# C_2014356EN.01003701.xml

| 9.10.2014 | EN | Official Journal of the European Union | C 356/37 |
| --- | --- | --- | --- |

9.10.2014

EN

Official Journal of the European Union

C 356/37

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Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the second half of 2012

2014/C 356/08

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 2012, at their meeting on 8 November 2013:

| 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| Annex IV | List of withdrawn marketing authorisations |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List of withdrawn marketing authorisations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 2012:

| EU-Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/11/685/001-005 | Ibandronic acid Sandoz | Norway | 31.7.2012 |
| EU/1/11/719/001-062 | Telmisartan Teva Pharma | Liechtenstein | 31.12.2012 |
| EU/1/11/744/001-002 | Topotecan Eagle | Norway | 30.8.2012 |
| EU/1/11/747/001 | Colobreathe | Norway | 11.7.2012 |
| EU/1/11/748/001-006 | Docetaxel Mylan | Norway | 17.12.2012 |
| EU/1/12/762/001-018 | Capecitabine Accord | Norway | 13.8.2012 |
| EU/1/12/768/001 | Riluzole Zentiva | Norway | 16.8.2012 |
| EU/1/12/769/001-003 | Docetaxel Accord | Norway | 13.8.2012 |
| EU/1/12/771/001-006 | Zoledronic Acid Teva | Iceland | 10.9.2012 |
| EU/1/12/771/001-006 | Zoledronic acid Teva | Norway | 12.10.2012 |
| EU/1/12/772/001-004 | Zoledronic acid Teva Pharma | Iceland | 10.9.2012 |
| EU/1/12/772/001-004 | Zoledronic acid Teva Pharma | Norway | 10.10.2012 |
| EU/1/12/773/001-003 | Jakavi | Liechtenstein | 31.8.2012 |
| EU/1/12/773/001-003 | Jakavi | Norway | 5.9.2012 |
| EU/1/12/773/001-003 | Jakavi | Iceland | 19.9.2012 |
| EU/1/12/774/001-002 | Rienso | Norway | 14.8.2012 |
| EU/1/12/774/001-002 | Rienso | Iceland | 20.7.2012 |
| EU/1/12/774/001-002 | Rienso | Liechtenstein | 31.12.2012 |
| EU/1/12/775/001 | NovoThirteen | Iceland | 17.9.2012 |
| EU/1/12/775/001 | Novo Thirteen | Norway | 19.9.2012 |
| EU/1/12/775/001 | Novo Thirteen | Liechtenstein | 31.10.2012 |
| EU/1/12/776/001-016 | Fycompa | Norway | 27.8.2012 |
| EU/1/12/776/001-016 | Fycompa | Liechtenstein | 31.8.2012 |
| EU/1/12/776/001-016 | Fycompa | Iceland | 11.9.2012 |
| EU/1/12/777/001-006 | Inlyta | Iceland | 14.9.2012 |
| EU/1/12/777/001-006 | Inlyta | Norway | 21.9.2012 |
| EU/1/12/777/001-006 | Inlyta | Liechtenstein | 31.10.2012 |
| EU/1/12/778/001-003 | Eklira Genuair | Iceland | 13.8.2012 |
| EU/1/12/778/001-003 | Eklira Genuair | Norway | 15.8.2012 |
| EU/1/12/778/001-003 | Eklira Genuair | Liechtenstein | 31.8.2012 |
| EU/1/12/779/001-006 | Zoledronic acid medac | Norway | 15.8.2012 |
| EU/1/12/779/001-006 | Zoledronic acid medac | Iceland | 27.8.2012 |
| EU/1/12/779/001-006 | Zoledronic acid medac | Liechtenstein | 31.8.2012 |
| EU/1/12/780/001-028 | Jentadueto | Norway | 31.7.2012 |
| EU/1/12/780/001-028 | Jentadueto | Liechtenstein | 31.8.2012 |
| EU/1/12/780/001-028 | Jentadueto | Iceland | 17.8.2012 |
| EU/1/12/781/001-003 | Bretaris Genuair | Iceland | 13.8.2012 |
| EU/1/12/781/001-003 | Bretaris Genuair | Norway | 15.8.2012 |
| EU/1/12/781/001-003 | Bretaris Genuair | Liechtenstein | 31.8.2012 |
| EU/1/12/782/001-002 | Kalydeco | Norway | 6.8.2012 |
| EU/1/12/782/001-002 | Kalydeco | Iceland | 21.8.2012 |
| EU/1/12/782/001-002 | Kalydeco | Liechtenstein | 31.8.2012 |
| EU/1/12/783/001-003 | Zyclara | Liechtenstein | 31.8.2012 |
| EU/1/12/783/001-003 | Zyclara | Iceland | 12.9.2012 |
| EU/1/12/783/001-003 | Zyclara | Norway | 10.10.2012 |
| EU/1/12/784/001 | Cuprymina | Iceland | 7.9.2012 |
| EU/1/12/784/001 | Cuprymina | Norway | 25.9.2012 |
| EU/1/12/784/001 | Cuprymina | Liechtenstein | 31.10.2012 |
| EU/1/12/785/001 | Zinforo | Liechtenstein | 31.8.2012 |
| EU/1/12/785/001 | Zinforo | Iceland | 6.9.2012 |
| EU/1/12/785/001 | Zinforo | Norway | 17.9.2012 |
| EU/1/12/786/001-003 | Zoledronic acid Mylan | Liechtenstein | 31.8.2012 |
| EU/1/12/786/001-003 | Zoledronic acid Mylan | Iceland | 4.9.2012 |
| EU/1/12/786/001-003 | Zoledronic acid Mylan | Norway | 12.10.2012 |
| EU/1/12/787/001 | Revestive | Iceland | 14.9.2012 |
| EU/1/12/787/001 | Revestive | Norway | 26.9.2012 |
| EU/1/12/787/001 | Revestive | Liechtenstein | 31.10.2012 |
| EU/1/12/788/001-006 | Seebri Breezhaler | Iceland | 16.10.2012 |
| EU/1/12/788/001-006 | Seebri Breezhaler | Norway | 17.10.2012 |
| EU/1/12/789/001-006 | Enurev Breezhaler | Iceland | 17.10.2012 |
| EU/1/12/789/001-006 | Enurev Breezhaler | Norway | 29.10.2012 |
| EU/1/12/790/001-006 | Tovanor Breezhaler | Iceland | 17.10.2012 |
| EU/1/12/790/001-006 | Tovanor Breezhaler | Norway | 29.10.2012 |
| EU/1/12/791/001 | Glybera | Iceland | 15.11.2012 |
| EU/1/12/791/001 | Glybera | Norway | 6.12.2012 |
| EU/1/12/792/001 | Dacogen | Iceland | 15.10.2012 |
| EU/1/12/792/001 | Dacogen | Norway | 17.10.2012 |
| EU/1/12/792/001 | Dacogen | Liechtenstein | 31.10.2012 |
| EU/1/12/793/001-004 | Xalkori | Iceland | 8.11.2012 |
| EU/1/12/793/001-004 | Xalkori | Norway | 14.11.2012 |
| EU/1/12/793/001-004 | Xalkori | Liechtenstein | 31.12.2012 |
| EU/1/12/794/001 | Adcetris | Norway | 10.12.2012 |
| EU/1/12/794/001 | Adectris | Liechtenstein | 31.12.2012 |
| EU/1/12/795/001-010 | Forxiga | Norway | 6.12.2012 |
| EU/1/12/795/001-010 | Forxiga | Iceland | 7.12.2012 |
| EU/1/12/796/001-002 | Picato | Norway | 27.11.2012 |
| EU/1/12/796/001-002 | Picato | Iceland | 7.12.2012 |
| EU/1/12/796/001-002 | Picato | Liechtenstein | 31.12.2012 |
| EU/1/12/797/001-002 | Eylea | Norway | 6.12.2012 |
| EU/1/12/797/001-002 | Eylea | Iceland | 13.12.2012 |
| EU/1/12/798/001-004 | Ibandronic acid Accord | Norway | 12.12.2012 |
| EU/1/12/798/001-004 | Ibandronic acid Accord | Iceland | 10.12.2012 |
| EU/1/12/798/001-004 | Ibandronic acid Accord | Liechtenstein | 31.12.2012 |
| EU/1/12/799/001-029 | Memantine Merz | Iceland | 12.12.2012 |
| EU/1/12/799/001-029 | Memantine Merz | Liechtenstein | 31.12.2012 |
| EU/1/12/800/001-004 | Zoledronic Acid Hospira | Iceland | 7.12.2012 |
| EU/1/12/800/001-004 | Zoledronic acid Hospira | Norway | 17.12.2012 |
| EU/1/12/800/001-004 | Zoledronic acid Hospira | Liechtenstein | 31.12.2012 |
| EU/1/12/801/001-004 | Constella | Iceland | 13.12.2012 |
| EU/1/12/801/001-004 | Constella | Liechtenstein | 31.12.2012 |
| EU/1/12/801/001-004 | Constella | Norway | 17.12.2012 |
| EU/1/12/802/001-042 | Capecitabine medac | Norway | 13.12.2012 |
| EU/1/12/802/001-042 | Capecitabine medac | Iceland | 18.12.2012 |
| EU/1/12/802/001-042 | Capecitabine medac | Liechtenstein | 31.12.2012 |
| EU/2/09/099/001-006 | Suvaxyn PCV | Iceland | 8.11.2012 |
| EU/2/11/122/001-003 | Bluevac BTV8 | Norway | 18.7.2012 |
| EU/2/12/138/001-003 | RevitaCAM | Norway | 19.9.2012 |
| EU/2/12/140/001-008 | Poulvac E. Coli | Iceland | 23.7.2012 |
| EU/2/12/141/001-009 | Porcilis ColiClos | Iceland | 5.7.2012 |
| EU/2/12/141/001-009 | Porcilis ColiClos | Norway | 31.7.2012 |
| EU/2/12/141/001-009 | Porcilis ColiClos | Liechtenstein | 31.8.2012 |
| EU/2/12/142/001-006 | Cardalis 2,5/20 mg | Iceland | 20.8.2012 |
| EU/2/12/143/001-005 | Nobivac L4 | Iceland | 20.8.2012 |
| EU/2/12/143/001-005 | Nobivac L4 | Norway | 28.8.2012 |
| EU/2/12/143/001-005 | Nobivac L4 | Liechtenstein | 31.8.2012 |

EU-Number

Product

Country

Date of authorisation

EU/1/11/685/001-005

Ibandronic acid Sandoz

Norway

31.7.2012

EU/1/11/719/001-062

Telmisartan Teva Pharma

Liechtenstein

31.12.2012

EU/1/11/744/001-002

Topotecan Eagle

Norway

30.8.2012

EU/1/11/747/001

Colobreathe

Norway

11.7.2012

EU/1/11/748/001-006

Docetaxel Mylan

Norway

17.12.2012

EU/1/12/762/001-018

Capecitabine Accord

Norway

13.8.2012

EU/1/12/768/001

Riluzole Zentiva

Norway

16.8.2012

EU/1/12/769/001-003

Docetaxel Accord

Norway

13.8.2012

EU/1/12/771/001-006

Zoledronic Acid Teva

Iceland

10.9.2012

EU/1/12/771/001-006

Zoledronic acid Teva

Norway

12.10.2012

EU/1/12/772/001-004

Zoledronic acid Teva Pharma

Iceland

10.9.2012

EU/1/12/772/001-004

Zoledronic acid Teva Pharma

Norway

10.10.2012

EU/1/12/773/001-003

Jakavi

Liechtenstein

31.8.2012

EU/1/12/773/001-003

Jakavi

Norway

5.9.2012

EU/1/12/773/001-003

Jakavi

Iceland

19.9.2012

EU/1/12/774/001-002

Rienso

Norway

14.8.2012

EU/1/12/774/001-002

Rienso

Iceland

20.7.2012

EU/1/12/774/001-002

Rienso

Liechtenstein

31.12.2012

EU/1/12/775/001

NovoThirteen

Iceland

17.9.2012

EU/1/12/775/001

Novo Thirteen

Norway

19.9.2012

EU/1/12/775/001

Novo Thirteen

Liechtenstein

31.10.2012

EU/1/12/776/001-016

Fycompa

Norway

27.8.2012

EU/1/12/776/001-016

Fycompa

Liechtenstein

31.8.2012

EU/1/12/776/001-016

Fycompa

Iceland

11.9.2012

EU/1/12/777/001-006

Inlyta

Iceland

14.9.2012

EU/1/12/777/001-006

Inlyta

Norway

21.9.2012

EU/1/12/777/001-006

Inlyta

Liechtenstein

31.10.2012

EU/1/12/778/001-003

Eklira Genuair

Iceland

13.8.2012

EU/1/12/778/001-003

Eklira Genuair

Norway

15.8.2012

EU/1/12/778/001-003

Eklira Genuair

Liechtenstein

31.8.2012

EU/1/12/779/001-006

Zoledronic acid medac

Norway

15.8.2012

EU/1/12/779/001-006

Zoledronic acid medac

Iceland

27.8.2012

EU/1/12/779/001-006

Zoledronic acid medac

Liechtenstein

31.8.2012

EU/1/12/780/001-028

Jentadueto

Norway

31.7.2012

EU/1/12/780/001-028

Jentadueto

Liechtenstein

31.8.2012

EU/1/12/780/001-028

Jentadueto

Iceland

17.8.2012

EU/1/12/781/001-003

Bretaris Genuair

Iceland

13.8.2012

EU/1/12/781/001-003

Bretaris Genuair

Norway

15.8.2012

EU/1/12/781/001-003

Bretaris Genuair

Liechtenstein

31.8.2012

EU/1/12/782/001-002

Kalydeco

Norway

6.8.2012

EU/1/12/782/001-002

Kalydeco

Iceland

21.8.2012

EU/1/12/782/001-002

Kalydeco

Liechtenstein

31.8.2012

EU/1/12/783/001-003

Zyclara

Liechtenstein

31.8.2012

EU/1/12/783/001-003

Zyclara

Iceland

12.9.2012

EU/1/12/783/001-003

Zyclara

Norway

10.10.2012

EU/1/12/784/001

Cuprymina

Iceland

7.9.2012

EU/1/12/784/001

Cuprymina

Norway

25.9.2012

EU/1/12/784/001

Cuprymina

Liechtenstein

31.10.2012

EU/1/12/785/001

Zinforo

Liechtenstein

31.8.2012

EU/1/12/785/001

Zinforo

Iceland

6.9.2012

EU/1/12/785/001

Zinforo

Norway

17.9.2012

EU/1/12/786/001-003

Zoledronic acid Mylan

Liechtenstein

31.8.2012

EU/1/12/786/001-003

Zoledronic acid Mylan

Iceland

4.9.2012

EU/1/12/786/001-003

Zoledronic acid Mylan

Norway

12.10.2012

EU/1/12/787/001

Revestive

Iceland

14.9.2012

EU/1/12/787/001

Revestive

Norway

26.9.2012

EU/1/12/787/001

Revestive

Liechtenstein

31.10.2012

EU/1/12/788/001-006

Seebri Breezhaler

Iceland

16.10.2012

EU/1/12/788/001-006

Seebri Breezhaler

Norway

17.10.2012

EU/1/12/789/001-006

Enurev Breezhaler

Iceland

17.10.2012

EU/1/12/789/001-006

Enurev Breezhaler

Norway

29.10.2012

EU/1/12/790/001-006

Tovanor Breezhaler

Iceland

17.10.2012

EU/1/12/790/001-006

Tovanor Breezhaler

Norway

29.10.2012

EU/1/12/791/001

Glybera

Iceland

15.11.2012

EU/1/12/791/001

Glybera

Norway

6.12.2012

EU/1/12/792/001

Dacogen

Iceland

15.10.2012

EU/1/12/792/001

Dacogen

Norway

17.10.2012

EU/1/12/792/001

Dacogen

Liechtenstein

31.10.2012

EU/1/12/793/001-004

Xalkori

Iceland

8.11.2012

EU/1/12/793/001-004

Xalkori

Norway

14.11.2012

EU/1/12/793/001-004

Xalkori

Liechtenstein

31.12.2012

EU/1/12/794/001

Adcetris

Norway

10.12.2012

EU/1/12/794/001

Adectris

Liechtenstein

31.12.2012

EU/1/12/795/001-010

Forxiga

Norway

6.12.2012

EU/1/12/795/001-010

Forxiga

Iceland

7.12.2012

EU/1/12/796/001-002

Picato

Norway

27.11.2012

EU/1/12/796/001-002

Picato

Iceland

7.12.2012

EU/1/12/796/001-002

Picato

Liechtenstein

31.12.2012

EU/1/12/797/001-002

Eylea

Norway

6.12.2012

EU/1/12/797/001-002

Eylea

Iceland

13.12.2012

EU/1/12/798/001-004

Ibandronic acid Accord

Norway

12.12.2012

EU/1/12/798/001-004

Ibandronic acid Accord

Iceland

10.12.2012

EU/1/12/798/001-004

Ibandronic acid Accord

Liechtenstein

31.12.2012

EU/1/12/799/001-029

Memantine Merz

Iceland

12.12.2012

EU/1/12/799/001-029

Memantine Merz

Liechtenstein

31.12.2012

EU/1/12/800/001-004

Zoledronic Acid Hospira

Iceland

7.12.2012

EU/1/12/800/001-004

Zoledronic acid Hospira

Norway

17.12.2012

EU/1/12/800/001-004

Zoledronic acid Hospira

Liechtenstein

31.12.2012

EU/1/12/801/001-004

Constella

Iceland

13.12.2012

EU/1/12/801/001-004

Constella

Liechtenstein

31.12.2012

EU/1/12/801/001-004

Constella

Norway

17.12.2012

EU/1/12/802/001-042

Capecitabine medac

Norway

13.12.2012

EU/1/12/802/001-042

Capecitabine medac

Iceland

18.12.2012

EU/1/12/802/001-042

Capecitabine medac

Liechtenstein

31.12.2012

EU/2/09/099/001-006

Suvaxyn PCV

Iceland

8.11.2012

EU/2/11/122/001-003

Bluevac BTV8

Norway

18.7.2012

EU/2/12/138/001-003

RevitaCAM

Norway

19.9.2012

EU/2/12/140/001-008

Poulvac E. Coli

Iceland

23.7.2012

EU/2/12/141/001-009

Porcilis ColiClos

Iceland

5.7.2012

EU/2/12/141/001-009

Porcilis ColiClos

Norway

31.7.2012

EU/2/12/141/001-009

Porcilis ColiClos

Liechtenstein

31.8.2012

EU/2/12/142/001-006

Cardalis 2,5/20 mg

Iceland

20.8.2012

EU/2/12/143/001-005

Nobivac L4

Iceland

20.8.2012

EU/2/12/143/001-005

Nobivac L4

Norway

28.8.2012

EU/2/12/143/001-005

Nobivac L4

Liechtenstein

31.8.2012

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ANNEX II

List of renewed marketing authorisations

The following marketing authorisations have been renewed in the EEA EFTA States during the period 1 July- 31 December 2012:

| EU-Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/01/187/001 | DepoCyte | Norway | 13.8.2012 |
| EU/1/01/197/001-005 | Foscan | Norway | 7.9.2012 |
| EU/1/02/222/001-005 | Tamiflu | Norway | 21.8.2012 |
| EU/1/02/223/001-003 | Evra | Iceland | 5.7.2012 |
| EU/1/02/223/001-003 | Evra | Norway | 27.8.2012 |
| EU/1/02/223/001-003 | Evra | Liechtenstein | 31.8.2012 |
| EU/1/02/224/001-005 | Ambirix | Iceland | 21.8.2012 |
| EU/1/02/224/001-005 | Ambirix | Norway | 27.8.2012 |
| EU/1/02/224/001-005 | Ambirix | Liechtenstein | 31.8.2012 |
| EU/1/02/226/001 | InductOs | Norway | 2.8.2012 |
| EU/1/02/226/001 | InductOs | Iceland | 14.8.2012 |
| EU/1/02/237/001-009 | Cialis | Norway | 11.10.2012 |
| EU/1/02/237/001-009 | Cialis | Iceland | 17.10.2012 |
| EU/1/02/237/001-009 | Cialis | Liechtenstein | 31.10.2012 |
| EU/1/02/238/001 | Zavesca | Iceland | 22.10.2012 |
| EU/1/02/238/001 | Zavesca | Norway | 29.10.2012 |
| EU/1/02/238/001 | Zavesca | Liechtenstein | 31.10.2012 |
| EU/1/05/314/001 | Kepivance | Norway | 11.9.2012 |
| EU/1/06/339/001-002 | Preotact | Norway | 28.8.2012 |
| EU/1/06/367/001-012 | Diacomit | Norway | 12.12.2012 |
| EU/1/06/367/001-012 | Diacomit | Iceland | 13.12.2012 |
| EU/1/06/367/001-012 | Diacomit | Liechtenstein | 31.12.2012 |
| EU/1/06/371/001-039 | Dafiro | Norway | 26.9.2012 |
| EU/1/06/376/001-039 | Irbesartan Zentiva | Iceland | 28.9.2012 |
| EU/1/07/393/001 | Soliris | Iceland | 5.7.2012 |
| EU/1/07/393/001 | Soliris | Norway | 13.8.2012 |
| EU/1/07/394/001-009 | Optaflu | Iceland | 8.11.2012 |
| EU/1/07/395/001-095 | Invega | Iceland | 31.8.2012 |
| EU/1/07/395/001-095 | Invega | Norway | 11.9.2012 |
| EU/1/07/397/001-004 | Siklos | Iceland | 23.7.2012 |
| EU/1/07/397/001-004 | Siklos | Norway | 9.8.2012 |
| EU/1/07/398/001-014 | Optimark | Iceland | 5.7.2012 |
| EU/1/07/398/001-014 | Optimark | Liechtenstein | 31.8.2012 |
| EU/1/07/401/007-016 | alli | Iceland | 20.7.2012 |
| EU/1/07/401/007-016 | alli | Liechtenstein | 31.8.2012 |
| EU/1/07/402/001 | Increlex | Iceland | 29.8.2012 |
| EU/1/07/402/001 | Increlex | Liechtenstein | 31.8.2012 |
| EU/1/07/402/001 | Increlex | Norway | 3.9.2012 |
| EU/1/07/403/001 | Atriance | Iceland | 20.7.2012 |
| EU/1/07/403/001 | Atriance | Norway | 7.8.2012 |
| EU/1/07/403/001 | Atriance | Liechtenstein | 31.8.2012 |
| EU/1/07/404/001-008 | Flebogamma DIF | Iceland | 11.9.2012 |
| EU/1/07/404/001-008 | Flebogamma DIF | Norway | 12.10.2012 |
| EU/1/07/405/001-040 | Rasilez | Liechtenstein | 31.8.2012 |
| EU/1/07/405/001-040 | Rasilez | Iceland | 19.9.2012 |
| EU/1/07/405/001-040 | Rasilez | Norway | 10.10.2012 |
| EU/1/07/409/001-040 | Riprazo | Iceland | 12.9.2012 |
| EU/1/07/409/001-040 | Riprazo | Norway | 10.10.2012 |
| EU/1/07/409/001-040 | Riprazo | Liechtenstein | 31.8.2012 |
| EU/1/07/410/001-052 | Binocrit | Norway | 27.8.2012 |
| EU/1/07/410/001-052 | Binocrit | Iceland | 20.7.2012 |
| EU/1/07/410/001-052 | Binocrit | Liechtenstein | 31.8.2012 |
| EU/1/07/411/001-052 | Epoetin alfa Hexal | Iceland | 19.7.2012 |
| EU/1/07/411/001-052 | Epoetin alfa Hexal | Norway | 27.8.2012 |
| EU/1/07/411/001-052 | Epoetin alfa Hexal | Liechtenstein | 31.8.2012 |
| EU/1/07/412/001-052 | Abseamed | Iceland | 20.7.2012 |
| EU/1/07/412/001-052 | Abseamed | Norway | 27.8.2012 |
| EU/1/07/413/001-003 | Gliolan | Iceland | 7.9.2012 |
| EU/1/07/413/001-003 | Gliolan | Norway | 15.10.2012 |
| EU/1/07/413/001-003 | Gliolan | Liechtenstein | 31.10.2012 |
| EU/1/07/414/001-010, 018 | Galvus | Iceland | 17.8.2012 |
| EU/1/07/414/001-010, 018 | Galvus | Norway | 31.7.2012 |
| EU/1/07/415/001-056 | Zalasta | Norway | 24.8.2012 |
| EU/1/07/415/001-056 | Zalasta | Iceland | 25.8.2012 |
| EU/1/07/415/001-056 | Zalasta | Liechtenstein | 31.8.2012 |
| EU/1/07/416/002 | Ecalta | Iceland | 3.9.2012 |
| EU/1/07/416/002 | Ecalta | Liechtenstein | 31.8.2012 |
| EU/1/07/416/002 | Ecalta | Norway | 26.9.2012 |
| EU/1/07/417/001-002 | Yondelis | Iceland | 28.8.2012 |
| EU/1/07/417/001-002 | Yondelis | Liechtenstein | 31.8.2012 |
| EU/1/07/417/001-002 | Yondelis | Norway | 17.9.2012 |
| EU/1/07/418/001-010 | Celsentri | Liechtenstein | 31.8.2012 |
| EU/1/07/418/001-010 | Celsentri | Iceland | 12.9.2012 |
| EU/1/07/418/001-010 | Celsentri | Norway | 18.9.2012 |
| EU/1/07/419/001-012 | Cervarix | Iceland | 12.10.2012 |
| EU/1/07/419/001-012 | Cervarix | Norway | 12.10.2012 |
| EU/1/07/419/001-012 | Cervarix | Liechtenstein | 31.10.2012 |
| EU/1/07/420/001-002 | Cyanokit | Iceland | 14.8.2012 |
| EU/1/07/420/001-002 | Cyanokit | Norway | 17.8.2012 |
| EU/1/07/420/001-002 | Cyanokit | Liechtenstein | 31.8.2012 |
| EU/1/07/421/001-009 | Glubrava | Iceland | 12.10.2012 |
| EU/1/07/421/001-009 | Glubrava | Norway | 12.10.2012 |
| EU/1/07/421/001-009 | Glubrava | Liechtenstein | 31.10.2012 |
| EU/1/07/422/001-012 | Tasigna | Norway | 24.10.2012 |
| EU/1/07/422/001-012 | Tasigna | Liechtenstein | 31.10.2012 |
| EU/1/07/422/001-012 | Tasigna | Iceland | 6.12.2012 |
| EU/1/07/424/001 | Torisel | Iceland | 12.10.2012 |
| EU/1/07/424/001 | Torisel | Norway | 22.10.2012 |
| EU/1/07/424/001 | Torisel | Liechtenstein | 31.10.2012 |
| EU/1/07/425/001-018 | Eucreas | Norway | 31.7.2012 |
| EU/1/07/425/001-018 | Eucreas | Iceland | 21.8.2012 |
| EU/1/07/425/001-018 | Eucreas | Liechtenstein | 31.8.2012 |
| EU/1/07/426/001-011 | Olanzapine Neopharma | Iceland | 17.10.2012 |
| EU/1/07/426/001-011 | Olanzapine Neopharma | Norway | 24.10.2012 |
| EU/1/07/426/001-011 | Olanzapine Neopharma | Liechtenstein | 31.10.2012 |
| EU/1/07/427/001-057 | Olanzapine Teva | Norway | 6.12.2012 |
| EU/1/07/427/001-057 | Olanzapine Teva | Iceland | 7.12.2012 |
| EU/1/07/427/001-057 | Olanzapine Teva | Liechtenstein | 31.12.2012 |
| EU/1/07/430/001-002 | Atripla | Norway | 26.9.2012 |
| EU/1/07/430/001-002 | Atripla | Iceland | 12.10.2012 |
| EU/1/07/431/001-025 | Retacrit | Iceland | 7.12.2012 |
| EU/1/07/431/001-025 | Retacrit | Norway | 17.12.2012 |
| EU/1/07/431/001-025 | Retacrit | Liechtenstein | 31.12.2012 |
| EU/1/07/432/001-022 | Silapo | Iceland | 22.8.2012 |
| EU/1/07/432/001-022 | Silapo | Norway | 24.8.2012 |
| EU/1/07/432/001-022 | Silapo | Liechtenstein | 31.8.2012 |
| EU/1/07/433/001 | Nevanac | Norway | 15.10.2012 |
| EU/1/07/433/001 | Nevanac | Liechtenstein | 31.10.2012 |
| EU/1/07/435/001-018 | Tesavel | Iceland | 15.10.2012 |
| EU/1/07/435/001-018 | Tesavel | Norway | 15.10.2012 |
| EU/1/07/437/001-004 | IVEMEND | Iceland | 7.12.2012 |
| EU/1/07/437/003-004 | IVEMEND | Norway | 6.12.2012 |
| EU/1/07/437/003-004 | IVEMEND | Liechtenstein | 31.12.2012 |
| EU/1/07/438/001-006 | Myfenax | Iceland | 12.12.2012 |
| EU/1/07/438/006 | Myfenax | Norway | 13.12.2012 |
| EU/1/07/439/001-006 | Mycophenolate mofetil Teva | Iceland | 12.12.2012 |
| EU/1/07/439/001-006 | Mycophenolate mofetil Teva | Norway | 17.12.2012 |
| EU/1/08/468/001-002 | INTELENCE | Iceland | 16.8.2012 |
| EU/1/08/468/001-002 | INTELENCE | Norway | 27.8.2012 |
| EU/1/08/468/001-002 | INTELENCE | Liechtenstein | 31.8.2012 |
| EU/1/11/710/001-007 | Votubia | Norway | 16.8.2012 |
| EU/1/11/710/001-007 | Votubia | Iceland | 25.8.2012 |
| EU/1/11/710/001-007 | Votubia | Liechtenstein | 31.8.2012 |
| EU/1/97/047/004-007 | BeneFIX | Iceland | 16.8.2012 |
| EU/1/97/047/004-007 | BeneFIX | Norway | 24.8.2012 |
| EU/1/97/047/004-007 | BeneFIX | Liechtenstein | 31.8.2012 |
| EU/2/02/032/001-002 | Vaxxitek HVT + IBD | Iceland | 23.7.2012 |
| EU/2/02/032/001-002 | Vaxxitek HVT + IBD | Liechtenstein | 31.8.2012 |
| EU/2/02/034/001 | Nobivac Bb | Iceland | 18.9.2012 |
| EU/2/02/034/001 | Nobivac Bb | Norway | 23.10.2012 |
| EU/2/02/034/001 | Nobivac Bb | Liechtenstein | 31.10.2012 |
| EU/2/07/072/001-004 | Suprelorin | Norway | 31.7.2012 |
| EU/2/07/072/001-004 | Suprelorin | Liechtenstein | 31.8.2012 |
| EU/2/07/074/001-006 | Prilactone | Liechtenstein | 31.8.2012 |
| EU/2/07/077/001-005 | Meloxivet | Iceland | 6.12.2012 |
| EU/2/07/077/001-005 | Meloxivet | Liechtenstein | 31.10.2012 |

EU-Number

Product

Country

Date of authorisation

EU/1/01/187/001

DepoCyte

Norway

13.8.2012

EU/1/01/197/001-005

Foscan

Norway

7.9.2012

EU/1/02/222/001-005

Tamiflu

Norway

21.8.2012

EU/1/02/223/001-003

Evra

Iceland

5.7.2012

EU/1/02/223/001-003

Evra

Norway

27.8.2012

EU/1/02/223/001-003

Evra

Liechtenstein

31.8.2012

EU/1/02/224/001-005

Ambirix

Iceland

21.8.2012

EU/1/02/224/001-005

Ambirix

Norway

27.8.2012

EU/1/02/224/001-005

Ambirix

Liechtenstein

31.8.2012

EU/1/02/226/001

InductOs

Norway

2.8.2012

EU/1/02/226/001

InductOs

Iceland

14.8.2012

EU/1/02/237/001-009

Cialis

Norway

11.10.2012

EU/1/02/237/001-009

Cialis

Iceland

17.10.2012

EU/1/02/237/001-009

Cialis

Liechtenstein

31.10.2012

EU/1/02/238/001

Zavesca

Iceland

22.10.2012

EU/1/02/238/001

Zavesca

Norway

29.10.2012

EU/1/02/238/001

Zavesca

Liechtenstein

31.10.2012

EU/1/05/314/001

Kepivance

Norway

11.9.2012

EU/1/06/339/001-002

Preotact

Norway

28.8.2012

EU/1/06/367/001-012

Diacomit

Norway

12.12.2012

EU/1/06/367/001-012

Diacomit

Iceland

13.12.2012

EU/1/06/367/001-012

Diacomit

Liechtenstein

31.12.2012

EU/1/06/371/001-039

Dafiro

Norway

26.9.2012

EU/1/06/376/001-039

Irbesartan Zentiva

Iceland

28.9.2012

EU/1/07/393/001

Soliris

Iceland

5.7.2012

EU/1/07/393/001

Soliris

Norway

13.8.2012

EU/1/07/394/001-009

Optaflu

Iceland

8.11.2012

EU/1/07/395/001-095

Invega

Iceland

31.8.2012

EU/1/07/395/001-095

Invega

Norway

11.9.2012

EU/1/07/397/001-004

Siklos

Iceland

23.7.2012

EU/1/07/397/001-004

Siklos

Norway

9.8.2012

EU/1/07/398/001-014

Optimark

Iceland

5.7.2012

EU/1/07/398/001-014

Optimark

Liechtenstein

31.8.2012

EU/1/07/401/007-016

alli

Iceland

20.7.2012

EU/1/07/401/007-016

alli

Liechtenstein

31.8.2012

EU/1/07/402/001

Increlex

Iceland

29.8.2012

EU/1/07/402/001

Increlex

Liechtenstein

31.8.2012

EU/1/07/402/001

Increlex

Norway

3.9.2012

EU/1/07/403/001

Atriance

Iceland

20.7.2012

EU/1/07/403/001

Atriance

Norway

7.8.2012

EU/1/07/403/001

Atriance

Liechtenstein

31.8.2012

EU/1/07/404/001-008

Flebogamma DIF

Iceland

11.9.2012

EU/1/07/404/001-008

Flebogamma DIF

Norway

12.10.2012

EU/1/07/405/001-040

Rasilez

Liechtenstein

31.8.2012

EU/1/07/405/001-040

Rasilez

Iceland

19.9.2012

EU/1/07/405/001-040

Rasilez

Norway

10.10.2012

EU/1/07/409/001-040

Riprazo

Iceland

12.9.2012

EU/1/07/409/001-040

Riprazo

Norway

10.10.2012

EU/1/07/409/001-040

Riprazo

Liechtenstein

31.8.2012

EU/1/07/410/001-052

Binocrit

Norway

27.8.2012

EU/1/07/410/001-052

Binocrit

Iceland

20.7.2012

EU/1/07/410/001-052

Binocrit

Liechtenstein

31.8.2012

EU/1/07/411/001-052

Epoetin alfa Hexal

Iceland

19.7.2012

EU/1/07/411/001-052

Epoetin alfa Hexal

Norway

27.8.2012

EU/1/07/411/001-052

Epoetin alfa Hexal

Liechtenstein

31.8.2012

EU/1/07/412/001-052

Abseamed

Iceland

20.7.2012

EU/1/07/412/001-052

Abseamed

Norway

27.8.2012

EU/1/07/413/001-003

Gliolan

Iceland

7.9.2012

EU/1/07/413/001-003

Gliolan

Norway

15.10.2012

EU/1/07/413/001-003

Gliolan

Liechtenstein

31.10.2012

EU/1/07/414/001-010, 018

Galvus

Iceland

17.8.2012

EU/1/07/414/001-010, 018

Galvus

Norway

31.7.2012

EU/1/07/415/001-056

Zalasta

Norway

24.8.2012

EU/1/07/415/001-056

Zalasta

Iceland

25.8.2012

EU/1/07/415/001-056

Zalasta

Liechtenstein

31.8.2012

EU/1/07/416/002

Ecalta

Iceland

3.9.2012

EU/1/07/416/002

Ecalta

Liechtenstein

31.8.2012

EU/1/07/416/002

Ecalta

Norway

26.9.2012

EU/1/07/417/001-002

Yondelis

Iceland

28.8.2012

EU/1/07/417/001-002

Yondelis

Liechtenstein

31.8.2012

EU/1/07/417/001-002

Yondelis

Norway

17.9.2012

EU/1/07/418/001-010

Celsentri

Liechtenstein

31.8.2012

EU/1/07/418/001-010

Celsentri

Iceland

12.9.2012

EU/1/07/418/001-010

Celsentri

Norway

18.9.2012

EU/1/07/419/001-012

Cervarix

Iceland

12.10.2012

EU/1/07/419/001-012

Cervarix

Norway

12.10.2012

EU/1/07/419/001-012

Cervarix

Liechtenstein

31.10.2012

EU/1/07/420/001-002

Cyanokit

Iceland

14.8.2012

EU/1/07/420/001-002

Cyanokit

Norway

17.8.2012

EU/1/07/420/001-002

Cyanokit

Liechtenstein

31.8.2012

EU/1/07/421/001-009

Glubrava

Iceland

12.10.2012

EU/1/07/421/001-009

Glubrava

Norway

12.10.2012

EU/1/07/421/001-009

Glubrava

Liechtenstein

31.10.2012

EU/1/07/422/001-012

Tasigna

Norway

24.10.2012

EU/1/07/422/001-012

Tasigna

Liechtenstein

31.10.2012

EU/1/07/422/001-012

Tasigna

Iceland

6.12.2012

EU/1/07/424/001

Torisel

Iceland

12.10.2012

EU/1/07/424/001

Torisel

Norway

22.10.2012

EU/1/07/424/001

Torisel

Liechtenstein

31.10.2012

EU/1/07/425/001-018

Eucreas

Norway

31.7.2012

EU/1/07/425/001-018

Eucreas

Iceland

21.8.2012

EU/1/07/425/001-018

Eucreas

Liechtenstein

31.8.2012

EU/1/07/426/001-011

Olanzapine Neopharma

Iceland

17.10.2012

EU/1/07/426/001-011

Olanzapine Neopharma

Norway

24.10.2012

EU/1/07/426/001-011

Olanzapine Neopharma

Liechtenstein

31.10.2012

EU/1/07/427/001-057

Olanzapine Teva

Norway

6.12.2012

EU/1/07/427/001-057

Olanzapine Teva

Iceland

7.12.2012

EU/1/07/427/001-057

Olanzapine Teva

Liechtenstein

31.12.2012

EU/1/07/430/001-002

Atripla

Norway

26.9.2012

EU/1/07/430/001-002

Atripla

Iceland

12.10.2012

EU/1/07/431/001-025

Retacrit

Iceland

7.12.2012

EU/1/07/431/001-025

Retacrit

Norway

17.12.2012

EU/1/07/431/001-025

Retacrit

Liechtenstein

31.12.2012

EU/1/07/432/001-022

Silapo

Iceland

22.8.2012

EU/1/07/432/001-022

Silapo

Norway

24.8.2012

EU/1/07/432/001-022

Silapo

Liechtenstein

31.8.2012

EU/1/07/433/001

Nevanac

Norway

15.10.2012

EU/1/07/433/001

Nevanac

Liechtenstein

31.10.2012

EU/1/07/435/001-018

Tesavel

Iceland

15.10.2012

EU/1/07/435/001-018

Tesavel

Norway

15.10.2012

EU/1/07/437/001-004

IVEMEND

Iceland

7.12.2012

EU/1/07/437/003-004

IVEMEND

Norway

6.12.2012

EU/1/07/437/003-004

IVEMEND

Liechtenstein

31.12.2012

EU/1/07/438/001-006

Myfenax

Iceland

12.12.2012

EU/1/07/438/006

Myfenax

Norway

13.12.2012

EU/1/07/439/001-006

Mycophenolate mofetil Teva

Iceland

12.12.2012

EU/1/07/439/001-006

Mycophenolate mofetil Teva

Norway

17.12.2012

EU/1/08/468/001-002

INTELENCE

Iceland

16.8.2012

EU/1/08/468/001-002

INTELENCE

Norway

27.8.2012

EU/1/08/468/001-002

INTELENCE

Liechtenstein

31.8.2012

EU/1/11/710/001-007

Votubia

Norway

16.8.2012

EU/1/11/710/001-007

Votubia

Iceland

25.8.2012

EU/1/11/710/001-007

Votubia

Liechtenstein

31.8.2012

EU/1/97/047/004-007

BeneFIX

Iceland

16.8.2012

EU/1/97/047/004-007

BeneFIX

Norway

24.8.2012

EU/1/97/047/004-007

BeneFIX

Liechtenstein

31.8.2012

EU/2/02/032/001-002

Vaxxitek HVT + IBD

Iceland

23.7.2012

EU/2/02/032/001-002

Vaxxitek HVT + IBD

Liechtenstein

31.8.2012

EU/2/02/034/001

Nobivac Bb

Iceland

18.9.2012

EU/2/02/034/001

Nobivac Bb

Norway

23.10.2012

EU/2/02/034/001

Nobivac Bb

Liechtenstein

31.10.2012

EU/2/07/072/001-004

Suprelorin

Norway

31.7.2012

EU/2/07/072/001-004

Suprelorin

Liechtenstein

31.8.2012

EU/2/07/074/001-006

Prilactone

Liechtenstein

31.8.2012

EU/2/07/077/001-005

Meloxivet

Iceland

6.12.2012

EU/2/07/077/001-005

Meloxivet

Liechtenstein

31.10.2012

---

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 2012:

| EU-Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/01/200/003-009 | Viread | Iceland | 18.12.2012 |
| EU/1/04/274/001-002 | Velcade | Norway | 18.10.2012 |
| EU/1/04/306/002-003 | Aloxi | Norway | 19.11.2012 |
| EU/1/06/368/169-174 | Insulin Human Winthrop | Liechtenstein | 31.8.2012 |
| EU/1/06/376/034, 036-039 | Irbesartan Zentiva | Liechtenstein | 31.10.2012 |
| EU/1/06/376/034, 036-039 | Irbesartan Zentiva | Norway | 30.8.2012 |
| EU/1/06/377/029-034 | Irbesartan HCT Zentiva | Liechtenstein | 31.8.2012 |
| EU/1/06/377/029-034 | Irbesartan HCT Zentiva | Norway | 12.11.2012 |
| EU/1/06/380/006 | Prezista | Iceland | 14.11.2012 |
| EU/1/06/380/006 | Prezista | Norway | 24.10.2012 |
| EU/1/07/389/004-009 | Orencia | Liechtenstein | 31.10.2012 |
| EU/1/07/389/004-009 | Orencia | Norway | 13.11.2012 |
| EU/1/07/389/004-009 | Orencia | Iceland | 19.10.2012 |
| EU/1/07/391/005-006 | Revlimid | Norway | 25.9.2012 |
| EU/1/07/391/005-006 | Revlimid | Iceland | 11.10.2012 |
| EU/1/07/440/007 | Tyverb | Liechtenstein | 31.8.2012 |
| EU/1/07/440/007 | Tyverb | Norway | 31.7.2012 |
| EU/1/09/514/021-023 | Zebinix | Liechtenstein | 31.8.2012 |
| EU/1/09/514/021-023 | Zebinix | Iceland | 3.9.2012 |
| EU/1/09/514/021-023 | Zebinix | Norway | 25.9.2012 |
| EU/1/10/616/025-036 | Temozolomide HEXAL | Liechtenstein | 31.8.2012 |
| EU/1/10/617/025-036 | Temozolomide Sandoz | Liechtenstein | 31.8.2012 |
| EU/1/11/691/006-013 | Eliquis | Iceland | 11.12.2012 |
| EU/1/11/691/006-013 | Eliquis | Norway | 19.12.2012 |
| EU/1/11/712/029-040 | Levetiracetam Accord | Liechtenstein | 31.10.2012 |
| EU/1/11/731/013-014 | Komboglyze | Liechtenstein | 31.10.2012 |
| EU/1/11/731/013-014 | Komboglyze | Norway | 24.9.2012 |
| EU/1/11/734/012-018 | Edarbi | Liechtenstein | 31.8.2012 |
| EU/1/11/735/012-018 | Ipreziv | Liechtenstein | 31.8.2012 |
| EU/1/12/752/002 | Vepacel | Liechtenstein | 31.10.2012 |
| EU/1/12/765/007-009 | Sabervel | Liechtenstein | 31.12.2012 |
| EU/1/97/030/196-201 | Insuman | Liechtenstein | 31.8.2012 |
| EU/1/97/047/008 | BeneFIX | Liechtenstein | 31.8.2012 |
| EU/1/97/047/008 | BeneFIX | Iceland | 4.9.2012 |
| EU/1/97/047/008 | BeneFIX | Norway | 10.10.2012 |
| EU/2/02/033/003-004 | Dexdomitor | Iceland | 13.9.2012 |
| EU/2/02/033/003-004 | Dexdomitor | Norway | 30.8.2012 |
| EU/2/02/033/003-004 | Dexdomitor | Liechtenstein | 31.10.2012 |
| EU/2/07/074/007-009 | Prilactone | Liechtenstein | 31.12.2012 |
| EU/2/07/078/018-020 | Rheumocam | Norway | 6.12.2012 |
| EU/2/07/078/018-020 | Rheumocam | Liechtenstein | 31.12.2012 |
| EU/2/08/090/028 | Loxicom | Liechtenstein | 31.12.2012 |
| EU/2/10/118/015-021 | Activyl | Liechtenstein | 31.8.2012 |
| EU/2/11/134/015-017 | Inflacam | Iceland | 5.9.2012 |
| EU/2/11/134/015-017 | Inflacam | Norway | 1.11.2012 |
| EU/2/11/134/015-017 | Inflacam | Liechtenstein | 31.8.2012 |
| EU/2/11/134/018-020 | Inflacam | Iceland | 6.12.2012 |
| EU/2/11/134/018-020 | Inflacam | Liechtenstein | 31.12.2012 |
| EU/2/99/015/003-004 | Oxyglobin | Liechtenstein | 31.12.2012 |

EU-Number

Product

Country

Date of authorisation

EU/1/01/200/003-009

Viread

Iceland

18.12.2012

EU/1/04/274/001-002

Velcade

Norway

18.10.2012

EU/1/04/306/002-003

Aloxi

Norway

19.11.2012

EU/1/06/368/169-174

Insulin Human Winthrop

Liechtenstein

31.8.2012

EU/1/06/376/034, 036-039

Irbesartan Zentiva

Liechtenstein

31.10.2012

EU/1/06/376/034, 036-039

Irbesartan Zentiva

Norway

30.8.2012

EU/1/06/377/029-034

Irbesartan HCT Zentiva

Liechtenstein

31.8.2012

EU/1/06/377/029-034

Irbesartan HCT Zentiva

Norway

12.11.2012

EU/1/06/380/006

Prezista

Iceland

14.11.2012

EU/1/06/380/006

Prezista

Norway

24.10.2012

EU/1/07/389/004-009

Orencia

Liechtenstein

31.10.2012

EU/1/07/389/004-009

Orencia

Norway

13.11.2012

EU/1/07/389/004-009

Orencia

Iceland

19.10.2012

EU/1/07/391/005-006

Revlimid

Norway

25.9.2012

EU/1/07/391/005-006

Revlimid

Iceland

11.10.2012

EU/1/07/440/007

Tyverb

Liechtenstein

31.8.2012

EU/1/07/440/007

Tyverb

Norway

31.7.2012

EU/1/09/514/021-023

Zebinix

Liechtenstein

31.8.2012

EU/1/09/514/021-023

Zebinix

Iceland

3.9.2012

EU/1/09/514/021-023

Zebinix

Norway

25.9.2012

EU/1/10/616/025-036

Temozolomide HEXAL

Liechtenstein

31.8.2012

EU/1/10/617/025-036

Temozolomide Sandoz

Liechtenstein

31.8.2012

EU/1/11/691/006-013

Eliquis

Iceland

11.12.2012

EU/1/11/691/006-013

Eliquis

Norway

19.12.2012

EU/1/11/712/029-040

Levetiracetam Accord

Liechtenstein

31.10.2012

EU/1/11/731/013-014

Komboglyze

Liechtenstein

31.10.2012

EU/1/11/731/013-014

Komboglyze

Norway

24.9.2012

EU/1/11/734/012-018

Edarbi

Liechtenstein

31.8.2012

EU/1/11/735/012-018

Ipreziv

Liechtenstein

31.8.2012

EU/1/12/752/002

Vepacel

Liechtenstein

31.10.2012

EU/1/12/765/007-009

Sabervel

Liechtenstein

31.12.2012

EU/1/97/030/196-201

Insuman

Liechtenstein

31.8.2012

EU/1/97/047/008

BeneFIX

Liechtenstein

31.8.2012

EU/1/97/047/008

BeneFIX

Iceland

4.9.2012

EU/1/97/047/008

BeneFIX

Norway

10.10.2012

EU/2/02/033/003-004

Dexdomitor

Iceland

13.9.2012

EU/2/02/033/003-004

Dexdomitor

Norway

30.8.2012

EU/2/02/033/003-004

Dexdomitor

Liechtenstein

31.10.2012

EU/2/07/074/007-009

Prilactone

Liechtenstein

31.12.2012

EU/2/07/078/018-020

Rheumocam

Norway

6.12.2012

EU/2/07/078/018-020

Rheumocam

Liechtenstein

31.12.2012

EU/2/08/090/028

Loxicom

Liechtenstein

31.12.2012

EU/2/10/118/015-021

Activyl

Liechtenstein

31.8.2012

EU/2/11/134/015-017

Inflacam

Iceland

5.9.2012

EU/2/11/134/015-017

Inflacam

Norway

1.11.2012

EU/2/11/134/015-017

Inflacam

Liechtenstein

31.8.2012

EU/2/11/134/018-020

Inflacam

Iceland

6.12.2012

EU/2/11/134/018-020

Inflacam

Liechtenstein

31.12.2012

EU/2/99/015/003-004

Oxyglobin

Liechtenstein

31.12.2012

---

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 2012:

| EU-Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/00/147/001-012 | Hexavac | Iceland | 23.7.2012 |
| EU/1/00/147/001-012 | Hexavac | Liechtenstein | 31.8.2012 |
| EU/1/01/193/001-002 | MabCampath | Norway | 8.8.2012 |
| EU/1/01/193/001-002 | MabCampath | Iceland | 30.8.2012 |
| EU/1/01/193/001-002 | MabCampath | Liechtenstein | 31.8.2012 |
| EU/1/02/205/005-006 | Lumigan | Liechtenstein | 31.12.2012 |
| EU/1/02/209/001-004 | Dynastat | Norway | 18.7.2012 |
| EU/1/04/281/001-002, 004 | Erbitux | Norway | 30.8.2012 |
| EU/1/07/407/001-040 | Sprimeo | Iceland | 23.7.2012 |
| EU/1/07/407/001-040 | Sprimeo | Norway | 4.7.2012 |
| EU/1/07/407/001-040 | Sprimeo | Liechtenstein | 31.8.2012 |
| EU/1/09/513/001-020 | Rivastigmine Teva | Norway | 10.9.2012 |
| EU/1/09/513/001-020 | Rivastigmine Teva | Iceland | 20.9.2012 |
| EU/1/09/513/001-020 | Rivastigmine Teva | Liechtenstein | 31.10.2012 |
| EU/1/09/520/001-020 | Exalief | Iceland | 6.12.2012 |
| EU/1/09/520/001-020 | Exalief | Norway | 30.7.2012 |
| EU/1/09/570/001-060 | Imprida HCT | Iceland | 7.12.2012 |
| EU/1/09/576/040 | Irbesartan Teva | Liechtenstein | 31.12.2012 |
| EU/1/09/582/001 | Rilonacept Regeneron | Iceland | 14.11.2012 |
| EU/1/09/582/001 | Rilonacept Regeneron | Norway | 24.10.2012 |
| EU/1/10/634/005-011 | Ribavirin Mylan | Liechtenstein | 31.12.2012 |
| EU/1/11/638/001-080 | Sprimeo HCT | Liechtenstein | 31.8.2012 |
| EU/1/11/669/005 | Teysuno | Liechtenstein | 31.12.2012 |
| EU/1/11/679/007 | Pravafenix | Liechtenstein | 31.12.2012 |
| EU/1/11/680/001-080 | Riprazo HCT | Norway | 30.8.2012 |
| EU/1/11/680/001-080 | Riprazo HCT | Iceland | 12.9.2012 |
| EU/1/11/683/001-080 | Sprimeo HCT | Norway | 6.7.2012 |
| EU/1/11/683/001-080 | Sprimeo HCT | Iceland | 23.7.2012 |
| EU/1/11/691/006-013 | Eliquis | Liechtenstein | 31.12.2012 |
| EU/1/11/697/013-024 | Temozolomide SUN | Liechtenstein | 31.12.2012 |
| EU/1/12/765/007-009 | Sabervel | Liechtenstein | 31.12.2012 |
| EU/1/12/776/017-023 | Fycompa | Liechtenstein | 31.12.2012 |
| EU/1/12/780/029-034 | Jentadueto | Liechtenstein | 31.12.2012 |
| EU/1/96/006/008-011 | NovoSeven | Liechtenstein | 31.12.2012 |
| EU/1/97/040/001-002 | Teslascan | Iceland | 14.9.2012 |
| EU/1/99/099/001-006 | Zerene | Norway | 23.8.2012 |
| EU/1/99/099/001-006 | Zerene | Iceland | 7.9.2012 |
| EU/1/99/099/001-006 | Zerene | Liechtenstein | 31.10.2012 |
| EU/1/99/101/001 | Regranex | Norway | 16.7.2012 |
| EU/1/99/101/001 | Regranex | Liechtenstein | 31.8.2012 |
| EU/1/99/101/001 | Regranex | Iceland | 14.8.2012 |
| EU/1/99/103/009 | Refacto AF | Liechtenstein | 31.12.2012 |

EU-Number

Product

Country

Date of authorisation

EU/1/00/147/001-012

Hexavac

Iceland

23.7.2012

EU/1/00/147/001-012

Hexavac

Liechtenstein

31.8.2012

EU/1/01/193/001-002

MabCampath

Norway

8.8.2012

EU/1/01/193/001-002

MabCampath

Iceland

30.8.2012

EU/1/01/193/001-002

MabCampath

Liechtenstein

31.8.2012

EU/1/02/205/005-006

Lumigan

Liechtenstein

31.12.2012

EU/1/02/209/001-004

Dynastat

Norway

18.7.2012

EU/1/04/281/001-002, 004

Erbitux

Norway

30.8.2012

EU/1/07/407/001-040

Sprimeo

Iceland

23.7.2012

EU/1/07/407/001-040

Sprimeo

Norway

4.7.2012

EU/1/07/407/001-040

Sprimeo

Liechtenstein

31.8.2012

EU/1/09/513/001-020

Rivastigmine Teva

Norway

10.9.2012

EU/1/09/513/001-020

Rivastigmine Teva

Iceland

20.9.2012

EU/1/09/513/001-020

Rivastigmine Teva

Liechtenstein

31.10.2012

EU/1/09/520/001-020

Exalief

Iceland

6.12.2012

EU/1/09/520/001-020

Exalief

Norway

30.7.2012

EU/1/09/570/001-060

Imprida HCT

Iceland

7.12.2012

EU/1/09/576/040

Irbesartan Teva

Liechtenstein

31.12.2012

EU/1/09/582/001

Rilonacept Regeneron

Iceland

14.11.2012

EU/1/09/582/001

Rilonacept Regeneron

Norway

24.10.2012

EU/1/10/634/005-011

Ribavirin Mylan

Liechtenstein

31.12.2012

EU/1/11/638/001-080

Sprimeo HCT

Liechtenstein

31.8.2012

EU/1/11/669/005

Teysuno

Liechtenstein

31.12.2012

EU/1/11/679/007

Pravafenix

Liechtenstein

31.12.2012

EU/1/11/680/001-080

Riprazo HCT

Norway

30.8.2012

EU/1/11/680/001-080

Riprazo HCT

Iceland

12.9.2012

EU/1/11/683/001-080

Sprimeo HCT

Norway

6.7.2012

EU/1/11/683/001-080

Sprimeo HCT

Iceland

23.7.2012

EU/1/11/691/006-013

Eliquis

Liechtenstein

31.12.2012

EU/1/11/697/013-024

Temozolomide SUN

Liechtenstein

31.12.2012

EU/1/12/765/007-009

Sabervel

Liechtenstein

31.12.2012

EU/1/12/776/017-023

Fycompa

Liechtenstein

31.12.2012

EU/1/12/780/029-034

Jentadueto

Liechtenstein

31.12.2012

EU/1/96/006/008-011

NovoSeven

Liechtenstein

31.12.2012

EU/1/97/040/001-002

Teslascan

Iceland

14.9.2012

EU/1/99/099/001-006

Zerene

Norway

23.8.2012

EU/1/99/099/001-006

Zerene

Iceland

7.9.2012

EU/1/99/099/001-006

Zerene

Liechtenstein

31.10.2012

EU/1/99/101/001

Regranex

Norway

16.7.2012

EU/1/99/101/001

Regranex

Liechtenstein

31.8.2012

EU/1/99/101/001

Regranex

Iceland

14.8.2012

EU/1/99/103/009

Refacto AF

Liechtenstein

31.12.2012

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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 2012:

| EU-Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/09/509/001-004 | Ribavirin Teva | Iceland | 14.12.2012 |
| EU/1/09/509/001-004 | Ribavirin Teva | Norway | 6.12.2012 |
| EU/1/09/527/001-016 | Ribavirin Teva Pharma BV | Iceland | 14.12.2012 |
| EU/1/09/527/001-016 | Ribavirin Teva Pharma BV | Norway | 6.12.2012 |

EU-Number

Product

Country

Date of authorisation

EU/1/09/509/001-004

Ribavirin Teva

Iceland

14.12.2012

EU/1/09/509/001-004

Ribavirin Teva

Norway

6.12.2012

EU/1/09/527/001-016

Ribavirin Teva Pharma BV

Iceland

14.12.2012

EU/1/09/527/001-016

Ribavirin Teva Pharma BV

Norway

6.12.2012

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