List of marketing authorisations granted by the EEA EFTA States for the first half of 2004
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

28.9.2006

EN

Official Journal of the European Union

C 233/37

List of marketing authorisations granted by the EEA EFTA States for the first half of 2004

(2006/C 233/10)

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 2004:

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List of withdrawn marketing authorisations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 233/38

EN

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 2004:

EU-Number

Product

Country

Date of
authorisation

EU/1/00/141/001/NO

Myocet

Norway

22.1.2004

EU/1/00/164/003-005

NutropinAq

Liechtenstein

31.3.2004

EU/1/02/212/026

Vfend

Liechtenstein

31.3.2004

EU/1/02/215/001-010/IS

PritorPlus tablets 40 mg and 80 mg

Iceland

10.2.2004

EU/1/03/263/001/NO-003/NO

Dukoral

Norway

11.5.2004

EU/1/03/263/001-003

EU/1/03/264/001

EU/1/03/264/001/IS

Dukoral

Zevalin

Liechtenstein

31.5.2004

Liechtenstein

31.1.2004

Zevalin 1.6 mg/ml kit for radiophar-
maceut. prep.

Iceland

13.2.2004

EU/1/03/264/001/NO

Zevalin

Norway

2.2.2004

EU/1/03/265/001/NO-002/NO

Bonviva

Norway

24.3.2004

EU/1/03/265/001-002

Bonviva

Liechtenstein

31.5.2004

EU/1/03/265/001-002/IS

Bonviva filmc. tabl. 2.5 mg

Iceland

23.3.2004

EU/1/03/266/001/NO-002/NO

Ibandronic Acid Roche

Norway

24.3.2004

EU/1/03/266/001-002

Ibandronic Acid Roche

Liechtenstein

31.5.2004

EU/1/03/266/001-002/IS

Ibandronic Acid Roche
2.5 mg

film.

tabl.

Iceland

23.3.2004

EU/1/03/267/001/NO-007/NO

Reyataz

Norway

26.3.2004

EU/1/03/267/001-006/IS

Reyataz
capsule
150 mg, 200 mg

hard

100 mg,

Iceland

30.3.2004

EU/1/03/267/001-007

Reyataz

Liechtenstein

31.3.2004

EU/1/03/267/007/IS

Reyataz oral powder 50 mg/1.5 g

Iceland

30.3.2004

EU/1/03/268/001/NO-003/NO

Cholestagel

Norway

24.3.2004

EU/1/03/268/001-003

Cholestagel

Liechtenstein

31.3.2004

EU/1/03/268/001-003/IS

Cholestagel filmc. tabl. 625 mg

Iceland

5.4.2004

EU/1/03/269/001/IS

EU/1/03/269/001/NO

Faslodex

Faslodex

Iceland

7.4.2004

Norway

6.4.2004

EU/1/03/270/001/NO-002/NO

Oxybutynin Nicobrand

Norway

28.6.2004

28.9.2006

EN

Official Journal of the European Union

C 233/39

EU-Number

Product

Country

Date of
authorisation

EU/1/03/271/001/IS

Advate powder for sol. for inj. 250 IU,
500 IU, 1000 IU, 150

Iceland

1.4.2004

EU/1/03/271/001/NO-004/NO

EU/1/03/271/001-004

Advate

Advate

Norway

29.3.2004

Liechtenstein

31.5.2004

EU/1/04/272/001/NO-002/NO

Photo Barr

Norway

23.4.2004

EU/1/04/272/001-002

Photo Barr

Liechtenstein

31.5.2004

EU/1/04/272/002/IS

Photo Barr Powder for sol. for inj. 15
or 75 mg

Iceland

23.4.2004

EU/1/04/273/001

Lysodren

Liechtenstein

31.5.2004

EU/1/04/273/001/IS

Lysodren tablets 500 mg

Iceland

19.5.2004

EU/1/04/273/001/NO

EU/1/04/274/001

EU/1/04/274/001/IS

Lysodren

Velcade

Velcade powder
3.5 mg

Norway

26.5.2004

Liechtenstein

31.5.2004

for

sol.

for

inj.

Iceland

26.5.2004

EU/1/04/274/001/NO

Velcade

Norway

25.5.2004

EU/1/04/275/001/NO-002/NO

EU/1/04/275/001-002

Litak

Litak

Norway

14.5.2004

Liechtenstein

31.5.2004

EU/1/04/275/001-002/IS

Litak Solution for inj. 2 mg/ml

Iceland

14.5.2004

EU/1/04/276/001/NO-020/NO

Abilify

Norway

24.6.2004

EU/1/04/278/001/NO-009/NO

Levemir

Norway

14.6.2004

EU/1/04/278/001-009/IS

Levemir Penfill/FlexPen/InnoLet, sol f.
inj.

Iceland

25.6.2004

EU/1/95/001/032

EU/1/95/001/033-035

Gonal

Gonal f

Liechtenstein

31.1.2004

Liechtenstein

31.3.2004

EU/1/97/031/045-046

NeoRecormon

Liechtenstein

31.3.2004

EU/1/97/046/016-030

EU/1/97/049/016-030

EU/1/97/054/006

EU/1/98/066/014-018

EU/1/98/085/011-020

EU/1/98/086/011-020

Aprovel

Karvea

Viracept

Exelon

Karvezide

CoAprovel

Liechtenstein

31.5.2004

Liechtenstein

31.5.2004

Liechtenstein

31.5.2004

Liechtenstein

31.3.2004

Liechtenstein

31.5.2004

Liechtenstein

31.5.2004

EU/1/98/091/001-014

Kinzalmono

Liechtenstein

31.1.2004

EU/1/98/092/014-018

Prometax

Liechtenstein

31.3.2004

C 233/40

EN

Official Journal of the European Union

28.9.2006

EU-Number

Product

Country

Date of
authorisation

EU/1/99/099/001-006

EU/1/99/113/003-004

Zerene

Paxene

Liechtenstein

31.5.2004

Liechtenstein

31.1.2004

EU/2/00/022/009-012/IS

Ibaflin oral gel 3% and 7.5%

Iceland

22.1.2004

EU/2/00/022/013-017

Ibaflin

Liechtenstein

31.3.2004

EU/2/02/032/001/IS

Gallivac HVT IDB Frosen susp. And
diluent for inj.

Iceland

13.4.2004

EU/2/04/042/001/NO-004/NO

Novem

Norway

10.5.2004

EU/2/04/042/001-002/IS

Novem sol. for inj. 5 mg/ml

Iceland

31.3.2004

EU/2/04/042/001-004

Novem

Liechtenstein

31.5.2004

EU/2/04/042/003-004/IS

Novem sol. for inj. 20 mg/ml

EU/2/04/043/001/IS

EU/2/97/004/010

EU/2/98/010/001-024

EU/2/99/011/001

Equilis StrepE lyophilisate and solvent
for suspension

Metacam

Econor

Locatim

Iceland

Iceland

31.3.2004

11.6.2004

Liechtenstein

31.3.2004

Liechtenstein

31.5.2004

Liechtenstein

31.5.2004

EU/2/99/014/001-011

Stronghold

Liechtenstein

31.3.2004

28.9.2006

EN

Official Journal of the European Union

C 233/41

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 2004:

EU-Number

Product

Country

Date of
authorisation

EU/1/97/037/001/NO

Vistide

Norway

31.3.2004

EU/1/98/084/001/IS

EU/1/98/084/002/IS

Simulect, powder and solvent for sol.
for injection, 20 mg

Iceland

27.1.2004

Simulect, powder and solvent for sol.
for injection, 10 mg

Iceland

27.1.2004

EU/1/98/085/001-010

Karvezide

Liechtenstein

31.1.2004

EU/1/98/086/001-003,007 and 009/IS

CoAprovel, tablets, 150 mg/12,5 mg

Iceland

23.1.2004

EU/1/98/086/004-006,008 and 010/IS

CoAprovel, tablets, 300 mg/12,5 mg

Iceland

23.1.2004

EU/1/98/086/001-010

CoAprovel

Liechtenstein

31.1.2004

EU/1/98/087/001/NO-003/NO

Infergen

Norway

23.4.2004

EU/1/98/087/001-003

Infergen

Liechtenstein

31.5.2004

EU/1/98/087/001-003/IS

Infergen solution for
micrograms

injection, 9

Iceland

21.6.2004

EU/1/98/089/001-016/IS

Pritor tablets, 20, 40 and 80 mg

Iceland

2.2.2004

EU/1/98/089/001-016/NO

Pritor tablets, 20, 40 and 80 mg

Norway

30.1.2004

EU/1/98/089/001-016

Pritor

Liechtenstein

31.1.2004

EU/1/98/090/001/NO-014/NO

Micardis

Norway

30.1.2004

EU/1/98/090/001-014

Micardis

Liechtenstein

31.1.2004

EU/1/98/090/001-014/IS

Micardis tablets, 20, 40 and 80 mg

Iceland

2.2.2004

EU/1/98/091/001/NO-014/NO

Kinzalmono

Norway

30.1.2004

EU/1/98/091/001-014/IS

Kinzalmono tablets, 20, 40 and
80 mg

Iceland

2.2.2004

EU/1/98/095/001/NO-002/NO

Emadine

Norway

5.4.2004

EU/1/98/095/001-004

Emadine

Liechtenstein

31.3.2004

EU/1/98/095/001-004/IS

Emadine, eye drops, solution, 0,5 mg/
ml

Iceland

1.4.2004

EU/1/98/096/001-002/IS

Temodal, capsule, hard, 5 mg

Iceland

7.4.2004

EU/1/98/096/001/NO-008/NO

Temodal

Norway

6.4.2004

EU/1/98/096/001-008

Temodal

Liechtenstein

31.3.2004

EU/1/98/096/003-004/IS

Temodal, capsule, hard, 20 mg

Iceland

7.4.2004

C 233/42

EN

Official Journal of the European Union

28.9.2006

EU-Number

Product

EU/1/98/096/005-006/IS

Temodal, capsule, hard, 100 mg

EU/1/98/096/007-008/IS

Temodal, capsule, hard, 250 mg

EU/1/99/097/001/NO

EU/1/99/098/001/NO-002/NO

EU/1/99/098/001-002

EU/1/99/098/001-002/IS

Beromun

Zenapax

Zenapax

Zenepax concentrate for solution for
infusion

EU/1/99/099/001-003/IS

Zerene, capsule, hard, 5 mg

EU/1/99/099/004-006/IS

Zerene, capsule, hard, 10 mg

EU/1/99/099/001-006/NO

Zerene 5 mg, 10 mg capsules

EU/1/99/101/001/NO

EU/1/99/101/001

Regranex

Regranex

EU/1/99/101/001/IS

Regranex, gel, 100 mcg/g

EU/1/99/102/001-003 and 007/IS

Sonata, capsule, hard, 5 mg

EU/1/99/102/001/NO-008/NO

EU/1/99/102/001-008

Sonata

Sonata

Country

Iceland

Iceland

Norway

Norway

Date of
authorisation

7.4.2004

7.4.2004

8.6.2004

14.5.2004

Liechtenstein

31.5.2004

Iceland

23.6.2004

Iceland

Iceland

Norway

Norway

28.4.2004

28.4.2004

29.4.2004

30.4.2004

Liechtenstein

31.5.2004

Iceland

Iceland

30.4.2004

29.4.2004

Norway

29.4.2004

Liechtenstein

31.5.2004

EU/1/99/102/004-006 and 008/IS

Sonata, capsule, hard, 10 mg

Iceland

29.4.2004

EU/1/99/110/001/NO-009/NO

EU/1/99/110/001-009

EU/1/99/110/001-009/IS

Sustiva

Sustiva

Norway

24.5.2004

Liechtenstein

31.5.2004

Sustiva
and oral sol.

filmcoated tablets,

capsules

Iceland

28.5.2004

EU/1/99/111/001-009/IS

Stocrin tablets, capsules and oral sol.

Iceland

21.5.2004

EU/1/99/111/001/NO-009/NO

EU/1/99/111/001-009

Stocrin

Stocrin

EU/1/99/111/002/IS

Stocrin, capsule, hard, 100 mg

EU/1/99/111/003-004/IS

Stocrin, capsule, hard, 200 mg

EU/1/99/111/005/IS

Stocrin, oral solution, 30 mg/ml

EU/1/99/111/006-007/IS

Stocrin, film-coated tablet, 300 mg

Karvezide, tablets, 150 mg/12,5 mg

Norway

24.5.2004

Liechtenstein

31.5.2004

Iceland

Iceland

Iceland

Iceland

Iceland

21.5.2004

21.5.2004

21.5.2004

21.5.2004

22.1.2004

EU/1/98/085/004-006, 008, 010,
017-020/IS

EU/1/98/085/001-003, 007, 009,
011-015/IS

Karvezide, tablets, 300 mg/12,5 mg

Iceland

22.1.2004

EU/2/98/009/001/NO-006/NO

Suvaxyn Aujeszky 783+ O/W

Norway

14.4.2004

EU/2/98/009/001-006

Suvaxyn Aujeszky 783+ O/W

Liechtenstein

31.3.2004

EU/2/99/011/001/IS

Locatim oral solution

Iceland

27.5.2004

EU/2/99/011/001/NO

Locatim

Norway

28.5.2004

28.9.2006

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Official Journal of the European Union

C 233/43

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 2004:

EU-Number

Product

Country

Date of extention

EU/1/01/198/007/NO-010/NO

Glivec

EU/1/01/198/007-010/IS

EU/1/02/212/026/IS

EU/1/02/212/026/NO

EU/1/95/001/033/NO-035/NO

EU/1/95/001/033-035/IS

Glivec 100 mg and 400 mg film-
coated tablets

Norway

Iceland

5.1.2004

15.1.2004

Vfend, powder
40 mg/ml

Vfend

Gonal-f

for oral

suspension

Iceland

18.6.2004

Norway

Norway

5.3.2004

24.3.2004

GONAL-f,
prefilled pen

solution for

injection in

Iceland

19.3.2004

EU/1/96/012/009-010/IS

Bondronat, film coated tablets 50 mg

Iceland

7.1.2004

EU/1/97/031/045/NO-046/NO

NeoRecormon

Norway

23.3.2004

EU/1/97/031/045-046/IS

NeoRecormon 30.000 IU Sol.
injection pref.syr.

for

Iceland

30.3.2004

EU/1/97/046/016/NO-030/NO

EU/1/97/049/016/NO-030/NO

Aprovel

Karvea

Norway

Norway

30.3.2004

30.3.2004

EU/1/97/054/006/IS

Viracept 625 mg film-coated tablets

Iceland

28.5.2004

EU/1/97/054/006/NO

Viracept

EU/1/98/085/011/NO-020/NO

Karvezide

EU/1/98/086/011/NO-020/NO

CoAprovel

EU/2/00/022/013/NO-017/NO

Ibaflin

EU/2/97/004/010/NO

Metacam

Norway

Norway

Norway

Norway

Norway

21.5.2004

23.6.2004

23.6.2004

24.3.2004

11.5.2004

C 233/44

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Official Journal of the European Union

28.9.2006

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 2004:

EU-Number

Product

Country

Date of
withdrawal

EU/1/00/158/001/NO-034/NO

EU/1/00/158/001-034

EU/1/00/159/001/NO-034/NO

EU/1/00/159/001-034

EU/1/00/159/001-034/IS

EU/1/02/208/001/NO-008/NO

EU/1/02/208/001-008

Opulis

Opulis

Allex

Allex

Allex

Xapit

Xapit

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

Valdyn

Norway

29.3.2004

Liechtenstein

31.3.2004

Norway

29.3.2004

Liechtenstein

31.3.2004

Iceland

10.3.2004

Norway

29.3.2004

Liechtenstein

31.3.2004

Norway

29.3.2004

EU/1/99/106/001-003

Cotronak

Liechtenstein

31.3.2004

ANNEX V

5. Suspended Marketing Authorisations

The following marketing authorisations have been suspended in the EEA EFTA States during the period 1 January —
30 June 2004:

EU-Number

Product

Country

Date of
suspension

EU/1/98/093/002

Forcaltonin

Liechtenstein

31.5.2004