EU/1/10/613/001/NO-002/NO | ImmunoGam | Norway | 1.11.2010 |
| EU/1/10/613/001-002/IS | ImmunoGam | Iceland | 30.9.2010 |
| EU/1/10/624/001 | Arepanrix | Liechtenstein | 31.12.2010 |
| EU/2/00/024/001 | Pruban | Liechtenstein | 31.8.2010 |
| EU/2/07/073/001-004 | Nobilis Influenza H7N1 | Liechtenstein | 31.8.2010 |
| EU/2/00/024/001/IS | Pruban 0,1 % | Iceland | 16.11.2010 |
| EU/2/06/067/001-002 | Medicinal Oxygen Air Liquide Santé | Liechtenstein | 31.8.2010 |
| EU/2/06/067/001-002/IS | Medicinal oxygen | Iceland | 1.9.2010 |
| EU/2/07/073/001-004/IS | Nobilis Influenza H7N1 | Iceland | 1.9.2010 |
| EU/2/07/076/001-004 | Nobilis Influenza H5N6 | Liechtenstein | 31.8.2010 |
| EU/2/07/076/001-004/IS | Nobilis Influenza H5N6 | Iceland | 1.9.2010 |

EU-Number

Product

Country

Date of withdrawal

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

Agenerase

Norway

14.9.2010

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

NeoSpect

Norway

8.12.2010

EU/1/00/154/001-002

NeoSpect

Liechtenstein

31.12.2010

EU/1/02/239/001-030/IS

Bextra

Iceland

31.8.2010

EU/1/02/244/001-020/IS

Valdyn

Iceland

31.8.2010

EU/1/07/406/001-020

Enviage

Liechtenstein

31.10.2010

EU/1/10/613/001-002

ImmunoGam

Liechtenstein

31.10.2010

EU/1/10/613/001/NO-002/NO

ImmunoGam

Norway

1.11.2010

EU/1/10/613/001-002/IS

ImmunoGam

Iceland

30.9.2010

EU/1/10/624/001

Arepanrix

Liechtenstein

31.12.2010

EU/2/00/024/001

Pruban

Liechtenstein

31.8.2010

EU/2/07/073/001-004

Nobilis Influenza H7N1

Liechtenstein

31.8.2010

EU/2/00/024/001/IS

Pruban 0,1 %

Iceland

16.11.2010

EU/2/06/067/001-002

Medicinal Oxygen Air Liquide Santé

Liechtenstein

31.8.2010

EU/2/06/067/001-002/IS

Medicinal oxygen

Iceland

1.9.2010

EU/2/07/073/001-004/IS

Nobilis Influenza H7N1

Iceland

1.9.2010

EU/2/07/076/001-004

Nobilis Influenza H5N6

Liechtenstein

31.8.2010

EU/2/07/076/001-004/IS

Nobilis Influenza H5N6

Iceland

1.9.2010

---

ANNEX V

List of suspended marketing authorisations

The following marketing authorisations have been suspended in the EEA EFTA States during the period 1 July-31 December 2010:

| EU-Number | Product | Country | Date of suspension |
| --- | --- | --- | --- |
| EU/1/00/137/002/NO-018/NO | Avandia (1) | Norway | 3.12.2010 |
| EU/1/00/137/002-018 | Avandia | Liechtenstein | 31.12.2010 |
| EU/1/03/258/001/NO-022/NO | Avandamet (1) | Norway | 3.12.2010 |
| EU/1/03/258/001-022 | Avandamet | Liechtenstein | 31.12.2010 |
| EU/1/06/349/001/NO-010/NO | Avaglim (1) | Norway | 3.12.2010 |
| EU/1/06/349/001-010 | Avaglim | Liechtenstein | 31.12.2010 |
| EU/2/06/058/001-003 | Flexicam | Liechtenstein | 31.10.2010 |

EU-Number

Product

Country

Date of suspension

EU/1/00/137/002/NO-018/NO

Avandia (1)

Norway

3.12.2010

EU/1/00/137/002-018

Avandia

Liechtenstein

31.12.2010

EU/1/03/258/001/NO-022/NO

Avandamet (1)

Norway

3.12.2010

EU/1/03/258/001-022

Avandamet

Liechtenstein

31.12.2010

EU/1/06/349/001/NO-010/NO

Avaglim (1)

Norway

3.12.2010

EU/1/06/349/001-010

Avaglim

Liechtenstein

31.12.2010

EU/2/06/058/001-003

Flexicam

Liechtenstein

31.10.2010

---

(1)  Suspended in Norway without notification.

---