Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 July 2008 to 31 July 2008 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC of the European Parliament and of the Council or Article 38 of Directive 2001/82/EC of the European Parliament and of the Council )
Date: 2008-08-29
Institutions: European Commission
Subjects: EU Member State, market approval, marketing standard, medicinal product, pharmaceutical legislation

29.8.2008

EN

Official Journal of the European Union

C 220/17

Summary of Community decisions on marketing authorizations in respect of medicinal products
from 1 July 2008 to 31 July 2008

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC of the European Parliament and of the Council (1)
or Article 38 of Directive 2001/82/EC of the European Parliament and of the Council (2))

(2008/C 220/04)

— Issuing, maintenance or modification of a national marketing authorisation

Date of the
decision

Name(s) of the
medicinal
product

9.7.2008

Latixa

Holder(s) of the marketing
authorization

Member State concerned

CV Therapeutics Europe Limited
15 Meadway Court
Rutherford Close
Stevenage
Hertfordshire SG1 2EF
United Kingdom

This Decision is addressed to
the Member States

11.7.2008

Alvesco

See Annex I

11.7.2008

Singulair

See Annex II

14.7.2008

Octegra

See Annex III

14.7.2008

Actira

See Annex IV

14.7.2008

Avalox

See Annex V

22.7.2008

Oracea

See Annex VI

See Annex I

See Annex II

See Annex III

See Annex IV

See Annex V

See Annex VI

23.7.2008

Lamictal

See Annex VII

See Annex VII

31.7.2008

Revlimid

Celgene Europe Limited
Morgan House
Madeira Walk
Windsor
Berkshire SL4 1EP
United Kingdom

This Decision is addressed to
the Member States

Date of
notification

10.7.2008

14.7.2008

14.7.2008

15.7.2008

16.7.2008

16.7.2008

23.7.2008

28.7.2008

4.8.2008

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

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE
OF ADMINISTRATION, APPLICANT(S), MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

ANNEX I

Member State

Marketing Authorisation Holder

Applicant

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Austria

Austria

Austria

Austria

Austria

Austria

Belgium

Belgium

Nycomed Pharma GmbH
EUROPLAZA
Gebäude F
Technologiestraße 5
A-1120 Wien

Nycomed Pharma GmbH
EUROPLAZA
Gebäude F
Technologiestraße 5
A-1120 Wien

Nycomed Pharma GmbH
EUROPLAZA
Gebäude F
Technologiestraße 5
A-1120 Wien

Nycomed GmbH
Byk-Gulden-Straße 2
D-78467 Konstanz

Nycomed GmbH
Byk-Gulden-Straße 2
D-78467 Konstanz

Nycomed GmbH
Byk-Gulden-Straße 2
D-78467 Konstanz

Alvesco 40 Mikrogramm Dosier-
aerosol

40 µg

Pressurised inhalation, solution

Inhalation use

Alvesco 80 Mikrogramm Dosier-
aerosol

80 µg

Pressurised inhalation, solution

Inhalation use

Alvesco 160 Mikrogramm Dosier-
aerosol

160 µg

Pressurised inhalation, solution

Inhalation use

Amavio 40 Mikrogramm Dosier-
aerosol

40 µg

Pressurised inhalation, solution

Inhalation use

Amavio 80 Mikrogramm Dosier-
aerosol

80 µg

Pressurised inhalation, solution

Inhalation use

Amavio 160 Mikrogramm Dosier-
aerosol

40 µg

Pressurised inhalation, solution

Inhalation use

Alvesco 40 microgram, aërosol,
oplossing

40 µg

Pressurised inhalation, solution

Inhalation use

Alvesco 80 microgram, aërosol,
oplossing

80 µg

Pressurised inhalation, solution

Inhalation use

Nycomed Belgium s.c.a./c.v.a.
Gentsesteenweg 615
B-1080 Brussels

Nycomed Belgium s.c.a./c.v.a.
Gentsesteenweg 615
B-1080 Brussels

C

2
2
0
/
1
8

E
N

O

f
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i

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2
9
8
2
0
0
8

Member State

Marketing Authorisation Holder

Applicant

Invented Name

Strength

Pharmaceutical Form

Route of
administration

.

.

2
9
8
2
0
0
8

Belgium

Bulgaria

Bulgaria

Bulgaria

Cyprus

Cyprus

Cyprus

Czech Republic

Czech Republic

Denmark

Denmark

Denmark

Nycomed Belgium s.c.a./c.v.a.
Gentsesteenweg 615
B-1080 Brussels

Alvesco 160 microgram, aërosol,
oplossing

160 µg

Pressurised inhalation, solution

Inhalation use

Altana Pharma AG
Byk-Gulden-Straße 2
D-78467 Konstanz

Altana Pharma AG
Byk-Gulden-Straße 2
D-78467 Konstanz

Altana Pharma AG
Byk-Gulden-Straße 2
D-78467 Konstanz

Nycomed GmbH
Byk-Gulden-Straße 2
D-78467 Konstanz

Nycomed GmbH
Byk-Gulden-Straße 2
D-78467 Konstanz

Nycomed GmbH
Byk-Gulden-Straße 2
D-78467 Konstanz

Alvesco 40 Inhaler

40 µg

Pressurised inhalation, solution

Inhalation use

Alvesco 80 Inhaler

80 µg

Pressurised inhalation, solution

Inhalation use

Alvesco 160 Inhaler

160 µg

Pressurised inhalation, solution

Inhalation use

Alvesco 40 micrograms Inhaler

40 µg

Pressurised inhalation, solution

Inhalation use

Alvesco 80 micrograms Inhaler

80 µg

Pressurised inhalation, solution

Inhalation use

Alvesco 160 micrograms Inhaler

160 µg

Pressurised inhalation, solution

Inhalation use

Alvesco 80 Inhaler

80 µg

Pressurised inhalation, solution

Inhalation use

Alvesco 160 Inhaler

160 µg

Pressurised inhalation, solution

Inhalation use

Alvesco 40 micrograms
surised inhalation, solution

Alvesco 80 micrograms
surised inhalation, solution

pres-

40 µg

Pressurised inhalation, solution

Inhalation use

pres-

80 µg

Pressurised inhalation, solution

Inhalation use

Alvesco 160 micrograms pres-
surised inhalation, solution

160 µg

Pressurised inhalation, solution

Inhalation use

E
N

O

f
f
i
c
i
a
l

J
o
u
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n
a
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o
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t
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e

E
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a
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i

C

2
2
0
/
1
9

Altana Pharma AG
Byk-Gulden-Straße 2
D-78467 Konstanz

Altana Pharma AG
Byk-Gulden-Straße 2
D-78467 Konstanz

Altana Pharma AG
Byk-Gulden-Straße 2
D-78467 Konstanz

Altana Pharma AG
Byk-Gulden-Straße 2
D-78467 Konstanz

Altana Pharma AG
Byk-Gulden-Straße 2
D-78467 Konstanz

Member State

Marketing Authorisation Holder

Applicant

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Estonia

Estonia

Estonia

Finland

Finland

Finland

France

France

France

Germany

Germany

Germany

Nycomed GmbH
Byk-Gulden-Straße 2
D-78467 Konstanz

Nycomed GmbH
Byk-Gulden-Straße 2
D-78467 Konstanz

Nycomed GmbH
Byk-Gulden-Straße 2
D-78467 Konstanz

Altana Pharma AG
Byk-Gulden-Straße 2
D-78467 Konstanz

Altana Pharma AG
Byk-Gulden-Straße 2
D-78467 Konstanz

Altana Pharma AG
Byk-Gulden-Straße 2
D-78467 Konstanz

Nycomed GmbH
Byk-Gulden-Straße 2
D-78467 Konstanz

Nycomed GmbH
Byk-Gulden-Straße 2
D-78467 Konstanz

Nycomed GmbH
Byk-Gulden-Straße 2
D-78467 Konstanz

Alvesco 40 micrograms
surised inhalation, solution

Alvesco 80 micrograms
surised inhalation, solution

pres-

40 µg

Pressurised inhalation, solution

Inhalation use

pres-

80 µg

Pressurised inhalation, solution

Inhalation use

Alvesco 160 micrograms pres-
surised inhalation, solution

160 µg

Pressurised inhalation, solution

Inhalation use

Alvesco 40 micrograms
surised inhalation, solution

Alvesco 80 micrograms
surised inhalation, solution

pres-

40 µg

Pressurised inhalation, solution

Inhalation use

pres-

80 µg

Pressurised inhalation, solution

Inhalation use

Alvesco 160 micrograms pres-
surised inhalation, solution

160 µg

Pressurised inhalation, solution

Inhalation use

Alvesco 40 microgrammes, dose
solution pour inhalation en flacon
pressurisé

Alvesco 80 microgrammes, dose
solution pour inhalation en flacon
pressurisé

Alvesco 160 microgrammes, dose
solution pour inhalation en flacon
pressurisé

Alvesco 40 Mikrogramm Druckga-
sinhalation, Lösung

40 µg

Pressurised inhalation, solution

Inhalation use

80 µg

Pressurised inhalation, solution

Inhalation use

160 µg

Pressurised inhalation, solution

Inhalation use

40 µg

Pressurised inhalation, solution

Inhalation use

Alvesco 80 Mikrogramm Druckga-
sinhalation, Lösung

80 µg

Pressurised inhalation, solution

Inhalation use

Alvesco 160 Mikrogramm Druck-
gasinhalation, Lösung

160 µg

Pressurised inhalation, solution

Inhalation use

Nycomed GmbH
Byk-Gulden-Straße 2
D-78467 Konstanz

Nycomed GmbH
Byk-Gulden-Straße 2
D-78467 Konstanz

Nycomed GmbH
Byk-Gulden-Straße 2
D-78467 Konstanz

C

2
2
0
/
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E
N

O

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J
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E
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a
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U
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i

.

.

2
9
8
2
0
0
8

Member State

Marketing Authorisation Holder

Applicant

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Greece

Greece

Greece

Greece

Greece

Greece

Hungary

Hungary

Hungary

Iceland

Iceland

Iceland

Nycomed Hellas S.A.
Kifissias Ave 196
GR-15231 Chalandri

Nycomed Hellas S.A.
Kifissias Ave 196
GR-15231 Chalandri

Nycomed Hellas S.A.
Kifissias Ave 196
GR-15231 Chalandri

Nycomed Hellas S.A.
Kifissias Ave 196
GR-15231 Chalandri

Nycomed Hellas S.A.
Kifissias Ave 196
GR-15231 Chalandri

Nycomed Hellas S.A.
Kifissias Ave 196
GR-15231 Chalandri

Altana Pharma AG
Byk-Gulden-Straße 2
D-78467 Konstanz

Altana Pharma AG
Byk-Gulden-Straße 2
D-78467 Konstanz

Altana Pharma AG
Byk-Gulden-Straße 2
D-78467 Konstanz

Altana Pharma AG
Byk-Gulden-Straße 2
D-78467 Konstanz

Altana Pharma AG
Byk-Gulden-Straße 2
D-78467 Konstanz

Altana Pharma AG
Byk-Gulden-Straße 2
D-78467 Konstanz

Alvesco 80 mcg/Dose

80 µg

Pressurised inhalation, solution

Inhalation use

Alvesco 160 mcg/Dose

160 µg

Pressurised inhalation, solution

Inhalation use

Freathe 80 mcg/Dose

80 µg

Pressurised inhalation, solution

Inhalation use

Freathe 160 mcg/Dose

160 µg

Pressurised inhalation, solution

Inhalation use

Amavio 80 mcg/Dose

80 µg

Pressurised inhalation, solution

Inhalation use

Amavio 160 mcg/Dose

160 µg

Pressurised inhalation, solution

Inhalation use

Alvesco 40 mikrogramm túlnyo-
másos inhalációs oldat

40 µg

Pressurised inhalation, solution

Inhalation use

Alvesco 80 mikrogramm túlnyo-
másos inhalációs oldat

80 µg

Pressurised inhalation, solution

Inhalation use

Alvesco 160 mikrogramm túlnyo-
másos inhalációs oldat

160 µg

Pressurised inhalation, solution

Inhalation use

Alvesco 40 innúdalyf

40 µg

Pressurised inhalation, solution

Inhalation use

Alvesco 80 innúdalyf

80 µg

Pressurised inhalation, solution

Inhalation use

Alvesco 160 innúdalyf

160 µg

Pressurised inhalation, solution

Inhalation use

.

.

2
9
8
2
0
0
8

E
N

O

f
f
i
c
i
a
l

J
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n
a
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o
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t
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2
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/
2
1

Member State

Marketing Authorisation Holder

Applicant

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Ireland

Ireland

Ireland

Italy

Italy

Italy

Latvia

Latvia

Latvia

Lithuania

Lithuania

Lithuania

Nycomed GmbH
Byk-Gulden-Straße 2
D-78467 Konstanz

Nycomed GmbH
Byk-Gulden-Straße 2
D-78467 Konstanz

Nycomed GmbH
Byk-Gulden-Straße 2
D-78467 Konstanz

Altana Pharma AG
Byk-Gulden-Straße 2
D-78467 Konstanz

Altana Pharma AG
Byk-Gulden-Straße 2
D-78467 Konstanz

Altana Pharma AG
Byk-Gulden-Straße 2
D-78467 Konstanz

Altana Pharma AG
Byk-Gulden-Straße 2
D-78467 Konstanz

Altana Pharma AG
Byk-Gulden-Straße 2
D-78467 Konstanz

Altana Pharma AG
Byk-Gulden-Straße 2
D-78467 Konstanz

Alvesco 40 micrograms
surised inhalation solution

Alvesco 80 micrograms
surised inhalation solution

pres-

40 µg

Pressurised inhalation, solution

Inhalation use

pres-

80 µg

Pressurised inhalation, solution

Inhalation use

Alvesco 160 micrograms pres-
surised inhalation solution

160 µg

Pressurised inhalation, solution

Inhalation use

Altana Pharma AG
Byk-Gulden-Straße 2
D-78467 Konstanz

Altana Pharma AG
Byk-Gulden-Straße 2
D-78467 Konstanz

Altana Pharma AG
Byk-Gulden-Straße 2
D-78467 Konstanz

Alvesco

Alvesco

Alvesco

40 µg

Pressurised inhalation, solution

Inhalation use

80 µg

Pressurised inhalation, solution

Inhalation use

160 µg

Pressurised inhalation, solution

Inhalation use

Alvesco 40 inhalators

40 µg

Pressurised inhalation, solution

Inhalation use

Alvesco 80 inhalators

80 µg

Pressurised inhalation, solution

Inhalation use

Alvesco 160 inhalators

160 µg

Pressurised inhalation, solution

Inhalation use

Alvesco

Alvesco

Alvesco

40 µg

Pressurised inhalation, solution

Inhalation use

80 µg

Pressurised inhalation, solution

Inhalation use

160 µg

Pressurised inhalation, solution

Inhalation use

C

2
2
0
/
2
2

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
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t
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E
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U
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n

i

.

.

2
9
8
2
0
0
8

Member State

Marketing Authorisation Holder

Applicant

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Nycomed GmbH
Byk-Gulden-Straße 2
D-78467 Konstanz

Nycomed GmbH
Byk-Gulden-Straße 2
D-78467 Konstanz

Nycomed GmbH
Byk-Gulden-Straße 2
D-78467 Konstanz

Luxembourg

Luxembourg

Luxembourg

Malta

Malta

Malta

Netherlands

Netherlands

Netherlands

Norway

Norway

Norway

Nycomed Belgium s.c.a./c.v.a.
Gentsesteenweg 615
B-1080 Brussels

Nycomed Belgium s.c.a./c.v.a.
Gentsesteenweg 615
B-1080 Brussels

Nycomed Belgium s.c.a./c.v.a.
Gentsesteenweg 615
B-1080 Brussels

Nycomed GmbH
Byk-Gulden-Straße 2
D-78467 Konstanz

Nycomed GmbH
Byk-Gulden-Straße 2
D-78467 Konstanz

Nycomed GmbH
Byk-Gulden-Straße 2
D-78467 Konstanz

Altana Pharma AG
Byk-Gulden-Straße 2
D-78467 Konstanz

Altana Pharma AG
Byk-Gulden-Straße 2
D-78467 Konstanz

Altana Pharma AG
Byk-Gulden-Straße 2
D-78467 Konstanz

Alvesco 40 Aérosol doseur

40 µg

Pressurised inhalation, solution

Inhalation use

Alvesco 80 Aérosol doseur

80 µg

Pressurised inhalation, solution

Inhalation use

Alvesco 160 Aérosol doseur

160 µg

Pressurised inhalation, solution

Inhalation use

Alvesco 40 Inhaler

40 µg

Pressurised inhalation, solution

Inhalation use

Alvesco 80 Inhaler

80 µg

Pressurised inhalation, solution

Inhalation use

Alvesco 160 Inhaler

160 µg

Pressurised inhalation, solution

Inhalation use

Alvesco 40 Inhalator

40 µg

Pressurised inhalation, solution

Inhalation use

Alvesco 80 Inhalator

80 µg

Pressurised inhalation, solution

Inhalation use

Alvesco 160 Inhalator

160 µg

Pressurised inhalation, solution

Inhalation use

Alvesco 40 micrograms/dose inha-
lasjonsaerosol, oppløsing

40 µg

Pressurised inhalation, solution

Inhalation use

Alvesco 80 micrograms/dose inha-
lasjonsaerosol, oppløsing

80 µg

Pressurised inhalation, solution

Inhalation use

Alvesco
inhalasjonsaerosol, oppløsing

160 micrograms/dose

160 µg

Pressurised inhalation, Solution

Inhalation use

.

.

2
9
8
2
0
0
8

E
N

O

f
f
i
c
i
a
l

J
o
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n
a
l

o
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t
h
e

E
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a
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U
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i

C

2
2
0
/
2
3

Member State

Marketing Authorisation Holder

Applicant

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Altana Pharma AG
Byk-Gulden-Straße 2
D-78467 Konstanz

Altana Pharma AG
Byk-Gulden-Straße 2
D-78467 Konstanz

Altana Pharma AG
Byk-Gulden-Straße 2
D-78467 Konstanz

Poland

Poland

Poland

Portugal

Portugal

Portugal

Romania

Romania

Romania

Slovakia

Slovakia

Slovakia

Nycomed Pharma Sp. z o.o.
Al. Jerozolimskie 146 A
PL-02-305 Warszawa

Nycomed Pharma Sp. z o.o.
Al. Jerozolimskie 146 A
PL-02-305 Warszawa

Altana Pharma AG
Byk-Gulden-Straße 2
D-78467 Konstanz

Nycomed GmbH
Byk-Gulden-Straße 2
D-78467 Konstanz

Nycomed GmbH
Byk-Gulden-Straße 2
D-78467 Konstanz

Nycomed GmbH
Byk-Gulden-Straße 2
D-78467 Konstanz

Altana Pharma AG
Byk-Gulden-Straße 2
D-78467 Konstanz

Altana Pharma AG
Byk-Gulden-Straße 2
D-78467 Konstanz

Altana Pharma AG
Byk-Gulden-Straße 2
D-78467 Konstanz

Alvesco 40

40 µg

Pressurised inhalation, solution

Inhalation use

Alvesco 80

80 µg

Pressurised inhalation, solution

Inhalation use

Alvesco 160

160 µg

Pressurised inhalation, solution

Inhalation use

Alvesco 40 Inalador

40 µg

Pressurised inhalation, solution

Inhalation use

Alvesco 80 Inalador

80 µg

Pressurised inhalation, solution

Inhalation use

Alvesco 160 Inalador

160 µg

Pressurised inhalation, solution

Inhalation use

Alvesco 40 Inhaler

40 µg

Pressurised inhalation, solution

Inhalation use

Alvesco 80 Inhaler

80 µg

Pressurised inhalation, solution

Inhalation use

Alvesco 160 Inhaler

160 µg

Pressurised inhalation, solution

Inhalation use

Alvesco 40 Inhalátor

40 µg

Pressurised inhalation, solution

Inhalation use

Alvesco 80 Inhalátor

80 µg

Pressurised inhalation, solution

Inhalation use

Alvesco 160 Inhalátor

160 µg

Pressurised inhalation, solution

Inhalation use

C

2
2
0
/
2
4

E
N

O

f
f
i
c
i
a
l

J
o
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n
a
l

o
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t
h
e

E
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a
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U
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i

.

.

2
9
8
2
0
0
8

Member State

Marketing Authorisation Holder

Applicant

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Slovenia

Slovenia

Slovenia

Spain

Spain

Spain

Sweden

Sweden

Sweden

United Kingdom

United Kingdom

United Kingdom

Altana Pharma AG
Byk-Gulden-Straße 2
D-78467 Konstanz

Altana Pharma AG
Byk-Gulden-Straße 2
D-78467 Konstanz

Altana Pharma AG
Byk-Gulden-Straße 2
D-78467 Konstanz

Nycomed GmbH
Byk-Gulden-Straße 2
D-78467 Konstanz

Nycomed GmbH
Byk-Gulden-Straße 2
D-78467 Konstanz

Nycomed GmbH
Byk-Gulden-Straße 2
D-78467 Konstanz

Nycomed GmbH
Byk-Gulden-Straße 2
D-78467 Konstanz

Nycomed GmbH
Byk-Gulden-Straße 2
D-78467 Konstanz

Nycomed GmbH
Byk-Gulden-Straße 2
D-78467 Konstanz

Altana Pharma AG
Byk-Gulden-Straße 2
D-78467 Konstanz

Altana Pharma AG
Byk-Gulden-Straße 2
D-78467 Konstanz

Altana Pharma AG
Byk-Gulden-Straße 2
D-78467 Konstanz

Alvesco 40 µg inhalacijska razto-
pina pod tlakom

Alvesco 80 µg inhalacijska razto-
pina pod tlakom

Alvesco 160 µg inhalacijska razto-
pina pod tlakom

Alvesco 40 mcg solución para
inhalación en envase a presión

Alvesco 80 mcg solución para
inhalación en envase a presión

Alvesco 160 mcg solución para
inhalación en envase a presión

Alvesco

Alvesco

Alvesco

40 µg

Pressurised inhalation, solution

Inhalation use

80 µg

Pressurised inhalation, solution

Inhalation use

160 µg

Pressurised inhalation, solution

Inhalation use

40 µg

Pressurised inhalation, solution

Inhalation use

80 µg

Pressurised inhalation, solution

Inhalation use

160 µg

Pressurised inhalation, solution

Inhalation use

40 µg/dose

Pressurised inhalation, solution

Inhalation use

80 µg/dose

Pressurised inhalation, solution

Inhalation use

160 µg/dose

Pressurised inhalation, solution

Inhalation use

Alvesco 40 Inhaler

40 µg

Pressurised inhalation, solution

Inhalation use

Alvesco 80 Inhaler

80 µg

Pressurised inhalation, solution

Inhalation use

Alvesco 160 Inhaler

160 µg

Pressurised inhalation, solution

Inhalation use

.

.

2
9
8
2
0
0
8

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C

2
2
0
/
2
5

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

ANNEX II

Member State

Marketing Authorisation Holder

(Invented) name

Strength

Pharmaceutical Form

Route of
administration

Content
(concen-
tration)

Austria

Belgium

Bulgaria

Bulgaria

Cyprus

Cyprus

Czech Republic

Merck Sharp & Dohme GmbH
Donau-City-Straße 6
A-1220 Vienne

Merck Sherp & Dohme
Chaussée de Waterloo 1135
B-1180 Bruxelles

Merck Sharp and Dohme Bulgaria EOOD
55, Nikola Vaptzarov blvd.
EXPO 2000, east wing, sectors B1 & B2, 1st fl.
BG-1407 Sofia

Merck Sharp and Dohme Bulgaria EOOD
55, Nikola Vaptzarov blvd.
EXPO 2000, east wing, sectors B1 & B2, 1st fl.
BG-1407 Sofia

Merck Sharp & Dohme B.V.
Postbox 581
Waarderweg 39
2031 BN Haarlem
Nederland

Merck Sharp & Dohme B.V.
Postbox 581
Waarderweg 39
2031 BN Haarlem
Nederland

Merck Sharp & Dohme B.V.
Postbox 581
Waarderweg 39
2031 BN Haarlem
Nederland

Singulair 4 mg — Kautabletten für
Kleinkinder

4 mg

Chewable tablets

Oral use

4 mg

Singulair

4 mg

Chewable tablets

Oral use

4 mg

Singulair

4 mg

Granules

Oral use

Singulair

4 mg

Chewable tablets

Oral use

4 mg

Singulair

4 mg

Granules

Oral use

Singulair Paediatric

4 mg

Chewable tablets

Oral use

4 mg

Singulair 4 Mini

4 mg

Chewable tablets

Oral use

4 mg

C

2
2
0
/
2
6

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

.

2
9
8
2
0
0
8

Member State

Marketing Authorisation Holder

(Invented) name

Strength

Pharmaceutical Form

Route of
administration

Content
(concen-
tration)

Denmark

Estonia

Estonia

Finland

Finland

Germany

Germany

Greece

Greece

Merck Sharp & Dohme B.V.
Postbox 581
Waarderweg 39
2031 BN Haarlem
Nederland

Merck Sharp & Dohme OÜ
Peterburi tee 46
EE-11415 Tallinn

Merck Sharp & Dohme OÜ
Peterburi tee 46
EE-11415 Tallinn

Merck Sharp & Dohme B.V.
Postbox 581
Waarderweg 39
2031 BN Haarlem
Nederland

Merck Sharp & Dohme B.V.
Postbox 581
Waarderweg 39
2031 BN Haarlem
Nederland

Dieckmann Arzneimittel GmbH
Lindenplatz 1
D-85540 Haar

Dieckmann Arzneimittel GmbH
Lindenplatz 1
D-85540 Haar

VIANEX A.E.
Tatoiou Street
GR-146 71 Nea Erythrea/GR-146 71 Νέα
Ερυθραία

VIANEX A.E.
Tatoiou Street
GR-146 71 Nea Erythrea/GR-146 71 Νέα
Ερυθραία

Singulair

4 mg

Chewable tablets

Oral use

4 mg

Singulair Mini 4 mg

4 mg

Granules

Oral use

Singulair 4 mg

4 mg

Chewable tablets

Oral use

4 mg

Singulair

4 mg

Granules

Oral use

Singulair

4 mg

Chewable tablets

Oral use

4 mg

Singulair mini 4 mg Granulat

4 mg

Granules

Oral use

Singulair mini 4 mg Kautabletten

4 mg

Chewable tablets

Oral use

4 mg

Singulair

4 mg

Granules

Oral use

Singulair

4 mg

Chewable tablets

Oral use

4 mg

.

.

2
9
8
2
0
0
8

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C

2
2
0
/
2
7

Member State

Marketing Authorisation Holder

(Invented) name

Strength

Pharmaceutical Form

Route of
administration

Content
(concen-
tration)

Hungary

Iceland

Iceland

Ireland

Ireland

Italy

Italy

Italy

Italy

MSD Magyarország Kft.
Alkotás u. 50
H-1123 Budapest

Merck Sharp & Dohme B.V.
Postbox 581
Waarderweg 39
2031 BN Haarlem
Nederland

Merck Sharp & Dohme B.V.
Postbox 581
Waarderweg 39
2031 BN Haarlem
Nederland

Merck Sharp & Dohme Ltd
Hertford Road
Hoddesdon
Hertfordshire EN119BU
United Kingdom

Merck Sharp & Dohme Ltd
Hertford Road
Hoddesdon
Hertfordshire EN119BU
United Kingdom

Merck Sharp E Dohme (Italia) S.p.A.
Via G. Fabbroni, 6
I-00191 Roma

Istituto Gentili S.p.A
Via B. Croce, 37
I-56125 Pisa

Merck Sharp E Dohme (Italia) S.p.A.
Via G. Fabbroni, 6
I-00191 Roma

Istituto Gentili S.p.A
Via B. Croce, 37
I-56125 Pisa

Singulair

4 mg

Chewable tablets

Oral use

4 mg

Singulair

4 mg

Granules

Oral use

Singulair

4 mg

Chewable tablets

Oral use

4 mg

Singulair Paediatric

4 mg

Granules

Oral use

Singulair Paediatric

4 mg

Chewable Tablets

Oral use

4 mg

Singulair

4 mg

Granules

Oral use

Montegen

4 mg

Granules

Oral use

Singulair

4 mg

Chewable tablets

Oral use

4 mg

Montegen

4 mg

Chewable tablets

Oral use

4 mg

C

2
2
0
/
2
8

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

.

2
9
8
2
0
0
8

Member State

Marketing Authorisation Holder

(Invented) name

Strength

Pharmaceutical Form

Route of
administration

Content
(concen-
tration)

.

.

2
9
8
2
0
0
8

Latvia

Latvia

Lithuania

Lithuania

Luxembourg

Luxembourg

Malta

Malta

Netherlands

SIA “Merck Sharp & Dohme Latvija”
Skanstes 13, second floor
LV-1013 Riga

SIA “Merck Sharp & Dohme Latvija”
Skanstes 13, second floor
LV-1013 Riga

Merck Sharp & Dohme
UAB, Kestucio str. 59/27
LT-08124 Vilnius

Merck Sharp & Dohme
UAB, Kestucio str. 59/27
LT-08124 Vilnius

Merck Sharp & Dohme
Chaussée de Waterloo 1135
B-1180 Bruxelles

Merck Sharp & Dohme B.V.
Chaussée de Waterloo 1135
B-1180 Bruxelles

Merck Sharp & Dohme
Hertfordshire Road
Hoddesdon
Hertfordshire EN11 9BU
United Kingdom

Merck Sharp & Dohme
Hertfordshire Road
Hoddesdon
Hertfordshire EN11 9BU
United Kingdom

Merck Sharp & Dohme B.V.
Postbox 581
Waarderweg 39
2031 BN Haarlem
Nederland

Singulair mini 4 mg granulas

4 mg

Granules

Oral use

Singulair 4 mg košļājamās tabletes

4 mg

Chewable tablets

Oral use

4 mg

Singulair Mini

4 mg

Granules

Oral use

Singulair

4 mg

Chewable tablets

Oral use

4 mg

Singulair Mini

4 mg

Granules

Oral use

Singulair

4 mg

Chewable tablets

Oral use

4 mg

Singulair Paediatric 4 mg Granules

4 mg

Granules

Oral use

Singulair Paediatric 4 mg

4 mg

Chewable Tablets

Oral use

4 mg

Singulair Kleuter

4 mg

Chewable tablets

Oral use

4 mg

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C

2
2
0
/
2
9

Member State

Marketing Authorisation Holder

(Invented) name

Strength

Pharmaceutical Form

Route of
administration

Content
(concen-
tration)

Norway

Norway

Poland

Portugal

Portugal

Romania

Romania

Slovenia

Merck Sharp & Dohme B.V.
Postbox 581
Waarderweg 39
2031 BN Haarlem
Nederland

Merck Sharp & Dohme B.V.
Postbox 581
Waarderweg 39
2031 BN Haarlem
Nederland

MSD Polska Sp. z o.o.
Ul. Chłodna 51
PL-00-867 Varsovie

Merck Sharp & Dohme, Lda.
Quinta da Fonte — Edifício Vasco da Gama, n.o
19 — Porto Salvo
P.O. Box 214
PT-2770-192 Paço d'Arcos

Merck Sharp & Dohme, Lda.
Quinta da Fonte — Edifício Vasco da Gama, n.o
19 — Porto Salvo
P.O. Box 214
PT-2770-192 Paço d'Arcos

Merck Sharp & Dohme Romania S.R.L.
Bucharest Business Park
Şos. Bucureşti-Ploieşti, nr. 1A
Corp clădire C1, Etaj 3
Sector 1, Bucarest
România

Merck Sharp & Dohme Romania S.R.L.
Bucharest Business Park
Şos. Bucureşti-Ploieşti, nr.1A
Corp clădire C1, Etaj 3
Sector 1, Bucarest
România

Merck Sharp & Dohme
Šmartinska cesta 140
SLO-1000 Ljubljana

Singulair

4 mg

Granules

Oral use

Singulair

4 mg

Chewable tablets

Oral use

4 mg

Singulair 4

4 mg

Chewable tablets

Oral use

4 mg

Singulair Infantil 4 mg Granulado

4 mg

Granules

Oral use

Singulair Infantil

4 mg

Chewable tablets

Oral use

4 mg

Singulair, granule, 4 mg/plic

4 mg

Granules

Oral use

Singulair 4 mg, comprimate mastica-
bile

4 mg

Chewable tablets

Oral use

4 mg

Singulair 4 mg zrnca

4 mg

Granules

Oral use

C

2
2
0
/
3
0

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

.

2
9
8
2
0
0
8

Member State

Marketing Authorisation Holder

(Invented) name

Strength

Pharmaceutical Form

Route of
administration

Content
(concen-
tration)

.

.

2
9
8
2
0
0
8

Slovenia

Slovakia

Spain

Spain

Sweden

Sweden

United Kingdom

United Kingdom

Merck Sharp & Dohme
Šmartinska cesta 140
SLO-1000 Ljubljana

Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
P.O. Box 581
2003 PC Haarlem
Nederland

Merck Sharp and Dohme de España, SA
Josefa Valcarcel, no 38
E-28027 Madrid

Merck Sharp and Dohme de España, SA
Josefa Valcarcel, no 38
E-28027 Madrid

Merck Sharp & Dohme B.V.
Postbox 581
Waarderweg 39
2031 BN Haarlem
Nederland

Merck Sharp & Dohme B.V.
Postbox 581
Waarderweg 39
2031 BN Haarlem
Nederland

Merck Sharp & Dohme Limited
Hertford Road
Hoddesdon
Hertfordshire EN11 9BU
United Kingdom

Merck Sharp & Dohme Limited
Hertford Road
Hoddesdon
Hertfordshire EN11 9BU
United Kingdom

Singulair 4 mg žvečljive tablete

4 mg

Chewable tablets

Oral use

4 mg

Singulair 4 mg

4 mg

Chewable tablets

Oral use

4 mg

E
N

Singulair 4 mg granulado

4 mg

Granules

Oral use

Singulair 4 mg comprimidos mastic-
ables

4 mg

Chewable tablets

Oral use

4 mg

Singulair

4 mg

Granules

Oral use

Singulair

4 mg

Chewable tablets

Oral use

4 mg

Singulair Paediatric 4 mg Granules

4 mg

Granules

Oral use

Singulair Paediatric 4 mg Chewable
tablets

4 mg

Chewable Tablets

Oral use

4 mg

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C

2
2
0
/
3
1

ANNEX III

LIST OF THE NAMES, PHARMACEUTICAL FORM(S), STRENGTH(S) OF THE MEDICINAL PRODUCT(S),
IN THE
ROUTE(S) OF ADMINISTRATION, APPLICANT(S) MARKETING AUTHORISATION HOLDER(S)

MEMBER STATES

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of
administration

Austria

Belgium

Germany

Greece

Spain

France

Italy

Luxembourg

Netherlands

Portugal

Bayer HealthCare AG
D-51368 Leverkusen

THERABEL PHARMA S.A.
Rue Egide Van Ophem 108
B-1180 Bruxelles

Bayer HealthCare AG
D-51368 Leverkusen

ELPEN A.E. Pharmaceutical Industry
95 Marathonos Av.
GR-190 09 Pikermi, Athens

Procter and Gamble Pharmaceuticals Iberia, SL
WTC Almeda park, edificio 1, 2a planta
Cornellá de Llobregat — Barcelona
España

Bayer HealthCare AG
D-51368 Leverkusen

Innova Pharma S.p.A.
Via M. Civitali, 1
I-20148 Milano

Therabel Pharma
110 Rue Egide Van Ochem
B-1180 Bruxelles

Bayer Healthcare AG
D-51368 Leverkusen

Bialfar — Produtos Farmacêuticos, SA
À Av. da Siderurgia Nacional
P.O. Box 56
P-4745-457 S. Mamede do Coronado

Octegra 400 mg — Filmtabletten

400 mg

Film-coated tablet

Oral use

Proflox 400 mg

400 mg

Film-coated tablet

Oral use

Octegra 400 mg Filmtabletten

400 mg

Film-coated tablet

Oral use

Octegra

400 mg

Film-coated tablet

Oral use

Octegra 400 mg comprimidos recubiertos con película

400 mg

Film-coated tablet

Oral use

Octegra 400 mg, comprimé pelliculé

400 mg

Film-coated tablet

Oral use

Octegra

Proflox

400 mg

Film-coated tablet

Oral use

400 mg

Film-coated tablet

Oral use

Octegra 400 mg tabletten

400 mg

Film-coated tablet

Oral use

Proflox

400 mg

Film-coated tablet

Oral use

C

2
2
0
/
3
2

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

.

2
9
8
2
0
0
8

ANNEX IV

LIST OF THE NAMES, PHARMACEUTICAL FORM(S), STRENGTH(S) OF THE MEDICINAL PRODUCT(S),
IN THE
ROUTE(S) OF ADMINISTRATION, APPLICANT(S) MARKETING AUTHORISATION HOLDER(S)

MEMBER STATES

.

.

2
9
8
2
0
0
8

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of
administration

E
N

Austria

Belgium

Germany

Denmark

Greece

Spain

Finland

Italy

Luxembourg

Portugal

Sweden

Bayer HealthCare AG
D-51368 Leverkusen

Bayer AG
D-51368 Leverkusen

Bayer HealthCare AG
D-51368 Leverkusen

Bayer HealthCare AG
D-51368 Leverkusen

Bayer plc
Bayer Schering Pharma
Bayer House
Strawberry Hill
Newbury
Berkshire RG14 1JA
United Kingdom

Química Farmaceútica Bayer, SL
Av. Baix Llobregat, nos 3 y 5
E-08970 Sant Joan Despi — Barcelona

Bayer HealthCare AG
D-51368 Leverkusen

Sigma-Tau Industrie
Farmaceutiche riunite S.p.A.
Viale Shakespeare, 47
I-00144 Roma

Bayer Healthcare AG
D-51368 Leverkusen

Bayer AG
D-51368 Leverkusen

Bayer HealthCare AG
D-51368 Leverkusen

Actira 400 mg — Filmtabletten

400 mg

Film-coated tablet

Oral use

Actira 400 mg

400 mg

Film-coated tablet

Oral use

Actira 400 mg Filmtabletten

400 mg

Film-coated tablet

Oral use

Actira

Proflox

400 mg

Film-coated tablet

Oral use

400 mg

Film-coated tablet

Oral use

Actira 400 mg comprimidos recubiertos con película

400 mg

Film-coated tablet

Oral use

Actira

Actira

Actira

Actira

Actira

400 mg

Film-coated tablet

Oral use

400 mg

Film-coated tablet

Oral use

400 mg

Film-coated tablet

Oral use

400 mg

Film-coated tablet

Oral use

400 mg

Film-coated tablet

Oral use

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C

2
2
0
/
3
3

ANNEX V

LIST OF THE NAMES, PHARMACEUTICAL FORM(S), STRENGTH(S) OF THE MEDICINAL PRODUCT(S),
IN THE
ROUTE(S) OF ADMINISTRATION, APPLICANT(S) MARKETING AUTHORISATION HOLDER(S)

MEMBER STATES

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of
administration

Austria

Belgium

Cyprus

Czech Republic

Germany

Denmark

Estonia

Greece

Spain

Finland

France

Bayer Austria Gesellschaft m.b.H.
Herbststraße 6-10
A-1160 Wien

Bayer s.a.-n.v.
Avenue Louise 143
B-1050 Bruxelles

Bayer Hellas S.A.
Sorou 18-20
GR-151 25 Marousi, Athens

Bayer HealthCare AG
D-51368 Leverkusen

Bayer Vital GmbH
D-51368 Leverkusen

Bayer HealthCare AG
D-51368 Leverkusen

Bayer HealthCare AG
D-51368 Leverkusen

Bayer Hellas S.A.
Sorou 18-20
GR-151 25 Marousi, Athens

Recordati España, SL
Crta. De Zeneta, 149
E-30588 Murcia

Bayer HealthCare AG
D-51368 Leverkusen

Bayer Santé
13, rue Jean Jaurès
F-92807 Puteaux Cedex

Avelox 400 mg — Filmtabletten

400 mg

Film-coated tablet

Oral use

Avelox 400 mg

400 mg

Film-coated tablet

Oral use

Avelox

Avelox

400 mg

Film-coated tablet

Oral use

400 mg

Film-coated tablet

Oral use

Avalox 400 mg Filmtabletten

400 mg

Film-coated tablet

Oral use

Avelox

Avelox

Avelox

400 mg

Film-coated tablet

Oral use

400 mg

Film-coated tablet

Oral use

400 mg

Film-coated tablet

Oral use

Havelox 400 mg comprimidos recubiertos con película

400 mg

Film-coated tablet

Oral use

Avelox

400 mg

Film-coated tablet

Oral use

Izilox 400 mg, comprimé pelliculé

400 mg

Film-coated tablet

Oral use

C

2
2
0
/
3
4

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

.

2
9
8
2
0
0
8

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of
administration

Avelox

Avelox

Avalox

Avelox

Avelox

Avelox

Avalox

Hungary

Ireland

Italy

Lithuania

Luxembourg

Latvia

Malta

Netherlands

Poland

Portugal

Sweden

Bayer Hungária Kft
Alkotás ut. 50
H-1123 Budapest

Bayer Limited
The Atrium
Blackthorn Road
Dublin 18
Ireland

Bayer S.p.A.
Viale Certosa, 130
I-20156 Milano

Bayer HealthCare AG
D-51368 Leverkusen

Bayer s.a.-n.v.
Avenue Louise 143
B-1050 Bruxelles

Bayer HealthCare AG
D-51368 Leverkusen

Bayer Vital GmbH
D-51368 Leverkusen

Bayer BV
Energieweg 1
3641 RT Mijdrecht
Nederland

Bayer HealthCare AG
D-51368 Leverkusen

BayHealth — Comercialização de Produtos Farmacêu-
ticos Unipessoal, Lda.
Rua Quinta do Pinheiro, n.o 5
P-2794-003 Carnaxide

Bayer HealthCare AG
D-51368 Leverkusen

400 mg

Film-coated tablet

Oral use

400 mg

Film-coated tablet

Oral use

E
N

400 mg

Film-coated tablet

Oral use

400 mg

Film-coated tablet

Oral use

400 mg

Film-coated tablet

Oral use

400 mg

Film-coated tablet

Oral use

400 mg

Film-coated tablet

Oral use

.

.

2
9
8
2
0
0
8

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C

2
2
0
/
3
5

Avelox 400 mg tabletten

400 mg

Film-coated tablet

Oral use

Avelox

Avelox

Avelox

400 mg

Film-coated tablet

Oral use

400 mg

Film-coated tablet

Oral use

400 mg

Film-coated tablet

Oral use

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of
administration

Slovenia

Slovakia

United Kingdom

BAYER d.o.o.
Bravničarjeva 13
SLO-1000 Ljubljana

Bayer HealthCare AG
D-51368 Leverkusen

Bayer plc
Bayer Schering Pharma
Bayer House
Strawberry Hill
Newbury
Berkshire RG14 1JA
United Kingdom

Avelox 400 mg filmsko obložene tablete

400 mg

Film-coated tablet

Oral use

Avelox 400

400 mg

Film-coated tablet

Oral use

Avelox 400 mg Tablets

400 mg

Film-coated tablet

Oral use

C

2
2
0
/
3
6

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

.

2
9
8
2
0
0
8

LIST OF THE NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF
ADMINISTRATION, APPLICANT(S) IN THE MEMBER STATES

ANNEX VI

Member State

Marketing Authorisation Holder

Applicant

Invented name

Strength

Pharmaceutical Form

Route of
administration

Austria

Finland

Germany

Ireland

Italy

Luxembourg

Netherlands

Sweden

United Kingdom

(1) Name approval pending.

FGK Representative Service GmbH
Heimeranstraße 35
D-80339 München

FGK Representative Service GmbH
Heimeranstraße 35
D-80339 München

FGK Representative Service GmbH
Heimeranstraße 35
D-80339 München

FGK Representative Service GmbH
Heimeranstraße 35
D-80339 München

FGK Representative Service GmbH
Heimeranstraße 35
D-80339 München

FGK Representative Service GmbH
Heimeranstraße 35
D-80339 München

FGK Representative Service GmbH
Heimeranstraße 35
D-80339 München

FGK Representative Service GmbH
Heimeranstraße 35
D-80339 München

FGK Representative Service GmbH
Heimeranstraße 35
D-80339 München

Oracea

Oracea

Oracea

40 mg

Modified-release capsule, hard

Oral use

40 mg

40 mg

Prolonged-release
hard

capsule,

Oral use

Prolonged-release
hard

capsule,

Oral use

Oracea (1)

40 mg

Modified-release capsule, hard

Oral use

Oracea

Oracea

Oracea (1)

Oracea

Oracea

40 mg

40 mg

40 mg

Prolonged-release
hard

capsule,

Oral use

Prolonged-release
hard

capsule,

Oral use

Prolonged-release
hard

capsule,

Oral use

40 mg

Modified-release capsule, hard

Oral use

40 mg

Prolonged-release
hard

capsule,

Oral use

.

.

2
9
8
2
0
0
8

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C

2
2
0
/
3
7

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

ANNEX VII

Member State

Marketing Authorisation Holder

(Invented) Name

Strength

Pharmaceutical form

Route of
administration

Austria

Austria

Austria

Austria

Austria

Belgium

Belgium

Belgium

Belgium

Belgium

GlaxoSmithKline Pharma GmbH
Albert-Schweitzer-Gasse 6
A-1140 Wien

GlaxoSmithKline Pharma GmbH
Albert-Schweitzer-Gasse 6
A-1140 Wien

GlaxoSmithKline Pharma GmbH
Albert-Schweitzer-Gasse 6
A-1140 Wien

GlaxoSmithKline Pharma GmbH
Albert-Schweitzer-Gasse 6
A-1140 Wien

GlaxoSmithKline Pharma GmbH
Albert-Schweitzer-Gasse 6
A-1140 Wien

GlaxoSmithKline s.a.
Rue du Tilleul 13
B-1332 Genval

GlaxoSmithKline s.a.
Rue du Tilleul 13
B-1332 Genval

GlaxoSmithKline s.a.
Rue du Tilleul 13
B-1332 Genval

GlaxoSmithKline s.a.
Rue du Tilleul 13
B-1332 Genval

GlaxoSmithKline s.a.
Rue du Tilleul 13
B-1332 Genval

Lamictal 5 mg — lösliche Tabletten

5 mg

Dispersible tablet

Oral use

Lamictal 25 mg — lösliche Tabletten

25 mg

Dispersible tablet

Oral use

Lamictal 50 mg — lösliche Tabletten

50 mg

Dispersible tablet

Oral use

Lamictal 100 mg — lösliche Tabletten

100 mg

Dispersible tablet

Oral use

Lamictal 200 mg — lösliche Tabletten

200 mg

Dispersible tablet

Oral use

Lamictal

Lamictal

Lamictal

25 mg

Tablet

Oral use

50 mg

Tablet

Oral use

100 mg

Tablet

Oral use

Lamictal Dispersible 25 mg Starter-Pack Mono

25 mg

Dispersible tablet

Oral use

Lamictal Dispersible 25 mg Starter-Pack Add-on

25 mg

Dispersible tablet

Oral use

C

2
2
0
/
3
8

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

.

2
9
8
2
0
0
8

Member State

Marketing Authorisation Holder

(Invented) Name

Strength

Pharmaceutical form

Route of
administration

Lamictal Dispersible 50 mg Starter-Pack add-on

50 mg

Dispersible tablet

Oral use

.

.

2
9
8
2
0
0
8

Belgium

Belgium

Belgium

Belgium

Belgium

Belgium

Belgium

Bulgaria

Bulgaria

Bulgaria

GlaxoSmithKline s.a.
Rue du Tilleul 13
B-1332 Genval

GlaxoSmithKline s.a.
Rue du Tilleul 13
B-1332 Genval

GlaxoSmithKline s.a.
Rue du Tilleul 13
B-1332 Genval

GlaxoSmithKline s.a.
Rue du Tilleul 13
B-1332 Genval

GlaxoSmithKline s.a.
Rue du Tilleul 13
B-1332 Genval

GlaxoSmithKline s.a.
Rue du Tilleul 13
B-1332 Genval

GlaxoSmithKline s.a.
Rue du Tilleul 13
B-1332 Genval

GlaxoSmithKline EOOD
Ivan Vazov complex
Dimitar Manov street, bl. 10
BG-1408 Sofia

GlaxoSmithKline EOOD
Ivan Vazov complex
Dimitar Manov street, bl. 10
BG-1408 Sofia

GlaxoSmithKline EOOD
Ivan Vazov complex
Dimitar Manov street, bl. 10
BG-1408 Sofia

Lamictal dispersible

2 mg

Dispersible tablet

Oral use

E
N

Lamictal dispersible

5 mg

Dispersible tablet

Oral use

Lamictal dispersible

25 mg

Dispersible tablet

Oral use

Lamictal dispersible

50 mg

Dispersible tablet

Oral use

Lamictal dispersible

100 mg

Dispersible tablet

Oral use

Lamictal dispersible

200 mg

Dispersible tablet

Oral use

Lamictal

Lamictal

Lamictal

25 mg

Tablet

Oral use

50 mg

Tablet

Oral use

100 mg

Tablet

Oral use

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C

2
2
0
/
3
9

Member State

Marketing Authorisation Holder

(Invented) Name

Strength

Pharmaceutical form

Route of
administration

Bulgaria

Cyprus

Cyprus

Cyprus

Cyprus

Cyprus

Glaxo Group Ltd
Greenford Road
Greenford
Middlesex UB6 0NN
United Kingdom

Glaxo Group Ltd
Berkeley Avenue
Greenford
Middlesex UB6 0NN
United Kingdom

Glaxo Group Ltd
Berkeley Avenue
Greenford
Middlesex UB6 0NN
United Kingdom

Glaxo Group Ltd
Berkeley Avenue
Greenford
Middlesex UB6 0NN
United Kingdom

Glaxo Group Ltd
Berkeley Avenue
Greenford
Middlesex UB6 0NN
United Kingdom

Glaxo Group Ltd
Berkeley Avenue
Greenford
Middlesex UB6 0NN
United Kingdom

Lamictal

5 mg

Dispersible tablet

Oral use

Lamictal

5 mg

Dispersible tablet

Oral use

Lamictal

25 mg

Dispersible tablet

Oral use

Lamictal

50 mg

Dispersible tablet

Oral use

Lamictal

100 mg

Dispersible tablet

Oral use

Lamictal

200 mg

Dispersible tablet

Oral use

Czech Republic

The Wellcome Foundation Limited
Glaxo Wellcome House
Berkeley Avenue
Greenford
Middlesex UB6 0NN
United Kingdom

Lamictal 25 mg

25 mg

Tablet

Oral use

C

2
2
0
/
4
0

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

.

2
9
8
2
0
0
8

Member State

Marketing Authorisation Holder

(Invented) Name

Strength

Pharmaceutical form

Route of
administration

Czech Republic

Czech Republic

Czech Republic

Czech Republic

Czech Republic

Czech Republic

Czech Republic

The Wellcome Foundation Limited
Glaxo Wellcome House
Berkeley Avenue
Greenford
Middlesex UB6 0NN
United Kingdom

The Wellcome Foundation Limited
Glaxo Wellcome House
Berkeley Avenue
Greenford
Middlesex UB6 0NN
United Kingdom

The Wellcome Foundation Limited
Glaxo Wellcome House
Berkeley Avenue
Greenford
Middlesex UB6 0NN
United Kingdom

The Wellcome Foundation Limited
Glaxo Wellcome House
Berkeley Avenue
Greenford
Middlesex UB6 0NN
United Kingdom

The Wellcome Foundation Limited
Glaxo Wellcome House
Berkeley Avenue
Greenford
Middlesex UB6 0NN
United Kingdom

The Wellcome Foundation Limited
Glaxo Wellcome House
Berkeley Avenue
Greenford
Middlesex UB6 0NN
United Kingdom

The Wellcome Foundation Limited
Glaxo Wellcome House
Berkeley Avenue
Greenford
Middlesex UB6 0NN
United Kingdom

Lamictal 50 mg

50 mg

Tablet

Oral use

Lamictal 100 mg

100 mg

Tablet

Oral use

Lamictal 2 mg

2 mg

Dispersible tablet

Oral use

Lamictal 5 mg

5 mg

Dispersible tablet

Oral use

Lamictal 25 mg

25 mg

Dispersible tablet

Oral use

Lamictal 50 mg

50 mg

Dispersible tablet

Oral use

Lamictal 100 mg

100 mg

Dispersible tablet

Oral use

.

.

2
9
8
2
0
0
8

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C

2
2
0
/
4
1

Member State

Marketing Authorisation Holder

(Invented) Name

Strength

Pharmaceutical form

Route of
administration

Denmark

Denmark

Denmark

Denmark

Denmark

Denmark

Denmark

Denmark

Denmark

Denmark

Estonia

GlaxoSmithKline Pharma A/S
Nykær 68
DK-2605 Brøndby

GlaxoSmithKline Pharma A/S
Nykær 68
DK-2605 Brøndby

GlaxoSmithKline Pharma A/S
Nykær 68
DK-2605 Brøndby

GlaxoSmithKline Pharma A/S
Nykær 68
DK-2605 Brøndby

GlaxoSmithKline Pharma A/S
Nykær 68
DK-2605 Brøndby

GlaxoSmithKline Pharma A/S
Nykær 68
DK-2605 Brøndby

GlaxoSmithKline Pharma A/S
Nykær 68
DK-2605 Brøndby

GlaxoSmithKline Pharma A/S
Nykær 68
DK-2605 Brøndby

GlaxoSmithKline Pharma A/S
Nykær 68
DK-2605 Brøndby

GlaxoSmithKline Pharma A/S
Nykær 68
DK-2605 Brøndby

Glaxo Wellcome Operations
Greenford Road
Greenford
Middlesex UB6 0NN
United Kingdom

Lamictal

Lamictal

Lamictal

Lamictal

Lamictal

Lamictal

Lamictal

Lamictal

Lamictal

Lamictal

Lamictal

25 mg

Tablet

Oral use

50 mg

Tablet

Oral use

100 mg

Tablet

Oral use

200 mg

Tablet

Oral use

2 mg

Dispersible tablet

Oral use

5 mg

Dispersible tablet

Oral use

25 mg

Dispersible tablet

Oral use

50 mg

Dispersible tablet

Oral use

100 mg

Dispersible tablet

Oral use

200 mg

Dispersible tablet

Oral use

2 mg

Dispersible tablet

Oral use

C

2
2
0
/
4
2

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

.

2
9
8
2
0
0
8

Member State

Marketing Authorisation Holder

(Invented) Name

Strength

Pharmaceutical form

Route of
administration

Estonia

Estonia

Estonia

Estonia

Estonia

Finland

Finland

Finland

Finland

Glaxo Wellcome Operations
Greenford Road
Greenford
Middlesex UB6 0NN
United Kingdom

Glaxo Wellcome Operations
Greenford Road
Greenford
Middlesex UB6 0NN
United Kingdom

Glaxo Wellcome Operations
Greenford Road
Greenford
Middlesex UB6 0NN
United Kingdom

Glaxo Wellcome Operations
Greenford Road
Greenford
Middlesex UB6 0NN
United Kingdom

Glaxo Wellcome Operations
Greenford Road
Greenford
Middlesex UB6 0NN
United Kingdom

GlaxoSmithKline Oy
Piispansilta 9 A
FI-02230 Espoo

GlaxoSmithKline Oy
Piispansilta 9 A
FI-02230 Espoo

GlaxoSmithKline Oy
Piispansilta 9 A
FI-02230 Espoo

GlaxoSmithKline Oy
Piispansilta 9 A
FI-02230 Espoo

Lamictal

5 mg

Dispersible tablet

Oral use

Lamictal

25 mg

Dispersible tablet

Oral use

Lamictal

50 mg

Dispersible tablet

Oral use

Lamictal

100 mg

Dispersible tablet

Oral use

Lamictal

200 mg

Dispersible tablet

Oral use

Lamictal

Lamictal

Lamictal

Lamictal

2 mg

Dispersible tablet

Oral use

5 mg

Dispersible tablet

Oral use

25 mg

Dispersible tablet

Oral use

50 mg

Dispersible tablet

Oral use

.

.

2
9
8
2
0
0
8

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C

2
2
0
/
4
3

Member State

Marketing Authorisation Holder

(Invented) Name

Strength

Pharmaceutical form

Route of
administration

Finland

Finland

France

France

France

France

France

France

France

France

Germany

Germany

GlaxoSmithKline Oy
Piispansilta 9 A
FI-02230 Espoo

GlaxoSmithKline Oy
Piispansilta 9 A
FI-02230 Espoo

Laboratoire GlaxoSmithKline
100, route de Versailles
F-78163 Marly-le-Roi Cedex

Laboratoire GlaxoSmithKline
100, route de Versailles
F-78163 Marly-le-Roi Cedex

Laboratoire GlaxoSmithKline
100, route de Versailles
F-78163 Marly-le-Roi Cedex

Laboratoire GlaxoSmithKline
100, route de Versailles
F-78163 Marly-le-Roi Cedex

Laboratoire GlaxoSmithKline
100, route de Versailles
F-78163 Marly-le-Roi Cedex

Laboratoire GlaxoSmithKline
100, route de Versailles
F-78163 Marly-le-Roi Cedex

Laboratoire GlaxoSmithKline
100, route de Versailles
F-78163 Marly-le-Roi Cedex

Laboratoire GlaxoSmithKline
100, route de Versailles
F-78163 Marly-le-Roi Cedex

GlaxoSmithKline GmbH & Co. KG
Theresienhöhe 11
D-80339 München

GlaxoSmithKline GmbH & Co. KG
Theresienhöhe 11
D-80339 München

Lamictal

Lamictal

100 mg

Dispersible tablet

Oral use

200 mg

Dispersible tablet

Oral use

Lamicstart 25 mg, comprimé

25 mg

Tablet

Oral use

Lamicstart 50 mg, comprimé

50 mg

Tablet

Oral use

Lamictal 2 mg, comprimé dispersible

2 mg

Dispersible tablet

Oral use

Lamictal 5 mg, comprimé dispersible ou à croquer

5 mg

Dispersible or chewable
tablet

Oral use

Lamictal 25 mg, comprimé dispersible ou à croquer

25 mg

Dispersible or chewable
tablet

Oral use

Lamictal 50 mg, comprimé dispersible ou à croquer

50 mg

Dispersible or chewable
tablet

Oral use

Lamictal 100 mg, comprimé dispersible ou à croquer

100 mg

Dispersible or chewable
tablet

Oral use

Lamictal 200 mg, comprimé dispersible ou à croquer

200 mg

Dispersible or chewable
tablet

Oral use

Lamictal 2 mg Tabletten zur Herstellung einer Suspen-
sion zum Einnehmen

2 mg

Dispersible tablet

Oral use

Lamictal 5 mg Tabletten zur Herstellung einer Suspen-
sion zum Einnehmen

5 mg

Dispersible tablet

Oral use

C

2
2
0
/
4
4

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

.

2
9
8
2
0
0
8

Member State

Marketing Authorisation Holder

(Invented) Name

Strength

Pharmaceutical form

Route of
administration

Germany

Germany

Germany

Germany

Greece

Greece

Greece

Greece

Greece

Greece

Greece

Greece

GlaxoSmithKline GmbH & Co. KG
Theresienhöhe 11
D-80339 München

GlaxoSmithKline GmbH & Co. KG
Theresienhöhe 11
D-80339 München

GlaxoSmithKline GmbH & Co. KG
Theresienhöhe 11
D-80339 München

GlaxoSmithKline GmbH & Co. KG
Theresienhöhe 11
D-80339 München

GlaxoSmithKline α.ε.β.ε
266 Kifissias Ave
GR-152 32 Halandri, Athens

GlaxoSmithKline α.ε.β.ε
266 Kifissias Ave
GR-152 32 Halandri, Athens

GlaxoSmithKline α.ε.β.ε
266 Kifissias Ave
GR-152 32 Halandri, Athens

GlaxoSmithKline α.ε.β.ε
266 Kifissias Ave
GR-152 32 Halandri, Athens

GlaxoSmithKline α.ε.β.ε
266 Kifissias Ave
GR-152 32 Halandri, Athens

GlaxoSmithKline α.ε.β.ε
266 Kifissias Ave
GR-152 32 Halandri, Athens

GlaxoSmithKline α.ε.β.ε
266 Kifissias Ave
GR-152 32 Halandri, Athens

GlaxoSmithKline α.ε.β.ε
266 Kifissias Ave
GR-152 32 Halandri, Athens

Lamictal 25 mg Tabletten zur Herstellung einer Suspen-
sion zum Einnehmen

25 mg

Dispersible tablet

Oral use

Lamictal 50 mg Tabletten zur Herstellung einer Suspen-
sion zum Einnehmen

50 mg

Dispersible tablet

Oral use

Lamictal 100 mg Tabletten zur Herstellung einer Suspen-
sion zum Einnehmen

100 mg

Dispersible tablet

Oral use

Lamictal 200 mg Tabletten zur Herstellung einer Suspen-
sion zum Einnehmen

200 mg

Dispersible tablet

Oral use

Lamictal

Lamictal

Lamictal

Lamictal

Lamictal

Lamictal

Lamictal

Lamictal

25 mg

Tablet

Oral use

50 mg

Tablet

Oral use

100 mg

Tablet

Oral use

200 mg

Tablet

Oral use

2 mg

5 mg

25 mg

50 mg

Dispersible/Chewable
tablets

Oral use

Dispersible/Chewable
tablets

Oral use

Dispersible/Chewable
tablets

Oral use

Dispersible/Chewable
tablets

Oral use

.

.

2
9
8
2
0
0
8

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C

2
2
0
/
4
5

Member State

Marketing Authorisation Holder

(Invented) Name

Strength

Pharmaceutical form

Route of
administration

Greece

Greece

Hungary

Hungary

Hungary

Hungary

Hungary

Iceland

Iceland

Iceland

Iceland

Iceland

GlaxoSmithKline α.ε.β.ε
266 Kifissias Ave
GR-152 32 Halandri, Athens

GlaxoSmithKline α.ε.β.ε
266 Kifissias Ave
GR-152 32 Halandri, Athens

GlaxoSmithKline Kft.
Csorsz u. 43. MOM Park Gesztenyes torony
HU-1124 Budapest

GlaxoSmithKline Kft.
Csorsz u. 43. MOM Park Gesztenyes torony
HU-1124 Budapest

GlaxoSmithKline Kft.
Csorsz u. 43. MOM Park Gesztenyes torony
HU-1124 Budapest

GlaxoSmithKline Kft.
Csorsz u. 43. MOM Park Gesztenyes torony
HU-1124 Budapest

GlaxoSmithKline Kft.
Csorsz u. 43. MOM Park Gesztenyes torony
HU-1124 Budapest

GlaxoSmithKline ehf.
Thverholt 14
IS-105 Reykjavik

GlaxoSmithKline ehf.
Thverholt 14
IS-105 Reykjavik

GlaxoSmithKline ehf.
Thverholt 14
IS-105 Reykjavik

GlaxoSmithKline ehf.
Thverholt 14
IS-105 Reykjavik

GlaxoSmithKline ehf.
Thverholt 14
IS-105 Reykjavik

Lamictal

Lamictal

Lamictal

Lamictal

Lamictal

Lamictal

Lamictal

Lamictal

Lamictal

Lamictal

Lamictal

Lamictal

100 mg

Dispersible/Chewable
tablets

Oral use

200 mg

Dispersible/Chewable
tablets

Oral use

25 mg

Tablet

Oral use

50 mg

Tablet

Oral use

100 mg

Tablet

Oral use

5 mg

Dispersible tablet

Oral use

200 mg

Dispersible tablet

Oral use

2 mg

Dispersible tablet

Oral use

5 mg

Dispersible tablet

Oral use

25 mg

Dispersible tablet

Oral use

50 mg

Dispersible tablet

Oral use

100 mg

Dispersible tablet

Oral use

C

2
2
0
/
4
6

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

.

2
9
8
2
0
0
8

Member State

Marketing Authorisation Holder

(Invented) Name

Strength

Pharmaceutical form

Route of
administration

Iceland

Ireland

Ireland

Ireland

Ireland

Ireland

Ireland

Ireland

GlaxoSmithKline ehf.
Thverholt 14
IS-105 Reykjavik

GlaxoSmithKline (Ireland) Ltd
Stonemasons Way
Rathfarnham
Dublin 16
Ireland

GlaxoSmithKline (Ireland) Ltd
Stonemasons Way
Rathfarnham
Dublin 16
Ireland

GlaxoSmithKline (Ireland) Ltd
Stonemasons Way
Rathfarnham
Dublin 16
Ireland

GlaxoSmithKline (Ireland) Ltd
Stonemasons Way
Rathfarnham
Dublin 16
Ireland

GlaxoSmithKline (Ireland) Ltd
Stonemasons Way
Rathfarnham
Dublin 16
Ireland

GlaxoSmithKline (Ireland) Ltd
Stonemasons Way
Rathfarnham
Dublin 16
Ireland

GlaxoSmithKline (Ireland) Ltd
Stonemasons Way
Rathfarnham
Dublin 16
Ireland

Lamictal

200 mg

Dispersible tablet

Oral use

Lamictal tablets 25 mg

25 mg

Tablet

Oral use

Lamictal tablets 50 mg

50 mg

Tablet

Oral use

Lamictal tablets 100 mg

100 mg

Tablet

Oral use

Lamictal tablets 200 mg

200 mg

Tablet

Oral use

Lamictal 2 mg dispersible tablets

2 mg

Dispersible tablet

Oral use

Lamictal dispersible tablets 5 mg

5 mg

Dispersible tablet

Oral use

Lamictal dispersible tablets 25 mg

25 mg

Dispersible tablet

Oral use

.

.

2
9
8
2
0
0
8

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C

2
2
0
/
4
7

Member State

Marketing Authorisation Holder

(Invented) Name

Strength

Pharmaceutical form

Route of
administration

Ireland

Ireland

Ireland

Italy

Italy

Italy

Italy

Italy

Latvia

Latvia

GlaxoSmithKline (Ireland) Ltd
Stonemasons Way
Rathfarnham
Dublin 16
Ireland

GlaxoSmithKline (Ireland) Ltd
Stonemasons Way
Rathfarnham
Dublin 16
Ireland

GlaxoSmithKline (Ireland) Ltd
Stonemasons Way
Rathfarnham
Dublin 16
Ireland

GlaxoSmithKline SpA
Via Fleming, 2
I-37135 Verona

GlaxoSmithKline SpA
Via Fleming, 2
I-37135 Verona

GlaxoSmithKline SpA
Via Fleming, 2
I-37135 Verona

GlaxoSmithKline SpA
Via Fleming, 2
I-37135 Verona

GlaxoSmithKline SpA
Via Fleming, 2
I-37135 Verona

GlaxoSmithKline Latvia SIA
Bruņinieku iela 5
LV-1001 Riga

GlaxoSmithKline Latvia SIA
Bruņinieku iela 5
LV-1001 Riga

Lamictal dispersible tablets 50 mg

50 mg

Dispersible tablet

Oral use

Lamictal dispersible tablets 100 mg

100 mg

Dispersible tablet

Oral use

Lamictal dispersible tablets 200 mg

200 mg

Dispersible tablet

Oral use

Lamictal

Lamictal

Lamictal

Lamictal

Lamictal

5 mg

Dispersible Tablet

Oral use

25 mg

Dispersible tablet

Oral use

50 mg

Dispersible tablet

Oral use

100 mg

Dispersible tablet

Oral use

200 mg

Dispersible tablet

Oral use

Lamictal 2 mg dispersible tablets

2 mg

Dispersible tablet

Oral use

Lamictal 5 mg dispersible tablets

5 mg

Dispersible tablet

Oral use

C

2
2
0
/
4
8

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

.

2
9
8
2
0
0
8

Member State

Marketing Authorisation Holder

(Invented) Name

Strength

Pharmaceutical form

Route of
administration

Latvia

Latvia

Latvia

Latvia

Lithuania

Lithuania

Lithuania

Lithuania

GlaxoSmithKline Latvia SIA
Bruņinieku iela 5
LV-1001 Riga

GlaxoSmithKline Latvia SIA
Bruņinieku iela 5
LV-1001 Riga

GlaxoSmithKline Latvia SIA
Bruņinieku iela 5
LV-1001 Riga

GlaxoSmithKline Latvia SIA
Bruņinieku iela 5
LV-1001 Riga

The Wellcome Foundation Limited
Glaxo Wellcome House
Berkeley Avenue
Greenford
Middlesex UB6 0NN
United Kingdom

The Wellcome Foundation Limited
Glaxo Wellcome House
Berkeley Avenue
Greenford
Middlesex UB6 0NN
United Kingdom

The Wellcome Foundation Limited
Glaxo Wellcome House
Berkeley Avenue
Greenford
Middlesex UB6 0NN
United Kingdom

The Wellcome Foundation Limited
Glaxo Wellcome House
Berkeley Avenue
Greenford
Middlesex UB6 0NN
United Kingdom

Lamictal 25 mg dispersible tablets

25 mg

Dispersible tablet

Oral use

Lamictal 50 mg dispersible tablets

50 mg

Dispersible tablet

Oral use

Lamictal 100 mg dispersible tablets

100 mg

Dispersible tablet

Oral use

Lamictal 200 mg dispersible tablets

200 mg

Dispersible tablet

Oral use

Lamictal

5 mg

Dispersible tablet

Oral use

Lamictal

25 mg

Dispersible tablet

Oral use

Lamictal

50 mg

Dispersible tablet

Oral use

Lamictal

100 mg

Dispersible tablet

Oral use

.

.

2
9
8
2
0
0
8

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C

2
2
0
/
4
9

Member State

Marketing Authorisation Holder

(Invented) Name

Strength

Pharmaceutical form

Route of
administration

Lithuania

Luxembourg

Luxembourg

Luxembourg

Luxembourg

Luxembourg

Luxembourg

Luxembourg

Luxembourg

Luxembourg

Luxembourg

The Wellcome Foundation Limited
Glaxo Wellcome House
Berkeley Avenue
Greenford
Middlesex UB6 0NN
United Kingdom

GlaxoSmithKline s.a.
Rue du Tilleul 13
B-1332 Genval

GlaxoSmithKline s.a.
Rue du Tilleul 13
B-1332 Genval

GlaxoSmithKline s.a.
Rue du Tilleul 13
B-1332 Genval

GlaxoSmithKline s.a.
Rue du Tilleul 13
B-1332 Genval

GlaxoSmithKline s.a.
Rue du Tilleul 13
B-1332 Genval

GlaxoSmithKline s.a.
Rue du Tilleul 13
B-1332 Genval

GlaxoSmithKline s.a.
Rue du Tilleul 13
B-1332 Genval

GlaxoSmithKline s.a.
Rue du Tilleul 13
B-1332 Genval

GlaxoSmithKline s.a.
Rue du Tilleul 13
B-1332 Genval

GlaxoSmithKline s.a.
Rue du Tilleul 13
B-1332 Genval

Lamictal

200 mg

Dispersible tablet

Oral use

Lamictal

Lamictal

Lamictal

25 mg

Tablet

Oral use

50 mg

Tablet

Oral use

100 mg

Tablet

Oral use

Lamictal Dispersible 25mg Starter-Pack Mono

25 mg

Dispersible tablet

Oral use

Lamictal Dispersible 25mg Starter-Pack Add-on

25 mg

Dispersible tablet

Oral use

Lamictal Dispersible 50mg Starter-Pack add-on

50 mg

Dispersible tablet

Oral use

Lamictal dispersible

2 mg

Dispersible tablet

Oral use

Lamictal dispersible

5 mg

Dispersible tablet

Oral use

Lamictal dispersible

25 mg

Dispersible tablet

Oral use

Lamictal dispersible

50 mg

Dispersible tablet

Oral use

C

2
2
0
/
5
0

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

.

2
9
8
2
0
0
8

Member State

Marketing Authorisation Holder

(Invented) Name

Strength

Pharmaceutical form

Route of
administration

Luxembourg

Luxembourg

Malta

Malta

Malta

Malta

Malta

Malta

GlaxoSmithKline s.a.
Rue du Tilleul 13
B-1332 Genval

GlaxoSmithKline s.a.
Rue du Tilleul 13
B-1332 Genval

GlaxoSmithKline (Ireland) Ltd
Stonemasons Way
Rathfarnham
Dublin 16
Ireland

GlaxoSmithKline (Ireland) Ltd
Stonemasons Way
Rathfarnham
Dublin 16
Ireland

GlaxoSmithKline (Ireland) Ltd
Stonemasons Way
Rathfarnham
Dublin 16
Ireland

GlaxoSmithKline (Ireland) Ltd
Stonemasons Way
Rathfarnham
Dublin 16
Ireland

GlaxoSmithKline (Ireland) Ltd
Stonemasons Way
Rathfarnham
Dublin 16
Ireland

GlaxoSmithKline (Ireland) Ltd
Stonemasons Way
Rathfarnham
Dublin 16
Ireland

Lamictal dispersible

100 mg

Dispersible tablet

Oral use

Lamictal dispersible

200 mg

Dispersible tablet

Oral use

Lamictal

25 mg

Tablet

Oral use

Lamictal

50 mg

Tablet

Oral use

Lamictal

100 mg

Tablet

Oral use

Lamictal

2 mg

Dispersible/Chewable tablet Oral use

Lamictal

5 mg

Dispersible/Chewable tablet Oral use

Lamictal

25 mg

Dispersible/Chewable tablet Oral use

.

.

2
9
8
2
0
0
8

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C

2
2
0
/
5
1

Member State

Marketing Authorisation Holder

(Invented) Name

Strength

Pharmaceutical form

Route of
administration

Netherlands

Netherlands

Netherlands

Netherlands

Netherlands

Netherlands

Norway

Norway

Norway

GlaxoSmithKline BV
Huis ter Heideweg 62
3705 LZ Zeist
Nederland

GlaxoSmithKline BV
Huis ter Heideweg 62
3705 LZ Zeist
Nederland

GlaxoSmithKline BV
Huis ter Heideweg 62
3705 LZ Zeist
Nederland

GlaxoSmithKline BV
Huis ter Heideweg 62
3705 LZ Zeist
Nederland

GlaxoSmithKline BV
Huis ter Heideweg 62
3705 LZ Zeist
Nederland

GlaxoSmithKline BV
Huis ter Heideweg 62
3705 LZ Zeist
Nederland

GlaxoSmithKline AS
Forskningsveien 2a
Postbox 180 Vinderen
N-0319 Oslo

GlaxoSmithKline AS
Forskningsveien 2a
Postbox 180 Vinderen
N-0319 Oslo

GlaxoSmithKline AS
Forskningsveien 2a
Postbox 180 Vinderen
N-0319 Oslo

Lamictal 2 Dispers

2 mg

Dispersible tablet

Oral use

Lamictal 5 Dispers

5 mg

Dispersible tablet

Oral use

Lamictal 25 Dispers

25 mg

Dispersible tablet

Oral use

Lamictal 50 Dispers

50 mg

Dispersible tablet

Oral use

Lamictal 100 Dispers

100 mg

Dispersible tablet

Oral use

Lamictal 200 Dispers

200 mg

Dispersible tablet

Oral use

Lamictal

Lamictal

Lamictal

2 mg

Dispersible tablet

Oral use

5 mg

Dispersible tablet

Oral use

25 mg

Dispersible tablet

Oral use

C

2
2
0
/
5
2

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

.

2
9
8
2
0
0
8

Member State

Marketing Authorisation Holder

(Invented) Name

Strength

Pharmaceutical form

Route of
administration

Norway

Norway

Norway

Poland

Poland

Poland

Poland

Poland

GlaxoSmithKline AS
Forskningsveien 2a
Postbox 180 Vinderen
N-0319 Oslo

GlaxoSmithKline AS
Forskningsveien 2a
Postbox 180 Vinderen
N-0319 Oslo

GlaxoSmithKline AS
Forskningsveien 2a
Postbox 180 Vinderen
N-0319 Oslo

GlaxoSmithKline Export Ltd
980 Great West Road
Brentford
Middlesex TW8 9GS
United Kingdom

GlaxoSmithKline Export Ltd
980 Great West Road
Brentford
Middlesex TW8 9GS
United Kingdom

GlaxoSmithKline Export Ltd
980 Great West Road
Brentford
Middlesex TW8 9GS
United Kingdom

GlaxoSmithKline Export Ltd
980 Great West Road
Brentford
Middlesex TW8 9GS
United Kingdom

GlaxoSmithKline Export Ltd
980 Great West Road
Brentford
Middlesex TW8 9GS
United Kingdom

Lamictal

Lamictal

Lamictal

Lamitrin

50 mg

Dispersible tablet

Oral use

100 mg

Dispersible tablet

Oral use

200 mg

Dispersible tablet

Oral use

25 mg

Tablet

Oral use

Lamitrin

50 mg

Tablet

Oral use

Lamitrin

100 mg

Tablet

Oral use

Lamitrin S

2 mg

Dispersible tablet

Oral use

Lamitrin S

5 mg

Dispersible tablet

Oral use

.

.

2
9
8
2
0
0
8

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C

2
2
0
/
5
3

Member State

Marketing Authorisation Holder

(Invented) Name

Strength

Pharmaceutical form

Route of
administration

Poland

Poland

Poland

Poland

Portugal

Portugal

Portugal

Portugal

GlaxoSmithKline Export Ltd
980 Great West Road
Brentford
Middlesex TW8 9GS
United Kingdom

GlaxoSmithKline Export Ltd
980 Great West Road
Brentford
Middlesex TW8 9GS
United Kingdom

GlaxoSmithKline Export Ltd
980 Great West Road
Brentford
Middlesex TW8 9GS
United Kingdom

GlaxoSmithKline Export Ltd
980 Great West Road
Brentford
Middlesex TW8 9GS
United Kingdom

Laboratórios Wellcome de Portugal Lda.
Rua Dr. António Loureiro Borges n.o 3
Arquiparque-Miraflores
P-1495-131 Algés

Laboratórios Wellcome de Portugal Lda.
Rua Dr. António Loureiro Borges n.o 3
Arquiparque-Miraflores
P-1495-131 Algés

Laboratórios Wellcome de Portugal Lda.
Rua Dr. António Loureiro Borges n.o 3
Arquiparque-Miraflores
P-1495-131 Algés

Laboratórios Wellcome de Portugal Lda.
Rua Dr. António Loureiro Borges n.o 3
Arquiparque-Miraflores
P-1495-131 Algés

Lamitrin S

25 mg

Dispersible tablet

Oral use

Lamitrin S

50 mg

Dispersible tablet

Oral use

Lamitrin S

100 mg

Dispersible tablet

Oral use

Lamitrin S

200 mg

Dispersible tablet

Oral use

Lamictal

Lamictal

Lamictal

Lamictal

25 mg

Tablet

Oral use

50 mg

Tablet

Oral use

100 mg

Tablet

Oral use

200 mg

Tablet

Oral use

C

2
2
0
/
5
4

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

.

2
9
8
2
0
0
8

Member State

Marketing Authorisation Holder

(Invented) Name

Strength

Pharmaceutical form

Route of
administration

Portugal

Portugal

Portugal

Portugal

Portugal

Portugal

Romania

Romania

Laboratórios Wellcome de Portugal Lda.
Rua Dr. António Loureiro Borges n.o 3
Arquiparque-Miraflores
P-1495-131 Algés

Laboratórios Wellcome de Portugal Lda.
Rua Dr. António Loureiro Borges n.o 3
Arquiparque-Miraflores
P-1495-131 Algés

Laboratórios Wellcome de Portugal Lda.
Rua Dr. António Loureiro Borges n.o 3
Arquiparque-Miraflores
P-1495-131 Algés

Laboratórios Wellcome de Portugal Lda.
Rua Dr. António Loureiro Borges n.o 3
Arquiparque-Miraflores
P-1495-131 Algés

Laboratórios Wellcome de Portugal Lda.
Rua Dr. António Loureiro Borges n.o 3
Arquiparque-Miraflores
P-1495-131 Algés

Laboratórios Wellcome de Portugal Lda.
Rua Dr. António Loureiro Borges n.o 3
Arquiparque-Miraflores
P-1495-131 Algés

The Wellcome Foundation Limited
Glaxo Wellcome House
Berkeley Avenue
Greenford
Middlesex UB6 0NN
United Kingdom

The Wellcome Foundation Limited
Glaxo Wellcome House
Berkeley Avenue
Greenford
Middlesex UB6 0NN
United Kingdom

Lamictal

Lamictal

Lamictal

Lamictal

Lamictal

Lamictal

2 mg

Dispersible tablet

Oral use

5 mg

Dispersible tablet

Oral use

25 mg

Dispersible tablet

Oral use

50 mg

Dispersible tablet

Oral use

100 mg

Dispersible tablet

Oral use

200 mg

Dispersible tablet

Oral use

Lamictal 25 mg

25 mg

Tablet

Oral use

Lamictal 50 mg

50 mg

Tablet

Oral use

.

.

2
9
8
2
0
0
8

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C

2
2
0
/
5
5

Member State

Marketing Authorisation Holder

(Invented) Name

Strength

Pharmaceutical form

Route of
administration

Romania

Romania

Romania

Romania

Romania

Slovakia

Slovakia

Slovakia

The Wellcome Foundation Limited
Glaxo Wellcome House
Berkeley Avenue
Greenford
Middlesex UB6 0NN
United Kingdom

The Wellcome Foundation Limited
Glaxo Wellcome House
Berkeley Avenue
Greenford
Middlesex UB6 0NN
United Kingdom

The Wellcome Foundation Limited
Glaxo Wellcome House
Berkeley Avenue
Greenford
Middlesex UB6 0NN
United Kingdom

The Wellcome Foundation Limited
Glaxo Wellcome House
Berkeley Avenue
Greenford
Middlesex UB6 0NN
United Kingdom

The Wellcome Foundation Limited
Glaxo Wellcome House
Berkeley Avenue
Greenford
Middlesex UB6 0NN
United Kingdom

GlaxoSmithKline Slovakia s.r.o.
Galvaniho 7/A
SK-82104 Bratislava

GlaxoSmithKline Slovakia s.r.o.
Galvaniho 7/A
SK-82104 Bratislava

GlaxoSmithKline Slovakia s.r.o.
Galvaniho 7/A
SK-82104 Bratislava

Lamictal 100 mg

100 mg

Tablet

Oral use

Lamictal 2 mg

2 mg

Dispersible/Chewable tablet Oral use

Lamictal 5 mg

5 mg

Dispersible/Chewable tablet Oral use

Lamictal 25 mg

25 mg

Dispersible/Chewable tablet Oral use

Lamictal 100 mg

100 mg

Dispersible/Chewable tablet Oral use

Lamictal 25 mg

25 mg

Tablet

Oral use

Lamictal 50 mg

50 mg

Tablet

Oral use

Lamictal 100 mg

100 mg

Tablet

Oral use

C

2
2
0
/
5
6

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

.

2
9
8
2
0
0
8

Member State

Marketing Authorisation Holder

(Invented) Name

Strength

Pharmaceutical form

Route of
administration

Slovakia

Slovakia

Slovakia

Slovakia

Slovenia

Slovenia

Slovenia

Slovenia

Slovenia

Slovenia

Slovenia

Slovenia

GlaxoSmithKline Slovakia s.r.o.
Galvaniho 7/A
SK-82104 Bratislava

GlaxoSmithKline Slovakia s.r.o.
Galvaniho 7/A
SK-82104 Bratislava

GlaxoSmithKline Slovakia s.r.o.
Galvaniho 7/A
SK-82104 Bratislava

GlaxoSmithKline Slovakia s.r.o.
Galvaniho 7/A
SK-82104 Bratislava

GSK d.o.o.
Knezov štradon 90
SLO-1000 Ljubljana

GSK d.o.o.
Knezov štradon 90
SLO-1000 Ljubljana

GSK d.o.o.
Knezov štradon 90
SLO-1000 Ljubljana

GSK d.o.o.
Knezov štradon 90
SLO-1000 Ljubljana

GSK d.o.o.
Knezov štradon 90
SLO-1000 Ljubljana

GSK d.o.o.
Knezov štradon 90
SLO-1000 Ljubljana

GSK d.o.o.
Knezov štradon 90
SLO-1000 Ljubljana

GSK d.o.o.
Knezov štradon 90
SLO-1000 Ljubljana

Lamictal 2 mg

2 mg

Dispersible tablet

Oral use

Lamictal 5 mg

5 mg

Dispersible tablet

Oral use

Lamictal 25 mg

25 mg

Dispersible tablet

Oral use

Lamictal 100 mg

100 mg

Dispersible tablet

Oral use

Lamictal 25 mg tablete

25 mg

Tablet

Oral use

Lamictal 50 mg tablete

50 mg

Tablet

Oral use

Lamictal 100 mg tablete

100 mg

Tablet

Oral use

Lamictal 200 mg tablete

200 mg

Tablet

Oral use

Lamictal 5 mg disperzibilne/žvečljive tablete

5 mg

Dispersible/Chewable tablet Oral use

Lamictal 25 mg disperzibilne/žvečljive tablete

25 mg

Dispersible/Chewable tablet Oral use

Lamictal 50 mg disperzibilne/žvečljive tablete

50 mg

Dispersible/Chewable tablet Oral use

Lamictal 100 mg disperzibilne/žvečljive tablete

100 mg

Dispersible/Chewable tablet Oral use

.

.

2
9
8
2
0
0
8

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C

2
2
0
/
5
7

Member State

Marketing Authorisation Holder

(Invented) Name

Strength

Pharmaceutical form

Route of
administration

Slovenia

Spain

Spain

Spain

Spain

Spain

Spain

Spain

Spain

Spain

Sweden

Sweden

GSK d.o.o.
Knezov štradon 90
SLO-1000 Ljubljana

GlaxoSmithKline SA
Severo Ochoa no 2
E-28760 Tres Cantos Madrid

GlaxoSmithKline SA
Severo Ochoa no 2
E-28760 Tres Cantos Madrid

GlaxoSmithKline SA
Severo Ochoa no 2
E-28760 Tres Cantos Madrid

GlaxoSmithKline SA
Severo Ochoa no 2
E-28760 Tres Cantos Madrid

GlaxoSmithKline SA
Severo Ochoa no 2
E-28760 Tres Cantos Madrid

GlaxoSmithKline SA
Severo Ochoa no 2
E-28760 Tres Cantos Madrid

GlaxoSmithKline SA
Severo Ochoa no 2
E-28760 Tres Cantos Madrid

GlaxoSmithKline SA
Severo Ochoa no 2
E-28760 Tres Cantos Madrid

GlaxoSmithKline SA
Severo Ochoa no 2
E-28760 Tres Cantos Madrid

GlaxoSmithKline AB
Box 516
S-169 29 Solna

GlaxoSmithKline AB
Box 516
S-169 29 Solna

Lamictal 200 mg disperzibilne/žvečljive tablete

200 mg

Dispersible/Chewable tablet Oral use

Lamictal

Lamictal

Lamictal

Lamictal

Lamictal

Lamictal

Lamictal

Lamictal

Lamictal

Lamictal

Lamictal

50 mg

Tablet

Oral use

100 mg

Tablet

Oral use

200 mg

Tablet

Oral use

2 mg

Dispersible tablet

Oral use

5 mg

Dispersible tablet

Oral use

25 mg

Dispersible tablet

Oral use

50 mg

Dispersible tablet

Oral use

100 mg

Dispersible tablet

Oral use

200 mg

Dispersible tablet

Oral use

25 mg

Tablet

Oral use

50 mg

Tablet

Oral use

C

2
2
0
/
5
8

E
N

O

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J
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2
9
8
2
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8

Member State

Marketing Authorisation Holder

(Invented) Name

Strength

Pharmaceutical form

Route of
administration

Lamictal

Lamictal

Lamictal

Lamictal

Lamictal

Lamictal

Lamictal

Lamictal

Lamictal

Sweden

Sweden

Sweden

Sweden

Sweden

Sweden

Sweden

Sweden

GlaxoSmithKline AB
Box 516
S-169 29 Solna

GlaxoSmithKline AB
Box 516
S-169 29 Solna

GlaxoSmithKline AB
Box 516
S-169 29 Solna

GlaxoSmithKline AB
Box 516
S-169 29 Solna

GlaxoSmithKline AB
Box 516
S-169 29 Solna

GlaxoSmithKline AB
Box 516
S-169 29 Solna

GlaxoSmithKline AB
Box 516
S-169 29 Solna

GlaxoSmithKline AB
Box 516
S-169 29 Solna

United Kingdom

The Wellcome Foundation Limited
Glaxo Wellcome House
Berkeley Avenue
Greenford
Middlesex UB6 0NN
United Kingdom

Trading as
GlaxoSmithKline UK
Stockley Park West
Uxbridge
Middlesex UB11 1BT
United Kingdom

100 mg

Tablet

Oral use

200 mg

Tablet

Oral use

2 mg

Soluble tablet

Oral use

5 mg

Soluble tablet

Oral use

25 mg

Soluble tablet

Oral use

50 mg

Soluble tablet

Oral use

100 mg

Soluble tablet

Oral use

200 mg

Soluble tablet

Oral use

25 mg

Tablet

Oral use

.

.

2
9
8
2
0
0
8

E
N

O

f
f
i
c
i
a
l

J
o
u
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n
a
l

o
f

t
h
e

E
u
r
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p
e
a
n
U
n
o
n

i

C

2
2
0
/
5
9

Member State

Marketing Authorisation Holder

(Invented) Name

Strength

Pharmaceutical form

Route of
administration

Lamictal

50 mg

Tablet

Oral use

Lamictal

100 mg

Tablet

Oral use

Lamictal

200 mg

Tablet

Oral use

United Kingdom

The Wellcome Foundation Limited
Glaxo Wellcome House
Berkeley Avenue
Greenford
Middlesex UB6 0NN
United Kingdom

Trading as
GlaxoSmithKline UK
Stockley Park West
Uxbridge
Middlesex UB11 1BT
United Kingdom

United Kingdom

The Wellcome Foundation Limited
Glaxo Wellcome House
Berkeley Avenue
Greenford
Middlesex UB6 0NN
United Kingdom

Trading as
GlaxoSmithKline UK
Stockley Park West
Uxbridge
Middlesex UB11 1BT
United Kingdom

United Kingdom

The Wellcome Foundation Limited
Glaxo Wellcome House
Berkeley Avenue
Greenford
Middlesex UB6 0NN
United Kingdom

Trading as
GlaxoSmithKline UK
Stockley Park West
Uxbridge
Middlesex UB11 1BT
United Kingdom

C

2
2
0
/
6
0

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

.

2
9
8
2
0
0
8

Member State

Marketing Authorisation Holder

(Invented) Name

Strength

Pharmaceutical form

Route of
administration

Lamictal

2 mg

Dispersible tablet

Oral use

Lamictal

5 mg

Dispersible tablet

Oral use

Lamictal

25 mg

Dispersible tablet

Oral use

United Kingdom

The Wellcome Foundation Limited
Glaxo Wellcome House
Berkeley Avenue
Greenford
Middlesex UB6 0NN
United Kingdom

Trading as
GlaxoSmithKline UK
Stockley Park West
Uxbridge
Middlesex UB11 1BT
United Kingdom

United Kingdom

The Wellcome Foundation Limited
Glaxo Wellcome House
Berkeley Avenue
Greenford
Middlesex UB6 0NN
United Kingdom

Trading as
GlaxoSmithKline UK
Stockley Park West
Uxbridge
Middlesex UB11 1BT
United Kingdom

United Kingdom

The Wellcome Foundation Limited
Glaxo Wellcome House
Berkeley Avenue
Greenford
Middlesex UB6 0NN
United Kingdom

Trading as
GlaxoSmithKline UK
Stockley Park West
Uxbridge
Middlesex UB11 1BT
United Kingdom

.

.

2
9
8
2
0
0
8

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
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e

E
u
r
o
p
e
a
n
U
n
o
n

i

C

2
2
0
/
6
1

Member State

Marketing Authorisation Holder

(Invented) Name

Strength

Pharmaceutical form

Route of
administration

Lamictal

50 mg

Dispersible tablet

Oral use

Lamictal

100 mg

Dispersible tablet

Oral use

Lamictal

200 mg

Dispersible tablet

Oral use

United Kingdom

United Kingdom

United Kingdom

The Wellcome Foundation Limited
Glaxo Wellcome House
Berkeley Avenue
Greenford
Middlesex UB6 0NN
United Kingdom

Trading as
GlaxoSmithKline UK
Stockley Park West
Uxbridge
Middlesex UB11 1BT
United Kingdom

The Wellcome Foundation Limited
Glaxo Wellcome House
Berkeley Avenue
Greenford
Middlesex UB6 0NN
United Kingdom

Trading as
GlaxoSmithKline UK
Stockley Park West
Uxbridge
Middlesex UB11 1BT
United Kingdom

The Wellcome Foundation Limited
Glaxo Wellcome House
Berkeley Avenue
Greenford
Middlesex UB6 0NN
United Kingdom

Trading as
GlaxoSmithKline UK
Stockley Park West
Uxbridge
Middlesex UB11 1BT
United Kingdom

C

2
2
0
/
6
2

E
N

O

f
f
i
c
i
a
l

J
o
u
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n
a
l

o
f

t
h
e

E
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p
e
a
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U
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i

.

.

2
9
8
2
0
0
8