List of marketing authorisations granted by the EEA EFTA States for the first half of 2005
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

C 233/54

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Official Journal of the European Union

28.9.2006

List of marketing authorisations granted by the EEA EFTA States for the first half of 2005

(2006/C 233/12)

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 2005:

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List of withdrawn marketing authorisations

28.9.2006

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Official Journal of the European Union

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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 2005:

EU-Number

Product

Country

Date of
authorisation

EU/1/00/146/028-029

EU/1/00/149/001/NO

Keppra

Panretin

Liechtenstein

31.3.2005

Norway

28.2.2005

EU/1/01/171/011-012

Rapamune

Liechtenstein

31.3.2005

EU/1/01/178/001/IS

Targretin 75 mg, capsule, soft

Iceland

31.1.2005

EU/1/01/183/019

HBVAXPRO

Liechtenstein

31.5.2005

EU/1/01/184/045-056

EU/1/01/185/045-056

EU/1/01/198/011-013

EU/1/02/227/002

EU/1/02/228/002

EU/1/02/237/005

EU/1/02/239/025-030

EU/1/02/246/003

EU/1/04/285/021-028

EU/1/04/296/001/IS

Nespo

Aranesp

Glivec

Neulasta

Neupopeg

Cialis

Bextra

Carbaglu

Apidra

Cymbalta
capsule, hard

30 mg, Gastro-resistant

Liechtenstein

31.3.2005

Liechtenstein

31.3.2005

Liechtenstein

31.1.2005

Liechtenstein

31.3.2005

Liechtenstein

31.3.2005

Liechtenstein

31.1.2005

Liechtenstein

31.1.2005

Liechtenstein

31.5.2005

Liechtenstein

31.5.2005

Iceland

14.1.2005

EU/1/04/296/001/NO-004/NO

Cymbalta

Norway

11.1.2005

EU/1/04/296/001-004

Cymbalta

Liechtenstein

31.1.2005

EU/1/04/296/002-005/IS

Cymbalta
capsule, hard

60 mg, Gastro-resistant

Iceland

14.1.2005

EU/1/04/297/001/IS

Xeristar 30 mg, Gastro-resistant tablet
hard

Iceland

14.1.2005

EU/1/04/297/001/NO-004/NO

EU/1/04/297/001-004

EU/1/04/297/002-005/IS

Xeristar

Xeristar

Xeristar 60 mg, Gastro-resistant tablet
hard

EU/1/04/298/001/NO-002/NO

EU/1/04/298/001-002

Kivexa

Kivexa

Norway

11.1.2005

Liechtenstein

31.1.2005

Iceland

14.1.2005

Norway

11.1.2005

Liechtenstein

31.1.2005

EU/1/04/298/001-002/IS

Kivexa 600 mg, film-coated tablet

Iceland

11.1.2005

EU/1/04/299/001/NO-003/NO

EU/1/04/299/001-003

EU/1/04/299/001-003/IS

Fendrix

Fendrix

Fendrix 20 microg/0,5 ml, suspension
for injection

Norway

15.2.2005

Liechtenstein

31.3.2005

Iceland

25.2.2005

C 233/56

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Official Journal of the European Union

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EU-Number

Product

Country

Date of
authorisation

EU/1/04/300/001/NO-002/NO

EU/1/04/300/001-002

EU/1/04/300/001-002/IS

Avastin

Avastin

Avastin 25 mg/ml, concentrate for
sol. For infusion

Norway

18.1.2005

Liechtenstein

31.1.2005

Iceland

11.2.2005

EU/1/04/301/001/NO-005/NO

Quintanrix

Norway

1.3.2005

EU/1/04/301/001-005

Quintanrix

Liechtenstein

31.3.2005

EU/1/04/301/001-005/IS

Quintanrix, powder and solvent
susp. for injection

for

Iceland

14.3.2005

EU/1/04/302/001/NO-003/NO

EU/1/04/302/001-003

Prialt

Prialt

EU/1/04/302/001-003/IS

Prialt, solution for injection

EU/1/04/303/001/IS

Orfadin 2 mg, capsule, hard

EU/1/04/303/003/IS

Orfadin 10 mg, capsule, hard

EU/1/04/303/001/NO-003/NO

EU/1/04/303/001-003

Orfadin

Orfadin

Norway

17.3.2005

Liechtenstein

31.3.2005

Iceland

Iceland

Iceland

18.3.2005

19.3.2005

19.3.2005

Norway

17.3.2005

Liechtenstein

31.3.2005

EU/1/04/303/002/IS

Orfadin 5 mg, capsule, hard

Iceland

19.3.2005

EU/1/04/304/001/NO-007/NO

EU/1/04/304/001-007

Azilect

Azilect

Norway

21.3.2005

Liechtenstein

31.3.2005

EU/1/04/304/001-007/IS

Azilect 1 mg, tablet

Iceland

17.3.2005

EU/1/04/305/001

EU/1/04/305/001/IS

EU/1/04/305/001/NO

EU/1/04/306/001

EU/1/04/306/001/IS

Truvada

Truvada
tablet

Truvada

Aloxi

Liechtenstein

31.3.2005

245/200 mg,

film-coated

Iceland

16.3.2005

Norway

7.3.2005

Liechtenstein

31.5.2005

Aloxi 0,25 mg/5 ml,
injection

solution for

Iceland

7.4.2005

EU/1/04/306/001/NO

Aloxi

Norway

20.4.2005

EU/1/04/307/001/NO-004/NO

Zonegran

Norway

9.4.2005

EU/1/04/307/001-004

Zonegran

Liechtenstein

31.5.2005

EU/1/04/307/003/IS

Zonegran 25 mg, capsule, hard

EU/1/04/307/003/IS

Zonegran 50 mg, capsule, hard

Iceland

Iceland

6.4.2005

6.4.2005

EU/1/05/308/001

Aclasta

Liechtenstein

31.5.2005

EU/1/05/308/001/IS

Aclasta 5 mg/ml, solution for infusion

Iceland

9.5.2005

EU/1/05/308/001/NO

EU/1/97/044/001-006/IS

Aclasta

Tasmar

Norway

10.5.2005

Iceland

18.1.2005

EU/1/97/045/004

Helicobacter Test INFAI

Liechtenstein

31.3.2005

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EU-Number

Product

Country

Date of
authorisation

EU/1/99/107/004

Rebetol

Liechtenstein

31.3.2005

EU/1/99/120/001/NO-004/NO

Ammonaps

Norway

21.4.2005

EU/1/99/123/011

Renagel

Liechtenstein

31.3.2005

EU/1/99/125/005-008

Zyprexa Velotab

Liechtenstein

31.3.2005

EU/1/99/126/004-005

EU/1/99/126/006-011

Enbrel

Enbrel

Liechtenstein

31.3.2005

Liechtenstein

31.5.2005

EU/2/00/019/005-007

Eurifel FeLV

Liechtenstein

31.5.2005

EU/2/03/037/001-004/IS

EU/2/03/038/001-004/IS

ProteqFlu, powder and solvent
susp. for inj.

for

Iceland

9.5.2005

ProteqFlu-Te, powder and solvent for
susp. for inj.

Iceland

18.2.2005

EU/2/04/046/001-003/IS

Nobivac Piro, suspension for injection

Iceland

12.5.2005

EU/2/04/047/001/NO-002/NO

Purevax RCPCh FeLV

Norway

21.3.2005

EU/2/04/047/001-002

Purevax RCPCh FeLV

Liechtenstein

31.3.2005

EU/2/04/047/001-002/IS

Purevax RCPCh Fel V

Iceland

30.6.2005

EU/2/04/048/001/NO-002/NO

Purevax RCP FeLV

Norway

21.3.2005

EU/2/04/048/001-002

Purevax RCP FeLV

Liechtenstein

31.3.2005

EU/2/04/048/001-002/IS

Purevax RCP FeL V

Iceland

30.6.2005

EU/2/04/049/001/NO-002/NO

Purevax RCCh

Norway

21.3.2005

EU/2/04/049/001-002

Purevax RCCh

Liechtenstein

31.3.2005

EU/2/04/050/001/NO-002/NO

Purevax RCPCh

Norway

21.3.2005

EU/2/04/050/001-002

Purevax RCPCh

Liechtenstein

31.3.2005

EU/2/04/051/001/NO-002/NO

Purevax RC

Norway

21.3.2005

EU/2/04/051/001-002

Purevax RC

Liechtenstein

31.3.2005

EU/2/04/051/001-002/IS

Purevax RC, powder and solvent for
susp. for inj.

Iceland

30.6.2005

EU/2/04/052/001/NO-002/NO

Purevax RCP

Norway

21.3.2005

EU/2/04/052/001-002

Purevax RCP

Liechtenstein

31.3.2005

EU/2/04/052/001-002/IS

EU/2/04/49/001-002/IS

EU/2/04/50/001-002/IS

EU/2/05/053/001/IS

EU/2/05/053/001/NO

EU/2/99/014/012

EU/2/99/015/001/NO

Purevax RCP, powder and solvent for
susp. for injection

Purevax RCCh, powder and solvent for
susp. for inj.

Purevax RCPCh, powder and solvent
for susp. for inj.

Iceland

30.6.2005

Iceland

30.6.2005

Iceland

30.6.2005

Naxel 100 mg/ml,
injection

suspension for

Iceland

9.6.2005

Naxcel

Stronghold

Oxyglobin

Norway

17.6.2005

Liechtenstein

31.1.2005

Norway

Iceland

5.1.2005

10.5.2005

EU/2/99/017/001-006/IS

Ibraxion, emulsion for injection

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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 2005:

EU-Number

Product

Country

Date of renewal

EU/1/00/129/001/NO-003/NO

Azopt

Norway

30.6.2005

EU/1/00/129/001-003/IS

Azopt, eye drops, suspension, 1%

Iceland

30.6.2005

EU/1/00/130/001/NO-002/NO

Orgalutran

Norway

4.4.2005

EU/1/00/130/001-002

EU/1/00/130/001-002/IS

Orgalutran

Orgalutran

Liechtenstein

31.3.2005

Iceland

18.4.2005

EU/1/00/131/001/NO-050/NO

PegIntron

Norway

24.6.2005

EU/1/00/131/001-050/IS

PegIntron

Iceland

28.6.2005

EU/1/00/132/001/NO-050/NO

ViraferonPeg

Norway

24.6.2005

EU/1/00/132/001-050/IS

ViraferonPeg

Iceland

28.6.2005

EU/1/99/100/001/NO-003/NO

Cetrotide

Norway

4.1.2005

EU/1/99/120/001-002/IS

Ammonaps, tablets, 500 mg

Iceland

29.4.2005

EU/1/99/120/003-004/IS

Ammonaps 940 mg/g, granules

Iceland

29.4.2005

EU/1/99/122/001/NO-002/NO

Thyrogen

Norway

15.4.2005

EU/1/99/122/001-002/IS

Thyrogen, powder
injection, 0,9 mg

for

solution for

Iceland

14.4.2005

EU/1/99/123/001/NO-011/NO

Renagel

Norway

4.2.2005

EU/1/99/123/001-004/IS

Renagel, capsule, hard, 403 mg

Iceland

25.2.2005

EU/1/99/123/001-010

Renagel

Liechtenstein

31.3.2005

EU/1/99/123/005-007/IS

Renagel, film-coated tablet, 400 mg

Iceland

25.2.2005

EU/1/99/123/008-011/IS

Renagel, film-coated tablet, 800 mg

Iceland

25.2.2005

EU/1/99/124/001/IS

Tractocile,
7,5 mg/ml

solution

for

injection,

Iceland

1.3.2005

EU/1/99/124/001/NO-002/NO

Tractocile

Norway

7.3.2005

EU/1/99/124/001-002

Tractocile

Liechtenstein

31.3.2005

EU/1/99/124/002/IS

Tractocile, concentrate for solution for
infusion, 7,5 mg/ml

Iceland

1.3.2005

EU/1/99/125/001-004

Zyprexa Velotab

Liechtenstein

31.3.2005

EU/1/99/126/001/NO-005/NO

EU/1/99/126/001-003

EU/1/99/126/001-005/IS

Enbrel

Enbrel

Enbrel

Norway

6.4.2005

Liechtenstein

31.3.2005

Iceland

15.4.2005

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EU-Number

Product

Country

Date of renewal

EU/1/99/127/001/NO-044/NO

EU/1/99/127/001-044/IS

EU/1/99/128/001/NO-037/NO

EU/1/99/128/001-037/IS

IntronA

IntronA

Viraferon

Viraferon

EU/2/00/018/001/IS

Incurin, tablet, 1mg

EU/2/00/018/001/NO

Incurin

EU/2/00/019/001/NO-003/NO

Eurifel FeLV

Norway

20.6.2005

Iceland

27.6.2005

Norway

20.6.2005

Iceland

Iceland

Norway

Norway

27.6.2005

10.5.2005

16.6.2005

31.5.2005

EU/2/00/019/001-003

Eurifel FeLV

Liechtenstein

31.5.2005

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

Rabigen

Norway

23.5.2005

EU/2/00/021/001-002/IS

RABIGEN SAG2, oral suspension

Iceland

9.5.2005

EU/2/99/013/001-002

Halocur

Liechtenstein

31.1.2005

EU/2/99/013/001-002/IS

Halocur 0.5 mg/ml, oral solution

EU/2/99/014/001/NO-012/NO

Stronghold

Iceland

Norway

18.2.2005

6.1.2005

EU/2/99/014/001-011

Stronghold

Liechtenstein

31.1.2005

EU/2/99/014/001-012/IS

Stronghold spot on solution 6% and
12%

Iceland

7.1.2005

EU/2/99/015/001

Oxyglobin

Liechtenstein

31.1.2005

EU/2/99/015/001/IS

Oxyglobin 13g/dl, solution for infu-
sion

Iceland

5.1.2005

EU/2/99/017/001/NO-006/NO

EU/2/99/017/001-006

Ibraxion

Ibraxion

Norway

2.6.2005

Liechtenstein

31.5.2005

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ANNEX IV

4. Withdrawn Marketing Authorisations

The following marketing authorisations have been withdrawn in EEA EFTA States during the period 1 January — 31
June 2005:

EU-Number

Product

Country

Date of extention

EU/1/01/171/011/NO-012/NO

Rapamune

EU/1/01/171/011-012/IS

Rapamune 5 mg filmcoated tablets

EU/1/02/206/009-011/IS

EU/1/02/206/012-014/IS

EU/1/02/206/015-017/IS

EU/1/02/207/009-011/IS

EU/1/02/207/012-014/IS

EU/1/02/207/015-017/IS

Norway

2.2.2005

Iceland

Iceland

1.3.2005

10.3.2005

Arixtra 5mg/0,4 ml solution for injec-
tion

Arixtra 7,5mg/0,6 ml
injection

Arixtra 10mg/0,8 ml
injection

Quixidar 5mg/0,4 ml
injection

solution for

Iceland

10.3.2005

solution for

Iceland

10.3.2005

solution for

Iceland

9.3.2005

Quixidar 7,5mg/0,6 ml solution for
injection

Iceland

9.3.2005

Quixidar 10mg/0,8 ml
injection

solution for

Iceland

9.3.2005

EU/1/96/026/002/NO

Invirase

EU/1/99/107/004/IS

Rebetol, oral solution 40 mg/ml

EU/1/99/107/004/NO

EU/1/99/126/006/NO-011/NO

Rebetol

Enbrel

EU/1/99/126/006-011/IS

Enbrel, 50 mg

Norway

Iceland

Norway

Norway

Iceland

9.6.2005

22.3.2005

22.2.2005

19.5.2005

24.5.2005

EU/2/00/019/005/NO-007/NO

Eurifel FeLV

Norway

15.4.2005

ANNEX IV

4. Withdrawn Marketing Authorisations

The following marketing authorisations have been withdrawn in EEA EFTA States during the period 1 January — 31
June 2005:

EU-Number

Product

Country

Date of
withdrawal

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

EU/1/00/138/001-012

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

EU/1/00/139/001-012

EU/1/01/181/001/NO-007/NO

Venvia

Venvia

Nyracta

Nyracta

Ixense

EU/1/97/048/001/NO-014/NO

Infanrix HepB

EU/1/97/048/001-014

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

Infanrix HepB

Infanrix HepB

Norway

4.1.2005

Liechtenstein

31.1.2005

Norway

4.1.2005

Liechtenstein

31.1.2005

Norway

Norway

6.1.2005

25.5.2005

Liechtenstein

31.5.2005

Iceland

15.6.2005