28.9.2006   

EN

Official Journal of the European Union

C 233/45


List of marketing authorisations granted by the EEA EFTA States for the second half of 2004

(2006/C 233/11)

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 July — 31 December 2004:

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List of withdrawn marketing authorisations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 July31 December 2004:

EU-Number

Product

Country

Date of authorisation

EU/1/00/134/022-029

Lantus

Liechtenstein

30.9.2004

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

Venvia

Norway

30.7.2004

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

Nyracta

Norway

30.7.2004

EU/1/00/143/004-006

Kogenate Bayer

Liechtenstein

30.9.2004

EU/1/01/178/001/NO

Targretin

Norway

13.7.2004

EU/1/01/184/033-044

Nespo

Liechtenstein

30.11.2004

EU/1/01/185/033-044

Aranesp

Liechtenstein

30.11.2004

EU/1/01/189/004-006

Replagal

Liechtenstein

30.9.2004

EU/1/01/191/005

Ketek

Liechtenstein

30.11.2004

EU/1/01/192/005

Levviax

Liechtenstein

30.11.2004

EU/1/01/193/002

MabCampath

Liechtenstein

30.11.2004

EU/1/02/206/009-017

Arixtra

Liechtenstein

30.11.2004

EU/1/02/207/009-017

Quixidar

Liechtenstein

30.11.2004

EU/1/02/221/009-010

Pegasys

Liechtenstein

30.11.2004

EU/1/03/258/007-012

Avandamet

Liechtenstein

30.9.2004

EU/1/03/270/001-002

Oxybutynin

Liechtenstein

31.7.2004

EU/1/03/270/001-002/IS

Oxybutynin Nicobrand transderm. patches, 3,9 mg/24hours

Iceland

28.7.2004

EU/1/04/276/001-005/IS

Abilify, tablets, 5 mg

Iceland

1.7.2004

EU/1/04/276/001-020

Abilify

Liechtenstein

31.7.2004

EU/1/04/276/006-010/IS

Abilify, tablets,10 mg

Iceland

1.7.2004

EU/1/04/276/011-015/IS

Abilify, tablets, 15 mg

Iceland

1.7.2004

EU/1/04/276/016-020/IS

Abilify, tablets, 30 mg

Iceland

1.7.2004

EU/1/04/277/001/IS

TachoSil, medicated sponge, 5,5 mg + 2,0 IU

Iceland

8.7.2004

EU/1/04/277/001/NO-004/NO

TachoSil

Norway

5.7.2004

EU/1/04/277/001-004

TachoSil

Liechtenstein

31.7.2004

EU/1/04/278/001-009

Levemir

Liechtenstein

31.7.2004

EU/1/04/279/001/NO-025/NO

Lyrica

Norway

4.8.2004

EU/1/04/279/001-005/IS

LYRICA, capsule, hard, 25 mg

Iceland

26.8.2004

EU/1/04/279/001-025

Lyrica

Liechtenstein

30.9.2004

EU/1/04/279/006-010/IS

LYRICA, capsule, hard, 50 mg

Iceland

26.8.2004

EU/1/04/279/011-013/IS

LYRICA, capsule, hard, 75 mg

Iceland

26.8.2004

EU/1/04/279/014-016/IS

LYRICA, capsule, hard, 150 mg

Iceland

26.8.2004

EU/1/04/279/017-019/IS

LYRICA, capsule, hard, 300 mg

Iceland

26.8.2004

EU/1/04/279/020-022/IS

LYRICA, capsule, hard, 100 mg

Iceland

26.8.2004

EU/1/04/279/023-025/IS

LYRICA, capsule, hard, 200 mg

Iceland

26.8.2004

EU/1/04/280/001/IS

Yentreve, gastro-resistant capsule, hard, 20 mg

Iceland

9.9.2004

EU/1/04/280/001/NO-006/NO

Yentreve

Norway

26.8.2004

EU/1/04/280/001-006

Yentreve

Liechtenstein

30.9.2004

EU/1/04/280/002-006/IS

Yentreve, gastro-resistant capsule, hard, 40 mg

Iceland

9.9.2004

EU/1/04/281/001

Erbitux

Liechtenstein

31.7.2004

EU/1/04/281/001/IS

Erbitux, solution for infusion, 2 mg/ml

Iceland

26.7.2004

EU/1/04/281/001/NO

Erbitux

Norway

9.7.2004

EU/1/04/282/001/NO-002/NO

Telzir

Norway

19.7.2004

EU/1/04/282/001-002

Telzir

Liechtenstein

30.9.2004

EU/1/04/282/001-002/IS

Telzir tablets and oral susp.

Iceland

10.8.2004

EU/1/04/283/001/IS

Ariclaim, gastro-resistant capsule, hard, 20 mg

Iceland

11.9.2004

EU/1/04/283/001/NO-006/NO

Ariclaim

Norway

27.8.2004

EU/1/04/283/001-006

Ariclaim

Liechtenstein

30.9.2004

EU/1/04/283/002-006/IS

Ariclaim, gastro-resistant capsule, hard, 40 mg

Iceland

11.9.2004

EU/1/04/284/001

Pedea

Liechtenstein

30.9.2004

EU/1/04/284/001/IS

Pedea, solution for injection, 5mg/ml

Iceland

12.8.2004

EU/1/04/284/001/NO

Pedea

Norway

18.8.2004

EU/1/04/285/001/NO-020/NO

Apidra

Norway

25.10.2004

EU/1/04/285/001-004/IS

Apidra, solution for injection,vial, 100 units/ml

Iceland

27.10.2004

EU/1/04/285/001-020

Apidra

Liechtenstein

30.11.2004

EU/1/04/285/005/012/IS

Apidra, solution for injection,cartridge, 100 units/ml

Iceland

27.10.2004

EU/1/04/285/013-020/IS

Apidra, solution for injection, pre-filled pen, 100 units/ml

Iceland

27.10.2004

EU/1/04/286/001/IS

Wilzin, capsule, hard, 25 mg

Iceland

11.11.2004

EU/1/04/286/001/NO-002/NO

Wilzin

Norway

12.11.2004

EU/1/04/286/001-002

Wilzin

Liechtenstein

30.11.2004

EU/1/04/286/002/IS

Wilzin, capsule, hard, 50 mg

Iceland

11.11.2004

EU/1/04/287/001/NO-006/NO

Osseor

Norway

18.10.2004

EU/1/04/287/001-006

Osseor

Liechtenstein

30.11.2004

EU/1/04/287/001-006/IS

Osseor, powder for oral suspension, 2g

Iceland

 27.10.2004

EU/1/04/288/001/NO-006/NO

Protelos

Norway

18.10.2004

EU/1/04/288/001-006

Protelos

Liechtenstein

30.11.2004

EU/1/04/288/001-006/IS

Protelos, powder for oral suspension, 2g

Iceland

20.10.2004

EU/1/04/289/001

Angiox

Liechtenstein

30.9.2004

EU/1/04/289/001/NO

Angiox

Norway

8.10.2004

EU/1/04/290/001

Alimta

Liechtenstein

30.9.2004

EU/1/04/290/001/IS

Alimta, concentrate for solution for infusion, 500 mg

Iceland

19.10.2004

EU/1/04/290/001/NO

Alimta, concentrate for solution for infusion, 500 mg

Norway

19.10.2004

EU/1/04/291/001/NO-002/NO

Raptiva

Norway

30.9.2004

EU/1/04/291/001-001/IS

Raptiva 100 mg/ml Powder and solvent for solution for injection

Iceland

18.10.2004

EU/1/04/291/001-002

Raptiva

Liechtenstein

30.9.2004

EU/1/04/292/001/NO-012/NO

Mimpara

Norway

11.11.2004

EU/1/04/292/001-004/IS

Mimpara, film-coated tablet, 30 mg

Iceland

19.11.2004

EU/1/04/292/001-012

Mimpara

Liechtenstein

30.11.2004

EU/1/04/292/005-008/IS

Mimpara, film-coated tablet, 60 mg

Iceland

19.11.2004

EU/1/04/292/009-012/IS

Mimpara, film-coated tablet, 90 mg

Iceland

19.11.2004

EU/1/04/293/001/NO-012/NO

Parareg

Norway

11.11.2004

EU/1/04/293/001-004/IS

Parareg, film-coated tablet, 30 mg

Iceland

18.11.2004

EU/1/04/293/001-012

Parareg

Liechtenstein

30.11.2004

EU/1/04/293/005-008/IS

Parareg, film-coated tablet, 60 mg

Iceland

18.11.2004

EU/1/04/293/009-012/IS

Parareg, film-coated tablet, 90 mg

Iceland

18.11.2004

EU/1/04/294/001/NO-012/NO

Emselex

Norway

16.11.2004

EU/1/04/294/001-006/IS

Emselex 7,5 mg prolonged release tablets

Iceland

24.11.2004

EU/1/04/294/001-012

Emselex

Liechtenstein

30.11.2004

EU/1/04/294/007-012/IS

Emselex 15 mg prolonged release tablets

Iceland

24.11.2004

EU/1/04/295/001

Xagrid

Liechtenstein

30.11.2004

EU/1/04/295/001/IS

Xagrid, Capsules, hard, 0,5 mg

Iceland

29.12.2004

EU/1/04/295/001/NO

Xagrid

Norway

15.12.2004

EU/1/96/008/040-041

Puregon

Liechtenstein

30.9.2004

EU/1/96/013/001-004

Destara

Liechtenstein

31.7.2004

EU/1/96/022/019-022

Zyprexa

Liechtenstein

30.11.2004

EU/1/97/044/001-006

Tasmar

Liechtenstein

30.11.2004

EU/1/99/104/001/NO

Procomvax

Norway

17.9.2004

EU/2/04/043/001/NO

Equilis StrepE

Norway

13.9.2004

EU/2/04/044/001/IS

Aivlozin 42,5 mg/g premix for medicated feeding stuff for pigs

Iceland

22.9.2004

EU/2/04/044/001/NO

Aivlosin

Norway

8.10.2004

EU/2/04/045/001/NO-004/NO

Previcox

Norway

13.10.2004

EU/2/04/045/001-002/IS

Previcox, chewable tablet, 57 mg

Iceland

4.10.2004

EU/2/04/045/001-004

Previcox

Liechtenstein

30.9.2004

EU/2/04/045/003-004/IS

Previcox, chewable tablet, 227 mg

Iceland

4.10.2004

EU/2/04/046/001/NO-003/NO

Nobivac Piro

Norway

2.10.2004

EU/2/04/046/001-003

Nobivac Piro-606

Liechtenstein

30.9.2004

EU/2/96/001/009-010

Porcilis Porcoli

Liechtenstein

30.9.2004


ANNEX II

2.   Renewed Marketing Authorisations

The following marketing authorisations have been renewed in the EEA EFTA States during the period 1 July31 December 2004:

EU-Number

Product

Country

Date of renewal

EU/1/99/119/009/IS-011/IS

NovoRapid FlexPen, solution for injection, 100 units/ml

Iceland

11.11.2004

EU/1/99/097/001

Beromun

Liechtenstein

31.7.2004

EU/1/99/097/001/IS

Beromun, powder and solvent for solution for infusion, 1 mg

Iceland

9.8.2004

EU/1/99/100/001-002/IS

Cetrotide, powder for solution for injection, 0,25 mg

Iceland

15.9.2004

EU/1/99/100/001-003

Cetrotide

Liechtenstein

30.9.2004

EU/1/99/100/003/IS

Cetrotide, powder for solution for injection, 3 mg

Iceland

15.9.2004

EU/1/99/103/001/IS

Refacto, powder and solvent for sol. for injection, 250 a.e.

Iceland

19.8.2004

EU/1/99/103/001/NO-004/NO

ReFacto

Norway

16.8.2004

EU/1/99/103/001-004

ReFacto

Liechtenstein

30.9.2004

EU/1/99/103/002/IS

Refacto, powder and solvent for sol. for injection, 500 a.e.

Iceland

19.8.2004

EU/1/99/103/003/IS

Refacto, powder and solvent for sol. for injection, 1 000 a.e.

Iceland

19.8.2004

EU/1/99/103/004/IS

Refacto, powder and solvent for sol. for injection, 2 000 a.e.

Iceland

19.8.2004

EU/1/99/104/001

Procomvax

Liechtenstein

30.9.2004

EU/1/99/104/001/IS

Procomvax, suspension for injection

Iceland

2.9.2004

EU/1/99/107/001/IS

Rebetol, capsule, hard, 200 mg

Iceland

29.9.2004

EU/1/99/107/001/NO-003/NO

Rebetol

Norway

28.9.2004

EU/1/99/107/001-003

Rebetol

Liechtenstein

30.9.2004

EU/1/99/108/001

Ferriprox

Liechtenstein

30.9.2004

EU/1/99/108/001/IS

Ferriprox, film coated tablet, 500 mg

Iceland

22.9.2004

EU/1/99/108/001/NO

Ferriprox

Norway

27.9.2004

EU/1/99/109/001/IS

Integrilin, solution for infusion, 0,75 mg/ml

Iceland

1.10.2004

EU/1/99/109/001/NO-002/NO

Integrilin

Norway

28.9.2004

EU/1/99/109/001-002

Integrilin

Liechtenstein

30.9.2004

EU/1/99/109/002/IS

Integrilin, solution for injection, 2 mg/ml

Iceland

1.10.2004

EU/1/99/111/001-009

Stocrin

Liechtenstein

31.7.2004

EU/1/99/112/001/IS

Ziagen, film-coated tablet, 300 mg

Iceland

16.9.2004

EU/1/99/112/001/NO-002/NO

Ziagen

Norway

18.9.2004

EU/1/99/112/002/IS

Ziagen, oral liquid, 20 mg/ml

Iceland

16.9.2004

EU/1/99/113/001/NO-004/NO

Paxene

Norway

11.11.2004

EU/1/99/113/001-004

Paxene

Liechtenstein

30.11.2004

EU/1/99/113/001-004/IS

Paxene, concentrate foer solution for infusion, 6 mg/ml

Iceland

23.11.2004

EU/1/99/114/001/NO-003/NO

Zeffix

Norway

18.11.2004

EU/1/99/114/001-002/IS

Zeffix, film-coated tablet, 100 mg

Iceland

19.11.2004

EU/1/99/114/001-003

Zeffix

Liechtenstein

30.11.2004

EU/1/99/114/003/IS

Zeffix, oral solution, 5 mg/ml

Iceland

19.11.2004

EU/1/99/116/001/NO-003/NO

Remicade

Norway

11.10.2004

EU/1/99/116/001-003

Remicade

Liechtenstein

30.9.2004

EU/1/99/117/001/IS

Synagis, powder and solvent fol sol. for injection, 50 mg/hgl

Iceland

7.10.2004

EU/1/99/117/001/NO-002/NO

Synagis

Norway

8.10.2004

EU/1/99/117/001-002

Synagis

Liechtenstein

30.9.2004

EU/1/99/117/002/IS

Synagis, powder and solvent fol sol. for injection, 100 mg/hgl

Iceland

7.10.2004

EU/1/99/118/001/NO-010/NO

Arava

Norway

4.11.2004

EU/1/99/118/001-004/IS

Arava, tablet, 10 mg

Iceland

8.11.2004

EU/1/99/118/001-010

Arava

Liechtenstein

30.11.2004

EU/1/99/118/005-009/IS

Arava, tablet, 20 mg

Iceland

8.11.2004

EU/1/99/118/009/IS

Arava, tablet, 100 mg

Iceland

8.11.2004

EU/1/99/119/001

NovoRapid

Liechtenstein

30.11.2004

EU/1/99/119/001/IS and 008/IS

NovoRapid, solution for injection, 100 units/ml

Iceland

11.11.2004

EU/1/99/119/001/NO

EU/1/99/119/003/NO

EU/1/99/119/005/NO-014/NO

NovoRapid

Norway

4.11.2004

EU/1/99/119/003

NovoRapid

Liechtenstein

30.11.2004

EU/1/99/119/003/IS and 006/IS

NovoRapid Penfill, solution for injection, 100 units/ml

Iceland

11.11.2004

EU/1/99/119/005/IS and 007/IS

NovoRapid NovoLet, solution for injection, 100 units/ml

Iceland

11.11.2004

EU/1/99/119/005-014

NovoRapid

Liechtenstein

30.11.2004

EU/1/99/119/012-014/IS

NovoRapid InnoLet, solution for injection, 100 units/ml

Iceland

11.11.2004

EU/1/99/125/001/NO-008/NO

Zyprexa Velotab

Norway

4.12.2004

EU/1/99/125/001-004/IS

Zyprexa Velotab, orodispersible tablet

Iceland

1.12.2004

EU/2/98/009/001-006/IS

Suvaxyn Aujezky 738+O/W, emulsion for injection,

Iceland

6.8.2004

EU/2/99/013/001/NO-002/NO

Halocur

Norway

21.12.2004


ANNEX III

3.   Extended Marketing Authorisations

The following marketing authorisations have been extended in the EEA EFTA States during the period 1 July31 December 2004:

EU-Number

Product

Country

Date of extention

EU/03/258/007-009/IS

Avandamet 2 mg/1 000 mg, film-coated tablets

Iceland

20.10.2004

EU/03/258/010-012/IS

Avandamet 4 mg/1 000 mg, film-coated tablets

Iceland

20.10.2004

EU/1/00/143/004/IS

KOGENATE Bayer 250 IU Powder and solvent for solution for injection

Iceland

23.10.2004

EU/1/00/143/004/NO-006/NO

Kogenate

Norway

21.10.2004

EU/1/00/143/005/IS

KOGENATE Bayer 500 IU Powder and solvent for solution for injection

Iceland

23.10.2004

EU/1/00/143/006/IS

KOGENATE Bayer 1 000 IU Powder and solvent for solution for injection

Iceland

23.10.2004

EU/1/01/193/002/IS

MabCampath, conc. for sol. for inf. 30 mg/ml

Iceland

26.11.2004

EU/1/02/206/009/NO-017/NO

Arixtra

Norway

8.12.2004

EU/1/02/207/009/NO-017/NO

Quixidar

Norway

8.12.2004

EU/1/03/258/007/NO-012/NO

Avandamet

Norway

24.9.2004

EU/1/97/046/016-030/IS

Aprovel 75, 150 and 300 mg film-coated tablets

Iceland

25.8.2004

EU/1/97/049/016-030/IS

Karvea 75, 150 and 300 mg film-coated tablets

Iceland

25.8.2004

EU/1/98/085/011-020/IS

Karvezide, 150 mg/12,5 mg and 300 mg/12,5 mg film-coated tablets

Iceland

25.8.2004

EU/1/98/086/011-020/IS

CoAprovel 150 mg/12,5 mg and 300 mg/12,5 mg film-coated tablets

Iceland

25.8.2004


ANNEX IV

4.   Withdrawn Marketing Authorisations

The following marketing authorisations have been withdrawn in the EEA EFTA States during the period 1 July31 December 2004:

EU-Number

Product

Country

Date of withdrawal

EU/1/01/181/001-007

Ixense

Liechtenstein

30.11.2004

EU/1/01/181/001-007/IS

Ixense

Iceland

8.11.2004

EU/1/01/182/001/NO-010/NO

Taluvian

Norway

10.8.2004

EU/1/01/182/001-010

Taluvian

Liechtenstein

30.9.2004

EU/1/01/182/001-010/IS

Taluvian

Iceland

26.10.2004