Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 September 2008 to 30 September 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: 2008-10-31
Institutions: European Commission
Subjects: EU Member State, market approval, marketing standard, medicinal product, pharmaceutical legislation, withdrawal from the market

31.10.2008

EN

Official Journal of the European Union

C 276/9

Summary of Community decisions on marketing authorizations in respect of medicinal products
from 1 September 2008 to 30 September 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 276/03)

— Issuing, maintenance or modification of a national marketing authorisation

Date of the
decision

Name(s) of the medicinal
product

Holder(s) of the marketing
authorization

Member State concerned

3.9.2008

Cozaar

See Annex I

3.9.2008

Cozaar Comp

See Annex II

9.9.2008

Arcoxia

9.9.2008

Etoricoxib

11.9.2008

Activelle

11.9.2008

Rapinyl

See Annex III

See Annex IV

See Annex V

See Annex VI

See Annex I

See Annex II

See Annex III

See Annex IV

See Annex V

See Annex VI

15.9.2008

Remeron

See Annex VII

See Annex VII

23.9.2008

Gemzar

See Annex VIII

See Annex VIII

26.9.2008

Sodium Salicylate

See Annex IX

26.9.2008

Toltrazuril

See Annex X

See Annex IX

See Annex X

26.9.2008

Aclasta

This Decision is addressed
to the Member States

Novartis Europharm
Limited
Wimblehurst Road
Horsham
West Sussex RH12 5AB
United Kingdom

— Suspension of a national marketing authorization

Date of the
decision

Name(s) of the medicinal
product

Holder(s) of the marketing
authorization

Member State concerned

9.9.2008

Pulairmax

See Annex XI

See Annex XI

— Lift of suspension of a national marketing authorization

Date of the
decision

Name(s) of the medicinal
product

Holder(s) of the marketing
authorization

Member State concerned

5.9.2008

Suramox 15 % LA —
Stabox 15 % LA

See Annex XII

See Annex XII

Date of
notification

8.9.2008

8.9.2008

11.9.2008

11.9.2008

15.9.2008

15.9.2008

17.9.2008

24.9.2008

29.9.2008

29.9.2008

29.9.2008

Date of
notification

11.9.2008

Date of
notification

9.9.2008

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

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

ANNEX I

Member State

Marketing Authorisation Holder

(Invented) Name
Losartan potassium

Strength

Pharmaceutical Form

Route of administration

Austria

Austria

Austria

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

Cosaar 12,5 mg — Filmtabletten

12,5 mg

Film-coated tablet

Oral use

Cosaar 50 mg — Filmtabletten

50 mg

Film-coated tablet

Oral use

Cosaar 100 mg — Filmtabletten

100 mg

Film-coated tablet

Oral use

Cozaar 100 mg

100 mg

Film-coated tablet

Oral use

Cozaar 50 MG

50 mg

Film-coated tablet

Oral use

Cozaar 12,5 mg

12,5 mg

Film-coated tablet

Oral use

Cozaar Cardio Start

21 X 12,5 mg + 14 X 50 mg

Film-coated tablet

Oral use

Loortan 100 mg

100 mg

Film-coated tablet

Oral use

C

2
7
6
/
1
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

.

3
1
1
0
2
0
0
8

.

Member State

Marketing Authorisation Holder

(Invented) Name
Losartan potassium

Strength

Pharmaceutical Form

Route of administration

Belgium

Belgium

Belgium

Bulgaria

Cyprus

Cyprus

Denmark

Denmark

Denmark

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

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

Merck Sharp & Dohme BV
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

Loortan 50 mg

50 mg

Film-coated tablet

Oral use

Loortan 12,50 mg

12,5 mg

Film-coated tablet

Oral use

Loortan Cardio Start

21 X 12,5 mg + 14 X 50 mg

Film-coated tablet

Oral use

Cozaar

50 mg

Film-coated tablet

Oral use

Cozaar

50 mg

Film-coated tablet

Oral use

Cozaar

100 mg

Film-coated tablet

Oral use

Cozaar

12,5 mg

Film-coated tablet

Oral use

Cozaar

50 mg

Film-coated tablet

Oral use

Cozaar

100 mg

Film-coated tablet

Oral use

.

3
1
1
0
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
7
6
/
1
1

Member State

Marketing Authorisation Holder

(Invented) Name
Losartan potassium

Strength

Pharmaceutical Form

Route of administration

Denmark

Estonia

Estonia

Estonia

Finland

Finland

Finland

Finland

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
Postbus 581
2003 PC Haarlem
Nederland

Merck Sharp & Dohme B.V.
Waarderweg 39
Postbus 581
2003 PC Haarlem
Nederland

Merck Sharp & Dohme B.V.
Waarderweg 39
Postbus 581
2003 PC Haarlem
Nederland

Merck Sharp & Dohme B.V.
Waarderweg 39
Postbus 581
2003 PC Haarlem
Nederland

Cozaar Startpakke

12,5 mg + 50 mg

Film-coated tablet

Oral use

Cozaar

Cozaar

100 mg

Film-coated tablet

Oral use

50 mg

Film-coated tablet

Oral use

Cozaar 12,5 mg

12,5 mg

Film-coated tablet

Oral use

Cozaar

12,5 mg

Film-coated tablet

Oral use

Cozaar

12,5 mg and 50 mg (initiation
pack)

Film-coated tablet

Oral use

Cozaar

50 mg

Film-coated tablet

Oral use

Cozaar

100 mg

Film-coated tablet

Oral use

C

2
7
6
/
1
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

.

3
1
1
0
2
0
0
8

.

Member State

Marketing Authorisation Holder

(Invented) Name
Losartan potassium

Strength

Pharmaceutical Form

Route of administration

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

Cozaar 50 mg scored coated tablets

50 mg

Scored coated tablet

Oral use

Cardopal Start 12,5 mg Filmtabletten

12,5 mg

Film-coated tablet

Oral use

Lorzaar 100 mg Filmtabletten

100 mg

Film-coated tablet

Oral use

Lorzaar 50 mg Filmtabletten

50 mg

Film-coated tablet

Oral use

Lorzaar Protect 100 mg Filmtabletten

100 mg

Film-coated tablet

Oral use

Lorzaar Protect 50 mg Filmtabletten

50 mg

Film-coated tablet

Oral use

Lorzaar Start 12,5 mg Filmtabletten

12,5 mg

Film-coated tablet

Oral use

Pinzaar 100 mg Filmtabletten

100 mg

Film-coated tablet

Oral use

Pinzaar 50 mg Filmtabletten

50 mg

Film-coated tablet

Oral use

VARIPHARM ARZNEIMITTEL GmbH
Lindenplatz 1
D-85540 Haar

Lorzaar Varipharmstart 12,5 mg Film-
tabletten

12,5 mg

Film-coated tablet

Oral use

.

3
1
1
0
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
7
6
/
1
3

Member State

Marketing Authorisation Holder

(Invented) Name
Losartan potassium

Strength

Pharmaceutical Form

Route of administration

Greece

Greece

Greece

Hungary

Hungary

Hungary

Ireland

Ireland

Ireland

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

Merck Sharp & Dohme Hungary Ltd
50, Alkotas u.
H-1123 Budapest

Merck Sharp & Dohme Hungary Ltd
50, Alkotas u.
H-1123 Budapest

Merck Sharp & Dohme Hungary Ltd
50, Alkotas u.
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

50 mg

Film-coated tablet

Oral use

100 mg

Film-coated tablet

Oral use

12,5 mg

Film-coated tablet

Oral use

50 mg

Film-coated tablet

Oral use

100 mg

Film-coated tablet

Oral use

Cozaar 50 mg Film-coated tablets

50 mg

Film-coated tablet

Oral use

Cozaar 100 mg Film-coated tablets

100 mg

Film-coated tablet

Oral use

Cozaar 12,5 mg Film-coated tablets

12,5 mg

Film-coated tablet

Oral use

C

2
7
6
/
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

.

3
1
1
0
2
0
0
8

.

Member State

Marketing Authorisation Holder

(Invented) Name
Losartan potassium

Strength

Pharmaceutical Form

Route of administration

Italy

Italy

Italy

Italy

Italy

Italy

Italy

Italy

Italy

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

Lortaan 50 mg compresse rivestite con
film

50 mg

Film-coated tablet

Oral use

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

Lortaan 12,5 mg compresse rivestite
con film

12,5 mg

Film-coated tablet

Oral use

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

Lortaan 100 mg compresse rivestite
con film

100 mg

Film-coated tablet

Oral use

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

Neo-Lotan 50 mg compresse rivestite
con film

50 mg

Film-coated tablet

Oral use

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

Neo-Lotan 12,5 mg compresse rivestite
con film

12,5 mg

Film-coated tablet

Oral use

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

Neo-Lotan 100 mg compresse rivestite
con film

100 mg

Film-coated tablet

Oral use

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

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

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

Losaprex 50 mg compresse rivestite
con film

50 mg

Film-coated tablet

Oral use

Losaprex 12,5 mg compresse rivestite
con film

12.5 mg

Film-coated tablet

Oral use

Losaprex 100 mg compresse rivestite
con film

100 mg

Film-coated tablet

Oral use

.

3
1
1
0
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
7
6
/
1
5

Member State

Marketing Authorisation Holder

(Invented) Name
Losartan potassium

Strength

Pharmaceutical Form

Route of administration

Latvia

Latvia

Lithuania

Lithuania

Lithuania

SIA Merck Sharp & Dohme Latvia
Skanstes street 13
LV-1013 Riga

SIA Merck Sharp & Dohme Latvia
Skanstes street 13
LV-1013 Riga

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

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

Cozaar 50 mg film-coated tablets

50 mg

Film-coated tablet

Oral use

Cozaar 100 mg film-coated tablets

100 mg

Film-coated tablet

Oral use

Cozaar
(Losartan)

Cozaar
(Losartan)

Cozaar
(Losartan)

12,5 mg

Film-coated tablet

Oral use

50 mg

Film-coated tablet

Oral use

100 mg

Film-coated tablet

Oral use

Cozaar 100 mg

100 mg

Film-coated tablet

Oral use

Cozaar 50 MG

50 mg

Film-coated tablet

Oral use

Cozaar 12,5 mg

12,5 mg

Film-coated tablet

Oral use

Cozaar Cardio Start

21 X 12,5 mg + 14 X 50 mg

Film-coated tablet

Oral use

Loortan 100 mg

100 mg

Film-coated tablet

Oral use

C

2
7
6
/
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

.

3
1
1
0
2
0
0
8

.

Member State

Marketing Authorisation Holder

(Invented) Name
Losartan potassium

Strength

Pharmaceutical Form

Route of administration

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

Malta

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

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

The Netherlands

Merck Sharp & Dohme
Postbus 581
2003 PC Haarlem
Nederland

The Netherlands

Merck Sharp & Dohme
Postbus 581
2003 PC Haarlem
Nederland

Poland

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

Loortan 50 mg

50 mg

Film-coated tablet

Oral use

Loortan 12,50 mg

12,5 mg

Film-coated tablet

Oral use

Loortan Cardio Start

21 X 12,5 mg + 14 X 50 mg

Film-coated tablet

Oral use

“Cozaar 100 mg”
pilloli miksija b'rita

“Cozaar 50 mg”
pilloli miksija b'rita

10 mg

Film-coated tablet

Oral use

50 mg

Film-coated tablet

Oral use

Cozaar 50

50 mg

Film-coated tablet

Oral use

Cozaar 100

100 mg

Film-coated tablet

Oral use

Cozaar

12,5 mg

Film-coated tablet

Oral use

.

3
1
1
0
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
7
6
/
1
7

Member State

Marketing Authorisation Holder

(Invented) Name
Losartan potassium

Strength

Pharmaceutical Form

Route of administration

Poland

Poland

Portugal

Portugal

Portugal

Portugal

Portugal

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

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

Cozaar

Cozaar

Cozaar

50 mg

Film-coated tablet

Oral use

100 mg

Film-coated tablet

Oral use

50 mg

Film-coated tablet

Oral use

Cozaar 100 mg

100 mg

Film-coated tablet

Oral use

Cozaar IC

12,5 mg

Film-coated tablet

Oral use

Cozaar IC — Titulação

12,5 mg + 50 mg

Film-coated tablet

Oral use

Lortaan IC

12,5 mg

Film-coated tablet

Oral use

C

2
7
6
/
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

.

3
1
1
0
2
0
0
8

.

Member State

Marketing Authorisation Holder

(Invented) Name
Losartan potassium

Strength

Pharmaceutical Form

Route of administration

Portugal

Portugal

Portugal

Romania

Slovenia

Slovenia

Slovenia

Spain

LABORATÓRIO MEDINFAR
Produtos Farmacêuticos, SA
Rua Manuel Ribeiro de Pavia, 1-1
Venda Nova
PT-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,
inovativna zdravila d.o.o.
Šmartinska cesta 140
SLO-1000 Ljubljana

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

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

Lortaan IC — Titulação

12,5 mg + 50 mg

Film-coated tablet

Oral use

Lortaan

50 mg

Film-coated tablet

Oral use

Lortaan 100 mg

100 mg

Film-coated tablet

Oral use

Cozaar, comprimate filmate, 50 mg

50 mg

Film-coated tablet

Oral use

Cozaar 12,5 mg filmsko obložene
tablete

12,5 mg

Film-coated tablet

Oral use

Cozaar 50 mg filmsko obložene
tablete

50 mg

Film-coated tablet

Oral use

Cozaar 100 mg filmsko obložene
tablete

100 mg

Film-coated tablet

Oral use

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

Cozaar 12,5 mg Inicio

12,5 mg

Film-coated tablet

Oral use

.

3
1
1
0
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
7
6
/
1
9

Member State

Marketing Authorisation Holder

(Invented) Name
Losartan potassium

Strength

Pharmaceutical Form

Route of administration

Spain

Spain

Sweden

Sweden

Sweden

Sweden

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

Merck Sharp & Dohme
PO Box 581
2003 PC Haarlem
Nederland

Merck Sharp & Dohme
PO Box 581
2003 PC Haarlem
Nederland

Cozaar 50 mg

50 mg

Film-coated tablet

Oral use

Cozaar 100 mg

100 mg

Film-coated tablet

Oral use

Cozaar 12,5 mg filmdragerade tabletter

12,5 mg

Film-coated tablet

Oral use

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

12,5 + 50 mg

Film-coated tablet

Oral use

Cozaar 50 mg filmdragerade tabletter

50 mg

Film-coated tablet

Oral use

Cozaar 100 mg filmdragerade tabletter

100 mg

Film-coated tablet

Oral use

United Kingdom Merck Sharp & Dohme Limited

Cozaar 50 mg Film-coated tablets

50 mg

Film-coated tablet

Oral use

Hertford Road
Hoddesdon
Herts EN11 9BU
United Kingdom

United Kingdom Merck Sharp & Dohme Limited

Cozaar 25 mg Film-coated tablets

25 mg

Film-coated tablet

Oral use

Hertford Road
Hoddesdon
Herts EN11 9BU
United Kingdom

United Kingdom Merck Sharp & Dohme Limited

Cozaar 100 mg Film-coated tablets

100 mg

Film-coated tablet

Oral use

Hertford Road
Hoddesdon
Herts EN11 9BU
United Kingdom

C

2
7
6
/
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

.

3
1
1
0
2
0
0
8

.

Member State

Marketing Authorisation Holder

(Invented) Name
Losartan potassium

Strength

Pharmaceutical Form

Route of administration

Iceland

Iceland

Iceland

Norway

Norway

Norway

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

Merck Sharp & Dohme
PO Box 581
2003 PC Haarlem
Nederland

Merck Sharp & Dohme
PO Box 581
2003 PC Haarlem
Nederland

Cozaar

Cozaar

Cozaar

Cozaar

Cozaar

Cozaar

12,5 mg

Film-coated tablet

Oral use

50 mg

Film-coated tablet

Oral use

100 mg

Film-coated tablet

Oral use

12,5 mg

Film-coated tablet

Oral use

50 mg

Film-coated tablet

Oral use

100 mg

Film-coated tablet

Oral use

.

3
1
1
0
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
7
6
/
2
1

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

ANNEX II

Member State

Marketing Authorisation Holder

(Invented) Name
Losartan potassium and hydrochlorothiazide

Strength

Pharmaceutical Form

Route of administration

Austria

Austria

Belgium

Belgium

Belgium

Belgium

Bulgaria

Cyprus

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

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 Plus — Filmtabletten

50 mg losartan potassium —
12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Fortzaar-Filmtabletten

100 mg losartan potassium —
25 mg hydrochlorothiazide

Film-coated tablet

Cozaar Plus Forte 100 mg/25 mg

100 mg losartan potassium —
25 mg hydrochlorothiazide

Film-coated tablet

Oral use

Oral use

Cozaar Plus 50 mg/12,5 mg

50 mg losartan potassium —
12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Loortan Plus Forte 100 mg/25 mg

100 mg losartan potassium —
25 mg hydrochlorothiazide

Film-coated tablet

Oral use

Loortan Plus 50 mg/12,5 mg

50 mg losartan potassium —
12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

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

Hyzaar

50 mg losartan potassium —
12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Merck Sharp & Dohme BV
Postbus 581
2003 PC Haarlem
Nederland

Fortzaar

100 mg losartan potassium —
25 mg hydrochlorothiazide

Film-coated tablet

Oral use

C

2
7
6
/
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

.

3
1
1
0
2
0
0
8

.

Member State

Marketing Authorisation Holder

(Invented) Name
Losartan potassium and hydrochlorothiazide

Strength

Pharmaceutical Form

Route of administration

Cyprus

Denmark

Denmark

Denmark

Denmark

Estonia

Estonia

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 BV
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

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
2031 BN Haarlem
Nederland

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

Hyzaar

50 mg losartan potassium —
12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Cozaar Comp.

50 mg losartan potassium —
12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Cozaar Comp. Forte

100 mg losartan potassium —
25 mg hydrochlorothiazide

Film-coated tablet

Cozaar Comp. 100 mg/12,5 mg

100 mg losartan potassium —
12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Oral use

Fortzaar

Hyzaar

Fortzaar

100 mg losartan potassium —
25 mg hydrochlorothiazide

Film-coated tablets

Oral use

50 mg losartan potassium —
12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

100 mg losartan potassium —
25 mg hydrochlorothiazide

Film-coated tablet

Oral use

Cozaar Comp

50 mg losartan potassium —
12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Cozaar Comp

100 mg losartan potassium —
12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

.

3
1
1
0
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
7
6
/
2
3

Member State

Marketing Authorisation Holder

(Invented) Name
Losartan potassium and hydrochlorothiazide

Strength

Pharmaceutical Form

Route of administration

Finland

France

France

France

France

France

Germany

Germany

Germany

Germany

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

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

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

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

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

Cozaar Comp Forte

100 mg losartan potassium —
25 mg hydrochlorothiazide

Film-coated tablet

Fortzaar 100 mg/25 mg comprimé pelli-
culé

100 mg losartan potassium —
25 mg hydrochlorothiazide

Film-coated tablet

Hyzaar 100 mg/25 mg comprimé pelliculé

100 mg losartan potassium —
25 mg hydrochlorothiazide

Film-coated tablet

Oral use

Oral use

Oral use

Fortzaar 50 mg/12,5 mg comprimé pelli-
culé

50 mg losartan potassium —
12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Hyzaar 50 mg/12,5 mg comprimé pelli-
culé

50 mg losartan potassium —
12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Fortzaar 100 mg/12,5 mg comprimé pelli-
culé

100 mg losartan potassium —
12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Lorzaar Plus 50/12,5 mg Filmtabletten

50 mg losartan potassium —
12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Cardopal Plus 50/12,5 mg Filmtabletten

50 mg losartan potassium —
12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

VARIPHARM ARZNEIMITTEL GmbH
Lindenplatz 1
D-85540 Haar

MSD Chibropharm GmbH
Postfach 1202
D-85530 Haar

Lorzaar Varipharm Plus 50/12,5 mg Film-
tabletten

50 mg losartan potassium —
12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Fortzaar 100/25 mg Filmtabletten

100 mg losartan potassium —
25 mg hydrochlorothiazide

Film-coated tablet

Oral use

C

2
7
6
/
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

.

3
1
1
0
2
0
0
8

.

Member State

Marketing Authorisation Holder

(Invented) Name
Losartan potassium and hydrochlorothiazide

Strength

Pharmaceutical Form

Route of administration

VARIPHARM ARZNEIMITTEL GmbH
Lindenplatz 1
D-85540 Haar

Fortzaar Varipharm 100/25 mg
Filmtabletten

100 mg losartan potassium —
25 mg hydrochlorothiazide

Film-coated tablet

Oral use

Lorzaar Plus Forte 100/12,5 mg
Filmtabletten

100 mg losartan potassium —
12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

E
N

Germany

Germany

Greece

Greece

Hungary

Hungary

Iceland

Iceland

Iceland

Ireland

MSD Chibropharm GmbH
Postfach 1202
D-85530 Haar

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

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

Hyzaar

Hyzaar 100/25

50 mg losartan potassium —
12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

100 mg losartan potassium —
25 mg hydrochlorothiazide

Film-coated tablet

Oral use

Merck Sharp & Dohme Hungary Ltd
50, Alkotas u.
H-1123 Budapest

Hyzaar 50/12,5 mg

50 mg losartan potassium —
12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Merck Sharp & Dohme Hungary Ltd
50, Alkotas u.
H-1123 Budapest

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

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

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

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

Hyzaar Forte 100/25 mg

100 mg losartan potassium —
25 mg hydrochlorothiazide

Film-coated tablet

Oral use

Cozaar' Comp 50 mg/12,5 mg film-coated
tablets

50 mg losartan potassium —
12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Cozaar' Comp 100 mg/25 mg film-coated
tablets

100 mg losartan potassium —
25 mg hydrochlorothiazide

Film-coated tablet

Oral use

Hizaar 50 mg + 12,5 mg compresse
rivestite con film

50 mg losartan potassium —
12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Hizaar 100 mg + 25 mg compresse
rivestite con film

100 mg losartan potassium —
25 mg hydrochlorothiazide

Film-coated tablet

Oral use

.

3
1
1
0
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
7
6
/
2
5

Member State

Marketing Authorisation Holder

(Invented) Name
Losartan potassium and hydrochlorothiazide

Strength

Pharmaceutical Form

Route of administration

Ireland

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

Forzaar 100 mg + 25 mg compresse
rivestite con film

100 mg losartan potassium —
25 mg hydrochlorothiazide

Film-coated tablet

Oral use

Italy

Italy

Italy

Italy

Italy

Italy

Italy

Latvia

Latvia

Neopharmed S.p.A.
Via G. Fabbroni, 6
I-00191 Roma

Neopharmed S.p.A.
Via G. Fabbroni, 6
I-00191 Roma

Sigma-Tau Industrie Farmaceutiche
Riunite S.p.A.
viale Shakespeare 47
I-00144 Roma

Sigma-Tau Industrie Farmaceutiche
Riunite S.p.A.
viale Shakespeare 47
I-00144 Roma

SIA Merck Sharp & Dohme Latvia
Skanstes street 13
LV-1013 Riga

SIA Merck Sharp & Dohme Latvia
Skanstes street 13
LV-1013 Riga

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

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

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

Neo-Lotan Plus 50 mg + 12,5 mg
compresse rivestite con film

50 mg losartan potassium —
12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Neo-Lotan Plus 100 mg + 25 mg
compresse rivestite con film

100 mg losartan potassium —
25 mg hydrochlorothiazide

Film-coated tablet

Oral use

Losazid 50 mg + 12,5 mg compresse
rivestite con film

50 mg losartan potassium —
12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Losazid 100 mg + 25 mg compresse
rivestite con film

100 mg losartan potassium —
25 mg hydrochlorothiazide

Film-coated tablet

Oral use

Hyzaar 50 mg/12,5 mg

50 mg losartan potassium —
12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Fortzaar 100 mg/25 mg

100 mg losartan potassium —
25 mg hydrochlorothiazide

Film-coated tablet

Fortzaar (Losartan/Hydrochlorothiazide)

100 mg losartan potassium —
25 mg hydrochlorothiazide

Film-coated tablet

Oral use

Oral use

Hyzaar (Losartan/Hydrochlorothiazide)

50 mg losartan potassium —
12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Cozaar Plus Forte 100 mg/25 mg

100 mg losartan potassium —
25 mg hydrochlorothiazide

Film-coated tablet

Oral use

C

2
7
6
/
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

.

3
1
1
0
2
0
0
8

.

Member State

Marketing Authorisation Holder

(Invented) Name
Losartan potassium and hydrochlorothiazide

Strength

Pharmaceutical Form

Route of administration

Lithuania

Lithuania

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

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

Luxembourg

Luxembourg

Malta

Malta

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

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

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

Merck Sharp & Dohme
Postbus 581
2003 PC Haarlem
Nederland

Merck Sharp & Dohme
Postbus 581
2003 PC Haarlem
Nederland

Cozaar Plus 50 mg/12,5 mg

50 mg losartan potassium —
12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Loortan Plus Forte 100 mg/25 mg

100 mg losartan potassium —
25 mg hydrochlorothiazide

Film-coated tablet

Oral use

Loortan Plus 50 mg/12,5 mg

50 mg losartan potassium —
12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

“Cozaar Comp” 50/12,5 mg pilloli miksija
b'rita

50 mg losartan potassium —
12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

“Cozaar Comp” 100/25 mg pilloli miksija
b'rita

100 mg losartan potassium —
25 mg hydrochlorothiazide

Film-coated tablet

“Cozaar Comp” 100/12,5 mg pilloli
miksija b'rita

100 mg losartan potassium —
12,5 mg hydrochlorothiazide

Film-coated tablet

Cozaar Plus 100/12,5

100 mg losartan potassium —
12,5 mg hydrochlorothiazide

Film-coated tablet

Fortzaar 100/25

100 mg losartan potassium —
25 mg hydrochlorothiazide

Film-coated tablet

Oral use

Oral use

Oral use

Oral use

.

3
1
1
0
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
7
6
/
2
7

Member State

Marketing Authorisation Holder

(Invented) Name
Losartan potassium and hydrochlorothiazide

Strength

Pharmaceutical Form

Route of administration

Hyzaar 50/12,5

50 mg losartan potassium —
12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Hyzaar

Hyzaar Forte

Cozaar Plus

50 mg losartan potassium —
12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

100 mg losartan potassium —
25 mg hydrochlorothiazide

Film-coated tablet

Oral use

50 mg losartan potassium —
12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Cozaar Plus

100 mg losartan potassium —
12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Fortzaar

100 mg losartan potassium —
25 mg hydrochlorothiazide

Film-coated tablet

Oral use

Malta

Merck Sharp & Dohme
Postbus 581
2003 PC Haarlem
Nederland

The Netherlands

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

The Netherlands

MSD Polska Sp. z o.o.
ul. 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

The Netherlands

Norway

Norway

Norway

Siaara

Heptafarma- Companhia Farmacêutica
Sociedade Unipessoal, Lda
Quinta da Fonte
Edifício Vasco da Gama, 19
Porto Salvo
P.O. Box 214
P-2770-192 Paço d'Arcos

100 mg losartan potassium —
25 mg hydrochlorothiazide

Film-coated tablet

Oral use

C

2
7
6
/
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

.

3
1
1
0
2
0
0
8

.

Member State

Marketing Authorisation Holder

(Invented) Name
Losartan potassium and hydrochlorothiazide

Strength

Pharmaceutical Form

Route of administration

Poland

Poland

Portugal

Portugal

Portugal

Portugal

Portugal

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

Frosst Portuguesa
Produtos Farmacêuticos, Lda.
Quinte da Fonte
Edificio Vasco da Gama, 19
P.O. BOX 214
Porto Salvo
P-2780-730 Paço d'Arcos

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 Romania S.R.L.
Bucharest Business Park
Şos. Bucureşti-Ploieşti, Nr. 1A
Clădirea C1, Etaj 3
Sector 1, Bucureşti
România

Lortaan Plus

50 mg losartan potassium —
12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Lortaan Plus

100 mg losartan potassium —
12,5 mg hydrochlorothiazide

Film-coated tablet

Losartan + Hidroclorotiazida Frosst

100 mg losartan potassium —
12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Oral use

Hyzaar® 50 mg/12,5 mg comprimate
filmate

50 mg losartan potassium —
12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Fortzaar® 100/25 mg comprimate filmate

100 mg losartan potassium —
25 mg hydrochlorothiazide

Film-coated tablet

Oral use

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

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

Hyzaar

Hyzaar

50 mg losartan potassium —
12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

100 mg losartan potassium —
12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

.

3
1
1
0
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
7
6
/
2
9

Member State

Marketing Authorisation Holder

(Invented) Name
Losartan potassium and hydrochlorothiazide

Strength

Pharmaceutical Form

Route of administration

Portugal

Portugal

Romania

Romania

Slovenia

Slovenia

Slovenia

Spain

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

Fortzaar

100 mg losartan potassium —
25 mg hydrochlorothiazide

Film-coated tablet

Oral use

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

Cozaar Plus

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

Fortzaar

50 mg losartan potassium —
12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

100 mg losartan potassium —
25 mg hydrochlorothiazide

Film-coated tablet

Oral use

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 Limited
Hertford Road
Hoddesdon
Herts EN11 9BU
United Kingdom

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

Cozaar Comp 50 mg/12,5 mg filmdra-
gerade tabletter

50 mg losartan potassium —
12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Cozaar Comp 100 mg/12,5 mg filmdra-
gerade tabletter

100 mg losartan potassium —
12,5 mg hydrochlorothiazide

Film-coated tablet

Cozaar Comp Forte 100 mg/25 mg film-
dragerade tabletter

100 mg losartan potassium —
25 mg hydrochlorothiazide

Film-coated tablet

Oral use

Oral use

Cozaar-Comp 50/12,5 mg film-coated
tablets

50 mg losartan potassium —
12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Cozaar-Comp 100/25 mg film-coated
tablets

100 mg losartan potassium —
25 mg hydrochlorothiazide

Film-coated tablet

Oral use

C

2
7
6
/
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

.

3
1
1
0
2
0
0
8

.

Member State

Marketing Authorisation Holder

(Invented) Name
Losartan potassium and hydrochlorothiazide

Strength

Pharmaceutical Form

Route of administration

Spain

Sweden

Sweden

Sweden

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

Cozaar-Comp 100 mg/12,5 mg
film-coated tablets

100 mg losartan potassium —
12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Cozaar-Comp 50/12,5 mg

50 mg losartan potassium —
12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Cozaar-Comp Forte

100 mg losartan potassium —
25 mg hydrochlorothiazide

Film-coated tablet

Cozaar-Comp 100/12,5 mg

100 mg losartan potassium —
12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Oral use

United Kingdom MSD BV

Cozaar Comp

Waarderweg 39
2031 BN Haarlem
Nederland

United Kingdom MSD BV

Cozaar Comp

Waarderweg 39
2031 BN Haarlem
Nederland

United Kingdom MSD BV

Cozaar Comp Forte

Waarderweg 39
2031 BN Haarlem
Nederland

50 mg losartan potassium —
12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

100 mg losartan potassium —
12,5 mg hydrochlorothiazide

Film-coated tablet

100 mg losartan potassium —
25 mg hydrochlorothiazide

Film-coated tablet

Oral use

Oral use

.

3
1
1
0
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
7
6
/
3
1

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

ANNEX III

Member State

Marketing Authorisation Holder

(Invented) Name

Strength

Pharmaceutical Form

Route of adminitration

Austria

Belgium

Czech Republic

Cyprus

Denmark

Estonia

Finland

France

Germany

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

Merck Sharp and Dohme
Chaussée de Waterloo, 1135
B-1180 Brussels

Merck Sharp & Dohme B.V.
Waanderweg 39
2031 BN Haarlem
Nederland

Merck Sharp & Dohme B.V.
Waanderweg 39
2031 BN Haarlem
Nederland

Merck Sharp & Dohme B.V.
Waanderweg 39
2031 BN Haarlem
Nederland

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

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

Merck Sharp Dohme Chibret
3, avenue Hoche
F-75114 Paris Cedex 8

MSD Sharp & Dohme GmbH
Lindenplatz 1
D-85540 Haar

Arcoxia

Arcoxia

Arcoxia

90 mg

90 mg

90 mg

Film-coated tablets

Oral use

Film-coated tablets

Oral use

Film-coated tablets

Oral use

Arcoxia

90 mg

Film-coated tablets

Oral use

Arcoxia

90 mg

Film-coated tablets

Oral use

Arcoxia

Arcoxia

Arcoxia

Arcoxia

90 mg

90 mg

90 mg

90 mg

Film-coated tablets

Oral use

Film-coated tablets

Oral use

Film-coated tablets

Oral use

Film-coated tablets

Oral use

C

2
7
6
/
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

.

3
1
1
0
2
0
0
8

.

Member State

Marketing Authorisation Holder

(Invented) Name

Strength

Pharmaceutical Form

Route of adminitration

Greece

Hungary

Iceland

Ireland

Italy

Latvia

Lithuania

Luxembourg

Malta

VIANEX S.A.
Tatoiou Street,
GR-14671 Nea Erythrea

Merck Sharp & Dohme
Magyarország Kft.
Alkotás utca 50
H-1123 Budapest

Merck Sharp & Dohme
Regulatory Affairs Iceland
Smedeland 8
DK-2600 Glostrup

Merck Sharp and Dohme Ltd
Hertford Road
Hoddesdon
Hertfordshire EN11 9B4
United Kingdom

Merck Sharp & Dohme S.p.A.
Via G. Fabbroni, 6
I-00191 Roma

SIA Merck Sharp & Dohme Latvija
Skanstes 13
LV-1013 Riga

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

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

Merck, Sharp & Dohme Ltd
Hertfordshire Road
Hoddesdon
Hertsfordshire EN11 9BU
United Kindgdom

Arcoxia

90 mg

Film-coated tablets

Oral use

Arcoxia

90 mg

Film-coated tablets

Oral use

Arcoxia

90 mg

Film-coated tablets

Oral use

Arcoxia

90 mg

Film-coated tablets

Oral use

Arcoxia

90 mg

Film-coated tablets

Oral use

Arcoxia

90 mg

Film-coated tablets

Oral use

Arcoxia

90 mg

Film-coated tablets

Oral use

Arcoxia

90 mg

Film-coated tablets

Oral use

Arcoxia

90 mg

Film-coated tablets

Oral use

.

3
1
1
0
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
7
6
/
3
3

Member State

Marketing Authorisation Holder

(Invented) Name

Strength

Pharmaceutical Form

Route of adminitration

The Netherlands

Norway

Poland

Portugal

Slovakia

Slovenia

Spain

Sweden

United Kingdom

Merck Sharp & Dohme B.V.
Waanderweg 39
2031 BN Haarlem
Nederland

Merck Sharp & Dohme B.V.
Waanderweg 39
2031 BN Haarlem
Nederland

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

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

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

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

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

Merck Sharp & Dohme BV
PO Box 581
2003 PC Haarlem
Nederland

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

Arcoxia

90 mg

Film-coated tablets

Oral use

Arcoxia

90 mg

Film-coated tablets

Oral use

Arcoxia

Arcoxia

90 mg

90 mg

Film-coated tablets

Oral use

Film-coated tablets

Oral use

Arcoxia

90 mg

Film-coated tablets

Oral use

Arcoxia

90 mg

Film-coated tablets

Oral use

Arcoxia

Arcoxia

90 mg

90 mg

Film-coated tablets

Oral use

Film-coated tablets

Oral use

Arcoxia

90 mg

Film-coated tablets

Oral use

C

2
7
6
/
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

.

3
1
1
0
2
0
0
8

.

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

ANNEX IV

Member State

Marketing Authorisation Holder

(Invented) Name

Strength

Pharmaceutical Form

Route of administration

Austria

Belgium

Bulgaria

Czech Republic

Cyprus

Denmark

Estonia

Finland

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

Merck Sharp and Dohme
Chaussée de Waterloo, 1135
B-1180 Brussels

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

Arcoxia

Auxib

Arcoxia

Ranacox

Arcoxia

90 mg

90 mg

90 mg

90 mg

90 mg

Film-coated tablets

Film-coated tablets

Film-coated tablets

Film-coated tablets

Film-coated tablets

Oral use

Oral use

Oral use

Oral use

Oral use

Merck Sharp & Dohme B.V.
Waanderweg 39
2031 BN Haarlem
Nederland

Merck Sharp & Dohme BV.
Waarderweg 39
2031 BN Haarlem
Nederland

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

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

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

Arcoxia

90 mg

Film-coated tablets

Oral use

Arcoxia

90 mg

Film-coated tablets

Oral use

Arcoxia

90 mg

Film-coated tablets

Oral use

Arcoxia

Arcoxia

Turox

90 mg

90 mg

90 mg

Film-coated tablets

Oral use

Film-coated tablets

Film-coated tablets

Oral use

Oral use

.

3
1
1
0
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
7
6
/
3
5

Member State

Marketing Authorisation Holder

(Invented) Name

Strength

Pharmaceutical Form

Route of administration

France

Germany

Greece

Hungary

Iceland

Ireland

Italy

Italy

Italy

Italy

Merck Sharp Dohme Chibret
3, avenue Hoche
F-75114 Paris Cedex 8

MSD Sharp & Dohme GmbH
Lindenplatz 1
D-85540 Haar

VIANEX S.A.
Tatoiou Street,
GR-14671 Nea Erythrea

Merck Sharp & Dohme
Magyarország Kft.
Alkotás utca 50
H-1123 Budapest

Merck Sharp & Dohme
Regulatory Affairs Iceland
Smedeland 8
DK-2600 Glostrup

Merck Sharp and Dohme Ltd
Hertford Road
Hoddesdon
Hertfordshire EN11 9B4
United Kingdom

Merck Sharp & Dohme S.p.A.
Via G. Fabbroni 6
I-00191 Roma

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

Neopharmed S.p.A.
Via G. Fabbroni 6
I-00191 Roma

Addenda Pharma S.r.l
Viale Shakespeare 47
I-00144 Roma

Arcoxia

90 mg

Film-coated tablets

Oral use

Arcoxia

90 mg

Film-coated tablets

Oral use

Arcoxia

90 mg

Film-coated tablets

Oral use

Arcoxia

90 mg

Film-coated tablets

Oral use

Arcoxia

90 mg

Film-coated tablets

Oral use

Arcoxia

90 mg

Film-coated tablets

Oral use

Arcoxia

90 mg

Film-coated tablet

Oral use

Algix

90 mg

Film-coated tablet

Oral use

Recoxib

90 mg

Film-coated tablets

Oral use

Tauxib

90 mg

Film-coated tablets

Oral use

C

2
7
6
/
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

.

3
1
1
0
2
0
0
8

.

Member State

Marketing Authorisation Holder

(Invented) Name

Strength

Pharmaceutical Form

Route of administration

Latvia

Lithuania

Luxembourg

Malta

The Netherlands

Norway

Poland

Portugal

Portugal

SIA Merck Sharp & Dohme Latvija
Skanstes 13
LV-1013 Riga

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

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

Merck, Sharp & Dohme Ltd
Hertfordshire Road
Hoddesdon
Hertsfordshire EN11 9BU
United Kindgdom

Merck Sharp & Dohme B.V.
Waanderweg 39
2031 BN Haarlem
Nederland

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

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

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

Arcoxia

90 mg

Film-coated tablets

Oral use

Arcoxia

90 mg

Film-coated tablets

Oral use

Arcoxia

Ranacox

Arcoxia

Arcoxia

Auxib

Arcoxia

90 mg

90 mg

90 mg

90 mg

90 mg

90 mg

Film-coated tablets

Film-coated tablets

Film-coated tablets

Film-coated tablets

Film-coated tablets

Oral use

Oral use

Oral use

Oral use

Oral use

Film-coated tablets

Oral use

Arcoxia

90 mg

Film-coated tablets

Oral use

Arcoxia

90 mg

Film-coated tablets

Oral use

Laboratórios Bial — Portela & Ca, S.A. PRT
Av. da Siderurgia Nacional
S. Mamede do Coronado
Portugal

Exxiv

90 mg

Film-coated tablets

Oral use

.

3
1
1
0
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
7
6
/
3
7

Member State

Marketing Authorisation Holder

(Invented) Name

Strength

Pharmaceutical Form

Route of administration

Portugal

Romania

Slovakia

Slovenia

Spain

Spain

Sweden

United Kingdom

Farmacox — Companhia
Farmacêutica Sociedade Unipessoal, Lda.
PRT
Quinta da Fonte
Edifício Vasco da Gama, 19
Porto Salvo
Paço d'Arcos
Portugal

Merck Sharp & Dohme Romania S.R.L.
Bucharest Business Park
Soseaua Bucuresti-Ploiesti nr. 1A
Corp C1, etaj 3, sector 1
RO-013681 Bucharest

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

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

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

Laboratorios Abello, S.A.
Josefa Valcárcel, 38
E-28027 Madrid

Merck Sharp & Dohme BV
PO Box 581
2003 PC Haarlem
Nederland

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

Turox

90 mg

Film-coated tablets

Oral use

Arcoxia

90 mg

Film-coated tablets

Oral use

Arcoxia

90 mg

Film-coated tablets

Oral use

Arcoxia

90 mg

Film-coated tablets

Oral use

Arcoxia

Exxiv

Arcoxia

Turox

Arcoxia

Auxib 90

Exxiv 90

Turox 90

90 mg

90 mg

90 mg

90 mg

90 mg

90 mg

90 mg

90 mg

Film-coated tablets

Oral use

Film-coated tablets

Oral use

Film-coated tablets

Film-coated tablets

Film-coated tablets

Film-coated tablets

Film-coated tablets

Film-coated tablets

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

C

2
7
6
/
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

.

3
1
1
0
2
0
0
8

.

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

ANNEX V

Member State

Marketing Authorisation
Holder

Applicant

(Invented) Name

Strength

Pharmaceutical Form

Route of administration

.

3
1
1
0
2
0
0
8

.

Austria

Belgium

Bulgaria

Czech Republic

Denmark

Estonia

Finland

France

Germany

Novo Nordisk Pharma GmbH
Opernring 3-5
A-1010 Wien

Novo Nordisk Pharma N.V
Boulevard International 55/6,
B-1070 Brussel

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Noviana 0,5 mg/0,1 mg Film-
tabletten

Estradiol (as hemihydrate) 0,5 mg
+ Norethisterone acetate 0,1 mg

Film-coated tablets

Oral use

Activelle minor comprimés
pelliculés

Estradiol (as hemihydrate) 0,5 mg
+ Norethisterone acetate 0,1 mg

Film-coated tablets

Oral use

Eviana филмирани таблетки

Estradiol (as hemihydrate) 0,5 mg
+ Norethisterone acetate 0,1 mg

Film-coated tablets

Oral use

Noviana potahované tablety

Estradiol (as hemihydrate) 0,5 mg
+ Norethisterone acetate 0,1 mg

Film-coated tablets

Oral use

Activelle low filmovertrukne
tabletter

Estradiol (as hemihydrate) 0,5 mg
+ Norethisterone acetate 0,1 mg

Film-coated tablets

Oral use

Activelle

Estradiol (as hemihydrate) 0,5 mg
+ Norethisterone acetate 0,1 mg

Film-coated tablets

Oral use

Activelle 0,5 mg/0,1 mg tabl.

Estradiol (as hemihydrate) 0,5 mg
+ Norethisterone acetate 0,1 mg

Film-coated tablets

Oral use

Novo Nordisk Pharmaceutique S.A.S
30, rue De Valmy
F-92936 Paris La Défense Cedex

Activelle 0,5 mg/0,1 mg,
comprimé pelliculé

Estradiol (as hemihydrate) 0,5 mg
+ Norethisterone acetate 0,1 mg

Film-coated tablets

Oral use

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Noviana

Estradiol (as hemihydrate) 0,5 mg
+ Norethisterone acetate 0,1 mg

Film-coated tablets

Oral use

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
7
6
/
3
9

Member State

Marketing Authorisation
Holder

Applicant

(Invented) Name

Strength

Pharmaceutical Form

Route of administration

Hungary

Iceland

Ireland

Italy

Latvia

Lithuania

Luxembourg

The Netherlands

Norway

Portugal

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Novo Nordisk Pharma N.V
Riverside Business Park
Boulevard International
B-1070 Brussels

Novo Nordisk Farma B.V.
Flemingweg 18
2408 AV Alphen a/d Rijn
Nederland

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Novo Nordisk, A/S DNK
Novo Allé
DK-2880 Bagsværd

Noviana filmtabletta

Estradiol (as hemihydrate) 0,5 mg
+ Norethisterone acetate 0,1 mg

Film-coated tablets

Oral use

Activelle low 0,5 mg/0,1 mg
tablets filmuhúðaðar töflur

Estradiol (as hemihydrate) 0,5 mg
+ Norethisterone acetate 0,1 mg

Film-coated tablets

Oral use

Activelle Tablets

Estradiol (as hemihydrate) 0,5 mg
+ Norethisterone acetate 0,1 mg

Film-coated tablets

Oral use

Activelle 0,5 mg/0,1 mg
compresse film-rivestite

Estradiol (as hemihydrate) 0,5 mg
+ Norethisterone acetate 0,1 mg

Film-coated tablets

Oral use

Noviana 0,5 mg/0,1 mg apvalk-
otās tabletes

Estradiol (as hemihydrate) 0,5 mg
+ Norethisterone acetate 0,1 mg

Film-coated tablets

Oral use

Activelle

Estradiol (as hemihydrate) 0,5 mg
+ Norethisterone acetate 0,1 mg

Film-coated tablets

Oral use

Activelle comprimés pelliculés

Estradiol (as hemihydrate) 0,5 mg
+ Norethisterone acetate 0,1 mg

Film-coated tablets

Oral use

Activelle filmomhulde tabletten

Estradiol (as hemihydrate) 0,5 mg
+ Norethisterone acetate 0,1 mg

Film-coated tablets

Oral use

Noviana 0,5 mg/0,1 mg tablett
filmdrasjert

Estradiol (as hemihydrate) 0,5 mg
+ Norethisterone acetate 0,1 mg

Film-coated tablets

Oral use

Activelle

Estradiol (as hemihydrate) 0,5 mg
+ Norethisterone acetate 0,1 mg

Film-coated tablets

Oral use

C

2
7
6
/
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

.

3
1
1
0
2
0
0
8

.

Member State

Marketing Authorisation
Holder

Applicant

(Invented) Name

Strength

Pharmaceutical Form

Route of administration

Romania

Slovak Republic

Slovenia

Spain

Sweden

United Kingdom

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Novo Nordisk Pharma Ltd
Broadfield Park
Brighton Road
RH11 9RT Crawley West Sussex
United Kingdom

Noviana comprimate filmate

Estradiol (as hemihydrate) 0,5 mg
+ Norethisterone acetate 0,1 mg

Film-coated tablets

Oral use

Noviana

Estradiol (as hemihydrate) 0,5 mg
+ Norethisterone acetate 0,1 mg

Film-coated tablets

Oral use

Noviana filmsko obložene
tablete

Estradiol (as hemihydrate) 0,5 mg
+ Norethisterone acetate 0,1 mg

Film-coated tablets

Oral use

Activelle 0,5 mg/ 0,1 mg
comprimidos recubiertos de
película

Activelle

Estradiol (as hemihydrate) 0,5 mg
+ Norethisterone acetate 0,1 mg

Film-coated tablets

Oral use

Estradiol (as hemihydrate) 0,5 mg
+ Norethisterone acetate 0,1 mg

Film-coated tablets

Oral use

Noviana film-coated tablets

Estradiol (as hemihydrate) 0,5 mg
+ Norethisterone acetate 0,1 mg

Film-coated tablets

Oral use

.

3
1
1
0
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
7
6
/
4
1

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF
ADMINISTRATION, APPLICANTS AND MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES

ANNEX VI

Member State

Marketing Authorisation Holder

Applicant

(Invented) Name

Strength

Pharmaceutical Form

Route of administration

Austria

Belgium

Cyprus

Czech Republic

Denmark

ProStrakan Ltd
Galabank Business Park
Galashiels TD1 1QH
United Kingdom

ProStrakan Ltd
Galabank Business Park
Galashiels TD1 1QH
United Kingdom

ProStrakan Ltd
Galabank Business Park
Galashiels TD1 1QH
United Kingdom

ProStrakan Ltd,
Galabank Business Park
Galashiels TD1 1QH
United Kingdom

ProStrakan Ltd
Galabank Business Park
Galashiels TD1 1QH
United Kingdom

Sublingual tablet

Sublingual use

Sublingual tablet

Sublingual use

Sublingual tablet

Sublingual use

Sublingual tablet

Sublingual use

Sublingual tablet

Sublingual use

Rapinyl

Rapinyl

Rapinyl (1)

Rapinyl

Rapinyl

50 µg
100 µg
200 µg
300 µg
400 µg
600 µg
800 µg

50 µg
100 µg
200 µg
300 µg
400 µg
600 µg
800 µg

50 µg
100 µg
200 µg
300 µg
400 µg
600 µg
800 µg

50 µg
100 µg
200 µg
300 µg
400 µg
600 µg
800 µg

50 µg
100 µg
200 µg
300 µg
400 µg
600 µg
800 µg

C

2
7
6
/
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

.

3
1
1
0
2
0
0
8

.

Member State

Marketing Authorisation Holder

Applicant

(Invented) Name

Strength

Pharmaceutical Form

Route of administration

Estonia

Finland

France

Germany

Greece

Hungary

ProStrakan Ltd
Galabank Business Park
Galashiels TD1 1QH
United Kingdom

ProStrakan Ltd
Galabank Business Park
Galashiels TD1 1QH
United Kingdom

ProStrakan Ltd
Galabank Business Park
Galashiels TD1 1QH
United Kingdom

ProStrakan Ltd
Galabank Business Park
Galashiels TD1 1QH
United Kingdom

ProStrakan Ltd
Galabank Business Park
Galashiels TD1 1QH
United Kingdom

ProStrakan Ltd
Galabank Business Park
Galashiels TD1 1QH
United Kingdom

Sublingual tablet

Sublingual use

Sublingual tablet

Sublingual use

Sublingual tablet

Sublingual use

Sublingual tablet

Sublingual use

Sublingual tablet

Sublingual use

Sublingual tablet

Sublingual use

Rapinyl

Rapinyl (1)

Rapinyl

Rapinyl

Rapinyl

Rapinyl

50 µg
100 µg
200 µg
300 µg
400 µg
600 µg
800 µg

50 µg
100 µg
200 µg
300 µg
400 µg
600 µg
800 µg

50 µg
100 µg
200 µg
300 µg
400 µg
600 µg
800 µg

50 µg
100 µg
200 µg
300 µg
400 µg
600 µg
800 µg

50 µg
100 µg
200 µg
300 µg
400 µg
600 µg
800 µg

50 µg
100 µg
200 µg
300 µg
400 µg
600 µg
800 µg

.

3
1
1
0
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
7
6
/
4
3

Member State

Marketing Authorisation Holder

Applicant

(Invented) Name

Strength

Pharmaceutical Form

Route of administration

Iceland

Ireland

Italy

Latvia

Lithuania

Luxembourg

ProStrakan Ltd
Galabank Business Park
Galashiels TD1 1QH
United Kingdom

ProStrakan Ltd
Galabank Business Park
Galashiels TD1 1QH
United Kingdom

ProStrakan Ltd
Galabank Business Park,
Galashiels TD1 1QH
United Kingdom

ProStrakan Ltd
Galabank Business Park
Galashiels TD1 1QH
United Kingdom

ProStrakan Ltd
Galabank Business Park
Galashiels TD1 1QH
United Kingdom

ProStrakan Ltd
Galabank Business Park
Galashiels TD1 1QH
United Kingdom

Sublingual tablet

Sublingual use

Sublingual tablet

Sublingual use

Sublingual tablet

Sublingual use

Sublingual tablet

Sublingual use

Sublingual tablet

Sublingual use

Sublingual tablet

Sublingual use

Rapinyl

Rapinyl

Rapinyl (1)

Rapinyl

Rapinyl

Rapinyl

50 µg
100 µg
200 µg
300 µg
400 µg
600 µg
800 µg

50 µg
100 µg
200 µg
300 µg
400 µg
600 µg
800 µg

50 µg
100 µg
200 µg
300 µg
400 µg
600 µg
800 µg

50 µg
100 µg
200 µg
300 µg
400 µg
600 µg
800 µg

50 µg
100 µg
200 µg
300 µg
400 µg
600 µg
800 µg

50 µg
100 µg
200 µg
300 µg
400 µg
600 µg
800 µg

C

2
7
6
/
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

.

3
1
1
0
2
0
0
8

.

Member State

Marketing Authorisation Holder

Applicant

(Invented) Name

Strength

Pharmaceutical Form

Route of administration

Norway

Poland

Portugal

Slovak Republic

Slovenia

Spain

ProStrakan Ltd
Galabank Business Park
Galashiels TD1 1QH
United Kingdom

ProStrakan Ltd
Galabank Business Park
Galashiels TD1 1QH
United Kingdom

ProStrakan Ltd
Galabank Business Park
Galashiels TD1 1QH
United Kingdom

ProStrakan Ltd
Galabank Business Park
Galashiels TD1 1QH
United Kingdom

ProStrakan Ltd
Galabank Business Park
Galashiels TD1 1QH
United Kingdom

ProStrakan Ltd
Galabank Business Park
Galashiels TD1 1QH
United Kingdom

Sublingual tablet

Sublingual use

Sublingual tablet

Sublingual use

Sublingual tablet

Sublingual use

Sublingual tablet

Sublingual use

Sublingual tablet

Sublingual use

Sublingual tablet

Sublingual use

Rapinyl

Rapinyl

Rapinyl

Rapinyl

Rapinyl

Rapinyl (1)

50 µg
100 µg
200 µg
300 µg
400 µg
600 µg
800 µg

50 µg
100 µg
200 µg
300 µg
400 µg
600 µg
800 µg

50 µg
100 µg
200 µg
300 µg
400 µg
600 µg
800 µg

50 µg
100 µg
200 µg
300 µg
400 µg
600 µg
800 µg

50 µg
100 µg
200 µg
300 µg
400 µg
600 µg
800 µg

50 µg
100 µg
200 µg
300 µg
400 µg
600 µg
800 µg

.

3
1
1
0
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
7
6
/
4
5

Member State

Marketing Authorisation Holder

Applicant

(Invented) Name

Strength

Pharmaceutical Form

Route of administration

Sweden

ProStrakan Ltd
Galabank Business Park
Galashiels TD1 1QH
United Kingdom

United Kingdom

(1) Name approval pending.

ProStrakan Ltd
Galabank Business Park
Galashiels TD1 1QH
United Kingdom

Abstral

Rapinyl

50 µg
100 µg
200 µg
300 µg
400 µg
600 µg
800 µg

50 µg
100 µg
200 µg
300 µg
400 µg
600 µg
800 µg

Sublingual tablet

Sublingual use

Sublingual tablet

Sublingual use

C

2
7
6
/
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

.

3
1
1
0
2
0
0
8

.

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

ANNEX VII

Member State

Marketing Authorisation Holder

INN

(Invented) Name

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

Austria

Organon GesmbH
Siebenbrunnengasse 21/D/IV
A-1050 Wien

Mirtazapine

Remeron SolTab Schmelz-
tabletten

15 mg

Orodispersible tablets

Oral use

Belgium

Organon Europe B.V.
Kloosterstraat 6
5349AB Oss
Nederland

Delegation of power:
Organon België n.v.
Terhulpsesteenweg, 166
B-1170 Brussels

Mirtazapine

Remeron SolTab Schmelz-
tabletten

30 mg

Orodispersible tablets

Oral use

Mirtazapine

Remeron SolTab Schmelz-
tabletten

45 mg

Orodispersible tablets

Oral use

Mirtazapine

Remergon

15 mg

Film-coated tablets

Oral use

Mirtazapine

Remergon

30 mg

Film-coated tablets

Oral use

Mirtazapine

Remergon

45 mg

Film-coated tablets

Oral use

Mirtazapine

Remergon SolTab

15 mg

Orodispersible tablets

Oral use

Mirtazapine

Remergon SolTab

30 mg

Orodispersible tablets

Oral use

Mirtazapine

Remergon SolTab

45 mg

Orodispersible tablets

Oral use

Mirtazapine

Remergon

15 mg/ml

Oral solution

Oral use

990 mg/66 ml

Cyprus

C.A.Papaellinas & Co Ltd
179 Yiannos Kranidiotis Avenue
2235 Latsia, Nicosia
Cyprus

Mirtazapine

Remeron

30 mg

Film-coated tablets

Oral use

.

3
1
1
0
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
7
6
/
4
7

Member State

Marketing Authorisation Holder

INN

(Invented) Name

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

Czech Republic

N.V. Organon
Kloosterstraat 6
P.O. Box 20
5340 BH Oss
Nederland

Mirtazapine

REMERON 15 MG

15 mg

Film-coated tablets

Mirtazapine

REMERON 30 MG

30 mg

Film-coated tablets

Mirtazapine

REMERON 45 MG

45 mg

Film-coated tablets

Oral use

Oral use

Oral use

Mirtazapine

REMERON SOLTAB 15 MG 15 mg

Orodispersible tablets

Oral use

Mirtazapine

REMERON SOLTAB 30 MG 30 mg

Orodispersible tablets

Oral use

Mirtazapine

REMERON SOLTAB 45 MG 45 mg

Orodispersible tablets

Oral use

Denmark

IMI Pharma A/S
Literbuen 9
DK-2740 Skovlunde

Mirtazapine

Mitazon Smelt

15 mg

Orodispersible tablets

Oral use

Mirtazapine

Mitazon Smelt

30 mg

Orodispersible tablets

Oral use

N.V. Organon
Kloosterstraat 6
P.O. Box 20
5340 BH Oss
Nederland

N.V. Organon
Kloosterstraat 6
P.O. Box 20
5340 BH Oss
Nederland

Estonia

Mirtazapine

Mitazon Smelt

45 mg

Orodispersible tablets

Oral use

Mirtazapine

Mitazon

30 mg

Film-coated tablets

Oral use

Mirtazapine

Remeron Smelt

15 mg

Orodispersible tablets

Oral use

Mirtazapine

Remeron Smelt

30 mg

Orodispersible tablets

Oral use

Mirtazapine

Remeron Smelt

45 mg

Orodispersible tablets

Oral use

Mirtazapine

Remeron Oral, opløsning

15 mg/ml

Oral solution

Oral use

990 mg/66 ml

Mirtazapine

Remeron

15 mg

Film-coated tablets

Mirtazapine

Remeron

30 mg

Film-coated tablets

Mirtazapine

Remeron

45 mg

Film-coated tablets

Oral use

Oral use

Oral use

Mirtazapine

Remeron SolTab

15 mg

Orodispersible tablets

Oral use

Mirtazapine

Remeron SolTab

30 mg

Orodispersible tablets

Oral use

Mirtazapine

Remeron SolTab

45 mg

Orodispersible tablets

Oral use

C

2
7
6
/
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

.

3
1
1
0
2
0
0
8

.

Member State

Marketing Authorisation Holder

INN

(Invented) Name

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

Finland

N.V. Organon
Kloosterstraat 6
P.O. Box 20
5340 BH Oss
Nederland

Mirtazapine

Remeron Soltab

15 mg

Orodispersible tablets

Oral use

Mirtazapine

Remeron Soltab

30 mg

Orodispersible tablets

Oral use

Mirtazapine

Remeron Soltab

45 mg

Orodispersible tablets

Oral use

Mirtazapine

Remeron

15 mg

Film-coated tablets

Oral use

Mirtazapine

Remeron

30 mg

Film-coated tablets

Oral use

Mirtazapine

Remeron

45 mg

Film-coated tablets

Oral use

Mirtazapine

Remeron

15 mg/ml

Oral solution

Oral use

990 mg/66 ml

Oy Organon Ab
Maistraatinportti 2
FI-00240 Helsinki

Mirtazapine

Mirtazon

30 mg

Film-coated tablets

Oral use

Mirtazapine

Mirtazon Smelt

15 mg

Orodispersible tablets

Oral use

Mirtazapine

Mirtazon Smelt

30 mg

Orodispersible tablets

Oral use

Mirtazapine

Mirtazon Smelt

45 mg

Orodispersible tablets

Oral use

France

Organon S.A.
Immeuble Optima
10, rue Godefroy
F-92821 PUTEAUX Cedex

Mirtazapine

Norset

15 mg

Film-coated tablets

Oral use

Mirtazapine

Norset

30 mg

Film-coated tablets

Oral use

Mirtazapine

Norset

15 mg

Orodispersible tablets

Oral use

Mirtazapine

Norset

30 mg

Orodispersible tablets

Oral use

Mirtazapine

Norset

45 mg

Orodispersible tablets

Oral use

Mirtazapine

Norset

15 mg/ml

Oral solution

Oral use

990 mg/66 ml

.

3
1
1
0
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
7
6
/
4
9

Member State

Marketing Authorisation Holder

INN

(Invented) Name

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

Germany

Organon GmbH
Mittenheimer Straße 62
D-85764 Oberschleißheim

Mirtazapine

Remergil

15 mg

Film-coated tablets

Oral use

Mirtazapine

Remergil

30 mg

Film-coated tablets

Oral use

Mirtazapine

Remergil

45 mg

Film-coated tablets

Oral use

Mirtazapine

Remergil SolTab

15 mg

Orodispersible tablets

Oral use

Mirtazapine

Remergil SolTab

30 mg

Orodispersible tablets

Oral use

Mirtazapine

Remergil SolTab

45 mg

Orodispersible tablets

Oral use

Mirtazapine

Remergil

15 mg/ml

Oral solution

Oral use

990 mg/66 ml

STADApharm GmbH
Stadastraße 2-18
D-61118 Bad Vilbel

Mirtazapine

Mirtazapin STADA

15 mg

Orodispersible tablets

Oral use

Mirtazapine

Mirtazapin STADA

30 mg

Orodispersible tablets

Oral use

Mirtazapine

Mirtazapin STADA

45 mg

Orodispersible tablets

Oral use

Greece

Organon Hellas S.A.
122, Vouliagmenis Av. Helliniko
GR-167 77 Athens

Mirtazapine

Remeron

15 mg

Film-coated tablets

Oral use

Mirtazapine

Remeron

30 mg

Film-coated tablets

Oral use

C

2
7
6
/
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

Mirtazapine

Remeron

45 mg

Film-coated tablets

Oral use

Mirtazapine

Remeron SolTab

15 mg

Orodispersible tablets

Oral use

Mirtazapine

Remeron SolTab

30 mg

Orodispersible tablets

Oral use

Mirtazapine

Remeron SolTab

45 mg

Orodispersible tablets

Oral use

Mirtazapine

Remeron

15 mg/ml

Oral solution

Oral use

990 mg/66 ml

.

3
1
1
0
2
0
0
8

.

Member State

Marketing Authorisation Holder

INN

(Invented) Name

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

Hungary

Iceland

N.V. Organon,
Kloosterstraat 6
P.O. Box 20
5340 BH Oss
Nederland

N.V. Organon
Kloosterstraat 6
P.O. Box 20
5340 BH Oss
Nederland

Mirtazapine

Remeron

30 mg

Film-coated tablets

Oral use

Mirtazapine

Remeron

45 mg

Film-coated tablets

Oral use

Mirtazapine

Remeron SolTab

30 mg

Orodispersible tablets

Oral use

Mirtazapine

Remeron SolTab

45 mg

Orodispersible tablets

Oral use

Mirtazapine

Remeron

15 mg

Film-coated tablets

Oral use

Mirtazapine

Remeron

30 mg

Film-coated tablets

Oral use

Mirtazapine

Remeron

45 mg

Film-coated tablets

Oral use

Mirtazapine

Remeron Smelt

15 mg

Orodispersible tablets

Oral use

Mirtazapine

Remeron Smelt

30 mg

Orodispersible tablets

Oral use

Mirtazapine

Remeron Smelt

45 mg

Orodispersible tablets

Oral use

Mirtazapine

Remeron 15 mg/ml

15 mg/ml

Oral solution

Oral use

990 mg/66 ml

Ireland

Organon Laboratories Ltd
Cambridge Science Park
Milton Road CB4 0FL
United Kingdom

Mirtazapine

Zispin® film-coated tablets

15 mg

Film-coated tablets

Oral use

Mirtazapine

Zispin® film-coated tablets

30 mg

Film-coated tablets

Oral use

Organon (Ireland) Limited
PO Box 2857
Drynam Road
Swords, Co. Dublin
Ireland

Mirtazapine

Zispin® film-coated tablets

45 mg

Film-coated tablets

Oral use

Mirtazapine

Zispin® Soltab® orodisper-
sible tablets

15 mg

Orodispersible tablets

Oral use

Mirtazapine

Zispin® Soltab® orodisper-
sible tablets

30 mg

Orodispersible tablets

Oral use

Mirtazapine

Zispin® Soltab® orodisper-
sible tablets

45 mg

Orodispersible tablets

Oral use

Mirtazapine

Zispin® oral solution

15 mg/ml

Oral solution

Oral use

990 mg/66 ml

.

3
1
1
0
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
7
6
/
5
1

Member State

Marketing Authorisation Holder

INN

(Invented) Name

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

Italy

N.V. Organon
Kloosterstraat 6
P.O. Box 20
5340 BH Oss
Nederland

mirtazapine

Remeron

15 mg

Film-coated tablets

Oral use

mirtazapine

Remeron

30 mg

Film-coated tablets

Oral use

Mirtazapine

Remeron

45 mg

Film-coated tablets

Oral use

Mirtazapine

Remeron

15 mg/ml

Oral solution

Oral use

990 mg/66 ml

Mirtazapine

Remeron

15 mg

Orodispersible tablets

Oral use

Mirtazapine

Remeron

30 mg

Orodispersible tablets

Oral use

Mirtazapine

Remeron

45 mg

Orodispersible tablets

Oral use

Mirtazapine

Mirtazapina Organon

15 mg

Orodispersible tablets

Oral use

Mirtazapine

Mirtazapina Organon

30 mg

Orodispersible tablets

Oral use

Mirtazapine

Mirtazapina Organon

45 mg

Orodispersible tablets

Oral use

Mirtazapine

Remeron

30 mg

Film-coated tablets

Oral use

Mirtazapine

Remeron SolTab

15 mg

Orodispersible tablets

Oral use

Mirtazapine

Remeron SolTab

30 mg

Orodispersible tablets

Oral use

Mirtazapine

Remeron SolTab

45 mg

Orodispersible tablets

Oral use

Mirtazapine

Remeron

30 mg

Film-coated tablets

Oral use

Mirtazapine

Remeron Sol Tab

15 mg

Orodispersible tablets

Oral use

Mirtazapine

Remeron Sol Tab

30 mg

Orodispersible tablets

Oral use

Mirtazapine

Remeron Sol Tab

45 mg

Orodispersible tablets

Oral use

Latvia

Lithuania

N.V. Organon
Kloosterstraat 6
P.O. Box 20
5340 BH Oss
Nederland

N.V. Organon
Kloosterstraat 6
P.O. Box 20
5340 BH Oss
Nederland

C

2
7
6
/
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

.

3
1
1
0
2
0
0
8

.

Member State

Marketing Authorisation Holder

INN

(Invented) Name

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

Luxembourg

Organon Europe B.V.
Kloosterstraat 6
5349AB Oss
Nederland

Delegation of power:
Organon België n.v.
Terhulpsesteenweg, 166
B-1170 Brussels

Mirtazapine

Remergon

15 mg

Film-coated tablets

Oral use

Mirtazapine

Remergon

30 mg

Film-coated tablets

Oral use

Mirtazapine

Remergon

45 mg

Film-coated tablets

Oral use

Mirtazapine

Remergon SolTab

15 mg

Orodispersible tablets

Oral use

Mirtazapine

Remergon SolTab

30 mg

Orodispersible tablets

Oral use

Mirtazapine

Remergon SolTab

45 mg

Orodispersible tablets

Oral use

Mirtazapine

Remergon

15 mg/ml

Oral solution

Oral use

990 mg/66 ml

The Netherlands

N.V. Organon
Kloosterstraat 6
Postbus 20
5340 BH Oss
Nederland

Mirtazapine

Remeron

15 mg

Film-coated tablets

Oral use

Mirtazapine

Remeron

30 mg

Film-coated tablets

Oral use

Mirtazapine

Remeron

45 mg

Film-coated tablets

Oral use

Mirtazapine

Remeron drank

15 mg/ml

Oral solution

Oral use

990 mg/66 ml

Mirtazapine

Remeron SolTab

15 mg

Orodispersible tablets

Oral use

Mirtazapine

Remeron SolTab

30 mg

Orodispersible tablets

Oral use

Mirtazapine

Remeron SolTab

45 mg

Orodispersible tablets

Oral use

Mirtazapine

Mirtazapine orodispergeer-
bare tabletten

15 mg

Orodispersible tablets

Oral use

Mirtazapine

Mirtazapine orodispergeer-
bare tabletten

30 mg

Orodispersible tablets

Oral use

Mirtazapine

Mirtazapine orodispergeer-
bare tabletten

45 mg

Orodispersible tablets

Oral use

.

3
1
1
0
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
7
6
/
5
3

Member State

Marketing Authorisation Holder

INN

(Invented) Name

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

Norway

N.V. Organon
Kloosterstraat 6
P.O. Box 20
5340 BH Oss
Nederland

Poland

Portugal

N.V. Organon
Kloosterstraat 6
P.O. Box 20
5340 BH Oss
Nederland

Organon Portuguesa
Produtos Químicos e Farmacêuticos, Lda
Av. José Malhoa, 16-B -2o
P-1070-159 Lisboa

Mirtazapine

Remeron

30 mg

Film-coated tablets

Oral use

Mirtazapine

Remeron

45 mg

Film-coated tablets

Oral use

Mirtazapine

Remeron-S smeltetabletter

15 mg

Orodispersible tablets

Oral use

Mirtazapine

Remeron-S smeltetabletter

30 mg

Orodispersible tablets

Oral use

Mirtazapine

Remeron-S smeltetabletter

45 mg

Orodispersible tablets

Oral use

Mirtazapine

Remeron mikstur,
oppløsning

15 mg/ml

Oral solution

Oral use

990 mg/66 ml

Mirtazapine

Remeron

30 mg

Film-coated tablets

Oral use

Mirtazapine

Mirtazapina Organon

15 mg

Film-coated tablets

Oral use

Mirtazapine

Mirtazapina Organon

30 mg

Film-coated tablets

Oral use

Mirtazapine

Remeron

45 mg

Film-coated tablets

Oral use

Mirtazapine

Remeron SolTab

15 mg

Orodispersible tablets

Oral use

Mirtazapine

Remeron SolTab

30 mg

Orodispersible tablets

Oral use

Mirtazapine

Remeron SolTab

45 mg

Orodispersible tablets

Oral use

C

2
7
6
/
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

Mirtazapine

Remeron

15 mg/ml

Oral solution

Oral use

990 mg/66 ml

Aacifar
Produtos Químicos e Farmacêuticos, Lda
Av. José Malhoa, 16-B -2o
P-1070-159 Lisboa

Mirtazapine

Mirtazon

15 mg

Orodispersible tablets

Oral use

Mirtazapine

Mirtazon

30 mg

Orodispersible tablets

Oral use

Mirtazapine

Mirtazon

45 mg

Orodispersible tablets

Oral use

.

3
1
1
0
2
0
0
8

.

Member State

Marketing Authorisation Holder

INN

(Invented) Name

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

Romania

Slovak Republic

N.V. Organon
Kloosterstraat 6
P.O. Box 20
5340 BH Oss
Nederland

N.V. Organon
Kloosterstraat 6
P.O. Box 20
5340 BH Oss
Nederland

Mirtazapine

Remeron SolTab 15 mg

15 mg

Orodispersible tablets

Oral use

Mirtazapine

Remeron SolTab 30 mg

30 mg

Orodispersible tablets

Oral use

Mirtazapine

Remeron SolTab 45 mg

45 mg

Orodispersible tablets

Oral use

Mirtazapine

REMERON 15 mg

15 mg

Film-coated tablets

Oral use

Mirtazapine

REMERON 30 mg

30 mg

Film-coated tablets

Oral use

Mirtazapine

REMERON 45 mg

45 mg

Film-coated tablets

Oral use

Mirtazapine

REMERON Soltab 15 mg

15 mg

Orodispersible tablets

Oral use

Mirtazapine

REMERON Soltab 30 mg

30 mg

Orodispersible tablets

Oral use

Mirtazapine

REMERON Soltab 45 mg

45 mg

Orodispersible tablets

Oral use

Spain

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

Mirtazapine

Mirtazapine

Rexer

Rexer

15 mg

Film-coated tablets

Oral use

30 mg

Film-coated tablets

Oral use

Mirtazapine

Rexer

45 mg

Film-coated tablets

Oral use

Mirtazapine

Rexer Flas

15 mg

Orodispersible tablets

Oral use

Mirtazapine

Rexer Flas

30 mg

Orodispersible tablets

Oral use

Mirtazapine

Rexer Flas

45 mg

Orodispersible tablets

Oral use

Mirtazapine

Rexer

15 mg/ml

Oral solution

Oral use

990 mg/66 ml

N.V. Organon
Kloosterstraat 6
P.O. Box 20
5340 BH Oss
Nederland

Mirtazapine

Mirtazapina Organon

15 mg

Orodispersible tablets

Oral use

Mirtazapine

Mirtazapina Organon

30 mg

Orodispersible tablets

Oral use

Mirtazapine

Mirtazapina Organon

45 mg

Orodispersible tablets

Oral use

.

3
1
1
0
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
7
6
/
5
5

Member State

Marketing Authorisation Holder

INN

(Invented) Name

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

Sweden

N.V. Organon
Kloosterstraat 6
P.O. Box 20
5340 BH Oss
Nederland

Mirtazapine

Mirtazapine

Mirtazapine

Mirtazapine

Remeron

Remeron

Remeron

Remeron

Mirtazapine

Remeron-S

Mirtazapine

Remeron-S

Mirtazapine

Remeron-S

Mirtazapine

Mirtazapin IP

Mirtazapine

Mirtazapin IP

Mirtazapine

Mirtazapin IP

15 mg

30 mg

45 mg

Film-coated tablets

Film-coated tablets

Film-coated tablets

15 mg/ml

Oral solution

15 mg

30 mg

45 mg

15 mg

30 mg

45 mg

Orodispersible tablets

Orodispersible tablets

Orodispersible tablets

Film-coated tablets

Film-coated tablets

Film-coated tablets

United Kingdom

Organon Laboratories Ltd
Cambridge Science Park
Milton Road
Cambridge CB4 0FL
United Kingdom

Mirtazapine

Mirtazapine 15 mg tablets

15 mg

Film-coated tablets

Mirtazapine

Mirtazapine 30 mg tablets

30 mg

Film-coated tablets

Mirtazapine

Mirtazapine 45 mg tablets

45 mg

Film-coated tablets

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

990 mg/66 ml

990 mg/66 ml

Mirtazapine

Mirtazapine

Mirtazapine

Mirtazapine

Mirtazapine 15 mg/ml oral
solution

15 mg/ml

Oral solution

Zispin SolTab 15 mg
orodispersible tablet

Zispin SolTab 30 mg
orodispersible tablet

Zispin SolTab 45 mg
orodispersible tablet

15 mg

Orodispersible tablets

Oral use

30 mg

Orodispersible tablets

Oral use

45 mg

Orodispersible tablets

Oral use

C

2
7
6
/
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

.

3
1
1
0
2
0
0
8

.

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

ANNEX VIII

Member State

Marketing Authorisation Holder

(Invented) Name

Strength

Pharmaceutical Form

Route of administration

Austria

Austria

Belgium

Belgium

Bulgaria

Bulgaria

Czech Republic

Czech Republic

Eli Lilly Ges.m.b.H
Kölblgasse 8-10
A-1030 Wien

Eli Lilly Ges.m.b.H
Kölblgasse 8-10
A-1030 Wien

Eli Lilly Benelux s.a.
Rue de L'Etuve, 52
B-1000 Brussels

Eli Lilly Benelux s.a.
Rue de L'Etuve, 52
B-1000 Brussels

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

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

Eli Lilly ČR, s. r. o
Pobřežní 1A
CZ-186 00 Praha 8

Eli Lilly ČR, s. r. o
Pobřežní 1A
CZ-186 00 Praha 8

Gemzar 200 mg — Trockensubstanz zur Infu-
sionsbereitung

200 mg

Powder for solution for infusion

Intravenous use

Gemzar 1 g — Trockensubstanz zur Infusions-
bereitung

1 000 mg

Powder for solution for infusion

Intravenous use

Gemzar 1000

1 000 mg

Powder for solution for infusion

Intravenous use

Gemzar 200

200 mg

Powder for solution for infusion

Intravenous use

Gemzar

200 mg

Powder for solution for infusion

Intravenous use

Gemzar

1 g

Powder for solution for infusion

Intravenous use

Gemzar 1 g

1 g

Powder for solution for infusion

Intravenous use

Gemzar 200 mg

200 mg

Powder for solution for infusion

Intravenous use

.

3
1
1
0
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
7
6
/
5
7

Member State

Marketing Authorisation Holder

(Invented) Name

Strength

Pharmaceutical Form

Route of administration

Cyprus

Cyprus

Denmark

Denmark

Estonia

Estonia

Finland

Finland

France

PHADISCO LTD
185 Giannou Kranidioti Avenue
CY-2234 Latsia

PHADISCO LTD
185 Giannou Kranidioti Avenue
CY-2234 Latsia

Eli Lilly Danmark A/S
Nybrovej 110
DK-2800 Kongens Lyngby

Eli Lilly Danmark A/S
Nybrovej 110
DK-2800 Kongens Lyngby

Eli Lilly Holdings Limited,
Kingsclere Road,
Basingstoke,
Hampshire,
RG21 6XA
United Kingdom

Eli Lilly Holdings Limited
Kingsclere Road
Basingstoke
Hampshire RG21 6XA
United Kingdom

Oy Eli Lilly Finland
Ab Rajatorpantie 41 C
PL 16
FI-01641 Vantaa

Oy Eli Lilly Finland
Ab Rajatorpantie 41 C
PL 16
FI-01641 Vantaa

LILLY France S.A.S.
13, rue Pagès
F-92158 Suresnes Cedex

Gemzar

Gemzar

Gemzar

Gemzar

200 mg

Powder for solution for infusion

Intravenous use

1 g

Powder for solution for infusion

Intravenous use

200 mg

Powder for solution for infusion

Intravenous use

1 g

Powder for solution for infusion

Intravenous use

Gemzar 200 mg powder for solution for infu-
sion

200 mg

Powder for solution for infusion

Intravenous use

Gemzar 1 g powder for solution for infusion 1 g

Powder for solution for infusion

Intravenous use

Gemzar 200 mg powder for solution for infu-
sion

200 mg

Powder for solution for infusion

Intravenous use

Gemzar 1 g powder for solution for infusion 1 g

Powder for solution for infusion

Intravenous use

Gemzar 1 000 mg, poudre pour solution pour
perfusion

1 000 mg

Powder for solution for infusion

Intravenous use

C

2
7
6
/
5
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

.

3
1
1
0
2
0
0
8

.

Member State

Marketing Authorisation Holder

(Invented) Name

Strength

Pharmaceutical Form

Route of administration

France

Germany

Germany

Greece

Greece

Hungary

Hungary

Ireland

Ireland

LILLY France S.A.S.
13, rue Pagès
F-92158 Suresnes Cedex

Lilly Deutschland GmbH
Teichweg 3
D-35396 Gießen

Lilly Deutschland GmbH
Teichweg 3
D-35396 Gießen

FARMASERVE LILLY S.A.Cl
15 Km National Road Athens-Lamia
GR-14564 Athens

FARMASERVE LILLY S.A.Cl
15 Km National Road Athens-Lamia
GR-14564 Athens

Eli Lilly Nederland BV
PO Box 379
3990 GD Houten
Nederland

Eli Lilly Nederland BV
PO Box 379
3990 GD Houten
Nederland

Eli Lilly and Company Limited
Lilly House
Priestley Road
Basingstoke
Hampshire RG24 9NL
United Kingdom

Eli Lilly and Company Limited
Lilly House
Priestley Road
Basingstoke
Hampshire RG24 9NL
United Kingdom

Gemzar 200 mg, poudre pour solution pour
perfusion

200 mg

Powder for solution for infusion

Intravenous use

Gemzar 200 mg Pulver zur Herstellung einer
Infusionslösung

200 mg

Powder for solution for infusion

Intravenous use

Gemzar 1 g Pulver zur Herstellung einer
Infusionslösung

1 000 mg

Powder for solution for infusion

Intravenous use

ΓΚΕΜΖΑΡ

200 mg

Powder for solution for infusion

Intravenous use

ΓΚΕΜΖΑΡ

1 000 mg

Powder for solution for infusion

Intravenous use

Gemzar 1 g powder for injection

1 g

Powder for injection

Intravenous use

Gemzar 200 mg powder for injection

200 mg

Powder for injection

Intravenous use

Gemzar 200 mg powder
infusion

for solution for

200 mg

Powder for solution for infusion

Intravenous use

Gemzar 1 g powder for solution for infusion 1 g

Powder for solution for infusion

Intravenous use

.

3
1
1
0
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
7
6
/
5
9

Member State

Marketing Authorisation Holder

(Invented) Name

Strength

Pharmaceutical Form

Route of administration

Iceland

Iceland

Italy

Italy

Latvia

Latvia

Lithuania

Lithuania

Eli Lilly Denmark
Nybrovej 110
DK-2800 Lyngby

Eli Lilly Denmark
Nybrovej 110
DK-2800 Lyngby

Eli Lilly Italia S.P.A.
Via Gramsci 731/733
I-50019 Sesto Fiorentino, Florence

Eli Lilly Italia S.P.A.
Via Gramsci 731/733
I-50019 Sesto Fiorentino, Florence

Eli Lilly Holdings Limited
Kingsclere Road
Basingstoke
Hampshire RG 216XA5
United Kingdom

Eli Lilly Holdings Limited
Kingsclere Road
Basingstoke
Hampshire RG 216XA5
United Kingdom

Eli Lilly Holdings Limited
Kingsclere Road
Basingstoke
Hampshire RG 216XA5
United Kingdom

Eli Lilly Holdings Limited
Kingsclere Road
Basingstoke
Hampshire RG 216XA5
United Kingdom

Gemzar

Gemzar

200 mg

Powder for solution for infusion

Intravenous use

1 g

Powder for solution for infusion

Intravenous use

Gemzar 200 mg powder
infusion and intravesical instillation

for solution for

200 mg

Powder for solution for infusion and intrave-
sical instillation

Intravenous use and intrave-
sical use

Gemzar 1 g powder for solution for infusion
and intravesical instillation

1 g

Powder for solution for infusion and intrave-
sical instillation

Intravenous use and intrave-
sical use

Gemzar

1 g

Powder for solution for infusion

Intravenous use

Gemzar

200 mg

Powder for solution for infusion

Intravenous use

Gemzar

200 mg

Powder for solution for infusion

Intravenous use

Gemzar

1 000 mg

Powder for solution for infusion

Intravenous use

C

2
7
6
/
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

Luxembourg

Eli Lilly Benelux s.a.
Rue de l'Etuve, 52
B-1000 Bruxelles

Gemzar

200 mg

Powder for solution for infusion

Intravenous use

.

3
1
1
0
2
0
0
8

.

Member State

Marketing Authorisation Holder

(Invented) Name

Strength

Pharmaceutical Form

Route of administration

Luxembourg

Eli Lilly Benelux s.a.
Rue de l'Etuve, 52
B-1000 Bruxelles

Malta

Malta

The Netherlands

The Netherlands

Norway

Norway

Poland

Eli Lilly and Company Limited
Lilly House
Priestley Road
Basingstoke
Hampshire RG24 9NL
United Kingdom

Eli Lilly and Company Limited
Lilly House
Priestley Road
Basingstoke
Hampshire RG24 9NL
United Kingdom

Eli Lilly Nederland BV
Grootslag 1-5
3991 RA Houten
Nederland

Eli Lilly Netherlands BV
Grootslag 1-5
3991 RA Houten
Nederland

Eli Lilly Norge AS
Postboks 6090 Etterstad
N-0601 Oslo

Eli Lilly Norge AS
Postboks 6090 Etterstad
N-0601 Oslo

Lilly France S.A.S.
2, rue du Colonel Lilly
F-67642 Fegersheim

Gemzar

Gemzar

1 g

Powder for solution for infusion

Intravenous use

200 mg

Powder for solution for infusion

Intravenous use

Gemzar

1 g

Powder for solution for infusion

Intravenous use

Gemzar

200 mg

Powder for solution for infusion

Intravenous use

Gemzar

1 g

Powder for solution for infusion

Intravenous use

Gemzar

Gemzar

Gemzar

1 g

Powder for solution for infusion

Intravenous use

200 mg

Powder for solution for infusion

Intravenous use

200 mg

Powder for solution for infusion

Intravenous use

.

3
1
1
0
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
7
6
/
6
1

Member State

Marketing Authorisation Holder

(Invented) Name

Strength

Pharmaceutical Form

Route of administration

Poland

Portugal

Portugal

Romania

Romania

Slovakia

Slovakia

Slovenia

Slovenia

Lilly France S.A.S.
2, rue du Colonel Lilly
F-67642 Fegersheim

Lilly Portugal — Produtos
Farmacêuticos, Lda
Rua Dr. António Loureiro Borges, 1
Piso 1
Arquiparque-Miraflores
P-1499-016 Algés

Lilly Portugal — Produtos
Farmacêuticos, Lda
Rua Dr. António Loureiro Borges, 1
Piso 1
Arquiparque-Miraflores
P-1499-016 Algés

Lilly France S.A.S.
2, rue du Colonel Lilly
F-67642 Fegersheim

Lilly France S.A.S.
2, rue du Colonel Lilly
F-67642 Fegersheim

Eli Lilly ČR, s. r. o.
Pobřežní 1A
CZ-186 00 Praha 8

Eli Lilly ČR, s. r. o.
Pobřežní 1A
CZ-186 00 Praha 8

Gemzar

Gemzar

1 g

Powder for solution for infusion

Intravenous use

200 mg

Powder for solution for infusion

Intravenous use

Gemzar

1 000 mg

Powder for solution for infusion

Intravenous use

Gemzar 1 g

1 000 mg

Powder for solution for infusion

Intravenous use

Gemzar 200 mg

200 mg

Powder for solution for infusion

Intravenous use

Gemzar 1 g

1 g

Powder for solution for infusion

Intravenous use

Gemzar 200 mg

200 mg

Powder for solution for infusion

Intravenous use

Eli Lilly farmacevtska družba, d.o.o.
Dunajska cesta 156
SLO-1000 Ljubljana

Gemzar 200 mg prašek za raztopino za
infundiranje

200 mg

Powder for solution for infusion

Intravenous use

Eli Lilly farmacevtska družba, d.o.o.
Dunajska cesta 156
SLO-1000 Ljubljana

Gemzar 1 g prašek za raztopino za
infundiranje

1 g

Powder for solution for infusion

Intravenous use

C

2
7
6
/
6
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

.

3
1
1
0
2
0
0
8

.

Member State

Marketing Authorisation Holder

(Invented) Name

Strength

Pharmaceutical Form

Route of administration

Spain

Spain

Sweden

Sweden

United Kingdom

United Kingdom

Lilly S.A.
Avenida de la Industria, 30
E-28108 Alcobendas, Madrid

Lilly S.A.
Avenida de la Industria, 30
E-28108 Alcobendas, Madrid

Eli Lilly Sweden AB
Box 721
S-169 27 Solna

Eli Lilly Sweden AB
Box 721
S-169 27 Solna

Eli Lilly and Company Limited
Lilly House
Priestley Road
Basingstoke
Hampshire RG24 9NL
United Kingdom

Eli Lilly and Company Limited
Lilly House
Priestley Road
Basingstoke
Hampshire RG24 9NL
United Kingdom

Gemzar 1 g powder for solution for
injection

Gemzar 200 mg powder for solution for
injection

Gemzar

Gemzar

1 g

Powder for solution for injection

Intravenous use

200 mg

Powder for solution for injection

Intravenous use

200 mg

Powder for solution for infusion

Intravenous use

1 g

Powder for solution for infusion

Intravenous use

Gemzar 200 mg powder for solution for
infusion

200 mg

Powder for solution for infusion

Intravenous use

Gemzar 1g powder for solution for infusion

1 g

Powder for solution for infusion

Intravenous use

.

3
1
1
0
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
7
6
/
6
3

NAME, PHARMACEUTICAL FORMS, STRENGTH OF THE MEDICINAL PRODUCT, ANIMAL SPECIES,
ROUTES OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDER/APPLICANT

ANNEX IX

Member State/Marketing Authorisation
Number

Marketing Authorisation Holder

Product invented name

Pharmaceutical Form

Strength/Active substance (INN)

Animal species

Austria
(8-00694)

The Netherlands
(REG NL 8913)

The Netherlands
(REG NL 10411)

Chevita Tierarzneimittel Ges.m.b.H.

Asprimax 850 mg/g

Powder for oral solution

Sodium salicylate

Pigs

Dopharma Research B.V.

NA-SALICYLAAT,
powder
administration

for

100
%,
solution for oral

Powder for oral solution

Sodium salicylate

Calves and pigs

Dopharma Research B.V.

NA-SALICYLAAT, 80 % WSP

Powder for oral solution

Sodium salicylate

Calves and pigs

Decentralised procedure subject
an Article 33 Referral
(CD 17 April 2008)

to

Eurovet Animal Health B.V.

SOLACYL 100 %, powder
oral solution for calves and pigs

for

Powder for oral solution

Calves and pigs

C

2
7
6
/
6
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

.

3
1
1
0
2
0
0
8

.

ANNEX X

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL
PRODUCTS, ANIMAL SPECIES, ROUTE(S) OF ADMINISTRATION, MARKETING AUTHORISATION
HOLDERS IN THE MEMBER STATES

.

3
1
1
0
2
0
0
8

.

Member State

Invented name

Marketing Authorisation Holder
Company Name and Address

Animal species

Pharmaceutical Form

Strength

Indications

Austria

Baycox 25 mg/ml Lösung zum
Eingeben für Hühner
und
Puten

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

Chickens and turkeys

Oral solution

25 mg/ml

Treatment of coccidiosis

Belgium

Baycox 2,5 % orale oplossing

Bayer SA-NV
Health Care
Animal Health
Louizalaan 143, Avenue Louise
B-1050 Brussel

Chickens and turkeys

Oral solution

25 mg/ml

Treatment of coccidiosis

Bulgaria

Baycox 2,5 % solution

Bayer HealthCare AG
D-51368 Leverkusen

Chickens and turkeys

Oral solution

25 mg/ml

Treatment of coccidiosis

Bulgaria

Cevazuril oral solution

Ceva Santé Animale
La Balastrière
F-33501 Libourne Cedex

Broilers, breeders, pullets and
turkeys

Oral solution

25 mg/ml

Prevention and treatment of
coccidiosis

Cyprus

Baycox 2,5 % oral solution

Bayer HealthCare AG
D-51368 Leverkusen

Broilers and turkeys

Oral solution

25 mg/ml

Treatment of coccidiosis

Czech Republic

Baycox 2,5 % sol. ad us. vet.

France

Baycox 2,5 %

France

CEVAZURIL

Bayer s. r. o.
Litvínovská 609/3
CZ-190 21 Praha 9

BAYER SANTE
13, rue Jean Jaurès
F-92807 Puteaux

Ceva Santé Animale
La Balastrière
F-33501 Libourne Cedex

Chickens and turkeys

Oral solution

25 mg/ml

Treatment of coccidiosis

Chickens: broilers, pullets and
breeders

Oral solution

25 mg/ml

Prevention and treatment of
coccidiosis

Chickens: broilers, pullets and
breeders

Oral solution

25 mg/ml

Prevention and treatment of
coccidiosis

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
7
6
/
6
5

Member State

Invented name

Marketing Authorisation Holder
Company Name and Address

Animal species

Pharmaceutical Form

Strength

Indications

Germany

Baycox 2,5 %

Greece

Baycox 2,5 % oral solution

Hungary

Baycox 2,5 % solution A.U.V.

Ireland

Baycox 2,5 % Solution

Italy

Baycox soluzione 2,5 %

Italy

Cevazuril (1)

Bayer Vital GmbH
D-51368 Leverkusen

Bayer HealthCare AG
D-51368 Leverkusen

Bayer Hungaria Kft.Co. Ltd.
Alkotás u. 50
H-1123 Budapest

Bayer Ltd
Animal Health Division
The Atrium
Blackthorn Road
Dublin 18
Ireland

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

CEVA VETEM S.p.A.
Via Colleoni 15
Agrate Brianza
Italia

Chickens and turkeys

Oral solution

25 mg/ml

Treatment of coccidiosis

Broilers and turkeys

Oral solution

25 mg/ml

Treatment of coccidiosis

Chickens and turkeys

Oral solution

25 mg/ml

Treatment of coccidiosis

Chickens

Oral solution

25 mg/ml

Treatment and control of cocci-
diosis

Chickens and turkeys

Oral solution

25 mg/ml

Treatment of coccidiosis

Chickens and turkeys

Oral solution

25 mg/ml

Treatment of coccidiosis

C

2
7
6
/
6
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

Poland

Baycox 2,5 %

Bayer HealthCare AG
D-51368 Leverkusen

Broilers, breeders, turkeys and
pigeons

Oral solution

25 mg/ml

Chickens and turkeys: treatment
of coccidiosis
Pigeons: Treatment and preven-
tion of coccidiosis

Portugal

Baycox 2,5 % oral solution

Romania

Cevazuril

Bayer Portugal S.A
Rua Da Quinta do Pinheiro, No 5
P-2794-003 Carnaxide

Ceva Santé Animale
La Balastrière
F-33501 Libourne Cedex

Chickens and turkeys

Oral solution

25 mg/ml

Treatment of coccidiosis

Broilers, breeders, pullets and
turkeys

Oral solution

25 mg/ml

Treatment of coccidiosis

.

3
1
1
0
2
0
0
8

.

Member State

Invented name

Marketing Authorisation Holder
Company Name and Address

Animal species

Pharmaceutical Form

Strength

Indications

Slovakia

Baycox 2,5 % sol. a.u.v.

Bayer s. r. o.
Litvínovská 609/3
CZ-190 21 Praha 9

Chickens and turkeys

Oral solution

25 mg/ml

Treatment of coccidiosis

Slovenia

Baycox 2,5 % w/v oral solution Bayer d.o.o.

Chickens and turkeys

Oral solution

25 mg/ml

Treatment of coccidiosis

The Netherlands

Baycox 2,5 %

The Netherlands

Baycox oplossing 2,5 %

United Kingdom

Baycox 2,5 % oral solution

(1) The marketing authorisation is suspended on 12 June 2007.

Bravničarjeva ulica 13
SLO-1000 Ljubljana

Bayer BV
HealthCare
Animal Health
Postbus 80
3640 AB Mijdrecht
Energieweg 1
3641 RT Mijdrecht
Nederland

Bayer BV
HealthCare
Animal Health
Postbus 80
3640 AB Mijdrecht
Energieweg 1
3641 RT Mijdrecht
Nederland

Bayer Plc
Animal Health Division
Bayer House
Strawberry Hill
Newbury
Berkshire RG14 1JA
United Kingdom

Chickens and turkeys

Oral solution

25 mg/ml

Treatment of coccidiosis

Chickens and turkeys

Oral solution

25 mg/ml

Treatment of coccidiosis

Broilers and broiler breeders

Oral solution

25 mg/ml

Treatment of coccidiosis

.

3
1
1
0
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
7
6
/
6
7

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

ANNEX XI

Member State

Marketing Authorisation Holder

Applicant

(Invented) Name

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

Austria

Belgium

Cyprus

Czech Republic

IVAX Pharmaceuticals UK Ltd
IVAX Quays
Albert Basin
Royal Docks
London E16 2QJ
United Kingdom

Pulairmax 100 µg/Dosis
Pulver zur Inhalation

Pulairmax 200 µg/Dosis
Pulver zur Inhalation

100 µg

Inhalation powder

Inhalation use

100 micrograms

200 µg

Inhalation powder

Inhalation use

200 micrograms

IVAX Pharmaceuticals UK Ltd
IVAX Quays
Albert Basin
Royal Docks
London E16 2QJ
United Kingdom

IVAX Pharmaceuticals UK Ltd
IVAX Quays
Albert Basin
Royal Docks
London E16 2QJ
United Kingdom

IVAX Pharmaceuticals UK Ltd
IVAX Quays
Albert Basin
Royal Docks
London E16 2QJ
United Kingdom

Pulairmax 400 µg/Dosis
Pulver zur Inhalation

Pulairmax 100 µg inhala-
tiepoeder

Pulairmax 200 µg inhala-
tiepoeder

Pulairmax 400 µg inhala-
tiepoeder

Pulairmax 100 µg Σκόνη
για εισπνοή

Pulairmax 200 µg Σκόνη
για εισπνοή

Pulairmax 400 µg Σκόνη
για εισπνοή

Pulmax 100 μg Prášek k
inhalaci

Pulmax 200 μg Prášek k
inhalaci

Pulmax 400 μg Prášek k
inhalaci

400 µg

Inhalation powder

Inhalation use

400 micrograms

100 µg

Inhalation powder

Inhalation use

100 micrograms

200 µg

Inhalation powder

Inhalation use

200 micrograms

400 µg

Inhalation powder

Inhalation use

400 micrograms

100 µg

Inhalation powder

Inhalation use

100 micrograms

200 µg

Inhalation powder

Inhalation use

200 micrograms

400 µg

Inhalation powder

Inhalation use

400 micrograms

100 µg

Inhalation powder

Inhalation use

100 micrograms

200 µg

Inhalation powder

Inhalation use

200 micrograms

400 µg

Inhalation powder

Inhalation use

400 micrograms

C

2
7
6
/
6
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

.

3
1
1
0
2
0
0
8

.

Member State

Marketing Authorisation Holder

Applicant

(Invented) Name

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

Denmark

Estonia

Finland

Germany

IVAX Pharmaceuticals UK Ltd
IVAX Quays
Albert Basin
Royal Docks
London E16 2QJ
United Kingdom

Pulairmax

100 µg

Inhalation powder

Inhalation use

100 micrograms

Pulairmax

200 µg

Inhalation powder

Inhalation use

200 micrograms

Pulairmax

400 µg

Inhalation powder

Inhalation use

400 micrograms

IVAX Pharmaceuticals UK Ltd
IVAX Quays
Albert Basin
Royal Docks
London E16 2QJ
United Kingdom

Pulairmax

100 µg

Inhalation powder

Inhalation use

100 micrograms

Pulairmax

200 µg

Inhalation powder

Inhalation use

200 micrograms

Pulairmax

400 µg

Inhalation powder

Inhalation use

400 micrograms

IVAX Pharmaceuticals UK Ltd
IVAX Quays
Albert Basin
Royal Docks
London E16 2QJ
United Kingdom

Pulairmax 100 µg inha-
laatiojauhe

Pulairmax 200 µg inha-
laatiojauhe

100 µg

Inhalation powder

Inhalation use

100 micrograms

200 µg

Inhalation powder

Inhalation use

200 micrograms

IVAX Pharmaceuticals UK Ltd
IVAX Quays
Albert Basin
Royal Docks
London E16 2QJ
United Kingdom

Pulairmax 400 µg inha-
laatiojauhe

Pulairmax 100 Mikro-
gramm/Dosis Pulver zur
Inhalation

Pulairmax 200 Mikro-
gramm/Dosis Pulver zur
Inhalation

Pulairmax 400 Mikro-
gramm/Dosis Pulver zur
Inhalation

400 µg

Inhalation powder

Inhalation use

400 micrograms

100 µg

Inhalation powder

Inhalation use

100 micrograms

200 µg

Inhalation powder

Inhalation use

200 micrograms

400 µg

Inhalation powder

Inhalation use

400 micrograms

.

3
1
1
0
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
7
6
/
6
9

Member State

Marketing Authorisation Holder

Applicant

(Invented) Name

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

Greece

Ireland

Italy

Latvia

Lithuania

IVAX Pharmaceuticals UK Ltd
IVAX Quays
Albert Basin
Royal Docks
London E16 2QJ
United Kingdom

Pulairmax 100 µg Κόνις
για εισπνοή

Pulairmax 200 µg Κόνις
για εισπνοή

100 µg

Inhalation powder

Inhalation use

100 micrograms

200 µg

Inhalation powder

Inhalation use

200 micrograms

400 µg

Inhalation powder

Inhalation use

400 micrograms

100 µg

Inhalation powder

Inhalation use

100 micrograms

200 µg

Inhalation powder

Inhalation use

200 micrograms

400 µg

Inhalation powder

Inhalation use

400 micrograms

100 µg

Inhalation powder

Inhalation use

100 micrograms

200 µg

Inhalation powder

Inhalation use

200 micrograms

400 µg

Inhalation powder

Inhalation use

400 micrograms

Pulairmax 400 µg Κόνις
για εισπνοή

Pulairmax 100 µg Inhala-
tion Powder

Pulairmax 200 µg Inhala-
tion Powder

Pulairmax 400 µg Inhala-
tion Powder

Pulairmax 100 polvere
per inalazione

Pulairmax 200 mcg
polvere per inalazione

Pulairmax 400 mcg
polvere per inalazione

Pulairmax

100 µg

Inhalation powder

Inhalation use

100 micrograms

Pulairmax

200 µg

Inhalation powder

Inhalation use

200 micrograms

Pulairmax

400 µg

Inhalation powder

Inhalation use

400 micrograms

Pulairmax

100 µg

Inhalation powder

Inhalation use

100 micrograms

Pulairmax

200 µg

Inhalation powder

Inhalation use

200 micrograms

Pulairmax

400 µg

Inhalation powder

Inhalation use

400 micrograms

IVAX Pharmaceuticals UK Ltd
IVAX Quays
Albert Basin
Royal Docks
London E16 2QJ
United Kingdom

IVAX Pharmaceuticals UK Ltd
IVAX Quays
Albert Basin
Royal Docks
London E16 2QJ
United Kingdom

IVAX Pharmaceuticals UK Ltd
IVAX Quays
Albert Basin
Royal Docks
London E16 2QJ
United Kingdom

IVAX Pharmaceuticals UK Ltd
IVAX Quays
Albert Basin
Royal Docks
London E16 2QJ
United Kingdom

C

2
7
6
/
7
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

.

3
1
1
0
2
0
0
8

.

Member State

Marketing Authorisation Holder

Applicant

(Invented) Name

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

Luxembourg

Malta

The Netherlands

Norway

IVAX Pharmaceuticals UK Ltd
IVAX Quays
Albert Basin
Royal Docks
London E16 2QJ
United Kingdom

IVAX Pharmaceuticals UK Ltd
IVAX Quays
Albert Basin
Royal Docks
London E16 2QJ
United Kingdom

IVAX Pharmaceuticals UK Ltd
IVAX Quays
Albert Basin
Royal Docks
London E16 2QJ
United Kingdom

IVAX Pharmaceuticals UK Ltd
IVAX Quays
Albert Basin
Royal Docks
London E16 2QJ
United Kingdom

Pulairmax 100 µg poudre
pour inhalation

Pulairmax 200 µg poudre
pour inhalation

Pulairmax 400 µg poudre
pour inhalation

Pulairmax 100 µg Trab li
jittiehed bin-nifs

Pulairmax 200 µg Trab li
jittiehed bin-nifs

Pulairmax 400 µg Trab li
jittiehed bin-nifs

Pulmax 100 mg, inhala-
tiepoeder

Pulmax 200 mg, inhala-
tiepoeder

Pulmax 400 mg, inhala-
tiepoeder

Pulairmax 100 µg inha-
lasjonspulver

Pulairmax 200 µg inha-
lasjonspulver

Pulairmax 400 µg inha-
lasjonspulver

100 µg

Inhalation powder

Inhalation use

100 micrograms

200 µg

Inhalation powder

Inhalation use

200 micrograms

400 µg

Inhalation powder

Inhalation use

400 micrograms

100 µg

Inhalation powder

Inhalation use

100 micrograms

200 µg

Inhalation powder

Inhalation use

200 micrograms

400 µg

Inhalation powder

Inhalation use

400 micrograms

100 µg

Inhalation powder

Inhalation use

100 micrograms

200 µg

Inhalation powder

Inhalation use

200 micrograms

400 µg

Inhalation powder

Inhalation use

400 micrograms

100 µg

Inhalation powder

Inhalation use

100 micrograms

200 µg

Inhalation powder

Inhalation use

200 micrograms

400 µg

Inhalation powder

Inhalation use

400 micrograms

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Member State

Marketing Authorisation Holder

Applicant

(Invented) Name

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

Teva Pharma — Produtos
Farmaceuticos, Lda.
Lagoas Park
Edificio 1, Piso 3
P-2740-264 Porto Salvo

Poland

Portugal

Slovak Republic

Spain

Sweden

IVAX Pharmaceuticals UK Ltd
IVAX Quays
Albert Basin
Royal Docks
London E16 2QJ
United Kingdom

IVAX Pharmaceuticals UK Ltd
IVAX Quays
Albert Basin
Royal Docks
London E16 2QJ
United Kingdom

IVAX Pharmaceuticals UK Ltd
IVAX Quays
Albert Basin
Royal Docks
London E16 2QJ
United Kingdom

Pulmax 100 µg proszek
do inhalacji

Pulmax 200 µg proszek
do inhalacji

Pulmax 400 µg proszek
do inhalacji

Pulmax, 100 µg pó para
inalação

Pulmax, 200 µg pó para
inalação

Pulmax, 400 µg pó para
inalação

Pulmax 100 mcg
Inhalačný prášok

Pulmax 200 mcg
Inhalačný prášok

Pulmax 400 mcg
Inhalačný prášok

Budesonida TEVA 100
microgramos polvo para
inhalación EFG

Budesonida TEVA 200
microgramos polvo para
inhalación EFG

Budesonida TEVA 400
microgramos polvo para
inhalación EFG

100 µg

Inhalation powder

Inhalation use

100 micrograms

200 µg

Inhalation powder

Inhalation use

200 micrograms

400 µg

Inhalation powder

Inhalation use

400 micrograms

100 µg

Inhalation powder

Inhalation use

100 micrograms

200 µg

Inhalation powder

Inhalation use

200 micrograms

400 µg

Inhalation powder

Inhalation use

400 micrograms

100 µg

Inhalation powder

Inhalation use

100 micrograms

200 µg

Inhalation powder

Inhalation use

200 micrograms

400 µg

Inhalation powder

Inhalation use

400 micrograms

100 µg

Inhalation powder

Inhalation use

100 micrograms

200 µg

Inhalation powder

Inhalation use

200 micrograms

400 µg

Inhalation powder

Inhalation use

400 micrograms

IVAX Pharmaceuticals UK Ltd
IVAX Quays
Albert Basin
Royal Docks
London E16 2QJ
Royaume-Uni

Pulairmax

Pulairmax

Pulairmax

100 µg

Inhalation powder

Inhalation use

100 micrograms

200 µg

Inhalation powder

Inhalation use

200 micrograms

400 µg

Inhalation powder

Inhalation use

400 micrograms

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ANNEX XII

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS, ANIMAL SPECIES, FREQUENCY AND
ROUTES OF ADMINISTRATION, RECOMMENDED DOSES, WITHDRAWAL PERIODS AND MARKETING
AUTHORISATION HOLDERS IN THE MEMBER STATES CONCERNED BY THE REFERRAL

Member State

Marketing Authorisation
Holder

(Invented) Name

Pharmaceutical Form

Strength

Animal species

Frequency and route of
administration

Recommended dose

Withdrawal period
(meat and milk)

Czech Republic

Spain (1)

Italy

France (2)

Virbac S.A.
1ère Avenue
2056 M Lid
F-06516 Carros Cedex

Virbac S.A.
1ère Avenue
2056 M Lid
F-06516 Carros Cedex

Virbac S.A.
1ère Avenue
2056 M Lid
F-06516 Carros Cedex

Virbac S.A.
1ère Avenue
2056 M Lid
F-06516 Carros Cedex

Suramox 15 % LA

Suspension for injection

150 mg/ml

Cattle, pigs

Two intramuscular injec-
tions at 48 hours interval

15 mg amoxicillin/kg bw
(equivalent to 1 ml/10 kg)

Stabox 15 % LA

Suspension for injection

150 mg/ml

Cattle, pigs

Two intramuscular injec-
tions at 48 hours interval

15 mg amoxicillin/kg bw
(equivalent to 1 ml/10 kg)

Stabox 15 % LA

Suspension for injection

150 mg/ml

Cattle, pigs

Two intramuscular injec-
tions at 48 hours interval

15 mg amoxicillin/kg bw
(equivalent to 1 ml/10 kg)

Suramox 15 % LA

Suspension for injection

150 mg/ml

Cattle, pigs

Two intramuscular injec-
tions at 48 hours interval

15 mg amoxicillin/kg bw
(equivalent to 1 ml/10 kg)

Meat and offal:
Cattle: 58 days
Pigs: 35 days
Milk: 2,5 days

Meat and offal:
Cattle: 58 days
Pigs: 35 days
Milk: 2,5 days

Meat and offal:
Cattle: 58 days
Pigs: 35 days
Milk: 2,5 days

Meat and offal:
Cattle: 58 days
Pigs: 35 days
Milk: 2,5 days

(1) Marketing Authorisation not granted.
(2) Reference Member State for the Mutual recognition Procedure.

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