Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 January 2009 to 31 January 2009 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC )
Date: 2009-02-27
Institutions: European Commission
Subjects: EU Member State, market approval, marketing standard, medicinal product, pharmaceutical legislation, withdrawal from the market

C 48/12

EN

Official Journal of the European Union

27.2.2009

Summary of Community decisions on marketing authorizations in respect of medicinal products
from 1 January 2009 to 31 January 2009

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

(2009/C 48/05)

— Issuing, maintenance or modification of a national marketing authorization

Date of the
decision

Name(s) of the
medicinal
product

16.1.2009

STELARA

16.1.2009

RoActemra

Holder(s) of the marketing
authorization

Member State concerned

Date of
notification

20.1.2009

This Decision is addressed
to the Member States

This Decision is addressed
to the Member States

20.1.2009

Janssen-Cilag International NV
Turnhoutseweg, 30
B-2340 Beerse

Roche Registration Limited
6 Falcon Way
Shire Park
Welwyn Garden City AL7 1TW
United Kingdom

22.1.2009

Cozaar

Voir annexe I

See Annex I

30.1.2009

Thalidomide
Celgene

Celgene Europe Limited
Riverside House
Riverside Walk
Windsor SL4 1NA
United Kingdom

This Decision is addressed
to the Member States

26.1.2009

3.2.2009

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

LIST OF THE NAMES, PHARMACEUTICAL FORM(S), STRENGTH(S), ROUTE(S) OF ADMINISTRATION OF
THE MEDICINAL PRODUCT(S), MARKETING AUTHORIZATION HOLDER(S) IN THE MEMBER STATES

ANNEX I

Member State

Marketing Authorization Holder

Invented name
Losartan potassium

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

Austria

Austria

Austria

Belgium

Belgium

Belgium

Belgium

Belgium

Belgium

Belgium

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

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

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

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

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

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

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

Therabel Pharma S.A.
Rue Egide Van Ophem, 108
B-1180 Bruxelles

Therabel Pharma S.A.
Rue Egide Van Ophem, 108
B-1180 Bruxelles

Therabel Pharma S.A.
Rue Egide Van Ophem, 108
B-1180 Bruxelles

Cosaar 12,5 mg — Filmtabletten

12,5 mg

Film-coated tablet

Oral use

N/A

Cosaar 50 mg — Filmtabletten

50 mg

Film-coated tablet

Oral use

N/A

Cosaar 100 mg — Filmtabletten

100 mg

Film-coated tablet

Oral use

N/A

Cozaar 100 mg

100 mg

Film-coated tablet

Oral use

N/A

Cozaar 50 mg

50 mg

Film-coated tablet

Oral use

N/A

Cozaar 12,5 mg

12,5 mg

Film-coated tablet

Oral use

N/A

Cozaar Cardio Start

21 × 12,5 mg + 14 × 50 mg

Film-coated tablet

Oral use

N/A

Loortan 100 mg

100 mg

Film-coated tablet

Oral use

N/A

Loortan 50 mg

50 mg

Film-coated tablet

Oral use

N/A

Loortan 12,50 mg

12,5 mg

Film-coated tablet

Oral use

N/A

.

.

2
7
2
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

4
8
/
1
3

Member State

Marketing Authorization Holder

Invented name
Losartan potassium

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

Belgium

Bulgaria

Cyprus

Cyprus

Therabel Pharma S.A.
Rue Egide Van Ophem, 108
B-1180 Bruxelles

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

Merck Sharp & Dohme BV
Postbus 581
2003 PC Haarlem
Nederland

Merck Sharp & Dohme BV
Postbus 581
2003 PC Haarlem
Nederland

Loortan Cardio Start

21 × 12,5 mg + 14 × 50 mg

Film-coated tablet

Oral use

N/A

Cozaar

50 mg

Film-coated tablet

Oral use

N/A

Cozaar

50 mg

Film-coated tablet

Oral use

N/A

Cozaar

100 mg

Film-coated tablet

Oral use

N/A

Czech Republic Merck Sharp & Dohme BV

Cozaar 12,5 mg

12,5 mg

Film-coated tablet

Oral use

N/A

Postbus 581
2003 PC Haarlem
Nederland

Czech Republic Merck Sharp & Dohme BV

Cozaar 50 mg

50 mg

Film-coated tablet

Oral use

N/A

Postbus 581
2003 PC Haarlem
Nederland

Czech Republic Merck Sharp & Dohme BV

Cozaar 100 mg

100 mg

Film-coated tablet

Oral use

N/A

C

4
8
/
1
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

Denmark

Denmark

Postbus 581
2003 PC Haarlem
Nederland

Merck Sharp & Dohme BV
Postbus 581
2003 PC Haarlem
Nederland

Merck Sharp & Dohme BV
Postbus 581
2003 PC Haarlem
Nederland

Cozaar

12,5 mg

Film-coated tablet

Oral use

N/A

Cozaar

50 mg

Film-coated tablet

Oral use

N/A

.

.

2
7
2
2
0
0
9

Member State

Marketing Authorization Holder

Invented name
Losartan potassium

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

Denmark

Denmark

Estonia

Estonia

Estonia

Finland

Finland

Finland

Finland

Merck Sharp & Dohme BV
Postbus 581
2003 PC Haarlem
Nederland

Merck Sharp & Dohme BV
Postbus 581
2003 PC 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 OÜ
Peterburi tee 46
EE-11415 Tallinn

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

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

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

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

Cozaar

100 mg

Film-coated tablet

Oral use

N/A

Cozaar Startpakke

12,5 mg + 50 mg

Film-coated tablet

Oral use

N/A

Cozaar

Cozaar

100 mg

Film-coated tablet

Oral use

N/A

50 mg

Film-coated tablet

Oral use

N/A

Cozaar 12,5 mg

12,5 mg

Film-coated tablet

Oral use

N/A

Cozaar

12,5 mg

Film-coated tablet

Oral use

N/A

Cozaar

12,5 mg and 50 mg (initiation
pack)

Film-coated tablet

Oral use

N/A

Cozaar

50 mg

Film-coated tablet

Oral use

N/A

Cozaar

100 mg

Film-coated tablet

Oral use

N/A

.

.

2
7
2
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

4
8
/
1
5

Member State

Marketing Authorization Holder

Invented name
Losartan potassium

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

France

France

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Merck Sharp Dohme Chibret
3, av. Hoche
F-75114 Paris Cedex 08

Merck Sharp Dohme Chibret
3, av. Hoche
F-75114 Paris Cedex 08

MSD Chibropharm GmbH
Postfach 1202
D-85530 Haar

MSD Chibropharm GmbH
Postfach 1202
D-85530 Haar

MSD Chibropharm GmbH
Postfach 1202
D-85530 Haar

MSD Chibropharm GmbH
Postfach 1202
D-85530 Haar

MSD Chibropharm GmbH
Postfach 1202
D-85530 Haar

MSD Chibropharm GmbH
Postfach 1202
D-85530 Haar

MSD Chibropharm GmbH
Postfach 1202
D-85530 Haar

MSD Chibropharm GmbH
Postfach 1202
D-85530 Haar

Cozaar 100 mg film-coated tablets

100 mg

Film-coated tablet

Oral use

N/A

Cozaar 50 mg scored coated tablets

50 mg

Scored coated tablet

Oral use

N/A

Cardopal Start 12,5 mg Filmtabletten

12,5 mg

Film-coated tablet

Oral use

N/A

Lorzaar 100 mg Filmtabletten

100 mg

Film-coated tablet

Oral use

N/A

Lorzaar 50 mg Filmtabletten

50 mg

Film-coated tablet

Oral use

N/A

Lorzaar Protect 100 mg Filmtabletten

100 mg

Film-coated tablet

Oral use

N/A

Lorzaar Protect 50 mg Filmtabletten

50 mg

Film-coated tablet

Oral use

N/A

Lorzaar Start 12,5 mg Filmtabletten

12,5 mg

Film-coated tablet

Oral use

N/A

Pinzaar 100 mg Filmtabletten

100 mg

Film-coated tablet

Oral use

N/A

Pinzaar 50 mg Filmtabletten

50 mg

Film-coated tablet

Oral use

N/A

VARIPHARM Arzneimittel GmbH
Lindenplatz 1
D-85540 Haar

Lorzaar Varipharmstart 12,5 mg Film-
tabletten

12,5 mg

Film-coated tablet

Oral use

N/A

C

4
8
/
1
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
2
2
0
0
9

Member State

Marketing Authorization Holder

Invented name
Losartan potassium

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

Greece

Greece

Greece

Hungary

Hungary

Hungary

Ireland

Ireland

Ireland

Italy

VIANEX A.E.
Tatoiou Street
GR-14671 Nea Erythraia

VIANEX A.E.
Tatoiou Street
GR-14671 Nea Erythraia

VIANEX A.E.
Tatoiou Street
GR-14671 Nea Erythraia

MSD Hungary Ltd
Alkotás u. 50
H-1123 Budapest

MSD Hungary Ltd
Alkotás u. 50
H-1123 Budapest

MSD Hungary Ltd
Alkotás u. 50
H-1123 Budapest

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

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

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

Cozaar

Cozaar

Cozaar

Cozaar

Cozaar

Cozaar

12,5 mg

Film-coated tablet

Oral use

N/A

50 mg

Film-coated tablet

Oral use

N/A

100 mg

Film-coated tablet

Oral use

N/A

12,5 mg

Tablets, film-coated

Oral use

N/A

50 mg

Tablets, film-coated

Oral use

N/A

100 mg

Tablets, film-coated

Oral use

N/A

Cozaar 50 mg Film-coated tablets

50 mg

Film-coated tablet

Oral use

N/A

Cozaar 100 mg Film-coated tablets

100 mg

Film-coated tablet

Oral use

N/A

Cozaar 12,5 mg Film-coated tablets

12,5 mg

Film-coated tablet

Oral use

N/A

Merck Sharp & Dohme (Italia) SpA
Via G. Fabbroni 6
I-00191 Roma

Lortaan 50 mg compresse rivestite con
film

50 mg

Film-coated tablet

Oral use

N/A

.

.

2
7
2
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

4
8
/
1
7

Member State

Marketing Authorization Holder

Invented name
Losartan potassium

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

Italy

Italy

Italy

Italy

Italy

Italy

Italy

Italy

Latvia

Latvia

Merck Sharp & Dohme (Italia) SpA
Via G. Fabbroni 6
I-00191 Roma

Merck Sharp & Dohme (Italia) SpA
Via G. Fabbroni 6
I-00191 Roma

Neopharmed SpA
Via G. Fabbroni 6
I-00191 Roma

Neopharmed SpA
Via G. Fabbroni 6
I-00191 Roma

Neopharmed SpA
Via G. Fabbroni 6
I-00191 Roma

Lortaan 12,5 mg compresse rivestite
con film

12,5 mg

Film-coated tablet

Oral use

N/A

Lortaan 100 mg compresse rivestite
con film

100 mg

Film-coated tablet

Oral use

N/A

Neo-Lotan 50 mg compresse rivestite
con film

50 mg

Film-coated tablet

Oral use

N/A

Neo-Lotan 12,5 mg compresse rivestite
con film

12,5 mg

Film-coated tablet

Oral use

N/A

Neo-Lotan 100 mg compresse rivestite
con film

100 mg

Film-coated tablet

Oral use

N/A

Sigma-Tau Industrie Farmaceutiche Riunite SpA
Viale Shakespeare 47
I-00144 Roma

Losaprex 50 mg compresse rivestite
con film

50 mg

Film-coated tablet

Oral use

N/A

Sigma-Tau Industrie Farmaceutiche Riunite SpA
Viale Shakespeare 47
I-00144 Roma

Losaprex 12,5 mg compresse rivestite
con film

12,5 mg

Film-coated tablet

Oral use

N/A

Sigma-Tau Industrie Farmaceutiche Riunite SpA
Viale Shakespeare 47
I-00144 Roma

Losaprex 100 mg compresse rivestite
con film

100 mg

Film-coated tablet

Oral use

N/A

SIA Merck Sharp & Dohme Latvia
Skanstes iela 13
LV-1013 Rīga

SIA Merck Sharp & Dohme Latvia
Skanstes iela 13
LV-1013 Rīga

Cozaar 50 mg film-coated tablets

50 mg

Film-coated tablets

Oral use

N/A

Cozaar 100 mg film-coated tablets

100 mg

Film-coated tablets

Oral use

N/A

Lithuania

UAB Merck Sharp & Dohme
Geležinio Vilko 18A
LT-01112 Vilnius

Cozaar (Losartan)

12,5 mg

film-coated tablet

oral use

N/A

C

4
8
/
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
2
2
0
0
9

Member State

Marketing Authorization Holder

Invented name
Losartan potassium

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

Lithuania

Lithuania

UAB Merck Sharp & Dohme
Geležinio Vilko 18A
LT-01112 Vilnius

UAB Merck Sharp & Dohme
Geležinio Vilko 18A
LT-01112 Vilnius

Luxembourg

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

Luxembourg

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

Luxembourg

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

Luxembourg

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

Luxembourg

Therabel Pharma S.A.
Rue Egide Van Ophem, 108
B-1180 Bruxelles

Luxembourg

Therabel Pharma S.A.
Rue Egide Van Ophem, 108
B-1180 Bruxelles

Luxembourg

Therabel Pharma S.A.
Rue Egide Van Ophem, 108
B-1180 Bruxelles

Luxembourg

Therabel Pharma S.A.
Rue Egide Van Ophem, 108
B-1180 Bruxelles

Malta

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

Cozaar (Losartan)

50 mg

film-coated tablet

oral use

N/A

Cozaar (Losartan)

100 mg

film-coated tablet

oral use

N/A

Cozaar 100 mg

100 mg

Film-coated tablet

Oral use

N/A

Cozaar 50 mg

50 mg

Film-coated tablet

Oral use

N/A

Cozaar 12,5 mg

12,5 mg

Film-coated tablet

Oral use

N/A

Cozaar Cardio Start

21 × 12,5 mg + 14 × 50 mg

Film-coated tablet

Oral use

N/A

Loortan 100 mg

100 mg

Film-coated tablet

Oral use

N/A

Loortan 50 mg

50 mg

Film-coated tablet

Oral use

N/A

Loortan 12,50 mg

12,5 mg

Film-coated tablet

Oral use

N/A

Loortan Cardio Start

21 × 12,5 mg + 14 × 50 mg

Film-coated tablet

Oral use

N/A

‘Cozaar 100 mg’ pilloli miksija b'rita

100 mg

Film-coated tablet

Oral use

N/A

.

.

2
7
2
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

4
8
/
1
9

Member State

Marketing Authorization Holder

Invented name
Losartan potassium

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

Malta

Netherlands

Netherlands

Poland

Poland

Poland

Portugal

Portugal

Portugal

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

Merck Sharp & Dohme
PO Box 581
2003 PC Haarlem
Nederland

Merck Sharp & Dohme
PO Box 581
2003 PC Haarlem
Nederland

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

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

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

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

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

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

‘Cozaar 50 mg’ pilloli miksija b'rita

50 mg

Film-coated tablet

Oral use

N/A

Cozaar 50

50 mg

Film-coated tablet

Oral use

N/A

Cozaar 100

100 mg

Film-coated tablet

Oral use

N/A

Cozaar

Cozaar

Cozaar

Cozaar

12,5 mg

Film-coated tablet

Oral use

N/A

50 mg

Film-coated tablet

Oral use

N/A

100 mg

Film-coated tablet

Oral use

N/A

50 mg

Film-coated tablet

Oral use

N/A

Cozaar 100 mg

100 mg

Film-coated tablet

Oral use

N/A

Cozaar IC

12,5 mg

Film-coated tablet

Oral use

N/A

C

4
8
/
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
2
2
0
0
9

Member State

Marketing Authorization Holder

Invented name
Losartan potassium

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

Portugal

Portugal

Portugal

Portugal

Portugal

Romania

Slovakia

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

LABORATÓRIO MEDINFAR
Produtos Farmacêuticos, SA
Rua Manuel Ribeiro de Pavia, 1-1
Venda Nova
P-2700-547 Amadora

LABORATÓRIO MEDINFAR
Produtos Farmacêuticos, SA
Rua Manuel Ribeiro de Pavia, 1-1
Venda Nova
P-2700-547 Amadora

LABORATÓRIO MEDINFAR
Produtos Farmacêuticos, SA
Rua Manuel Ribeiro de Pavia, 1-1
Venda Nova
P-2700-547 Amadora

LABORATÓRIO MEDINFAR
Produtos Farmacêuticos, SA
Rua Manuel Ribeiro de Pavia, 1-1
Venda Nova
P-2700-547 Amadora

Merck Sharp & Dohme Romania S.R.L.
Bucharest Business Park
Şos. Bucureşti-Ploieşti, Nr. 1A
Clădirea C1, etaj 3
Sector 1, Bucureşti
România

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

Cozaar IC — Titulação

12,5 mg + 50 mg

Film-coated tablet

Oral use

N/A

Lortaan IC

12,5 mg

Film-coated tablet

Oral use

N/A

Lortaan IC — Titulação

12,5 mg + 50 mg

Film-coated tablet

Oral use

N/A

Lortaan

50 mg

Film-coated tablet

Oral use

N/A

Lortaan 100 mg

100 mg

Film-coated tablet

Oral use

N/A

Cozaar, comprimate filmate, 50 mg

50 mg

Film-coated tablet

Oral use

N/A

Cozaar 12,5 mg

12,5 mg

Film-coated tablet

Oral use

N/A

.

.

2
7
2
2
0
0
9

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
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8
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2
1

Member State

Marketing Authorization Holder

Invented name
Losartan potassium

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

Slovakia

Slovakia

Slovenia

Slovenia

Slovenia

Spain

Spain

Spain

Sweden

Sweden

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

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

Cozaar 50 mg

50 mg

Film-coated tablet

Oral use

N/A

Cozaar 100 mg

100 mg

Film-coated tablet

Oral use

N/A

Merck Sharp & Dohme, inovativna zdravila d.o.o.
Šmartinska cesta 140
SLO-1000 Ljubljana

Cozaar 12,5 mg filmsko obložene
tablete

12,5 mg

Film-coated tablet

Oral use

N/A

Merck Sharp & Dohme, inovativna zdravila d.o.o.
Šmartinska cesta 140
SLO-1000 Ljubljana

Cozaar 50 mg
tablete

filmsko obložene

50 mg

Film-coated tablet

Oral use

N/A

Merck Sharp & Dohme, inovativna zdravila d.o.o.
Šmartinska cesta 140
SLO-1000 Ljubljana

Cozaar 100 mg filmsko obložene
tablete

100 mg

Film-coated tablet

Oral use

N/A

Merck Sharp and Dohme de España, S.A.
C/ Josefa Valcárcel, 38
E-28027 Madrid

Merck Sharp and Dohme de España, S.A.
C/ Josefa Valcárcel, 38
E-28027 Madrid

Merck Sharp and Dohme de España, S.A.
C/ Josefa Valcárcel, 38
E-28027 Madrid

Merck Sharp & Dohme
PO Box 581
2003 PC Haarlem
Nederland

Merck Sharp & Dohme
PO Box 581
2003 PC Haarlem
Nederland

Cozaar 12,5 mg Inicio

12,5 mg

Film-coated tablet

Oral use

N/A

Cozaar 50 mg

50 mg

Film-coated tablet

Oral use

N/A

Cozaar 100 mg

100 mg

Film-coated tablet

Oral use

N/A

Cozaar 12,5 mg filmdragerade tabletter 12,5 mg

Film-coated tablet

Oral use

N/A

Cozaar 12,5 mg + 50 mg filmdra-
gerade tabletter

12,5 + 50 mg

Film-coated tablet

Oral use

N/A

C

4
8
/
2
2

E
N

O

f
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J
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.

2
7
2
2
0
0
9

Member State

Marketing Authorization Holder

Invented name
Losartan potassium

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

Sweden

Sweden

United
Kingdom

United
Kingdom

United
Kingdom

Iceland

Iceland

Iceland

Norway

Merck Sharp & Dohme
PO Box 581
2003 PC Haarlem
Nederland

Merck Sharp & Dohme
PO Box 581
2003 PC Haarlem
Nederland

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

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

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

Merck Sharp & Dohme
PO Box 581
2003 PC Haarlem
Nederland

Merck Sharp & Dohme
PO Box 581
2003 PC Haarlem
Nederland

Merck Sharp & Dohme
PO Box 581
2003 PC Haarlem
Nederland

Merck Sharp & Dohme
PO Box 581
2003 PC Haarlem
Nederland

Cozaar 50 mg filmdragerade tabletter

50 mg

Film-coated tablet

Oral use

N/A

Cozaar 100 mg filmdragerade tabletter 100 mg

Film-coated tablet

Oral use

N/A

Cozaar 25 mg Film-coated tablets

25 mg

Film-coated tablet

Oral use

N/A

Cozaar 50 mg Film-coated tablets

50 mg

Film-coated tablet

Oral use

N/A

Cozaar 100 mg Film-coated tablets

100 mg

Film-coated tablet

Oral use

N/A

Cozaar

Cozaar

Cozaar

Cozaar

12,5 mg

Film-coated tablet

Oral use

N/A

50 mg

Film-coated tablet

Oral use

N/A

100 mg

Film-coated tablet

Oral use

N/A

12,5 mg

Film-coated tablet

Oral use

N/A

.

.

2
7
2
2
0
0
9

E
N

O

f
f
i
c
i
a
l

J
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n
a
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f

t
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E
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p
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a
n
U
n
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n

i

C

4
8
/
2
3

Member State

Marketing Authorization Holder

Invented name
Losartan potassium

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

Norway

Norway

Merck Sharp & Dohme
PO Box 581
2003 PC Haarlem
Nederland

Merck Sharp & Dohme
PO Box 581
2003 PC Haarlem
Nederland

Cozaar

Cozaar

50 mg

Film-coated tablet

Oral use

N/A

100 mg

Film-coated tablet

Oral use

N/A

C

4
8
/
2
4

E
N

O

f
f
i
c
i
a
l

J
o
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n
a
l

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E
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p
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U
n
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.

.

2
7
2
2
0
0
9