Summary of Community decisions on marketing authorizations in respect of medicinal products from  1 February 2009 to 28 February 2009 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC )
Date: 2009-03-27
Institutions: European Commission
Subjects: EU Member State, market approval, marketing standard, medicinal product, pharmaceutical legislation, withdrawal from the market

C 73/16

EN

Official Journal of the European Union

27.3.2009

Summary of Community decisions on marketing authorizations in respect of medicinal products
from 1 February 2009 to 28 February 2009

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

(2009/C 73/04)

— Issuing, maintenance or modification of a national marketing authorization

Date of the
decision

Name(s) of the
medicinal product

Holder(s) of the marketing
authorization

Member State concerned

4.2.2009

Nplate

Amgen Europe B.V.
Minervum 7061
4817 ZK Breda
NEDERLAND

This Decision is addressed to
the Member States

6.2.2009

Implanon

See Annex I

See Annex I

16.2.2009

Diovan

See Annex II

See Annex II

Date of
notification

6.2.2009

9.2.2009

17.2.2009

18.2.2009

This Decision is addressed to
the Member States

This Decision is addressed to
the Member States

23.2.2009

This Decision is addressed to
the Member States

23.2.2009

This Decision is addressed to
the Member States

23.2.2009

This Decision is addressed to
the Member States

25.2.2009

This Decision is addressed to
the Member States

26.2.2009

Ferring Pharmaceuticals A/S
Kay Fiskers Plads 11
Copenhagen S 2300
DANMARK

Laboratoires Servier
22 rue Garnier
92200 Neuilly-sur-Seine
FRANCE

Howmedica International S. de
R. L.
Raheen Business Park
Limerick
IRELAND

Servier (Ireland) Industries
Limited
Gorey Road
Arklow
Co. Wicklow
IRELAND

Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
UNITED KINGDOM

Menarini International Opera-
tions Luxembourg S.A.
1, Avenue de la Gare
L-1611 Luxembourg
LUXEMBOURG
CV Therapeutics Europe
Limited

15 Meadway Court
Rutherford Close
Stevenage
Hertfordshire SG1 2EF
UNITED KINGDOM

17.2.2009

FIRMAGON

19.2.2009

Valdoxan

19.2.2009

Opgenra

19.2.2009

Thymanax

24.2.2009

FABLYN

25.2.2009

Ranexa

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

27.3.2009

EN

Official Journal of the European Union

C 73/17

Date of the
decision

Name(s) of the
medicinal product

Holder(s) of the marketing
authorization

Member State concerned

25.2.2009

Efient

26.2.2009

ReFacto AF

Eli Lilly Nederland B.V.
Grootslag 1-5
3991 RA Houten
NEDERLAND

Wyeth Europa Ltd
Huntercombe Lane
South Taplow
Maidenhead
Berkshire SL6 0PH
UNITED KINGDOM

This Decision is addressed to
the Member States

Date of
notification

27.2.2009

This Decision is addressed to
the Member States

27.2.2009

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF
ADMINISTRATION AND MARKETING AUTHORIZATION HOLDERS IN THE MEMBER STATES

ANNEX I

Member State EU/EEA

Marketing Authorization Holder

Applicant

(Invented) Name

Strength

Pharmaceutical form

Route of administration

Austria

Belgium

Czech Republic

Denmark

Finland

France

Germany

N.V. Organon
Kloosterstraat 6
PO Box 20
5349 AB, Oss
NEDERLAND

N.V. Organon
Kloosterstraat 6
PO Box 20
5340 BH, Oss
NEDERLAND

N.V. Organon
Kloosterstraat 6
PO Box 20
5340 BH, Oss
NEDERLAND

N.V. Organon
Kloosterstraat 6
PO Box 20
5340 BH, Oss
NEDERLAND

N.V. Organon
Kloosterstraat 6
PO Box 20
5340 BH, Oss
NEDERLAND

Organon SA
Immeuble Optima
10 rue Godefroy
92821 Puteaux Cedex
FRANCE

Essex Pharma GmbH
Thomas-Dehler-Straße, 27
81737 München
DEUTSCHLAND

Implanon — Implantat

68 mg

Implant

Subcutaneous use

Implanon

68 mg

Implant

Subcutaneous use

Implanon

68 mg

Implant

Subcutaneous use

Implanon

68 mg

Implant

Subcutaneous use

Implanon

68 mg

Implant

Subcutaneous use

Implanon

68 mg

Implant

Subcutaneous use

Implanon

68 mg

Implant

Subcutaneous use

C

7
3
/
1
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
7
3
2
0
0
9

Member State EU/EEA

Marketing Authorization Holder

Applicant

(Invented) Name

Strength

Pharmaceutical form

Route of administration

Hungary

Iceland

Ireland

Italy

Luxembourg

Malta

Netherlands

N.V. Organon
Kloosterstraat 6
PO Box 20
5340 BH, Oss
NEDERLAND

N.V. Organon
Kloosterstraat 6
PO Box 20
5340 BH, Oss
NEDERLAND

Organon Ireland Ltd
Drynam Road
Swords
Co. Dublin
IRELAND

N.V. Organon
Kloosterstraat 6
PO Box 20
5340 BH, Oss
NEDERLAND

N.V. Organon
Kloosterstraat 6
PO Box 20
5340 BH, Oss
NEDERLAND

Organon Laboratories Ltd
Cambridge Science Park
Milton Road
Cambridge CB4 0FL
UNITED KINGDOM

N.V. Organon
Kloosterstraat 6
PO Box 20
5340 BH, Oss
NEDERLAND

Implanon

68 mg

Implant

Subcutaneous use

Implanon

68 mg

Implant

Subcutaneous use

Implanon 68 mg implant

68 mg

Implant

Subcutaneous use

Implanon

68 mg

Implant

Subcutaneous use

Implanon

68 mg

Implant

Subcutaneous use

Implanon

68 mg

Implant

Subcutaneous use

Implanon 68 mg

68 mg

Implant

Subcutaneous use

.

.

2
7
3
2
0
0
9

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

7
3
/
1
9

Member State EU/EEA

Marketing Authorization Holder

Applicant

(Invented) Name

Strength

Pharmaceutical form

Route of administration

Norway

Portugal

Slovak Republic

Spain

Sweden

United Kingdom

N.V. Organon
Kloosterstraat 6
PO Box 20
5340 BH, Oss
NEDERLAND

Organon Portuguesa
Produtos Químicos e Farmacêuticos, Lda
Av. José Malhoa, 16B — 2°
1070-159 Lisboa
PORTUGAL

N.V. Organon
Kloosterstraat 6
PO Box 20
5340 BH, Oss
NEDERLAND

Organon Española, S.A.
Ctra. de Hospitalet, 147-149
Cityparc Ronda de Dalt
Edificio Amsterdam
08940 Cornellá de Llobregat, Barcelona
ESPAÑA

N.V. Organon
Kloosterstraat 6
PO Box 20
5340 BH, Oss
NEDERLAND

Organon Laboratories Ltd
Cambridge Science Park
Milton Road
Cambridge CB4 0FL
UNITED KINGDOM

Implanon

68 mg

Implant

Subcutaneous use

Implanon

68 mg

Implant

Subcutaneous use

Implanon

68 mg

Implant

Subcutaneous use

Implanon

68 mg

Implant

Subcutaneous use

Implanon

68 mg

Implant

Subcutaneous use

Implanon

68 mg

Implant

Subcutaneous use

C

7
3
/
2
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
7
3
2
0
0
9

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

ANNEX II

Member State EU/EEA

Marketing Authorization Holder

(Invented) Name

Strength

Pharmaceutical form

Route of
administration

.

.

2
7
3
2
0
0
9

Austria

Austria

Austria

Austria

Austria

Austria

Austria

Austria

Novartis Pharma GmbH
Brunner Strasse 59
1235 Wien
ÖSTERREICH

Novartis Pharma GmbH
Brunner Strasse 59
1235 Wien
ÖSTERREICH

Novartis Pharma GmbH
Brunner Strasse 59
1235 Wien
ÖSTERREICH

Novartis Pharma GmbH
Brunner Strasse 59
1235 Wien
ÖSTERREICH

Novartis Pharma GmbH
Brunner Strasse 59
1235 Wien
ÖSTERREICH

Novartis Pharma GmbH
Brunner Strasse 59
1235 Wien
ÖSTERREICH

Novartis Pharma GmbH
Brunner Strasse 59
1235 Wien
ÖSTERREICH

Novartis Pharma GmbH
Brunner Strasse 59
1235 Wien
ÖSTERREICH

Diovan 40 mg Filmtabletten

40 mg

Film-coated tablets

Angiosan 40 mg Filmtabletten

40 mg

Film-coated tablets

Diovan 80 mg Filmtabletten

80 mg

Film-coated tablets

Angiosan 80 mg Filmtabletten

80 mg

Film-coated tablets

Diovan 160 mg Filmtabletten

160 mg

Film-coated tablets

Angiosan 160 mg Filmtabletten

160 mg

Film-coated tablets

Diovan 320 mg Filmtabletten

320 mg

Film-coated tablets

Angiosan 320 mg Filmtabletten

320 mg

Film-coated tablets

Oral

Oral

Oral

Oral

Oral

Oral

Oral

Oral

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

7
3
/
2
1

Member State EU/EEA

Marketing Authorization Holder

(Invented) Name

Strength

Pharmaceutical form

Route of
administration

Belgium

Belgium

Belgium

Belgium

Belgium

Belgium

Belgium

Belgium

Bulgaria

N.V. Novartis Pharma S.A.
Medialaan 40, bus 1
1800 Vilvoorde
BELGIQUE

N.V. Novartis Pharma S.A.
Medialaan 40, bus 1
1800 Vilvoorde
BELGIQUE

N.V. Novartis Pharma S.A.
Medialaan 40, bus 1
1800 Vilvoorde
BELGIQUE

N.V. Novartis Pharma S.A.
Medialaan 40, bus 1
1800 Vilvoorde
BELGIQUE

N.V. Novartis Pharma S.A.
Medialaan 40, bus 1
1800 Vilvoorde
BELGIQUE

N.V. Novartis Pharma S.A.
Medialaan 40, bus 1
1800 Vilvoorde
BELGIQUE

N.V. Novartis Pharma S.A.
Medialaan 40, bus 1
1800 Vilvoorde
BELGIQUE

N.V. Novartis Pharma S.A.
Medialaan 40, bus 1
1800 Vilvoorde
BELGIQUE

Novartis Pharma GmbH
Roonstraße 25
90429 Nürnberg
DEUTSCHLAND

Diovane 40 mg

40 mg

Film-coated tablets

Novacard 40 mg

40 mg

Film-coated tablets

Diovane 80 mg

80 mg

Film-coated tablets

Novacard 80 mg

80 mg

Film-coated tablets

Diovane 160 mg

160 mg

Film-coated tablets

Novacard 160 mg

160 mg

Film-coated tablets

Diovane 320 mg

320 mg

Film-coated tablets

Novacard 320 mg

320 mg

Film-coated tablets

Diovan 40 mg

40 mg

Film-coated tablets

Oral

Oral

Oral

Oral

Oral

Oral

Oral

Oral

Oral

C

7
3
/
2
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
7
3
2
0
0
9

Member State EU/EEA

Marketing Authorization Holder

(Invented) Name

Strength

Pharmaceutical form

Route of
administration

Bulgaria

Bulgaria

Cyprus

Cyprus

Cyprus

Cyprus

Czech Republic

Czech Republic

Denmark

Novartis Pharma GmbH
Roonstrasse 25
90429 Nürnberg
DEUTSCHLAND

Novartis Pharma GmbH
Roonstrasse 25
90429 Nürnberg
DEUTSCHLAND

Demetriades & Papaellinas ltd
21 Kasou
P.O. Box 23490 Nicosia
CYPRUS

Demetriades & Papaellinas ltd
21 Kasou
P.O. Box 23490 Nicosia
CYPRUS

Demetriades & Papaellinas ltd
21 Kasou
P.O. Box 23490 Nicosia
CYPRUS

Demetriades & Papaellinas ltd
21 Kasou
P.O. Box 23490 Nicosia
CYPRUS

NOVARTIS s.r.o. Pharma
Nagano III.
U Nákladového nádraží 10
130 00 Praha 3
ČESKÁ REPUBLIKA

NOVARTIS s.r.o. Pharma
Nagano III.
U Nákladového nádraží 10
130 00 Praha 3
ČESKÁ REPUBLIKA

Novartis Healthcare A/S
Lyngbyvej 172
2100 Kopenhagen Ø
DANEMARK

Diovan 80 mg

80 mg

Film-coated tablets

Diovan 160 mg

160 mg

Film-coated tablets

Diovan 40 mg

40 mg

Film-coated tablets

Diovan 80 mg

80 mg

Film-coated tablets

Diovan 160 mg

160 mg

Film-coated tablets

Diovan 320 mg

320 mg

Film-coated tablets

Diovan 40 mg

40 mg

Film-coated tablets

Diovan 160 mg

160 mg

Film-coated tablets

Diovan 40 mg

40 mg

Film-coated tablets

Oral

Oral

Oral

Oral

Oral

Oral

Oral

Oral

Oral

.

.

2
7
3
2
0
0
9

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

7
3
/
2
3

Member State EU/EEA

Marketing Authorization Holder

(Invented) Name

Strength

Pharmaceutical form

Route of
administration

Denmark

Denmark

Denmark

Estonia

Estonia

Estonia

Estonia

Finland

Finland

Novartis Healthcare A/S
Lyngbyvej 172
2100 Kopenhagen Ø
DANEMARK

Novartis Healthcare A/S
Lyngbyvej 172
2100 Kopenhagen Ø
DANEMARK

Novartis Healthcare A/S
Lyngbyvej 172
2100 Kopenhagen Ø
DANEMARK

Novartis Finland OY
Metsänneidonkuja 10
FI-02130 Espoo
SUOMI/FINLAND

Novartis Finland OY
Metsänneidonkuja 10
FI-02130 Espoo
SUOMI/FINLAND

Novartis Finland OY
Metsänneidonkuja 10
FI-02130 Espoo
SUOMI/FINLAND

Novartis Finland OY
Metsänneidonkuja 10
FI-02130 Espoo
SUOMI/FINLAND

Novartis Finland Oy
Metsänneidonkuja 10
FI-02130 Espoo
SUOMI/FINLAND

Novartis Finland Oy
Metsänneidonkuja 10
FI-02130 Espoo
SUOMI/FINLAND

Diovan 80 mg

80 mg

Film-coated tablets

Diovan 160 mg

160 mg

Film-coated tablets

Diovan 320 mg

320 mg

Film-coated tablets

Diovan 40 mg

40 mg

Film-coated tablets

Diovan 80 mg

80 mg

Film-coated tablets

Diovan 160 mg

160 mg

Film-coated tablets

Diovan 320 mg

320 mg

Film-coated tablets

Diovan 40 mg

40 mg

Film-coated tablets

Diovan 80 mg

80 mg

Film-coated tablets

Oral

Oral

Oral

Oral

Oral

Oral

Oral

Oral

Oral

C

7
3
/
2
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
7
3
2
0
0
9

Member State EU/EEA

Marketing Authorization Holder

(Invented) Name

Strength

Pharmaceutical form

Route of
administration

Finland

Finland

France

France

France

Germany

Germany

Germany

Germany

Novartis Finland Oy
Metsänneidonkuja 10
FI-02130 Espoo
SUOMI/FINLAND

Novartis Finland Oy
Metsänneidonkuja 10
FI-02130 Espoo
SUOMI/FINLAND

Novartis Pharma S.A.S.
2 and 4, rue Lionel Terray
92500 RUEIL-MALMAISON
FRANCE

Novartis Pharma S.A.S.
2 and 4, rue Lionel Terray
92500 RUEIL-MALMAISON
FRANCE

Novartis Pharma S.A.S.
2 and 4, rue Lionel Terray
92500 RUEIL-MALMAISON
FRANCE

Novartis Pharma GmbH
Roonstraße 25
90429 Nürnberg
DEUTSCHLAND

Novartis Pharma GmbH
Roonstraße 25
90429 Nürnberg
DEUTSCHLAND

Novartis Pharma GmbH
Roonstraße 25
90429 Nürnberg
DEUTSCHLAND

Novartis Pharma GmbH
Roonstraße 25
90429 Nürnberg
DEUTSCHLAND

Diovan 160 mg

160 mg

Film-coated tablets

Diovan 320 mg

320 mg

Film-coated tablets

Tareg 40 mg

40 mg

Film-coated tablets

Tareg 80 mg

80 mg

Film-coated tablets

Tareg 160 mg

160 mg

Film-coated tablets

Diovan 40 mg

40 mg

Film-coated tablets

Cordinate 40 mg

40 mg

Film-coated tablets

Provas 40 mg

40 mg

Film-coated tablets

Diovan 80 mg

80 mg

Film-coated tablets

Oral

Oral

Oral

Oral

Oral

Oral

Oral

Oral

Oral

.

.

2
7
3
2
0
0
9

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

7
3
/
2
5

Member State EU/EEA

Marketing Authorization Holder

(Invented) Name

Strength

Pharmaceutical form

Route of
administration

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Greece

Novartis Pharma GmbH
Roonstraße 25
90429 Nürnberg
DEUTSCHLAND

Novartis Pharma GmbH
Roonstraße 25
90429 Nürnberg
DEUTSCHLAND

Novartis Pharma GmbH
Roonstraße 25
90429 Nürnberg
DEUTSCHLAND

Novartis Pharma GmbH
Roonstraße 25
90429 Nürnberg
DEUTSCHLAND

Novartis Pharma GmbH
Roonstraße 25
90429 Nürnberg
DEUTSCHLAND

Novartis Pharma GmbH
Roonstraße 25
90429 Nürnberg
DEUTSCHLAND

Novartis Pharma GmbH
Roonstraße 25
90429 Nürnberg
DEUTSCHLAND

Novartis Pharma GmbH
Roonstraße 25
90429 Nürnberg
DEUTSCHLAND

Novartis (Hellas) S.A.C.I.
National Road No. 1 (12th Km)
Metamorphosis
144 51 Athens
ΕΛΛΑΔΑ/GREECE

Cordinate 80 mg

80 mg

Film-coated tablets

Provas 80 mg

80 mg

Film-coated tablets

Diovan 160 mg

160 mg

Film-coated tablets

Cordinate 160 mg

160 mg

Film-coated tablets

Provas 160 mg

160 mg

Film-coated tablets

Diovan 320 mg

320 mg

Film-coated tablets

Cordinate 320 mg

320 mg

Film-coated tablets

Provas 320 mg

320 mg

Film-coated tablets

Diovan 40 mg

40 mg

Film-coated tablets

Oral

Oral

Oral

Oral

Oral

Oral

Oral

Oral

Oral

C

7
3
/
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
7
3
2
0
0
9

Member State EU/EEA

Marketing Authorization Holder

(Invented) Name

Strength

Pharmaceutical form

Route of
administration

Greece

Greece

Greece

Greece

Greece

Greece

Greece

Novartis (Hellas) S.A.C.I.
National Road No. 1 (12th Km)
Metamorphosis
144 51 Athens
ΕΛΛΑΔΑ/GREECE

Novartis (Hellas) S.A.C.I.
National Road No. 1 (12th Km)
Metamorphosis
144 51 Athens
ΕΛΛΑΔΑ/GREECE

Novartis (Hellas) S.A.C.I.
National Road No. 1 (12th Km)
Metamorphosis
144 51 Athens
ΕΛΛΑΔΑ/GREECE

Novartis (Hellas) S.A.C.I.
National Road No. 1 (12th Km)
Metamorphosis
144 51 Athens
ΕΛΛΑΔΑ/GREECE

Novartis (Hellas) S.A.C.I.
National Road No. 1 (12th Km)
Metamorphosis
144 51 Athens
ΕΛΛΑΔΑ/GREECE

Novartis (Hellas) S.A.C.I.
National Road No. 1 (12th Km)
Metamorphosis
144 51 Athens
ΕΛΛΑΔΑ/GREECE

Novartis (Hellas) S.A.C.I.
National Road No. 1 (12th Km)
Metamorphosis
144 51 Athens
ΕΛΛΑΔΑ/GREECE

Dalzad 40 mg

40 mg

Film-coated tablets

Oral

Diovan 80 mg

80 mg

Film-coated tablets

Oral

Dalzad 80 mg

80 mg

Film-coated tablets

Oral

Diovan 160 mg

160 mg

Film-coated tablets

Oral

Dalzad 160 mg

160 mg

Film-coated tablets

Oral

Diovan 320 mg

320 mg

Film-coated tablets

Oral

Dalzad 320 mg

320 mg

Film-coated tablets

Oral

.

.

2
7
3
2
0
0
9

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

7
3
/
2
7

Member State EU/EEA

Marketing Authorization Holder

(Invented) Name

Strength

Pharmaceutical form

Route of
administration

Greece

Greece

Greece

Greece

Hungary

Hungary

Hungary

Novartis (Hellas) S.A.C.I.
National Road No. 1 (12th Km)
Metamorphosis
144 51 Athens
ΕΛΛΑΔΑ/GREECE

Novartis (Hellas) S.A.C.I.
National Road No. 1 (12th Km)
Metamorphosis
144 51 Athens
ΕΛΛΑΔΑ/GREECE

Novartis (Hellas) S.A.C.I.
National Road No. 1 (12th Km)
Metamorphosis
144 51 Athens
ΕΛΛΑΔΑ/GREECE

Novartis (Hellas) S.A.C.I.
National Road No. 1 (12th Km)
Metamorphosis
144 51 Athens
ΕΛΛΑΔΑ/GREECE

Novartis Hungaria Kft.
Bartók Béla út 43-47
1114 Budapest
MAGYARORSZÁG/HUNGARY

Novartis Hungaria Kft.
Bartók Béla út 43-47
1114 Budapest
MAGYARORSZÁG/HUNGARY

Novartis Hungaria Kft.
Bartók Béla út 43-47
1114 Budapest
MAGYARORSZÁG/HUNGARY

Diovan 80 mg

80 mg

Hard gelatine capsules

Oral

Dalzad 80 mg

80 mg

Hard gelatine capsules

Oral

Diovan 160 mg

160 mg

Hard gelatine capsules

Oral

Dalzad 160 mg

160 mg

Hard gelatine capsules

Oral

Diovan 40 mg

40 mg

Film-coated tablets

Varexan 40 mg

40 mg

Film-coated tablets

Diovan 80 mg

80 mg

Film-coated tablets

Oral

Oral

Oral

C

7
3
/
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
7
3
2
0
0
9

Member State EU/EEA

Marketing Authorization Holder

(Invented) Name

Strength

Pharmaceutical form

Route of
administration

Hungary

Hungary

Hungary

Hungary

Iceland

Iceland

Iceland

Iceland

Ireland

Novartis Hungaria Kft.
Bartók Béla út 43-47
1114 Budapest
MAGYARORSZÁG/HUNGARY

Novartis Hungaria Kft.
Bartók Béla út 43-47
1114 Budapest
MAGYARORSZÁG/HUNGARY

Novartis Hungaria Kft.
Bartók Béla út 43-47
1114 Budapest
MAGYARORSZÁG/HUNGARY

Novartis Hungaria Kft.
Bartók Béla út 43-47
1114 Budapest
MAGYARORSZÁG/HUNGARY

Novartis Healthcare A/S
Lyngbyvej 172
2100 Kopenhagen Ø
DANMARK

Novartis Healthcare A/S
Lyngbyvej 172
2100 Kopenhagen Ø
DANMARK

Novartis Healthcare A/S
Lyngbyvej 172
2100 Kopenhagen Ø
DANMARK

Novartis Healthcare A/S
Lyngbyvej 172
2100 Kopenhagen Ø
DANMARK

Novartis Pharmaceuticals UK Ltd
Frimley Business Park
Frimley
Camberley
Surrey GU16 7SR
UNITED-KINGDOM

Varexan 80 mg

80 mg

Film-coated tablets

Diovan 160 mg

160 mg

Film-coated tablets

Varexan 160 mg

160 mg

Film-coated tablets

Diovan 320 mg

320 mg

Film-coated tablets

Diovan 40 mg

40 mg

Film-coated tablets

Diovan 80 mg

80 mg

Film-coated tablets

Diovan 160 mg

160 mg

Film-coated tablets

Diovan 320 mg

320 mg

Film-coated tablets

Diovan 40 mg

40 mg

Film-coated tablets

Oral

Oral

Oral

Oral

Oral

Oral

Oral

Oral

Oral

.

.

2
7
3
2
0
0
9

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

7
3
/
2
9

Member State EU/EEA

Marketing Authorization Holder

(Invented) Name

Strength

Pharmaceutical form

Route of
administration

Ireland

Ireland

Ireland

Italy

Italy

Italy

Italy

Italy

Novartis Pharmaceuticals UK Ltd
Frimley Business Park
Frimley
Camberley
Surrey GU16 7SR
UNITED-KINGDOM

Novartis Pharmaceuticals UK Ltd
Frimley Business Park
Frimley
Camberley
Surrey GU16 7SR
UNITED-KINGDOM

Novartis Pharmaceuticals UK Ltd
Frimley Business Park
Frimley
Camberley
Surrey GU16 7SR
UNITED-KINGDOM

Novartis Farma S.p.A.
Largo Umberto Boccioni 1
21040 Origgio
ITALIA

LPB Instituto Farmaceutico S.r.l.
Largo Umberto Boccioni 1
21040 Origgio
ITALIA

Novartis Farma S.p.A.
Largo Umberto Boccioni 1
21040 Origgio
ITALIA

LPB Instituto Farmaceutico S.r.l.
Largo Umberto Boccioni 1
21040 Origgio
ITALIA

Novartis Farma S.p.A.
Largo Umberto Boccioni 1
21040 Origgio
ITALIA

Diovan 80 mg

80 mg

Film-coated tablets

Oral

Diovan 160 mg

160 mg

Film-coated tablets

Oral

Diovan 320 mg

320 mg

Film-coated tablets

Oral

Tareg 40 mg

40 mg

Film-coated tablets

Rixil

Tareg

Rixil

Tareg

40 mg

Film-coated tablets

80 mg

Film-coated tablets

80 mg

Film-coated tablets

160 mg

Film-coated tablets

Oral

Oral

Oral

Oral

Oral

C

7
3
/
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
7
3
2
0
0
9

Member State EU/EEA

Marketing Authorization Holder

(Invented) Name

Strength

Pharmaceutical form

Route of
administration

Italy

Italy

Italy

Italy

Italy

Latvia

Latvia

Latvia

LPB Instituto Farmaceutico S.r.l.
Largo Umberto Boccioni 1
21040 Origgio
ITALIA

Novartis Farma S.p.A.
Largo Umberto Boccioni 1
21040 Origgio
ITALIA

LPB Instituto Farmaceutico S.r.l.
Largo Umberto Boccioni 1
21040 Origgio
ITALIA

Novartis Farma S.p.A.
Largo Umberto Boccioni 1
21040 Origgio
ITALIA

LPB Instituto Farmaceutico S.r.l.
Largo Umberto Boccioni 1
21040 Origgio
ITALIA

Novartis Finland OY
Metsänneidonkuja 10
FI-02130 Espoo
SUOMI/FINLAND

Novartis Finland OY
Metsänneidonkuja 10
FI-02130 Espoo
SUOMI/FINLAND

Novartis Finland OY
Metsänneidonkuja 10
FI-02130 Espoo
SUOMI/FINLAND

Rixil

Tareg

Rixil

Tareg

Rixil

160 mg

Film-coated tablets

80 mg

Hard capsules

80 mg

Hard capsules

160 mg

Hard capsules

160 mg

Hard capsules

Diovan 40 mg

40 mg

Film-coated tablets

Diovan 80 mg

80 mg

Film-coated tablets

Diovan 160 mg

160 mg

Film-coated tablets

Oral

Oral

Oral

Oral

Oral

Oral

Oral

Oral

.

.

2
7
3
2
0
0
9

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

7
3
/
3
1

Member State EU/EEA

Marketing Authorization Holder

(Invented) Name

Strength

Pharmaceutical form

Route of
administration

Latvia

Lithuania

Lithuania

Lithuania

Luxembourg

Luxembourg

Luxembourg

Luxembourg

Novartis Finland OY
Metsänneidonkuja 10
FI-02130 Espoo
SUOMI/FINLAND

Novartis Finland Oy
Metsänneidonkuja 10
FI-02130 Espoo
SUOMI/FINLAND

Novartis Finland Oy
Metsänneidonkuja 10
FI-02130 Espoo
SUOMI/FINLAND

Novartis Finland Oy
Metsänneidonkuja 10
FI-02130 Espoo
SUOMI/FINLAND

Novartis Pharma GmbH
Roonstraße 25
90429 Nürnberg
DEUTSCHLAND

Novartis Pharma GmbH
Roonstraße 25
90429 Nürnberg
DEUTSCHLAND

Novartis Pharma GmbH
Roonstraße 25
90429 Nürnberg
DEUTSCHLAND

Novartis Pharma GmbH
Roonstraße 25
90429 Nürnberg
DEUTSCHLAND

Diovan 320 mg

320 mg

Film-coated tablets

Diovan 80 mg

80 mg

Film-coated tablets

Diovan 160 mg

160 mg

Film-coated tablets

Diovan 320 mg

320 mg

Film-coated tablets

Diovan 40 mg

40 mg

Film-coated tablets

Diovan 80 mg

80 mg

Film-coated tablets

Diovan 160 mg

160 mg

Film-coated tablets

Diovan 320 mg

320 mg

Film-coated tablets

Oral

Oral

Oral

Oral

Oral

Oral

Oral

Oral

C

7
3
/
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
7
3
2
0
0
9

Member State EU/EEA

Marketing Authorization Holder

(Invented) Name

Strength

Pharmaceutical form

Route of
administration

Malta

Malta

Malta

Malta

Novartis Pharmaceuticals UK Ltd
Frimley Business Park
Frimley
Camberley
Surrey GU16 7SR
UNITED-KINGDOM

Novartis Pharmaceuticals UK Ltd
Frimley Business Park
Frimley
Camberley
Surrey GU16 7SR
UNITED-KINGDOM

Novartis Pharmaceuticals UK Ltd
Frimley Business Park
Frimley
Camberley
Surrey GU16 7SR
UNITED-KINGDOM

Novartis Pharmaceuticals UK Ltd
Frimley Business Park
Frimley
Camberley
Surrey GU16 7SR
UNITED-KINGDOM

Netherlands

Netherlands

Netherlands

Novartis Pharma B.V.
Postbus 241
6824 DP Arnhem
NEDERLAND

Novartis Pharma B.V.
Postbus 241
6824 DP Arnhem
NEDERLAND

Novartis Pharma B.V.
Postbus 241
6824 DP Arnhem
NEDERLAND

Diovan 40 mg

40 mg

Film-coated tablets

Oral

Diovan 80 mg

80 mg

Film-coated tablets

Oral

Diovan 160 mg

160 mg

Film-coated tablets

Oral

Diovan 320 mg

320 mg

Film-coated tablets

Oral

Diovan 40

40 mg

Film-coated tablets

Diovan 80

80 mg

Film-coated tablets

Diovan 160

160 mg

Film-coated tablets

Oral

Oral

Oral

.

.

2
7
3
2
0
0
9

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

7
3
/
3
3

Member State EU/EEA

Marketing Authorization Holder

(Invented) Name

Strength

Pharmaceutical form

Route of
administration

Netherlands

Norway

Norway

Norway

Norway

Poland

Poland

Poland

Poland

Novartis Pharma B.V.
Postbus 241
6824 DP Arnhem
NEDERLAND

Novartis Norge AS
Postboks 237 Økern
NO-0510 Oslo

Novartis Norge AS
Postboks 237 Økern
NO-0510 Oslo

Novartis Norge AS
Postboks 237 Økern
NO-0510 Oslo

Novartis Norge AS
Postboks 237 Økern
NO-0510 Oslo

Novartis Pharma GmbH
Roonstrasse 25
90429 Nürnberg
DEUTSCHLAND

Novartis Pharma GmbH
Roonstraße 25
90429 Nürnberg
DEUTSCHLAND

Novartis Pharma GmbH
Roonstraße 25
90429 Nürnberg
DEUTSCHLAND

Novartis Pharma GmbH
Roonstraße 25
90429 Nürnberg
DEUTSCHLAND

Diovan 320

320 mg

Film-coated tablets

Diovan 40 mg

40 mg

Film-coated tablets

Diovan 80 mg

80 mg

Film-coated tablets

Diovan 160 mg

160 mg

Film-coated tablets

Diovan 320 mg

320 mg

Film-coated tablets

Diovan

Diovan

Diovan

Diovan

40 mg

Film-coated tablets

80 mg

Film-coated tablets

160 mg

Film-coated tablets

320 mg

Film-coated tablets

Oral

Oral

Oral

Oral

Oral

Oral

Oral

Oral

Oral

C

7
3
/
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
7
3
2
0
0
9

Member State EU/EEA

Marketing Authorization Holder

(Invented) Name

Strength

Pharmaceutical form

Route of
administration

Portugal

Portugal

Portugal

Portugal

Romania

Romania

Romania

Novartis Farma — Produtos Farmacêuticos S.A.
Rua do Centro Empresarial, Edificio 8
Quinta da Beloura
P-2710-444 Sintra
PORTUGAL

Novartis Farma — Produtos Farmacêuticos S.A.
Rua do Centro Empresarial, Edificio 8
Quinta da Beloura
P-2710-444 Sintra
PORTUGAL

Novartis Farma — Produtos Farmacêuticos S.A.
Rua do Centro Empresarial, Edificio 8
Quinta da Beloura
P-2710-444 Sintra
PORTUGAL

Novartis Farma — Produtos Farmacêuticos S.A.
Rua do Centro Empresarial, Edificio 8
Quinta da Beloura
P-2710-444 Sintra
PORTUGAL

Novartis Pharma GmbH
Roonstraße 25
90429 Nürnberg
DEUTSCHLAND

Novartis Pharma GmbH
Roonstraße 25
90429 Nürnberg
DEUTSCHLAND

Novartis Pharma GmbH
Roonstraße 25
90429 Nürnberg
DEUTSCHLAND

Diovan

40 mg

Film-coated tablets

Oral

Diovan

80 mg

Film-coated tablets

Oral

Diovan g

160 mg

Film-coated tablets

Oral

Diovan

320 mg

Film-coated tablets

Oral

Diovan 40 mg

40 mg

Film-coated tablets

Diovan 80 mg

80 mg

Film-coated tablets

Diovan 160 mg

160 mg

Film-coated tablets

Oral

Oral

Oral

.

.

2
7
3
2
0
0
9

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

7
3
/
3
5

Member State EU/EEA

Marketing Authorization Holder

(Invented) Name

Strength

Pharmaceutical form

Route of
administration

Slovak Republic

Slovak Republic

Slovak Republic

Slovak Republic

Slovak Republic

Slovak Republic

Slovenia

Slovenia

Slovenia

Slovenia

Novartis s.r.o.
Praha
ČESKÁ REPUBLIKA

Novartis s.r.o.
Praha
ČESKÁ REPUBLIKA

Novartis s.r.o.
Praha
ČESKÁ REPUBLIKA

Novartis s.r.o.
Praha
ČESKÁ REPUBLIKA

Novartis s.r.o.
Praha
ČESKÁ REPUBLIKA

Novartis s.r.o.
Praha
ČESKÁ REPUBLIKA

Novartis Pharma GmbH
Roonstraße 25
90429 Nürnberg
DEUTSCHLAND

Novartis Pharma GmbH
Roonstraße 25
90429 Nürnberg
DEUTSCHLAND

Novartis Pharma GmbH
Roonstraße 25
90429 Nürnberg
DEUTSCHLAND

Novartis Pharma GmbH
Roonstraße 25
90429 Nürnberg
DEUTSCHLAND

Diovan 40 mg

40 mg

Film-coated tablets

Diovan 80 mg

80 mg

Film-coated tablets

Diovan 160 mg

160 mg

Film-coated tablets

Diovan 320 mg

320 mg

Film-coated tablets

Diovan 80 mg

80 mg

Hard gelatine capsules

Diovan 160 mg

160 mg

Hard gelatine capsules

Diovan 40 mg filmsko obložene tablete

40 mg

Film-coated tablets

Diovan 80 mg filmsko obložene tablete

80 mg

Film-coated tablets

Diovan 160 mg filmsko obložene tablete

160 mg

Film-coated tablets

Diovan 320 mg filmsko obložene tablete

320 mg

Film-coated tablets

Oral

Oral

Oral

Oral

Oral

Oral

Oral

Oral

Oral

Oral

C

7
3
/
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
7
3
2
0
0
9

Member State EU/EEA

Marketing Authorization Holder

(Invented) Name

Strength

Pharmaceutical form

Route of
administration

Spain

Spain

Spain

Spain

Spain

Spain

Spain

Spain

Spain

Novartis Farmacéutica S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
ESPAÑA

Novartis Farmacéutica S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
ESPAÑA

Novartis Farmacéutica S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
ESPAÑA

Novartis Farmacéutica S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
ESPAÑA

Novartis Farmacéutica S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
ESPAÑA

Novartis Farmacéutica S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
ESPAÑA

Novartis Farmacéutica S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
ESPAÑA

Novartis Farmacéutica S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
ESPAÑA

Novartis Farmacéutica S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
ESPAÑA

Diovan Cardio 40 mg

40 mg

Film-coated tablets

Kalpress Cardio 40 mg

40 mg

Film-coated tablets

Miten Cardio 40 mg

40 mg

Film-coated tablets

Diovan 80 mg

80 mg

Film-coated tablets

Kalpress 80 mg

80 mg

Film-coated tablets

Miten 80 mg

80 mg

Film-coated tablets

Diovan 160 mg

160 mg

Film-coated tablets

Kalpress 160 mg

160 mg

Film-coated tablets

Miten 160 mg

160 mg

Film-coated tablets

Oral

Oral

Oral

Oral

Oral

Oral

Oral

Oral

Oral

.

.

2
7
3
2
0
0
9

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

7
3
/
3
7

Member State EU/EEA

Marketing Authorization Holder

(Invented) Name

Strength

Pharmaceutical form

Route of
administration

Spain

Spain

Spain

Sweden

Sweden

Sweden

Sweden

Sweden

Novartis Farmacéutica S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
ESPAÑA

Novartis Farmacéutica S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
ESPAÑA

Novartis Farmacéutica S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
ESPAÑA

Novartis Sverige AB
Kemistvägen 1B
P.O. Box 1150
SE-183 11 Täby
SVERIGE

Novartis Sverige AB
Kemistvägen 1B
P.O. Box 1150
SE-183 11 Täby
SVERIGE

Novartis Sverige AB
Kemistvägen 1B
P.O. Box 1150
SE-183 11 Täby
SVERIGE

Novartis Sverige AB
Kemistvägen 1B
P.O. Box 1150
SE-183 11 Täby
SVERIGE

Novartis Sverige AB
Kemistvägen 1B
P.O. Box 1150
SE-183 11 Täby
SVERIGE

Diovan 320 mg

320 mg

Film-coated tablets

Kalpress 320 mg

320 mg

Film-coated tablets

Miten 320 mg

320 mg

Film-coated tablets

Diovan

40 mg

Film-coated tablets

Angiosan

40 mg

Film-coated tablets

Valsartan Novartis

40 mg

Film-coated tablets

Diovan

80 mg

Film-coated tablets

Angiosan

80 mg

Film-coated tablets

Oral

Oral

Oral

Oral

Oral

Oral

Oral

Oral

C

7
3
/
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
7
3
2
0
0
9

Member State EU/EEA

Marketing Authorization Holder

(Invented) Name

Strength

Pharmaceutical form

Route of
administration

Sweden

Sweden

Sweden

Sweden

Sweden

Sweden

Sweden

Sweden

Novartis Sverige AB
Kemistvägen 1B
P.O. Box 1150
SE-183 11 Täby
SVERIGE

Novartis Sverige AB
Kemistvägen 1B
P.O. Box 1150
SE-183 11 Täby
SVERIGE

Novartis Sverige AB
Kemistvägen 1B
P.O. Box 1150
SE-183 11 Täby
SVERIGE

Novartis Sverige AB
Kemistvägen 1B
P.O. Box 1150
SE-183 11 Täby
SVERIGE

Novartis Sverige AB
Kemistvägen 1B
P.O. Box 1150
SE-183 11 Täby
SVERIGE

Novartis Sverige AB
Kemistvägen 1B
P.O. Box 1150
SE-183 11 Täby
SVERIGE

Novartis Sverige AB
Kemistvägen 1B
P.O. Box 1150
SE-183 11 Täby
SVERIGE

Novartis Sverige AB
Kemistvägen 1B
P.O. Box 1150
SE-183 11 Täby
SVERIGE

Valsartan Novartis

80 mg

Film-coated tablets

Diovan

160 mg

Film-coated tablets

Angiosan

160 mg

Film-coated tablets

Valsartan Novartis

160 mg

Film-coated tablets

Diovan

320 mg

Film-coated tablets

Angiosan

320 mg

Film-coated tablets

Valsartan Novartis

320 mg

Film-coated tablets

Diovan

80 mg

Hard gelatine capsules

Oral

Oral

Oral

Oral

Oral

Oral

Oral

Oral

.

.

2
7
3
2
0
0
9

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

7
3
/
3
9

Member State EU/EEA

Marketing Authorization Holder

(Invented) Name

Strength

Pharmaceutical form

Route of
administration

Sweden

United Kingdom

United Kingdom

United Kingdom

United Kingdom

United Kingdom

Novartis Sverige AB
Kemistvägen 1B
P.O. Box 1150
SE-183 11 Täby
SVERIGE

Novartis Pharmaceuticals UK Ltd
Frimley Business Park
Frimley
Camberley
Surrey GU16 7SR
UNITED-KINGDOM

Novartis Pharmaceuticals UK Ltd
Frimley Business Park
Frimley
Camberley
Surrey GU16 7SR
UNITED-KINGDOM

Novartis Pharmaceuticals UK Ltd
Frimley Business Park
Frimley
Camberley
Surrey GU16 7SR
UNITED-KINGDOM

Novartis Pharmaceuticals UK Ltd
Frimley Business Park
Frimley
Camberley
Surrey GU16 7SR
UNITED-KINGDOM

Novartis Pharmaceuticals UK Ltd
Frimley Business Park
Frimley
Camberley
Surrey GU16 7SR
UNITED-KINGDOM

Diovan

160 mg

Hard gelatine capsules

Diovan 40 mg

40 mg

Film-coated tablets

Diovan 320 mg

320 mg

Film-coated tablets

Oral

Oral

Oral

Diovan 40 mg

40 mg

Hard gelatine capsules

Oral

Diovan 80 mg

80 mg

Hard gelatine capsules

Oral

Diovan 160 mg

160 mg

Hard gelatine capsules

Oral

C

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