Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 December 2006 to 31 December 2006 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
Date: 2007-01-26
Institutions: European Commission
Subjects: EU Member State, market approval, marketing standard, medicinal product, pharmaceutical legislation, withdrawal from the market

C 18/4

EN

Official Journal of the European Union

26.1.2007

Summary of Community decisions on marketing authorizations in respect of medicinal products
from 1 December 2006 to 31 December 2006

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2))

(2007/C 18/03)

— Issuing, maintenance or modification of a national marketing authorisation

Date of the
decision

Name(s) of the medicinal
product

Holder(s) of the
marketing authorization

Member State concerned

Date of notification

13.12.2006

Glucomed

See Annex I

See Annex I

14.12.2006

13.12.2006

Agopton

See Annex II

See Annex II

14.12.2006

— Suspension of a national marketing authorization

Date of the
decision

Name(s) of the medicinal
product

Holder(s) of the
marketing authorization

Member State concerned

Date of notification

19.12.2006

Cetirizine Nordic Drugs

See Annex III

See Annex III

21.12.2006

19.12.2006

Cetirizine Dermapharm

See Annex IV

See Annex IV

21.12.2006

19.12.2006

Cetirizine Apex

See Annex V

See Annex V

21.12.2006

(1) OJ L 311, 28.11.2001, p. 67.
(2) OJ L 311, 28.11.2001, p. 1.

26.1.2007

EN

Official Journal of the European Union

C 18/5

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF
ADMINISTRATION, APPLICANT, MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES

ANNEX I

Member State

Marketing
Authorisation Holder

Applicant

Invented name

Strength

Pharmaceutical Form

Route of
administration

Austria

Belgium

Cyprus

Czech Republic

Denmark

Estonia

Finland

France

Germany

Greece

Hungary

Ireland

Italy

—

—

—

—

—

—

—

—

—

—

—

—

—

Navamedic ASA
Vollsveien 13 C
N-1327 Lysaker

Navamedic ASA
Vollsveien 13 C
N-1327 Lysaker

Navamedic ASA
Vollsveien 13 C
N-1327 Lysaker

Navamedic ASA
Vollsveien 13 C
N-1327 Lysaker

Navamedic ASA
Vollsveien 13 C
N-1327 Lysaker

Navamedic ASA
Vollsveien 13 C
N-1327 Lysaker

Navamedic ASA
Vollsveien 13 C
N-1327 Lysaker

Navamedic ASA
Vollsveien 13 C
N-1327 Lysaker

Navamedic ASA
Vollsveien 13 C
N-1327 Lysaker

Navamedic ASA
Vollsveien 13 C
N-1327 Lysaker

Navamedic ASA
Vollsveien 13 C
N-1327 Lysaker

Navamedic ASA
Vollsveien 13 C
N-1327 Lysaker

Navamedic ASA
Vollsveien 13 C
N-1327 Lysaker

Flexove

625 mg

Tablet

Oral use

Flexove

625 mg

Tablet

Oral use

Glucomed

625 mg

Tablet

Oral use

Flexove

625 mg

Tablet

Oral use

Glucomed

625 mg

Tablet

Oral use

Glucomed

625 mg

Tablet

Oral use

Glucomed

625 mg

Tablet

Oral use

Glucomed

625 mg

Tablet

Oral use

Glucomed

625 mg

Tablet

Oral use

Glucomed

625 mg

Tablet

Oral use

Flexove

625 mg

Tablet

Oral use

Flexove

625 mg

Tablet

Oral use

Glucomed

625 mg

Tablet

Oral use

C 18/6

EN

Official Journal of the European Union

26.1.2007

Member State

Marketing
Authorisation Holder

Applicant

Invented name

Strength

Pharmaceutical Form

Route of
administration

Latvia

Lithuania

Luxemburg

The Netherlands

Poland

Portugal

Slovakia

Spain

Sweden

United Kingdom

Iceland

Norway

—

—

—

—

—

—

—

—

—

—

—

—

Navamedic ASA
Vollsveien 13 C
N-1327 Lysaker

Navamedic ASA
Vollsveien 13 C
N-1327 Lysaker

Navamedic ASA
Vollsveien 13 C
N-1327 Lysaker

Navamedic ASA
Vollsveien 13 C
N-1327 Lysaker

Navamedic ASA
Vollsveien 13 C
N-1327 Lysaker

Navamedic ASA
Vollsveien 13 C
N-1327 Lysaker

Navamedic ASA
Vollsveien 13 C
N-1327 Lysaker

Navamedic ASA
Vollsveien 13 C
N-1327 Lysaker

Navamedic ASA
Vollsveien 13 C
N-1327 Lysaker

Navamedic ASA
Vollsveien 13 C
N-1327 Lysaker

Navamedic ASA
Vollsveien 13 C
N-1327 Lysaker

Navamedic ASA
Vollsveien 13 C
N-1327 Lysaker

Glucomed

625 mg

Tablet

Oral use

Glucomed

625 mg

Tablet

Oral use

Glucomed

625 mg

Tablet

Oral use

Glucomed

625 mg

Tablet

Oral use

Glucomed

625 mg

Tablet

Oral use

Glucomed

625 mg

Tablet

Oral use

Glucomed

625 mg

Tablet

Oral use

Glucomed

625 mg

Tablet

Oral use

Glucomed

625 mg

Tablet

Oral use

Glucomed

625 mg

Tablet

Oral use

Glucomed

625 mg

Tablet

Oral use

Flexove

625 mg

Tablet

Oral use

26.1.2007

EN

Official Journal of the European Union

C 18/7

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE
OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

ANNEX II

Member State

Marketing Authorisation Holder

Product name

Strength

Pharmaceutical form

Austria

Takeda Pharma Ges.m.b.H.
Seidengasse 33-35
A-1070 Vienna

AGOPTON

15 mg

Capsule

AGOPTON

30 mg

Capsule

Route of
administration

Oral use

Oral use

AGOPTON Rapid

15 mg

Oro-dispersible tablet

Oral use

AGOPTON Rapid

30 mg

Oro-dispersible tablet

Oral use

Sanofi-Synthelabo SA NV
Dobbelenberg
5, Avenue de la Metrologie
B-1130 Brussels

DAKAR

DAKAR

15mg

Capsule

30 mg

Capsule

NIBITOR

30 mg

Capsule

Belgium

Denmark

Finland

Wyeth ab
Box 1822
S-171 24 Solna

Wyeth AB
Box 1822
S-171 24 Solna

France

Laboratoires Takeda SA
15, quai de Dion Bouton
F-92816 Puteaux Cedex

Sanofi-Aventis
46 quai de la Râpée
F-75601 Paris Cedex 12

Germany

Takeda Pharma GmbH
Viktoriaallee 3-5
D-52066 Aachen

Greece

Vianex S.A.
Tatoiou Street
EL-146 71 Nea Erythrea, Athens

Hungary

Gedeon Richter
Gyomrói út 19-21
H-1103 Budapest

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

15 mg

Oro-dispersible tablet

Oral use

30 mg

Oro-dispersible tablet

Oral use

LANZO

LANZO

LANZO

LANZO

LANZO

OGAST

OGAST

15 mg

Capsule

30 mg

Capsule

30 mg

Capsule

15 mg

Capsule

30 mg

Capsule

LANZOR

15 mg

Capsule

LANZOR

30 mg

Capsule

AGOPTON

15 mg

Capsule

AGOPTON

30 mg

Capsule

LANZOR

15 mg

Capsule

LANZOR

30 mg

Capsule

LAPRAZOL

15 mg

Capsule

LAPRAZOL

30 mg

Capsule

LAPRAZOL FasTab

15 mg

Oro-dispersible tablet

Oral use

LAPRAZOL FasTab

30 mg

Oro-dispersible tablet

Oral use

LANSONE

30 mg

Capsule

Oral use

C 18/8

EN

Official Journal of the European Union

26.1.2007

Member State

Marketing Authorisation Holder

Product name

Strength

Pharmaceutical form

Ireland

John Wyeth & Brother Limited
Trading as Wyeth Pharmaceuticals
Huntercombe Lane South
Taplow, Maidenhead
Berkshire SL6 0PH
United Kingdom

Cyanamid of Great Briain Ltd.
Fareham Road
GOSPORT Hampshire PO13 0AS
United Kingdom

Italy

Takeda Italia Farmaceutici S.p.A.
Via Elio Vittorini 129
I-00144 Roma

Route of
administration

Oral use

Oral use

ZOTON

ZOTON

15 mg

Capsule

30 mg

Capsule

ZOTON FasTab

15 mg

Oro-dispersible tablet

Oral use

ZOTON FasTab

30 mg

Oro-dispersible tablet

Oral use

ZOTON

30mg

Gastro-resistant
for oral suspension

granules

Oral use

LANSOX

15 mg

Capsule

LANSOX

30 mg

Capsule

LANGAST

15 mg

Capsule

LANGAST

30 mg

Capsule

Oral use

Oral use

Oral use

Oral use

LANSOX

15 mg

Oro-dispersible tablet

Oral use

LANSOX

30 mg

Oro-dispersible tablet

Oral use

Sigma-Tau S.p.A.
Via Pontina km. 30,400
I-00040 Pomezia, Roma

LIMPIDEX

15 mg

Capsule

LIMPIDEX

30 mg

Capsule

Oral use

Oral use

LIMPIDEX

15 mg

Oro-dispersible tablet

Oral use

LIMPIDEX

30 mg

Oro-dispersible tablet

Oral use

Wyeth Lederle S.p.A.
Via Nettunense, 90
I-04011 Aprilia (LT)

Luxembourg

Sanofi-Synthelabo SA NV
Dobbelenberg, 5, Avenue de la Metrologie
B-1130 Brussels

Netherlands

Sanofi-Synthelabo B.V./Aventis Pharma B.V.
Kampenringweg 45 D-E (toren D en E)
2803 PE Gouda
Nederland

ZOTON

ZOTON

ZOTON

ZOTON

DAKAR

DAKAR

PREZAL

PREZAL

15 mg

Capsule

30 mg

Capsule

Oral use

Oral use

15 mg

Oro-dispersible tablet

Oral use

30 mg

Oro-dispersible tablet

Oral use

15 mg

Capsule

30 mg

Capsule

15 mg

Capsule

30 mg

Capsule

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Portugal

Seber Portuguesa Farmacêutica, SA
Rua Norberto de Oliveira, 1 a 5
P-2620-111 Póvoa de Santo Adrião

OGASTO

15 mg

Capsule

OGASTO

30 mg

Capsule

OGASTO

15 mg

Oro-dispersible tablet

Oral use

OGASTO

30 mg

Oro-dispersible tablet

Oral use

26.1.2007

EN

Official Journal of the European Union

C 18/9

Member State

Marketing Authorisation Holder

Product name

Strength

Pharmaceutical form

Spain

Almirall Prodesfarma, S.A.
General Mitre, 151
E-08022 Barcelona

OPIREN

OPIREN

BAMALITE

BAMALITE

15 mg

Capsule

30 mg

Capsule

15 mg

Capsule

30 mg

Capsule

Route of
administration

Oral use

Oral use

Oral use

Oral use

Sweden

Wyeth AB
Box 1822
S-171 24 Solna

United Kingdom John Wyeth & Brother Limited

Trading as Wyeth Pharmaceuticals
Huntercombe Lane South
Taplow, Maidenhead
Berkshire SL6 0PH
United Kingdom

Iceland

Wyeth AB
Box 1822
S-171 24 Solna

Norway

Wyeth AB
Box 1822
S-171 24 Solna

OPIREN Flas

15 mg

Oro-dispersible tablet

Oral use

OPIREN Flas

30 mg

Oro-dispersible tablet

Oral use

BAMALITE Flas

15 mg

Oro-dispersible tablet

Oral use

BAMALITE Flas

30 mg

Oro-dispersible tablet

Oral use

LANZO

LANZO

LANZO

LANZO

ZOTON

ZOTON

ZOTON

15 mg

Capsule

30 mg

Capsule

Oral use

Oral use

15 mg

Oro-dispersible tablet

Oral use

30 mg

Oro-dispersible tablet

Oral use

15 mg

Capsule

30 mg

Capsule

Oral use

Oral use

30 mg

Gastro-resistant
for oral suspension

granules

Oral use

ZOTON FasTab

15 mg

Oro-dispersible Tablet

Oral use

ZOTON FasTab

30 mg

Oro-dispersible Tablet

Oral use

LANZO

LANZO

ZOTON

ZOTON

LANZO

LANZO

LANZO

LANZO

LANZO

LANZO

15 mg

Capsule

30 mg

Capsule

15 mg

Capsule

30 mg

Capsule

Oral use

Oral use

Oral use

Oral use

15 mg

Oro-dispersible tablet

Oral use

30 mg

Oro-dispersible tablet

Oral use

15 mg

Capsule

30 mg

Capsule

Oral use

Oral use

15 mg

Oro-dispersible tablet

Oral use

30 mg

Oro-dispersible tablet

Oral use

C 18/10

EN

Official Journal of the European Union

26.1.2007

ANNEX III

LIST OF THE INVENTED NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS,
ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

CETIRIZINE DIHYDROCHLORIDE NORDIC DRUGS 10 mg AND ASSOCIATED NAMES

Member State

Marketing Authorisation
Holder

Product Name

Strength

Pharmaceutical Form

Route of administration

Denmark

Finland

Netherlands

Norway

Sweden

Nordic Drugs AB
Geijersgatan 4 C
S-200 61 Limhamn

Nordic Drugs AB
Geijersgatan 2A
Box 30035
S-200 61 Limhamn

Nordic Drugs AB
Box 30035
S-200 61 Limhamn

Nordic Drugs AB,
Box 30035
S-200 61 Limhamn

Nordic Drugs AB
Box 300 35
S-200 61 Limhamn

Gardex

10 mg

Film coated tablet

Oral

Gardex 10 mg tabletti,
kalvopäällysteinen

10 mg

Film coated tablet

Oral

Cetirizine dihydrochloride
Nordic Drugs 10 mg

10 mg

Film coated tablet

Oral

Acura

Acura

10 mg

Film coated tablet

Oral

10 mg

Film coated tablet

Oral

26.1.2007

EN

Official Journal of the European Union

C 18/11

ANNEX IV

LIST OF THE INVENTED NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS,
ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

CETIRIZINE DIHYDROCHLORIDE DERMAPHARM 10 mg AND ASSOCIATED NAMES

Member State

Marketing Authorisation
Holder

Product Name

Strength

Pharmaceutical Form

Route of administration

Austria

Belgium

Germany

Netherlands

Dermapharm GmbH
Türkenstr. 25/12
A-1090 Wien

Cetiderm 10 mg Filmtable-
tten

Dermapharm AG
Luise-Ullrich-Str. 6
D-82031 Grünwald

Cetirizine
dihydrochloride
Dermapharm 10 mg filmom-
hulde tabletten

Dermapharm AG
Luise-Ullrich-Str. 6
D-82031 Grünwald

Cetiderm 10 mg Filmtable-
tten

Dermapharm AG
Luise-Ullrich-Str. 6
D-82031 Grünwald

Cetirizine
dihydrochloride
Dermapharm 10 mg table-
tten

10 mg

Film coated tablet

Oral

10 mg

Film coated tablet

Oral

10 mg

Film coated tablet

Oral

10 mg

Film coated tablet

Oral

C 18/12

EN

Official Journal of the European Union

26.1.2007

ANNEX V

LIST OF THE INVENTED NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS,
ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

CETIRIZINE DIHYDROCHLORIDE APEX 10 mg AND ASSOCIATED NAMES

Member State

Marketing Authorisation Holder

Product Name

Strength

Pharmaceutical Form

Route of
administration

Belgium

Luxembourg

Netherlands

Docpharma N.V.
Ambachtenlaan 13 H
B-3001 Heverlee

Docpharma N.V.
Ambachtenlaan 13 H
B-3001 Heverlee

Apex Pharmaceuticals Ltd.
2nd Floor, Devlin House
36 Saint George Street
Mayfair
W1S 2FW London
United Kingdom

Doccetiri

10 mg

Film coated tablet

Oral

Doccetiri-10

10 mg

Film coated tablet

Oral

Cetirizine dihydrochloride-APEX
10 mg

10 mg

Film coated tablet

Oral