List of marketing authorisations granted by the EEA EFTA States for the second half of 2005
Date: 2006-11-30
Institutions: EFTA Surveillance Authority
Subjects: EFTA countries, European Economic Area, market approval, marketing, medicinal product

30.11.2006

EN

Official Journal of the European Union

C 291/69

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

(2006/C 291/20)

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 2 June 2006, the following lists concerning marketing authorisations
for medicinal products for the period 1 June — 31 December 2005:

Annex I

Annex II

Annex III

Annex IV

Annex V

List of new marketing authorisations

List of renewed marketing authorisations

List of extended marketing authorisations

List of withdrawn marketing authorisations

List of suspended marketing authorisations

C 291/70

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Official Journal of the European Union

30.11.2006

1. New Marketing Authorisations:

ANNEX I

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

EU-Number

Product

Country

Date of authorisation

EU/1/00/129/001-003

EU/1/00/131/001-030

EU/1/00/134/008-011

EU/1/00/135/002

EU/1/00/142/009-010

EU/1/00/142/011-016

EU/1/00/142/017-022

EU/1/01/198/007-010

Azopt

PegIntron

Lantus

DaTSCAN

NovoMix

NovoMix

NovoMix

Glivec

Liechtenstein

31.7.2005

Liechtenstein

30.9.2005

Liechtenstein

30.9.2005

Liechtenstein

30.9.2005

Liechtenstein

30.9.2005

Liechtenstein

30.11.2005

Liechtenstein

30.11.2005

Liechtenstein

31.7.2005

EU/1/02/215/001/NO-010/NO

Pritor Plus

Norway

7.9.2005

EU/1/02/227/003

EU/1/02/228/003

EU/1/03/255/001-003

Neulasta

Neupopeg

Ventavis

Liechtenstein

30.11.2005

Liechtenstein

30.11.2005

Liechtenstein

30.11.2005

EU/1/03/258/013-014

Avandamet

Liechtenstein

30.9.2005

EU/1/03/263/001-003/IS

Dukoral, Suspension of vaccine and
effervescent granules for oral solu-
tion

Iceland

6.10.2005

EU/1/03/265/003-004

EU/1/03/266/003-004

EU/1/03/269/001

EU/1/03/270/003

EU/1/04/276/021-032

EU/1/04/276/033-035

EU/1/04/279/030-032

EU/1/04/280/007

EU/1/04/283/007

EU/1/04/289/002

EU/1/04/296/005-006

EU/1/04/297/005-006

Bonviva

Bondenza

Faslodex

Kentera

Abilify

Abilify

Lyrica

Yentreve

Ariclaim

Angiox

Cymbalta

Xeristar

Liechtenstein

30.9.2005

Liechtenstein

30.9.2005

Liechtenstein

30.11.2005

Liechtenstein

31.7.2005

Liechtenstein

31.7.2005

Liechtenstein

30.11.2005

Liechtenstein

30.9.2005

Liechtenstein

30.9.2005

Liechtenstein

30.9.2005

Liechtenstein

31.7.2005

Liechtenstein

31.7.2005

Liechtenstein

31.7.2005

EU/1/05/310/001/NO-005/NO

Fosavance

Norway

6.9.2005

EU/1/05/310/001-005

Fosavance

Liechtenstein

30.9.2005

EU/1/05/310/001-005/IS

Fosavance tablets

EU/1/05/311/001/NO-003/NO

Tarceva

Iceland

Norway

20.9.2005

26.9.2005

EU/1/05/311/001-003

Tarceva

Liechtenstein

30.9.2005

30.11.2006

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Official Journal of the European Union

C 291/71

EU-Number

Product

Country

Date of authorisation

EU/1/05/311/001-003/IS

EU/1/05/312/001/IS

EU/1/05/312/001/NO

Tarceva

Xyrem

Xyrem

EU/1/05/313/001/NO-009/NO

Vasovist

EU/1/05/313/001-009

EU/1/05/313/001-009/IS

EU/1/05/314/001

EU/1/05/314/001/IS

EU/1/05/314/001/NO

EU/1/05/315/001

EU/1/05/315/001/IS

EU/1/05/315/001/NO

Vasovist

Vasovist

Kepivance

Kepivance

Kepivance

Aptivus

Aptivus

Aptivus

EU/1/05/316/001/NO-014/NO

Procoralan

EU/1/05/316/001-014

EU/1/05/316/001-014/IS

Procoralan

Procoralan

Iceland

Iceland

Norway

Norway

18.10.2005

18.11.2005

18.11.2005

14.10.2005

Liechtenstein

30.11.2005

Iceland

2.11.2005

Liechtenstein

30.11.2005

Iceland

24.11.2005

Norway

22.11.2005

Liechtenstein

30.11.2005

Iceland

25.11.2005

Norway

Norway

2.11.2005

10.11.2005

Liechtenstein

30.11.2005

Iceland

24.11.2005

EU/1/05/317/001/NO-014/NO

Corlentor

Norway

10.11.2005

EU/1/05/317/001-014

EU/1/05/317/001-014/IS

Corlentor

Corlentor

EU/1/05/318/001

EU/1/05/318/001/IS

EU/1/05/318/001/NO

EU/1/05/319/001/NO-002/NO

EU/1/05/319/001-002

EU/1/05/319/001-002/IS

EU/1/05/320/001

EU/1/05/320/001/IS

EU/1/05/320/001/NO

Revatio

Revatio

Revatio

Xolair

Xolair

Xolair

Noxafil

Noxafil

Noxafil

Liechtenstein

30.11.2005

Iceland

24.11.2005

Liechtenstein

30.11.2005

Iceland

28.11.2005

Norway

Norway

11.11.2005

7.11.2005

Liechtenstein

30.11.2005

Iceland

25.11.2005

Liechtenstein

30.11.2005

Iceland

20.11.2005

Norway

23.11.2005

EU/1/05/321/001

Posaconazole SP

Liechtenstein

30.11.2005

EU/1/05/321/001/IS

Posaconazole SP

Iceland

24.11.2005

EU/1/05/321/001/NO

Posaconazole SP

Norway

23.11.2005

EU/2/01/030/003-004

Virbagen Omega

Liechtenstein

30.9.2005

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

Purevax RCPCh Fel V, powder and
solv. for susp. for injection

Iceland

30.6.2005

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

Purevax RCP Fel V, powder and
solv. for susp. for injection

Iceland

30.6.2005

C 291/72

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Official Journal of the European Union

30.11.2006

EU-Number

Product

Country

Date of authorisation

EU/2/04/049/001-002/IS

EU/2/04/050/001-002/IS

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

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

Purevax RCCh, powder and solvent
for suspension for injection

Purevax RCPCh, powder and solv.
for susp. for injection

Purevax RC, powder and solvent for
suspension for injection

Purevax RCP, powder and solvent
for suspension for injection

Iceland

30.6.2005

Iceland

30.6.2005

Iceland

30.6.2005

Iceland

30.6.2005

EU/2/05/053/001

Naxcel

Liechtenstein

31.7.2005

EU/2/05/053/001/IS

Naxcel, suspension for injection

EU/2/05/053/001/NO

Naxcel

EU/2/05/054/001/NO-017/NO

Profender

Iceland

Norway

Norway

9.6.2005

17.6.2005

30.8.2005

EU/2/05/054/001-017

Profender

Liechtenstein

30.9.2005

EU/2/05/054/001-017/IS

Profender Spot-on solution

EU/2/05/055/001/NO-002/NO

Equilis Te

Iceland

Norway

26.8.2005

12.8.2005

EU/2/05/055/001-002

Equilis Te

Liechtenstein

30.9.2005

EU/2/05/055/001-002/IS

Equilis Te, susp. for injection

EU/2/05/056/001/NO-002/NO

Equilis Prequenza

Iceland

Norway

2.8.2005

12.8.2005

EU/2/05/056/001-002

Equilis Prequenza

Liechtenstein

30.9.2005

EU/2/05/056/001-002/IS

Equilis Prequenza, susp.
tion

for injec-

Iceland

2.08.2005

EU/2/05/057/001/NO-002/NO

Equilis Prequenza Te

Norway

12.8.2005

EU/2/05/057/001-002

Equilis Prequenza Te

Liechtenstein

30.9.2005

EU/2/05/057/001-002/IS

Equilis Prequenza Te, susp. for injec-
tion

Iceland

2.8.2005

EU/2/97/004/011

EU/2/97/004/012-013

Metacam

Metacam

Liechtenstein

31.7.2005

Liechtenstein

30.9.2005

30.11.2006

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Official Journal of the European Union

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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 June — 31
December 2005:

EU-Number

Product

Country

Date of renewal

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

Azopt

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

Azopt, eye drops, suspension, 1%

EU/1/05/131/001/NO-005/NO

PegIntron

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

EU/1/00/131/031-050

PegIntron

PegIntron

Norway

Iceland

Norway

Iceland

30.6.2005

30.6.2005

24.06.2005

28.6.2005

Liechtenstein

30.9.2005

EU/1/05/132/001/NO-005/NO

ViraferonPeg

Norway

24.6.2005

EU/1/00/132/001-050

ViraferonPeg

Liechtenstein

31.7.2005

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

ViraferonPeg

EU/1/00/133/001/NO-008/NO

Optisulin

EU/1/00/133/001-008

EU/1/00/133/001-008/IS

Optisulin

Optisulin

EU/1/00/134/001/NO-029/NO

Lantus

Iceland

Norway

28.6.2005

27.7.2005

Liechtenstein

30.9.2005

Iceland

Norway

29.8.2005

27.7.2005

EU/1/00/134/001-007, 012-029

Lantus

Liechtenstein

30.9.2005

EU/1/00/134/001-029/IS

Lantus

Iceland

29.8.2005

EU/1/00/135/001

DaTSCAN

Liechtenstein

30.9.2005

EU/1/00/135/001/NO-002/NO

DaTSCAN

EU/1/00/135/001-002/IS

DaTSCAN

EU/1/00/137/001/NO-012/NO

Avandia

EU/1/00/137/001-012

EU/1/00/137/001-012/IS

EU/1/00/140/001

EU/1/00/140/001/IS

Avandia

Avandia

Visudyne

Visudyne 15 mg Powder for solu-
tion for injection

Norway

Iceland

Norway

20.9.2005

11.10.2005

27.7.2005

Liechtenstein

30.9.2005

Iceland

16.9.2005

Liechtenstein

31.7.2005

Iceland

14.7.2005

EU/1/00/140/001/NO

Visudyne

Norway

27.7.2005

EU/1/00/141/001

EU/1/00/141/001/IS

EU/1/00/141/001/NO

Myocet

Myocet

Myocet

EU/1/00/142/004/NO-005/NO

NovoMix Penfill

Liechtenstein

30.9.2005

Iceland

Norway

Norway

13.10.2005

28.9.2005

13.10.2005

EU/1/00/142/004-005

NovoMix

Liechtenstein

30.9.2005

EU/1/00/142/004-005/IS

NovoMix 30 Penfill

EU/1/00/142/009/NO-010/NO

NovoMix Flexpen

EU/1/00/142/009-010/IS

NovoMix 30 FlexPen

Iceland

Norway

Iceland

21.10.2005

13.10.2005

21.10.2005

C 291/74

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Official Journal of the European Union

30.11.2006

EU-Number

Product

Country

Date of renewal

EU/1/00/143/001/NO-006/NO

Kogenate Bayer

Norway

7.9.2005

EU/1/00/143/001-006

Kogenate

Liechtenstein

30.9.2005

EU/1/00/143/001-006/IS

Kogenate Bayer

EU/1/00/144/001/NO-003/NO

Helixate NexGen

Iceland

Norway

7.10.2005

7.9.2005

EU/1/00/144/001-003

Helixate

Liechtenstein

30.9.2005

EU/1/00/144/001-003/IS

Helixate NexGen

Iceland

7.10.2005

EU/1/00/145/001

EU/1/00/145/001/IS

EU/1/00/145/001/NO

Herceptin

Herceptin

Herceptin

EU/1/00/146/001/NO-029/NO

Keppra

EU/1/00/146/001-029

EU/1/00/146/001-029/IS

Keppra

Keppra

Liechtenstein

30.9.2005

Iceland

Norway

Norway

28.11.2005

23.9.2005

08.8.2005

Liechtenstein

30.9.2005

Iceland

12.9.2005

EU/1/00/148/001/NO-004/NO

Agenerase

Norway

12.12.2005

EU/1/00/148/001-004

EU/1/00/148/001-004/IS

EU/1/00/149/001

EU/1/00/149/001/IS

EU/1/00/149/001/NO

EU/1/00/150/001/NO-015/NO

EU/1/00/150/001-015

EU/1/00/150/001-015/IS

Agenerase

Agenerase

Panretin

Panretin

Panretin

Actos

Actos

Actos

EU/1/00/151/001/NO-013/NO

Glustin

EU/1/00/151/001-013

EU/1/00/151/001-013/IS

Glustin

Glustin

Liechtenstein

30.11.2005

Iceland

16.12.2005

Liechtenstein

30.11.2005

Iceland

Norway

Norway

16.12.2005

9.12.2005

2.11.2005

Liechtenstein

30.11.2005

Iceland

Norway

11.11.2005

2.11.2005

Liechtenstein

30.11.2005

Iceland

11.11.2005

EU/1/00/152/001-018

Infanrix hexa

Liechtenstein

30.11.2005

EU/1/00/153/001-010

Infanrix penta

Liechtenstein

30.11.2005

EU/1/00/153/001-010/IS

Infanrix penta

EU/1/00/153/001-010/NO

Infanrix penta

EU/1/00152/001-018/NO

Infanrix hexa

EU/1/95/001/001,
009,
012, 021-022, 025-028, 031-035/IS

003-005,

Gonal-F

EU/1/95/001/001/NO

Gonal-F

EU/1/95/001/003/NO-006/NO

Gonal-F

EU/1/95/001/009/NO

EU/1/95/001/012/NO

Gonal-F

Gonal-F

Iceland

Norway

Norway

Iceland

Norway

Norway

Norway

Norway

16.12.2005

7.12.2005

7.12.2005

15.11.2005

11.11.2005

11.11.2005

11.11.2005

11.11.2005

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EU-Number

Product

Country

Date of renewal

EU/1/95/001/021/NO-022/NO

EU/1/95/001/025/NO-028/NO

EU/1/95/001/031/NO-035/NO

Gonal-F

Gonal-F

Gonal-F

Norway

Norway

Norway

11.11.2005

11.11.2005

11.11.2005

EU/1/98/093/002

Forcaltonin

Liechtenstein

31.7.2005

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

EU/1/99/127/001-044

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

IntronA

IntronA

IntronA

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

Viraferon

EU/1/99/128/001-037

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

EU/2/00/018/001

EU/2/00/018/001/NO

EU/2/00/022//002b-03a

EU/2/00/022/001/NO-017/NO

EU/2/00/022/001-017/IS

EU/2/00/022/001a

EU/2/00/022/001b-02a

EU/2/00/022/003b-04a

EU/2/00/022/004b

EU/2/00/022/005-017

EU/2/00/024/001/IS

Viraferon

Viraferon

Incurin

Incurin

Ibaflin

Ibaflin

Ibaflin

Ibaflin

Ibaflin

Ibaflin

Ibaflin

Ibaflin

Pruban

EU/2/99/016/001/NO-006/NO

Porcilis Pesti

EU/2/99/016/001-006

EU/2/99/016/001-006/IS

Porcilis Pesti

Porcilis Pesti

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

Ibraxion

Norway

20.6.2005

Liechtenstein

31.7.2005

Iceland

Norway

27.6.2005

20.6.2005

Liechtenstein

31.7.2005

Iceland

27.6.2005

Liechtenstein

31.7.2005

Norway

16.6.2005

Liechtenstein

30.9.2005

Norway

Iceland

31.8.2005

15.07.2005

Liechtenstein

30.9.2005

Liechtenstein

30.9.2005

Liechtenstein

30.9.2005

Liechtenstein

30.9.2005

Liechtenstein

30.9.2005

Iceland

Norway

16.12.2005

18.7.2005

Liechtenstein

31.7.2005

Iceland

Norway

13.7.2005

2.6.2005

C 291/76

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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 June — 31
December 2005:

EU-Number

Product

Country

Date of extention

EU/1/00/142/011/NO-013/NO

NovoMix Penfill 50

Norway

1.11.2005

EU/1/00/142/001-013/IS

NovoMix 50 Penfill suspension for injection

Iceland

5.10.2005

EU/1/00/142/014/NO-016/NO

NovoMix Flexpen 50

Norway

1.11.2005

EU/1/00/142/014-016/IS

NovoMix 50 FlexPen suspension for injec-
tion

Iceland

5.10.2005

EU/1/00/142/017/NO-019/NO

NovoMix Penfill 70

Norway

1.11.2005

EU/1/00/142/017-019/IS

NovoMix 70 Penfill suspension for injection

Iceland

5.10.2005

EU/1/00/142/020/NO-022/NO

NovoMix Flexpen 70

Norway

1.11.2005

EU/1/00/142/020-022/IS

NovoMix 70 FlexPen suspension for injec-
tion

Iceland

5.10.2005

EU/1/03/265/003/NO-004/NO

Bonviva, film-coated tablets

Norway

28.9.2005

EU/1/03/265/003-004/IS

Bonviva, film-coated tablets

Iceland

25.10.2005

EU/1/03/266/003/NO-004/NO

Bondenza, film-coated tablets

Norway

28.9.2005

EU/1/03/266/003-004/IS

Bondenza, film-coated tablets

Iceland

21.10.2005

EU/1/04/276/021/NO-023/NO

Abilify, orodispersible tablet 5 mg

Norway

18.7.2005

EU/1/04/276/021-023/IS

Abilify, orodispersible tablet 5 mg

Iceland

14.7.2005

EU/1/04/276/024/NO-026/NO

Abilify, orodispersible tablet 10 mg

Norway

18.7.2005

EU/1/04/276/024-026/IS

Abilify, orodispersible tablet 10 mg

Iceland

14.7.2005

EU/1/04/276/027/NO-029/NO

Abilify, orodispersible tablet 15 mg

Norway

18.7.2005

EU/1/04/276/027-029/IS

Abilify, orodispersible tablet 15 mg

Iceland

14.7.2005

EU/1/04/276/030/NO-032/NO

Abilify, orodispersible tablet 30 mg

Norway

18.7.2005

EU/1/04/276/030-032/IS

Abilify, orodispersible tablet 30 mg

Iceland

14.7.2005

EU/1/04/276/033/NO-035/NO

Abilify 1mg/ml, oral solution

Norway

9.11.2005

EU/1/04/276/033-035/IS

Abilify 1 mg/ml, oral solution

EU/1/96/026/002/IS

Invirase, filmcoated tablet 500 mg

EU/1/96/026/002/NO

Invirase

EU/2/97/004/012/NO-013/NO

Metacam, 0,5 mg/ml oral suspension for
dogs

Iceland

Iceland

1.12.2005

19.7.2005

Norway

9.6.2005

Norway

5.9.2005

EU/2/97/004/012-013/IS

Metacam, 0,5 mg/ml oral suspension for
dogs

Iceland

2.9.2005

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ANNEX IV

4. Withdrawn Marketing Authorisations

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

EU-Number

Product

Country

Date of withdrawal

EU/1/00/158/001-034/IS

Opulis

EU/1/00/168/001/NO-006/NO

Tenecteplase

Iceland

Norway

9.9.2005

9.8.2005

EU/1/00/168/001-006

Tenecteplase

Liechtenstein

30.9.2005

EU/1/02/208/001-008/IS

EU/1/02/210/001/NO-008/NO

EU/1/02/210/001-008

EU/1/02/210/001-008/IS

EU/1/02/242/001-024

Xapit

Rayzon

Rayzon

Rayzon

Valdyn

EU/1/02/242/001-024/IS

Valdyn, filmcoated tablets

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

EU/1/02/244/001-024/IS

Valdyn

Valdyn

EU/1/96/009/010/NO-017/NO

Zerit

EU/1/96/009/010-017/IS

Zerit prolonged-release capsules

EU/1/96/023/001

EU/1/96/023/001/IS

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

Cea-Scan

CEA-Scan

Infanrix HepB, suspension for injec-
tion

Iceland

Norway

9.9.2005

22.7.2005

Liechtenstein

31.7.2005

Iceland

5.7.2005

Liechtenstein

30.9.2005

Iceland

Norway

5.07.2005

22.7.2005

Liechtenstein

31.7.2005

Norway

Iceland

30.9.2005

29.11.2005

Liechtenstein

30.11.2005

Iceland

Iceland

9.11.2005

15.6.2005

EU/2/00/023/001-003

Pulsaflox

Liechtenstein

30.11.2005

ANNEX V

5. Suspended Marketing Authorisations

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

EU-Number

Product

Country

Date of suspension

EU/1/00/147/001/NO-012/NO

Hexavac

Norway

17.11.2005

EU/1/00/147/001-008

EU/1/00/147/001-008/IS

Hexavac

Hexavac

Liechtenstein

30.11.2005

Iceland

17.11.2005