# C_2014356EN.01000701.xml

| 9.10.2014 | EN | Official Journal of the European Union | C 356/7 |
| --- | --- | --- | --- |

9.10.2014

EN

Official Journal of the European Union

C 356/7

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Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the second half of 2011

2014/C 356/06

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 2011, at their meeting on 15 June 2012:

| 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| Annex IV | List of withdrawn marketing authorisations |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

Annex I

List of new marketing authorisations

Annex II

Annex II

List of renewed marketing authorisations

Annex III

Annex III

List of extended marketing authorisations

Annex IV

Annex IV

List of withdrawn marketing authorisations

Annex V

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 2011:

| EU-Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/09/543/001-002 | Cayston (1) | Liechtenstein | 31.10.2011 |
| EU/1/10/642/001-004 | Ibandronic Acid Teva | Norway | 23.8.2011 |
| EU/1/10/649/001-016 | Clopidogrel Teva Pharma B.V | Norway | 19.7.2011 |
| EU/1/10/649/001-016 | Clopidogrel Teva Pharma B.V. | Liechtenstein | 31.8.2011 |
| EU/1/10/652/001-003 | TOBI Podhaler | Liechtenstein | 31.8.2011 |
| EU/1/10/652/001-003 | TOBI Podhaler | Norway | 17.8.2011 |
| EU/1/10/652/001-003 | TOBI Podhaler | Iceland | 9.8.2011 |
| EU/1/10/654/001-004 | Leflunomide ratiopharm | Norway | 25.8.2011 |
| EU/1/10/660/001-002 | Potactasol | Norway | 24.8.2011 |
| EU/1/10/661/001-002 | Fluenz | Norway | 23.8.2011 |
| EU/1/11/672/001-006 | Xeplion | Liechtenstein | 31.10.2011 |
| EU/1/11/683/001-080 | Sprimeo HCT | Liechtenstein | 31.8.2011 |
| EU/1/11/683/001-080 | Sprimeo HCT | Norway | 22.8.2011 |
| EU/1/11/683/001-080 | Sprimeo HCT | Iceland | 10.8.2011 |
| EU/1/11/685/001-005 | Ibandronic acid Sandoz | Liechtenstein | 31.8.2011 |
| EU/1/11/685/001-005 | Ibandronic acid Sandoz | Iceland | 18.8.2011 |
| EU/1/11/689/001-002 | IOA | Liechtenstein | 31.12.2011 |
| EU/1/11/689/001-002 | IOA | Norway | 6.12.2011 |
| EU/1/11/689/001-002 | Ioa | Iceland | 25.11.2011 |
| EU/1/11/690/001-002 | Zoely | Liechtenstein | 31.8.2011 |
| EU/1/11/690/001-002 | Zoely | Norway | 18.8.2011 |
| EU/1/11/690/001-002 | Zoely | Iceland | 9.8.2011 |
| EU/1/11/691/001-005 | Eliquis | Iceland | 8.8.2011 |
| EU/1/11/693/001-016 | Rivastigmin Actavis | Norway | 19.8.2011 |
| EU/1/11/694/001-002 | Nulojix | Liechtenstein | 31.8.2011 |
| EU/1/11/694/001-002 | Nulojix | Norway | 1.8.2011 |
| EU/1/11/694/001-002 | Nulojix | Iceland | 6.7.2011 |
| EU/1/11/695/001-055 | Leganto | Liechtenstein | 31.8.2011 |
| EU/1/11/695/001-055 | Leganto | Norway | 23.8.2011 |
| EU/1/11/695/001-055 | Leganto | Iceland | 6.7.2011 |
| EU/1/11/696/001-002 | Bydureon | Norway | 5.7.2011 |
| EU/1/11/696/001-002 | Bydureon | Iceland | 6.7.2011 |
| EU/1/11/696/001-002 | Bydureon | Liechtenstein | 31.8.2011 |
| EU/1/11/697/001-012 | Temozolomide Sun | Liechtenstein | 31.8.2011 |
| EU/1/11/697/001-012 | Temozolomide SUN | Norway | 22.8.2011 |
| EU/1/11/697/001-012 | Temozolomide SUN | Iceland | 9.8.2011 |
| EU/1/11/698/001-002 | Yervoy | Liechtenstein | 31.8.2011 |
| EU/1/11/698/001-002 | Yervoy | Norway | 18.8.2011 |
| EU/1/11/698/001-002 | Yervoy | Iceland | 21.7.2011 |
| EU/1/11/699/001-002 | Fampyra | Liechtenstein | 31.8.2011 |
| EU/1/11/699/001-002 | Fampyra | Norway | 23.8.2011 |
| EU/1/11/699/001-002 | Fampyra | Iceland | 9.8.2011 |
| EU/1/11/700/001-002 | Benlysta | Liechtenstein | 31.8.2011 |
| EU/1/11/700/001-002 | Benlysta | Norway | 27.7.2011 |
| EU/1/11/700/001-002 | Benlysta | Iceland | 21.7.2011 |
| EU/1/11/701/001-028 | Levetiracetam Teva | Liechtenstein | 31.10.2011 |
| EU/1/11/701/001-028 | Levetiracetam Teva | Norway | 26.9.2011 |
| EU/1/11/701/001-028 | Levetiracetam Teva | Iceland | 16.9.2011 |
| EU/1/11/702/001-031 | Levetiracetam Ratiopharm | Liechtenstein | 31.10.2011 |
| EU/1/11/702/001-031 | Levetiracetam ratiopharm | Norway | 26.9.2011 |
| EU/1/11/702/001-031 | Levetiracetam ratiopharm | Iceland | 16.9.2011 |
| EU/1/11/703/001-002 | Xgeva | Liechtenstein | 31.8.2011 |
| EU/1/11/703/001-002 | Xgeva | Norway | 15.8.2011 |
| EU/1/11/703/001-002 | XGEVA | Iceland | 21.7.2011 |
| EU/1/11/704/001 | Victrelis | Liechtenstein | 31.8.2011 |
| EU/1/11/704/001 | Victrelis | Norway | 16.8.2011 |
| EU/1/11/704/001 | Victrelis | Iceland | 10.8.2011 |
| EU/1/11/705/001-002 | Vibativ | Liechtenstein | 31.10.2011 |
| EU/1/11/705/001-002 | Vibativ | Norway | 19.9.2011 |
| EU/1/11/705/001-002 | Vibativ | Iceland | 16.9.2011 |
| EU/1/11/706/001-033 | Levodopa/Cardidopa/Entacapone Orion | Liechtenstein | 31.10.2011 |
| EU/1/11/706/001-033 | Levodopa/Carbidopa/Entacapone Orion | Norway | 23.9.2011 |
| EU/1/11/706/001-033 | Levodopa/Carbidopa/Entacapone Orion | Iceland | 14.9.2011 |
| EU/1/11/707/001-011 | Trajenta | Liechtenstein | 31.10.2011 |
| EU/1/11/707/001-011 | Trajenta | Norway | 12.9.2011 |
| EU/1/11/707/001-011 | Trajenta | Iceland | 14.9.2011 |
| EU/1/11/708/001-004 | Entacapone Orion | Liechtenstein | 31.8.2011 |
| EU/1/11/708/001-004 | Entacapone Orion | Norway | 22.9.2011 |
| EU/1/11/708/001-004 | Entacapone Orion | Iceland | 26.8.2011 |
| EU/1/11/709/001-004 | Buccolam | Norway | 27.9.2011 |
| EU/1/11/709/001-03 | Buccolam | Iceland | 1.11.2011 |
| EU/1/11/710/001-007 | Votubia | Liechtenstein | 31.10.2011 |
| EU/1/11/710/001-007 | Votubia | Norway | 15.9.2011 |
| EU/1/11/710/001-007 | Votubia | Iceland | 16.9.2011 |
| EU/1/11/711/001-030 | Matever | Liechtenstein | 31.10.2011 |
| EU/1/11/711/001-030 | Matever | Iceland | 13.10.2011 |
| EU/1/11/712/001-028 | Levetiracetam Accord | Liechtenstein | 31.10.2011 |
| EU/1/11/712/001-028 | Levetiracetam Accord | Iceland | 6.11.2011 |
| EU/1/11/713/001-040 | Levetiracetam Actavis | Liechtenstein | 31.10.2011 |
| EU/1/11/713/001-040 | Levetiracetam Actavis | Iceland | 13.10.2011 |
| EU/1/11/714/001 | Zytiga | Liechtenstein | 31.10.2011 |
| EU/1/11/714/001 | Zytiga | Norway | 26.9.2011 |
| EU/1/11/714/001 | Zytiga 250 mg Tafla | Iceland | 19.9.2011 |
| EU/1/11/715/001-002 | Plenadren | Liechtenstein | 31.12.2011 |
| EU/1/11/715/001-002 | Plenadren | Norway | 25.11.2011 |
| EU/1/11/716/001-005 | Eurartesim | Liechtenstein | 31.12.2011 |
| EU/1/11/716/001-005 | Eurartesim | Norway | 21.12.2011 |
| EU/1/11/716/001-005 | Eurartesim | Iceland | 10.11.2011 |
| EU/1/11/717/001 | Vyndaqel | Liechtenstein | 31.12.2011 |
| EU/1/11/717/001 | Vyndaqel | Norway | 6.12.2011 |
| EU/1/11/717/001 | Vyndaqel | Iceland | 25.11.2011 |
| EU/1/11/718/001-006 | Dexdor | Liechtenstein | 31.10.2011 |
| EU/1/11/718/001-006 | Dexdor | Norway | 11.10.2011 |
| EU/1/11/718/001-006 | Dexdor | Iceland | 30.9.2011 |
| EU/1/11/719/001-060 | Telmisartan Teva Pharma | Norway | 18.10.2011 |
| EU/1/11/719/001-060 | Telmisartan Teva Pharma | Iceland | 6.11.2011 |
| EU/1/11/720/001 | Incivo | Liechtenstein | 31.10.2011 |
| EU/1/11/720/001 | Incivo | Norway | 6.10.2011 |
| EU/1/11/720/001 | Incivo 375 mg Filmuhúðuð tafla | Iceland | 8.10.2011 |
| EU/1/11/728/001-010 | Pramipexole Accord | Liechtenstein | 31.10.2011 |
| EU/1/11/728/001-010 | Pramipexole Accord | Norway | 18.10.2011 |
| EU/1/11/728/001-010 | Pramipexole Accord | Iceland | 10.10.2011 |
| EU/1/11/729/001-006 | Onduarp | Liechtenstein | 31.12.2011 |
| EU/1/11/729/001-006 | Onduarp | Iceland | 14.12.2011 |
| EU/1/11/730/001-060 | Rasitrio | Norway | 7.12.2011 |
| EU/1/11/731/001-012 | Komboglyze | Liechtenstein | 31.12.2011 |
| EU/1/11/731/001-012 | Komboglyze | Norway | 15.12.2011 |
| EU/1/11/731/001-012 | Komboglyze | Iceland | 8.12.2011 |
| EU/1/11/732/001-013 | Desloratadine Teva | Liechtenstein | 31.12.2011 |
| EU/1/11/732/001-013 | Desloratadine Teva | Norway | 20.12.2011 |
| EU/1/11/732/001-013 | Desloratadine Teva | Iceland | 8.12.2011 |
| EU/1/11/733/001-004 | Dificlir | Liechtenstein | 31.12.2011 |
| EU/1/11/733/001-004 | Dificlir | Norway | 20.12.2011 |
| EU/1/11/733/001-004 | Dificlir | Iceland | 14.12.2011 |
| EU/1/11/734/001-011 | Edarbi | Liechtenstein | 31.12.2011 |
| EU/1/11/734/001-011 | Edarbi | Norway | 21.12.2011 |
| EU/1/11/734/001-011 | Edarbi | Iceland | 17.12.2011 |
| EU/1/11/735/001-011 | Ipreziv | Liechtenstein | 31.12.2011 |
| EU/1/11/735/001-011 | Ipreziv | Norway | 21.12.2011 |
| EU/1/11/735/001-011 | Ipreziv | Iceland | 17.12.2011 |
| EU/1/11/736/001 | Edurant | Liechtenstein | 31.12.2011 |
| EU/1/11/736/001 | Edurant | Norway | 6.12.2011 |
| EU/1/11/736/001 | EDURANT | Iceland | 14.12.2011 |
| EU/1/11/737/001-002 | Eviplera | Liechtenstein | 31.12.2011 |
| EU/1/11/737/001-002 | Eviplera | Norway | 6.12.2011 |
| EU/1/11/737/001-002 | Eviplera | Iceland | 14.12.2011 |
| EU/1/11/738/001-003 | Levetiracetam Actavis Group | Liechtenstein | 31.12.2011 |
| EU/1/11/738/001-003 | Levetiracetam Actavis Group | Iceland | 14.12.2011 |
| EU/1/11/739/001-008 | Dasselta | Liechtenstein | 31.12.2011 |
| EU/1/11/739/001-008 | Dasselta | Iceland | 8.12.2011 |
| EU/1/11/740/001 | Ameluz | Liechtenstein | 31.12.2011 |
| EU/2/07/078/011-014 | Rheumocam | Norway | 6.7.2011 |
| EU/2/10/110/001-002 | Coxevac | Norway | 22.8.2011 |
| EU/2/10/112/001-005 | BTVPUR AlSap 1 | Norway | 22.8.2011 |
| EU/2/10/113/001-005 | BTVPUR AlSap 1-8 | Norway | 23.8.2011 |
| EU/2/11/122/001-003 | Bluevac BTV8 | Iceland | 12.7.2011 |
| EU/2/11/124/001-008 | Zuprevo | Norway | 6.7.2011 |
| EU/2/11/125/001-008 | Certifect | Norway | 1.9.2011 |
| EU/2/11/126/001 | MS-H-vaksine – Mycoplasma synoviae | Norway | 5.7.2011 |
| EU/2/11/127/001 | Recuvyra | Norway | 6.12.2011 |
| EU/2/11/127/001 | RECUVYRA | Iceland | 11.11.2011 |
| EU/2/11/128/001-003 | Emdocam | Norway | 14.9.2011 |
| EU/2/11/128/001-003 | Emdocam | Iceland | 8.9.2011 |
| EU/2/11/129/001-004 | Proteq West Nile | Norway | 19.8.2011 |
| EU/2/11/129/001-004 | Proteq West Nile | Iceland | 12.8.2011 |
| EU/2/11/130/001-003 | Zulvac 1 Bovis | Norway | 17.8.2011 |
| EU/2/11/130/001-003 | Zulvac 1 Bovis | Iceland | 18.8.2011 |
| EU/2/11/131/001-006 | Zulvac 1 Ovis | Norway | 17.8.2011 |
| EU/2/11/131/001-006 | Zulvac 1 Ovis | Iceland | 12.8.2011 |
| EU/2/11/132/001-004 | Nobivac Myxo-RHD | Norway | 19.9.2011 |
| EU/2/11/132/001-004 | Nobivac Myxo-RHD | Iceland | 20.9.2011 |
| EU/2/11/133/001-003 | Recocam | Norway | 6.10.2011 |
| EU/2/11/133/001-003 | Recocam 20 mg/ml | Iceland | 23.9.2011 |
| EU/2/11/134/001-014 | Inflacam | Iceland | 19.12.2011 |
| EU/2/11/135/001-003 | Panacur AquaSol | Iceland | 19.12.2011 |

EU-Number

Product

Country

Date of authorisation

EU/1/09/543/001-002

Cayston (1)

Liechtenstein

31.10.2011

EU/1/10/642/001-004

Ibandronic Acid Teva

Norway

23.8.2011

EU/1/10/649/001-016

Clopidogrel Teva Pharma B.V

Norway

19.7.2011

EU/1/10/649/001-016

Clopidogrel Teva Pharma B.V.

Liechtenstein

31.8.2011

EU/1/10/652/001-003

TOBI Podhaler

Liechtenstein

31.8.2011

EU/1/10/652/001-003

TOBI Podhaler

Norway

17.8.2011

EU/1/10/652/001-003

TOBI Podhaler

Iceland

9.8.2011

EU/1/10/654/001-004

Leflunomide ratiopharm

Norway

25.8.2011

EU/1/10/660/001-002

Potactasol

Norway

24.8.2011

EU/1/10/661/001-002

Fluenz

Norway

23.8.2011

EU/1/11/672/001-006

Xeplion

Liechtenstein

31.10.2011

EU/1/11/683/001-080

Sprimeo HCT

Liechtenstein

31.8.2011

EU/1/11/683/001-080

Sprimeo HCT

Norway

22.8.2011

EU/1/11/683/001-080

Sprimeo HCT

Iceland

10.8.2011

EU/1/11/685/001-005

Ibandronic acid Sandoz

Liechtenstein

31.8.2011

EU/1/11/685/001-005

Ibandronic acid Sandoz

Iceland

18.8.2011

EU/1/11/689/001-002

IOA

Liechtenstein

31.12.2011

EU/1/11/689/001-002

IOA

Norway

6.12.2011

EU/1/11/689/001-002

Ioa

Iceland

25.11.2011

EU/1/11/690/001-002

Zoely

Liechtenstein

31.8.2011

EU/1/11/690/001-002

Zoely

Norway

18.8.2011

EU/1/11/690/001-002

Zoely

Iceland

9.8.2011

EU/1/11/691/001-005

Eliquis

Iceland

8.8.2011

EU/1/11/693/001-016

Rivastigmin Actavis

Norway

19.8.2011

EU/1/11/694/001-002

Nulojix

Liechtenstein

31.8.2011

EU/1/11/694/001-002

Nulojix

Norway

1.8.2011

EU/1/11/694/001-002

Nulojix

Iceland

6.7.2011

EU/1/11/695/001-055

Leganto

Liechtenstein

31.8.2011

EU/1/11/695/001-055

Leganto

Norway

23.8.2011

EU/1/11/695/001-055

Leganto

Iceland

6.7.2011

EU/1/11/696/001-002

Bydureon

Norway

5.7.2011

EU/1/11/696/001-002

Bydureon

Iceland

6.7.2011

EU/1/11/696/001-002

Bydureon

Liechtenstein

31.8.2011

EU/1/11/697/001-012

Temozolomide Sun

Liechtenstein

31.8.2011

EU/1/11/697/001-012

Temozolomide SUN

Norway

22.8.2011

EU/1/11/697/001-012

Temozolomide SUN

Iceland

9.8.2011

EU/1/11/698/001-002

Yervoy

Liechtenstein

31.8.2011

EU/1/11/698/001-002

Yervoy

Norway

18.8.2011

EU/1/11/698/001-002

Yervoy

Iceland

21.7.2011

EU/1/11/699/001-002

Fampyra

Liechtenstein

31.8.2011

EU/1/11/699/001-002

Fampyra

Norway

23.8.2011

EU/1/11/699/001-002

Fampyra

Iceland

9.8.2011

EU/1/11/700/001-002

Benlysta

Liechtenstein

31.8.2011

EU/1/11/700/001-002

Benlysta

Norway

27.7.2011

EU/1/11/700/001-002

Benlysta

Iceland

21.7.2011

EU/1/11/701/001-028

Levetiracetam Teva

Liechtenstein

31.10.2011

EU/1/11/701/001-028

Levetiracetam Teva

Norway

26.9.2011

EU/1/11/701/001-028

Levetiracetam Teva

Iceland

16.9.2011

EU/1/11/702/001-031

Levetiracetam Ratiopharm

Liechtenstein

31.10.2011

EU/1/11/702/001-031

Levetiracetam ratiopharm

Norway

26.9.2011

EU/1/11/702/001-031

Levetiracetam ratiopharm

Iceland

16.9.2011

EU/1/11/703/001-002

Xgeva

Liechtenstein

31.8.2011

EU/1/11/703/001-002

Xgeva

Norway

15.8.2011

EU/1/11/703/001-002

XGEVA

Iceland

21.7.2011

EU/1/11/704/001

Victrelis

Liechtenstein

31.8.2011

EU/1/11/704/001

Victrelis

Norway

16.8.2011

EU/1/11/704/001

Victrelis

Iceland

10.8.2011

EU/1/11/705/001-002

Vibativ

Liechtenstein

31.10.2011

EU/1/11/705/001-002

Vibativ

Norway

19.9.2011

EU/1/11/705/001-002

Vibativ

Iceland

16.9.2011

EU/1/11/706/001-033

Levodopa/Cardidopa/Entacapone Orion

Liechtenstein

31.10.2011

EU/1/11/706/001-033

Levodopa/Carbidopa/Entacapone Orion

Norway

23.9.2011

EU/1/11/706/001-033

Levodopa/Carbidopa/Entacapone Orion

Iceland

14.9.2011

EU/1/11/707/001-011

Trajenta

Liechtenstein

31.10.2011

EU/1/11/707/001-011

Trajenta

Norway

12.9.2011

EU/1/11/707/001-011

Trajenta

Iceland

14.9.2011

EU/1/11/708/001-004

Entacapone Orion

Liechtenstein

31.8.2011

EU/1/11/708/001-004

Entacapone Orion

Norway

22.9.2011

EU/1/11/708/001-004

Entacapone Orion

Iceland

26.8.2011

EU/1/11/709/001-004

Buccolam

Norway

27.9.2011

EU/1/11/709/001-03

Buccolam

Iceland

1.11.2011

EU/1/11/710/001-007

Votubia

Liechtenstein

31.10.2011

EU/1/11/710/001-007

Votubia

Norway

15.9.2011

EU/1/11/710/001-007

Votubia

Iceland

16.9.2011

EU/1/11/711/001-030

Matever

Liechtenstein

31.10.2011

EU/1/11/711/001-030

Matever

Iceland

13.10.2011

EU/1/11/712/001-028

Levetiracetam Accord

Liechtenstein

31.10.2011

EU/1/11/712/001-028

Levetiracetam Accord

Iceland

6.11.2011

EU/1/11/713/001-040

Levetiracetam Actavis

Liechtenstein

31.10.2011

EU/1/11/713/001-040

Levetiracetam Actavis

Iceland

13.10.2011

EU/1/11/714/001

Zytiga

Liechtenstein

31.10.2011

EU/1/11/714/001

Zytiga

Norway

26.9.2011

EU/1/11/714/001

Zytiga 250 mg Tafla

Iceland

19.9.2011

EU/1/11/715/001-002

Plenadren

Liechtenstein

31.12.2011

EU/1/11/715/001-002

Plenadren

Norway

25.11.2011

EU/1/11/716/001-005

Eurartesim

Liechtenstein

31.12.2011

EU/1/11/716/001-005

Eurartesim

Norway

21.12.2011

EU/1/11/716/001-005

Eurartesim

Iceland

10.11.2011

EU/1/11/717/001

Vyndaqel

Liechtenstein

31.12.2011

EU/1/11/717/001

Vyndaqel

Norway

6.12.2011

EU/1/11/717/001

Vyndaqel

Iceland

25.11.2011

EU/1/11/718/001-006

Dexdor

Liechtenstein

31.10.2011

EU/1/11/718/001-006

Dexdor

Norway

11.10.2011

EU/1/11/718/001-006

Dexdor

Iceland

30.9.2011

EU/1/11/719/001-060

Telmisartan Teva Pharma

Norway

18.10.2011

EU/1/11/719/001-060

Telmisartan Teva Pharma

Iceland

6.11.2011

EU/1/11/720/001

Incivo

Liechtenstein

31.10.2011

EU/1/11/720/001

Incivo

Norway

6.10.2011

EU/1/11/720/001

Incivo 375 mg Filmuhúðuð tafla

Iceland

8.10.2011

EU/1/11/728/001-010

Pramipexole Accord

Liechtenstein

31.10.2011

EU/1/11/728/001-010

Pramipexole Accord

Norway

18.10.2011

EU/1/11/728/001-010

Pramipexole Accord

Iceland

10.10.2011

EU/1/11/729/001-006

Onduarp

Liechtenstein

31.12.2011

EU/1/11/729/001-006

Onduarp

Iceland

14.12.2011

EU/1/11/730/001-060

Rasitrio

Norway

7.12.2011

EU/1/11/731/001-012

Komboglyze

Liechtenstein

31.12.2011

EU/1/11/731/001-012

Komboglyze

Norway

15.12.2011

EU/1/11/731/001-012

Komboglyze

Iceland

8.12.2011

EU/1/11/732/001-013

Desloratadine Teva

Liechtenstein

31.12.2011

EU/1/11/732/001-013

Desloratadine Teva

Norway

20.12.2011

EU/1/11/732/001-013

Desloratadine Teva

Iceland

8.12.2011

EU/1/11/733/001-004

Dificlir

Liechtenstein

31.12.2011

EU/1/11/733/001-004

Dificlir

Norway

20.12.2011

EU/1/11/733/001-004

Dificlir

Iceland

14.12.2011

EU/1/11/734/001-011

Edarbi

Liechtenstein

31.12.2011

EU/1/11/734/001-011

Edarbi

Norway

21.12.2011

EU/1/11/734/001-011

Edarbi

Iceland

17.12.2011

EU/1/11/735/001-011

Ipreziv

Liechtenstein

31.12.2011

EU/1/11/735/001-011

Ipreziv

Norway

21.12.2011

EU/1/11/735/001-011

Ipreziv

Iceland

17.12.2011

EU/1/11/736/001

Edurant

Liechtenstein

31.12.2011

EU/1/11/736/001

Edurant

Norway

6.12.2011

EU/1/11/736/001

EDURANT

Iceland

14.12.2011

EU/1/11/737/001-002

Eviplera

Liechtenstein

31.12.2011

EU/1/11/737/001-002

Eviplera

Norway

6.12.2011

EU/1/11/737/001-002

Eviplera

Iceland

14.12.2011

EU/1/11/738/001-003

Levetiracetam Actavis Group

Liechtenstein

31.12.2011

EU/1/11/738/001-003

Levetiracetam Actavis Group

Iceland

14.12.2011

EU/1/11/739/001-008

Dasselta

Liechtenstein

31.12.2011

EU/1/11/739/001-008

Dasselta

Iceland

8.12.2011

EU/1/11/740/001

Ameluz

Liechtenstein

31.12.2011

EU/2/07/078/011-014

Rheumocam

Norway

6.7.2011

EU/2/10/110/001-002

Coxevac

Norway

22.8.2011

EU/2/10/112/001-005

BTVPUR AlSap 1

Norway

22.8.2011

EU/2/10/113/001-005

BTVPUR AlSap 1-8

Norway

23.8.2011

EU/2/11/122/001-003

Bluevac BTV8

Iceland

12.7.2011

EU/2/11/124/001-008

Zuprevo

Norway

6.7.2011

EU/2/11/125/001-008

Certifect

Norway

1.9.2011

EU/2/11/126/001

MS-H-vaksine – Mycoplasma synoviae

Norway

5.7.2011

EU/2/11/127/001

Recuvyra

Norway

6.12.2011

EU/2/11/127/001

RECUVYRA

Iceland

11.11.2011

EU/2/11/128/001-003

Emdocam

Norway

14.9.2011

EU/2/11/128/001-003

Emdocam

Iceland

8.9.2011

EU/2/11/129/001-004

Proteq West Nile

Norway

19.8.2011

EU/2/11/129/001-004

Proteq West Nile

Iceland

12.8.2011

EU/2/11/130/001-003

Zulvac 1 Bovis

Norway

17.8.2011

EU/2/11/130/001-003

Zulvac 1 Bovis

Iceland

18.8.2011

EU/2/11/131/001-006

Zulvac 1 Ovis

Norway

17.8.2011

EU/2/11/131/001-006

Zulvac 1 Ovis

Iceland

12.8.2011

EU/2/11/132/001-004

Nobivac Myxo-RHD

Norway

19.9.2011

EU/2/11/132/001-004

Nobivac Myxo-RHD

Iceland

20.9.2011

EU/2/11/133/001-003

Recocam

Norway

6.10.2011

EU/2/11/133/001-003

Recocam 20 mg/ml

Iceland

23.9.2011

EU/2/11/134/001-014

Inflacam

Iceland

19.12.2011

EU/2/11/135/001-003

Panacur AquaSol

Iceland

19.12.2011

---

(1)  From the conditional marketing authorisation with a marketing authorisation not subject to specific obligations.

---

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 2011:

| EU-Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/01/196/001
  EU/1/01/196/003 | Cancidas | Norway | 20.9.2011 |
| EU/1/01/196/001, 003 | Cancidas | Iceland | 20.9.2011 |
| EU/1/01/196/001, 003 | Cancidas | Liechtenstein | 31.10.2011 |
| EU/1/01/200/001-002 | Viread | Liechtenstein | 31.12.2011 |
| EU/1/06/336/001 | Tygacil | Iceland | 13.7.2011 |
| EU/1/06/340/001-002 | Ganfort | Liechtenstein | 31.8.2011 |
| EU/1/06/340/001-002 | Ganfort | Norway | 1.9.2011 |
| EU/1/06/340/001-002 | Ganfort | Iceland | 8.7.2011 |
| EU/1/06/342/001 | Nexavar | Liechtenstein | 31.8.2011 |
| EU/1/06/342/001 | Nexavar | Norway | 20.9.2011 |
| EU/1/06/342/001 | Nexavar | Iceland | 9.8.2011 |
| EU/1/06/343/001-007 | Baraclude | Norway | 6.7.2011 |
| EU/1/06/346/001 | Tysabri | Liechtenstein | 31.8.2011 |
| EU/1/06/346/001 | Tysabri | Norway | 19.7.2011 |
| EU/1/06/35/001-003 | Livensa | Liechtenstein | 31.8.2011 |
| EU/1/06/350/001 | Savene | Liechtenstein | 31.8.2011 |
| EU/1/06/350/001 | Savene | Norway | 18.8.2011 |
| EU/1/06/350/001 | Savene | Iceland | 9.8.2011 |
| EU/1/06/351/001-003 | Livensa | Norway | 12.8.2011 |
| EU/1/06/351/001-003 | Livensa | Iceland | 9.8.2011 |
| EU/1/06/352/001-003 | Intrinsa | Liechtenstein | 31.8.2011 |
| EU/1/06/352/001-003 | Intrinsa | Norway | 12.8.2011 |
| EU/1/06/352/001-003 | Intrinsa | Iceland | 10.8.2011 |
| EU/1/06/355/001-003 | ATryn | Liechtenstein | 31.8.2011 |
| EU/1/06/355/001-003 | ATryn | Norway | 1.9.2011 |
| EU/1/06/355/001-003 | ATryn | Iceland | 18.8.2011 |
| EU/1/06/356/001-009 | Exjade | Liechtenstein | 31.8.2011 |
| EU/1/06/356/001-009 | Exjade | Norway | 17.8.2011 |
| EU/1/06/356/001-009 | Exjade | Iceland | 9.8.2011 |
| EU/1/06/357/001-008, 018-021 | Gardasil | Iceland | 11.8.2011 |
| EU/1/06/357/001-008
  EU/1/06/357/018-021 | Gardasil | Norway | 19.8.2011 |
| EU/1/06/358/001-008, 018-021 | Silgard | Iceland | 10.8.2011 |
| EU/1/06/358/001-021 | Silgard | Liechtenstein | 31.8.2011 |
| EU/1/06/358/001-021 | Silgard | Norway | 12.8.2011 |
| EU/1/06/359/001-004 | Suboxone | Liechtenstein | 31.10.2011 |
| EU/1/06/359/001-004 | Suboxone | Norway | 14.10.2011 |
| EU/1/06/359/001-004 | Suboxone | Iceland | 4.10.2011 |
| EU/1/06/360/001-013 | Champix | Norway | 3.8.2011 |
| EU/1/06/360/001-013 | Champix | Iceland | 7.7.2011 |
| EU/1/06/361/001-002 | Luminity | Liechtenstein | 31.10.2011 |
| EU/1/06/361/001-002 | Luminity | Norway | 21.9.2011 |
| EU/1/06/361/001-002 | Luminity | Iceland | 21.9.2011 |
| EU/1/06/362/001-004 | Byetta | Liechtenstein | 31.10.2011 |
| EU/1/06/362/001-004 | Byetta | Norway | 6.10.2011 |
| EU/1/06/362/001-004 | Byetta | Iceland | 8.10.2011 |
| EU/1/06/363/001-015 | Sprycel | Liechtenstein | 31.10.2011 |
| EU/1/06/363/001-015 | Sprycel | Norway | 14.10.2011 |
| EU/1/06/363/001-015 | Sprycel | Iceland | 7.11.2011 |
| EU/1/06/364/001-004
  EU/1/06/364/006-008 | Adrovance | Norway | 23.12.2011 |
| EU/1/06/364/001-004, 006-008 | Adrovance | Iceland | 7.12.2011 |
| EU/1/06/364/006-008 | Adrovance | Liechtenstein | 31.12.2011 |
| EU/1/06/365/001-003 | Elaprase | Liechtenstein | 31.10.2011 |
| EU/1/06/365/001-003 | Elaprase | Norway | 14.10.2011 |
| EU/1/06/365/001-003 | Elaprase | Iceland | 6.11.2011 |
| EU/1/06/368/001-015, 020-024, 029-033, 038-042, 047-051, 056-057, 088-102, 113-150, 163-168 | Insulin Human Winthrop | Liechtenstein | 31.12.2011 |
| EU/1/06/368/001-168 | Insulin Human Winthrop | Iceland | 6.12.2011 |
| EU/1/06/370/001-039 | Exforge | Liechtenstein | 31.12.2011 |
| EU/1/06/372/001-039 | Copalia | Liechtenstein | 31.12.2011 |
| EU/1/06/372/001-039 | Copalia | Iceland | 7.12.2011 |
| EU/1/06/373/001-039 | Imprida | Liechtenstein | 31.12.2011 |
| EU/1/07/440/001-006 | Tyverb | Iceland | 22.8.2011 |
| EU/1/08/468/001 | Intelence | Liechtenstein | 31.8.2011 |
| EU/1/08/468/001 | Intelence | Norway | 17.8.2011 |
| EU/1/08/468/001 | INTELENCE | Iceland | 11.8.2011 |
| EU/1/09/543/001-002 | Cayston | Norway | 19.9.2011 |
| EU/1/09/543/001-002 | Cayston | Iceland | 19.9.2011 |
| EU/1/10/628/001-004 | Votrient | Norway | 21.10.2011 |
| EU/1/96/024/001-005 | Crixivan | Liechtenstein | 31.8.2011 |
| EU/1/96/024/001-005
  EU/1/96/024/010 | Crixivan | Norway | 18.8.2011 |
| EU/1/96/024/001-010 | Crixivan | Iceland | 10.8.2011 |
| EU/2/06/059/001 | Convenia | Norway | 6.7.2011 |
| EU/2/06/060/001-002 | Poulvac Flufend H5N3 RG | Iceland | 11.8.2011 |
| EU/2/06/061/001-004 | Nobilis Influenza H5N2 | Norway | 14.9.2011 |
| EU/2/06/061/001-004 | Nobilis Influenza H5N2 | Iceland | 8.9.2011 |
| EU/2/06/062/001-005 | Cerenia | Norway | 18.8.2011 |
| EU/2/06/062/001-005 | Cerenia | Iceland | 12.8.2011 |
| EU/2/06/064/001-004 | ProMeris | Norway | 8.12.2011 |
| EU/2/06/064/001-004 | ProMeris | Iceland | 21.11.2011 |
| EU/2/06/065/001-010 | ProMeris Duo | Iceland | 4.12.2011 |
| EU/2/06/065/001-010 | ProMeris Duo | Norway | 8.12.2011 |
| EU/2/06/066/001-012 | Prac-Tic | Norway | 8.12.2011 |
| EU/2/06/066/001-012 | Prac-tic | Iceland | 25.11.2011 |
| EU/2/06/069/001 | Cortavance | Norway | 27.9.2011 |
| EU/2/06/069/001 | Cortavance | Iceland | 23.9.2011 |
| EU/2/99/016/001-006 | Porcilis Pesti | Norway | 6.10.2011 |
| EU/2/99/016/001-006 | Porcilis Pesti | Iceland | 7.10.2011 |

EU-Number

Product

Country

Date of authorisation

EU/1/01/196/001

EU/1/01/196/003

Cancidas

Norway

20.9.2011

EU/1/01/196/001, 003

Cancidas

Iceland

20.9.2011

EU/1/01/196/001, 003

Cancidas

Liechtenstein

31.10.2011

EU/1/01/200/001-002

Viread

Liechtenstein

31.12.2011

EU/1/06/336/001

Tygacil

Iceland

13.7.2011

EU/1/06/340/001-002

Ganfort

Liechtenstein

31.8.2011

EU/1/06/340/001-002

Ganfort

Norway

1.9.2011

EU/1/06/340/001-002

Ganfort

Iceland

8.7.2011

EU/1/06/342/001

Nexavar

Liechtenstein

31.8.2011

EU/1/06/342/001

Nexavar

Norway

20.9.2011

EU/1/06/342/001

Nexavar

Iceland

9.8.2011

EU/1/06/343/001-007

Baraclude

Norway

6.7.2011

EU/1/06/346/001

Tysabri

Liechtenstein

31.8.2011

EU/1/06/346/001

Tysabri

Norway

19.7.2011

EU/1/06/35/001-003

Livensa

Liechtenstein

31.8.2011

EU/1/06/350/001

Savene

Liechtenstein

31.8.2011

EU/1/06/350/001

Savene

Norway

18.8.2011

EU/1/06/350/001

Savene

Iceland

9.8.2011

EU/1/06/351/001-003

Livensa

Norway

12.8.2011

EU/1/06/351/001-003

Livensa

Iceland

9.8.2011

EU/1/06/352/001-003

Intrinsa

Liechtenstein

31.8.2011

EU/1/06/352/001-003

Intrinsa

Norway

12.8.2011

EU/1/06/352/001-003

Intrinsa

Iceland

10.8.2011

EU/1/06/355/001-003

ATryn

Liechtenstein

31.8.2011

EU/1/06/355/001-003

ATryn

Norway

1.9.2011

EU/1/06/355/001-003

ATryn

Iceland

18.8.2011

EU/1/06/356/001-009

Exjade

Liechtenstein

31.8.2011

EU/1/06/356/001-009

Exjade

Norway

17.8.2011

EU/1/06/356/001-009

Exjade

Iceland

9.8.2011

EU/1/06/357/001-008, 018-021

Gardasil

Iceland

11.8.2011

EU/1/06/357/001-008

EU/1/06/357/018-021

Gardasil

Norway

19.8.2011

EU/1/06/358/001-008, 018-021

Silgard

Iceland

10.8.2011

EU/1/06/358/001-021

Silgard

Liechtenstein

31.8.2011

EU/1/06/358/001-021

Silgard

Norway

12.8.2011

EU/1/06/359/001-004

Suboxone

Liechtenstein

31.10.2011

EU/1/06/359/001-004

Suboxone

Norway

14.10.2011

EU/1/06/359/001-004

Suboxone

Iceland

4.10.2011

EU/1/06/360/001-013

Champix

Norway

3.8.2011

EU/1/06/360/001-013

Champix

Iceland

7.7.2011

EU/1/06/361/001-002

Luminity

Liechtenstein

31.10.2011

EU/1/06/361/001-002

Luminity

Norway

21.9.2011

EU/1/06/361/001-002

Luminity

Iceland

21.9.2011

EU/1/06/362/001-004

Byetta

Liechtenstein

31.10.2011

EU/1/06/362/001-004

Byetta

Norway

6.10.2011

EU/1/06/362/001-004

Byetta

Iceland

8.10.2011

EU/1/06/363/001-015

Sprycel

Liechtenstein

31.10.2011

EU/1/06/363/001-015

Sprycel

Norway

14.10.2011

EU/1/06/363/001-015

Sprycel

Iceland

7.11.2011

EU/1/06/364/001-004

EU/1/06/364/006-008

Adrovance

Norway

23.12.2011

EU/1/06/364/001-004, 006-008

Adrovance

Iceland

7.12.2011

EU/1/06/364/006-008

Adrovance

Liechtenstein

31.12.2011

EU/1/06/365/001-003

Elaprase

Liechtenstein

31.10.2011

EU/1/06/365/001-003

Elaprase

Norway

14.10.2011

EU/1/06/365/001-003

Elaprase

Iceland

6.11.2011

EU/1/06/368/001-015, 020-024, 029-033, 038-042, 047-051, 056-057, 088-102, 113-150, 163-168

Insulin Human Winthrop

Liechtenstein

31.12.2011

EU/1/06/368/001-168

Insulin Human Winthrop

Iceland

6.12.2011

EU/1/06/370/001-039

Exforge

Liechtenstein

31.12.2011

EU/1/06/372/001-039

Copalia

Liechtenstein

31.12.2011

EU/1/06/372/001-039

Copalia

Iceland

7.12.2011

EU/1/06/373/001-039

Imprida

Liechtenstein

31.12.2011

EU/1/07/440/001-006

Tyverb

Iceland

22.8.2011

EU/1/08/468/001

Intelence

Liechtenstein

31.8.2011

EU/1/08/468/001

Intelence

Norway

17.8.2011

EU/1/08/468/001

INTELENCE

Iceland

11.8.2011

EU/1/09/543/001-002

Cayston

Norway

19.9.2011

EU/1/09/543/001-002

Cayston

Iceland

19.9.2011

EU/1/10/628/001-004

Votrient

Norway

21.10.2011

EU/1/96/024/001-005

Crixivan

Liechtenstein

31.8.2011

EU/1/96/024/001-005

EU/1/96/024/010

Crixivan

Norway

18.8.2011

EU/1/96/024/001-010

Crixivan

Iceland

10.8.2011

EU/2/06/059/001

Convenia

Norway

6.7.2011

EU/2/06/060/001-002

Poulvac Flufend H5N3 RG

Iceland

11.8.2011

EU/2/06/061/001-004

Nobilis Influenza H5N2

Norway

14.9.2011

EU/2/06/061/001-004

Nobilis Influenza H5N2

Iceland

8.9.2011

EU/2/06/062/001-005

Cerenia

Norway

18.8.2011

EU/2/06/062/001-005

Cerenia

Iceland

12.8.2011

EU/2/06/064/001-004

ProMeris

Norway

8.12.2011

EU/2/06/064/001-004

ProMeris

Iceland

21.11.2011

EU/2/06/065/001-010

ProMeris Duo

Iceland

4.12.2011

EU/2/06/065/001-010

ProMeris Duo

Norway

8.12.2011

EU/2/06/066/001-012

Prac-Tic

Norway

8.12.2011

EU/2/06/066/001-012

Prac-tic

Iceland

25.11.2011

EU/2/06/069/001

Cortavance

Norway

27.9.2011

EU/2/06/069/001

Cortavance

Iceland

23.9.2011

EU/2/99/016/001-006

Porcilis Pesti

Norway

6.10.2011

EU/2/99/016/001-006

Porcilis Pesti

Iceland

7.10.2011

---

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 2011:

| EU-Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/00/165/008 | Ovitrelle | Liechtenstein | 31.8.2011 |
| EU/1/00/165/008 | Ovitrelle | Norway | 6.7.2011 |
| EU/1/01/176/007-009 | Zometa | Liechtenstein | 31.10.2011 |
| EU/1/01/176/007-009 | Zometa | Norway | 12.9.2011 |
| EU/1/01/176/007-009 | Zometa | Iceland | 12.11.2011 |
| EU/1/02/221/011-016 | Pegasys | Liechtenstein | 31.8.2011 |
| EU/1/03/248/013-023 | Levitra | Liechtenstein | 31.12.2011 |
| EU/1/03/249/013-015 | Vivanza | Liechtenstein | 31.12.2011 |
| EU/1/03/260/034-038 | Stalevo | Norway | 23.9.2011 |
| EU/1/03/260/034-038 | Stalevo | Liechtenstein | 31.10.2011 |
| EU/1/03/260/034-038 | Stalevo | Iceland | 13.9.2011 |
| EU/1/03/262/009-010 | Emend | Liechtenstein | 31.12.2011 |
| EU/1/03/270/004-005 | Kentera | Liechtenstein | 31.8.2011 |
| EU/1/03/270/004-005 | Kentera | Norway | 7.9.2011 |
| EU/1/03/270/004-005 | Kentera | Iceland | 9.9.2011 |
| EU/1/03/271/007-010 | Advate | Liechtenstein | 31.12.2011 |
| EU/1/05/322/002 | Yttriga | Liechtenstein | 31.8.2011 |
| EU/1/06/332/010-012 | Omnitrope | Norway | 25.8.2011 |
| EU/1/06/378/017 | Inovelon | Liechtenstein | 31.12.2011 |
| EU/1/06/378/017 | Inovelon | Norway | 20.12.2011 |
| EU/1/07/392/003 | Circadin | Liechtenstein | 31.10.2011 |
| EU/1/07/401/016 | Alli | Liechtenstein | 31.8.2011 |
| EU/1/07/422/007-008 | Tasigna | Liechtenstein | 31.8.2011 |
| EU/1/07/422/009-012 | Tasigna | Liechtenstein | 31.12.2011 |
| EU/1/08/442/009-013 | Pradaxa | Iceland | 10.8.2011 |
| EU/1/08/442/009-014 | Pradaxa | Liechtenstein | 31.8.2011 |
| EU/1/08/442/009-014 | Pradaxa | Norway | 17.8.2011 |
| EU/1/08/468/002 | Intelence | Liechtenstein | 31.12.2011 |
| EU/1/08/468/002 | Intelence | Norway | 15.12.2011 |
| EU/1/08/470/014-015 | Vimpat | Iceland | 8.12.2011 |
| EU/1/08/472/011-021 | Xarelto | Liechtenstein | 31.12.2011 |
| EU/1/08/472/011-021 | Xarelto | Iceland | 20.12.2011 |
| EU/1/09/508/011 | Synflorix | Liechtenstein | 31.8.2011 |
| EU/1/09/531/010-021 | Instanyl | Liechtenstein | 31.8.2011 |
| EU/1/09/531/010-021 | Instanyl | Norway | 1.8.2011 |
| EU/1/09/531/010-021 | Instanyl | Iceland | 13.7.2011 |
| EU/1/09/564/003 | Ilaris | Liechtenstein | 31.10.2011 |
| EU/1/09/564/003 | Ilaris | Iceland | 5.10.2011 |
| EU/1/09/564/003 | Ilaris | Norway | 27.9.2011 |
| EU/1/09/610/031-060 | Telmisartan Teva | Liechtenstein | 31.8.2011 |
| EU/1/10/614/003 | Menveo | Liechtenstein | 31.8.2011 |
| EU/1/10/636/004-007 | Daxas | Liechtenstein | 31.12.2011 |
| EU/1/10/646/003-006 | VPRIV | Liechtenstein | 31.8.2011 |
| EU/1/10/647/003-004 | Myclausen | Norway | 27.9.2011 |
| EU/1/10/647/003-004 | Myclausen | Iceland | 3.10.2011 |
| EU/1/95/003/011-012 | Betaferon | Liechtenstein | 31.8.2011 |
| EU/1/97/055/005-009 | Viramune | Norway | 14.10.2011 |
| EU/1/97/055/005-009 | Viramune | Iceland | 5.10.2011 |
| EU/1/98/090/021-022 | Micardis | Liechtenstein | 31.8.2011 |
| EU/1/99/119/019-023 | NovoRapid | Liechtenstein | 31.8.2011 |
| EU/1/99/126/022 | Enbrel | Iceland | 13.7.2011 |
| EU/2/08/090/010-018 | Loxicom | Norway | 15.8.2011 |
| EU/2/08/090/010-026 | Loxicom | Iceland | 22.7.2011 |
| EU/2/08/090/019-026 | Loxicom | Norway | 27.9.2011 |

EU-Number

Product

Country

Date of authorisation

EU/1/00/165/008

Ovitrelle

Liechtenstein

31.8.2011

EU/1/00/165/008

Ovitrelle

Norway

6.7.2011

EU/1/01/176/007-009

Zometa

Liechtenstein

31.10.2011

EU/1/01/176/007-009

Zometa

Norway

12.9.2011

EU/1/01/176/007-009

Zometa

Iceland

12.11.2011

EU/1/02/221/011-016

Pegasys

Liechtenstein

31.8.2011

EU/1/03/248/013-023

Levitra

Liechtenstein

31.12.2011

EU/1/03/249/013-015

Vivanza

Liechtenstein

31.12.2011

EU/1/03/260/034-038

Stalevo

Norway

23.9.2011

EU/1/03/260/034-038

Stalevo

Liechtenstein

31.10.2011

EU/1/03/260/034-038

Stalevo

Iceland

13.9.2011

EU/1/03/262/009-010

Emend

Liechtenstein

31.12.2011

EU/1/03/270/004-005

Kentera

Liechtenstein

31.8.2011

EU/1/03/270/004-005

Kentera

Norway

7.9.2011

EU/1/03/270/004-005

Kentera

Iceland

9.9.2011

EU/1/03/271/007-010

Advate

Liechtenstein

31.12.2011

EU/1/05/322/002

Yttriga

Liechtenstein

31.8.2011

EU/1/06/332/010-012

Omnitrope

Norway

25.8.2011

EU/1/06/378/017

Inovelon

Liechtenstein

31.12.2011

EU/1/06/378/017

Inovelon

Norway

20.12.2011

EU/1/07/392/003

Circadin

Liechtenstein

31.10.2011

EU/1/07/401/016

Alli

Liechtenstein

31.8.2011

EU/1/07/422/007-008

Tasigna

Liechtenstein

31.8.2011

EU/1/07/422/009-012

Tasigna

Liechtenstein

31.12.2011

EU/1/08/442/009-013

Pradaxa

Iceland

10.8.2011

EU/1/08/442/009-014

Pradaxa

Liechtenstein

31.8.2011

EU/1/08/442/009-014

Pradaxa

Norway

17.8.2011

EU/1/08/468/002

Intelence

Liechtenstein

31.12.2011

EU/1/08/468/002

Intelence

Norway

15.12.2011

EU/1/08/470/014-015

Vimpat

Iceland

8.12.2011

EU/1/08/472/011-021

Xarelto

Liechtenstein

31.12.2011

EU/1/08/472/011-021

Xarelto

Iceland

20.12.2011

EU/1/09/508/011

Synflorix

Liechtenstein

31.8.2011

EU/1/09/531/010-021

Instanyl

Liechtenstein

31.8.2011

EU/1/09/531/010-021

Instanyl

Norway

1.8.2011

EU/1/09/531/010-021

Instanyl

Iceland

13.7.2011

EU/1/09/564/003

Ilaris

Liechtenstein

31.10.2011

EU/1/09/564/003

Ilaris

Iceland

5.10.2011

EU/1/09/564/003

Ilaris

Norway

27.9.2011

EU/1/09/610/031-060

Telmisartan Teva

Liechtenstein

31.8.2011

EU/1/10/614/003

Menveo

Liechtenstein

31.8.2011

EU/1/10/636/004-007

Daxas

Liechtenstein

31.12.2011

EU/1/10/646/003-006

VPRIV

Liechtenstein

31.8.2011

EU/1/10/647/003-004

Myclausen

Norway

27.9.2011

EU/1/10/647/003-004

Myclausen

Iceland

3.10.2011

EU/1/95/003/011-012

Betaferon

Liechtenstein

31.8.2011

EU/1/97/055/005-009

Viramune

Norway

14.10.2011

EU/1/97/055/005-009

Viramune

Iceland

5.10.2011

EU/1/98/090/021-022

Micardis

Liechtenstein

31.8.2011

EU/1/99/119/019-023

NovoRapid

Liechtenstein

31.8.2011

EU/1/99/126/022

Enbrel

Iceland

13.7.2011

EU/2/08/090/010-018

Loxicom

Norway

15.8.2011

EU/2/08/090/010-026

Loxicom

Iceland

22.7.2011

EU/2/08/090/019-026

Loxicom

Norway

27.9.2011

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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 2011:

| EU-Number | Product | Country | Date of withdrawal |
| --- | --- | --- | --- |
| EU/1/02/225/001-002 | Xigris | Liechtenstein | 31.12.2011 |
| EU/1/03/259/001-006 | Onsenal | Norway | 5.8.2011 |
| EU/1/05/313/001-009 | Ablavar | Liechtenstein | 31.10.2011 |
| EU/1/05/313/001-009 | Ablavar | Norway | 29.11.2011 |
| EU/1/05/313/001-009 | Ablavar | Iceland | 6.11.2011 |
| EU/1/08/470/014-015 | Vimpat | Iceland | 8.12.2011 |
| EU/1/08/478/001 | Prepandemic influenza vaccine (H5N1) | Liechtenstein | 31.10.2011 |
| EU/1/08/478/001 | Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals | Iceland | 6.11.2011 |
| EU/1/09/547/001-007 | Clopidogrel Sandoz | Norway | 5.8.2011 |
| EU/1/09/547/001-007 | Clopidogrel Sandoz | Iceland | 23.8.2011 |
| EU/1/10/629/001 | Humenza | Norway | 5.8.2011 |
| EU/2/06/063/001-003 | Yarvitan | Norway | 22.9.2011 |
| EU/2/06/063/001-003 | Yarvitan | Iceland | 26.8.2011 |
| EU/1/06/349/001-010 | Avaglim | Norway | 18.8.2011 |

EU-Number

Product

Country

Date of withdrawal

EU/1/02/225/001-002

Xigris

Liechtenstein

31.12.2011

EU/1/03/259/001-006

Onsenal

Norway

5.8.2011

EU/1/05/313/001-009

Ablavar

Liechtenstein

31.10.2011

EU/1/05/313/001-009

Ablavar

Norway

29.11.2011

EU/1/05/313/001-009

Ablavar

Iceland

6.11.2011

EU/1/08/470/014-015

Vimpat

Iceland

8.12.2011

EU/1/08/478/001

Prepandemic influenza vaccine (H5N1)

Liechtenstein

31.10.2011

EU/1/08/478/001

Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals

Iceland

6.11.2011

EU/1/09/547/001-007

Clopidogrel Sandoz

Norway

5.8.2011

EU/1/09/547/001-007

Clopidogrel Sandoz

Iceland

23.8.2011

EU/1/10/629/001

Humenza

Norway

5.8.2011

EU/2/06/063/001-003

Yarvitan

Norway

22.9.2011

EU/2/06/063/001-003

Yarvitan

Iceland

26.8.2011

EU/1/06/349/001-010

Avaglim

Norway

18.8.2011

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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 2011:

| EU-Number | Product | Country | Date of suspension |
| --- | --- | --- | --- |
| EU/1/06/361/001-002 | Luminity | Liechtenstein | 31.12.2011 |
| EU/2/08/088/001-003 | Acticam | Iceland | 23.8.2011 |

EU-Number

Product

Country

Date of suspension

EU/1/06/361/001-002

Luminity

Liechtenstein

31.12.2011

EU/2/08/088/001-003

Acticam

Iceland

23.8.2011

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