# C_2012044EN.01000601.xml

| 16.2.2012 | EN | Official Journal of the European Union | C 44/6 |
| --- | --- | --- | --- |

16.2.2012

EN

Official Journal of the European Union

C 44/6

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

2012/C 44/05

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 January-30 June 2011, at their meeting on 30 September 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| Annex IV | List of withdrawn marketing authorisations |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List of withdrawn marketing authorisations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 January-30 June 2011:

| EU-Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/09/578/001 | Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals | Iceland | 29.4.2011 |
| EU/1/10/635/001-014 | Olanzapin Apotex | Norway | 14.2.2011 |
| EU/1/10/639/001-030 | Telmisartan Actavis | Norway | 17.3.2011 |
| EU/1/10/641/001 | Ruconest | Iceland | 24.1.2011 |
| EU/1/10/642/001-004 | Ibandronic Acid Teva | Iceland | 17.1.2011 |
| EU/1/10/647/001-002 | Myclausen | Iceland | 21.1.2011 |
| EU/1/10/647/001-028 | Twynsta | Iceland | 21.1.2011 |
| EU/1/10/650/001-015 | Clopidogrel Teva Generics BV | Iceland | 1.2.2011 |
| EU/1/10/651/001-015 | Clopidogrel HCS | Iceland | 1.2.2011 |
| EU/1/10/654/001-004 | Leflunomide ratiopharm | Iceland | 14.3.2011 |
| EU/1/10/656/001-006 | Possia | Iceland | 13.1.2011 |
| EU/1/10/656/001-006 | Possia | Norway | 25.1.2011 |
| EU/1/10/657/001-002 | Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Dia | Iceland | 14.3.2011 |
| EU/1/10/657/001-002 | Prepandemic Influenza Vaccine | Norway | 3.1.2011 |
| EU/1/10/658/001-002 | Aflunov | Iceland | 14.3.2011 |
| EU/1/10/658/001-002 | Aflunov | Norway | 3.1.2011 |
| EU/1/10/659/001-010 | Iasibon | Iceland | 14.2.2011 |
| EU/1/10/659/001-010 | Iasibon | Norway | 17.2.2011 |
| EU/1/10/659/001-010 | Iasibon | Liechtenstein | 28.2.2011 |
| EU/1/10/660/001-002 | Potactasol | Iceland | 16.3.2011 |
| EU/1/10/660/001-002 | Potactasol | Liechtenstein | 28.2.2011 |
| EU/1/10/661/001-002 | Fluenz | Iceland | 16.3.2011 |
| EU/1/10/661/001-002 | Fluenz | Liechtenstein | 28.2.2011 |
| EU/1/10/662/001-002 | Docetaxel Teva Pharma | Iceland | 17.2.2011 |
| EU/1/10/662/001-002 | Docetaxel Teva Pharma | Liechtenstein | 28.2.2011 |
| EU/1/10/662/001-002 | Docetaxel Teva Pharma | Norway | 17.3.2011 |
| EU/1/10/662/001-002 | Docetaxel Teva Pharma | Norway | 17.3.2011 |
| EU/1/10/663/001-002 | Lamivudine/Zidovudine Teva | Norway | 31.3.2011 |
| EU/1/10/663/001-002 | Lamivudine/Zidovudine Teva | Liechtenstein | 30.4.2011 |
| EU/1/10/664/001 | Pumarix | Iceland | 8.4.2011 |
| EU/1/10/664/001 | Pumarix | Norway | 13.4.2011 |
| EU/1/10/664/001 | Pumarix | Liechtenstein | 30.4.2011 |
| EU/1/10/665/001-004 | Entacapone Teva | Iceland | 21.3.2011 |
| EU/1/10/665/001-004 | Entacapone Teva | Norway | 4.4.2011 |
| EU/1/10/665/001-004 | Entacapone Teva | Liechtenstein | 30.4.2011 |
| EU/1/11/666/001-003 | Libertek | Iceland | 24.3.2011 |
| EU/1/11/666/001-003 | Libertek | Norway | 15.3.2011 |
| EU/1/11/666/001-003 | Libertek | Liechtenstein | 30.4.2011 |
| EU/1/11/667/001-003 | Esbriet | Liechtenstein | 30.4.2011 |
| EU/1/11/667/001-003 | Esbriet | Iceland | 25.3.2011 |
| EU/1/11/667/001-003 | Esbriet | Norway | 15.3.2011 |
| EU/1/11/667/001-003 | Esbriet | Norway | 15.3.2011 |
| EU/1/11/668/001-003 | Daliresp | Iceland | 12.4.2011 |
| EU/1/11/668/001-003 | Daliresp | Norway | 15.3.2011 |
| EU/1/11/668/001-003 | Daliresp | Liechtenstein | 30.4.2011 |
| EU/1/11/669/001-004 | Teysuno | Iceland | 12.4.2011 |
| EU/1/11/669/001-004 | Teysuno | Norway | 24.5.2011 |
| EU/1/11/669/001-004 | Teysuno | Liechtenstein | 30.4.2011 |
| EU/1/11/671/001 | Xiapex | Iceland | 28.3.2011 |
| EU/1/11/671/001 | Xiapex | Norway | 31.3.2011 |
| EU/1/11/671/001 | Xiapex | Liechtenstein | 30.4.2011 |
| EU/1/11/672/001-006 | Xeplion | Iceland | 8.4.2011 |
| EU/1/11/672/001-006 | Xeplion | Norway | 5.4.2011 |
| EU/1/11/672/001-006 | Xeplion | Liechtenstein | 30.4.2011 |
| EU/1/11/673/001-024 | Ifirmacombi | Iceland | 4.4.2011 |
| EU/1/11/673/001-024 | Ifirmacombi | Norway | 6.4.2011 |
| EU/1/11/673/001-024 | Ifirmacombi | Liechtenstein | 30.4.2011 |
| EU/1/11/674/001-010 | Repso | Iceland | 13.4.2011 |
| EU/1/11/674/001-010 | Repso | Norway | 26.4.2011 |
| EU/1/11/674/001-010 | Repso | Liechtenstein | 30.4.2011 |
| EU/1/11/675/001-0010 | Leflunomide Teva | Iceland | 8.4.2011 |
| EU/1/11/675/001-010 | Lefluomide Teva | Norway | 11.4.2011 |
| EU/1/11/675/001-010 | Leflunomid Teva | Liechtenstein | 30.4.2011 |
| EU/1/11/676/001 | Jevtana | Iceland | 12.4.2011 |
| EU/1/11/676/001 | Jevtana | Norway | 6.4.2011 |
| EU/1/11/676/001 | Jevtana | Liechtenstein | 30.4.2011 |
| EU/1/11/677/001-004 | Gilenya | Iceland | 13.4.2011 |
| EU/1/11/677/001-004 | Gilenya | Norway | 28.3.2011 |
| EU/1/11/677/001-004 | Gilenya | Liechtenstein | 30.4.2011 |
| EU/1/11/678/001-002 | Halaven | Iceland | 14.4.2011 |
| EU/1/11/678/001-002 | Halaven | Norway | 6.4.2011 |
| EU/1/11/678/001-002 | Halaven | Liechtenstein | 30.4.2011 |
| EU/1/11/679/001-006 | Pravafenix | Iceland | 10.5.2011 |
| EU/1/11/679/001-006 | Pravafenix | Norway | 11.5.2011 |
| EU/1/11/679/001-006 | Pravafenix | Liechtenstein | 30.4.2011 |
| EU/1/11/680/001-080 | Riprazo HCT | Iceland | 29.4.2011 |
| EU/1/11/680/001-080 | Riprazo HCT | Norway | 24.5.2011 |
| EU/1/11/680/001-080 | Riprazo HCT | Liechtenstein | 30.4.2011 |
| EU/1/11/681/001-013 | Trobalt | Iceland | 19.4.2011 |
| EU/1/11/681/001-013 | Trobalt | Norway | 4.4.2011 |
| EU/1/11/681/001-013 | Trobalt | Liechtenstein | 30.6.2011 |
| EU/1/11/681/001-013 | Trobalt | Liechtenstein | 30.4.2011 |
| EU/1/11/682/001 | Methylthioninium chloride Proveblue | Iceland | 6.6.2011 |
| EU/1/11/682/001 | Methylhionininium chloride Proveblue | Norway | 27.6.2011 |
| EU/1/11/682/001 | Methylthioninchlorid Proveblue | Liechtenstein | 30.6.2011 |
| EU/1/11/686/001-056 | Rasilamlo | Iceland | 12.5.2011 |
| EU/1/11/686/001-056 | Rasilamlo | Norway | 24.5.2011 |
| EU/1/11/686/001-056 | Rasilamlo | Liechtenstein | 30.4.2011 |
| EU/1/11/687/001-012 | Hizentra | Iceland | 12.5.2011 |
| EU/1/11/687/001-012 | Hizentra | Norway | 9.5.2011 |
| EU/1/11/687/001-012 | Hizentra | Liechtenstein | 30.4.2011 |
| EU/1/11/688/001 | Cinryze | Iceland | 28.6.2011 |
| EU/1/11/688/001 | Cinryze | Norway | 27.6.2011 |
| EU/1/11/691/001-005 | Eliquis | Norway | 31.5.2011 |
| EU/1/11/691/001-005 | Eliquis | Liechtenstein | 30.6.2011 |
| EU/1/11/692/001 | Yellox | Iceland | 28.6.2011 |
| EU/1/11/692/001 | Yellox | Norway | 10.6.2011 |
| EU/1/11/692/001 | Yellox | Liechtenstein | 30.6.2011 |
| EU/1/11/693/001-016 | Rivastigmine Actavis | Iceland | 28.6.2011 |
| EU/1/11/693/001-016 | Rivastigmine Actavis | Liechtenstein | 30.6.2011 |
| EU/1/190/649/001-016 | Clopidogrel Teva Pharma BV | Iceland | 30.6.2011 |
| EU/1/98/058/001-002 | Lamivudine/Zidovudine Teva | Iceland | 12.4.2011 |
| EU/1/98/058/001-002 | Lamivudine | Norway | 31.3.2011 |
| EU/2/11/120/001-003 | Zulvac 1 + 8 Ovis | Liechtenstein | 30.4.2011 |
| EU/2/11/126/001 | MS-H Impfstoff | Liechtenstein | 30.6.2011 |
| EU/2/10/107/001-014 | Veraflox | Iceland | 10.5.2011 |
| EU/2/10/107/001-014 | Veraflox | Norway | 24.6.2011 |
| EU/2/10/107/001-014 | Veraflox | Liechtenstein | 30.4.2011 |
| EU/2/10/109/001-009 | RHINISENG | Norway | 3.1.2011 |
| EU/2/10/110/001-002 | Coxevac | Iceland | 26.1.2011 |
| EU/2/10/111/001-004 | Meloxoral | Iceland | 14.3.2011 |
| EU/2/10/111/001-004 | Meloxoral | Norway | 3.1.2011 |
| EU/2/10/112/001-005 | BTVPUR ALSap 1 | Iceland | 10.2.2011 |
| EU/2/10/112/001-005 | BTVPUR ALSap 1 | Liechtenstein | 28.2.2011 |
| EU/2/10/113/001-005 | BTVPUR ALSap 1-8 | Iceland | 10.2.2011 |
| EU/2/10/113/001-005 | BTVPUR ALSap 1-8 | Liechtenstein | 28.2.2011 |
| EU/2/10/114/001-002 | Hiprabovis IBR Marker Live | Iceland | 16.3.2011 |
| EU/2/10/114/001-002 | Hiprabovis IBR Marker Live | Norway | 9.2.2011 |
| EU/2/10/114/001-002 | Hiprabovis IBR Marker Live | Liechtenstein | 28.2.2011 |
| EU/2/10/115/001-010 | Comfortis | Iceland | 22.3.2011 |
| EU/2/10/115/001-010 | Comfortis | Norway | 22.2.2011 |
| EU/2/10/115/001-010 | Comfortis | Liechtenstein | 30.4.2011 |
| EU/2/10/115/001-010 | Comfortis | Norway | 22.2.2011 |
| EU/2/10/116/001-004 | Melosus | Iceland | 24.3.2011 |
| EU/2/10/116/001-004 | Melosus | Norway | 14.4.2011 |
| EU/2/10/116/001-004 | Melosus | Liechtenstein | 30.4.2011 |
| EU/2/10/117/001-002 | Purevax Rabies | Iceland | 21.3.2011 |
| EU/2/10/117/001-002 | Purevax Rabies | Norway | 4.4.2011 |
| EU/2/10/117/001-002 | Purevax Rabies | Liechtenstein | 30.4.2011 |
| EU/2/10/118/001-014 | Activyl | Iceland | 21.3.2011 |
| EU/2/10/118/001-014 | Activyl | Norway | 1.4.2011 |
| EU/2/10/118/001-014 | Activyl | Liechtenstein | 30.4.2011 |
| EU/2/10/119/001-012 | Cimalgex | Iceland | 21.3.2011 |
| EU/2/10/119/001-012 | Cimalgex | Norway | 1.4.2011 |
| EU/2/108/001-005 | BTVPUR ALSap 2-4 0.72 U.SN | Iceland | 10.2.2011 |
| EU/2/11/120/001-003 | Zulvac 1 + 8 Ovis | Iceland | 13.4.2011 |
| EU/2/11/120/001-003 | Zulvac 1 + 8 Ovis | Norway | 18.4.2011 |
| EU/2/11/121/001-009 | CaniLeish | Iceland | 13.4.2011 |
| EU/2/11/121/001-009 | CaniLeish | Norway | 11.4.2011 |
| EU/2/11/121/001-009 | CaniLeish | Liechtenstein | 30.4.2011 |
| EU/2/11/123/001-002 | Procox | Iceland | 28.6.2011 |
| EU/2/11/123/001-002 | Procox | Norway | 20.6.2011 |
| EU/2/11/123/001-002 | Procox | Liechtenstein | 30.6.2011 |
| EU/2/11/124/001-008 | Zuprevo | Iceland | 6.6.2011 |
| EU/2/11/124/001-008 | Zuprevo | Liechtenstein | 30.6.2011 |
| EU/2/11/125/001-008 | Certifect | Iceland | 6.6.2011 |
| EU/2/11/125/001-008 | Certificet | Liechtenstein | 30.6.2011 |
| EU/2/11/126/001 | MS-H-vaccine | Iceland | 28.6.2011 |

EU-Number

Product

Country

Date of authorisation

EU/1/09/578/001

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

Iceland

29.4.2011

EU/1/10/635/001-014

Olanzapin Apotex

Norway

14.2.2011

EU/1/10/639/001-030

Telmisartan Actavis

Norway

17.3.2011

EU/1/10/641/001

Ruconest

Iceland

24.1.2011

EU/1/10/642/001-004

Ibandronic Acid Teva

Iceland

17.1.2011

EU/1/10/647/001-002

Myclausen

Iceland

21.1.2011

EU/1/10/647/001-028

Twynsta

Iceland

21.1.2011

EU/1/10/650/001-015

Clopidogrel Teva Generics BV

Iceland

1.2.2011

EU/1/10/651/001-015

Clopidogrel HCS

Iceland

1.2.2011

EU/1/10/654/001-004

Leflunomide ratiopharm

Iceland

14.3.2011

EU/1/10/656/001-006

Possia

Iceland

13.1.2011

EU/1/10/656/001-006

Possia

Norway

25.1.2011

EU/1/10/657/001-002

Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Dia

Iceland

14.3.2011

EU/1/10/657/001-002

Prepandemic Influenza Vaccine

Norway

3.1.2011

EU/1/10/658/001-002

Aflunov

Iceland

14.3.2011

EU/1/10/658/001-002

Aflunov

Norway

3.1.2011

EU/1/10/659/001-010

Iasibon

Iceland

14.2.2011

EU/1/10/659/001-010

Iasibon

Norway

17.2.2011

EU/1/10/659/001-010

Iasibon

Liechtenstein

28.2.2011

EU/1/10/660/001-002

Potactasol

Iceland

16.3.2011

EU/1/10/660/001-002

Potactasol

Liechtenstein

28.2.2011

EU/1/10/661/001-002

Fluenz

Iceland

16.3.2011

EU/1/10/661/001-002

Fluenz

Liechtenstein

28.2.2011

EU/1/10/662/001-002

Docetaxel Teva Pharma

Iceland

17.2.2011

EU/1/10/662/001-002

Docetaxel Teva Pharma

Liechtenstein

28.2.2011

EU/1/10/662/001-002

Docetaxel Teva Pharma

Norway

17.3.2011

EU/1/10/662/001-002

Docetaxel Teva Pharma

Norway

17.3.2011

EU/1/10/663/001-002

Lamivudine/Zidovudine Teva

Norway

31.3.2011

EU/1/10/663/001-002

Lamivudine/Zidovudine Teva

Liechtenstein

30.4.2011

EU/1/10/664/001

Pumarix

Iceland

8.4.2011

EU/1/10/664/001

Pumarix

Norway

13.4.2011

EU/1/10/664/001

Pumarix

Liechtenstein

30.4.2011

EU/1/10/665/001-004

Entacapone Teva

Iceland

21.3.2011

EU/1/10/665/001-004

Entacapone Teva

Norway

4.4.2011

EU/1/10/665/001-004

Entacapone Teva

Liechtenstein

30.4.2011

EU/1/11/666/001-003

Libertek

Iceland

24.3.2011

EU/1/11/666/001-003

Libertek

Norway

15.3.2011

EU/1/11/666/001-003

Libertek

Liechtenstein

30.4.2011

EU/1/11/667/001-003

Esbriet

Liechtenstein

30.4.2011

EU/1/11/667/001-003

Esbriet

Iceland

25.3.2011

EU/1/11/667/001-003

Esbriet

Norway

15.3.2011

EU/1/11/667/001-003

Esbriet

Norway

15.3.2011

EU/1/11/668/001-003

Daliresp

Iceland

12.4.2011

EU/1/11/668/001-003

Daliresp

Norway

15.3.2011

EU/1/11/668/001-003

Daliresp

Liechtenstein

30.4.2011

EU/1/11/669/001-004

Teysuno

Iceland

12.4.2011

EU/1/11/669/001-004

Teysuno

Norway

24.5.2011

EU/1/11/669/001-004

Teysuno

Liechtenstein

30.4.2011

EU/1/11/671/001

Xiapex

Iceland

28.3.2011

EU/1/11/671/001

Xiapex

Norway

31.3.2011

EU/1/11/671/001

Xiapex

Liechtenstein

30.4.2011

EU/1/11/672/001-006

Xeplion

Iceland

8.4.2011

EU/1/11/672/001-006

Xeplion

Norway

5.4.2011

EU/1/11/672/001-006

Xeplion

Liechtenstein

30.4.2011

EU/1/11/673/001-024

Ifirmacombi

Iceland

4.4.2011

EU/1/11/673/001-024

Ifirmacombi

Norway

6.4.2011

EU/1/11/673/001-024

Ifirmacombi

Liechtenstein

30.4.2011

EU/1/11/674/001-010

Repso

Iceland

13.4.2011

EU/1/11/674/001-010

Repso

Norway

26.4.2011

EU/1/11/674/001-010

Repso

Liechtenstein

30.4.2011

EU/1/11/675/001-0010

Leflunomide Teva

Iceland

8.4.2011

EU/1/11/675/001-010

Lefluomide Teva

Norway

11.4.2011

EU/1/11/675/001-010

Leflunomid Teva

Liechtenstein

30.4.2011

EU/1/11/676/001

Jevtana

Iceland

12.4.2011

EU/1/11/676/001

Jevtana

Norway

6.4.2011

EU/1/11/676/001

Jevtana

Liechtenstein

30.4.2011

EU/1/11/677/001-004

Gilenya

Iceland

13.4.2011

EU/1/11/677/001-004

Gilenya

Norway

28.3.2011

EU/1/11/677/001-004

Gilenya

Liechtenstein

30.4.2011

EU/1/11/678/001-002

Halaven

Iceland

14.4.2011

EU/1/11/678/001-002

Halaven

Norway

6.4.2011

EU/1/11/678/001-002

Halaven

Liechtenstein

30.4.2011

EU/1/11/679/001-006

Pravafenix

Iceland

10.5.2011

EU/1/11/679/001-006

Pravafenix

Norway

11.5.2011

EU/1/11/679/001-006

Pravafenix

Liechtenstein

30.4.2011

EU/1/11/680/001-080

Riprazo HCT

Iceland

29.4.2011

EU/1/11/680/001-080

Riprazo HCT

Norway

24.5.2011

EU/1/11/680/001-080

Riprazo HCT

Liechtenstein

30.4.2011

EU/1/11/681/001-013

Trobalt

Iceland

19.4.2011

EU/1/11/681/001-013

Trobalt

Norway

4.4.2011

EU/1/11/681/001-013

Trobalt

Liechtenstein

30.6.2011

EU/1/11/681/001-013

Trobalt

Liechtenstein

30.4.2011

EU/1/11/682/001

Methylthioninium chloride Proveblue

Iceland

6.6.2011

EU/1/11/682/001

Methylhionininium chloride Proveblue

Norway

27.6.2011

EU/1/11/682/001

Methylthioninchlorid Proveblue

Liechtenstein

30.6.2011

EU/1/11/686/001-056

Rasilamlo

Iceland

12.5.2011

EU/1/11/686/001-056

Rasilamlo

Norway

24.5.2011

EU/1/11/686/001-056

Rasilamlo

Liechtenstein

30.4.2011

EU/1/11/687/001-012

Hizentra

Iceland

12.5.2011

EU/1/11/687/001-012

Hizentra

Norway

9.5.2011

EU/1/11/687/001-012

Hizentra

Liechtenstein

30.4.2011

EU/1/11/688/001

Cinryze

Iceland

28.6.2011

EU/1/11/688/001

Cinryze

Norway

27.6.2011

EU/1/11/691/001-005

Eliquis

Norway

31.5.2011

EU/1/11/691/001-005

Eliquis

Liechtenstein

30.6.2011

EU/1/11/692/001

Yellox

Iceland

28.6.2011

EU/1/11/692/001

Yellox

Norway

10.6.2011

EU/1/11/692/001

Yellox

Liechtenstein

30.6.2011

EU/1/11/693/001-016

Rivastigmine Actavis

Iceland

28.6.2011

EU/1/11/693/001-016

Rivastigmine Actavis

Liechtenstein

30.6.2011

EU/1/190/649/001-016

Clopidogrel Teva Pharma BV

Iceland

30.6.2011

EU/1/98/058/001-002

Lamivudine/Zidovudine Teva

Iceland

12.4.2011

EU/1/98/058/001-002

Lamivudine

Norway

31.3.2011

EU/2/11/120/001-003

Zulvac 1 + 8 Ovis

Liechtenstein

30.4.2011

EU/2/11/126/001

MS-H Impfstoff

Liechtenstein

30.6.2011

EU/2/10/107/001-014

Veraflox

Iceland

10.5.2011

EU/2/10/107/001-014

Veraflox

Norway

24.6.2011

EU/2/10/107/001-014

Veraflox

Liechtenstein

30.4.2011

EU/2/10/109/001-009

RHINISENG

Norway

3.1.2011

EU/2/10/110/001-002

Coxevac

Iceland

26.1.2011

EU/2/10/111/001-004

Meloxoral

Iceland

14.3.2011

EU/2/10/111/001-004

Meloxoral

Norway

3.1.2011

EU/2/10/112/001-005

BTVPUR ALSap 1

Iceland

10.2.2011

EU/2/10/112/001-005

BTVPUR ALSap 1

Liechtenstein

28.2.2011

EU/2/10/113/001-005

BTVPUR ALSap 1-8

Iceland

10.2.2011

EU/2/10/113/001-005

BTVPUR ALSap 1-8

Liechtenstein

28.2.2011

EU/2/10/114/001-002

Hiprabovis IBR Marker Live

Iceland

16.3.2011

EU/2/10/114/001-002

Hiprabovis IBR Marker Live

Norway

9.2.2011

EU/2/10/114/001-002

Hiprabovis IBR Marker Live

Liechtenstein

28.2.2011

EU/2/10/115/001-010

Comfortis

Iceland

22.3.2011

EU/2/10/115/001-010

Comfortis

Norway

22.2.2011

EU/2/10/115/001-010

Comfortis

Liechtenstein

30.4.2011

EU/2/10/115/001-010

Comfortis

Norway

22.2.2011

EU/2/10/116/001-004

Melosus

Iceland

24.3.2011

EU/2/10/116/001-004

Melosus

Norway

14.4.2011

EU/2/10/116/001-004

Melosus

Liechtenstein

30.4.2011

EU/2/10/117/001-002

Purevax Rabies

Iceland

21.3.2011

EU/2/10/117/001-002

Purevax Rabies

Norway

4.4.2011

EU/2/10/117/001-002

Purevax Rabies

Liechtenstein

30.4.2011

EU/2/10/118/001-014

Activyl

Iceland

21.3.2011

EU/2/10/118/001-014

Activyl

Norway

1.4.2011

EU/2/10/118/001-014

Activyl

Liechtenstein

30.4.2011

EU/2/10/119/001-012

Cimalgex

Iceland

21.3.2011

EU/2/10/119/001-012

Cimalgex

Norway

1.4.2011

EU/2/108/001-005

BTVPUR ALSap 2-4 0.72 U.SN

Iceland

10.2.2011

EU/2/11/120/001-003

Zulvac 1 + 8 Ovis

Iceland

13.4.2011

EU/2/11/120/001-003

Zulvac 1 + 8 Ovis

Norway

18.4.2011

EU/2/11/121/001-009

CaniLeish

Iceland

13.4.2011

EU/2/11/121/001-009

CaniLeish

Norway

11.4.2011

EU/2/11/121/001-009

CaniLeish

Liechtenstein

30.4.2011

EU/2/11/123/001-002

Procox

Iceland

28.6.2011

EU/2/11/123/001-002

Procox

Norway

20.6.2011

EU/2/11/123/001-002

Procox

Liechtenstein

30.6.2011

EU/2/11/124/001-008

Zuprevo

Iceland

6.6.2011

EU/2/11/124/001-008

Zuprevo

Liechtenstein

30.6.2011

EU/2/11/125/001-008

Certifect

Iceland

6.6.2011

EU/2/11/125/001-008

Certificet

Liechtenstein

30.6.2011

EU/2/11/126/001

MS-H-vaccine

Iceland

28.6.2011

---

ANNEX II

List of renewed marketing authorisations

The following marketing authorisations have been renewed in the EEA EFTA States during the period 1 January-30 June 2011:

| EU-Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/00/135/001-002 | DaTSCAN | Iceland | 14.3.2011 |
| EU/1/00/149/001 | Panretin | Iceland | 18.1.2011 |
| EU/1/00/156/002-004 | Trizivir | Iceland | 14.2.2011 |
| EU/1/00/166/001-003 | NeuroBloc | Iceland | 15.2.2011 |
| EU/1/00/166/001-003 | NeuroBloc | Norway | 15.2.2011 |
| EU/1/00/167/001-008 | Prevenar | Iceland | 25.3.2011 |
| EU/1/00/167/001-008 | Prevenar | Norway | 3.3.2011 |
| EU/1/00/167/001-008 | Prevenar | Liechtenstein | 28.2.2011 |
| EU/1/00/173/001-003 | Vaniqa | Iceland | 15.4.2011 |
| EU/1/01/171/001, 007-010, 013-014 | Rapamune | Iceland | 21.2.2011 |
| EU/1/01/171/001, EU/1/01/171/007-010
  EU/1/01/171/013-014 | Rapamune | Norway | 2.2.2011 |
| EU/1/01/172/001-008 | Kaletra | Iceland | 21.3.2011 |
| EU/1/01/172/001-008 | Kaletra | Norway | 27.4.2011 |
| EU/1/01/172/001-008 | Kaletra | Liechtenstein | 30.4.2011 |
| EU/1/01/173/001-003 | Vaniqa | Norway | 3.5.2011 |
| EU/1/01/173/001-003 | Vaniqa | Liechtenstein | 30.4.2011 |
| EU/1/01/179/001 | Osigraft | Iceland | 17.5.2011 |
| EU/1/01/179/001 | Osigraft | Norway | 15.6.2011 |
| EU/1/01/179/001 | Osigraft | Liechtenstein | 30.6.2011 |
| EU/1/01/183/001&004-005, 007-008, 011, 013, 015, 018-032 | HBVAXPRO | Iceland | 18.4.2011 |
| EU/1/01/183/001, EU/1/01/183/004-005
  EU/1/01/183/007-008, EU/1/01/183/011
  EU/1/01/183/013, EU/1/01/183/015
  EU/1/01/183/018-032 | HBVAXPRO | Norway | 14.4.2011 |
| EU/1/01/187/001 | DepoCyte | Iceland | 23.6.2011 |
| EU/1/01/187/001 | DepoCyte | Liechtenstein | 30.6.2011 |
| EU/1/01/191/001-005 | Ketek 400 mg | Iceland | 9.6.2011 |
| EU/1/01/191/001-005 | Ketek | Norway | 31.5.2011 |
| EU/1/01/191/001-005 | Ketek | Liechtenstein | 30.6.2011 |
| EU/1/01/193/001-002 | MabCampath | Iceland | 23.6.2011 |
| EU/1/01/193/001-002 | MabCampath | Norway | 15.6.2011 |
| EU/1/05/312/001 | Xyrem | Iceland | 14.1.2011 |
| EU/1/05/313/001-009 | Ablavar | Iceland | 28.1.2011 |
| EU/1/05/314/001 | Kepivance | Iceland | 17.1.2011 |
| EU/1/05/315/001-002 | Aptivus | Iceland | 27.1.2011 |
| EU/1/05/320/001 | Noxafil | Iceland | 18.1.2011 |
| EU/1/05/322/001 | Yttriga | Iceland | 18.3.2011 |
| EU/1/05/322/001 | Yttriga | Norway | 20.1.2011 |
| EU/1/05/322/001 | Yttriga | Liechtenstein | 28.2.2011 |
| EU/1/05/323/001-013 | ProQuad | Iceland | 15.4.2011 |
| EU/1/05/323/001-013 | ProQuad | Norway | 6.4.2011 |
| EU/1/05/323/001-013 | ProQuad | Liechtenstein | 30.4.2011 |
| EU/1/05/324/001-002 | Naglazyme | Iceland | 23.3.2011 |
| EU/1/05/324/001-002 | Naglazyme | Norway | 7.2.2011 |
| EU/1/05/324/001-002 | Naglazyme | Liechtenstein | 28.2.2011 |
| EU/1/05/325/002 | Macugen | Iceland | 15.2.2011 |
| EU/1/05/325/002 | Macugen | Norway | 1.2.2011 |
| EU/1/05/325/002 | Macugen | Liechtenstein | 28.2.2011 |
| EU/1/05/328/001-004 | Cubicin | Iceland | 14.2.2011 |
| EU/1/05/328/001-004 | Cubicin | Norway | 11.1.2011 |
| EU/1/05/329/001-006 | Kiovig | Iceland | 24.2.2011 |
| EU/1/05/329/001-006 | Kiovig | Norway | 2.2.2011 |
| EU/1/05/329/001-006 | Kiovig | Liechtenstein | 28.2.2011 |
| EU/1/05/330/001-011 | Rotarix | Iceland | 22.3.2011 |
| EU/1/05/330/001-011 | Rotarix | Norway | 13.5.2011 |
| EU/1/05/331/001-055 | Neupro | Iceland | 15.2.2011 |
| EU/1/05/331/001-055 | Neupro | Norway | 10.1.2011 |
| EU/1/06/332/001-009 | Omnitrope | Iceland | 28.6.2011 |
| EU/1/06/332/001-009 | Omnitrope | Norway | 5.4.2011 |
| EU/1/06/332/001-009 | Omnitrope | Liechtenstein | 30.4.2011 |
| EU/1/06/333/001-003 | Myozyme | Iceland | 20.4.2011 |
| EU/1/06/333/001-003 | Myozyme | Norway | 22.3.2011 |
| EU/1/06/333/001-003 | Myozyme | Liechtenstein | 30.4.2011 |
| EU/1/06/334/001-005 | Evoltra | Iceland | 18.4.2011 |
| EU/1/06/334/001-005 | Evoltra | Norway | 25.5.2011 |
| EU/1/06/334/001-005 | Evoltra | Liechtenstein | 30.4.2011 |
| EU/1/06/335/001 | Valtropin | Iceland | 12.5.2011 |
| EU/1/06/335/001 | Valtropin | Norway | 3.6.2011 |
| EU/1/06/335/001 | Valtropin | Liechtenstein | 30.4.2011 |
| EU/1/06/336/001 | Tygacil | Norway | 31.5.2011 |
| EU/1/06/336/001 | Tygacil | Liechtenstein | 30.6.2011 |
| EU/1/06/337/001-013 | M-M-RVAXPRO | Iceland | 16.5.2011 |
| EU/1/06/337/001-013 | M-M-RVAXPRO | Norway | 31.5.2011 |
| EU/1/06/337/001-013 | M-M-RVAXPRO | Liechtenstein | 30.6.2011 |
| EU/1/06/338/001-003 | DuoTrav | Iceland | 21.1.2011 |
| EU/1/06/339/001-002 | Preotact | Iceland | 11.5.2011 |
| EU/1/06/339/001-002 | Preotact | Liechtenstein | 30.4.2011 |
| EU/1/06/341/001-013 | Zostavax | Iceland | 18.4.2011 |
| EU/1/06/341/001-013 | Zostavax | Liechtenstein | 30.4.2011 |
| EU/1/06/343/001-007 | Baraclude | Iceland | 23.6.2011 |
| EU/1/06/343/001-007 | Baraclude | Liechtenstein | 30.6.2011 |
| EU/1/06/346/001 | Tysabri | Iceland | 27.6.2011 |
| EU/1/06/348/001-002 | RotaTeq | Iceland | 23.6.2011 |
| EU/1/06/348/001-002 | RotaTeq | Norway | 17.6.2011 |
| EU/1/06/348/001-002 | RotaTeq | Liechtenstein | 28.2.2011 |
| EU/1/06/354/001-011 | Competact | Iceland | 24.6.2011 |
| EU/1/06/354/001-011 | Competact | Norway | 23.6.2011 |
| EU/1/06/354/001-011 | Competact | Liechtenstein | 30.6.2011 |
| EU/1/06/360/001-013 | Champix | Liechtenstein | 30.6.2011 |
| EU/1/06/367/001-012 | Diacomit | Iceland | 11.2.2011 |
| EU/1/06/367/001-012 | Diacomit | Norway | 15.2.2011 |
| EU/1/06/367/001-012 | Diacomit | Liechtenstein | 28.2.2011 |
| EU/1/07/423/001-003 | Vectibix | Iceland | 15.2.2011 |
| EU/1/07/423/001-003 | Vectibix | Norway | 25.1.2011 |
| EU/1/07/440/001-003 | Tyverb | Norway | 3.6.2011 |
| EU/1/10/625/001 | Arzerra | Iceland | 22.2.2011 |
| EU/1/10/625/001-002 | Arzerra | Norway | 17.2.2011 |
| EU/1/10/625/001-002 | Arzerra | Liechtenstein | 28.2.2011 |
| EU/1/10/628/001-004 | Votrient | Iceland | 6.6.2011 |
| EU/1/183/001, 004-005, 007-008, 011, 013, 015, 018-032 | HBVAXPRO | Liechtenstein | 30.4.2011 |
| EU/1/96/009/001-008 | Zerit | Iceland | 16.5.2011 |
| EU/1/96/009/001-009 | Zerit | Norway | 6.5.2011 |
| EU/1/96/009/001-009 | Zerit | Liechtenstein | 30.4.2011 |
| EU/2/00/026/001-004 | Porcilis AR-T DF | Norway | 3.1.2011 |
| EU/2/00/026/001-006 | Porcilis AR-T DF | Iceland | 17.1.2011 |
| EU/2/04/045/001-007 | Previcox | Norway | 18.4.2011 |
| EU/2/04/048/001-002 | Purevax RCP FeLV | Norway | 13.4.2011 |
| EU/2/04/049/001-002 | Purevax RCCh | Norway | 13.4.2011 |
| EU/2/04/050/001-002 | Purevax RCPCh | Norway | 13.4.2011 |
| EU/2/04/051/001-002 | Purevax RC | Norway | 13.4.2011 |
| EU/2/04/052/001-002 | Purevax RCP | Norway | 13.4.2011 |
| EU/2/06/058/004 | Flexicam | Iceland | 8.4.2011 |
| EU/2/06/058/004 | Flexicam | Norway | 26.4.2011 |
| EU/2/06/058/004 | Flexicam | Liechtenstein | 30.4.2011 |
| EU/2/06/059/001 | Convenia | Iceland | 27.6.2011 |

EU-Number

Product

Country

Date of authorisation

EU/1/00/135/001-002

DaTSCAN

Iceland

14.3.2011

EU/1/00/149/001

Panretin

Iceland

18.1.2011

EU/1/00/156/002-004

Trizivir

Iceland

14.2.2011

EU/1/00/166/001-003

NeuroBloc

Iceland

15.2.2011

EU/1/00/166/001-003

NeuroBloc

Norway

15.2.2011

EU/1/00/167/001-008

Prevenar

Iceland

25.3.2011

EU/1/00/167/001-008

Prevenar

Norway

3.3.2011

EU/1/00/167/001-008

Prevenar

Liechtenstein

28.2.2011

EU/1/00/173/001-003

Vaniqa

Iceland

15.4.2011

EU/1/01/171/001, 007-010, 013-014

Rapamune

Iceland

21.2.2011

EU/1/01/171/001, EU/1/01/171/007-010

EU/1/01/171/013-014

Rapamune

Norway

2.2.2011

EU/1/01/172/001-008

Kaletra

Iceland

21.3.2011

EU/1/01/172/001-008

Kaletra

Norway

27.4.2011

EU/1/01/172/001-008

Kaletra

Liechtenstein

30.4.2011

EU/1/01/173/001-003

Vaniqa

Norway

3.5.2011

EU/1/01/173/001-003

Vaniqa

Liechtenstein

30.4.2011

EU/1/01/179/001

Osigraft

Iceland

17.5.2011

EU/1/01/179/001

Osigraft

Norway

15.6.2011

EU/1/01/179/001

Osigraft

Liechtenstein

30.6.2011

EU/1/01/183/001&004-005, 007-008, 011, 013, 015, 018-032

HBVAXPRO

Iceland

18.4.2011

EU/1/01/183/001, EU/1/01/183/004-005

EU/1/01/183/007-008, EU/1/01/183/011

EU/1/01/183/013, EU/1/01/183/015

EU/1/01/183/018-032

HBVAXPRO

Norway

14.4.2011

EU/1/01/187/001

DepoCyte

Iceland

23.6.2011

EU/1/01/187/001

DepoCyte

Liechtenstein

30.6.2011

EU/1/01/191/001-005

Ketek 400 mg

Iceland

9.6.2011

EU/1/01/191/001-005

Ketek

Norway

31.5.2011

EU/1/01/191/001-005

Ketek

Liechtenstein

30.6.2011

EU/1/01/193/001-002

MabCampath

Iceland

23.6.2011

EU/1/01/193/001-002

MabCampath

Norway

15.6.2011

EU/1/05/312/001

Xyrem

Iceland

14.1.2011

EU/1/05/313/001-009

Ablavar

Iceland

28.1.2011

EU/1/05/314/001

Kepivance

Iceland

17.1.2011

EU/1/05/315/001-002

Aptivus

Iceland

27.1.2011

EU/1/05/320/001

Noxafil

Iceland

18.1.2011

EU/1/05/322/001

Yttriga

Iceland

18.3.2011

EU/1/05/322/001

Yttriga

Norway

20.1.2011

EU/1/05/322/001

Yttriga

Liechtenstein

28.2.2011

EU/1/05/323/001-013

ProQuad

Iceland

15.4.2011

EU/1/05/323/001-013

ProQuad

Norway

6.4.2011

EU/1/05/323/001-013

ProQuad

Liechtenstein

30.4.2011

EU/1/05/324/001-002

Naglazyme

Iceland

23.3.2011

EU/1/05/324/001-002

Naglazyme

Norway

7.2.2011

EU/1/05/324/001-002

Naglazyme

Liechtenstein

28.2.2011

EU/1/05/325/002

Macugen

Iceland

15.2.2011

EU/1/05/325/002

Macugen

Norway

1.2.2011

EU/1/05/325/002

Macugen

Liechtenstein

28.2.2011

EU/1/05/328/001-004

Cubicin

Iceland

14.2.2011

EU/1/05/328/001-004

Cubicin

Norway

11.1.2011

EU/1/05/329/001-006

Kiovig

Iceland

24.2.2011

EU/1/05/329/001-006

Kiovig

Norway

2.2.2011

EU/1/05/329/001-006

Kiovig

Liechtenstein

28.2.2011

EU/1/05/330/001-011

Rotarix

Iceland

22.3.2011

EU/1/05/330/001-011

Rotarix

Norway

13.5.2011

EU/1/05/331/001-055

Neupro

Iceland

15.2.2011

EU/1/05/331/001-055

Neupro

Norway

10.1.2011

EU/1/06/332/001-009

Omnitrope

Iceland

28.6.2011

EU/1/06/332/001-009

Omnitrope

Norway

5.4.2011

EU/1/06/332/001-009

Omnitrope

Liechtenstein

30.4.2011

EU/1/06/333/001-003

Myozyme

Iceland

20.4.2011

EU/1/06/333/001-003

Myozyme

Norway

22.3.2011

EU/1/06/333/001-003

Myozyme

Liechtenstein

30.4.2011

EU/1/06/334/001-005

Evoltra

Iceland

18.4.2011

EU/1/06/334/001-005

Evoltra

Norway

25.5.2011

EU/1/06/334/001-005

Evoltra

Liechtenstein

30.4.2011

EU/1/06/335/001

Valtropin

Iceland

12.5.2011

EU/1/06/335/001

Valtropin

Norway

3.6.2011

EU/1/06/335/001

Valtropin

Liechtenstein

30.4.2011

EU/1/06/336/001

Tygacil

Norway

31.5.2011

EU/1/06/336/001

Tygacil

Liechtenstein

30.6.2011

EU/1/06/337/001-013

M-M-RVAXPRO

Iceland

16.5.2011

EU/1/06/337/001-013

M-M-RVAXPRO

Norway

31.5.2011

EU/1/06/337/001-013

M-M-RVAXPRO

Liechtenstein

30.6.2011

EU/1/06/338/001-003

DuoTrav

Iceland

21.1.2011

EU/1/06/339/001-002

Preotact

Iceland

11.5.2011

EU/1/06/339/001-002

Preotact

Liechtenstein

30.4.2011

EU/1/06/341/001-013

Zostavax

Iceland

18.4.2011

EU/1/06/341/001-013

Zostavax

Liechtenstein

30.4.2011

EU/1/06/343/001-007

Baraclude

Iceland

23.6.2011

EU/1/06/343/001-007

Baraclude

Liechtenstein

30.6.2011

EU/1/06/346/001

Tysabri

Iceland

27.6.2011

EU/1/06/348/001-002

RotaTeq

Iceland

23.6.2011

EU/1/06/348/001-002

RotaTeq

Norway

17.6.2011

EU/1/06/348/001-002

RotaTeq

Liechtenstein

28.2.2011

EU/1/06/354/001-011

Competact

Iceland

24.6.2011

EU/1/06/354/001-011

Competact

Norway

23.6.2011

EU/1/06/354/001-011

Competact

Liechtenstein

30.6.2011

EU/1/06/360/001-013

Champix

Liechtenstein

30.6.2011

EU/1/06/367/001-012

Diacomit

Iceland

11.2.2011

EU/1/06/367/001-012

Diacomit

Norway

15.2.2011

EU/1/06/367/001-012

Diacomit

Liechtenstein

28.2.2011

EU/1/07/423/001-003

Vectibix

Iceland

15.2.2011

EU/1/07/423/001-003

Vectibix

Norway

25.1.2011

EU/1/07/440/001-003

Tyverb

Norway

3.6.2011

EU/1/10/625/001

Arzerra

Iceland

22.2.2011

EU/1/10/625/001-002

Arzerra

Norway

17.2.2011

EU/1/10/625/001-002

Arzerra

Liechtenstein

28.2.2011

EU/1/10/628/001-004

Votrient

Iceland

6.6.2011

EU/1/183/001, 004-005, 007-008, 011, 013, 015, 018-032

HBVAXPRO

Liechtenstein

30.4.2011

EU/1/96/009/001-008

Zerit

Iceland

16.5.2011

EU/1/96/009/001-009

Zerit

Norway

6.5.2011

EU/1/96/009/001-009

Zerit

Liechtenstein

30.4.2011

EU/2/00/026/001-004

Porcilis AR-T DF

Norway

3.1.2011

EU/2/00/026/001-006

Porcilis AR-T DF

Iceland

17.1.2011

EU/2/04/045/001-007

Previcox

Norway

18.4.2011

EU/2/04/048/001-002

Purevax RCP FeLV

Norway

13.4.2011

EU/2/04/049/001-002

Purevax RCCh

Norway

13.4.2011

EU/2/04/050/001-002

Purevax RCPCh

Norway

13.4.2011

EU/2/04/051/001-002

Purevax RC

Norway

13.4.2011

EU/2/04/052/001-002

Purevax RCP

Norway

13.4.2011

EU/2/06/058/004

Flexicam

Iceland

8.4.2011

EU/2/06/058/004

Flexicam

Norway

26.4.2011

EU/2/06/058/004

Flexicam

Liechtenstein

30.4.2011

EU/2/06/059/001

Convenia

Iceland

27.6.2011

---

ANNEX III

List of extended marketing authorisations

The following marketing authorisations have been extended in the EEA EFTA States during the period 1 January-30 June 2011:

| EU-Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/01/185/100-111 | Aranesp | Iceland | 15.4.2011 |
| EU/1/01/194/003-004 | INOmax | Iceland | 15.4.2011 |
| EU/1/02/227/003 | Neulasta | Liechtenstein | 30.4.2011 |
| EU/1/06/332/010-012 | Omnitrope | Iceland | 16.6.2011 |
| EU/1/06/332/010-012 | Omnitrope | Liechtenstein | 30.6.2011 |
| EU/1/06/354/010-011 | Competact | Liechtenstein | 28.2.2011 |
| EU/1/06/354/012 | Competact | Liechtenstein | 30.6.2011 |
| EU/1/06/370/037-039 | Exforge | Liechtenstein | 28.2.2011 |
| EU/1/06/371/037-039 | Dafiro | Liechtenstein | 28.2.2011 |
| EU/1/06/373/037-039 | Imprida | Liechtenstein | 28.2.2011 |
| EU/1/07/387/014-026 | Advagraf | Liechtenstein | 30.6.2011 |
| EU/1/07/397/002-004 | Siklos | Iceland | 25.3.2011 |
| EU/1/07/397/002-004 | Siklos | Norway | 5.4.2011 |
| EU/1/07/397/002-004 | Siklos | Liechtenstein | 30.4.2011 |
| EU/1/07/401/012-015 | Alli | Iceland | 16.2.2011 |
| EU/1/07/401/012-015 | Alli | Norway | 26.1.2011 |
| EU/1/07/404/006-008 | Flebogamma DIF | Iceland | 17.2.2011 |
| EU/1/07/404/006-008 | Flebogamma DIF | Norway | 14.1.2011 |
| EU/1/07/404/006-008 | Flebogamma DIF | Liechtenstein | 28.2.2011 |
| EU/1/07/407/021-040 | Sprimeo | Liechtenstein | 30.4.2011 |
| EU/1/07/410/027-052 | Binocrit | Liechtenstein | 30.4.2011 |
| EU/1/07/411/027-052 | Epoetin alfa Hexal | Liechtenstein | 30.4.2011 |
| EU/1/07/420/002 | Cyanokit | Iceland | 20.1.2011 |
| EU/1/07/420/002 | Cyanokit | Norway | 14.2.2011 |
| EU/1/07/422/005-006 | Tasigna | Iceland | 23.3.2011 |
| EU/1/07/422/005-006 | Tasigna | Norway | 21.1.2011 |
| EU/1/07/422/005-006 | Tasigna | Liechtenstein | 28.2.2011 |
| EU/1/07/438/005-006 | Myfenax | Liechtenstein | 30.6.2011 |
| EU/1/07/439/005-006 | Mycophenole mofetil Teva | Liechtenstein | 30.6.2011 |
| EU/1/08/461/002 | Firazyr | Liechtenstein | 30.4.2011 |
| EU/1/08/490/017-024 | Pramipexole Teva | Liechtenstein | 30.6.2011 |
| EU/1/09/511/005 | Conbriza | Liechtenstein | 30.4.2011 |
| EU/1/09/535/015-016 | Grepid | Liechtenstein | 28.2.2011 |
| EU/1/09/545/011-015 | Onglyza | Iceland | 14.4.2011 |
| EU/1/09/545/011-015 | Onglyza | Norway | 25.3.2011 |
| EU/1/09/545/011-015 | Onglyza | Liechtenstein | 30.4.2011 |
| EU/1/09/581/003-008 | Resolor | Liechtenstein | 28.2.2011 |
| EU/1/10/614/002 | Menveo | Liechtenstein | 30.4.2011 |
| EU/1/96/022/035-040 | Zyprexa | Liechtenstein | 28.2.2011 |
| EU/1/97/033/005-006 | Avonex | Liechtenstein | 30.6.2011 |
| EU/1/99/103/005 | ReFacto AF | Iceland | 6.6.2011 |
| EU/1/99/103/005-008 | ReFacto AF | Norway | 1.6.2011 |
| EU/1/99/103/005-008 | ReFacto AF | Liechtenstein | 30.6.2011 |
| EU/2/07/078/009-010 | Rheumocam | Iceland | 18.4.2011 |
| EU/2/07/078/009-010 | Rheumocam | Norway | 9.2.2011 |
| EU/2/07/078/009-010 | Rheumocam | Liechtenstein | 28.2.2011 |
| EU/2/07/078/011-014 | Rheumocam | Iceland | 28.6.2011 |
| EU/2/07/078/011-014 | Rheumocam | Liechtenstein | 30.6.2011 |
| EU/2/08/082/007 | Zactran | Liechtenstein | 30.6.2011 |
| EU/2/97/004/041-048 | Metacam | Liechtenstein | 28.2.2011 |
| EU/2/98/010/025 | Econor | Iceland | 18.2.2011 |
| EU/2/98/010/025 | Econor | Liechtenstein | 28.2.2011 |
| EU/99/119/017-018 | NovoRapid | Liechtenstein | 30.4.2011 |

EU-Number

Product

Country

Date of authorisation

EU/1/01/185/100-111

Aranesp

Iceland

15.4.2011

EU/1/01/194/003-004

INOmax

Iceland

15.4.2011

EU/1/02/227/003

Neulasta

Liechtenstein

30.4.2011

EU/1/06/332/010-012

Omnitrope

Iceland

16.6.2011

EU/1/06/332/010-012

Omnitrope

Liechtenstein

30.6.2011

EU/1/06/354/010-011

Competact

Liechtenstein

28.2.2011

EU/1/06/354/012

Competact

Liechtenstein

30.6.2011

EU/1/06/370/037-039

Exforge

Liechtenstein

28.2.2011

EU/1/06/371/037-039

Dafiro

Liechtenstein

28.2.2011

EU/1/06/373/037-039

Imprida

Liechtenstein

28.2.2011

EU/1/07/387/014-026

Advagraf

Liechtenstein

30.6.2011

EU/1/07/397/002-004

Siklos

Iceland

25.3.2011

EU/1/07/397/002-004

Siklos

Norway

5.4.2011

EU/1/07/397/002-004

Siklos

Liechtenstein

30.4.2011

EU/1/07/401/012-015

Alli

Iceland

16.2.2011

EU/1/07/401/012-015

Alli

Norway

26.1.2011

EU/1/07/404/006-008

Flebogamma DIF

Iceland

17.2.2011

EU/1/07/404/006-008

Flebogamma DIF

Norway

14.1.2011

EU/1/07/404/006-008

Flebogamma DIF

Liechtenstein

28.2.2011

EU/1/07/407/021-040

Sprimeo

Liechtenstein

30.4.2011

EU/1/07/410/027-052

Binocrit

Liechtenstein

30.4.2011

EU/1/07/411/027-052

Epoetin alfa Hexal

Liechtenstein

30.4.2011

EU/1/07/420/002

Cyanokit

Iceland

20.1.2011

EU/1/07/420/002

Cyanokit

Norway

14.2.2011

EU/1/07/422/005-006

Tasigna

Iceland

23.3.2011

EU/1/07/422/005-006

Tasigna

Norway

21.1.2011

EU/1/07/422/005-006

Tasigna

Liechtenstein

28.2.2011

EU/1/07/438/005-006

Myfenax

Liechtenstein

30.6.2011

EU/1/07/439/005-006

Mycophenole mofetil Teva

Liechtenstein

30.6.2011

EU/1/08/461/002

Firazyr

Liechtenstein

30.4.2011

EU/1/08/490/017-024

Pramipexole Teva

Liechtenstein

30.6.2011

EU/1/09/511/005

Conbriza

Liechtenstein

30.4.2011

EU/1/09/535/015-016

Grepid

Liechtenstein

28.2.2011

EU/1/09/545/011-015

Onglyza

Iceland

14.4.2011

EU/1/09/545/011-015

Onglyza

Norway

25.3.2011

EU/1/09/545/011-015

Onglyza

Liechtenstein

30.4.2011

EU/1/09/581/003-008

Resolor

Liechtenstein

28.2.2011

EU/1/10/614/002

Menveo

Liechtenstein

30.4.2011

EU/1/96/022/035-040

Zyprexa

Liechtenstein

28.2.2011

EU/1/97/033/005-006

Avonex

Liechtenstein

30.6.2011

EU/1/99/103/005

ReFacto AF

Iceland

6.6.2011

EU/1/99/103/005-008

ReFacto AF

Norway

1.6.2011

EU/1/99/103/005-008

ReFacto AF

Liechtenstein

30.6.2011

EU/2/07/078/009-010

Rheumocam

Iceland

18.4.2011

EU/2/07/078/009-010

Rheumocam

Norway

9.2.2011

EU/2/07/078/009-010

Rheumocam

Liechtenstein

28.2.2011

EU/2/07/078/011-014

Rheumocam

Iceland

28.6.2011

EU/2/07/078/011-014

Rheumocam

Liechtenstein

30.6.2011

EU/2/08/082/007

Zactran

Liechtenstein

30.6.2011

EU/2/97/004/041-048

Metacam

Liechtenstein

28.2.2011

EU/2/98/010/025

Econor

Iceland

18.2.2011

EU/2/98/010/025

Econor

Liechtenstein

28.2.2011

EU/99/119/017-018

NovoRapid

Liechtenstein

30.4.2011

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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 January-30 June 2011:

| EU-Number | Product | Country | Date of withdrawal |
| --- | --- | --- | --- |
| EU/1/03/259/001-006 | Onsenal | Iceland | 20.4.2011 |
| EU/1/03/259/001-006 | Onsenal | Liechtenstein | 30.4.2011 |
| EU/1/05/326/001 | Ionsys | Iceland | 20.4.2011 |
| EU/1/06/353/001-005 | Thelin | Iceland | 15.3.2011 |
| EU/1/06/353/001-005 | Thelin | Liechtenstein | 28.2.2011 |
| EU/1/08/449/001-008 | Filgrastim ratiopharm | Liechtenstein | 30.4.2011 |
| EU/1/08/449/001-008 | Filgrastim ratiopharm | Iceland | 12.5.2011 |
| EU/1/09/542/001-007 | Clopidogrel 1A Pharma | Liechtenstein | 28.2.2011 |
| EU/1/09/542/001-007 | Clopidogrel 1A Pharma | Iceland | 16.3.2011 |
| EU/1/09/547/001-007 | Clopidogrel Sandoz | Liechtenstein | 30.4.2011 |
| EU/1/10/629/001 | Humenza | Iceland | 29.6.2011 |
| EU/1/10/629/001 | Humenza | Liechtenstein | 30.6.2011 |

EU-Number

Product

Country

Date of withdrawal

EU/1/03/259/001-006

Onsenal

Iceland

20.4.2011

EU/1/03/259/001-006

Onsenal

Liechtenstein

30.4.2011

EU/1/05/326/001

Ionsys

Iceland

20.4.2011

EU/1/06/353/001-005

Thelin

Iceland

15.3.2011

EU/1/06/353/001-005

Thelin

Liechtenstein

28.2.2011

EU/1/08/449/001-008

Filgrastim ratiopharm

Liechtenstein

30.4.2011

EU/1/08/449/001-008

Filgrastim ratiopharm

Iceland

12.5.2011

EU/1/09/542/001-007

Clopidogrel 1A Pharma

Liechtenstein

28.2.2011

EU/1/09/542/001-007

Clopidogrel 1A Pharma

Iceland

16.3.2011

EU/1/09/547/001-007

Clopidogrel Sandoz

Liechtenstein

30.4.2011

EU/1/10/629/001

Humenza

Iceland

29.6.2011

EU/1/10/629/001

Humenza

Liechtenstein

30.6.2011

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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 January-30 June 2011:

| EU-Number | Product | Country | Date of suspension |
| --- | --- | --- | --- |
| EU/1/00/137/002-018 | Avandia | Iceland | 13.1.2011 |
| EU/1/03/258/001-022 | Avandamet | Iceland | 13.1.2011 |
| EU/1/06/349/001-010 | Avaglim | Iceland | 17.1.2011 |
| EU/2/06/058/001-003 | Flexicam | Iceland | 14.1.2011 |
| EU/2/08/088/001-003 | Acticam | Norway | 7.3.2011 |
| EU/2/09/099/001-006 | Suvaxyn PCV | Iceland | 22.3.2011 |

EU-Number

Product

Country

Date of suspension

EU/1/00/137/002-018

Avandia

Iceland

13.1.2011

EU/1/03/258/001-022

Avandamet

Iceland

13.1.2011

EU/1/06/349/001-010

Avaglim

Iceland

17.1.2011

EU/2/06/058/001-003

Flexicam

Iceland

14.1.2011

EU/2/08/088/001-003

Acticam

Norway

7.3.2011

EU/2/09/099/001-006

Suvaxyn PCV

Iceland

22.3.2011

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