28.9.2006   

EN

Official Journal of the European Union

C 233/54


List of marketing authorisations granted by the EEA EFTA States for the first half of 2005

(2006/C 233/12)

With reference to EEA Joint Committee Decision No. 74/1999 of 28 May 1999, the EEA Joint Committee is invited to note, at the meeting on 10 March 2006, the following lists concerning marketing authorisations for medicinal products for the period 1 January — 30 June 2005:

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List of withdrawn marketing authorisations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 I

1.   New Marketing Authorisations:

The following marketing authorisations have been granted In the EEA EFTA States during the period 1 January — 30 June 2005:

EU-Number

Product

Country

Date of authorisation

EU/1/00/146/028-029

Keppra

Liechtenstein

31.3.2005

EU/1/00/149/001/NO

Panretin

Norway

28.2.2005

EU/1/01/171/011-012

Rapamune

Liechtenstein

31.3.2005

EU/1/01/178/001/IS

Targretin 75 mg, capsule, soft

Iceland

31.1.2005

EU/1/01/183/019

HBVAXPRO

Liechtenstein

31.5.2005

EU/1/01/184/045-056

Nespo

Liechtenstein

31.3.2005

EU/1/01/185/045-056

Aranesp

Liechtenstein

31.3.2005

EU/1/01/198/011-013

Glivec

Liechtenstein

31.1.2005

EU/1/02/227/002

Neulasta

Liechtenstein

31.3.2005

EU/1/02/228/002

Neupopeg

Liechtenstein

31.3.2005

EU/1/02/237/005

Cialis

Liechtenstein

31.1.2005

EU/1/02/239/025-030

Bextra

Liechtenstein

31.1.2005

EU/1/02/246/003

Carbaglu

Liechtenstein

31.5.2005

EU/1/04/285/021-028

Apidra

Liechtenstein

31.5.2005

EU/1/04/296/001/IS

Cymbalta 30 mg, Gastro-resistant capsule, hard

Iceland

14.1.2005

EU/1/04/296/001/NO-004/NO

Cymbalta

Norway

11.1.2005

EU/1/04/296/001-004

Cymbalta

Liechtenstein

31.1.2005

EU/1/04/296/002-005/IS

Cymbalta 60 mg, Gastro-resistant capsule, hard

Iceland

14.1.2005

EU/1/04/297/001/IS

Xeristar 30 mg, Gastro-resistant tablet hard

Iceland

14.1.2005

EU/1/04/297/001/NO-004/NO

Xeristar

Norway

11.1.2005

EU/1/04/297/001-004

Xeristar

Liechtenstein

31.1.2005

EU/1/04/297/002-005/IS

Xeristar 60 mg, Gastro-resistant tablet hard

Iceland

14.1.2005

EU/1/04/298/001/NO-002/NO

Kivexa

Norway

11.1.2005

EU/1/04/298/001-002

Kivexa

Liechtenstein

31.1.2005

EU/1/04/298/001-002/IS

Kivexa 600 mg, film-coated tablet

Iceland

11.1.2005

EU/1/04/299/001/NO-003/NO

Fendrix

Norway

15.2.2005

EU/1/04/299/001-003

Fendrix

Liechtenstein

31.3.2005

EU/1/04/299/001-003/IS

Fendrix 20 microg/0,5 ml, suspension for injection

Iceland

25.2.2005

EU/1/04/300/001/NO-002/NO

Avastin

Norway

18.1.2005

EU/1/04/300/001-002

Avastin

Liechtenstein

31.1.2005

EU/1/04/300/001-002/IS

Avastin 25 mg/ml, concentrate for sol. For infusion

Iceland

11.2.2005

EU/1/04/301/001/NO-005/NO

Quintanrix

Norway

1.3.2005

EU/1/04/301/001-005

Quintanrix

Liechtenstein

31.3.2005

EU/1/04/301/001-005/IS

Quintanrix, powder and solvent for susp. for injection

Iceland

14.3.2005

EU/1/04/302/001/NO-003/NO

Prialt

Norway

17.3.2005

EU/1/04/302/001-003

Prialt

Liechtenstein

31.3.2005

EU/1/04/302/001-003/IS

Prialt, solution for injection

Iceland

18.3.2005

EU/1/04/303/001/IS

Orfadin 2 mg, capsule, hard

Iceland

19.3.2005

EU/1/04/303/003/IS

Orfadin 10 mg, capsule, hard

Iceland

19.3.2005

EU/1/04/303/001/NO-003/NO

Orfadin

Norway

17.3.2005

EU/1/04/303/001-003

Orfadin

Liechtenstein

31.3.2005

EU/1/04/303/002/IS

Orfadin 5 mg, capsule, hard

Iceland

19.3.2005

EU/1/04/304/001/NO-007/NO

Azilect

Norway

21.3.2005

EU/1/04/304/001-007

Azilect

Liechtenstein

31.3.2005

EU/1/04/304/001-007/IS

Azilect 1 mg, tablet

Iceland

17.3.2005

EU/1/04/305/001

Truvada

Liechtenstein

31.3.2005

EU/1/04/305/001/IS

Truvada 245/200 mg, film-coated tablet

Iceland

16.3.2005

EU/1/04/305/001/NO

Truvada

Norway

7.3.2005

EU/1/04/306/001

Aloxi

Liechtenstein

31.5.2005

EU/1/04/306/001/IS

Aloxi 0,25 mg/5 ml, solution for injection

Iceland

7.4.2005

EU/1/04/306/001/NO

Aloxi

Norway

20.4.2005

EU/1/04/307/001/NO-004/NO

Zonegran

Norway

9.4.2005

EU/1/04/307/001-004

Zonegran

Liechtenstein

31.5.2005

EU/1/04/307/003/IS

Zonegran 25 mg, capsule, hard

Iceland

6.4.2005

EU/1/04/307/003/IS

Zonegran 50 mg, capsule, hard

Iceland

6.4.2005

EU/1/05/308/001

Aclasta

Liechtenstein

31.5.2005

EU/1/05/308/001/IS

Aclasta 5 mg/ml, solution for infusion

Iceland

9.5.2005

EU/1/05/308/001/NO

Aclasta

Norway

10.5.2005

EU/1/97/044/001-006/IS

Tasmar

Iceland

18.1.2005

EU/1/97/045/004

Helicobacter Test INFAI

Liechtenstein

31.3.2005

EU/1/99/107/004

Rebetol

Liechtenstein

31.3.2005

EU/1/99/120/001/NO-004/NO

Ammonaps

Norway

21.4.2005

EU/1/99/123/011

Renagel

Liechtenstein

31.3.2005

EU/1/99/125/005-008

Zyprexa Velotab

Liechtenstein

31.3.2005

EU/1/99/126/004-005

Enbrel

Liechtenstein

31.3.2005

EU/1/99/126/006-011

Enbrel

Liechtenstein

31.5.2005

EU/2/00/019/005-007

Eurifel FeLV

Liechtenstein

31.5.2005

EU/2/03/037/001-004/IS

ProteqFlu, powder and solvent for susp. for inj.

Iceland

9.5.2005

EU/2/03/038/001-004/IS

ProteqFlu-Te, powder and solvent for susp. for inj.

Iceland

18.2.2005

EU/2/04/046/001-003/IS

Nobivac Piro, suspension for injection

Iceland

12.5.2005

EU/2/04/047/001/NO-002/NO

Purevax RCPCh FeLV

Norway

21.3.2005

EU/2/04/047/001-002

Purevax RCPCh FeLV

Liechtenstein

31.3.2005

EU/2/04/047/001-002/IS

Purevax RCPCh Fel V

Iceland

30.6.2005

EU/2/04/048/001/NO-002/NO

Purevax RCP FeLV

Norway

21.3.2005

EU/2/04/048/001-002

Purevax RCP FeLV

Liechtenstein

31.3.2005

EU/2/04/048/001-002/IS

Purevax RCP FeL V

Iceland

30.6.2005

EU/2/04/049/001/NO-002/NO

Purevax RCCh

Norway

21.3.2005

EU/2/04/049/001-002

Purevax RCCh

Liechtenstein

31.3.2005

EU/2/04/050/001/NO-002/NO

Purevax RCPCh

Norway

21.3.2005

EU/2/04/050/001-002

Purevax RCPCh

Liechtenstein

31.3.2005

EU/2/04/051/001/NO-002/NO

Purevax RC

Norway

21.3.2005

EU/2/04/051/001-002

Purevax RC

Liechtenstein

31.3.2005

EU/2/04/051/001-002/IS

Purevax RC, powder and solvent for susp. for inj.

Iceland

30.6.2005

EU/2/04/052/001/NO-002/NO

Purevax RCP

Norway

21.3.2005

EU/2/04/052/001-002

Purevax RCP

Liechtenstein

31.3.2005

EU/2/04/052/001-002/IS

Purevax RCP, powder and solvent for susp. for injection

Iceland

30.6.2005

EU/2/04/49/001-002/IS

Purevax RCCh, powder and solvent for susp. for inj.

Iceland

30.6.2005

EU/2/04/50/001-002/IS

Purevax RCPCh, powder and solvent for susp. for inj.

Iceland

30.6.2005

EU/2/05/053/001/IS

Naxel 100 mg/ml, suspension for injection

Iceland

9.6.2005

EU/2/05/053/001/NO

Naxcel

Norway

17.6.2005

EU/2/99/014/012

Stronghold

Liechtenstein

31.1.2005

EU/2/99/015/001/NO

Oxyglobin

Norway

5.1.2005

EU/2/99/017/001-006/IS

Ibraxion, emulsion for injection

Iceland

10.5.2005


ANNEX II

2.   Renewed Marketing Authorisations

The following marketing authorisations have been renewed in the EEA EFTA States during the period 1 January — 30 June 2005:

EU-Number

Product

Country

Date of renewal

EU/1/00/129/001/NO-003/NO

Azopt

Norway

30.6.2005

EU/1/00/129/001-003/IS

Azopt, eye drops, suspension, 1%

Iceland

30.6.2005

EU/1/00/130/001/NO-002/NO

Orgalutran

Norway

4.4.2005

EU/1/00/130/001-002

Orgalutran

Liechtenstein

31.3.2005

EU/1/00/130/001-002/IS

Orgalutran

Iceland

18.4.2005

EU/1/00/131/001/NO-050/NO

PegIntron

Norway

24.6.2005

EU/1/00/131/001-050/IS

PegIntron

Iceland

28.6.2005

EU/1/00/132/001/NO-050/NO

ViraferonPeg

Norway

24.6.2005

EU/1/00/132/001-050/IS

ViraferonPeg

Iceland

28.6.2005

EU/1/99/100/001/NO-003/NO

Cetrotide

Norway

4.1.2005

EU/1/99/120/001-002/IS

Ammonaps, tablets, 500 mg

Iceland

29.4.2005

EU/1/99/120/003-004/IS

Ammonaps 940 mg/g, granules

Iceland

29.4.2005

EU/1/99/122/001/NO-002/NO

Thyrogen

Norway

15.4.2005

EU/1/99/122/001-002/IS

Thyrogen, powder for solution for injection, 0,9 mg

Iceland

14.4.2005

EU/1/99/123/001/NO-011/NO

Renagel

Norway

4.2.2005

EU/1/99/123/001-004/IS

Renagel, capsule, hard, 403 mg

Iceland

25.2.2005

EU/1/99/123/001-010

Renagel

Liechtenstein

31.3.2005

EU/1/99/123/005-007/IS

Renagel, film-coated tablet, 400 mg

Iceland

25.2.2005

EU/1/99/123/008-011/IS

Renagel, film-coated tablet, 800 mg

Iceland

25.2.2005

EU/1/99/124/001/IS

Tractocile, solution for injection, 7,5 mg/ml

Iceland

1.3.2005

EU/1/99/124/001/NO-002/NO

Tractocile

Norway

7.3.2005

EU/1/99/124/001-002

Tractocile

Liechtenstein

31.3.2005

EU/1/99/124/002/IS

Tractocile, concentrate for solution for infusion, 7,5 mg/ml

Iceland

1.3.2005

EU/1/99/125/001-004

Zyprexa Velotab

Liechtenstein

31.3.2005

EU/1/99/126/001/NO-005/NO

Enbrel

Norway

6.4.2005

EU/1/99/126/001-003

Enbrel

Liechtenstein

31.3.2005

EU/1/99/126/001-005/IS

Enbrel

Iceland

15.4.2005

EU/1/99/127/001/NO-044/NO

IntronA

Norway

20.6.2005

EU/1/99/127/001-044/IS

IntronA

Iceland

27.6.2005

EU/1/99/128/001/NO-037/NO

Viraferon

Norway

20.6.2005

EU/1/99/128/001-037/IS

Viraferon

Iceland

27.6.2005

EU/2/00/018/001/IS

Incurin, tablet, 1mg

Iceland

10.5.2005

EU/2/00/018/001/NO

Incurin

Norway

16.6.2005

EU/2/00/019/001/NO-003/NO

Eurifel FeLV

Norway

31.5.2005

EU/2/00/019/001-003

Eurifel FeLV

Liechtenstein

31.5.2005

EU/2/00/021/001/NO-002/NO

Rabigen

Norway

23.5.2005

EU/2/00/021/001-002/IS

RABIGEN SAG2, oral suspension

Iceland

9.5.2005

EU/2/99/013/001-002

Halocur

Liechtenstein

31.1.2005

EU/2/99/013/001-002/IS

Halocur 0.5 mg/ml, oral solution

Iceland

18.2.2005

EU/2/99/014/001/NO-012/NO

Stronghold

Norway

6.1.2005

EU/2/99/014/001-011

Stronghold

Liechtenstein

31.1.2005

EU/2/99/014/001-012/IS

Stronghold spot on solution 6% and 12%

Iceland

7.1.2005

EU/2/99/015/001

Oxyglobin

Liechtenstein

31.1.2005

EU/2/99/015/001/IS

Oxyglobin 13g/dl, solution for infusion

Iceland

5.1.2005

EU/2/99/017/001/NO-006/NO

Ibraxion

Norway

2.6.2005

EU/2/99/017/001-006

Ibraxion

Liechtenstein

31.5.2005


ANNEX IV

4.   Withdrawn Marketing Authorisations

The following marketing authorisations have been withdrawn in EEA EFTA States during the period 1 January — 31 June 2005:

EU-Number

Product

Country

Date of extention

EU/1/01/171/011/NO-012/NO

Rapamune

Norway

2.2.2005

EU/1/01/171/011-012/IS

Rapamune 5 mg filmcoated tablets

Iceland

1.3.2005

EU/1/02/206/009-011/IS

Arixtra 5mg/0,4 ml solution for injection

Iceland

10.3.2005

EU/1/02/206/012-014/IS

Arixtra 7,5mg/0,6 ml solution for injection

Iceland

10.3.2005

EU/1/02/206/015-017/IS

Arixtra 10mg/0,8 ml solution for injection

Iceland

10.3.2005

EU/1/02/207/009-011/IS

Quixidar 5mg/0,4 ml solution for injection

Iceland

9.3.2005

EU/1/02/207/012-014/IS

Quixidar 7,5mg/0,6 ml solution for injection

Iceland

9.3.2005

EU/1/02/207/015-017/IS

Quixidar 10mg/0,8 ml solution for injection

Iceland

9.3.2005

EU/1/96/026/002/NO

Invirase

Norway

9.6.2005

EU/1/99/107/004/IS

Rebetol, oral solution 40 mg/ml

Iceland

22.3.2005

EU/1/99/107/004/NO

Rebetol

Norway

22.2.2005

EU/1/99/126/006/NO-011/NO

Enbrel

Norway

19.5.2005

EU/1/99/126/006-011/IS

Enbrel, 50 mg

Iceland

24.5.2005

EU/2/00/019/005/NO-007/NO

Eurifel FeLV

Norway

15.4.2005


ANNEX IV

4.   Withdrawn Marketing Authorisations

The following marketing authorisations have been withdrawn in EEA EFTA States during the period 1 January — 31 June 2005:

EU-Number

Product

Country

Date of withdrawal

EU/1/00/138/001/NO-012/NO

Venvia

Norway

4.1.2005

EU/1/00/138/001-012

Venvia

Liechtenstein

31.1.2005

EU/1/00/139/001/NO-012/NO

Nyracta

Norway

4.1.2005

EU/1/00/139/001-012

Nyracta

Liechtenstein

31.1.2005

EU/1/01/181/001/NO-007/NO

Ixense

Norway

6.1.2005

EU/1/97/048/001/NO-014/NO

Infanrix HepB

Norway

25.5.2005

EU/1/97/048/001-014

Infanrix HepB

Liechtenstein

31.5.2005

EU/1/97/048/001-014/IS

Infanrix HepB

Iceland

15.6.2005