List of marketing authorisations granted by the EEA EFTA States for the first half of 2003
Date: 2006-03-10
Institutions: Standing Committee of the EFTA States
Subjects: EFTA, Iceland, Liechtenstein, Norway, market approval, medicinal product, withdrawal from the market

28.9.2006

EN

Official Journal of the European Union

C 233/21

EUROPEAN ECONOMIC AREA

STANDING COMMITTEE OF THE EFTA STATES

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 authorisa-
tions for medicinal products for the period 1 January — 30 June 2003:

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List of withdrawn marketing authorisations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 233/22

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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 January —
30 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

EU/1/00/146/027

Lantus

Keppra

Liechtenstein

31.5.2003

Liechtenstein

31.3.2003

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

Hexavac

Norway

30.1.2003

EU/1/01/171/009-010

EU/1/01/176/004-006

Rapamune

Zometa

Liechtenstein

31.1.2003

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

EU/1/02/201/005-006

EU/1/02/202/005-006

EU/1/02/216/002

Liprolog

Protopic

Protopy

Invanz

Liechtenstein

31.3.2003

Liechtenstein

31.5.2003

Liechtenstein

31.5.2003

Liechtenstein

31.5.2003

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

Ambirix

Norway

8.1.2003

EU/1/02/226/001/IS

EU/1/02/233/001-015

EU/1/02/238/001

InductOs

Insulatard

Zavesca

Iceland

19.3.2003

Liechtenstein

31.1.2003

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

EU/1/02/242/001-024

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

EU/1/02/244/001-024

Valdyn

Valdyn

Kudeq

Kudeq

Norway

9.4.2003

Liechtenstein

31.5.2003

Norway

9.4.2003

Liechtenstein

31.5.2003

EU/1/02/245/001

Theryttrex

Liechtenstein

31.1.2003

28.9.2006

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Official Journal of the European Union

C 233/23

EU-Number

Product

Country

Date of
authorisation

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

EU/1/96/011/001-004

Humalog

Caelyx

Liechtenstein

31.1.2003

Liechtenstein

31.3.2003

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

Viracept

Liechtenstein

31.3.2003

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

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

EU/1/98/084/002

EU/1/99/103/004

Plavix

Iscover

Simulect

ReFacto

Liechtenstein

31.3.2003

Liechtenstein

31.3.2003

Liechtenstein

31.3.2003

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

C 233/24

EN

Official Journal of the European Union

28.9.2006

EU-Number

Product

Country

Date of
authorisation

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

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

EU/2/00/022/005-012

EU/2/00/024/001/NO

Ibaflin

Ibaflin

Ibaflin

Pruban

EU/2.2.20033/001/NO

Dexdomitor

EU/2.2.20034/001/IS

Nobivac Bb cat

Liechtenstein

31.3.2003

Liechtenstein

31.3.2003

Liechtenstein

31.3.2003

Norway

Norway

Iceland

6.5.2003

16.1.2003

21.1.2003

EU/2.2.20035/001-006

SevoFlo

Liechtenstein

31.1.2003

EU/2.2.20036/001-002

EU/2.2.20036/001-002

Nobilis OR inac

Nobilis OR inac

EU/2.3.20037/001/NO-004/NO

ProteqFlu

Liechtenstein

31.1.2003

Norway

Norway

31.1.2003

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

EU/2.3.20039/001-012

ProteqFlu-Te

Advocate

Liechtenstein

31.3.2003

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

28.9.2006

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Official Journal of the European Union

C 233/25

2. Renewed Marketing Authorisations

ANNEX II

The following marketing authorisations have been renewed in the EEA EFTA States during the period 1 January —
30 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,
033/IS

026,

030,

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

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

Sifrol

Sifrol

Norway

6.1.2003

Norway

6.1.2003

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

Mirapexin tab. 0,088 mg

Iceland

31.1.2003

C 233/26

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Official Journal of the European Union

28.9.2006

EU-Number

Product

Country

Date of renewal

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

Mirapexin tab. 0,18 mg

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

Mirapexin tab. 0,035 mg

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

Mirapexin tab. 0,7 mg

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

Mirapexin tab. 1,1 mg

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

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

Daquiran

Daquiran

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

Cerezyme

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

Cerezyme 200U

Iceland

Iceland

Iceland

Iceland

Norway

Norway

Norway

Iceland

31.1.2003

31.1.2003

31.1.2003

31.1.2003

28.1.2003

28.1.2003

6.1.2003

10.2.2003

EU/1/97/053/001-005

Cerezyme

Liechtenstein

31.1.2003

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

Cerezyme 400U

EU/1/97/054/001/IS

Viracept 50 mg/g oral powder

EU/1/97/054/001/NO

Viracept

Iceland

Iceland

10.2.2003

13.5.2003

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

EU/1/97/054/005/IS

Viracept film coated tablets 250 mg

EU/1/97/055/001/IS

Viramune tabl. 200 mg

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

EU/1/97/055/001-002

Viramune

Viramune

Norway

18.2.2003

Iceland

Iceland

13.5.2003

10.4.2003

Norway

6.3.2003

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

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

EU/1/98/065/001-002

Optison

Optison

Norway

Norway

5.5.2003

20.6.2003

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

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Official Journal of the European Union

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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 January —
30 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

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

Rapamune

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

Zometa

Iceland

Norway

Norway

11.6.2003

29.1.2003

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

EU/1/98/084/002/NO

EU/1/99/103/004/NO

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

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

Epivir

Simulect

ReFacto

Introna

Ibaflin

Norway

Norway

Norway

Norway

Norway

4.2.2003

18.3.2003

13.3.2003

21.1.2003

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 January —
30 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

EU/1/00/142/006/NO

Novomix 30 Novolet

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

EU/1/96/021/001-010

EU/2/00/019/004

EU/2/00/019/004/NO

Olansek

Olansek

Eurifel FelV

Eurifel FelV

Iceland

Norway

Norway

1.1.2003

12.3.2003

27.5.2003

Liechtenstein

31.3.2003

Liechtenstein

31.5.2003

Norway

27.5.2003