6.11.2014   

EN

Official Journal of the European Union

C 391/3


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

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List of withdrawn marketing authorisations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

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


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


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


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


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