List of marketing authorisations granted by the EEA EFTA States for the second half of 2004
Date: 2006-09-28
Institutions: Standing Committee of the EFTA States
Subjects: EFTA countries, Iceland, Liechtenstein, Norway, market approval, medicinal product, withdrawal from the market

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 authorisa-
tions for medicinal products for the period 1 July — 31 December 2004:

Annex I

Annex II

Annex III

Annex IV

List of new marketing authorisations

List of renewed marketing authorisations

List of extended marketing authorisations

List of withdrawn marketing authorisations

C 233/46

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Official Journal of the European Union

28.9.2006

1. New Marketing Authorisations:

ANNEX I

The following marketing authorisations have been granted in the EEA EFTA States during the period 1 July —
31 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

EU/1/01/185/033-044

EU/1/01/189/004-006

EU/1/01/191/005

EU/1/01/192/005

Nespo

Aranesp

Replagal

Ketek

Levviax

Liechtenstein

30.11.2004

Liechtenstein

30.11.2004

Liechtenstein

30.9.2004

Liechtenstein

30.11.2004

Liechtenstein

30.11.2004

EU/1/01/193/002

MabCampath

Liechtenstein

30.11.2004

EU/1/02/206/009-017

EU/1/02/207/009-017

EU/1/02/221/009-010

Arixtra

Quixidar

Pegasys

Liechtenstein

30.11.2004

Liechtenstein

30.11.2004

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
patches, 3,9 mg/24hours

transderm.

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

28.9.2006

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Official Journal of the European Union

C 233/47

EU-Number

Product

Country

Date of
authorisation

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,
hard, 20 mg

gastro-resistant

capsule,

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,
hard, 40 mg

gastro-resistant

capsule,

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

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

EU/1/04/282/001-002

Erbitux

Telzir

Telzir

Norway

9.7.2004

Norway

19.7.2004

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,
hard, 20 mg

gastro-resistant

capsule,

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,
hard, 40 mg

gastro-resistant

capsule,

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

C 233/48

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Official Journal of the European Union

28.9.2006

EU-Number

Product

Country

Date of
authorisation

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,
filled pen, 100 units/ml

solution for

injection, pre-

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

EU/1/04/286/001-002

Wilzin

Wilzin

Norway

12.11.2004

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

EU/1/04/287/001-006

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

Osseor

Osseor

Norway

18.10.2004

Liechtenstein

30.11.2004

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

EU/1/04/289/001/NO

EU/1/04/290/001

EU/1/04/290/001/IS

EU/1/04/290/001/NO

Angiox

Angiox

Alimta

Liechtenstein

30.9.2004

Norway

8.10.2004

Liechtenstein

30.9.2004

Alimta, concentrate for solution for
infusion, 500 mg

Iceland

19.10.2004

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

Powder
100 mg/ml
Raptiva
solvent for solution for injection

and

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

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Official Journal of the European Union

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EU-Number

Product

Country

Date of
authorisation

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

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

Parareg, film-coated tablet, 90 mg

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

Emselex

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

Emselex 7,5 mg prolonged release
tablets

Iceland

Iceland

18.11.2004

18.11.2004

Norway

16.11.2004

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

EU/1/96/008/040-041

EU/1/96/013/001-004

EU/1/96/022/019-022

EU/1/97/044/001-006

EU/1/99/104/001/NO

EU/2/04/043/001/NO

EU/2/04/044/001/IS

Xagrid

Puregon

Destara

Zyprexa

Tasmar

Procomvax

Equilis StrepE

Aivlozin 42,5 mg/g premix for medi-
cated feeding stuff for pigs

EU/2/04/044/001/NO

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

Aivlosin

Previcox

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

Previcox, chewable tablet, 57 mg

Norway

15.12.2004

Liechtenstein

30.9.2004

Liechtenstein

31.7.2004

Liechtenstein

30.11.2004

Liechtenstein

30.11.2004

Norway

Norway

Iceland

Norway

Norway

Iceland

17.9.2004

13.9.2004

22.9.2004

8.10.2004

13.10.2004

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

C 233/50

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Official Journal of the European Union

28.9.2006

2. Renewed Marketing Authorisations

ANNEX II

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

EU-Number

Product

Country

Date of renewal

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

NovoRapid FlexPen, solution for injec-
tion, 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
solution for infusion, 1 mg

for

Iceland

9.8.2004

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

Cetrotide, powder
injection, 0,25 mg

for

solution for

Iceland

15.9.2004

EU/1/99/100/001-003

Cetrotide

Liechtenstein

30.9.2004

EU/1/99/100/003/IS

EU/1/99/103/001/IS

Cetrotide, powder
injection, 3 mg

for

solution for

Iceland

15.9.2004

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

EU/1/99/103/003/IS

EU/1/99/103/004/IS

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

Iceland

19.8.2004

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

Iceland

19.8.2004

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

EU/1/99/108/001

Rebetol

Ferriprox

Liechtenstein

30.9.2004

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,
0,75 mg/ml

solution

for

infusion,

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

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Official Journal of the European Union

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EU-Number

Product

Country

Date of renewal

EU/1/99/109/002/IS

EU/1/99/111/001-009

Integrilin,
2 mg/ml

Stocrin

solution

for

injection,

Iceland

1.10.2004

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

EU/1/99/113/001-004

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

Paxene

Paxene

Norway

11.11.2004

Liechtenstein

30.11.2004

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 injec-
tion, 100 units/ml

Iceland

11.11.2004

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Official Journal of the European Union

28.9.2006

EU-Number

Product

Country

Date of renewal

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

NovoRapid NovoLet,
injection, 100 units/ml

solution for

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 injec-
tion, 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

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ANNEX III

3. Extended Marketing Authorisations

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

EU-Number

Product

Country

Date of extention

EU/03/258/007-009/IS

EU/03/258/010-012/IS

EU/1/00/143/004/IS

Avandamet 2 mg/1 000 mg,
coated tablets

Avandamet 4 mg/1 000 mg,
coated tablets

film-

Iceland

20.10.2004

film-

Iceland

20.10.2004

KOGENATE Bayer 250 IU Powder and
solvent for solution for injection

Iceland

23.10.2004

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

Kogenate

EU/1/00/143/005/IS

EU/1/00/143/006/IS

EU/1/01/193/002/IS

KOGENATE Bayer 500 IU Powder and
solvent for solution for injection

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

Norway

21.10.2004

Iceland

23.10.2004

Iceland

23.10.2004

MabCampath, conc.
30 mg/ml

for sol.

for inf.

Iceland

26.11.2004

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

Arixtra

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

Quixidar

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

Avandamet

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

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

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

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

Aprovel 75, 150 and 300 mg film-
coated tablets

Karvea 75, 150 and 300 mg film-
coated tablets

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

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

ANNEX IV

Norway

Norway

Norway

Iceland

8.12.2004

8.12.2004

24.9.2004

25.8.2004

Iceland

25.8.2004

Iceland

25.8.2004

Iceland

25.8.2004

4. Withdrawn Marketing Authorisations

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

EU-Number

Product

Country

Date of
withdrawal

EU/1/01/181/001-007

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

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

EU/1/01/182/001-010

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

Ixense

Ixense

Taluvian

Taluvian

Taluvian

Liechtenstein

30.11.2004

Iceland

8.11.2004

Norway

10.8.2004

Liechtenstein

30.9.2004

Iceland

26.10.2004