28.9.2006   

EN

Official Journal of the European Union

C 233/37

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

(2006/C 233/10)

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 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 List of withdrawn marketing authorisations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 V

 List of suspended 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 2004:

EU-Number

Product

Country

Date of authorisation

EU/1/00/141/001/NO

Myocet

Norway

22.1.2004

EU/1/00/164/003-005

NutropinAq

Liechtenstein

31.3.2004

EU/1/02/212/026

Vfend

Liechtenstein

31.3.2004

EU/1/02/215/001-010/IS

PritorPlus tablets 40 mg and 80 mg

Iceland

10.2.2004

EU/1/03/263/001/NO-003/NO

Dukoral

Norway

11.5.2004

EU/1/03/263/001-003

Dukoral

Liechtenstein

31.5.2004

EU/1/03/264/001

Zevalin

Liechtenstein

31.1.2004

EU/1/03/264/001/IS

Zevalin 1.6 mg/ml kit for radiopharmaceut. prep.

Iceland

13.2.2004

EU/1/03/264/001/NO

Zevalin

Norway

2.2.2004

EU/1/03/265/001/NO-002/NO

Bonviva

Norway

24.3.2004

EU/1/03/265/001-002

Bonviva

Liechtenstein

31.5.2004

EU/1/03/265/001-002/IS

Bonviva filmc. tabl. 2.5 mg

Iceland

23.3.2004

EU/1/03/266/001/NO-002/NO

Ibandronic Acid Roche

Norway

24.3.2004

EU/1/03/266/001-002

Ibandronic Acid Roche

Liechtenstein

31.5.2004

EU/1/03/266/001-002/IS

Ibandronic Acid Roche film. tabl. 2.5 mg

Iceland

23.3.2004

EU/1/03/267/001/NO-007/NO

Reyataz

Norway

26.3.2004

EU/1/03/267/001-006/IS

Reyataz capsule hard 100 mg, 150 mg, 200 mg

Iceland

30.3.2004

EU/1/03/267/001-007

Reyataz

Liechtenstein

31.3.2004

EU/1/03/267/007/IS

Reyataz oral powder 50 mg/1.5 g

Iceland

30.3.2004

EU/1/03/268/001/NO-003/NO

Cholestagel

Norway

24.3.2004

EU/1/03/268/001-003

Cholestagel

Liechtenstein

31.3.2004

EU/1/03/268/001-003/IS

Cholestagel filmc. tabl. 625 mg

Iceland

5.4.2004

EU/1/03/269/001/IS

Faslodex

Iceland

7.4.2004

EU/1/03/269/001/NO

Faslodex

Norway

6.4.2004

EU/1/03/270/001/NO-002/NO

Oxybutynin Nicobrand

Norway

28.6.2004

EU/1/03/271/001/IS

Advate powder for sol. for inj. 250 IU, 500 IU, 1000 IU, 150

Iceland

1.4.2004

EU/1/03/271/001/NO-004/NO

Advate

Norway

29.3.2004

EU/1/03/271/001-004

Advate

Liechtenstein

31.5.2004

EU/1/04/272/001/NO-002/NO

Photo Barr

Norway

23.4.2004

EU/1/04/272/001-002

Photo Barr

Liechtenstein

31.5.2004

EU/1/04/272/002/IS

Photo Barr Powder for sol. for inj. 15 or 75 mg

Iceland

23.4.2004

EU/1/04/273/001

Lysodren

Liechtenstein

31.5.2004

EU/1/04/273/001/IS

Lysodren tablets 500 mg

Iceland

19.5.2004

EU/1/04/273/001/NO

Lysodren

Norway

26.5.2004

EU/1/04/274/001

Velcade

Liechtenstein

31.5.2004

EU/1/04/274/001/IS

Velcade powder for sol. for inj. 3.5 mg

Iceland

26.5.2004

EU/1/04/274/001/NO

Velcade

Norway

25.5.2004

EU/1/04/275/001/NO-002/NO

Litak

Norway

14.5.2004

EU/1/04/275/001-002

Litak

Liechtenstein

31.5.2004

EU/1/04/275/001-002/IS

Litak Solution for inj. 2 mg/ml

Iceland

14.5.2004

EU/1/04/276/001/NO-020/NO

Abilify

Norway

24.6.2004

EU/1/04/278/001/NO-009/NO

Levemir

Norway

14.6.2004

EU/1/04/278/001-009/IS

Levemir Penfill/FlexPen/InnoLet, sol f. inj.

Iceland

25.6.2004

EU/1/95/001/032

Gonal

Liechtenstein

31.1.2004

EU/1/95/001/033-035

Gonal f

Liechtenstein

31.3.2004

EU/1/97/031/045-046

NeoRecormon

Liechtenstein

31.3.2004

EU/1/97/046/016-030

Aprovel

Liechtenstein

31.5.2004

EU/1/97/049/016-030

Karvea

Liechtenstein

31.5.2004

EU/1/97/054/006

Viracept

Liechtenstein

31.5.2004

EU/1/98/066/014-018

Exelon

Liechtenstein

31.3.2004

EU/1/98/085/011-020

Karvezide

Liechtenstein

31.5.2004

EU/1/98/086/011-020

CoAprovel

Liechtenstein

31.5.2004

EU/1/98/091/001-014

Kinzalmono

Liechtenstein

31.1.2004

EU/1/98/092/014-018

Prometax

Liechtenstein

31.3.2004

EU/1/99/099/001-006

Zerene

Liechtenstein

31.5.2004

EU/1/99/113/003-004

Paxene

Liechtenstein

31.1.2004

EU/2/00/022/009-012/IS

Ibaflin oral gel 3% and 7.5%

Iceland

22.1.2004

EU/2/00/022/013-017

Ibaflin

Liechtenstein

31.3.2004

EU/2/02/032/001/IS

Gallivac HVT IDB Frosen susp. And diluent for inj.

Iceland

13.4.2004

EU/2/04/042/001/NO-004/NO

Novem

Norway

10.5.2004

EU/2/04/042/001-002/IS

Novem sol. for inj. 5 mg/ml

Iceland

31.3.2004

EU/2/04/042/001-004

Novem

Liechtenstein

31.5.2004

EU/2/04/042/003-004/IS

Novem sol. for inj. 20 mg/ml

Iceland

31.3.2004

EU/2/04/043/001/IS

Equilis StrepE lyophilisate and solvent for suspension

Iceland

11.6.2004

EU/2/97/004/010

Metacam

Liechtenstein

31.3.2004

EU/2/98/010/001-024

Econor

Liechtenstein

31.5.2004

EU/2/99/011/001

Locatim

Liechtenstein

31.5.2004

EU/2/99/014/001-011

Stronghold

Liechtenstein

31.3.2004

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 2004:

EU-Number

Product

Country

Date of authorisation

EU/1/97/037/001/NO

Vistide

Norway

31.3.2004

EU/1/98/084/001/IS

Simulect, powder and solvent for sol. for injection, 20 mg

Iceland

27.1.2004

EU/1/98/084/002/IS

Simulect, powder and solvent for sol. for injection, 10 mg

Iceland

27.1.2004

EU/1/98/085/001-010

Karvezide

Liechtenstein

31.1.2004

EU/1/98/086/001-003,007 and 009/IS

CoAprovel, tablets, 150 mg/12,5 mg

Iceland

23.1.2004

EU/1/98/086/004-006,008 and 010/IS

CoAprovel, tablets, 300 mg/12,5 mg

Iceland

23.1.2004

EU/1/98/086/001-010

CoAprovel

Liechtenstein

31.1.2004

EU/1/98/087/001/NO-003/NO

Infergen

Norway

23.4.2004

EU/1/98/087/001-003

Infergen

Liechtenstein

31.5.2004

EU/1/98/087/001-003/IS

Infergen solution for injection, 9 micrograms

Iceland

21.6.2004

EU/1/98/089/001-016/IS

Pritor tablets, 20, 40 and 80 mg

Iceland

2.2.2004

EU/1/98/089/001-016/NO

Pritor tablets, 20, 40 and 80 mg

Norway

30.1.2004

EU/1/98/089/001-016

Pritor

Liechtenstein

31.1.2004

EU/1/98/090/001/NO-014/NO

Micardis

Norway

30.1.2004

EU/1/98/090/001-014

Micardis

Liechtenstein

31.1.2004

EU/1/98/090/001-014/IS

Micardis tablets, 20, 40 and 80 mg

Iceland

2.2.2004

EU/1/98/091/001/NO-014/NO

Kinzalmono

Norway

30.1.2004

EU/1/98/091/001-014/IS

Kinzalmono tablets, 20, 40 and 80 mg

Iceland

2.2.2004

EU/1/98/095/001/NO-002/NO

Emadine

Norway

5.4.2004

EU/1/98/095/001-004

Emadine

Liechtenstein

31.3.2004

EU/1/98/095/001-004/IS

Emadine, eye drops, solution, 0,5 mg/ml

Iceland

1.4.2004

EU/1/98/096/001-002/IS

Temodal, capsule, hard, 5 mg

Iceland

7.4.2004

EU/1/98/096/001/NO-008/NO

Temodal

Norway

6.4.2004

EU/1/98/096/001-008

Temodal

Liechtenstein

31.3.2004

EU/1/98/096/003-004/IS

Temodal, capsule, hard, 20 mg

Iceland

7.4.2004

EU/1/98/096/005-006/IS

Temodal, capsule, hard, 100 mg

Iceland

7.4.2004

EU/1/98/096/007-008/IS

Temodal, capsule, hard, 250 mg

Iceland

7.4.2004

EU/1/99/097/001/NO

Beromun

Norway

8.6.2004

EU/1/99/098/001/NO-002/NO

Zenapax

Norway

14.5.2004

EU/1/99/098/001-002

Zenapax

Liechtenstein

31.5.2004

EU/1/99/098/001-002/IS

Zenepax concentrate for solution for infusion

Iceland

23.6.2004

EU/1/99/099/001-003/IS

Zerene, capsule, hard, 5 mg

Iceland

28.4.2004

EU/1/99/099/004-006/IS

Zerene, capsule, hard, 10 mg

Iceland

28.4.2004

EU/1/99/099/001-006/NO

Zerene 5 mg, 10 mg capsules

Norway

29.4.2004

EU/1/99/101/001/NO

Regranex

Norway

30.4.2004

EU/1/99/101/001

Regranex

Liechtenstein

31.5.2004

EU/1/99/101/001/IS

Regranex, gel, 100 mcg/g

Iceland

30.4.2004

EU/1/99/102/001-003 and 007/IS

Sonata, capsule, hard, 5 mg

Iceland

29.4.2004

EU/1/99/102/001/NO-008/NO

Sonata

Norway

29.4.2004

EU/1/99/102/001-008

Sonata

Liechtenstein

31.5.2004

EU/1/99/102/004-006 and 008/IS

Sonata, capsule, hard, 10 mg

Iceland

29.4.2004

EU/1/99/110/001/NO-009/NO

Sustiva

Norway

24.5.2004

EU/1/99/110/001-009

Sustiva

Liechtenstein

31.5.2004

EU/1/99/110/001-009/IS

Sustiva filmcoated tablets, capsules and oral sol.

Iceland

28.5.2004

EU/1/99/111/001-009/IS

Stocrin tablets, capsules and oral sol.

Iceland

21.5.2004

EU/1/99/111/001/NO-009/NO

Stocrin

Norway

24.5.2004

EU/1/99/111/001-009

Stocrin

Liechtenstein

31.5.2004

EU/1/99/111/002/IS

Stocrin, capsule, hard, 100 mg

Iceland

21.5.2004

EU/1/99/111/003-004/IS

Stocrin, capsule, hard, 200 mg

Iceland

21.5.2004

EU/1/99/111/005/IS

Stocrin, oral solution, 30 mg/ml

Iceland

21.5.2004

EU/1/99/111/006-007/IS

Stocrin, film-coated tablet, 300 mg

Iceland

21.5.2004

EU/1/98/085/004-006, 008, 010, 017-020/IS

Karvezide, tablets, 150 mg/12,5 mg

Iceland

22.1.2004

EU/1/98/085/001-003, 007, 009, 011-015/IS

Karvezide, tablets, 300 mg/12,5 mg

Iceland

22.1.2004

EU/2/98/009/001/NO-006/NO

Suvaxyn Aujeszky 783+ O/W

Norway

14.4.2004

EU/2/98/009/001-006

Suvaxyn Aujeszky 783+ O/W

Liechtenstein

31.3.2004

EU/2/99/011/001/IS

Locatim oral solution

Iceland

27.5.2004

EU/2/99/011/001/NO

Locatim

Norway

28.5.2004

ANNEX III

3.   Extended Marketing Authorisations

The following marketing authorisations have been extended in the EEA EFTA States during the period 1 January — 30 June 2004:

EU-Number

Product

Country

Date of extention

EU/1/01/198/007/NO-010/NO

Glivec

Norway

5.1.2004

EU/1/01/198/007-010/IS

Glivec 100 mg and 400 mg filmcoated tablets

Iceland

15.1.2004

EU/1/02/212/026/IS

Vfend, powder for oral suspension 40 mg/ml

Iceland

18.6.2004

EU/1/02/212/026/NO

Vfend

Norway

5.3.2004

EU/1/95/001/033/NO-035/NO

Gonal-f

Norway

24.3.2004

EU/1/95/001/033-035/IS

GONAL-f, solution for injection in prefilled pen

Iceland

19.3.2004

EU/1/96/012/009-010/IS

Bondronat, film coated tablets 50 mg

Iceland

7.1.2004

EU/1/97/031/045/NO-046/NO

NeoRecormon

Norway

23.3.2004

EU/1/97/031/045-046/IS

NeoRecormon 30.000 IU Sol. for injection pref.syr.

Iceland

30.3.2004

EU/1/97/046/016/NO-030/NO

Aprovel

Norway

30.3.2004

EU/1/97/049/016/NO-030/NO

Karvea

Norway

30.3.2004

EU/1/97/054/006/IS

Viracept 625 mg film-coated tablets

Iceland

28.5.2004

EU/1/97/054/006/NO

Viracept

Norway

21.5.2004

EU/1/98/085/011/NO-020/NO

Karvezide

Norway

23.6.2004

EU/1/98/086/011/NO-020/NO

CoAprovel

Norway

23.6.2004

EU/2/00/022/013/NO-017/NO

Ibaflin

Norway

24.3.2004

EU/2/97/004/010/NO

Metacam

Norway

11.5.2004

ANNEX IV

4.   Withdrawn Marketing Authorisations

The following marketing authorisations have been withdrawn in the EEA EFTA States during the period 1 January — 30 June 2004:

EU-Number

Product

Country

Date of withdrawal

EU/1/00/158/001/NO-034/NO

Opulis

Norway

29.3.2004

EU/1/00/158/001-034

Opulis

Liechtenstein

31.3.2004

EU/1/00/159/001/NO-034/NO

Allex

Norway

29.3.2004

EU/1/00/159/001-034

Allex

Liechtenstein

31.3.2004

EU/1/00/159/001-034/IS

Allex

Iceland

10.3.2004

EU/1/02/208/001/NO-008/NO

Xapit

Norway

29.3.2004

EU/1/02/208/001-008

Xapit

Liechtenstein

31.3.2004

EU/1/02/242/001/NO-024/NO

Valdyn

Norway

29.3.2004

EU/1/99/106/001-003

Cotronak

Liechtenstein

31.3.2004

ANNEX V

5.   Suspended Marketing Authorisations

The following marketing authorisations have been suspended in the EEA EFTA States during the period 1 January — 30 June 2004:

EU-Number

Product

Country

Date of suspension

EU/1/98/093/002

Forcaltonin

Liechtenstein

31.5.2004