# C_2014391EN.01000301.xml

| 6.11.2014 | EN | Official Journal of the European Union | C 391/3 |
| --- | --- | --- | --- |

6.11.2014

EN

Official Journal of the European Union

C 391/3

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Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the first half of 2013

2014/C 391/03

Subcommitee I on the free movement of goods

Subcommitee 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 2013, at their meeting on 4 April 2014:

| 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| Annex IV | List of withdrawn marketing authorisations |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List of withdrawn marketing authorisations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 January-30 June 2013:

| EU-Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/12/788/001-006 | Seebri Breezhaler | Liechtenstein | 30.4.2013 |
| EU/1/12/789/001-006 | Enurev Breezhaler | Liechtenstein | 30.4.2013 |
| EU/1/12/790/001-006 | Tovanor Breezhaler | Liechtenstein | 30.4.2013 |
| EU/1/12/791/001 | Glybera | Liechtenstein | 30.4.2013 |
| EU/1/12/795/001-010 | Forxiga | Liechtenstein | 30.4.2013 |
| EU/1/12/797/001-002 | Eylea | Liechtenstein | 30.4.2013 |
| EU/1/12/803/001-002 | NexoBrid | Liechtenstein | 30.4.2013 |
| EU/1/12/803/001-002 | NexoBrid | Iceland | 14.1.2013 |
| EU/1/12/803/001-002 | NexoBrid | Norway | 11.1.2013 |
| EU/1/12/804/001-016 | BindRen | Liechtenstein | 30.4.2013 |
| EU/1/12/804/001-016 | BindRen | Iceland | 8.2.2013 |
| EU/1/12/804/001-016 | BindRen | Norway | 27.2.2013 |
| EU/1/12/805 | Amyvid | Liechtenstein | 28.2.2013 |
| EU/1/12/805/001-004 | AMYViD | Iceland | 6.2.2013 |
| EU/1/12/805/001-004 | AMYViD | Norway | 4.2.2013 |
| EU/1/12/806/001-005 | Ryzodeg | Liechtenstein | 28.2.2013 |
| EU/1/12/806/001-005 | Ryzodeg | Iceland | 20.2.2013 |
| EU/1/12/806/001-005 | Ryzodeg | Norway | 12.2.2013 |
| EU/1/12/807/001-009 | Tresiba | Liechtenstein | 28.2.2013 |
| EU/1/12/807/001-009 | Tresiba | Iceland | 20.2.2013 |
| EU/1/12/807/001-009 | Tresiba | Norway | 12.2.2013 |
| EU/1/12/808/001-040 | Imatinib Teva | Liechtenstein | 28.2.2013 |
| EU/1/12/808/001-040 | Imatinib Teva | Iceland | 5.2.2013 |
| EU/1/12/808/001-040 | Imatinib Teva | Norway | 22.1.2013 |
| EU/1/12/809/001-014 | Betmiga | Liechtenstein | 28.2.2013 |
| EU/1/12/809/001-014 | Betmiga | Iceland | 10.1.2013 |
| EU/1/12/809/001-014 | Betmiga | Norway | 17.1.2013 |
| EU/1/12/810 | Krystexxa | Liechtenstein | 30.4.2013 |
| EU/1/12/810/001 | Krystexxa | Iceland | 14.1.2013 |
| EU/1/12/810/001 | Krystexxa | Norway | 25.1.2013 |
| EU/1/12/811/001-005 | Lyxumia | Iceland | 12.2.2013 |
| EU/1/12/811/001-005 | Lyxumia | Norway | 12.2.2013 |
| EU/1/12/812 | Bexsero | Liechtenstein | 28.2.2013 |
| EU/1/12/812/001-004 | Bexsero | Iceland | 14.2.2013 |
| EU/1/12/812/001-004 | Bexsero | Norway | 4.2.2013 |
| EU/1/12/814 | Zaltrap | Liechtenstein | 28.2.2013 |
| EU/1/12/814/001-003 | Zaltrap | Iceland | 12.2.2013 |
| EU/1/12/814/001-003 | Zaltrap | Norway | 27.2.2013 |
| EU/1/12/815/001-005 | Selincro | Liechtenstein | 30.4.2013 |
| EU/1/12/815/001-005 | Selincro | Iceland | 19.3.2013 |
| EU/1/12/815/001-005 | Selincro | Norway | 11.3.2013 |
| EU/1/13/813/001 | Perjeta | Liechtenstein | 30.4.2013 |
| EU/1/13/813/001 | Perjeta | Iceland | 20.3.2013 |
| EU/1/13/813/001 | Perjeta | Norway | 9.4.2013 |
| EU/1/13/817/001-041 | Actelsar HCT | Iceland | 21.3.2013 |
| EU/1/13/817/001-041 | Actelsar HCT | Norway | 22.4.2013 |
| EU/1/13/818/001-004 | Bosulif | Iceland | 15.4.2013 |
| EU/1/13/818/001-004 | Bosulif | Norway | 30.4.2013 |
| EU/1/13/819/001 | JETREA | Liechtenstein | 30.4.2013 |
| EU/1/13/819/001 | JETREA | Iceland | 11.4.2013 |
| EU/1/13/819/001 | JETREA | Norway | 22.3.2013 |
| EU/1/13/820/001-026 | Maruxa | Liechtenstein | 30.6.2013 |
| EU/1/13/820/001-026 | Maruxa | Norway | 24.5.2013 |
| EU/1/13/821/001-030 | Tolucombi | Liechtenstein | 30.4.2013 |
| EU/1/13/821/001-030 | Tolucombi | Iceland | 21.3.2013 |
| EU/1/13/821/001-030 | Tolucombi | Norway | 22.3.2013 |
| EU/1/13/823/001-002 | Adasuve | Norway | 12.3.2013 |
| EU/1/13/823/001-002 | Adasuve | Liechtenstein | 30.4.2013 |
| EU/1/13/823/001-002 | Adasuve | Iceland | 18.3.2013 |
| EU/1/13/824 | Nemdatine | Liechtenstein | 30.4.2013 |
| EU/1/13/824/001-020 | Nemdatine | Iceland | 21.5.2013 |
| EU/1/13/824/001-020 | Nemdatine | Norway | 3.5.2013 |
| EU/1/13/825 | Imatinib Actavis | Liechtenstein | 30.6.2013 |
| EU/1/13/825/001-018 | Imatinib Actavis | Iceland | 16.5.2013 |
| EU/1/13/825/001-018 | Imatinib Actavis | Norway | 20.6.2013 |
| EU/1/13/826 | Memantine LEK | Liechtenstein | 30.4.2013 |
| EU/1/13/826/001-011 | Memantine LEK | Iceland | 21.5.2013 |
| EU/1/13/826/001-011 | Memantine LEK | Norway | 3.5.2013 |
| EU/1/13/827 | Memantine Mylan | Liechtenstein | 30.4.2013 |
| EU/1/13/827/001-036 | Memantine Mylan | Iceland | 21.5.2013 |
| EU/1/13/827/001-036 | Memantine Mylan | Norway | 3.5.2013 |
| EU/1/13/828 | Hexacima | Liechtenstein | 30.4.2013 |
| EU/1/13/828/001-007 | Hexacima | Iceland | 17.5.2013 |
| EU/1/13/828/001-007 | Hexacima | Norway | 15.5.2013 |
| EU/1/13/829 | Hexyon | Liechtenstein | 30.4.2013 |
| EU/1/13/829/001-007 | Hexyon | Iceland | 17.5.2013 |
| EU/1/13/829/001-007 | Hexyon | Norway | 15.5.2013 |
| EU/1/13/830/001-002 | Stribild | Iceland | 19.6.2013 |
| EU/1/13/830/001-002 | Stribild | Norway | 24.5.2013 |
| EU/1/13/835/001-018 | Voriconazole Accord | Iceland | 31.5.2013 |
| EU/1/13/835/001-018 | Voriconazole Accord | Norway | 31.5.2013 |
| EU/1/13/836 | Memantine ratiopharm | Liechtenstein | 30.6.2013 |
| EU/1/13/836/001-023 | Memantine ratiopharm | Norway | 25.6.2013 |
| EU/1/13/840/001-005 | HyQvia | Iceland | 27.5.2013 |
| EU/1/13/840/001-005 | HyQvia | Norway | 3.6.2013 |
| EU/2/12/142/001-006 | Cardalis | Norway | 20.6.2013 |
| EU/2/12/144/001-004 | Contacera | Liechtenstein | 28.2.2013 |
| EU/2/12/144/001-004 | Contacera | Iceland | 3.1.2013 |
| EU/2/12/144/001-004 | Contacera | Norway | 17.1.2013 |
| EU/2/12/145/001-003 | Kexxtone | Liechtenstein | 30.4.2013 |
| EU/2/12/145/001-003 | Kexxtone | Iceland | 27.2.2013 |
| EU/2/12/145/001-003 | Kexxtone | Norway | 8.3.2013 |
| EU/2/12/146/001 | Semintra | Liechtenstein | 30.4.2013 |
| EU/2/12/146/001 | Semintra | Iceland | 12.3.2013 |
| EU/2/12/146/001 | Semintra | Norway | 5.4.2013 |
| EU/2/12/147/001-004 | Pexion | Liechtenstein | 30.4.2013 |
| EU/2/12/147/001-004 | Pexion | Iceland | 19.3.2013 |
| EU/2/12/147/001-004 | Pexion | Norway | 8.3.2013 |
| EU/2/13/148 | Meloxidolor | Liechtenstein | 30.6.2013 |
| EU/2/13/148/001-007 | Meloxidolor | Iceland | 21.5.2013 |
| EU/2/13/148/001-007 | Meloxidolor | Norway | 22.4.2013 |
| EU/2/13/149 | ECOPORC SHIGA | Liechtenstein | 30.4.2013 |
| EU/2/13/149/001-002 | ECOPORC SHIGA | Iceland | 15.5.2013 |
| EU/2/13/149/001-002 | ECOPORC SHIGA | Norway | 13.5.2013 |
| EU/2/13/150 | Oncept IL-2 | Liechtenstein | 30.6.2013 |
| EU/2/13/151/001-003 | Equilis West Nile | Iceland | 27.6.2013 |

EU-Number

Product

Country

Date of authorisation

EU/1/12/788/001-006

Seebri Breezhaler

Liechtenstein

30.4.2013

EU/1/12/789/001-006

Enurev Breezhaler

Liechtenstein

30.4.2013

EU/1/12/790/001-006

Tovanor Breezhaler

Liechtenstein

30.4.2013

EU/1/12/791/001

Glybera

Liechtenstein

30.4.2013

EU/1/12/795/001-010

Forxiga

Liechtenstein

30.4.2013

EU/1/12/797/001-002

Eylea

Liechtenstein

30.4.2013

EU/1/12/803/001-002

NexoBrid

Liechtenstein

30.4.2013

EU/1/12/803/001-002

NexoBrid

Iceland

14.1.2013

EU/1/12/803/001-002

NexoBrid

Norway

11.1.2013

EU/1/12/804/001-016

BindRen

Liechtenstein

30.4.2013

EU/1/12/804/001-016

BindRen

Iceland

8.2.2013

EU/1/12/804/001-016

BindRen

Norway

27.2.2013

EU/1/12/805

Amyvid

Liechtenstein

28.2.2013

EU/1/12/805/001-004

AMYViD

Iceland

6.2.2013

EU/1/12/805/001-004

AMYViD

Norway

4.2.2013

EU/1/12/806/001-005

Ryzodeg

Liechtenstein

28.2.2013

EU/1/12/806/001-005

Ryzodeg

Iceland

20.2.2013

EU/1/12/806/001-005

Ryzodeg

Norway

12.2.2013

EU/1/12/807/001-009

Tresiba

Liechtenstein

28.2.2013

EU/1/12/807/001-009

Tresiba

Iceland

20.2.2013

EU/1/12/807/001-009

Tresiba

Norway

12.2.2013

EU/1/12/808/001-040

Imatinib Teva

Liechtenstein

28.2.2013

EU/1/12/808/001-040

Imatinib Teva

Iceland

5.2.2013

EU/1/12/808/001-040

Imatinib Teva

Norway

22.1.2013

EU/1/12/809/001-014

Betmiga

Liechtenstein

28.2.2013

EU/1/12/809/001-014

Betmiga

Iceland

10.1.2013

EU/1/12/809/001-014

Betmiga

Norway

17.1.2013

EU/1/12/810

Krystexxa

Liechtenstein

30.4.2013

EU/1/12/810/001

Krystexxa

Iceland

14.1.2013

EU/1/12/810/001

Krystexxa

Norway

25.1.2013

EU/1/12/811/001-005

Lyxumia

Iceland

12.2.2013

EU/1/12/811/001-005

Lyxumia

Norway

12.2.2013

EU/1/12/812

Bexsero

Liechtenstein

28.2.2013

EU/1/12/812/001-004

Bexsero

Iceland

14.2.2013

EU/1/12/812/001-004

Bexsero

Norway

4.2.2013

EU/1/12/814

Zaltrap

Liechtenstein

28.2.2013

EU/1/12/814/001-003

Zaltrap

Iceland

12.2.2013

EU/1/12/814/001-003

Zaltrap

Norway

27.2.2013

EU/1/12/815/001-005

Selincro

Liechtenstein

30.4.2013

EU/1/12/815/001-005

Selincro

Iceland

19.3.2013

EU/1/12/815/001-005

Selincro

Norway

11.3.2013

EU/1/13/813/001

Perjeta

Liechtenstein

30.4.2013

EU/1/13/813/001

Perjeta

Iceland

20.3.2013

EU/1/13/813/001

Perjeta

Norway

9.4.2013

EU/1/13/817/001-041

Actelsar HCT

Iceland

21.3.2013

EU/1/13/817/001-041

Actelsar HCT

Norway

22.4.2013

EU/1/13/818/001-004

Bosulif

Iceland

15.4.2013

EU/1/13/818/001-004

Bosulif

Norway

30.4.2013

EU/1/13/819/001

JETREA

Liechtenstein

30.4.2013

EU/1/13/819/001

JETREA

Iceland

11.4.2013

EU/1/13/819/001

JETREA

Norway

22.3.2013

EU/1/13/820/001-026

Maruxa

Liechtenstein

30.6.2013

EU/1/13/820/001-026

Maruxa

Norway

24.5.2013

EU/1/13/821/001-030

Tolucombi

Liechtenstein

30.4.2013

EU/1/13/821/001-030

Tolucombi

Iceland

21.3.2013

EU/1/13/821/001-030

Tolucombi

Norway

22.3.2013

EU/1/13/823/001-002

Adasuve

Norway

12.3.2013

EU/1/13/823/001-002

Adasuve

Liechtenstein

30.4.2013

EU/1/13/823/001-002

Adasuve

Iceland

18.3.2013

EU/1/13/824

Nemdatine

Liechtenstein

30.4.2013

EU/1/13/824/001-020

Nemdatine

Iceland

21.5.2013

EU/1/13/824/001-020

Nemdatine

Norway

3.5.2013

EU/1/13/825

Imatinib Actavis

Liechtenstein

30.6.2013

EU/1/13/825/001-018

Imatinib Actavis

Iceland

16.5.2013

EU/1/13/825/001-018

Imatinib Actavis

Norway

20.6.2013

EU/1/13/826

Memantine LEK

Liechtenstein

30.4.2013

EU/1/13/826/001-011

Memantine LEK

Iceland

21.5.2013

EU/1/13/826/001-011

Memantine LEK

Norway

3.5.2013

EU/1/13/827

Memantine Mylan

Liechtenstein

30.4.2013

EU/1/13/827/001-036

Memantine Mylan

Iceland

21.5.2013

EU/1/13/827/001-036

Memantine Mylan

Norway

3.5.2013

EU/1/13/828

Hexacima

Liechtenstein

30.4.2013

EU/1/13/828/001-007

Hexacima

Iceland

17.5.2013

EU/1/13/828/001-007

Hexacima

Norway

15.5.2013

EU/1/13/829

Hexyon

Liechtenstein

30.4.2013

EU/1/13/829/001-007

Hexyon

Iceland

17.5.2013

EU/1/13/829/001-007

Hexyon

Norway

15.5.2013

EU/1/13/830/001-002

Stribild

Iceland

19.6.2013

EU/1/13/830/001-002

Stribild

Norway

24.5.2013

EU/1/13/835/001-018

Voriconazole Accord

Iceland

31.5.2013

EU/1/13/835/001-018

Voriconazole Accord

Norway

31.5.2013

EU/1/13/836

Memantine ratiopharm

Liechtenstein

30.6.2013

EU/1/13/836/001-023

Memantine ratiopharm

Norway

25.6.2013

EU/1/13/840/001-005

HyQvia

Iceland

27.5.2013

EU/1/13/840/001-005

HyQvia

Norway

3.6.2013

EU/2/12/142/001-006

Cardalis

Norway

20.6.2013

EU/2/12/144/001-004

Contacera

Liechtenstein

28.2.2013

EU/2/12/144/001-004

Contacera

Iceland

3.1.2013

EU/2/12/144/001-004

Contacera

Norway

17.1.2013

EU/2/12/145/001-003

Kexxtone

Liechtenstein

30.4.2013

EU/2/12/145/001-003

Kexxtone

Iceland

27.2.2013

EU/2/12/145/001-003

Kexxtone

Norway

8.3.2013

EU/2/12/146/001

Semintra

Liechtenstein

30.4.2013

EU/2/12/146/001

Semintra

Iceland

12.3.2013

EU/2/12/146/001

Semintra

Norway

5.4.2013

EU/2/12/147/001-004

Pexion

Liechtenstein

30.4.2013

EU/2/12/147/001-004

Pexion

Iceland

19.3.2013

EU/2/12/147/001-004

Pexion

Norway

8.3.2013

EU/2/13/148

Meloxidolor

Liechtenstein

30.6.2013

EU/2/13/148/001-007

Meloxidolor

Iceland

21.5.2013

EU/2/13/148/001-007

Meloxidolor

Norway

22.4.2013

EU/2/13/149

ECOPORC SHIGA

Liechtenstein

30.4.2013

EU/2/13/149/001-002

ECOPORC SHIGA

Iceland

15.5.2013

EU/2/13/149/001-002

ECOPORC SHIGA

Norway

13.5.2013

EU/2/13/150

Oncept IL-2

Liechtenstein

30.6.2013

EU/2/13/151/001-003

Equilis West Nile

Iceland

27.6.2013

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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 January-30 June 2013:

| EU-Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/03/247 | Forsteo | Liechtenstein | 30.4.2013 |
| EU/1/03/247/001-002 | Forsteo | Iceland | 19.2.2013 |
| EU/1/03/247/001-002 | Forsteo | Norway | 6.3.2013 |
| EU/1/07/423 | Vectibix | Liechtenstein | 30.4.2013 |
| EU/1/07/423/001-003 | Vectibix | Iceland | 5.2.2013 |
| EU/1/07/423/001-003 | Vectibix | Norway | 12.2.2013 |
| EU/1/07/428/001 | Abraxane | Liechtenstein | 30.4.2013 |
| EU/1/07/428/001 | Abraxane | Iceland | 5.2.2013 |
| EU/1/07/428/001 | Abraxane | Norway | 11.2.2013 |
| EU/1/07/430/001-002 | Atripla | Liechtenstein | 30.4.2013 |
| EU/1/07/433/001 | Nevanac | Iceland | 9.1.2013 |
| EU/1/07/434 | Avamys | Liechtenstein | 28.2.2013 |
| EU/1/07/434/001-003 | Avamys | Iceland | 11.1.2013 |
| EU/1/07/434/001-003 | Avamys | Norway | 14.1.2013 |
| EU/1/07/435/001-018 | Tesavel | Liechtenstein | 30.4.2013 |
| EU/1/07/438/001-006 | Myfenax | Liechtenstein | 30.4.2013 |
| EU/1/07/439/001-006 | Mycophenolate mofetil Teva | Liechtenstein | 30.4.2013 |
| EU/1/07/440 | Tyverb | Liechtenstein | 30.4.2013 |
| EU/1/07/440/001-007 | Tyverb | Norway | 15.5.2013 |
| EU/1/08/441 | Effentora | Liechtenstein | 30.4.2013 |
| EU/1/08/441/001-010 | Effentora | Iceland | 20.3.2013 |
| EU/1/08/441/001-010 | Effentora | Norway | 12.3.2013 |
| EU/1/08/442/001-019 | Pradaxa | Norway | 26.2.2013 |
| EU/1/08/442/001-019 | Pradaxa | Liechtenstein | 30.4.2013 |
| EU/1/08/442/001-019 | Pradaxa | Iceland | 15.2.2013 |
| EU/1/08/443/001 | Thalidomide Celgene | Iceland | 14.1.2013 |
| EU/1/08/443/001 | Thalidomide Celgene | Norway | 16.1.2013 |
| EU/1/08/446/001-006 | Privigen | Iceland | 22.3.2013 |
| EU/1/08/446/001-006 | Privigen | Norway | 21.3.2013 |
| EU/1/08/447/001-012 | Adenuric | Norway | 15.1.2013 |
| EU/1/08/447/001-012 | Adenuric | Liechtenstein | 30.4.2013 |
| EU/1/08/447/001-012 | Adenuric | Iceland | 14.1.2013 |
| EU/1/08/448/001-002 | Mycamine | Liechtenstein | 30.4.2013 |
| EU/1/08/448/001-002 | Mycamine | Iceland | 24.1.2013 |
| EU/1/08/448/001-002 | Mycamine | Norway | 12.2.2013 |
| EU/1/08/451 | Volibris | Liechtenstein | 30.4.2013 |
| EU/1/08/451/001-004 | Volibris | Iceland | 5.2.2013 |
| EU/1/08/451/001-004 | Volibris | Norway | 12.2.2013 |
| EU/1/08/453 | Prepandrix | Liechtenstein | 30.4.2013 |
| EU/1/08/453/002 | Prepandrix | Iceland | 6.2.2013 |
| EU/1/08/453/002 | Prepandrix | Norway | 4.2.2013 |
| EU/1/08/454/001-002, 005-007 | Extavia | Iceland | 9.1.2013 |
| EU/1/08/454/001-002, 005-007 | Extavia | Liechtenstein | 30.4.2013 |
| EU/1/08/454/001-002, 005-007 | Extavia | Norway | 10.1.2013 |
| EU/1/08/455 | Janumet | Liechtenstein | 30.4.2013 |
| EU/1/08/455/001-006 | Janumet | Norway | 10.4.2013 |
| EU/1/08/455/001-016 | Janumet | Iceland | 25.3.2013 |
| EU/1/08/456 | Velmetia | Liechtenstein | 30.4.2013 |
| EU/1/08/456/001-016 | Velmetia | Iceland | 26.3.2013 |
| EU/1/08/457 | Efficib | Liechtenstein | 30.4.2013 |
| EU/1/08/457/001-016 | Efficib | Iceland | 26.3.2013 |
| EU/1/08/461 | Firazyr | Liechtenstein | 30.4.2013 |
| EU/1/08/461/001-002 | Firazyr | Iceland | 11.4.2013 |
| EU/1/08/461/001-002 | Firazyr | Norway | 10.4.2013 |
| EU/1/08/462 | Ranexa | Liechtenstein | 30.4.2013 |
| EU/1/08/462/001-002 | Ranexa | Norway | 9.4.2013 |
| EU/1/08/462/001-012 | Ranexa | Iceland | 20.3.2013 |
| EU/1/08/463 | Relistor | Liechtenstein | 30.6.2013 |
| EU/1/08/463/001-011 | Relistor | Iceland | 21.6.2013 |
| EU/1/08/463/001-011 | Relistor | Norway | 26.6.2013 |
| EU/1/08/465 | Clopidogrel Zentiva | Liechtenstein | 28.2.2013 |
| EU/1/08/465/001-021 | Clopidogrel Zentiva | Iceland | 3.1.2013 |
| EU/1/08/465/001-021 | Clopidogrel Zentiva | Norway | 5.2.2013 |
| EU/1/08/467 | Doribax | Liechtenstein | 30.6.2013 |
| EU/1/08/467/001-002 | Doribax | Iceland | 17.5.2013 |
| EU/1/08/469 | Oprymea | Liechtenstein | 30.4.2013 |
| EU/1/08/469/001-025 | Oprymea | Iceland | 14.5.2013 |
| EU/1/08/469/001-025 | Oprymea | Norway | 24.5.2013 |
| EU/1/08/472 | Xarelto | Liechtenstein | 30.6.2013 |
| EU/1/08/472/001-033 | Xarelto | Norway | 13.6.2013 |
| EU/1/08/472/001-033 | Xarelto | Iceland | 20.6.2013 |
| EU/1/08/475 | Olanzapine Mylan | Liechtenstein | 30.6.2013 |
| EU/1/08/475/001-060 | Olanzapine Mylan | Iceland | 20.6.2013 |
| EU/1/08/475/001-060 | Olanzapine Mylan | Norway | 7.6.2013 |
| EU/1/08/476 | Adcirca | Liechtenstein | 30.6.2013 |
| EU/1/08/476/005-006 | Adcirca | Iceland | 31.5.2013 |
| EU/1/08/476/005-006 | Adcirca | Norway | 4.6.2013 |
| EU/1/10/625 | Arzerra | Liechtenstein | 30.4.2013 |
| EU/1/10/625/001, 003 | Arzerra | Iceland | 15.3.2013 |
| EU/1/10/625/001, 003 | Arzerra | Norway | 9.4.2013 |
| EU/1/11/749 | Caprelsa | Liechtenstein | 30.4.2013 |
| EU/1/11/749/001-002 | Caprelsa | Iceland | 12.3.2013 |
| EU/1/11/749/001-002 | Caprelsa | Norway | 9.4.2013 |
| EU/1/12/764 | Pixuvri | Liechtenstein | 30.4.2013 |
| EU/1/12/764/001 | Pixuvri | Iceland | 12.4.2013 |
| EU/1/12/764/001 | Pixuvri | Norway | 9.4.2013 |
| EU/1/97/055/001-009 | Viramune | Liechtenstein | 30.4.2013 |
| EU/1/97/055/001-009 | Viramune | Iceland | 14.1.2013 |
| EU/1/97/055/001-009 | Viramune | Norway | 22.1.2013 |
| EU/2/02/032/001-002 | Vaxxitec HVT+IBD | Norway | 11.6.2013 |
| EU/2/03/037 | ProteqFlu | Liechtenstein | 30.4.2013 |
| EU/2/03/037/005 | ProteqFlu | Iceland | 21.3.2013 |
| EU/2/03/037/005 | ProteqFlu | Norway | 20.6.2013 |
| EU/2/03/038 | ProteqFlu-Te | Liechtenstein | 30.4.2013 |
| EU/2/03/038/005 | ProteqFlu-Te | Iceland | 21.3.2013 |
| EU/2/03/038/005 | ProteqFlu-Te | Norway | 20.6.2013 |
| EU/2/03/039 | Advocate | Liechtenstein | 28.2.2013 |
| EU/2/03/039/001-054 | Advocate | Iceland | 19.2.2013 |
| EU/2/03/039/001-054 | Advocate | Norway | 5.3.2013 |
| EU/2/07/074/001-006 | Prilactone | Norway | 11.6.2013 |
| EU/2/07/077/001-005 | Meloxivet | Norway | 5.4.2013 |
| EU/2/07/078 | Rheumocam | Liechtenstein | 28.2.2013 |
| EU/2/07/078/001-020 | Rheumocam | Iceland | 11.1.2013 |
| EU/2/07/078/001-020 | Rheumocam | Norway | 21.1.2013 |
| EU/2/07/079 | Ingelvac CircoFLEX | Liechtenstein | 30.4.2013 |
| EU/2/07/079/001-008 | Ingelvac CircoFLEX | Iceland | 7.2.2013 |
| EU/2/07/079/001-008 | Ingelvac CircoFLEX | Norway | 5.3.2013 |
| EU/2/08/081/001-003 | Posatex | Iceland | 14.6.2013 |
| EU/2/08/081/001-003 | Posatex | Norway | 11.6.2013 |
| EU/2/08/083/001-005 | Equioxx | Iceland | 28.6.2013 |
| EU/2/08/083/001-005 | Equioxx | Norway | 20.6.2013 |

EU-Number

Product

Country

Date of authorisation

EU/1/03/247

Forsteo

Liechtenstein

30.4.2013

EU/1/03/247/001-002

Forsteo

Iceland

19.2.2013

EU/1/03/247/001-002

Forsteo

Norway

6.3.2013

EU/1/07/423

Vectibix

Liechtenstein

30.4.2013

EU/1/07/423/001-003

Vectibix

Iceland

5.2.2013

EU/1/07/423/001-003

Vectibix

Norway

12.2.2013

EU/1/07/428/001

Abraxane

Liechtenstein

30.4.2013

EU/1/07/428/001

Abraxane

Iceland

5.2.2013

EU/1/07/428/001

Abraxane

Norway

11.2.2013

EU/1/07/430/001-002

Atripla

Liechtenstein

30.4.2013

EU/1/07/433/001

Nevanac

Iceland

9.1.2013

EU/1/07/434

Avamys

Liechtenstein

28.2.2013

EU/1/07/434/001-003

Avamys

Iceland

11.1.2013

EU/1/07/434/001-003

Avamys

Norway

14.1.2013

EU/1/07/435/001-018

Tesavel

Liechtenstein

30.4.2013

EU/1/07/438/001-006

Myfenax

Liechtenstein

30.4.2013

EU/1/07/439/001-006

Mycophenolate mofetil Teva

Liechtenstein

30.4.2013

EU/1/07/440

Tyverb

Liechtenstein

30.4.2013

EU/1/07/440/001-007

Tyverb

Norway

15.5.2013

EU/1/08/441

Effentora

Liechtenstein

30.4.2013

EU/1/08/441/001-010

Effentora

Iceland

20.3.2013

EU/1/08/441/001-010

Effentora

Norway

12.3.2013

EU/1/08/442/001-019

Pradaxa

Norway

26.2.2013

EU/1/08/442/001-019

Pradaxa

Liechtenstein

30.4.2013

EU/1/08/442/001-019

Pradaxa

Iceland

15.2.2013

EU/1/08/443/001

Thalidomide Celgene

Iceland

14.1.2013

EU/1/08/443/001

Thalidomide Celgene

Norway

16.1.2013

EU/1/08/446/001-006

Privigen

Iceland

22.3.2013

EU/1/08/446/001-006

Privigen

Norway

21.3.2013

EU/1/08/447/001-012

Adenuric

Norway

15.1.2013

EU/1/08/447/001-012

Adenuric

Liechtenstein

30.4.2013

EU/1/08/447/001-012

Adenuric

Iceland

14.1.2013

EU/1/08/448/001-002

Mycamine

Liechtenstein

30.4.2013

EU/1/08/448/001-002

Mycamine

Iceland

24.1.2013

EU/1/08/448/001-002

Mycamine

Norway

12.2.2013

EU/1/08/451

Volibris

Liechtenstein

30.4.2013

EU/1/08/451/001-004

Volibris

Iceland

5.2.2013

EU/1/08/451/001-004

Volibris

Norway

12.2.2013

EU/1/08/453

Prepandrix

Liechtenstein

30.4.2013

EU/1/08/453/002

Prepandrix

Iceland

6.2.2013

EU/1/08/453/002

Prepandrix

Norway

4.2.2013

EU/1/08/454/001-002, 005-007

Extavia

Iceland

9.1.2013

EU/1/08/454/001-002, 005-007

Extavia

Liechtenstein

30.4.2013

EU/1/08/454/001-002, 005-007

Extavia

Norway

10.1.2013

EU/1/08/455

Janumet

Liechtenstein

30.4.2013

EU/1/08/455/001-006

Janumet

Norway

10.4.2013

EU/1/08/455/001-016

Janumet

Iceland

25.3.2013

EU/1/08/456

Velmetia

Liechtenstein

30.4.2013

EU/1/08/456/001-016

Velmetia

Iceland

26.3.2013

EU/1/08/457

Efficib

Liechtenstein

30.4.2013

EU/1/08/457/001-016

Efficib

Iceland

26.3.2013

EU/1/08/461

Firazyr

Liechtenstein

30.4.2013

EU/1/08/461/001-002

Firazyr

Iceland

11.4.2013

EU/1/08/461/001-002

Firazyr

Norway

10.4.2013

EU/1/08/462

Ranexa

Liechtenstein

30.4.2013

EU/1/08/462/001-002

Ranexa

Norway

9.4.2013

EU/1/08/462/001-012

Ranexa

Iceland

20.3.2013

EU/1/08/463

Relistor

Liechtenstein

30.6.2013

EU/1/08/463/001-011

Relistor

Iceland

21.6.2013

EU/1/08/463/001-011

Relistor

Norway

26.6.2013

EU/1/08/465

Clopidogrel Zentiva

Liechtenstein

28.2.2013

EU/1/08/465/001-021

Clopidogrel Zentiva

Iceland

3.1.2013

EU/1/08/465/001-021

Clopidogrel Zentiva

Norway

5.2.2013

EU/1/08/467

Doribax

Liechtenstein

30.6.2013

EU/1/08/467/001-002

Doribax

Iceland

17.5.2013

EU/1/08/469

Oprymea

Liechtenstein

30.4.2013

EU/1/08/469/001-025

Oprymea

Iceland

14.5.2013

EU/1/08/469/001-025

Oprymea

Norway

24.5.2013

EU/1/08/472

Xarelto

Liechtenstein

30.6.2013

EU/1/08/472/001-033

Xarelto

Norway

13.6.2013

EU/1/08/472/001-033

Xarelto

Iceland

20.6.2013

EU/1/08/475

Olanzapine Mylan

Liechtenstein

30.6.2013

EU/1/08/475/001-060

Olanzapine Mylan

Iceland

20.6.2013

EU/1/08/475/001-060

Olanzapine Mylan

Norway

7.6.2013

EU/1/08/476

Adcirca

Liechtenstein

30.6.2013

EU/1/08/476/005-006

Adcirca

Iceland

31.5.2013

EU/1/08/476/005-006

Adcirca

Norway

4.6.2013

EU/1/10/625

Arzerra

Liechtenstein

30.4.2013

EU/1/10/625/001, 003

Arzerra

Iceland

15.3.2013

EU/1/10/625/001, 003

Arzerra

Norway

9.4.2013

EU/1/11/749

Caprelsa

Liechtenstein

30.4.2013

EU/1/11/749/001-002

Caprelsa

Iceland

12.3.2013

EU/1/11/749/001-002

Caprelsa

Norway

9.4.2013

EU/1/12/764

Pixuvri

Liechtenstein

30.4.2013

EU/1/12/764/001

Pixuvri

Iceland

12.4.2013

EU/1/12/764/001

Pixuvri

Norway

9.4.2013

EU/1/97/055/001-009

Viramune

Liechtenstein

30.4.2013

EU/1/97/055/001-009

Viramune

Iceland

14.1.2013

EU/1/97/055/001-009

Viramune

Norway

22.1.2013

EU/2/02/032/001-002

Vaxxitec HVT+IBD

Norway

11.6.2013

EU/2/03/037

ProteqFlu

Liechtenstein

30.4.2013

EU/2/03/037/005

ProteqFlu

Iceland

21.3.2013

EU/2/03/037/005

ProteqFlu

Norway

20.6.2013

EU/2/03/038

ProteqFlu-Te

Liechtenstein

30.4.2013

EU/2/03/038/005

ProteqFlu-Te

Iceland

21.3.2013

EU/2/03/038/005

ProteqFlu-Te

Norway

20.6.2013

EU/2/03/039

Advocate

Liechtenstein

28.2.2013

EU/2/03/039/001-054

Advocate

Iceland

19.2.2013

EU/2/03/039/001-054

Advocate

Norway

5.3.2013

EU/2/07/074/001-006

Prilactone

Norway

11.6.2013

EU/2/07/077/001-005

Meloxivet

Norway

5.4.2013

EU/2/07/078

Rheumocam

Liechtenstein

28.2.2013

EU/2/07/078/001-020

Rheumocam

Iceland

11.1.2013

EU/2/07/078/001-020

Rheumocam

Norway

21.1.2013

EU/2/07/079

Ingelvac CircoFLEX

Liechtenstein

30.4.2013

EU/2/07/079/001-008

Ingelvac CircoFLEX

Iceland

7.2.2013

EU/2/07/079/001-008

Ingelvac CircoFLEX

Norway

5.3.2013

EU/2/08/081/001-003

Posatex

Iceland

14.6.2013

EU/2/08/081/001-003

Posatex

Norway

11.6.2013

EU/2/08/083/001-005

Equioxx

Iceland

28.6.2013

EU/2/08/083/001-005

Equioxx

Norway

20.6.2013

---

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 2013:

| EU-Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/01/200/003-009 | Viread | Norway | 11.1.2013 |
| EU/1/02/221/017 | Pegasys | Iceland | 26.3.2013 |
| EU/1/02/221/017 | Pegasys | Norway | 26.3.2013 |
| EU/1/06/380/006-007 | Prezista | Liechtenstein | 28.2.2013 |
| EU/1/06/380/007 | Prezista | Iceland | 6.2.2013 |
| EU/1/06/380/007 | Prezista | Norway | 11.2.2013 |
| EU/1/07/433/002 | Nevanac | Norway | 24.5.2013 |
| EU/1/07/436/003-004 | Isentress | Iceland | 19.3.2013 |
| EU/1/07/436/003-004 | Isentress | Norway | 25.2.2013 |
| EU/1/08/468/003 | Intelence | Norway | 17.4.2013 |
| EU/1/09/538/009-010 | Afinitor | Iceland | 5.2.2013 |
| EU/1/09/538/009-010 | Afinitor | Norway | 16.1.2013 |
| EU/1/09/576/041-042 | Irbesartan Teva | Liechtenstein | 28.2.2013 |
| EU/1/11/690/003-004 | Zoely | Liechtenstein | 28.2.2013 |
| EU/1/11/693/017-024 | Rivastigmine Actavis | Iceland | 17.5.2013 |
| EU/1/11/693/017-024 | Rivastigmine Actavis | Norway | 25.6.2013 |
| EU/1/12/750/002 | Esmya | Liechtenstein | 28.2.2013 |
| EU/1/12/770/005 | Docetaxel Kabi | Liechtenstein | 28.2.2013 |
| EU/1/98/066/027-030 | Exelon | Iceland | 7.2.2013 |
| EU/1/98/066/027-030 | Exelon | Norway | 12.2.2013 |
| EU/1/98/077/020-023 | Viagra | Iceland | 17.5.2013 |
| EU/1/98/077/020-023 | Viagra | Norway | 15.5.2013 |
| EU/100/146/033-037 | Keppra | Liechtenstein | 28.2.2013 |
| EU/2/08/090/029-031 | Loxicom | Iceland | 21.3.2013 |
| EU/2/08/090/029-031 | Loxicom | Norway | 6.3.2013 |
| EU/2/10/115/016-019 | Comfortis | Iceland | 8.2.2013 |
| EU/2/10/115/016-019 | Comfortis | Norway | 14.1.2013 |
| EU/2/11/134/018-020 | Inflacam | Norway | 17.1.2013 |

EU-Number

Product

Country

Date of authorisation

EU/1/01/200/003-009

Viread

Norway

11.1.2013

EU/1/02/221/017

Pegasys

Iceland

26.3.2013

EU/1/02/221/017

Pegasys

Norway

26.3.2013

EU/1/06/380/006-007

Prezista

Liechtenstein

28.2.2013

EU/1/06/380/007

Prezista

Iceland

6.2.2013

EU/1/06/380/007

Prezista

Norway

11.2.2013

EU/1/07/433/002

Nevanac

Norway

24.5.2013

EU/1/07/436/003-004

Isentress

Iceland

19.3.2013

EU/1/07/436/003-004

Isentress

Norway

25.2.2013

EU/1/08/468/003

Intelence

Norway

17.4.2013

EU/1/09/538/009-010

Afinitor

Iceland

5.2.2013

EU/1/09/538/009-010

Afinitor

Norway

16.1.2013

EU/1/09/576/041-042

Irbesartan Teva

Liechtenstein

28.2.2013

EU/1/11/690/003-004

Zoely

Liechtenstein

28.2.2013

EU/1/11/693/017-024

Rivastigmine Actavis

Iceland

17.5.2013

EU/1/11/693/017-024

Rivastigmine Actavis

Norway

25.6.2013

EU/1/12/750/002

Esmya

Liechtenstein

28.2.2013

EU/1/12/770/005

Docetaxel Kabi

Liechtenstein

28.2.2013

EU/1/98/066/027-030

Exelon

Iceland

7.2.2013

EU/1/98/066/027-030

Exelon

Norway

12.2.2013

EU/1/98/077/020-023

Viagra

Iceland

17.5.2013

EU/1/98/077/020-023

Viagra

Norway

15.5.2013

EU/100/146/033-037

Keppra

Liechtenstein

28.2.2013

EU/2/08/090/029-031

Loxicom

Iceland

21.3.2013

EU/2/08/090/029-031

Loxicom

Norway

6.3.2013

EU/2/10/115/016-019

Comfortis

Iceland

8.2.2013

EU/2/10/115/016-019

Comfortis

Norway

14.1.2013

EU/2/11/134/018-020

Inflacam

Norway

17.1.2013

---

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 2013:

| EU-Number | Product | Country | Date of withdrawal |
| --- | --- | --- | --- |
| EU/1/03/266 | Bondenza | Liechtenstein | 30.4.2013 |
| EU/1/03/266/001-006 | Bondenza | Norway | 12.6.2013 |
| EU/1/07/409 | Riprazo | Liechtenstein | 30.4.2013 |
| EU/1/07/409/001-040 | Riprazo | Iceland | 27.5.2013 |
| EU/1/07/409/001-040 | Riprazo | Norway | 14.3.2013 |
| EU/1/08/458/001-014 | Trevaclyn | Iceland | 15.5.2013 |
| EU/1/08/458/001-014 | Trevaclyn | Norway | 23.4.2013 |
| EU/1/08/459/001-014 | Tredaptive | Iceland | 15.5.2013 |
| EU/1/08/459/001-014 | Tredaptive | Norway | 23.4.2013 |
| EU/1/08/460/001-014 | Pelzont | Iceland | 15.5.2013 |
| EU/1/08/460/001-014 | Pelzont | Norway | 23.4.2013 |
| EU/1/08/474/001-003 | Alisade | Iceland | 27.6.2013 |
| EU/1/09/582/001 | Rilonacept Regeneron | Liechtenstein | 28.2.2013 |
| EU/1/09/582/001 | Rilonacept Regeneron | Norway | 8.2.2013 |
| EU/1/10/656/001-006 | Possia | Iceland | 15.4.2013 |
| EU/1/10/656/001-006 | Possia | Norway | 12.6.2013 |
| EU/1/11/683/001-080 | Sprimeo HCT | Norway | 21.3.2013 |
| EU/1/12/754/001-021 | Sepioglin | Norway | 20.6.2013 |
| EU/1/97/040/001-002 | Teslascan | Liechtenstein | 28.2.2013 |
| EU/2/04/046 | Nobivac Piro | Liechtenstein | 30.6.2013 |
| EU/2/04/046/001-003 | Nobivac Piro | Iceland | 3.6.2013 |
| EU/2/04/046/001-003 | Nobivac Piro | Norway | 22.5.2013 |

EU-Number

Product

Country

Date of withdrawal

EU/1/03/266

Bondenza

Liechtenstein

30.4.2013

EU/1/03/266/001-006

Bondenza

Norway

12.6.2013

EU/1/07/409

Riprazo

Liechtenstein

30.4.2013

EU/1/07/409/001-040

Riprazo

Iceland

27.5.2013

EU/1/07/409/001-040

Riprazo

Norway

14.3.2013

EU/1/08/458/001-014

Trevaclyn

Iceland

15.5.2013

EU/1/08/458/001-014

Trevaclyn

Norway

23.4.2013

EU/1/08/459/001-014

Tredaptive

Iceland

15.5.2013

EU/1/08/459/001-014

Tredaptive

Norway

23.4.2013

EU/1/08/460/001-014

Pelzont

Iceland

15.5.2013

EU/1/08/460/001-014

Pelzont

Norway

23.4.2013

EU/1/08/474/001-003

Alisade

Iceland

27.6.2013

EU/1/09/582/001

Rilonacept Regeneron

Liechtenstein

28.2.2013

EU/1/09/582/001

Rilonacept Regeneron

Norway

8.2.2013

EU/1/10/656/001-006

Possia

Iceland

15.4.2013

EU/1/10/656/001-006

Possia

Norway

12.6.2013

EU/1/11/683/001-080

Sprimeo HCT

Norway

21.3.2013

EU/1/12/754/001-021

Sepioglin

Norway

20.6.2013

EU/1/97/040/001-002

Teslascan

Liechtenstein

28.2.2013

EU/2/04/046

Nobivac Piro

Liechtenstein

30.6.2013

EU/2/04/046/001-003

Nobivac Piro

Iceland

3.6.2013

EU/2/04/046/001-003

Nobivac Piro

Norway

22.5.2013

---

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 2013:

| EU-Number | Product | Country | Date of suspension |
| --- | --- | --- | --- |
| EU/1/09/509/001-004 | Ribavirin Teva | Norway | 3.1.2013 |
| EU/1/09/527/001-006 | Ribavirin Teva Pharma BV | Norway | 3.1.2013 |

EU-Number

Product

Country

Date of suspension

EU/1/09/509/001-004

Ribavirin Teva

Norway

3.1.2013

EU/1/09/527/001-006

Ribavirin Teva Pharma BV

Norway

3.1.2013

---