List of marketing authorisations granted by the EEA EFTA States for the second half of 2003
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 233/28

EN

Official Journal of the European Union

28.9.2006

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

(2006/C 233/09)

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 July — 31 December 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List of withdrawn marketing authorisations

28.9.2006

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Official Journal of the European Union

C 233/29

1. New Marketing Authorisations:

ANNEX I

The following marketing authorisations have been granted in the EEA EFTA States during the period 1 July —
31 December 2003:

EU-Number

Product

Country

Date of
authorisation

EU/1/00/141/001/IS

Myocet conc. F. inf. Liposomes

Iceland

31.7.2003

EU/1/00/150/011-015

EU/1/00/151/009-013

EU/1/00/165/007

EU/1/02/206/005-008

EU/1/02/207/005-008

EU/1/02/219/010-013

Actos

Glustin

Ovitrelle

Arixtra

Quixidar

Ebixa

Liechtenstein

30.9.2003

Liechtenstein

30.9.2003

Liechtenstein

30.11.2003

Liechtenstein

30.11.2003

Liechtenstein

30.11.2003

Liechtenstein

30.9.2003

EU/1/02/229/036-037

Actraphane

Liechtenstein

30.9.2003

EU/1/02/230/016-017

EU/1/02/231/036-037

EU/1/02/232/003

EU/1/02/233/016-017

EU/1/02/234/016-017

EU/1/02/240/004

Actrapid

Mixtard

Velosulin

Insulatard

Protaphane

Somavert

EU/1/02/242/001-010/IS

Valdyn tablets 10 mg

EU/1/02/242/011-020/IS

Valdyn tablets 20 mg

EU/1/02/242/021-024/IS

Valdyn tablets 40 mg

EU/1/02/244/001-010/IS

Kudeq tablets 10 mg

EU/1/02/244/011-020/IS

Kudeq tablets 20 mg

EU/1/02/244/021-024/IS

Kudeq tablets 40 mg

Liechtenstein

30.9.2003

Liechtenstein

30.9.2003

Liechtenstein

30.9.2003

Liechtenstein

30.9.2003

Liechtenstein

30.9.2003

Liechtenstein

30.9.2003

Iceland

Iceland

Iceland

Iceland

Iceland

Iceland

1.7.2003

1.7.2003

1.7.2003

1.7.2003

1.7.2003

1.7.2003

EU/1/03/247/001-002

Forsteo

Liechtenstein

31.7.2003

EU/1/03/247/001-002/IS

Forsteo sol for inj. in prefilled pen

Iceland

8.7.2003

EU/1/03/252/001-003

Fuzeon

Liechtenstein

31.7.2003

EU/1/03/253/001-003

EU/1/03/253/001-003/IS

EU/1/03/254/001

Aldurazyme

Aldurazyme
100 U/ml

Busilvex

Liechtenstein

31.7.2003

conc.

for

sol.

f.

inf.

Iceland

21.7.2003

Liechtenstein

30.9.2003

EU/1/03/254/001/IS

Busilvex 6 mg/ml conc.f. sol. f.inf.

Iceland

22.7.2003

EU/1/03/254/001/NO

Busilvex

Norway

17.7.2003

C 233/30

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Official Journal of the European Union

28.9.2006

EU-Number

Product

Country

Date of
authorisation

EU/1/03/255/001/NO-003/NO

Ventavis

Norway

30.10.2003

EU/1/03/255/001-003/IS

Ventavis Nebul. sol.- Inhal. 10 microg/
ml

Iceland

15.10.2003

EU/1/03/256/001/NO-006/NO

EU/1/03/256/001-006

Humira

Humira

Norway

11.9.2003

Liechtenstein

30.9.2003

EU/1/03/256/001-006/IS

Humira solution for injection

Iceland

25.9.2003

EU/1/03/257/001/NO-006/NO

Trudexa

Norway

17.9.2003

EU/1/03/257/001-006

Trudexa

Liechtenstein

30.9.2003

EU/1/03/257/001-006/IS

Trudexa solution for injection

Iceland

29.9.2003

EU/1/03/258/001/NO-006/NO

Avandamet

Norway

18.11.2003

EU/1/03/258/001-003/IS

Avandamet tabl. 1mg/500 mg

Iceland

19.11.2003

EU/1/03/258/001-006

Avandamet

Liechtenstein

30.11.2003

EU/1/03/258/004-006/IS

Avandamet tabl. 2mg/500mg

Iceland

19.11.2003

EU/1/03/259/001/NO-006/NO

Onsenal

Norway

5.11.2003

EU/1/03/259/001-004/IS

Onsenal Hard capsules 200 mg

Iceland

16.12.2003

EU/1/03/259/001-006

Onsenal

Liechtenstein

30.11.2003

EU/1/03/259/005-006/IS

Onsenal Hard capsules 400 mg

Iceland

16.12.2003

EU/1/03/260/001/NO-012/NO

Stalevo

Norway

5.11.2003

EU/1/03/260/001-004/IS

Stalevo tabl. 50/12.5/200 mg

Iceland

31.10.2003

EU/1/03/260/001-012

Stalevo

Liechtenstein

30.11.2003

EU/1/03/260/005-008/IS

Stalevo tab. 100/25/200 mg

Iceland

31.10.2003

EU/1/03/260/009-012/IS

Stalevo tabl. 150/37.5/200 mg

Iceland

31.10.2003

EU/1/03/261/001/NO-003/NO

Emtriva

Norway

5.11.2003

EU/1/03/261/001-002/IS

Emtriva hard caps. 200 mg

Iceland

8.11.2003

EU/1/03/261/001-003

Emtriva

Liechtenstein

30.11.2003

EU/1/03/261/003/IS

Emtriva oral sol. 10mg/ml

Iceland

8.11.2003

EU/1/03/262/001/NO-006/NO

Emend

Norway

15.12.2003

EU/1/03/262/001-003/IS

Emend hard caps. 80 mg

Iceland

11.12.2003

EU/1/03/262/004-006/IS

Emend
125 mg (comb.)

hard

caps.

80 mg

and

Iceland

11.12.2003

EU/1/03/262/005/IS

Emend hard caps. 125 mg

Iceland

11.12.2003

EU/1/96/012/001-013

Bondronat

Liechtenstein

30.11.2003

EU/1/96/015/004-005

Epivir

Liechtenstein

30.9.2003

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C 233/31

EU-Number

Product

Country

Date of
authorisation

EU/1/97/033/003

EU/1/98/064/001/NO

EU/1/98/076/001/NO-002/NO,
004/NO-009/NO

EU/1/98/076/011/NO-016/NO,
018/NO-021/NO

Avonex

Pylobactell

NovoNorm

NovoNorm

Liechtenstein

31.7.2003

Norway

Norway

1.7.2003

15.8.2003

Norway

15.8.2003

EU/1/99/119/012-014

NovoRapid

Liechtenstein

31.7.2003

EU/2/00/025/001/NO-006/NO

Bayovac CSF E2

EU/2/00/027/001/NO-003/NO

Pirsue

EU/2/01/030/001/IS

EU/2/01/030/002/IS

Virbagen Omega powd. & solv.
susp. f. inj. 5 MU

for

Virbagen Omega powd. & solv.
susp. f. inj. 10 MU

for

Norway

Norway

8.9.2003

2.9.2003

Iceland

10.12.2003

Iceland

10.12.2003

EU/2/02/035/001/NO-006/NO

SevoFlo

Norway

2.9.2003

EU/2/02/035/001-006/IS

SevoFlo Inhalation vapour,
dogs

liquid for

Iceland

1.8.2003

EU/2/03/039/001-004 & 013-014/IS

Advocate spot on sol. for cats

EU/2/03/039/005-012 & 015-018/IS

Advocate spot on sol for dogs

EU/2/03/039/013-018

EU/2/03/040/001

EU/2/03/040/001/IS

EU/2/03/040/001/NO

EU/2/03/041/001/NO-005/NO

EU/2/03/041/001-005

EU/2/03/041/001-005/IS

Advocate

Gonazon

Gonazon solution injection 1.600
microg/ml

Gonazon

Draxxin

Draxxin

Draxxin sol for injection, cattle and
pigs

EU/2/97/003/001-018

EU/2/97/004/009

Dicural

Metacam

Iceland

Iceland

25.9.2003

25.9.2003

Liechtenstein

31.7.2003

Liechtenstein

30.9.2003

Iceland

30.10.2003

Norway

Norway

18.8.2003

10.12.2003

Liechtenstein

30.11.2003

Iceland

12.12.2003

Liechtenstein

30.9.2003

Liechtenstein

30.11.2003

C 233/32

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Official Journal of the European Union

28.9.2006

2. Renewed Marketing Authorisations

ANNEX II

The following marketing authorisations have been renewed in the EEA EFTA States during the period 1 July —
31 December 2003:

EU-Number

Product

Country

Date of
authorisation

EU/1/00/162/001-006/IS

Prandin 0.5 mg tablets

Iceland

25.9.2003

EU/1/00/162/001-018

EU/1/00/162/001-018/NO

Prandin

Prandin

Liechtenstein

30.9.2003

Norway

15.8.2003

EU/1/00/162/007-012/IS

Prandin 1 mg tablets

Iceland

25.9.2003

EU/1/00/162/013-018/IS

Prandin 2 mg tablets

Iceland

25.9.2003

EU/1/97/047/001/NO-003/NO

Benefix

Norway

30.12.2003

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

InfanrixHep B

Norway

20.11.2003

EU/1/97/051/001/NO-006/NO,
009/NO-012/NO

Mirapexin

Norway

1.9.2003

EU/1/98/058/001-002

Combivir

Liechtenstein

31.7.2003

EU/1/98/058/001-002/IS

Combivir 150/300 mg film coated
tablets

Iceland

16.9.2003

EU/1/98/058/001-002/NO

Combivir

Norway

7.7.2003

EU/1/98/063/001-003/IS

Rebif 22 microg/0.5 ml. solution for
injection

Iceland

18.9.2003

EU/1/98/063/001-006

EU/1/98/063/001-006/NO

EU/1/98/063/004-006/IS

Rebif

Rebif

Liechtenstein

31.7.2003

Norway

19.8.2003

Rebif 44 microg/0.5 ml. solution for
injection

Iceland

18.9.2003

EU/1/98/064/001

Pylobactell

Liechtenstein

31.7.2003

EU/1/98/064/001/IS

Pylobactell 100 mg soluble tablet

Iceland

21.10.2003

EU/1/98/066/001-003/IS

Exelon capsules hard, 1.5 mg

Iceland

26.8.2003

EU/1/98/066/001-013

EU/1/98/066/001-013/NO

Exelon

Exelon

Liechtenstein

31.7.2003

Norway

15.7.2003

EU/1/98/066/004-006/IS

Exelon capsules hard, 3 mg

Iceland

26.8.2003

EU/1/98/066/007-009/IS

Exelon capsules hard, 4.5 mg

Iceland

26.8.2003

EU/1/98/066/010-012/IS

Exelon capsules hard, 6 mg

Iceland

26.8.2003

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C 233/33

EU-Number

Product

Country

Date of
authorisation

EU/1/98/066/013/IS

Exelon oral solution 2 mg/ml

Iceland

26.8.2003

EU/1/98/067/001/IS

MabThera Concentrate for solution for
infusion 100 mg

Iceland

13.10.2003

EU/1/98/067/001-002

Mabthera

Liechtenstein

30.9.2003

EU/1/98/067/001-002/NO

Mabthera

Norway

6.8.2003

EU/1/98/067/002/IS

MabThera Concentrate for solution for
infusion 500 mg

Iceland

13.10.2003

EU/1/98/069/001-004/IS

Plavix tablets 75 mg

Iceland

20.11.2003

EU/1/98/069/001a, 1b, 2a, 2b, 3a, 3b,
4a, 4b

Plavix

EU/1/98/069/001a, 1b, 2a, 2b, 3a, 3b,
4a, 4b/NO

Plavix

Liechtenstein

30.11.2003

Norway

7.11.2003

EU/1/98/070/001-004/IS

Iscover tablets 75 mg

Iceland

20.11.2003

EU/1/98/070/001a, 1b, 2a, 2b, 3a, 3b,
4a, 4b

Iscover

EU/1/98/070/001a, 1b, 2a, 2b, 3a, 3b,
4a, 4b/NO

Iscover

Liechtenstein

30.11.2003

Norway

7.11.2003

EU/1/98/071/001-006

Xenical

Liechtenstein

30.11.2003

EU/1/98/071/001-006/IS

Xenical hard capsules 120 mg

Iceland

1.12.2003

EU/1/98/071/001-006/NO

EU/1/98/073/001-004

Xenical

Evista

Norway

24.10.2003

Liechtenstein

30.9.2003

EU/1/98/073/001-004/IS

Evista film coated tablets 60 mg

Iceland

18.9.2003

EU/1/98/073/001-004/NO

Evista

Norway

1.8.2003

EU/1/98/074/001-004

Optruma

Liechtenstein

30.9.2003

EU/1/98/074/001-004/IS

Optruma film coated tablets 60 mg

Iceland

18.9.2003

EU/1/98/074/001-004/NO

Optruma

Norway

1.8.2003

EU/1/98/075/001-002

Fortovase

Liechtenstein

30.9.2003

EU/1/98/075/001-002/IS

Fortovase soft capsule 200 mg

Iceland

19.11.2003

EU/1/98/075/001-002/NO

Fortovase

Norway

8.10.2003

EU/1/98/076/001-002, 004-007/IS

NovoNorm 0.5 mg tablets

Iceland

25.9.2003

EU/1/98/076/001-002, 004-009

NovoNorm

Liechtenstein

30.9.2003

EU/1/98/076/008-009, 011-014/IS

NovoNorm 1 mg tablets

Iceland

25.9.2003

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EU-Number

Product

Country

Date of
authorisation

EU/1/98/076/011-016, 018-021

NovoNorm

Liechtenstein

30.9.2003

EU/1/98/076/015-016, 018-021/IS

NovoNorm 2 mg tablets

Iceland

25.9.2003

EU/1/98/077/001-012

EU/1/98/077/001-012/NO

EU/1/98/080/001

Viagra

Viagra

Aldara

Liechtenstein

30.11.2003

Norway

11.12.2003

Liechtenstein

30.11.2003

EU/1/98/080/001/IS

Aldara cream 5%

Iceland

3.12.2003

EU/1/98/080/001/NO

EU/1/98/081/001-004

Aldara

Comtan

Norway

14.11.2003

Liechtenstein

30.11.2003

EU/1/98/081/001-004/IS

Comtan filmcoated tablets

Iceland

16.12.2003

EU/1/98/081/001-004/NO

EU/1/98/082/001-004

Comtan

Comtess

Norway

3.11.2003

Liechtenstein

30.11.2003

EU/1/98/082/001-004/IS

Comtess filmcoated tablets

Iceland

27.11.2003

EU/1/98/082/001-004/NO

EU/1/98/084/001-002

EU/1/98/084/001-002/NO

Comtess

Simulect

Simulect

Norway

14.11.2003

Liechtenstein

30.11.2003

Norway

18.11.2003

EU/1/98/085/001/NO-010/NO

Karvezide

Norway

18.12.2003

EU/1/98/086/001/NO-010/NO

CoAprovel

Norway

19.12.2003

EU/1/98/092/001-003/IS

Prometax capsules hard 1.5 mg

Iceland

29.8.2003

EU/1/98/092/001-013

Prometax

Liechtenstein

31.7.2003

EU/1/98/092/001-013/NO

Prometax

Norway

15.7.2003

EU/1/98/092/004-006/IS

Prometax capsules hard, 3 mg

Iceland

29.8.2003

EU/1/98/092/007-009/IS

Prometax capsules hard, 4.5 mg

Iceland

29.8.2003

EU/1/98/092/010-012/IS

Prometax capsules hard, 6 mg

Iceland

29.8.2003

EU/1/98/092/013/IS

Prometax oral solution 2mg/ml

Iceland

29.8.2003

EU/2/96/002/001-003/IS

Fevaxyn Pentofelsol. for inject.

Iceland

15.10.2003

EU/2/97/003/001-003/IS

Dicural 100 mg/ml oral solution

Iceland

12.10.2003

EU/2/97/003/001-018/NO

Dicural

Norway

21.8.2003

EU/2/97/003/004-015/IS

Dicural 15 mg, 50 mg, 100 mg,
150 mg film coated tablets

Iceland

12.10.2003

EU/2/97/003/016-018/IS

Dicural 50 mg/ml solution for inject.

Iceland

12.10.2003

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EU-Number

Product

Country

Date of
authorisation

EU/2/97/004/001/IS

EU/2/97/004/003-005/IS

EU/2/97/004/006/IS

EU/2/97/004/007-008/IS

EU/2/97/005/001, 005/IS

Metacam 5 mg/ml solution for injec-
tion for cattle

Iceland

8.7.2003

Metacam 1.5 mg/ml oral suspension
for dogs

Iceland

8.7.2003

Metacam 5 mg/ml solution for injec-
tion for dogs and cats

Iceland

8.7.2003

Metacam 20 mg/ml solution for injec-
tion for cattle

Quadrisol oral gel for horses 100 mg/
ml

Iceland

8.7.2003

Iceland

27.10.2003

Iceland

Iceland

Iceland

27.10.2003

27.10.2003

27.10.2003

EU/2/97/005/002-003, 006-007/IS

Quadrisol oral gel for dogs 5 mg/ml

EU/2/97/005/004/IS

Quadrisol sol. for injection

EU/2/97/005/008-009/IS

Quadrisol oral gel for dogs 1 mg/ml

EU/2/98/006/001-010

Nobilis IB 4-91

Liechtenstein

30.9.2003

EU/2/98/006/001-010/IS

Nobilis IB 4-91 sol. for injection

Iceland

21.10.2003

EU/2/98/006/001-010/NO

Nobilis IB 4-91

EU/2/98/007/00/NO-003/NO

Clomicalm

EU/2/98/007/001-003/IS

Clomicalm tablets 5 mg, 20 mg,
80 mg

Norway

Norway

8.8.2003

1.9.2003

Iceland

27.10.2003

EU/2/98/008/001-004/IS

Neocolipor suspension for injection

Iceland

22.10.2003

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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 July —
31 December 2003:

EU-Number

Product

Country

Date of extention

EU/1/00/146/027/IS

Keppra oral solution

Iceland

19.8.2003

EU/1/00/150/011/NO-015/NO

Actos

Norway

25.9.2003

EU/1/00/150/011-015/IS

Actos tablets 45 mg

Iceland

27.11.2003

for

inj. 250 microg/

Iceland

16.12.2003

EU/1/00/165/007/IS

EU/1/00/165/007/NO

EU/1/02/206/005/NO-008/NO

EU/1/02/206/005-008/IS

Ovitrelle, sol.
0.5 ml

Ovitrelle

Arixtra

Arixtra solution for injection, 1.5 mg/
0.3 ml.

Norway

Norway

Iceland

7.11.2003

21.11.2003

4.12.2003

EU/1/02/207/00/NO-008/NO

Quixidar

Norway

21.11.2003

EU/1/02/207/005-009/IS

Quixidar
1.5 mg/0.3 ml

solution

for

injection,

Iceland

4.12.2003

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

Zerit caps. prolonged release

EU/1/96/012/009/NO-013/NO

Bondronat

EU/1/96/015/003/NO,
EU/1/96/015/004/NO-005/NO

Epivir

Iceland

Norway

Norway

9.10.2003

5.11.2003

29.7.2003

EU/1/97/033/003/IS

Avonex sol. for injection 30 microg/
0.5 ml

Iceland

7.11.2003

EU/1/97/033/003/NO

Avonex

Norway

4.7.2003

EU/2/97/004/009/IS

Metacam oral suspention for horses

Iceland

29.10.2003

EU/2/97/004/009/NO

Metacam

Norway

24.10.2003

ANNEX IV

4. Withdrawn Marketing Authorisations

The following marketing authorisations have been withdrawn in the EEA EFTA States during the period 1 July —
31 December 2003:

EU-Number

Product

Country

Date of
withdrawal

EU/1/96/021/001-010/IS

Olansek

Iceland

1.7.2003