28.9.2006   

EN

Official Journal of the European Union

C 233/21


List of marketing authorisations granted by the EEA EFTA States for the first half of 2003

(2006/C 233/08)

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 2003:

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List of withdrawn marketing authorisations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 January30 June 2003:

EU-Number

Product

Country

Date of authorisation

EU/1/00/131/031-050

PegIntron

Liechtenstein

31.1.2003

EU/1/00/134/013-021

Lantus

Liechtenstein

31.5.2003

EU/1/00/146/027

Keppra

Liechtenstein

31.3.2003

EU/1/00/147/001/NO-008/NO

Hexavac

Norway

30.1.2003

EU/1/01/171/009-010

Rapamune

Liechtenstein

31.1.2003

EU/1/01/176/004-006

Zometa

Liechtenstein

31.5.2003

EU/1/01/179/001/NO

Osteogent Protein 1

Norway

24.4.2003

EU/1/01/183/001/NO-017/NO

HBVAXPRO

Norway

5.3.2003

EU/1/01/188/004-006

Fabrazyme

Liechtenstein

31.1.2003

EU/1/01/195/008-015

Liprolog

Liechtenstein

31.3.2003

EU/1/02/201/005-006

Protopic

Liechtenstein

31.5.2003

EU/1/02/202/005-006

Protopy

Liechtenstein

31.5.2003

EU/1/02/216/002

Invanz

Liechtenstein

31.5.2003

EU/1/02/224/001/NO-005/NO

Ambirix

Norway

8.1.2003

EU/1/02/226/001/IS

InductOs

Iceland

19.3.2003

EU/1/02/233/001-015

Insulatard

Liechtenstein

31.1.2003

EU/1/02/238/001

Zavesca

Liechtenstein

31.1.2003

EU/1/02/239/001/NO-024/NO

Bextra

Norway

9.4.2003

EU/1/02/239/001-010/IS

Bextra tablets 10 mg*

Iceland

22.5.2003

EU/1/02/239/001-024

Bextra

Liechtenstein

31.5.2003

EU/1/02/239/011-020/IS

Bextra tablets 20 mg*

Iceland

22.5.2003

EU/1/02/239/021-024/IS

Bextra tablets 40 mg*

Iceland

22.5.2003

EU/1/02/240/001-003

Somavert

Liechtenstein

31.1.2003

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

Valdyn

Norway

9.4.2003

EU/1/02/242/001-024

Valdyn

Liechtenstein

31.5.2003

EU/1/02/244/001/NO-024/NO

Kudeq

Norway

9.4.2003

EU/1/02/244/001-024

Kudeq

Liechtenstein

31.5.2003

EU/1/02/245/001

Theryttrex

Liechtenstein

31.1.2003

EU/1/02/245/001-002/IS

Theryttrex radioact. precursor

Iceland

7.2.2002

EU/1/02/246/001/IS

Carbaglu dispersible tabl.

Iceland

17.2.2003

EU/1/02/246/001/NO-002/NO

Carbaglu

Norway

6.3.2003

EU/1/03/248/001/NO-012/NO

Levitra

Norway

10.3.2003

EU/1/03/248/001-004/IS

Levitra 5 mg

Iceland

24.3.2003

EU/1/03/248/001-012

Levitra

Liechtenstein

31.3.2003

EU/1/03/248/005-008/IS

Levitra 10 mg

Iceland

24.3.2003

EU/1/03/248/009-012/IS

Levitra 20 mg

Iceland

24.3.2003

EU/1/03/249/001/NO-012/NO

Vivanza

Norway

26.5.2003

EU/1/03/249/001-004/IS

Vivanza tabl. 5 mg

Iceland

24.3.2003

EU/1/03/249/001-012

Vivanza

Liechtenstein

31.3.2003

EU/1/03/249/005-008/IS

Vivanza tabl. 10 mg

Iceland

24.3.2003

EU/1/03/249/009-012/IS

Vivanza tabl. 20 mg

Iceland

24.3.2003

EU/1/03/250/001

Ytracis

Liechtenstein

31.5.2003

EU/1/03/250/001/IS

Ytracis 1850 MBq/ml

Iceland

16.4.2003

EU/1/03/250/001/NO

Ytracis 1850 MBq/ml

Norway

22.4.2003

EU/1/03/251/001

Hepsera

Liechtenstein

31.3.2003

EU/1/03/251/001/IS

Hepsera tabl. 10 mg

Iceland

4.4.2003

EU/1/03/251/001/NO

Hepsera

Norway

26.3.2003

EU/1/03/252/001/NO-003/NO

Fuzeon

Norway

5.6.2003

EU/1/03/252/001-002/IS

Fuzeon powder and solv. for sol. for inj.

Iceland

20.6.2003

EU/1/03/252/003/IS

Fuzeon powder for sol. for inj.

Iceland

20.6.2003

EU/1/96/007/021-028

Humalog

Liechtenstein

31.1.2003

EU/1/96/011/001-004

Caelyx

Liechtenstein

31.3.2003

EU/1/97/054/001 and 003-005

Viracept

Liechtenstein

31.3.2003

EU/1/98/069/004a, 4b

Plavix

Liechtenstein

31.3.2003

EU/1/98/070/004a, 4b

Iscover

Liechtenstein

31.3.2003

EU/1/98/084/002

Simulect

Liechtenstein

31.3.2003

EU/1/99/103/004

ReFacto

Liechtenstein

31.1.2003

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

Rabigen

Norway

19.5.2003

EU/2/00/022/001/NO-004/NO

Ibaflin

Norway

19.5.2003

EU/2/00/022/001a, b, 002a, b

Ibaflin

Liechtenstein

31.3.2003

EU/2/00/022/003a, b, 004a, b

Ibaflin

Liechtenstein

31.3.2003

EU/2/00/022/005-012

Ibaflin

Liechtenstein

31.3.2003

EU/2/00/024/001/NO

Pruban

Norway

6.5.2003

EU/2.2.20033/001/NO

Dexdomitor

Norway

16.1.2003

EU/2.2.20034/001/IS

Nobivac Bb cat

Iceland

21.1.2003

EU/2.2.20035/001-006

SevoFlo

Liechtenstein

31.1.2003

EU/2.2.20036/001-002

Nobilis OR inac

Liechtenstein

31.1.2003

EU/2.2.20036/001-002

Nobilis OR inac

Norway

31.1.2003

EU/2.3.20037/001/NO-004/NO

ProteqFlu

Norway

24.4.2003

EU/2.3.20037/001-004

ProteqFlu

Liechtenstein

31.3.2003

EU/2.3.20038/001/NO-004/NO

ProteqFlu-Te

Norway

24.4.2003

EU/2.3.20038/001-004

ProteqFlu-Te

Liechtenstein

31.3.2003

EU/2.3.20039/001-012

Advocate

Liechtenstein

31.5.2003

EU/2.3.20039/013/NO-018/NO

Advocate

Norway

25.6.2003

EU/2/97/004/001 and 003-008

Metacam

Liechtenstein

31.3.2003

EU/2/97/005/008-009

Quadrisol

Liechtenstein

31.1.2003


ANNEX II

2.   Renewed Marketing Authorisations

The following marketing authorisations have been renewed in the EEA EFTA States during the period 1 January30 June 2003:

EU-Number

Product

Country

Date of renewal

EU/1/96/006/001/NO-003/NO

NovoSeven

Norway

14.1.2003

EU/1/96/015/001/NO-002/NO

Epivir

Norway

31.1.2003

EU/1/97/032/001/IS

LeukoScan p.f. sol. for inj.

Iceland

29.1.2003

EU/1/97/039/001/NO-004/NO

Cystagon

Norway

3.3.2003

EU/1/97/039/001-002/IS

Cystagon capsule, hard

Iceland

29.1.2003

EU/1/97/039/003-004/IS

Cystagon capsule, hard

Iceland

29.1.2003

EU/1/97/040/001-002/IS

Teslascan 0,01 mmol/ml solution for infusion

Iceland

12.5.2003

EU/1/97/045/001, 006-007/IS

Helicobacter INFAI powder for oral solution, 75 mg

Iceland

12.5.2003

EU/1/97/045/008/IS

Helicobacter INFAI powder for oral solution, 45 mg

Iceland

12.5.2003

EU/1/97/046/001-003, -010, -013/IS

Aprovel tabl. 75 mg

Iceland

18.2.2003

EU/1/97/046/004-006, -011, -014/IS

Aprovel tabl. 150 mg

Iceland

18.2.2003

EU/1/97/046/007-009, 026, 030, 033/IS

Aprovel tabl. 300 mg

Iceland

18.2.2003

EU/1/97/047/001/IS

BeneFix powd. and solv. inj. 250 IU

Iceland

15.4.2003

EU/1/97/047/001-003

BeneFix

Liechtenstein

31.3.2003

EU/1/97/047/002/IS

BeneFix powd. and solv. inj. 500 IU

Iceland

15.4.2003

EU/1/97/047/003/IS

BeneFix powd. and solv. inj. 1000 IU

Iceland

15.4.2003

EU/1/97/048/001-014

Infanrix HepB

Liechtenstein

31.1.2003

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

Infanrix HepB

Iceland

11.2.2003

EU/1/97/049/001-003, -010, 013/IS

Karvea tabl. 75 mg

Iceland

12.2.2003

EU/1/97/049/004-006, -012, 015/IS

Karvea tabl. 300 mg

Iceland

12.2.2003

EU/1/97/049/004-006, -011, 014/IS

Karvea tabl. 150 mg

Iceland

12.2.2003

EU/1/97/050/001/NO

Sifrol

Norway

6.1.2003

EU/1/97/050/009/NO-012/NO

Sifrol

Norway

6.1.2003

EU/1/97/051/001-002/IS

Mirapexin tab. 0,088 mg

Iceland

31.1.2003

EU/1/97/051/003-004/IS

Mirapexin tab. 0,18 mg

Iceland

31.1.2003

EU/1/97/051/005-006/IS

Mirapexin tab. 0,035 mg

Iceland

31.1.2003

EU/1/97/051/007-008/IS

Mirapexin tab. 0,7 mg

Iceland

31.1.2003

EU/1/97/051/009-010/IS

Mirapexin tab. 1,1 mg

Iceland

31.1.2003

EU/1/97/052/001/NO-006/NO

Daquiran

Norway

28.1.2003

EU/1/97/052/009/NO-010/NO

Daquiran

Norway

28.1.2003

EU/1/97/053/001/NO-005/NO

Cerezyme

Norway

6.1.2003

EU/1/97/053/001-002/IS

Cerezyme 200U

Iceland

10.2.2003

EU/1/97/053/001-005

Cerezyme

Liechtenstein

31.1.2003

EU/1/97/053/003-005/IS

Cerezyme 400U

Iceland

10.2.2003

EU/1/97/054/001/IS

Viracept 50 mg/g oral powder

Iceland

13.5.2003

EU/1/97/054/001/NO

Viracept

Norway

18.2.2003 

EU/1/97/054/003/IS

Viracept tablets 250 mg

Iceland

13.5.2003

EU/1/97/054/003/NO-005/NO

Viracept

Norway

18.2.2003

EU/1/97/054/005/IS

Viracept film coated tablets 250 mg

Iceland

13.5.2003

EU/1/97/055/001/IS

Viramune tabl. 200 mg

Iceland

10.4.2003

EU/1/97/055/001/NO-002/NO

Viramune

Norway

6.3.2003

EU/1/97/055/001-002

Viramune

Liechtenstein

31.3.2003

EU/1/97/055/002/IS

Viramune mixt. susp. 50 mg/5ml

Iceland

10.4.2003

EU/1/97/057/001

Quadramet

Liechtenstein

31.3.2003

EU/1/97/057/001/IS

Quadramet solution for injection 1,3 GB/ml

Iceland

16.5.2003

EU/1/97/057/001/NO

Quadramet

Norway

5.5.2003

EU/1/98/065/001/NO-002/NO

Optison

Norway

20.6.2003

EU/1/98/065/001-002

Optison

Liechtenstein

31.5.2003

EU/1/98/065/001-002/IS

Optison, solution for injection

Iceland

25.6.2003

EU/2/98/007/001-003

Clomicalm

Liechtenstein

31.5.2003

EU/2/98/008/001/NO-004/NO

Neocolipor

Norway

18.6.2003

EU/2/98/008/001-004

Neocolipor

Liechtenstein

31.5.2003


ANNEX III

3.   Extended Marketing Authorisations

The following marketing authorisations have been extended in the EEA EFTA States during the period 1 January30 June 2003:

EU-Number

Product

Country

Date of extention

EU/1/00/146/027/NO

Keppra

Norway

18.3.2003

EU/1/01/171/009-010/IS

Rapamune filmc. tablets 2 mg

Iceland

11.6.2003

EU/1/01/171/009-010/NO

Rapamune

Norway

29.1.2003

EU/1/01/176/004/NO-006/NO

Zometa

Norway

29.4.2003

EU/1/01/176/004-006/IS

Zometa, concentrate for sol. for infus

Iceland

22.3.2003

EU/1/96/015/003/NO

Epivir

Norway

4.2.2003

EU/1/98/084/002/NO

Simulect

Norway

18.3.2003

EU/1/99/103/004/NO

ReFacto

Norway

13.3.2003

EU/1/99/127/040/NO-044/NO

Introna

Norway

21.1.2003

EU/2/00/022/009/NO-12/NO

Ibaflin

Norway

18.6.2003


ANNEX IV

4.   Withdrawn Marketing Authorisations

The following marketing authorisations have been withdrawn in the EEA EFTA States during the period 1 January30 June 2003:

EU-Number

Product

Country

Date of withdrawal

EU/1/00/142/003/IS

Novomix 30 Penfill

Iceland

1.1.2003

EU/1/00/142/003/NO

Novomix 30 Penfil

Norway

12.3.2003

EU/1/00/142/006/IS

Novomix 30 Novolet

Iceland

1.1.2003

EU/1/00/142/006/NO

Novomix 30 Novolet

Norway

12.3.2003

EU/1/96/021/001/NO-010/NO

Olansek

Norway

27.5.2003

EU/1/96/021/001-010

Olansek

Liechtenstein

31.3.2003

EU/2/00/019/004

Eurifel FelV

Liechtenstein

31.5.2003

EU/2/00/019/004/NO

Eurifel FelV

Norway

27.5.2003