Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 October 2008 to 31 October 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: 2008-11-28
Institutions: European Commission
Subjects: EU Member State, market approval, marketing standard, medicinal product, pharmaceutical legislation, withdrawal from the market

C 305/10

EN

Official Journal of the European Union

28.11.2008

Summary of Community decisions on marketing authorizations in respect of medicinal products
from 1 October 2008 to 31 October 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 305/05)

— Issuing, maintenance or modification of a national marketing authorization

Date of the
decision

Name(s) of the medicinal
product

Holder(s) of the marketing
authorization

Member State concerned

6.10.2008

Zyrtec

7.10.2008

Risperdal

See Annex I

See Annex II

See Annex I

See Annex II

7.10.2008

Risperdal Consta

See Annex III

See Annex III

7.10.2008

Ciprofloxacin Bayer

See Annex IV

See Annex IV

Date of
notification

7.10.2008

10.10.2008

9.10.2008

9.10.2008

24.10.2008

Moxifloxacin

See Annex V

See Annex V

27.10.2008

— Revocation of a national marketing authorization

Date of the
decision

Name(s) of the medicinal
product

Holder(s) of the marketing
authorization

Member State concerned

Date of
notification

24.10.2008

Ribavirin iQur

See Annex VI

See Annex VI

27.10.2008

(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, ROUTES
OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

ANNEX I

.

2
8
1
1
2
0
0
8

.

Member State

Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

Austria

Austria

Austria

Belgium

Belgium

Belgium

Belgium

Belgium

Belgium

UCB Pharma GmbH (AT)
Jacquingasse 16-18/3.OG
A-1030 Wien

UCB Pharma GmbH (AT)
Jacquingasse 16-18/3.OG
A-1030 Wien

UCB Pharma GmbH (AT)
Jacquingasse 16-18/3.OG
A-1030 Wien

McNeil
Roderveld 1
B-2600 Berchem

UCB Pharma S.A. (Brussels)
Allée de la Recherche, 60/Researchdreef, 60
B-1070 Bruxelles/Brussel

UCB Pharma S.A. (Brussels)
Allée de la Recherche, 60/Researchdreef, 60
B-1070 Bruxelles/Brussel

Zyrtec 10 mg — Filmtabletten

10 mg

Film-coated tablet

Oral use

Zyrtec 10 mg/ml — Tropfen

10 mg/ml

Oral drops, solution

Oral use

10 mg/ml

Zyrtec 1 mg/ml — orale Lösung

1 mg/ml

Oral solution

Oral use

1 mg/ml

Reactine

10 mg

Film-coated tablet

Oral use

Cetirizine-ucb

10 mg

Film-coated tablet

Oral use

Cetirizine-ucb

10 mg/ml

Oral drops, solution

Oral use

10 mg/ml

UCB Pharma S.A. (Brussels)
Allée de la Recherche, 60/Researchdreef, 60
B-1070 Bruxelles/Brussel

UCB Pharma S.A. (Brussels)
Allée de la Recherche, 60/Researchdreef, 60
B-1070 Bruxelles/Brussel

UCB Pharma S.A. (Brussels)
Allée de la Recherche, 60/Researchdreef, 60
B-1070 Bruxelles/Brussel

Virlix

Zyrtec

Zyrtec

10 mg/ml

Oral drops, solution

Oral use

10 mg/ml

10 mg

Film-coated tablet

Oral use

10 mg/ml

Oral drops, solution

Oral use

10 mg/ml

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

3
0
5
/
1
1

Member State

Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

Belgium

Bulgaria

Bulgaria

Cyprus

Cyprus

Czech Republic

Czech Republic

Denmark

Denmark

UCB Pharma S.A. (Brussels)
Allée de la Recherche, 60/Researchdreef, 60
B-1070 Bruxelles/Brussel

UCB Farchim S.A. (AG, Ltd)
Z.I. de Planchy
Ch. de Croix-Blanche 10
CH-1630 Bulle

UCB Farchim S.A. (AG, Ltd)
Z.I. de Planchy
Ch. de Croix-Blanche 10
CH-1630 Bulle

Lifepharma (Z.A.M.) Ltd (CY)
8 Ayiou Nicolaou Street
P.O. Box 22679
CY-1523 Nicosia

Lifepharma (Z.A.M.) Ltd (CY)
8 Ayiou Nicolaou Street
P.O. Box 22679
CY-1523 Nicosia

UCB Pharma S.A. (BRAINE)
Chemin du Foriest
Braine-l'Alleud
B-1420 Belgique

UCB Pharma S.A. (BRAINE)
Chemin du Foriest
Braine-l'Alleud
B-1420 Belgique

McNeil Denmark Aps
Bregnerødvej 133
DK-3460 Birkerød

McNeil Denmark Aps
Bregnerødvej 133
DK-3460 Birkerød

Zyrtec

Zyrtec

1 mg/ml

Oral solution

Oral use

1 mg/ml

10 mg

Film-coated tablet

Oral use

Zyrtec

10 mg/ml

Oral drops, solution

Oral use

10 mg/ml

Zyrtec

10 mg

Film-coated tablet

Oral use

Zyrtec

1 mg/ml

Oral solution

Oral use

1 mg/ml

Zyrtec

10 mg

Film-coated tablet

Oral use

Zyrtec

10 mg/ml

Oral drops, solution

Oral use

10 mg/ml

Benaday

10 mg

Film-coated tablet

Oral use

Benaday

1 mg/ml

Oral solution

Oral use

1 mg/ml

C

3
0
5
/
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

.

2
8
1
1
2
0
0
8

.

Member State

Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

Denmark

Denmark

Denmark

Estonia

Estonia

Estonia

Finland

Finland

Finland

Finland

France

UCB Nordic A/S (DK)
Arne Jacobsens Allé 15
DK-2300 København S

UCB Nordic A/S (DK)
Arne Jacobsens Allé 15
DK-2300 København S

UCB Nordic A/S (DK)
Arne Jacobsens Allé 15
DK-2300 København S

UCB Pharma Oy Finland
Malminkaari 5
FI-00700 Helsinki

UCB Pharma Oy Finland
Malminkaari 5
FI-00700 Helsinki

UCB Pharma Oy Finland
Malminkaari 5
FI-00700 Helsinki

McNeil, a division of Janssen-Cilag Oy
Metsänneidonkuja 8
FI-02130 Espoo

UCB Pharma Oy Finland
Malminkaari 5
FI-00700 Helsinki

UCB Pharma Oy Finland
Malminkaari 5
FI-00700 Helsinki

UCB Pharma Oy Finland
Malminkaari 5
FI-00700 Helsinki

Pfizer Santé Grand Public (FR)
23-25, avenue du docteur Lannelongue
F-75668 Paris Cedex 14

Zyrtec

Zyrtec

Zyrtec

Zyrtec

Zyrtec

Zyrtec

10 mg

Film-coated tablet

Oral use

10 mg/ml

Oral drops, solution

Oral use

10 mg/ml

1 mg/ml

Oral solution

Oral use

1 mg/ml

10 mg

Film-coated tablet

Oral use

10 mg/ml

Oral drops, solution

Oral use

10 mg/ml

1 mg/ml

Oral solution

Oral use

1 mg/ml

Benaday

10 mg

Film-coated tablet

Oral use

Zyrtec

Zyrtec

Zyrtec

10 mg

Film-coated tablet

Oral use

10 mg/ml

Oral drops, solution

Oral use

10 mg/ml

1 mg/ml

Oral solution

Oral use

1 mg/ml

Reactine

10 mg

Film-coated tablet

Oral use

.

2
8
1
1
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

3
0
5
/
1
3

Member State

Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

France

France

France

France

France

France

France

France

France

Germany

Germany

Sanofi Aventis France
9, Boulevard Romain Rolland
F-75159 Paris Cedex 14

Sanofi Aventis France
9, Boulevard Romain Rolland
F-75159 Paris Cedex 14

Sanofi Aventis France
9, Boulevard Romain Rolland
F-75159 Paris Cedex 14

UCB Pharma S.A.
21, Rue de Neuilly
F-92003 Nanterre

UCB Pharma S.A.
21, Rue de Neuilly
F-92003 Nanterre

UCB Pharma S.A.
21, Rue de Neuilly
F-92003 Nanterre

UCB Pharma S.A.
21, Rue de Neuilly
F-92003 Nanterre

Virlix

Virlix

Virlix

10 mg

Film-coated tablet

Oral use

10 mg/ml

Oral drops, solution

Oral use

10 mg/ml

1 mg/ml

Oral solution

Oral use

1 mg/ml

Cetirizine ucb 10 mg

10 mg

Film-coated tablet

Oral use

Zyrtec

Zyrtec

Zyrtec

10 mg

Film-coated tablet

Oral use

10 mg/ml

Oral drops, solution

Oral use

10 mg/ml

1 mg/ml

Oral solution

Oral use

1 mg/ml

Pfizer Santé Grand Public (FR)
23-25, avenue du docteur Lannelongue
F-75668 Paris Cedex 14

Actifed allergie cetirizine 10 mg

10 mg

Film-coated tablet

Oral use

UCB Pharma S.A.
21, Rue de Neuilly
F-92003 Nanterre

UCB GmbH
Alfred-Nobel-Str. 10
D-40789 Monheim

UCB GmbH
Alfred-Nobel-Str. 10
D-40789 Monheim

Zyrtecset

10 mg

Film-coated tablet

Oral use

Zyrtec

10 mg

Film-coated tablet

Oral use

Zyrtec p

10 mg

Film-coated tablet

Oral use

C

3
0
5
/
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

.

2
8
1
1
2
0
0
8

.

Member State

Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

Germany

Germany

Germany

Germany

Greece

Greece

Hungary

Hungary

Hungary

Hungary

UCB GmbH
Alfred-Nobel-Str. 10
D-40789 Monheim

UCB GmbH
Alfred-Nobel-Str. 10
D-40789 Monheim

UCB GmbH
Alfred-Nobel-Str. 10
D-40789 Monheim

Zyrtec p tropfen

10 mg/ml

Oral drops, solution

Oral use

10 mg/ml

Zyrtec saft

1 mg/ml

Oral solution

Oral use

1 mg/ml

Zyrtec tropfen

10 mg/ml

Oral drops, solution

Oral use

10 mg/ml

Pfizer Consumer Healthcare GmbH
Pfizerstr. 1
D-76139 Karlsruhe

Reactine

10 mg

Film-coated tablet

Oral use

UCB A.E.
580 Avenue Vouliagmenis
GR-16452 Argyroupoli

UCB A.E.
580 Avenue Vouliagmenis
GR-16452 Argyroupoli

UCB Magyarország Kft
Árpád fejedelem útja 26-28
H-1023 Budapest

UCB Magyarország Kft
Árpád fejedelem útja 26-28
H-1023 Budapest

UCB Magyarország Kft
Árpád fejedelem útja 26-28
H-1023 Budapest

UCB Magyarország Kft
Árpád fejedelem útja 26-28
H-1023 Budapest

Ziptek

Ziptek

10 mg

Film-coated tablet

Oral use

10 mg/ml

Oral drops, solution

Oral use

10 mg/ml

Zyrtec cseppek

10 mg/ml

Oral drops, solution

Oral use

10 mg/ml

Zyrtec filmtabletta

10 mg

Film-coated tablet

Oral use

Zyrtec oldat

1 mg/ml

Oral solution

Oral use

1 mg/ml

Zyrtec start filmtabletta

10 mg

Film-coated tablet

Oral use

.

2
8
1
1
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

3
0
5
/
1
5

Member State

Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

Ireland

Ireland

Italy

Italy

Italy

Italy

Italy

Italy

Italy

UCB Pharma Ireland Limited
United Drug House
Magna Drive
City West Road
Dublin 24
Ireland

UCB Pharma Ireland Limited
United Drug House
Magna Drive
City West Road
Dublin 24
Ireland

Istituto Lusofarmaco
Via Walter Tobagi 8
I-20068 Peschiera Borromeo (MI)

Istituto Lusofarmaco
Via Walter Tobagi 8
I-20068 Peschiera Borromeo (MI)

Pfizer Consumer Healthcare S.r.l.
SS 156km 50
I-04010 Borgo San Michele (LT)

Pfizer Consumer Healthcare S.r.l.
SS 156km 50
I-04010 Borgo San Michele (LT)

UCB Pharma SpA
Via Praglia, 15
I-10044 Pianezza (Torino)

UCB Pharma SpA
Via Praglia, 15
I-10044 Pianezza (Torino)

UCB Pharma SpA
Via Praglia, 15
I-10044 Pianezza (Torino)

Zirtek oral solution 1 mg/ml

1 mg/ml

Oral solution

Oral use

1 mg/ml

Zirtek tablets

10 mg

Film-coated tablet

Oral use

Formistin

10 mg

Film-coated tablet

Oral use

Formistin

10 mg/ml

Oral drops, solution

Oral use

10 mg/ml

Virlix

Virlix

10 mg

Film-coated tablet

Oral use

10 mg/ml

Oral drops, solution

Oral use

10 mg/ml

Zirtec 1 mg/ml soluzione orale

1 mg/ml

Oral solution

Oral use

1 mg/ml

Zirtec 10 mg compresse rivestite
con film

10 mg

Film-coated tablet

Oral use

Zirtec 10 mg/ml gocce orali solu-
zione

10 mg/ml

Oral drops, solution

Oral use

10 mg/ml

C

3
0
5
/
1
6

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

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

i

.

2
8
1
1
2
0
0
8

.

Member State

Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

Latvia

Latvia

Latvia

Lithuania

Lithuania

Lithuania

Luxembourg

Luxembourg

Luxembourg

Luxembourg

Luxembourg

UCB Pharma Oy Finland
Malminkaari 5
FI-00700 Helsinki

UCB Pharma Oy Finland
Malminkaari 5
FI-00700 Helsinki

UCB Pharma Oy
Finland Malminkaari 5
FI-00700 Helsinki

UCB Pharma Oy Finland
Malminkaari 5
FI-00700 Helsinki

UCB Pharma Oy Finland
Malminkaari 5
FI-00700 Helsinki

UCB Pharma Oy Finland
Malminkaari 5
FI-00700 Helsinki

McNeil
Roderveld 1
B-2600 Berchem

McNeil
Roderveld 1
B-2600 Berchem

Zyrtec

Zyrtec

Zyrtec

Zyrtec

Zyrtec

Zyrtec

10 mg

Film-coated tablet

Oral use

10 mg/ml

Oral drops, solution

Oral use

10 mg/ml

1 mg/ml

Oral solution

Oral use

1 mg/ml

10 mg

Film-coated tablet

Oral use

10 mg/ml

Oral drops, solution

Oral use

10 mg/ml

1 mg/ml

Oral solution

Oral use

1 mg/ml

Reactine

10 mg

Film-coated tablet

Oral use

Sinutab Decongestif & Antihistami-
nicum

5 mg

Film-coated tablet

Oral use

UCB Pharma S.A. (Brussels)
Allée de la Recherche, 60/Researchdreef, 60
B-1070 Bruxelles/Brussel

UCB Pharma S.A. (Brussels)
Allée de la Recherche, 60/Researchdreef, 60
B-1070 Bruxelles/Brussel

UCB Pharma S.A. (Brussels)
Allée de la Recherche, 60/Researchdreef, 60
B-1070 Bruxelles/Brussel

Virlix

Zyrtec

Zyrtec

10 mg/ml

Oral drops, solution

Oral use

10 mg/ml

10 mg

Film-coated tablet

Oral use

10 mg/ml

Oral drops, solution

Oral use

10 mg/ml

.

2
8
1
1
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

3
0
5
/
1
7

Member State

Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

Luxembourg

Luxembourg

Luxembourg

Malta

Malta

Netherlands

Netherlands

Netherlands

Norway

UCB Pharma S.A. (Brussels)
Allée de la Recherche, 60/Researchdreef, 60
B-1070 Bruxelles/Brussel

UCB Pharma S.A. (Brussels)
Allée de la Recherche, 60/Researchdreef, 60
B-1070 Bruxelles/Brussel

UCB Pharma S.A. (Brussels)
Allée de la Recherche, 60/Researchdreef, 60
B-1070 Bruxelles/Brussel

Pharmasud Ltd
38 Triq l-Isturnell
San Gwann SGN02
Malta

Pharmasud Ltd
38 Triq l-Isturnell
San Gwann SGN02
Malta

Pfizer Consumer Healthcare BV
Rivium Westlaan 142
2909 LD Capelle a/d IJsel
Nederland

UCB Pharma B.V.
Lage Mosten 33
4822 NK Breda
Nederland

UCB Pharma B.V.
Lage Mosten 33
4822 NK Breda
Nederland

McNeil Sweden AB
Sollentuna
Sweden

Zyrtec

1 mg/ml

Oral solution

Oral use

1 mg/ml

Cetirizine-ucb

10 mg

Film-coated tablet

Oral use

Cetirizine-ucb

10 mg/ml

Oral drops, solution

Oral use

10 mg/ml

Zyrtec

10 mg

Film-coated tablet

Oral use

Zyrtec

1 mg/ml

Oral solution

Oral use

1 mg/ml

Reactine

10 mg

Film-coated tablet

Oral use

Zyrtec

10 mg

Film-coated tablet

Oral use

Zyrtec

1 mg/ml

Oral solution

Oral use

1 mg/ml

Reactine

10 mg

Film-coated tablet

Oral use

C

3
0
5
/
1
8

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

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

i

.

2
8
1
1
2
0
0
8

.

Member State

Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

Norway

Norway

Norway

Poland

Poland

Poland

Poland

Poland

Poland

Poland

UCB Nordic A/S (DK)
Arne Jacobsens Allé 15
DK-2300 København S

UCB Nordic A/S (DK)
Arne Jacobsens Allé 15
DK-2300 København S

UCB Nordic A/S (DK)
Arne Jacobsens Allé 15
DK-2300 København S

Pfizer Consumer Healthcare
Walton Oaks Dorking Road
Walton on the Hill
Surrey KT 20 7 NS
United Kingdom

PLIVA Kraków Zakłady Farmaceutyczne S.A.
ul. Mogilska 80
PL-31-546 Krakow

PLIVA Kraków Zakłady Farmaceutyczne S.A.
ul. Mogilska 80
PL-31-546 Krakow

Vedim Sp. z.o.o.
ul. Kruczkowskiego 8
PL-00-380 Warszawa

Vedim Sp. z.o.o.
ul. Kruczkowskiego 8
PL-00-380 Warszawa

Vedim Sp. z.o.o.
ul. Kruczkowskiego 8
PL-00-380 Warszawa

Vedim Sp. z.o.o.
ul. Kruczkowskiego 8
PL-00-380 Warszawa

Zyrtec

Zyrtec

Zyrtec

10 mg

Film-coated tablet

Oral use

10 mg/ml

Oral drops, solution

Oral use

10 mg/ml

1 mg/ml

Oral solution

Oral use

1 mg/ml

Reactine

10 mg

Film-coated tablet

Oral use

Virlix

Virlix

Zyrtec

Zyrtec

Zyrtec

10 mg

Film-coated tablet

Oral use

1 mg/ml

Oral solution

Oral use

1 mg/ml

10 mg

Film-coated tablet

Oral use

10 mg/ml

Oral drops, solution

Oral use

10 mg/ml

1 mg/ml

Oral solution

Oral use

1 mg/ml

Zyrtec ucb

10 mg

Film-coated tablet

Oral use

.

2
8
1
1
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

3
0
5
/
1
9

Member State

Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

Portugal

Portugal

Portugal

Portugal

Portugal

Romania

Romania

Slovakia

UCB Pharma
Ed. Maria I
Q 60, piso 1 A
Quinta da Fonte
P-2770-229 Paço de Arcos

UCB Pharma
Ed. Maria I
Q 60, piso 1 A
Quinta da Fonte
P-2770-229 Paço de Arcos

UCB Pharma
Ed. Maria I
Q 60, piso 1 A
Quinta da Fonte
P-2770-229 Paço de Arcos

Vedim Pharma Lda
Ed. D. Maria I
Piso 1 A
Quinta da Fonte
P-2770-229 Paço de Arcos

Vedim Pharma Lda
Ed. D. Maria I
Piso 1 A
Quinta da Fonte
P-2770-229 Paço de Arcos

UCB GmbH
Huttenstraße 205
D-50170 Kerpen

UCB GmbH
Huttenstraße 205
D-50170 Kerpen

UCB S.A. Pharma Secteur
Chemin du Foriest
B-1420 Braine l'Alleud

Zyrtec

10 mg

Film-coated tablet

Oral use

Zyrtec

10 mg/ml

Oral drops, solution

Oral use

10 mg/ml

Zyrtec

1 mg/ml

Oral solution

Oral use

1 mg/ml

Virlix

10 mg

Film-coated tablet

Oral use

Virlix

1 mg/ml

Oral solution

Oral use

1 mg/ml

Zyrtec

Zyrtec

10 mg

Film-coated tablet

Oral use

10 mg/ml

Oral drops, solution

Oral use

10 mg/ml

Zyrtec gtt por 10 mg/ml

10 mg/ml

Oral drops, solution

Oral use

10 mg/ml

C

3
0
5
/
2
0

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

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

i

.

2
8
1
1
2
0
0
8

.

Member State

Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

Slovakia

Slovenia

Slovenia

Slovenia

Spain

Spain

Spain

Spain

Spain

Spain

UCB S.A. Pharma Secteur
Chemin du Foriest
B-1420 Braine l'Alleud

Medis – Podjetje za proizvodnjo in trženje
d.o.o. (Slovenia)
Brnčičeva 1
SLO-1001 Ljubljana

Medis – Podjetje za proizvodnjo in trženje
d.o.o. (Slovenia)
Brnčičeva 1
SLO-1001 Ljubljana

Medis – Podjetje za proizvodnjo in trženje
d.o.o. (Slovenia)
Brnčičeva 1
SLO-1001 Ljubljana

Laboratorios Menarini S.A.
Alfonso XII, 587
E-08918 Badalona (Barcelona)

Laboratorios Menarini S.A.
Alfonso XII, 587
E-08918 Badalona (Barcelona)

Laboratorios Menarini S.A.
Alfonso XII, 587
E-08918 Badalona (Barcelona)

Lacer SA
Sardenya 346-350
E-08025 Barcelona

Lacer SA
Sardenya 346-350
E-08025 Barcelona

Lacer SA
Sardenya 346-350
E-08025 Barcelona

Zyrtec tbl flm 10 mg

10 mg

Film-coated tablet

Oral use

Zyrtec 1 mg/ml peroralna razto-
pina

1 mg/ml

Oral solution

Oral use

1 mg/ml

Zyrtec 10 mg filmsko obložene
tablete

10 mg

Film-coated tablet

Oral use

Zyrtec 10 mg/ml peroralne
kapljice, raztopina

10 mg/ml

Oral drops, solution

Oral use

10 mg/ml

Alerlisin

10 mg

Film-coated tablet

Oral use

Alerlisin

10 mg/ml

Oral drops, solution

Oral use

10 mg/ml

Alerlisin

1 mg/ml

Oral solution

Oral use

1 mg/ml

Virdos

10 mg/ml

Oral drops, solution

Oral use

10 mg/ml

Virlix

Virlix

10 mg

Film-coated tablet

Oral use

1 mg/ml

Oral solution

Oral use

1 mg/ml

.

2
8
1
1
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

3
0
5
/
2
1

Member State

Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

Spain

Spain

Spain

Spain

Spain

Spain

Sweden

Sweden

Sweden

Sweden

United Kingdom

Pfizer Consumer Healthcare
Plaza Xavier Cugat, 2. Edificio D.
E-08174 Sant Cugat del Vallés

Pfizer Consumer Healthcare
Plaza Xavier Cugat, 2. Edificio D.
E-08174 Sant Cugat del Vallés

UCB Pharma S.A.
Avenida de Barcelona 239
E-08750 Molins de Rei

UCB Pharma S.A.
Avenida de Barcelona 239
E-08750 Molins de Rei

UCB Pharma S.A.
Avenida de Barcelona 239
E-08750 Molins de Rei

Vedim Pharma S.A.
Avenida de Barcelona, 239
E-08750 Molins de Rei (Barcelona)

UCB Nordic A/S
Arne Jacobsens Allé 15
DK-2300 København S

UCB Nordic A/S
Arne Jacobsens Allé 15
DK-2300 København S

UCB Nordic A/S
Arne Jacobsens Allé 15
DK-2300 København S

UCB Nordic A/S
Arne Jacobsens Allé 15
DK-2300 København S

McNeil Products Limited
Foundation Park
Roxborough Way
Maidenhead
Berkshire SL6 3UG
United Kingdom

Reactine

10 mg

Film-coated tablet

Oral use

Reactine 5 mg/5 ml solución oral

1 mg/ml

Oral solution

Oral use

1 mg/ml

Zyrtec comprimidos recubiertos
con pelicula

10 mg

Film-coated tablet

Oral use

Zyrtec gotas orales en solución

10 mg/ml

Oral drops, solution

Oral use

10 mg/ml

Zyrtec solución oral

1 mg/ml

Oral solution

Oral use

1 mg/ml

Alerrid 10 mg comprimidos recu-
bierto con pelicula

10 mg

Film-coated tablet

Oral use

Alerid

Zyrlex

Zyrlex

Zyrlex

10 mg

Film-coated tablet

Oral use

10 mg

Film-coated tablet

Oral use

10 mg/ml

Oral drops, solution

Oral use

10 mg/ml

1 mg/ml

Oral solution

Oral use

1 mg/ml

Benadryl allergy oral syrup

1 mg/ml

Oral solution

Oral use

1 mg/ml

C

3
0
5
/
2
2

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

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

i

.

2
8
1
1
2
0
0
8

.

Member State

Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

United Kingdom

United Kingdom

United Kingdom

United Kingdom

United Kingdom

United Kingdom

United Kingdom

United Kingdom

McNeil Products Limited
Foundation Park
Roxborough Way
Maidenhead
Berkshire SL6 3UG
United Kingdom

McNeil Products Limited
Walton Oaks
Dorking Road
Walton on the Hill
Surrey KT20 7NS
United Kingdom

McNeil Products Limited
Foundation Park
Roxborough way
Maidenhead
Berkshire SL6 3UG
United Kingdom

UCB Pharma Limited
208 Bath Road
Slough
Berkshire SL1 3WE
United Kingdom

UCB Pharma Limited
208 Bath Road
Slough
Berkshire SL1 3WE
United Kingdom

UCB Pharma Limited
208 Bath Road
Slough
Berkshire SL1 3WE
United Kingdom

UCB Pharma Limited
208 Bath Road
Slough
Berkshire SL1 3WE
United Kingdom

UCB Pharma Limited
208 Bath Road
Slough
Berkshire SL1 3WE
United Kingdom

Benadryl for children allergy
solution

1 mg/ml

Oral solution

Oral use

1 mg/ml

Benadryl one a day

10 mg

Film-coated tablet

Oral use

Benadryl one a day

10 mg

Film-coated tablet

Oral use

Zirtek allergy relief for children

1 mg/ml

Oral solution

Oral use

1 mg/ml

Zirtek allergy relief tablets

10 mg

Film-coated tablet

Oral use

Zirtek allergy solution

1 mg/ml

Oral solution

Oral use

1 mg/ml

Benadryl allergy solution

1 mg/ml

Oral solution

Oral use

1 mg/ml

Benadryl allergy oral solution

1 mg/ml

Oral solution

Oral use

1 mg/ml

.

2
8
1
1
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

3
0
5
/
2
3

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

ANNEX II

Member State

Marketing Authorisation Holder

INN

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

Austria

Austria

Austria

Austria

Austria

Austria

Austria

Austria

Austria

Janssen-Cilag Pharma GmbH
Pfarrgasse 75
A-1232 Wien

Janssen-Cilag Pharma GmbH
Pfarrgasse 75
A-1232 Wien

Janssen-Cilag Pharma GmbH
Pfarrgasse 75
A-1232 Wien

Janssen-Cilag Pharma GmbH
Pfarrgasse 75
A-1232 Wien

Janssen-Cilag Pharma GmbH
Pfarrgasse 75
A-1232 Wien

Janssen-Cilag Pharma GmbH
Pfarrgasse 75
A-1232 Wien

Janssen-Cilag Pharma GmbH
Pfarrgasse 75
A-1232 Wien

Janssen-Cilag Pharma GmbH
Pfarrgasse 75
A-1232 Wien

Janssen-Cilag Pharma GmbH
Pfarrgasse 75
A-1232 Wien

Risperidone

Risperdal Quicklet 0,5 mg —
Tabletten

0,5 mg

Orodispersible tablet

Oral use

Risperidone

Risperdal Quicklet 1 mg —
Tabletten

1 mg

Orodispersible tablet

Oral use

Risperidone

Risperdal Quicklet 2 mg —
Tabletten

2 mg

Orodispersible tablet

Oral use

Risperidone

Risperdal Quicklet 3 mg —
Tabletten

3 mg

Orodispersible tablet

Oral use

Risperidone

Risperdal Quicklet 4 mg —
Tabletten

4 mg

Orodispersible tablet

Oral use

Risperidone

Risperdal 0,5 mg — Film-
tabletten

0,5 mg

Film-coated tablet

Oral use

Risperidone

Risperdal 1 mg — Film-
tabletten

1 mg

Film-coated tablet

Oral use

Risperidone

Risperdal 2 mg — Film-
tabletten

2 mg

Film-coated tablet

Oral use

Risperidone

Risperdal 3 mg — Film-
tabletten

3 mg

Film-coated tablet

Oral use

C

3
0
5
/
2
4

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

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

i

.

2
8
1
1
2
0
0
8

.

Member State

Marketing Authorisation Holder

INN

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

Austria

Austria

Austria

Austria

Austria

Austria

Austria

Austria

Austria

Austria

Austria

Janssen-Cilag Pharma GmbH
Pfarrgasse 75
A-1232 Wien

Janssen-Cilag Pharma GmbH
Pfarrgasse 75
A-1232 Wien

Janssen-Cilag Pharma GmbH
Pfarrgasse 75
A-1232 Wien

Janssen-Cilag Pharma GmbH
Pfarrgasse 75
A-1232 Wien

Janssen-Cilag Pharma GmbH
Pfarrgasse 75
A-1232 Wien

Janssen-Cilag Pharma GmbH
Pfarrgasse 75
A-1232 Wien

Janssen-Cilag Pharma GmbH
Pfarrgasse 75
A-1232 Wien

Janssen-Cilag Pharma GmbH
Pfarrgasse 75
A-1232 Wien

Janssen-Cilag Pharma GmbH
Pfarrgasse 75
A-1232 Wien

Janssen-Cilag Pharma GmbH
Pfarrgasse 75
A-1232 Wien

Janssen-Cilag Pharma GmbH
Pfarrgasse 75
A-1232 Wien

Risperidone

Risperdal 4 mg — Film-
tabletten

4 mg

Film-coated tablet

Oral use

Risperidone

Risperdal 6 mg — Film-
tabletten

6 mg

Film-coated tablet

Oral use

Risperidone

Risperdal 1 mg/ml — orale
Lösung

1 mg

Oral solution

Oral use

1 mg/ml

Risperidone

Rispolin Quicklet 0,5 mg —
Tabletten

0,5 mg

Orodispersible tablet

Oral use

Risperidone

Rispolin Quicklet 1 mg —
Tabletten

1 mg

Orodispersible tablet

Oral use

Risperidone

Rispolin Quicklet 2 mg —
Tabletten

2 mg

Orodispersible tablet

Oral use

Risperidone

Rispolin Quicklet 3 mg —
Tabletten

3 mg

Orodispersible tablet

Oral use

Risperidone

Rispolin Quicklet 4 mg —
Tabletten

4 mg

Orodispersible tablet

Oral use

Risperidone

Rispolin 0,5 mg — Filmtable-
tten

0,5 mg

Film-coated tablet

Oral use

Risperidone

Rispolin 1 mg — Filmtabletten

1 mg

Film-coated tablet

Oral use

Risperidone

Rispolin 2 mg — Filmtabletten

2 mg

Film-coated tablet

Oral use

.

2
8
1
1
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

3
0
5
/
2
5

Member State

Marketing Authorisation Holder

INN

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

Austria

Austria

Austria

Austria

Belgium

Belgium

Belgium

Belgium

Belgium

Belgium

Belgium

Janssen-Cilag Pharma GmbH
Pfarrgasse 75
A-1232 Wien

Janssen-Cilag Pharma GmbH
Pfarrgasse 75
A-1232 Wien

Janssen-Cilag Pharma GmbH
Pfarrgasse 75
A-1232 Wien

Janssen-Cilag Pharma GmbH
Pfarrgasse 75
A-1232 Wien

Janssen Cilag N.V.
Roderveldlaan 1
B-2600 Berchem

Janssen Cilag N.V.
Roderveldlaan 1
B-2600 Berchem

Janssen Cilag N.V.
Roderveldlaan 1
B-2600 Berchem

Janssen Cilag N.V.
Roderveldlaan 1
B-2600 Berchem

Janssen Cilag N.V.
Roderveldlaan 1
B-2600 Berchem

Janssen Cilag N.V.
Roderveldlaan 1
B-2600 Berchem

Janssen Cilag N.V.
Roderveldlaan 1
B-2600 Berchem

Risperidone

Rispolin 3 mg — Filmtabletten

3 mg

Film-coated tablet

Oral use

Risperidone

Rispolin 4 mg — Filmtabletten

4 mg

Film-coated tablet

Oral use

Risperidone

Rispolin 6 mg — Filmtabletten

6 mg

Film-coated tablet

Oral use

Risperidone

Rispolin 1 mg/ml — orale
Lösung

1 mg

Oral solution

Oral use

1 mg/ml

Risperidone

Risperidone J-C Instasolv

0,5 mg

Orodispersible tablet

Oral use

Risperidone

Risperdal

1 mg

Oral solution

Oral use

1 mg/ml

Risperidone

Risperdal

0,5 mg

Film-coated tablet

Oral use

Risperidone

Risperdal

1 mg

Film-coated tablet

Oral use

Risperidone

Risperdal

2 mg

Film-coated tablet

Oral use

Risperidone

Risperdal

3 mg

Film-coated tablet

Oral use

Risperidone

Risperdal

4 mg

Film-coated tablet

Oral use

C

3
0
5
/
2
6

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

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

i

.

2
8
1
1
2
0
0
8

.

Member State

Marketing Authorisation Holder

INN

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

Belgium

Belgium

Belgium

Belgium

Belgium

Belgium

Belgium

Belgium

Belgium

Belgium

Belgium

Janssen Cilag N.V.
Roderveldlaan 1
B-2600 Berchem

Janssen Cilag N.V.
Roderveldlaan 1
B-2600 Berchem

Janssen Cilag N.V.
Roderveldlaan 1
B-2600 Berchem

Janssen Cilag N.V.
Roderveldlaan 1
B-2600 Berchem

Janssen Cilag N.V.
Roderveldlaan 1
B-2600 Berchem

Janssen Cilag N.V.
Roderveldlaan 1
B-2600 Berchem

Janssen Cilag N.V.
Roderveldlaan 1
B-2600 Berchem

Janssen Cilag N.V.
Roderveldlaan 1
B-2600 Berchem

Janssen Cilag N.V.
Roderveldlaan 1
B-2600 Berchem

Janssen Cilag N.V.
Roderveldlaan 1
B-2600 Berchem

Janssen Cilag N.V.
Roderveldlaan 1
B-2600 Berchem

Risperidone

Risperdal

6 mg

Film-coated tablet

Oral use

Risperidone

Risperdal Instasolv

0,5 mg

Orodispersible tablet

Oral use

Risperidone

Risperdal Instasolv

1 mg

Orodispersible tablet

Oral use

Risperidone

Risperdal Instasolv

2 mg

Orodispersible tablet

Oral use

Risperidone

Risperidone J-C

0,5 mg

Film-coated tablet

Oral use

Risperidone

Risperidone J-C

1 mg

Film-coated tablet

Oral use

Risperidone

Risperidone J-C

1 mg

Oral solution

Oral use

1 mg/ml

Risperidone

Risperidone J-C

2 mg

Film-coated tablet

Oral use

Risperidone

Risperidone J-C

3 mg

Film-coated tablet

Oral use

Risperidone

Risperidone J-C

4 mg

Film-coated tablet

Oral use

Risperidone

Risperidone J-C

6 mg

Film-coated tablet

Oral use

.

2
8
1
1
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

3
0
5
/
2
7

Member State

Marketing Authorisation Holder

INN

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

Belgium

Belgium

Bulgaria

Bulgaria

Bulgaria

Bulgaria

Bulgaria

Cyprus

Cyprus

Cyprus

Cyprus

Janssen Cilag N.V.
Roderveldlaan 1
B-2600 Berchem

Janssen Cilag N.V.
Roderveldlaan 1
B-2600 Berchem

Johnson & Johnson d.o.o.
Šmartinska cesta 53
SLO-1000 Ljubljana

Johnson & Johnson d.o.o.
Šmartinska cesta 53
SLO-1000 Ljubljana

Johnson & Johnson d.o.o.
Šmartinska cesta 53
SLO-1000 Ljubljana

Johnson & Johnson d.o.o.
Šmartinska cesta 53
SLO-1000 Ljubljana

Johnson & Johnson d.o.o.
Šmartinska cesta 53
SLO-1000 Ljubljana

Janssen-Cilag International N.V.
Turnhoutseweg 30
B-2340 Beerse

Janssen-Cilag International N.V.
Turnhoutseweg 30
B-2340 Beerse

Janssen-Cilag International N.V.
Turnhoutseweg 30
B-2340 Beerse

Janssen-Cilag International N.V.
Turnhoutseweg 30
B-2340 Beerse

Risperidone

Risperidone J-C Instasolv

1 mg

Orodispersible tablet

Oral use

Risperidone

Risperidone J-C Instasolv

2 mg

Orodispersible tablet

Oral use

Risperidone

Rispolept

1 mg

Oral solution

Oral use

1 mg/ml

Risperidone

Rispolept

1 mg

Film-coated tablet

Oral use

Risperidone

Rispolept

2 mg

Film-coated tablet

Oral use

Risperidone

Rispolept

3 mg

Film-coated tablet

Oral use

Risperidone

Rispolept

4 mg

Film-coated tablet

Oral use

Risperidone

Risperdal

1 mg

Film-coated tablet

Oral use

Risperidone

Risperdal

2 mg

Film-coated tablet

Oral use

Risperidone

Risperdal

3 mg

Film-coated tablet

Oral use

Risperidone

Risperdal

4 mg

Film-coated tablet

Oral use

C

3
0
5
/
2
8

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

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

i

.

2
8
1
1
2
0
0
8

.

Cyprus

Czech Republic

Czech Republic

Czech Republic

Czech Republic

Czech Republic

Czech Republic

Czech Republic

Czech Republic

Denmark

Denmark

Member State

Marketing Authorisation Holder

INN

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

Janssen-Cilag International N.V.
Turnhoutseweg 30
B-2340 Beerse

Risperidone

Risperdal

1 mg/ml

Oral solution

Oral use

1 mg/ 1 ml

.

2
8
1
1
2
0
0
8

.

Janssen-Cilag s. r. o.
Karla Engliše 3201/6
CZ-150 00 Praha 5

Janssen-Cilag s. r. o.
Karla Engliše 3201/6
CZ-150 00 Praha 5

Janssen-Cilag s. r. o.
Karla Engliše 3201/6
CZ-150 00 Praha 5

Janssen-Cilag s. r. o.
Karla Engliše 3201/6
CZ-150 00 Praha 5

Janssen-Cilag s. r. o.
Karla Engliše 3201/6
CZ-150 00 Praha 5

Janssen-Cilag s. r. o.
Karla Engliše 3201/6
CZ-150 00 Praha 5

Janssen-Cilag s. r. o.
Karla Engliše 3201/6
CZ-150 00 Praha 5

Janssen-Cilag s. r. o.
Karla Engliše 3201/6
CZ-150 00 Praha 5

Janssen-Cilag A/S
Postboks 149
Hammerbakken 19
DK-3460 Birkerød

Janssen-Cilag A/S
Postboks 149
Hammerbakken 19
DK-3460 Birkerød

Risperidone

Risperdal 1 mg

1 mg

Film-coated tablet

Oral use

Risperidone

Risperdal 2 mg

2 mg

Film-coated tablet

Oral use

Risperidone

Risperdal 3 mg

3 mg

Film-coated tablet

Oral use

Risperidone

Risperdal 4 mg

4 mg

Film-coated tablet

Oral use

Risperidone

Risperdal

1 mg

Oral solution

Oral use

1 mg/ 1 ml

Risperidone

Risperdal Quicklet

2 mg

Orodispersible tablet

Oral use

Risperidone

3 mg

Orodispersible tablet

Oral use

Risperidone

Risperdal Quicklet

4 mg

Orodispersible tablet

Oral use

Risperidone

Belivon

1 mg

Oral solution

Oral use

1 mg/ 1 ml

Risperidone

Belivon

1 mg

Film-coated tablet

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

3
0
5
/
2
9

Member State

Marketing Authorisation Holder

INN

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

Denmark

Denmark

Denmark

Denmark

Denmark

Denmark

Denmark

Denmark

Denmark

Janssen-Cilag A/S
Postboks 149
Hammerbakken 19
DK-3460 Birkerød

Janssen-Cilag A/S
Postboks 149
Hammerbakken 19
DK-3460 Birkerød

Janssen-Cilag A/S
Postboks 149
Hammerbakken 19
DK-3460 Birkerød

Janssen-Cilag A/S
Postboks 149
Hammerbakken 19
DK-3460 Birkerød

Janssen-Cilag A/S
Postboks 149
Hammerbakken 19
DK-3460 Birkerød

Janssen-Cilag A/S
Postboks 149
Hammerbakken 19
DK-3460 Birkerød

Janssen-Cilag A/S
Postboks 149
Hammerbakken 19
DK-3460 Birkerød

Janssen-Cilag A/S
Postboks 149
Hammerbakken 19
DK-3460 Birkerød

Janssen-Cilag A/S
Postboks 149
Hammerbakken 19
DK-3460 Birkerød

Risperidone

Belivon

2 mg

Film-coated tablet

Oral use

Risperidone

Belivon

3 mg

Film-coated tablet

Oral use

Risperidone

Belivon

4 mg

Film-coated tablet

Oral use

Risperidone

Risperdal

0,5 mg

Film-coated tablet

Oral use

Risperidone

Risperdal

1 mg

Film-coated tablet

Oral use

Risperidone

Risperdal

2 mg

Film-coated tablet

Oral use

Risperidone

Risperdal

3 mg

Film-coated tablet

Oral use

Risperidone

Risperdal

4 mg

Film-coated tablet

Oral use

Risperidone

Risperdal

1 mg

Oral solution

Oral use

1 mg/ 1 ml

C

3
0
5
/
3
0

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

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

i

.

2
8
1
1
2
0
0
8

.

Member State

Marketing Authorisation Holder

INN

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

Denmark

Denmark

Denmark

Estonia

Estonia

Estonia

Estonia

Estonia

Estonia

Estonia

Janssen-Cilag A/S
Postboks 149
Hammerbakken 19
DK-3460 Birkerød

Janssen-Cilag A/S
Postboks 149
Hammerbakken 19
DK-3460 Birkerød

Janssen-Cilag A/S
Postboks 149
Hammerbakken 19
DK-3460 Birkerød

Johnson & Johnson UAB
Šeimyniškių g. 1A
LT-09312 Vilnius

Johnson & Johnson UAB
Šeimyniškių g. 1A
LT-09312 Vilnius

Johnson & Johnson UAB
Šeimyniškių g. 1A
LT-09312 Vilnius

Johnson & Johnson UAB
Šeimyniškių g. 1A
LT-09312 Vilnius

Johnson & Johnson UAB
Šeimyniškių g. 1A
LT-09312 Vilnius

Johnson & Johnson UAB
Šeimyniškių g. 1A
LT-09312 Vilnius

Johnson & Johnson UAB
Šeimyniškių g. 1A
LT-09312 Vilnius

Risperidone

Risperdal

0,5 mg

Oral lyophilisate

Oral use

Risperidone

Risperdal

1 mg

Oral lyophilisate

Oral use

Risperidone

Risperdal

2 mg

Oral lyophilisate

Oral use

Risperidone

Rispolept

1 mg

Film-coated tablet

Oral use

Risperidone

Rispolept

2 mg

Film-coated tablet

Oral use

Risperidone

Rispolept

3 mg

Film-coated tablet

Oral use

Risperidone

Rispolept

4 mg

Film-coated tablet

Oral use

Risperidone

Rispolept

1 mg/ml

Oral solution

Oral use

1 mg/ml

Risperidone

Rispolept Quicklet

1 mg

Orodispersible tablet

Oral use

Risperidone

Rispolept Quicklet

2 mg

Orodispersible tablet

Oral use

.

2
8
1
1
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

3
0
5
/
3
1

Member State

Marketing Authorisation Holder

INN

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

Finland

Finland

Finland

Finland

Finland

Finland

Finland

Finland

Finland

Finland

Finland

Jansen-Cilag Oy
Metsänneidonkuja 8
FI-02130 Espoo

Jansen-Cilag Oy
Metsänneidonkuja 8
FI-02130 Espoo

Jansen-Cilag Oy
Metsänneidonkuja 8
FI-02130 Espoo

Jansen-Cilag Oy
Metsänneidonkuja 8
FI-02130 Espoo

Jansen-Cilag Oy
Metsänneidonkuja 8
FI-02130 Espoo

Jansen-Cilag Oy
Metsänneidonkuja 8
FI-02130 Espoo

Jansen-Cilag Oy
Metsänneidonkuja 8
FI-02130 Espoo

Jansen-Cilag Oy
Metsänneidonkuja 8
FI-02130 Espoo

Jansen-Cilag Oy
Metsänneidonkuja 8
FI-02130 Espoo

Jansen-Cilag Oy
Metsänneidonkuja 8
FI-02130 Espoo

Jansen-Cilag Oy
Metsänneidonkuja 8
FI-02130 Espoo

Risperidone

Risperdal

1 mg

Oral solution

Oral use

1 mg/ml

Risperidone

Risperdal

0,25 mg

Film-coated tablet

Oral use

Risperidone

Risperdal

0,5 mg

Film-coated tablet

Oral use

Risperidone

Risperdal

1 mg

Film-coated tablet

Oral use

Risperidone

Risperdal

2 mg

Film-coated tablet

Oral use

Risperidone

Risperdal

3 mg

Film-coated tablet

Oral use

Risperidone

Risperdal

4 mg

Film-coated tablet

Oral use

Risperidone

Risperdal

6 mg

Film-coated tablet

Oral use

Risperidone

Risperdal Instasolv

0,5 mg

Orodispersible tablet

Oral use

Risperidone

Risperdal Instasolv

1 mg

Orodispersible tablet

Oral use

Risperidone

Risperdal Instasolv

2 mg

Orodispersible tablet

Oral use

C

3
0
5
/
3
2

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

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

i

.

2
8
1
1
2
0
0
8

.

Member State

Marketing Authorisation Holder

INN

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

Finland

Finland

France

France

France

France

France

France

France

Jansen-Cilag Oy
Metsänneidonkuja 8
FI-02130 Espoo

Jansen-Cilag Oy
Metsänneidonkuja 8
FI-02130 Espoo

Laboratoires Janssen-Cilag
1, rue Desmoulins
TSA 91003
F-92787 Issy-les-Moulineaux Cedex 9

Laboratoires Janssen-Cilag
1, rue Desmoulins
TSA 91003
F-92787 Issy-les-Moulineaux Cedex 9

Laboratoires Janssen-Cilag
1, rue Desmoulins
TSA 91003
F-92787 Issy-les-Moulineaux Cedex 9

Laboratoires Janssen-Cilag
1, rue Desmoulins
TSA 91003
F-92787 Issy-les-Moulineaux Cedex 9

Laboratoires Janssen-Cilag
1, rue Desmoulins
TSA 91003
F-92787 Issy-les-Moulineaux Cedex 9

Laboratoires Janssen-Cilag
1, rue Desmoulins
TSA 91003
F-92787 Issy-les-Moulineaux Cedex 9

Laboratoires Janssen-Cilag
1, rue Desmoulins
TSA 91003
F-92787 Issy-les-Moulineaux Cedex 9

Risperidone

Risperdal Instasolv

3 mg

Orodispersible tablet

Oral use

Risperidone

Risperdal Instasolv

4 mg

Orodispersible tablet

Oral use

Risperidone

Belivon

1 mg

Scored tablet

Oral use

Risperidone

Belivon

2 mg

Scored tablet

Oral use

Risperidone

Belivon

3 mg

Scored tablet

Oral use

Risperidone

Belivon

4 mg

Scored tablet

Oral use

Risperidone

Risperdal

0,5 mg

Film-coated tablet

Oral use

Risperidone

Risperdal

1 mg

Half-scored tablet

Oral use

Risperidone

Risperdal

2 mg

Half-scored tablet

Oral use

.

2
8
1
1
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

3
0
5
/
3
3

Member State

Marketing Authorisation Holder

INN

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

France

France

France

France

France

France

France

France

Laboratoires Janssen-Cilag
1, rue Desmoulins
TSA 91003
F-92787 Issy-les-Moulineaux Cedex 9

Laboratoires Janssen-Cilag
1, rue Desmoulins
TSA 91003
F-92787 Issy-les-Moulineaux Cedex 9

Laboratoires Janssen-Cilag
1, rue Desmoulins
TSA 91003
F-92787 Issy-les-Moulineaux Cedex 9

Laboratoires Janssen-Cilag
1, rue Desmoulins
TSA 91003
F-92787 Issy-les-Moulineaux Cedex 9

Laboratoires Janssen-Cilag
1, rue Desmoulins
TSA 91003
F-92787 Issy-les-Moulineaux Cedex 9

Laboratoires Janssen-Cilag
1, rue Desmoulins
TSA 91003
F-92787 Issy-les-Moulineaux Cedex 9

Laboratoires Janssen-Cilag
1, rue Desmoulins
TSA 91003
F-92787 Issy-les-Moulineaux Cedex 9

Laboratoires Janssen-Cilag
1, rue Desmoulins
TSA 91003
F-92787 Issy-les-Moulineaux Cedex 9

Risperidone

Risperdal

3 mg

Half-scored tablet

Oral use

Risperidone

Risperdal

4 mg

Half-scored tablet

Oral use

Risperidone

Risperdal

1 mg/ml

Oral solution

Oral use

1 mg/ml

Risperidone

Risperdaloro

0,5 mg

Orodispersible tablet

Oral use

Risperidone

Risperdaloro

1 mg

Orodispersible tablet

Oral use

Risperidone

Risperdaloro

2 mg

Orodispersible tablet

Oral use

Risperidone

Risperdaloro

3 mg

Orodispersible tablet

Oral use

Risperidone

Risperdaloro

4 mg

Orodispersible tablet

Oral use

C

3
0
5
/
3
4

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

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

i

.

2
8
1
1
2
0
0
8

.

Member State

Marketing Authorisation Holder

INN

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

Germany

Germany

Germany

Germany

Germany

Germany

Janssen-Cilag GmbH
D-41457 Neuss

or

Janssen-Cilag GmbH
Raiffeisenstr. 8
D-41470 Neuss

Janssen-Cilag GmbH
D-41457 Neuss

or

Janssen-Cilag GmbH
Raiffeisenstr. 8
D-41470 Neuss

Janssen-Cilag GmbH
D-41457 Neuss

or

Janssen-Cilag GmbH
Raiffeisenstr. 8
D-41470 Neuss

Janssen-Cilag GmbH
D-41457 Neuss

or

Janssen-Cilag GmbH
Raiffeisenstr. 8
D-41470 Neuss

Janssen-Cilag GmbH
D-41457 Neuss

or

Janssen-Cilag GmbH
Raiffeisenstr. 8
D-41470 Neuss

Janssen-Cilag GmbH
D-41457 Neuss

or

Janssen-Cilag GmbH
Raiffeisenstr. 8
D-41470 Neuss

Risperidone

Risperdal 1 mg

1 mg

Film-coated tablet

Oral use

Risperidone

Risperdal 2 mg

2 mg

Film-coated tablet

Oral use

Risperidone

Risperdal 3 mg

3 mg

Film-coated tablet

Oral use

Risperidone

Risperdal 4 mg

4 mg

Film-coated tablet

Oral use

Risperidone

Risperdal Filmtabletten 0,25 mg 0,25 mg

Film-coated tablet

Oral use

Risperidone

Risperdal Filmtabletten 0,5 mg

0,5 mg

Film-coated tablet

Oral use

.

2
8
1
1
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

3
0
5
/
3
5

Member State

Marketing Authorisation Holder

INN

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

Germany

Germany

Germany

Germany

Germany

Germany

Janssen-Cilag GmbH
D-41457 Neuss

or

Janssen-Cilag GmbH
Raiffeisenstr. 8
D-41470 Neuss

Janssen-Cilag GmbH
D-41457 Neuss

or

Janssen-Cilag GmbH
Raiffeisenstr. 8
D-41470 Neuss

Janssen-Cilag GmbH
D-41457 Neuss

or

Janssen-Cilag GmbH
Raiffeisenstr. 8
D-41470 Neuss

Janssen-Cilag GmbH
D-41457 Neuss

or

Janssen-Cilag GmbH
Raiffeisenstr. 8
D-41470 Neuss

Janssen-Cilag GmbH
D-41457 Neuss

or

Janssen-Cilag GmbH
Raiffeisenstr. 8
D-41470 Neuss

Janssen-Cilag GmbH
D-41457 Neuss

or

Janssen-Cilag GmbH
Raiffeisenstr. 8
D-41470 Neuss

Risperidone

Risperdal Filmtabletten 6 mg

6 mg

Film-coated tablet

Oral use

Risperidone

Risperdal Lösung 1 mg/ml

1 mg

Oral solution

Oral use

1 mg/ml

Risperidone

Risperdal Quicklet 1 mg

1 mg

Orodispersible tablet

Oral use

Risperidone

Risperdal Quicklet 2 mg

2 mg

Orodispersible tablet

Oral use

Risperidone

Risperdal Quicklet 3 mg

3 mg

Orodispersible tablet

Oral use

Risperidone

Risperdal Quicklet 4 mg

4 mg

Orodispersible tablet

Oral use

C

3
0
5
/
3
6

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

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

i

.

2
8
1
1
2
0
0
8

.

Member State

Marketing Authorisation Holder

INN

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

Germany

Germany

Germany

Germany

Germany

Germany

Janssen-Cilag GmbH
D-41457 Neuss

or

Janssen-Cilag GmbH
Raiffeisenstr. 8
D-41470 Neuss

Janssen-Cilag GmbH
D-41457 Neuss

or

Janssen-Cilag GmbH
Raiffeisenstr. 8
D-41470 Neuss

Janssen-Cilag GmbH
D-41457 Neuss

or

Janssen-Cilag GmbH
Raiffeisenstr. 8
D-41470 Neuss

Janssen-Cilag GmbH
D-41457 Neuss

or

Janssen-Cilag GmbH
Raiffeisenstr. 8
D-41470 Neuss

Janssen-Cilag GmbH
D-41457 Neuss

or

Janssen-Cilag GmbH
Raiffeisenstr. 8
D-41470 Neuss

Janssen-Cilag GmbH
D-41457 Neuss

or

Janssen-Cilag GmbH
Raiffeisenstr. 8
D-41470 Neuss

Risperidone

Risperidon-Janssen Film-
tabletten 6 mg

6 mg

Film-coated tablet

Oral use

Risperidone

Risperidon-Janssen Loesung
1 mg/ml

1 mg

Oral solution

Oral use

1 mg/ml

Risperidone

Belivon 0,5 mg Filmtabletten

0,5 mg

Film-coated tablet

Oral use

Risperidone

Belivon 1 mg Filmtabletten

1 mg

Film-coated tablet

Oral use

Risperidone

Belivon 1 mg/ml Lösung

1 mg

Oral solution

Oral use

1 mg/ml

Risperidone

Belivon 2 mg Filmtabletten

2 mg

Film-coated tablet

Oral use

.

2
8
1
1
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

3
0
5
/
3
7

Member State

Marketing Authorisation Holder

INN

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

Germany

Germany

Germany

Germany

Germany

Germany

Janssen-Cilag GmbH
D-41457 Neuss

or

Janssen-Cilag GmbH
Raiffeisenstr. 8
D-41470 Neuss

Janssen-Cilag GmbH
D-41457 Neuss

or

Janssen-Cilag GmbH
Raiffeisenstr. 8
D-41470 Neuss

Janssen-Cilag GmbH
D-41457 Neuss

or

Janssen-Cilag GmbH
Raiffeisenstr. 8
D-41470 Neuss

Janssen-Cilag GmbH
D-41457 Neuss

or

Janssen-Cilag GmbH
Raiffeisenstr. 8
D-41470 Neuss

Janssen-Cilag GmbH
D-41457 Neuss

or

Janssen-Cilag GmbH
Raiffeisenstr. 8
D-41470 Neuss

Janssen-Cilag GmbH
D-41457 Neuss

or

Janssen-Cilag GmbH
Raiffeisenstr. 8
D-41470 Neuss

Risperidone

Belivon 3 mg Filmtabletten

3 mg

Film-coated tablet

Oral use

Risperidone

Belivon 4 mg Filmtabletten

4 mg

Film-coated tablet

Oral use

Risperidone

Belivon 6 mg Filmtabletten

6 mg

Film-coated tablet

Oral use

Risperidone

Rehablit 1 mg

1 mg

Film-coated tablet

Oral use

Risperidone

Rehablit 2 mg

2 mg

Film-coated tablet

Oral use

Risperidone

Rehablit 3 mg

3 mg

Film-coated tablet

Oral use

C

3
0
5
/
3
8

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

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

i

.

2
8
1
1
2
0
0
8

.

Member State

Marketing Authorisation Holder

INN

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

Germany

Germany

Germany

Greece

Greece

Greece

Greece

Greece

Janssen-Cilag GmbH
D-41457 Neuss

or

Janssen-Cilag GmbH
Raiffeisenstr. 8
D-41470 Neuss

Janssen-Cilag GmbH
D-41457 Neuss

or

Janssen-Cilag GmbH
Raiffeisenstr. 8
D-41470 Neuss

Janssen-Cilag GmbH
D-41457 Neuss

or

Janssen-Cilag GmbH
Raiffeisenstr. 8
D-41470 Neuss

Janssen-Cilag Pharmaceutical S.A.C.I
56 Eirinis Avenue
GR-15121 Pefki

Janssen-Cilag Pharmaceutical S.A.C.I
56 Eirinis Avenue
GR-15121 Pefki

Janssen-Cilag Pharmaceutical S.A.C.I
56 Eirinis Avenue
GR-15121 Pefki

Janssen-Cilag Pharmaceutical S.A.C.I
56 Eirinis Avenue
GR-15121 Pefki

Janssen-Cilag Pharmaceutical S.A.C.I
56 Eirinis Avenue
GR-15121 Pefki

Risperidone

Rehablit 4 mg

4 mg

Film-coated tablet

Oral use

Risperidone

Rehablit Filmtabletten 6 mg

6 mg

Film-coated tablet

Oral use

Risperidone

Rehablit Lösung 1 mg/ml

1 mg

Oral solution

Oral use

1 mg/ml

Risperidone

Risperdal

1 mg

Film-coated tablet

Oral use

Risperidone

Risperdal

2 mg

Film-coated tablet

Oral use

Risperidone

Risperdal

3 mg

Film-coated tablet

Oral use

Risperidone

Risperdal

4 mg

Film-coated tablet

Oral use

Risperidone

Risperdal

6 mg

Film-coated tablet

Oral use

.

2
8
1
1
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

3
0
5
/
3
9

Member State

Marketing Authorisation Holder

INN

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

Greece

Greece

Greece

Greece

Greece

Greece

Greece

Hungary

Hungary

Hungary

Hungary

Hungary

Hungary

Janssen-Cilag Pharmaceutical S.A.C.I
56 Eirinis Avenue
GR-15121 Pefki

Janssen-Cilag Pharmaceutical S.A.C.I
56 Eirinis Avenue
GR-15121 Pefki

Janssen-Cilag Pharmaceutical S.A.C.I
56 Eirinis Avenue
GR-15121 Pefki

Janssen-Cilag Pharmaceutical S.A.C.I
56 Eirinis Avenue
GR-15121 Pefki

Janssen-Cilag Pharmaceutical S.A.C.I
56 Eirinis Avenue
GR-15121 Pefki

Janssen-Cilag Pharmaceutical S.A.C.I
56 Eirinis Avenue
GR-15121 Pefki

Janssen-Cilag Pharmaceutical S.A.C.I
56 Eirinis Avenue
GR-15121 Pefki

Janssen-Cilag Kft.
H-2045 Törökbálint, Tó park

Janssen-Cilag Kft.
Tó park
H-2045 Törökbálint

Janssen-Cilag Kft.
Tó park
H-2045 Törökbálint

Janssen-Cilag Kft.
Tó park
H-2045 Törökbálint

Janssen-Cilag Kft.
Tó park
H-2045 Törökbálint

Janssen-Cilag Kft.
Tó park
H-2045 Törökbálint

Risperidone

Risperdal

8 mg

Film-coated tablet

Oral use

Risperidone

Risperdal

1 mg/1 ml

Oral solution

Oral use

1 mg/ml

Risperidone

Risperdal Quicklet

0,5 mg

Orodispersible tablet

Oral use

Risperidone

Risperdal Quicklet

1 mg

Orodispersible tablet

Oral use

Risperidone

Risperdal Quicklet

2 mg

Orodispersible tablet

Oral use

Risperidone

Risperdal Quicklet

3 mg

Orodispersible tablet

Oral use

Risperidone

Risperdal Quicklet

4 mg

Orodispersible tablet

Oral use

Risperidone

Risperdal

1 mg

Film-coated tablet

Oral use

Risperidone

Risperdal

2 mg

Film-coated tablet

Oral use

Risperidone

Risperdal

3 mg

Film-coated tablet

Oral use

Risperidone

Risperdal

4 mg

Film-coated tablet

Oral use

Risperidone

Risperdal

1 mg

Oral solution

Oral use

1 mg/ml

Risperidone

Risperdal Quicklet

2 mg

Orodispersible tablet

Oral use

C

3
0
5
/
4
0

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

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

i

.

2
8
1
1
2
0
0
8

.

Member State

Marketing Authorisation Holder

INN

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

Hungary

Hungary

Iceland

Iceland

Iceland

Iceland

Iceland

Iceland

Iceland

Iceland

Iceland

Janssen-Cilag Kft.
Tó park
H-2045 Törökbálint

Janssen-Cilag Kft.
Tó park
H-2045 Törökbálint

Janssen-Cilag AB
Box 7073
S-192 07 Sollentuna

Janssen-Cilag AB
Box 7073
S-192 07 Sollentuna

Janssen-Cilag AB
Box 7073
S-192 07 Sollentuna

Janssen-Cilag AB
Box 7073
S-192 07 Sollentuna

Janssen-Cilag AB
Box 7073
S-192 07 Sollentuna

Janssen-Cilag AB
Box 7073
S-192 07 Sollentuna

Janssen-Cilag AB
Box 7073
S-192 07 Sollentuna

Janssen-Cilag AB
Box 7073
S-192 07 Sollentuna

Janssen-Cilag AB
Box 7073
S-192 07 Sollentuna

Risperidone

Risperdal Quicklet

3 mg

Orodispersible tablet

Oral use

Risperidone

Risperdal Quicklet

4 mg

Orodispersible tablet

Oral use

Risperidone

Risperdal

0,5 mg

Oral lyophilisate

Oral use

Risperidone

Risperdal

1 mg

Oral lyophilisate

Oral use

Risperidone

Risperdal

2 mg

Oral lyophilisate

Oral use

Risperidone

Risperdal

3 mg

Oral lyophilisate

Oral use

Risperidone

Risperdal

4 mg

Oral lyophilisate

Oral use

Risperidone

Risperdal

0,5 mg

Film-coated tablet

Oral use

Risperidone

Risperdal

1 mg

Oral solution

Oral use

1 mg/ml

Risperidone

Risperdal

1 mg

Film-coated tablet

Oral use

Risperidone

Risperdal

2 mg

Film-coated tablet

Oral use

.

2
8
1
1
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

3
0
5
/
4
1

Member State

Marketing Authorisation Holder

INN

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

Iceland

Iceland

Ireland

Ireland

Ireland

Ireland

Ireland

Ireland

Ireland

Janssen-Cilag AB
Box 7073
S-192 07 Sollentuna

Janssen-Cilag AB
Box 7073
S-192 07 Sollentuna

Janssen-Cilag Ltd
Saunderton
High Wycombe
Buckinghamshire HP14 4HJ
United Kingdom

Janssen-Cilag Ltd
Saunderton
High Wycombe
Buckinghamshire HP14 4HJ
United Kingdom

Janssen-Cilag Ltd
Saunderton
High Wycombe
Buckinghamshire HP14 4HJ
United Kingdom

Janssen-Cilag Ltd
Saunderton
High Wycombe
Buckinghamshire HP14 4HJ
United Kingdom

Janssen-Cilag Ltd
Saunderton
High Wycombe
Buckinghamshire HP14 4HJ
United Kingdom

Janssen-Cilag Ltd
Saunderton
High Wycombe
Buckinghamshire HP14 4HJ
United Kingdom

Janssen-Cilag Ltd
Saunderton
High Wycombe
Buckinghamshire HP14 4HJ
United Kingdom

Risperidone

Risperdal

3 mg

Film-coated tablet

Oral use

Risperidone

Risperdal

4 mg

Film-coated tablet

Oral use

Risperidone

Risperdal liquid

1 mg

Oral solution

Oral use

1 mg/ml

Risperidone

Risperdal

6 mg

Film-coated tablet

Oral use

Risperidone

Risperdal

1 mg

Film-coated tablet

Oral use

Risperidone

Risperdal

2 mg

Film-coated tablet

Oral use

Risperidone

Risperdal

3 mg

Film-coated tablet

Oral use

Risperidone

Risperdal

4 mg

Film-coated tablet

Oral use

Risperidone

Risperdal

0,25 mg

Film-coated tablet

Oral use

C

3
0
5
/
4
2

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

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

i

.

2
8
1
1
2
0
0
8

.

Member State

Marketing Authorisation Holder

INN

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

Ireland

Ireland

Ireland

Ireland

Ireland

Ireland

Italy

Janssen-Cilag Ltd
Saunderton
High Wycombe
Buckinghamshire HP14 4HJ
United Kingdom

Janssen-Cilag Ltd
Saunderton
High Wycombe
Buckinghamshire HP14 4HJ
United Kingdom

Janssen-Cilag Ltd
Saunderton
High Wycombe
Buckinghamshire HP14 4HJ
United Kingdom

Janssen-Cilag Ltd
Saunderton
High Wycombe
Buckinghamshire HP14 4HJ
United Kingdom

Janssen-Cilag Ltd
Saunderton
High Wycombe
Buckinghamshire HP14 4HJ
United Kingdom

Janssen-Cilag Ltd
Saunderton
High Wycombe
Buckinghamshire HP14 4HJ
United Kingdom

Janssen Cilag Spa
Via Michelangelo Buonarroti n. 23
Cologno Monzese
I-20093 Milano

Risperidone

Risperdal

0,5 mg

Film-coated tablet

Oral use

Risperidone

Risperdal quicklet

0,5 mg

Orodispersible tablet

Oral use

Risperidone

Risperdal quicklet

1 mg

Orodispersible tablet

Oral use

Risperidone

Risperdal quicklet

2 mg

Orodispersible tablet

Oral use

Risperidone

Risperdal quicklet

3 mg

Orodispersible tablet

Oral use

Risperidone

Risperdal quicklet

4 mg

Orodispersible tablet

Oral use

Risperidone

Risperdal

1 mg

Film-coated tablet

Oral use

.

2
8
1
1
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

3
0
5
/
4
3

Member State

Marketing Authorisation Holder

INN

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

Italy

Italy

Italy

Italy

Italy

Italy

Italy

Italy

Italy

Janssen Cilag Spa
Via Michelangelo Buonarroti n. 23
Cologno Monzese
I-20093 Milano

Janssen Cilag Spa
Via Michelangelo Buonarroti n. 23
Cologno Monzese
I-20093 Milano

Janssen Cilag Spa
Via Michelangelo Buonarroti n. 23
Cologno Monzese
I-20093 Milano

Janssen Cilag Spa
Via Michelangelo Buonarroti n. 23
Cologno Monzese
I-20093 Milano

Janssen Cilag Spa
Via Michelangelo Buonarroti n. 23
Cologno Monzese
I-20093 Milano

Janssen Cilag Spa
Via Michelangelo Buonarroti n. 23
Cologno Monzese
I-20093 Milano

Janssen Cilag Spa
Via Michelangelo Buonarroti n. 23
Cologno Monzese
I-20093 Milano

Janssen Cilag Spa
Via Michelangelo Buonarroti n. 23
Cologno Monzese
I-20093 Milano

Janssen Cilag Spa
Via Michelangelo Buonarroti n. 23
Cologno Monzese
I-20093 Milano

Risperidone

Risperdal

2 mg

Film-coated tablet

Oral use

Risperidone

Risperdal

3 mg

Film-coated tablet

Oral use

Risperidone

Risperdal

4 mg

Film-coated tablet

Oral use

Risperidone

Risperdal

1 mg

Oral solution

Oral use

1 mg/ml

Risperidone

Risperdal

0,5 mg

Tablet

Oral use

Risperidone

Risperdal

0,25 mg

Tablet

Oral use

Risperidone

Risperdal

6 mg

Film-coated tablet

Oral use

Risperidone

Risperdal

0,5 mg

Orodispersible tablet

Oral use

Risperidone

Risperdal

1 mg

Orodispersible tablet

Oral use

C

3
0
5
/
4
4

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

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

i

.

2
8
1
1
2
0
0
8

.

Member State

Marketing Authorisation Holder

INN

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

Italy

Italy

Italy

Italy

Italy

Italy

Italy

Italy

Italy

Janssen Cilag Spa
Via Michelangelo Buonarroti n. 23
Cologno Monzese
I-20093 Milano

J.C. Healthcare Srl
Via Michelangelo Buonarroti n. 23
Cologno Monzese
I-20093 Milano

J.C. Healthcare Srl
Via Michelangelo Buonarroti n. 23
Cologno Monzese
I-20093 Milano

J.C. Healthcare Srl
Via Michelangelo Buonarroti n. 23
Cologno Monzese
I-20093 Milano

J.C. Healthcare Srl
Via Michelangelo Buonarroti n. 23
Cologno Monzese
I-20093 Milano

J.C. Healthcare Srl
Via Michelangelo Buonarroti n. 23
Cologno Monzese
I-20093 Milano

J.C. Healthcare Srl
Via Michelangelo Buonarroti n. 23
Cologno Monzese
I-20093 Milano

J.C. Healthcare Srl
Via Michelangelo Buonarroti n. 23
Cologno Monzese
I-20093 Milano

J.C. Healthcare Srl
Via Michelangelo Buonarroti n. 23
Cologno Monzese
I-20093 Milano

Risperidone

Risperdal

2 mg

Orodispersible tablet

Oral use

Risperidone

Belivon

1 mg

Oral solution

Oral use

1 mg/ml

Risperidone

Belivon

1 mg

Film-coated tablet

Oral use

Risperidone

Belivon

2 mg

Film-coated tablet

Oral use

Risperidone

Belivon

3 mg

Film-coated tablet

Oral use

Risperidone

Belivon

4 mg

Film-coated tablet

Oral use

Risperidone

Actase

1 mg

Oral solution

Oral use

1 mg/ml

Risperidone

Actase

1 mg

Film-coated tablet

Oral use

Risperidone

Actase

2 mg

Film-coated tablet

Oral use

.

2
8
1
1
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

3
0
5
/
4
5

Member State

Marketing Authorisation Holder

INN

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

Italy

Italy

Latvia

Latvia

Latvia

Latvia

Latvia

Latvia

Latvia

Latvia

Lithuania

J.C. Healthcare Srl
Via Michelangelo Buonarroti n. 23
Cologno Monzese
I-20093 Milano

J.C. Healthcare Srl
Via Michelangelo Buonarroti n. 23
Cologno Monzese
I-20093 Milano

UAB Johnson & Johnson
Šeimyniškių g. 1A
LT-09312 Vilnius

UAB Johnson & Johnson
Šeimyniškių g. 1A
LT-09312 Vilnius

UAB Johnson & Johnson
Šeimyniškių g. 1A
LT-09312 Vilnius

UAB Johnson & Johnson
Šeimyniškių g. 1A
LT-09312 Vilnius

UAB Johnson & Johnson
Šeimyniškių g. 1A
LT-09312 Vilnius

UAB Johnson & Johnson
Šeimyniškių g. 1A
LT-09312 Vilnius

UAB Johnson & Johnson
Šeimyniškių g. 1A
LT-09312 Vilnius

UAB Johnson & Johnson
Šeimyniškių g. 1A
LT-09312 Vilnius

UAB Johnson & Johnson
Šeimyniškių g. 1A
LT-09312 Vilnius

Risperidone

Actase

3 mg

Film-coated tablet

Oral use

Risperidone

Actase

4 mg

Film-coated tablet

Oral use

Risperidone

Rispolept

1 mg

Tablets

Oral use

Risperidone

Rispolept

2 mg

Tablets

Oral use

Risperidone

Rispolept

3 mg

Tablets

Oral use

Risperidone

Rispolept

4 mg

Tablets

Oral use

Risperidone

Rispolept

1 mg

Oral solution

Oral use

1 mg/ml

Risperidone

Risperdal Quicklet

1 mg

Orodispersible tablets

Oral use

Risperidone

Risperdal Quicklet

2 mg

Orodispersible tablets

Oral use

Risperidone

Risperdal Quicklet

4 mg

Orodispersible tablets

Oral use

Risperidone

Rispolept

1 mg

Film-coated tablet

Oral use

C

3
0
5
/
4
6

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

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

i

.

2
8
1
1
2
0
0
8

.

Member State

Marketing Authorisation Holder

INN

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

Lithuania

Lithuania

Lithuania

Lithuania

Lithuania

Lithuania

Luxembourg

Luxembourg

Luxembourg

Luxembourg

Luxembourg

UAB Johnson & Johnson
Šeimyniškių g. 1A
LT-09312 Vilnius

UAB Johnson & Johnson
Šeimyniškių g. 1A
LT-09312 Vilnius

UAB Johnson & Johnson
Šeimyniškių g. 1A
LT-09312 Vilnius

UAB Johnson & Johnson
Šeimyniškių g. 1A
LT-09312 Vilnius

UAB Johnson & Johnson
Šeimyniškių g. 1A
LT-09312 Vilnius

UAB Johnson & Johnson
Šeimyniškių g. 1A
LT-09312 Vilnius

Janssen Cilag N.V.
Roderveldlaan 1
B-2600 Berchem

Janssen Cilag N.V.
Roderveldlaan 1
B-2600 Berchem

Janssen Cilag N.V.
Roderveldlaan 1
B-2600 Berchem

Janssen Cilag N.V.
Roderveldlaan 1
B-2600 Berchem

Janssen Cilag N.V.
Roderveldlaan 1
B-2600 Berchem

Risperidone

Rispolept

2 mg

Film-coated tablet

Oral use

Risperidone

Rispolept

3 mg

Film-coated tablet

Oral use

Risperidone

Rispolept

4 mg

Film-coated tablet

Oral use

Risperidone

Rispolept

1 mg

Oral solution

Oral use

1 mg/ml

Risperidone

Rispolept Quicklet

1 mg

Orodispersible tablet

Oral use

Risperidone

Rispolept Quicklet

2 mg

Orodispersible tablet

Oral use

Risperidone

Risperidone J-C Instasolv

0,5 mg

Orodispersible tablet

Oral use

Risperidone

Risperdal

1 mg

Oral solution

Oral use

1 mg/ml

Risperidone

Risperdal

0,5 mg

Film-coated tablet

Oral use

Risperidone

Risperdal

1 mg

Film-coated tablet

Oral use

Risperidone

Risperdal

2 mg

Film-coated tablet

Oral use

.

2
8
1
1
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

3
0
5
/
4
7

Member State

Marketing Authorisation Holder

INN

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

Luxembourg

Luxembourg

Luxembourg

Luxembourg

Luxembourg

Luxembourg

Luxembourg

Luxembourg

Luxembourg

Luxembourg

Luxembourg

Janssen Cilag N.V.
Roderveldlaan 1
B-2600 Berchem

Janssen Cilag N.V.
Roderveldlaan 1
B-2600 Berchem

Janssen Cilag N.V.
Roderveldlaan 1
B-2600 Berchem

Janssen Cilag N.V.
Roderveldlaan 1
B-2600 Berchem

Janssen Cilag N.V.
Roderveldlaan 1
B-2600 Berchem

Janssen Cilag N.V.
Roderveldlaan 1
B-2600 Berchem

Janssen Cilag N.V.
Roderveldlaan 1
B-2600 Berchem

Janssen Cilag N.V.
Roderveldlaan 1
B-2600 Berchem

Janssen Cilag N.V.
Roderveldlaan 1
B-2600 Berchem

Janssen Cilag N.V.
Roderveldlaan 1
B-2600 Berchem

Janssen Cilag N.V.
Roderveldlaan 1
B-2600 Berchem

Risperidone

Risperdal

3 mg

Film-coated tablet

Oral use

Risperidone

Risperdal

4 mg

Film-coated tablet

Oral use

Risperidone

Risperdal

6 mg

Film-coated tablet

Oral use

Risperidone

Risperdal Instasolv

0,5 mg

Orodispersible tablet

Oral use

Risperidone

Risperdal Instasolv

1 mg

Orodispersible tablet

Oral use

Risperidone

Risperdal Instasolv

2 mg

Orodispersible tablet

Oral use

Risperidone

Risperidone J-C

0,5 mg

Film-coated tablet

Oral use

Risperidone

Risperidone J-C

1 mg

Film-coated tablet

Oral use

Risperidone

Risperidone J-C

1 mg

Oral solution

Oral use

1 mg/ml

Risperidone

Risperidone J-C

2 mg

Film-coated tablet

Oral use

Risperidone

Risperidone J-C

3 mg

Film-coated tablet

Oral use

C

3
0
5
/
4
8

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

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

i

.

2
8
1
1
2
0
0
8

.

Member State

Marketing Authorisation Holder

INN

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

Luxembourg

Luxembourg

Luxembourg

Luxembourg

Janssen Cilag N.V.
Roderveldlaan 1
B-2600 Berchem

Janssen Cilag N.V.
Roderveldlaan 1
B-2600 Berchem

Janssen Cilag N.V.
Roderveldlaan 1
B-2600 Berchem

Janssen Cilag N.V.
Roderveldlaan 1
B-2600 Berchem

Malta

Malta

Malta

Malta

Malta

Malta

Malta

Jansen Cilag International N.V.
Turnhoutseweg 30
B-2340 Beerse

Jansen Cilag International N.V.
Turnhoutseweg 30
B-2340 Beerse

Jansen Cilag International N.V.
Turnhoutseweg 30
B-2340 Beerse

Jansen Cilag International N.V.
Turnhoutseweg 30
B-2340 Beerse

Jansen Cilag International N.V.
Turnhoutseweg 30
B-2340 Beerse

Jansen Cilag International N.V.
Turnhoutseweg 30
B-2340 Beerse

Jansen Cilag International N.V.
Turnhoutseweg 30
B-2340 Beerse

Risperidone

Risperidone J-C

4 mg

Film-coated tablet

Oral use

Risperidone

Risperidone J-C

6 mg

Film-coated tablet

Oral use

Risperidone

Risperidone J-C Instasolv

1 mg

Orodispersible tablet

Oral use

Risperidone

Risperidone J-C Instasolv

2 mg

Orodispersible tablet

Oral use

Risperidone

Risperdal

1 mg

Tablets

Oral use

Risperidone

Risperdal

2 mg

Tablets

Oral use

Risperidone

Risperdal

3 mg

Tablets

Oral use

Risperidone

Risperdal

1 mg

Oral solution

Oral use

1 mg/ml

Risperidone

Risperdal Quicklets

0,5 mg

Orodispersible tablet

Oral use

Risperidone

Risperdal Quicklets

1 mg

Orodispersible tablet

Oral use

Risperidone

Risperdal Quicklets

2 mg

Orodispersible tablet

Oral use

.

2
8
1
1
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

3
0
5
/
4
9

Member State

Marketing Authorisation Holder

INN

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

Netherlands

Netherlands

Netherlands

Netherlands

Netherlands

Netherlands

Netherlands

Janssen-Cilag N.V.
Dr. Paul Janssenweg 150
PO Box 90240
5000 LT Tilburg
Nederland

Janssen-Cilag N.V.
Dr. Paul Janssenweg 150
PO Box 90240
5000 LT Tilburg
Nederland

Janssen-Cilag BV
Dr. Paul Janssenweg 150
PO Box 90240
5000 LT Tilburg
Nederland

Janssen-Cilag N.V.
Dr. Paul Janssenweg 150
PO Box 90240
5000 LT Tilburg
Nederland

Janssen-Cilag N.V.
Dr. Paul Janssenweg 150
PO Box 90240
5000 LT Tilburg
Nederland

Janssen-Cilag N.V.
Dr. Paul Janssenweg 150
PO Box 90240
5000 LT Tilburg
Nederland

Janssen-Cilag N.V.
Dr. Paul Janssenweg 150
PO Box 90240
5000 LT Tilburg
Nederland

Risperidone

Risperidone

Risperidone

Risperidone

Risperidone

Risperidone

Risperidone

Risperdal
Risperdal
0,5 mg

Risperdal
Risperdal
1 mg

Risperdal
Risperdal
2 mg

Risperdal
Risperdal
3 mg

Risperdal
Risperdal
4 mg

Risperdal
Risperdal
6 mg

Risperdal
Risperdal
8 mg

omhulde

tabletten

0,5 mg

Film-coated tablets

Oral use

omhulde

tabletten

1 mg

Film-coated tablets

Oral use

omhulde

tabletten

2 mg

Film-coated tablets

Oral use

omhulde

tabletten

3 mg

Film-coated tablets

Oral use

omhulde

tabletten

4 mg

Film-coated tablets

Oral use

omhulde

tabletten

6 mg

Film-coated tablets

Oral use

omhulde

tabletten

8 mg

Film-coated tablets

Oral use

C

3
0
5
/
5
0

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

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

i

.

2
8
1
1
2
0
0
8

.

Member State

Marketing Authorisation Holder

INN

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

Netherlands

Netherlands

Netherlands

Netherlands

Netherlands

Netherlands

Norway

Norway

Janssen-Cilag N.V.
Dr. Paul Janssenweg 150
PO Box 90240
5000 LT Tilburg
Nederland

Janssen-Cilag N.V.
Dr. Paul Janssenweg 150
PO Box 90240
5000 LT Tilburg
Nederland

Janssen-Cilag N.V.
Dr. Paul Janssenweg 150
PO Box 90240
5000 LT Tilburg
Nederland

Janssen-Cilag N.V.
Dr. Paul Janssenweg 150
PO Box 90240
5000 LT Tilburg
Nederland

Janssen-Cilag N.V.
Dr. Paul Janssenweg 150
PO Box 90240
5000 LT Tilburg
Nederland

Janssen-Cilag N.V.
Dr. Paul Janssenweg 150
PO Box 90240
5000 LT Tilburg
Nederland

Janssen-Cilag AS
Hoffsveien 1D
N-0275 Oslo

Janssen-Cilag AS
Hoffsveien 1D
N-0275 Oslo

Risperidone

Belivon
Belivon omhulde tabletten 1 mg

1 mg

Film-coated tablets

Oral use

Risperidone

Belivon
Belivon omhulde tabletten 2 mg

2 mg

Film-coated tablets

Oral use

Risperidone

Belivon
Belivon omhulde tabletten 3 mg

3 mg

Film-coated tablets

Oral use

Risperidone

Belivon

4 mg

Film-coated tablets

Oral use

Risperidone

Risperdal
Risperdal 1 mg/ml, drank

1 mg

Oral solution

Oral use

1 mg/ml

Risperidone

Belivon
Belivon 1 mg/ml

1 mg

Oral solution

Oral use

1 mg/ml

Risperidone

Belivon

1 mg

Oral solution

Oral use

1 mg/ml

Risperidone

Belivon

1 mg

Film-coated tablets

Oral use

.

2
8
1
1
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

3
0
5
/
5
1

Member State

Marketing Authorisation Holder

INN

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

Norway

Norway

Norway

Norway

Norway

Norway

Norway

Norway

Norway

Norway

Norway

Janssen-Cilag AS
Hoffsveien 1D
N-0275 Oslo

Janssen-Cilag AS
Hoffsveien 1D
N-0275 Oslo

Janssen-Cilag AS
Hoffsveien 1D
N-0275 Oslo

Janssen-Cilag AS
Hoffsveien 1D
N-0275 Oslo

Janssen-Cilag AS
Hoffsveien 1D
N-0275 Oslo

Janssen-Cilag AS
Hoffsveien 1D
N-0275 Oslo

Janssen-Cilag AS
Hoffsveien 1D
N-0275 Oslo

Janssen-Cilag AS
Hoffsveien 1D
N-0275 Oslo

Janssen-Cilag AS
Hoffsveien 1D
N-0275 Oslo

Janssen-Cilag AS
Hoffsveien 1D
N-0275 Oslo

Janssen-Cilag AS
Hoffsveien 1D
N-0275 Oslo

Risperidone

Belivon

2 mg

Film-coated tablets

Oral use

Risperidone

Belivon

3 mg

Film-coated tablets

Oral use

Risperidone

Belivon

4 mg

Film-coated tablets

Oral use

Risperidone

Risperdal

0,5 mg

Orodispersible tablet

Oral use

Risperidone

Risperdal

1 mg

Orodispersible tablet

Oral use

Risperidone

Risperdal

2 mg

Orodispersible tablet

Oral use

Risperidone

Risperdal

3 mg

Orodispersible tablet

Oral use

Risperidone

Risperdal

4 mg

Orodispersible tablet

Oral use

Risperidone

Risperdal

0,5 mg

Film-coated tablet

Oral use

Risperidone

Risperdal

1 mg

Film-coated tablet

Oral use

Risperidone

Risperdal

2 mg

Film-coated tablet

Oral use

C

3
0
5
/
5
2

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

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

i

.

2
8
1
1
2
0
0
8

.

Member State

Marketing Authorisation Holder

INN

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

Norway

Norway

Norway

Poland

Poland

Poland

Poland

Poland

Poland

Poland

Janssen-Cilag AS
Hoffsveien 1D
N-0275 Oslo

Janssen-Cilag AS
Hoffsveien 1D
N-0275 Oslo

Janssen-Cilag AS
Hoffsveien 1D
N-0275 Oslo

Jansen Cilag International N.V.
Turnhoutseweg 30
B-2340 Beerse

Jansen Cilag International N.V.
Turnhoutseweg 30
B-2340 Beerse

Jansen Cilag International N.V.
Turnhoutseweg 30
B-2340 Beerse

Jansen Cilag International N.V.
Turnhoutseweg 30
B-2340 Beerse

Jansen Cilag International N.V.
Turnhoutseweg 30
B-2340 Beerse

Jansen Cilag International N.V.
Turnhoutseweg 30
B-2340 Beerse

Jansen Cilag International N.V.
Turnhoutseweg 30
B-2340 Beerse

Risperidone

Risperdal

3 mg

Film-coated tablet

Oral use

Risperidone

Risperdal

4 mg

Film-coated tablet

Oral use

Risperidone

Risperdal

1 mg

Oral solution

Oral use

1 mg/ml

Risperidone

Rispolept

1 mg

Oral solution

Oral use

1 mg/ml

Risperidone

Rispolept

1 mg

Film-coated tablet

Oral use

Risperidone

Rispolept

2 mg

Film-coated tablet

Oral use

Risperidone

Rispolept

3 mg

Film-coated tablet

Oral use

Risperidone

Rispolept

4 mg

Film-coated tablet

Oral use

Risperidone

Rispolept Quicklet

0,5 mg

Orodispersible tablet

Oral use

Risperidone

Rispolept Quicklet

1 mg

Orodispersible tablet

Oral use

.

2
8
1
1
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

3
0
5
/
5
3

Member State

Marketing Authorisation Holder

INN

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

Poland

Portugal

Portugal

Portugal

Portugal

Portugal

Portugal

Portugal

Portugal

Jansen Cilag International N.V.
Turnhoutseweg 30
B-2340 Beerse

Janssen Farmacêutica Portugal, Lda
Estrada Consiglieri Pedroso, 69 A
Queluz de Baixo
P-2734-503 Barcarena

Janssen Farmacêutica Portugal, Lda
Estrada Consiglieri Pedroso, 69 A
Queluz de Baixo
P-2734-503 Barcarena

Janssen Farmacêutica Portugal, Lda
Estrada Consiglieri Pedroso, 69 A
Queluz de Baixo
P-2734-503 Barcarena

Janssen Farmacêutica Portugal, Lda
Estrada Consiglieri Pedroso, 69 A
Queluz de Baixo
P-2734-503 Barcarena

Janssen Farmacêutica Portugal, Lda
Estrada Consiglieri Pedroso, 69 A
Queluz de Baixo
P-2734-503 Barcarena

Janssen Farmacêutica Portugal, Lda
Estrada Consiglieri Pedroso, 69 A
Queluz de Baixo
P-2734-503 Barcarena

Janssen Farmacêutica Portugal, Lda
Estrada Consiglieri Pedroso, 69 A
Queluz de Baixo
P-2734-503 Barcarena

Janssen Farmacêutica Portugal, Lda
Estrada Consiglieri Pedroso, 69 A
Queluz de Baixo
P-2734-503 Barcarena

Risperidone

Rispolept Quicklet

2 mg

Orodispersible tablet

Oral use

Risperidone

Risperdal

1 mg

Film-coated tablet

Oral use

Risperidone

Risperdal

2 mg

Film-coated tablet

Oral use

Risperidone

Risperdal

3 mg

Film-coated tablet

Oral use

Risperidone

Risperdal

4 mg

Film-coated tablet

Oral use

Risperidone

Risperdal

1 mg

Oral solution

Oral use

1 mg/ml

Risperidone

Risperdal

0,25 mg

Film-coated tablet

Oral use

Risperidone

Risperdal

0,5 mg

Film-coated tablet

Oral use

Risperidone

Risperdal Quicklet

0,5 mg

Orodispersible tablet

Oral use

C

3
0
5
/
5
4

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

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

i

.

2
8
1
1
2
0
0
8

.

Member State

Marketing Authorisation Holder

INN

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

Portugal

Portugal

Portugal

Portugal

Romania

Romania

Romania

Romania

Romania

Romania

Janssen Farmacêutica Portugal, Lda
Estrada Consiglieri Pedroso, 69 A
Queluz de Baixo
P-2734-503 Barcarena

Janssen Farmacêutica Portugal, Lda
Estrada Consiglieri Pedroso, 69 A
Queluz de Baixo
P-2734-503 Barcarena

Janssen Farmacêutica Portugal, Lda
Estrada Consiglieri Pedroso, 69 A
Queluz de Baixo
P-2734-503 Barcarena

Janssen Farmacêutica Portugal, Lda
Estrada Consiglieri Pedroso, 69 A
Queluz de Baixo
P-2734-503 Barcarena

Janssen Pharmaceutica N.V.
Turnhoutseweg 30
B-2340 Beerse

Janssen Pharmaceutica N.V.
Turnhoutseweg 30
B-2340 Beerse

Janssen Pharmaceutica N.V.
Turnhoutseweg 30
B-2340 Beerse

Janssen Pharmaceutica N.V.
Turnhoutseweg 30
B-2340 Beerse

Janssen Pharmaceutica N.V.
Turnhoutseweg 30
B-2340 Beerse

Janssen Pharmaceutica N.V.
Turnhoutseweg 30
B-2340 Beerse

Risperidone

Risperdal Quicklet

1 mg

Orodispersible tablet

Oral use

Risperidone

Risperdal Quicklet

2 mg

Orodispersible tablet

Oral use

Risperidone

Risperdal Quicklet

3 mg

Orodispersible tablet

Oral use

Risperidone

Risperdal Quicklet

4 mg

Orodispersible tablet

Oral use

Risperidone

Rispolept 1 mg

1 mg

Film-coated tablet

Oral use

Risperidone

Rispolept 2 mg

2 mg

Film-coated tablet

Oral use

Risperidone

Rispolept 3 mg

3 mg

Film-coated tablet

Oral use

Risperidone

Rispolept 4 mg

4 mg

Film-coated tablet

Oral use

Risperidone

Rispolept

1 mg

Oral solution

Oral use

1 mg/ml

Risperidone

Rispolept Quicklet

1 mg

Orodispersible tablet

Oral use

.

2
8
1
1
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

3
0
5
/
5
5

Member State

Marketing Authorisation Holder

INN

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

Romania

Janssen Pharmaceutica N.V.
Turnhoutseweg 30
B-2340 Beerse

Risperidone

Rispolept Quicklet

2 mg

Orodispersible tablet

Oral use

Slovak Republic

Slovak Republic

Slovak Republic

Slovak Republic

Slovak Republic

Slovak Republic

Slovak Republic

Slovak Republic

Slovak Republic

Slovenia

Johnson & Johnson s. r. o.
Plynárenská 7/B
SK-824 78 Bratislava

Johnson & Johnson s. r. o.
Plynárenská 7/B
SK-824 78 Bratislava

Johnson & Johnson s. r. o.
Plynárenská 7/B
SK-824 78 Bratislava

Johnson & Johnson s. r. o.
Plynárenská 7/B
SK-824 78 Bratislava

Johnson & Johnson s. r. o.
Plynárenská 7/B
SK-824 78 Bratislava

Johnson & Johnson s. r. o.
Plynárenská 7/B
SK-824 78 Bratislava

Johnson & Johnson s. r. o.
Plynárenská 7/B
SK-824 78 Bratislava

Johnson & Johnson s. r. o.
Plynárenská 7/B
SK-824 78 Bratislava

Johnson & Johnson s. r. o.
Plynárenská 7/B
SK-824 78 Bratislava

Johnson & Johnson d.o.o.
Šmartinska cesta 53
SLO-1000 Ljubljana

Risperidone

Risperdal

1 mg

Film-coated tablet

Oral use

Risperidone

Risperdal

2 mg

Film-coated tablet

Oral use

Risperidone

Risperdal

3 mg

Film-coated tablet

Oral use

Risperidone

Risperdal

4 mg

Film-coated tablet

Oral use

Risperidone

Risperdal

1 mg

Oral solution

Oral use

1 mg/ml

Risperidone

Risperdal Quicklet

1 mg

Orodispersible tablet

Oral use

Risperidone

Risperdal Quicklet

2 mg

Orodispersible tablet

Oral use

Risperidone

Risperdal Quicklet

3 mg

Orodispersible tablet

Oral use

Risperidone

Risperdal Quicklet

4 mg

Orodispersible tablet

Oral use

Risperidone

Risperdal 1 mg filmsko oblo-
žene tablete

1 mg

Film-coated tablet

Oral use

C

3
0
5
/
5
6

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

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

i

.

2
8
1
1
2
0
0
8

.

Member State

Marketing Authorisation Holder

INN

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

Slovenia

Slovenia

Slovenia

Slovenia

Slovenia

Slovenia

Slovenia

Spain

Spain

Johnson & Johnson d.o.o.
Šmartinska cesta 53
SLO-1000 Ljubljana

Johnson & Johnson d.o.o.
Šmartinska cesta 53
SLO-1000 Ljubljana

Johnson & Johnson d.o.o.
Šmartinska cesta 53
SLO-1000 Ljubljana

Johnson & Johnson d.o.o.
Šmartinska cesta 53
SLO-1000 Ljubljana

Johnson & Johnson d.o.o.
Šmartinska cesta 53
SLO-1000 Ljubljana

Johnson & Johnson d.o.o.
Šmartinska cesta 53
SLO-1000 Ljubljana

Johnson & Johnson d.o.o.
Šmartinska cesta 53
SLO-1000 Ljubljana

Janssen Cilag, SA
Paseo de las Doce Estrellas, 5-7
E-28042 Madrid

Janssen Cilag, SA
Paseo de las Doce Estrellas, 5-7
E-28042 Madrid

Risperidone

Risperdal 2 mg filmsko oblo-
žene tablete

2 mg

Film-coated tablet

Oral use

Risperidone

Risperdal 3 mg filmsko oblo-
žene tablete

3 mg

Film-coated tablet

Oral use

Risperidone

Risperdal 4 mg filmsko oblo-
žene tablete

4 mg

Film-coated tablet

Oral use

Risperidone

Risperdal 1 mg/ml peroralna
raztopina

1 mg/ml

Oral solution

Oral use

1 mg/ml

Risperidone

Risperdal Quicklet 0,5 mg
orodisperzibilna tableta

0,5 mg

Orodispersible tablet

Oral use

Risperidone

Risperdal Quicklet 1 mg
orodisperzibilna tableta

1 mg

Orodispersible tablet

Oral use

Risperidone

Risperdal Quicklet 2 mg
orodisperzibilna tableta

2 mg

Orodispersible tablet

Oral use

Risperidone

Risperdal flas

3 mg

Orodispersible tablet

Oral use

Risperidone

Risperdal flas

4 mg

Orodispersible tablet

Oral use

.

2
8
1
1
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

3
0
5
/
5
7

Member State

Marketing Authorisation Holder

INN

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

Spain

Spain

Spain

Spain

Spain

Spain

Spain

Spain

Sweden

Sweden

Sweden

Janssen Cilag, SA
Paseo de las Doce Estrellas, 5-7
E-28042 Madrid

Janssen Cilag, SA
Paseo de las Doce Estrellas, 5-7
E-28042 Madrid

Janssen Cilag, SA
Paseo de las Doce Estrellas, 5-7
E-28042 Madrid

Janssen Cilag, SA
Paseo de las Doce Estrellas, 5-7
E-28042 Madrid

Janssen Cilag, SA
Paseo de las Doce Estrellas, 5-7
E-28042 Madrid

Janssen Cilag, SA
Paseo de las Doce Estrellas, 5-7
E-28042 Madrid

Janssen Cilag, SA
Paseo de las Doce Estrellas, 5-7
E-28042 Madrid

Janssen Cilag, SA
Paseo de las Doce Estrellas, 5-7
E-28042 Madrid

Janssen-Cilag AB
Box 7073
S-192 07 Sollentuna

Janssen-Cilag AB
Box 7073
S-192 07 Sollentuna

Janssen-Cilag AB
Box 7073
S-192 07 Sollentuna

Risperidone

Risperdal flas

0,5 mg

Orodispersible tablet

Oral use

Risperidone

Risperdal flas

2 mg

Orodispersible tablet

Oral use

Risperidone

Risperdal flas

1 mg

Orodispersible tablet

Oral use

Risperidone

Risperdal

1 mg

Film-coated tablet

Oral use

Risperidone

Risperdal

2 mg

Film-coated tablet

Oral use

Risperidone

Risperdal

3 mg

Film-coated tablet

Oral use

Risperidone

Risperdal

6 mg

Film-coated tablet

Oral use

Risperidone

Risperdal

1 mg

Oral solution

Oral use

1 mg/ml

Risperidone

Belivon

1 mg

Film-coated tablet

Oral use

Risperidone

Belivon

2 mg

Film-coated tablet

Oral use

Risperidone

Belivon

3 mg

Film-coated tablet

Oral use

C

3
0
5
/
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

.

2
8
1
1
2
0
0
8

.

Member State

Marketing Authorisation Holder

INN

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

Sweden

Sweden

Sweden

Sweden

Sweden

Sweden

Sweden

Sweden

Sweden

Sweden

Sweden

Janssen-Cilag AB
Box 7073
S-192 07 Sollentuna

Janssen-Cilag AB
Box 7073
S-192 07 Sollentuna

Janssen-Cilag AB
Box 7073
S-192 07 Sollentuna

Janssen-Cilag AB
Box 7073
S-192 07 Sollentuna

Janssen-Cilag AB
Box 7073
S-192 07 Sollentuna

Janssen-Cilag AB
Box 7073
S-192 07 Sollentuna

Janssen-Cilag AB
Box 7073
S-192 07 Sollentuna

Janssen-Cilag AB
Box 7073
S-192 07 Sollentuna

Janssen-Cilag AB
Box 7073
S-192 07 Sollentuna

Janssen-Cilag AB
Box 7073
S-192 07 Sollentuna

Janssen-Cilag AB
Box 7073
S-192 07 Sollentuna

Risperidone

Belivon

4 mg

Film-coated tablet

Oral use

Risperidone

Belivon

6 mg

Film-coated tablet

Oral use

Risperidone

Belivon

1 mg

Oral solution

Oral use

1 mg/1ml

Risperidone

Risperdal

0,5 mg

Film-coated tablet

Oral use

Risperidone

Risperdal

1 mg

Film-coated tablet

Oral use

Risperidone

Risperdal

2 mg

Film-coated tablet

Oral use

Risperidone

Risperdal

3 mg

Film-coated tablet

Oral use

Risperidone

Risperdal

4 mg

Film-coated tablet

Oral use

Risperidone

Risperdal

1 mg

Oral solution

Oral use

1 mg/ml

Risperidone

Risperdal

0,5 mg

Oral lyophilisate

Oral use

Risperidone

Risperdal

1 mg

Oral lyophilisate

Oral use

.

2
8
1
1
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

3
0
5
/
5
9

Member State

Marketing Authorisation Holder

INN

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

Sweden

Sweden

Sweden

United Kingdom

United Kingdom

United Kingdom

United Kingdom

United Kingdom

Janssen-Cilag AB
Box 7073
S-192 07 Sollentuna

Janssen-Cilag AB
Box 7073
S-192 07 Sollentuna

Janssen-Cilag AB
Box 7073
S-192 07 Sollentuna

Janssen-Cilag Ltd
Saunderton
High Wycombe
Buckinghamshire HP 14 4HJ
United Kingdom

Janssen-Cilag Ltd
Saunderton
High Wycombe
Buckinghamshire HP 14 4HJ
United Kingdom

Janssen-Cilag Ltd
Saunderton
High Wycombe
Buckinghamshire HP 14 4HJ
United Kingdom

Janssen-Cilag Ltd
Saunderton
High Wycombe
Buckinghamshire HP 14 4HJ
United Kingdom

Janssen-Cilag Ltd
Saunderton
High Wycombe
Buckinghamshire HP 14 4HJ
United Kingdom

Risperidone

Risperdal

2 mg

Oral lyophilisate

Oral use

Risperidone

Risperdal

3 mg

Oral lyophilisate

Oral use

Risperidone

Risperdal

4 mg

Oral lyophilisate

Oral use

Risperidone

Risperdal

0,25 mg

Film-coated tablet

Oral use

Risperidone

Risperdal

0,5 mg

Film-coated tablet

Oral use

Risperidone

Risperdal

1 mg

Film-coated tablet

Oral use

Risperidone

Risperdal

2 mg

Film-coated tablet

Oral use

Risperidone

Risperdal

3 mg

Film-coated tablet

Oral use

C

3
0
5
/
6
0

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

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

i

.

2
8
1
1
2
0
0
8

.

Member State

Marketing Authorisation Holder

INN

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

United Kingdom

United Kingdom

United Kingdom

United Kingdom

United Kingdom

United Kingdom

United Kingdom

United Kingdom

Janssen-Cilag Ltd
Saunderton
High Wycombe
Buckinghamshire HP 14 4HJ
United Kingdom

Janssen-Cilag Ltd
Saunderton
High Wycombe
Buckinghamshire HP 14 4HJ
United Kingdom

Janssen-Cilag Ltd
Saunderton
High Wycombe
Buckinghamshire HP 14 4HJ
United Kingdom

Janssen-Cilag Ltd
Saunderton
High Wycombe
Buckinghamshire HP 14 4HJ
United Kingdom

Janssen-Cilag Ltd
Saunderton
High Wycombe
Buckinghamshire HP 14 4HJ
United Kingdom

Janssen-Cilag Ltd
Saunderton
High Wycombe
Buckinghamshire HP 14 4HJ
United Kingdom

Janssen-Cilag Ltd
Saunderton
High Wycombe
Buckinghamshire HP 14 4HJ
United Kingdom

Janssen-Cilag Ltd
Saunderton
High Wycombe
Buckinghamshire HP 14 4HJ
United Kingdom

Risperidone

Risperdal

4 mg

Film-coated tablet

Oral use

Risperidone

Risperdal

6 mg

Film-coated tablet

Oral use

Risperidone

Risperdal liquid

1 mg

Oral solution

Oral use

1 mg/ml

Risperidone

Risperdal quicklet

0,5 mg

Orodispersible tablet

Oral use

Risperidone

Risperdal quicklet

1 mg

Orodispersible tablet

Oral use

Risperidone

Risperdal quicklet

2 mg

Orodispersible tablet

Oral use

Risperidone

Risperdal quicklet

3 mg

Orodispersible tablet

Oral use

Risperidone

Risperdal quicklet

4 mg

Orodispersible tablet

Oral use

.

2
8
1
1
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

3
0
5
/
6
1

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

ANNEX III

Member State

Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical Form

Route of administration

Content
(concentration)

Austria

Austria

Austria

Austria

Austria

Austria

Austria

Austria

Janssen-Cilag Pharma GmbH
Pfarrgasse 75
A-1232 Wien

Janssen-Cilag Pharma GmbH
Pfarrgasse 75
A-1232 Wien

Janssen-Cilag Pharma GmbH
Pfarrgasse 75
A-1232 Wien

Janssen-Cilag Pharma GmbH
Pfarrgasse 75
A-1232 Wien

Janssen-Cilag Pharma GmbH
Pfarrgasse 75
A-1232 Wien

Janssen-Cilag Pharma GmbH
Pfarrgasse 75
A-1232 Wien

Janssen-Cilag Pharma GmbH
Pfarrgasse 75
A-1232 Wien

Janssen-Cilag Pharma GmbH
Pfarrgasse 75
A-1232 Wien

Risperdal Consta

12,5 mg

Powder and solvent for prolonged-release suspen-
sion for injection

Intramuscular use

12,5 mg/2 ml

Risperdal Consta

25 mg

Powder and solvent for prolonged-release suspen-
sion for injection

Intramuscular use

25 mg/2 ml

Risperdal Consta

37,5 mg

Powder and solvent for prolonged-release suspen-
sion for injection

Intramuscular use

37,5 mg/2 ml

Risperdal Consta

50 mg

Powder and solvent for prolonged-release suspen-
sion for injection

Intramuscular use

50 mg/2 ml

Rispolin Consta

12,5 mg

Powder and solvent for prolonged-release suspen-
sion for injection

Intramuscular use

12,5 mg/2ml

Rispolin Consta

25 mg

Powder and solvent for prolonged-release suspen-
sion for injection

Intramuscular use

25 mg/2ml

Rispolin Consta

37,5 mg

Powder and solvent for prolonged-release suspen-
sion for injection

Intramuscular use

37,5 mg/2 ml

Rispolin Consta

50 mg

Powder and solvent for prolonged-release suspen-
sion for injection

Intramuscular use

50 mg/2 ml

Belgium

Janssen Cilag N.V.
Roderveldlaan 1
B-2600 Berchem

Belivon Consta

25 mg

Powder and solvent for solution for injection

Intramuscular use

25 mg/2 ml

C

3
0
5
/
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

.

2
8
1
1
2
0
0
8

.

Member State

Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical Form

Route of administration

Content
(concentration)

Belgium

Belgium

Belgium

Belgium

Belgium

Bulgaria

Bulgaria

Bulgaria

Cyprus

Cyprus

Cyprus

Janssen Cilag N.V.
Roderveldlaan 1
B-2600 Berchem

Janssen Cilag N.V.
Roderveldlaan 1
B-2600 Berchem

Janssen Cilag N.V.
Roderveldlaan 1
B-2600 Berchem

Janssen Cilag N.V.
Roderveldlaan 1
B-2600 Berchem

Janssen Cilag N.V.
Roderveldlaan 1
B-2600 Berchem

Johnson & Johnson d.o.o.
Šmartinska cesta 53
SLO-1000 Ljubljana

Johnson & Johnson d.o.o.
Šmartinska cesta 53
SLO-1000 Ljubljana

Johnson & Johnson d.o.o.
Šmartinska cesta 53
SLO-1000 Ljubljana

Janssen-Cilag International N.V.
Turnhoutseweg 30
B-2340 Beerse

Janssen-Cilag International N.V.
Turnhoutseweg 30
B-2340 Beerse

Janssen-Cilag International N.V.
Turnhoutseweg 30
B-2340 Beerse

Belivon Consta

37,5 mg

Powder and solvent for solution for injection

Intramuscular use

37,5 mg/2 ml

Belivon Consta

50 mg

Powder and solvent for solution for injection

Intramuscular use

50 mg/2 ml

Risperdal Consta

25 mg

Powder and solvent for solution for injection

Intramuscular use

25 mg/2 ml

Risperdal Consta

37,5 mg

Powder and solvent for solution for injection

Intramuscular use

37,5 mg/2 ml

Risperdal Consta

50 mg

Powder and solvent for solution for injection

Intramuscular use

50 mg/2 ml

Rispolept Consta

25 mg

Powder and solvent for solution for injection

Intramuscular use

25 mg/2 ml

Rispolept Consta

37,5 mg

Powder and solvent for solution for injection

Intramuscular use

37,5 mg/2 ml

Rispolept Consta

50 mg

Powder and solvent for solution for injection

Intramuscular use

50 mg/2 ml

Risperdal Consta

25 mg

Powder for suspension for injection

Intramuscular use

25 mg/2 ml

Risperdal Consta

37,5 mg

Powder for suspension for injection

Intramuscular use

37,5 mg/2 ml

Risperdal Consta

50 mg

Powder for suspension for injection

Intramuscular use

50 mg/2 ml

.

2
8
1
1
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

3
0
5
/
6
3

Member State

Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical Form

Route of administration

Content
(concentration)

Czech Republic

Czech Republic

Czech Republic

Estonia

Estonia

Estonia

Finland

Finland

Finland

Finland

Janssen-Cilag s. r. o.
Karla Engliše 3201/6
CZ-150 00 Praha 5

Janssen-Cilag s. r. o.
Karla Engliše 3201/6
CZ-150 00 Praha 5

Janssen-Cilag s. r. o.
Karla Engliše 3201/6
CZ-150 00 Praha 5

Johnson & Johnson UAB
Šeimyniškių g. 1A
LT-09312 Vilnius

Johnson & Johnson UAB
Šeimyniškių g. 1A
LT-09312 Vilnius

Johnson & Johnson UAB
Šeimyniškių g. 1A
LT-09312 Vilnius

Jansen-Cilag Oy
Metsänneidonkuja 8
FI-02130 Espoo

Jansen-Cilag Oy
Metsänneidonkuja 8
FI-02130 Espoo

Jansen-Cilag Oy
Metsänneidonkuja 8
FI-02130 Espoo

Jansen-Cilag Oy
Metsänneidonkuja 8
FI-02130 Espoo

Risperdal Consta 25 mg

25 mg

Powder and solvent for suspension for injection

Intramuscular use

25 mg/2 ml

Risperdal Consta 37,5 mg

37,5 mg

Powder and solvent for suspension for injection

Intramuscular use

37,5 mg/2ml

Risperdal Consta 50 mg

50 mg

Powder and solvent for suspension for injection

Intramuscular use

50 mg/2ml

Rispolept Consta

25 mg

Powder and solvent for suspension for injection

Intramuscular use

25mg/2ml

Rispolept Consta

37,5 mg

Powder and solvent for suspension for injection

Intramuscular use

37,5mg/2ml

Rispolept Consta

50 mg

Powder and solvent for suspension for injection

Intramuscular use

50mg/2ml

Risperdal Consta

12,5 mg

Powder and solvent for prolonged-release suspen-
sion for injection

Intramuscular use

12,5 mg/2ml

Risperdal Consta

25 mg

Powder and solvent for prolonged-release suspen-
sion for injection

Intramuscular use

25mg/2ml

Risperdal Consta

37,5 mg

Powder and solvent for prolonged-release suspen-
sion for injection

Intramuscular use

37,5 mg/2 ml

Risperdal Consta

50 mg

Powder and solvent for prolonged-release suspen-
sion for injection

Intramuscular use

50 mg/2 ml

C

3
0
5
/
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

.

2
8
1
1
2
0
0
8

.

Member State

Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical Form

Route of administration

Content
(concentration)

France

France

France

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Janssen Cilag
1, rue Desmoulins
TSA 91003
F-92787 Issy-les-Moulineaux Cedex 9

Janssen Cilag
1, rue Desmoulins
TSA 91003
F-92787 Issy-les-Moulineaux Cedex 9

Janssen Cilag
1, rue Desmoulins
TSA 91003
F-92787 Issy-les-Moulineaux Cedex 9

Janssen-Cilag GmbH
Raiffeisenstr. 8
D-41470 Neuss

Janssen-Cilag GmbH
Raiffeisenstr. 8
D-41470 Neuss

Janssen-Cilag GmbH
Raiffeisenstr. 8
D-41470 Neuss

Janssen-Cilag GmbH
Raiffeisenstr. 8
D-41470 Neuss

Janssen-Cilag GmbH
Raiffeisenstr. 8
D-41470 Neuss

Janssen-Cilag GmbH
Raiffeisenstr. 8
D-41470 Neuss

Janssen-Cilag GmbH
Raiffeisenstr. 8
D-41470 Neuss

Risperdalconsta LP

25 mg

Powder for suspension for injection

Intramuscular use

25 mg/2 ml

Risperdalconsta LP

37,5 mg

Powder for suspension for injection

Intramuscular use

37,5 mg/2 ml

Risperdalconsta LP

50 mg

Powder for suspension for injection

Intramuscular use

50 mg/2 ml

Risperdal Consta

25 mg

Powder and solvent for suspension for injection

Intramuscular use

25 mg/2 ml

Risperdal Consta

37,5 mg

Powder and solvent for suspension for injection

Intramuscular use

37,5 mg/2 ml

Risperdal Consta

50 mg

Powder and solvent for suspension for injection

Intramuscular use

50 mg/2 ml

Risperidon-Janssen Consta

25 mg

Powder and solvent for suspension for injection

Intramuscular use

25 mg/2 ml

Risperidon-Janssen Consta

37,5 mg

Powder and solvent for suspension for injection

Intramuscular use

37,5 mg/2 ml

Risperidon-Janssen Consta

50 mg

Powder and solvent for suspension for injection

Intramuscular use

50 mg/2 ml

Rispon-Janssen Consta

25 mg

Powder and solvent for suspension for injection

Intramuscular use

25 mg/2 ml

.

2
8
1
1
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

3
0
5
/
6
5

Member State

Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical Form

Route of administration

Content
(concentration)

Germany

Germany

Greece

Greece

Greece

Iceland

Iceland

Iceland

Ireland

Janssen-Cilag GmbH
Raiffeisenstr. 8
D-41470 Neuss

Janssen-Cilag GmbH
Raiffeisenstr. 8
D-41470 Neuss

Janssen-Cilag Pharmaceutical
Aebe Eirinis Avenue 56
GR-15121 Pefki

Janssen-Cilag Pharmaceutical
Aebe Eirinis Avenue 56
GR-15121 Pefki

Janssen-Cilag Pharmaceutical
Aebe Eirinis Avenue 56
GR-15121 Pefki

Janssen-Cilag AB
c/o Vistor hf.Hörgatúni 2
Garðabær
Iceland

Janssen-Cilag AB
c/o Vistor hf.Hörgatúni 2
Garðabær
Iceland

Janssen-Cilag AB
c/o Vistor hf.Hörgatúni 2
Garðabær
Iceland

Janssen-Cilag Ltd
Saunderton
High Wycombe
Buckinghamshire HP14 4HJ
United Kingdom

Rispon-Janssen Consta

37,5 mg

Powder and solvent for suspension for injection

Intramuscular use

37,5 mg/2 ml

Rispon-Janssen Consta

50 mg

Powder and solvent for suspension for injection

Intramuscular use

50 mg/2 ml

Risperdal Consta

25 mg

Powder and solvent for suspension for injection

Intramuscular use

25 mg/2 ml

Risperdal Consta

37,5 mg

Powder and solvent for suspension for injection

Intramuscular use

37,5 mg/2 ml

Risperdal Consta

50 mg

Powder and solvent for suspension for injection

Intramuscular use

50 mg/2ml

Risperdal Consta

50 mg

Powder and solvent for suspension for injection

Intramuscular use

50 mg/2 ml

Risperdal Consta

37,5 mg

Powder and solvent for suspension for injection

Intramuscular use

37,5 mg/2 ml

Risperdal Consta

25 mg

Powder and solvent for suspension for injection

Intramuscular use

25 mg/2 ml

Risperdal Consta

25 mg

Powder for suspension for injection

Intramuscular use

25 mg/2 ml

C

3
0
5
/
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

.

2
8
1
1
2
0
0
8

.

Member State

Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical Form

Route of administration

Content
(concentration)

Ireland

Ireland

Italy

Italy

Italy

Latvia

Latvia

Latvia

Lithuania

Janssen-Cilag Ltd
Saunderton
High Wycombe
Buckinghamshire HP14 4HJ
United Kingdom

Janssen-Cilag Ltd
Saunderton
High Wycombe
Buckinghamshire HP14 4HJ
United Kingdom

Janssen Cilag Spa
Via Michelangelo Buonarroti n. 23
Cologno Monzese
I-20093 Milano

Janssen Cilag Spa
Via Michelangelo Buonarroti n. 23
Cologno Monzese
I-20093 Milano

Janssen Cilag Spa
Via Michelangelo Buonarroti n. 23
Cologno Monzese
I-20093 Milano

UAB Johnson & Johnson
Šeimyniškių g. 1A
LT-09312 Vilnius

UAB Johnson & Johnson
Šeimyniškių g. 1A
LT-09312 Vilnius

UAB Johnson & Johnson
Šeimyniškių g. 1A
LT-09312 Vilnius

UAB Johnson & Johnson
Šeimyniškių g. 1A
LT-09312 Vilnius

Risperdal Consta

37,5 mg

Powder for suspension for injection

Intramuscular use

37,5 mg/2 ml

Risperdal Consta

50 mg

Powder for suspension for injection

Intramuscular use

50 mg/2 ml

Risperdal

25 mg

Powder for suspension for injection

Intramuscular use

25 mg/2 ml

Risperdal

37,5 mg

Powder for suspension for injection

Intramuscular use

37,5 mg/2 ml

Risperdal

50 mg

Powder for suspension for injection

Intramuscular use

50 mg/2 ml

Rispolept Consta

25 mg

Prolonged release powder and solvent for suspen-
sion for injection

Intramuscular use

25 mg/2 ml

Rispolept Consta

50 mg

Prolonged release powder and solvent for suspen-
sion for injection

Intramuscular use

50 mg/2 ml

Rispolept Consta

37,5 mg

Prolonged release powder and solvent for suspen-
sion for injection

Intramuscular use

37,5 mg/2 ml

Rispolept Consta

25 mg

Prolonged-release powder and solvent for solution
for injection

Intramuscular use

25 mg/2 ml

.

2
8
1
1
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

3
0
5
/
6
7

Member State

Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical Form

Route of administration

Content
(concentration)

Lithuania

Lithuania

Malta

Malta

Malta

Netherlands

Netherlands

Netherlands

Netherlands

UAB Johnson & Johnson
Šeimyniškių g. 1A
LT-09312 Vilnius

UAB Johnson & Johnson
Šeimyniškių g. 1A
LT-09312 Vilnius

JansenCilag International N.V.
Turnhoutseweg 30
B-2340 Beerse

JansenCilag International N.V.
Turnhoutseweg 30
B-2340 Beerse

JansenCilag International N.V.
Turnhoutseweg 30
B-2340 Beerse

Janssen-Cilag B.V.
Dr. Paul Janssenweg 150
PO Box 90240
5000 LT Tilburg
Nederland

Janssen-Cilag B.V.
Dr. Paul Janssenweg 150
PO Box 90240
5000 LT Tilburg
Nederland

Janssen-Cilag B.V.
Dr. Paul Janssenweg 150
PO Box 90240
5000 LT Tilburg
Nederland

Janssen-Cilag B.V.
Dr. Paul Janssenweg 150
PO Box 90240
5000 LT Tilburg
Nederland

Rispolept Consta

37,5 mg

Prolonged-release powder and solvent for solution
for injection

Intramuscular use

37,5 mg/2 ml

Rispolept Consta

50 mg

Prolonged-release powder and solvent for solution
for injection

Intramuscular use

50 mg/2ml

Risperdal Consta

25 mg

Powder for suspension for injection

Intramuscular use

25 mg/2 ml

Risperdal Consta

37,5 mg

Powder for suspension for injection

Intramuscular use

37,5 mg/2 ml

Risperdal Consta

50 mg

Powder for suspension for injection

Intramuscular use

50 mg/2ml

Risperdal Consta

12,5 mg

Powder and solution for suspension and injection

Intramuscular use

12,5 mg/2 ml

Risperdal Consta

25 mg

Powder and solution for suspension and injection

Intramuscular use

25 mg/2 ml

Risperdal Consta

37,5 mg

Powder and solution for suspension and injection

Intramuscular use

37,5 mg/2 ml

Risperdal Consta

50 mg

Powder and solution for suspension and injection

Intramuscular use

50 mg/2ml

C

3
0
5
/
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

.

2
8
1
1
2
0
0
8

.

Member State

Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical Form

Route of administration

Content
(concentration)

Risperdal Consta

25 mg

Prolonged-release powder (microspheres) and a
solvent for suspension for injection

Intramuscular use

25 mg/2 ml

Norway

Norway

Norway

Poland

Poland

Poland

Portugal

Portugal

Portugal

Janssen-Cilag AS
Hoffsveien 1D
N-0275 Oslo

Janssen-Cilag AS
Hoffsveien 1D
N-0275 Oslo

Janssen-Cilag AS
Hoffsveien 1D
N-0275 Oslo

Janssen-Cilag International N.V.
Turnhoutseweg 30
B-2340 Beerse

Janssen-Cilag International N.V.
Turnhoutseweg 30
B-2340 Beerse

Janssen-Cilag International N.V.
Turnhoutseweg 30
B-2340 Beerse

Janssen Farmacêutica Portugal, Lda.
Estrada Consiglieri Pedroso, 69 A
Queluz de Baixo
P-2734-503 Barcarena

Janssen Farmacêutica Portugal, Lda.
Estrada Consiglieri Pedroso, 69 A
Queluz de Baixo
P-2734-503 Barcarena

Janssen Farmacêutica Portugal, Lda.
Estrada Consiglieri Pedroso, 69 A
Queluz de Baixo
P-2734-503 Barcarena

Risperdal Consta

37,5 mg

Prolonged-release powder (microspheres) and a
solvent for suspension for injection

Intramuscular use

37,5 mg/2 ml

E
N

Risperdal Consta

50 mg

Prolonged-release powder (microspheres) and a
solvent for suspension for injection

Intramuscular use

50 mg/2ml

Rispolept Consta

25 mg

Prolonged-release microcapsule and solvent
suspension for injection

for

Intramuscular use

25 mg/2 ml

Rispolept Consta

37,5 mg

Prolonged-release microcapsule and solvent
suspension for injection

for

Intramuscular use

37,5 mg/2 ml

Rispolept Consta

50 mg

Prolonged-release microcapsule and solvent
suspension for injection

for

Intramuscular use

50 mg/2ml

Risperdal Consta

25 mg

Powder and solvent for suspension for injection

Intramuscular use

25 mg/2 ml

Risperdal Consta

37,5 mg

Powder and solvent for suspension for injection

Intramuscular use

37,5 mg/2 ml

Risperdal Consta

50 mg

Powder and solvent for suspension for injection

Intramuscular use

50 mg/2ml

Romania

Janssen Pharmaceutica N.V.
Turnhoutseweg 30
B-2340 Beerse

Rispolept Consta

25 mg

Powder and solvent for suspension for injection

Intramuscular use

25 mg/2 ml

.

2
8
1
1
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

3
0
5
/
6
9

Member State

Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical Form

Route of administration

Content
(concentration)

Romania

Romania

Slovak Republic

Slovak Republic

Slovak Republic

Slovenia

Slovenia

Slovenia

Spain

Spain

Spain

Janssen Pharmaceutica N.V.
Turnhoutseweg 30
B-2340 Beerse

Janssen Pharmaceutica N.V.
Turnhoutseweg 30
B-2340 Beerse

Johnson & Johnson s. r. o.
Plynárenská 7/B
SK-824 78 Bratislava

Johnson & Johnson s. r. o.
Plynárenská 7/B
SK-824 78 Bratislava

Johnson & Johnson s. r. o.
Plynárenská 7/B
SK-824 78 Bratislava

Johnson & Johnson d.o.o.
Šmartinska cesta 53
SLO-1000 Ljubljana

Johnson & Johnson d.o.o.
Šmartinska cesta 53
SLO-1000 Ljubljana

Johnson & Johnson d.o.o.
Šmartinska cesta 53
SLO-1000 Ljubljana

Janssen Cilag, SA
Paseo de las 12 estrellas, 5-7
E-28042 Madrid

Janssen Cilag, SA
Paseo de las 12 estrellas, 5-7
E-28042 Madrid

Janssen Cilag, SA
Paseo de las 12 estrellas, 5-7
E-28042 Madrid

Rispolept Consta

37,5 mg

Powder and solvent for suspension for injection

Intramuscular use

37,5 mg/2ml

Rispolept Consta

50 mg

Powder and solvent for suspension for injection

Intramuscular use

50 mg/2ml

Risperdal Consta

25 mg

Powder and solvent for suspension for injection

Intramuscural use

25 mg/2 ml

Risperdal Consta

37,5 mg

Powder and solvent for suspension for injection

Intramuscural use

37,5 mg/2 ml

Risperdal Consta

50 mg

Powder and solvent for suspension for injection

Intramuscural use

50 mg/2ml

Risperdal Consta

25 mg

Prolonged release powder and solvent for suspen-
sion for injection

Intramuscural use

25 mg/2 ml

Risperdal Consta

37,5 mg

Prolonged release powder and solvent for suspen-
sion for injection

Intramuscural use

37,5 mg/2ml

Risperdal Consta

50 mg

Prolonged release powder and solvent for suspen-
sion for injection

Intramuscural use

50 mg/2ml

Risperdal Consta

25 mg

Powder and solvent for solution for injection

Intramuscular use

25 mg/2ml

Risperdal Consta

37.5 mg

Powder and solvent for solution for injection

Intramuscular use

37,5 mg/2 ml

Risperdal Consta

50 mg

Powder and solvent for solution for injection

Intramuscular use

50 mg/2 ml

C

3
0
5
/
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

.

2
8
1
1
2
0
0
8

.

Member State

Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical Form

Route of administration

Content
(concentration)

Sweden

Sweden

Sweden

United Kingdom

United Kingdom

United Kingdom

Janssen-Cilag AB
Box 7073
S-192 07 Sollentuna

Janssen-Cilag AB
Box 7073
S-192 07 Sollentuna

Janssen-Cilag AB
Box 7073
S-192 07 Sollentuna

Janssen-Cilag Ltd
Saunderton
High Wycombe
Buckinghamshire HP 14 4HJ
United Kingdom

Janssen-Cilag Ltd
Saunderton
High Wycombe
Buckinghamshire HP 14 4HJ
United Kingdom

Janssen-Cilag Ltd
Saunderton
High Wycombe
Buckinghamshire HP 14 4HJ
United Kingdom

Risperdal Consta

25 mg

Powder and solvent for prolonged-release suspen-
sion for injection

Intramuscular use

25 mg/2 ml

Risperdal Consta

37,5 mg

Powder and solvent for prolonged-release suspen-
sion for injection

Intramuscular use

37,5 mg/2ml

Risperdal Consta

50 mg

Powder and solvent for prolonged-release suspen-
sion for injection

Intramuscular use

50 mg/2ml

Risperdal Consta

25 mg

Powder for suspension for injection

Intramuscular use

25 mg/2 ml

Risperdal Consta

37,5 mg

Powder for suspension for injection

Intramuscular use

37,5 mg/2 ml

Risperdal Consta

50 mg

Powder for suspension for injection

Intramuscular use

50 mg/2 ml

.

2
8
1
1
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

3
0
5
/
7
1

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

ANNEX IV

Member State

Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical Form

Route of administration

Content
(concentration)

Austria

Bayer Austria GmbH
Herbststraße 6-10
A-1160 Wien

Belgium

Bayer S.A.-N.V.
Avenue Louise 143/Louizalaan 143
B-1050 Bruxelles/Brussel

Ciproxin

Ciproxin

Ciproxin

Ciproxin

Ciproxin

Ciproxin

250 mg

500 mg

750 mg

Film-coated tablets

Film-coated tablets

Film-coated tablets

Oral use

Oral use

Oral use

100 mg/50 ml

Solution for infusion

Intravenous use

200 mg/100 ml

Solution for infusion

Intravenous use

400 mg/200 ml

Solution for infusion

Intravenous use

Ciprofloxacine ‘BAYER’

200 mg/100 ml

Solution for infusion

Intravenous use

Ciprofloxacine ‘BAYER’

400 mg/200 ml

Solution for infusion

Intravenous use

Ciproxin

Ciproxin

Ciproxine

Ciproxine

Ciproxine

Ciproxine

Ciproxine

Ciproxine

Ciproxine

Ciproxine

Ciproxine

5 %

10 %

Oral suspension

Oral suspension

Oral use

Oral use

200 mg/100 ml

Solution for infusion

Intravenous use

100 mg/50 ml

Solution for infusion

Intravenous use

100 mg

250 mg

500 mg

750 mg

Film-coated tablets

Film-coated tablets

Film-coated tablets

Film-coated tablets

5 g/100 ml

Oral suspension

Oral use

Oral use

Oral use

Oral use

Oral use

200 mg/100 ml

Solution for infusion

Intravenous use

400 mg/200 ml

Solution for infusion

Intravenous use

250 mg

500 mg

750 mg

2 mg/ml

2 mg/ml

2 mg/ml

2 mg/ml

2 mg/ml

5 %

10 %

2 mg/ml

2 mg/ml

100 mg

250 mg

500 mg

750 mg

50 mg/ ml

2 mg/ml

2 mg/ml

C

3
0
5
/
7
2

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

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

i

.

2
8
1
1
2
0
0
8

.

Member State

Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical Form

Route of administration

Content
(concentration)

Bulgaria

Bayer HealthCare AG
D-51368 Leverkusen

Cyprus

Bayer Hellas Abee
18-20 Sorou Street
GR-15125 Marousi Athens

Czech Republic

Bayer HealthCare AG
D-51368 Leverkusen

Denmark

Bayer HealthCare AG
D-51368 Leverkusen

Ciprobay

Ciprobay

Ciprobay

Ciprobay

Ciprobay XR

Ciproxin

Ciproxin

Ciproxin

Ciprobay

Ciprobay

Ciprobay

Ciprobay Uro

Ciprobay

Ciprobay

Ciprobay

Ciproxin

Ciproxin

Ciproxin

Ciproxin

Ciproxin

Ciproxin

Ciproxin

250 mg

500 mg

Film-coated tablets

Film-coated tablets

Oral use

Oral use

200 mg /100ml

Solution for infusion

Intravenous use

400 mg/200 ml

Solution for infusion

Intravenous use

500 mg

250 mg

500 mg

Modified release tablets

Film-coated tablets

Film-coated tablets

Oral use

Oral use

Oral use

200 mg/100 ml

Solution for infusion

Intravenous use

100 mg/50 ml

Solution for infusion

Intravenous use

200 mg/100 ml

Solution for infusion

Intravenous use

400 mg/200 ml

Solution for infusion

Intravenous use

100 mg

250 mg

500 mg

750 mg

250 mg

500 mg

750 mg

Film-coated tablets

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

Oral use

200 mg/100 ml

Solution for infusion

Intravenous use

400 mg/200 ml

Solution for infusion

Intravenous use

250 mg

500 mg

2 mg/ml

2 mg/ml

500 mg

250 mg

500 mg

2 mg/ml

2 mg/ml

2 mg/ml

2 mg/ml

100 mg

250 mg

500 mg

750 mg

250 mg

500 mg

750 mg

2 mg/ml

2 mg/ml

50 mg/ml

Oral suspension

100 mg/ml

Oral suspension

Oral use

Oral use

50 mg/ml

100 mg/ml

.

2
8
1
1
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

3
0
5
/
7
3

Member State

Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical Form

Route of administration

Estonia

Bayer HealthCare AG
D-51368 Leverkusen

Finland

Bayer HealthCare AG
D-51368 Leverkusen

France

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

Ciproxin

Ciproxin

Ciproxin

Ciproxin

Ciproxin

Ciproxin

Ciproxin

Ciproxin

Ciproxin

Ciflox

Ciflox

Uniflox

Ciflox

Ciflox

Ciflox

Ciflox

Ciflox

Content
(concentration)

250 mg

500 mg

250 mg

Film-coated tablets

Oral use

500 mg

Film-coated tablets

Oral use

200 mg/100 ml

Solution for infusion

Intravenous use

2 mg/ml

400 mg/200 ml

Solution for infusion

Intravenous use

2 mg/ml

250 mg

Film-coated tablets

Oral use

500 mg

Film-coated tablets

Oral use

750 mg

Film-coated tablets

Oral use

250 mg

500 mg

750 mg

200 mg/100 ml

Solution for infusion

Intravenous use

2 mg/ml

400 mg/200 ml

Solution for infusion

Intravenous use

2 mg/ml

250 mg

Film-coated tablets

Oral use

500 mg

Film-coated tablets

Oral use

500 mg

Film-coated tablets

Oral use

750 mg

Film-coated tablets

Oral use

250 mg/5 ml

Oral suspension

500 mg/5 ml

Oral suspension

Oral use

Oral use

250 mg

500 mg

500 mg

750 mg

50 mg/ml

100 mg/ml

200 mg/100 ml

Solution for infusion

Intravenous use

2 mg/ml

400 mg/200 ml

Solution for infusion

Intravenous use

2 mg/ml

C

3
0
5
/
7
4

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

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

i

.

2
8
1
1
2
0
0
8

.

Member State

Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical Form

Route of administration

Content
(concentration)

Germany

Bayer Vital GmbH
D-51368 Leverkusen

CIPROBAY

CIPROBAY

CIPROBAY

CIPROBAY URO

CIPROBAY

CIPROBAY

CIPROBAY

CIPROBAY

CIPROBAY

100 mg/50 ml

Solution for infusion

Intravenous use

200 mg/100 ml

Solution for infusion

Intravenous use

400 mg/200 ml

Solution for infusion

Intravenous use

100 mg

250 mg

500 mg

750 mg

Film-coated tablets

Film-coated tablets

Film-coated tablets

Film-coated tablets

5 g/100 ml

Oral suspension

10 g/100 ml

Oral suspension

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Bayer Healthcare AG
D-51368 Leverkusen

Ciprofloxacin ANTIBAC

Ciprofloxacin ANTIBAC

Ciprofloxacin ANTIBAC

250 mg

500 mg

750 mg

Film-coated tablets

Film-coated tablets

Film-coated tablets

Ciprofloxacin ANTIBAC

100 mg/50 ml

Solution for infusion

Intravenous use

Ciprofloxacin ANTIBAC

200 mg/100 ml

Solution for infusion

Intravenous use

Ciprofloxacin ANTIBAC

400 mg/200 ml

Solution for infusion

Intravenous use

Ciprofloxacin BAYER

100 mg/50 ml

Solution for infusion

Intravenous use

Ciprofloxacin BAYER

200 mg/100 ml

Solution for infusion

Intravenous use

Ciprofloxacin BAYER

400 mg/200 ml

Solution for infusion

Intravenous use

Ciprofloxacin VITAL

100 mg/50 ml

Solution for infusion

Intravenous use

Ciprofloxacin VITAL

200 mg/100 ml

Solution for infusion

Intravenous use

Ciprofloxacin VITAL

400 mg/200 ml

Solution for infusion

Intravenous use

.

2
8
1
1
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

3
0
5
/
7
5

2 mg/ml

2 mg/ml

2 mg/ml

100 mg

250 mg

500 mg

750 mg

50 mg/ml

100 mg/ml

250 mg

500 mg

750 mg

2 mg/ml

2 mg/ml

2 mg/ml

2 mg/ml

2 mg/ml

2 mg/ml

2 mg/ml

2 mg/ml

2 mg/ml

Member State

Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical Form

Route of administration

Content
(concentration)

Greece

Bayer Hellas Abee
18-20 Sorou Street
GR-15125 Marousi Athens

Hungary

Bayer Hungária Kft.
Alkotás u. 50.
H-1123 Budapest

Iceland

Bayer Healthcare AG
D-51368 Leverkusen

CIPROXIN

CIPROXIN

CIPROXIN

CIPROXIN

CIPROXIN

CIPROXIN

CIPROXIN

100 mg/50 ml

Solution for infusion

Intravenous use

2 mg/ml

200 mg/100 ml

Solution for infusion

Intravenous use

2 mg/ml

400 mg/200 ml

Solution for infusion

Intravenous use

2 mg/ml

500 mg

Film-coated tablets

750 mg

Film-coated tablets

250 mg/5 ml

Oral suspension

500 mg/5 ml

Oral suspension

Oral use

Oral use

Oral use

Oral use

500 mg

750 mg

50 mg/ml

100 mg/ml

CIPROXIN XR

500 mg

Modified release tablets

Oral use

500 mg

CIPROXIN XR

1 000 mg

Modified release tablets

Oral use

1 000 mg

Ciprobay

Ciprobay

Ciprobay

Ciprobay

Ciprobay

Ciproxin

Ciproxin

Ciproxin

Ciproxin

Ciproxin

250 mg

Film-coated tablets

500 mg

Film-coated tablets

Oral use

Oral use

250 mg

500 mg

100 mg/50 ml

Solution for infusion

Intravenous use

2 mg/ml

200 mg/100 ml

Solution for infusion

Intravenous use

2 mg/ml

400 mg/200 ml

Solution for infusion

Intravenous use

2 mg/ml

250 mg

Film-coated tablets

500 mg

Film-coated tablets

750 mg

Film-coated tablets

Oral use

Oral use

Oral use

250 mg

500 mg

750mg

200 mg/100 ml

Solution for infusion

Intravenous use

2 mg/ml

400 mg/200 ml

Solution for infusion

Intravenous use

2 mg/ml

C

3
0
5
/
7
6

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

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

i

.

2
8
1
1
2
0
0
8

.

Member State

Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical Form

Route of administration

Ireland

Bayer Limited
The Atrium
Blackthorn Road
Dublin 18
Ireland

Italy

Bayer HealthCare AG
D-51368 Leverkusen

Bayer Spa
Viale Certosa 130
I-20156 Milano

Latvia

Not authorised

Lithuania

Not authorised

Ciproxin

Ciproxin

Ciproxin

Ciproxin

Ciproxin

Ciproxin

Ciproxin

Ciproxin

Ciproxin

CIFLOX

CIFLOX

CIPROXIN

CIPROXIN

CIPROXIN

CIPROXIN

CIPROXIN

CIPROXIN

CIPROXIN

CIPROXIN

CIPROXIN

CIPROXIN

100 mg

250 mg

500 mg

750 mg

Film-coated tablets

Film-coated tablets

Film-coated tablets

Film-coated tablets

250 mg/5 ml

Oral suspension

500 mg/5 ml

Oral suspension

Oral use use

Oral use use

Oral use use

Oral use use

Oral use use

Oral use use

100 mg/50ml

Solution for infusion

Intravenous use

200 mg/100ml

Solution for infusion

Intravenous use

400 mg/200ml

Solution for infusion

Intravenous use

250 mg

500 mg

250 mg

500 mg

750 mg

500 mg

Film-coated tablets

Film-coated tablets

Film-coated tablets

Film-coated tablets

Film-coated tablets

Modified release tablets

1 000 mg

Modified release tablets

250 mg

500 mg

Oral suspension

Oral suspension

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

100 mg/50 ml

Solution for infusion

Intravenous use

200 mg/100 ml

Solution for infusion

Intravenous use

400 mg/200 ml

Solution for infusion

Intravenous use

Content
(concentration)

100 mg

250 mg

500 mg

750 mg

50 mg/ml

100 mg/ml

2 mg/ml

2 mg/ml

2 mg/ml

250 mg

500 mg

250 mg

500 mg

750 mg

500 mg

1 000 mg

50 mg/ml

100 mg/ml

2 mg/ml

2 mg/ml

2 mg/ml

.

2
8
1
1
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

3
0
5
/
7
7

Member State

Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical Form

Route of administration

Content
(concentration)

Luxembourg

Bayer S.A.-N.V.
Avenue Louise 143
B-1050 Bruxelles

Malta

Bayer Plc
Bayer House
Newbury
Berkshire RG14 1JA
United Kingdom
Trading as: Bayer plc
Bayer Schering Pharma

Netherlands

Bayer BV
Energieweg 1
3641 RT Mijdrecht
Nederland

Ciproxine

Ciproxine

Ciproxine

Ciproxine

Ciproxine

Ciproxine

Ciproxine

Ciproxine

Ciproxin

Ciproxin

Ciproxin

Ciproxin

Ciproxin

Ciproxin

Ciproxin

Ciproxin

Ciproxin

Ciproxin

Ciproxin

Ciproxin

Ciproxin

Ciproxin

100 mg/50 ml

Solution for infusion

Intravenous use

2 mg/ml

100 mg

250 mg

500 mg

750 mg

Film-coated tablets

Film-coated tablets

Film-coated tablets

Film-coated tablets

5 g/100 ml

Oral suspension

Oral use

Oral use

Oral use

Oral use

Oral use

200 mg/100 ml

Solution for infusion

Intravenous use

400 mg/200 ml

Solution for infusion

Intravenous use

250 mg

500 mg

Film-coated tablets

Film-coated tablets

Oral use

Oral use

100 mg/50 ml

Solution for infusion

Intravenous use

200 mg/100 ml

Solution for infusion

Intravenous use

400 mg/200 ml

Solution for infusion

Intravenous use

100 mg

250 mg

500 mg

750 mg

Film-coated tablets

Film-coated tablets

Film-coated tablets

Film-coated tablets

5 g/100 ml

Oral suspension

10 g/100 ml

Oral suspension

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

100 mg/50 ml

Solution for infusion

Intravenous use

200 mg/100 ml

Solution for infusion

Intravenous use

400 mg/200 ml

Solution for infusion

Intravenous use

100 mg

250 mg

500 mg

750 mg

250 mg/5 ml

2 mg/ml

2 mg/ml

250 mg

500 mg

2 mg/ml

2 mg/ml

2 mg/ml

100 mg

250 mg

500 mg

750 mg

50 mg/ml

100 mg/ml

2 mg/ml

2 mg/ml

2 mg/ml

C

3
0
5
/
7
8

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

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

i

.

2
8
1
1
2
0
0
8

.

Member State

Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical Form

Route of administration

Norway

Bayer HealthCare AG
D-51368 Leverkusen

Ciproxin

Ciproxin

Ciproxin

Ciproxin

Ciproxin

Poland

Bayer HealthCare AG
D-51368 Leverkusen

Ciprobay Uro

Ciprobay

Ciprobay

Ciprobay

Ciprobay

Ciprobay

Ciproxina

Ciproxina

Ciproxina

Ciproxina OD

Portugal

Bayer Portugal S.A.
Rua Quinta do
Pinheiro 5
P-2794-003 Carnaxide

Content
(concentration)

250 mg

500 mg

750 mg

250 mg

500 mg

750 mg

Film-coated tablets

Film-coated tablets

Film-coated tablets

Oral use

Oral use

Oral use

200 mg/100 ml

Solution for infusion

Intravenous use

2 mg/ml

400 mg/200 ml

Solution for infusion

Intravenous use

2 mg/ml

100 mg

250 mg

500 mg

Film-coated tablet

Film-coated tablet

Film-coated tablet

Oral use

Oral use

Oral use

100 mg

250 mg

500 mg

100 mg/50 ml

Solution for infusion

Intravenous use

2 mg/ml

200 mg/100 ml

Solution for infusion

Intravenous use

2 mg/ml

400 mg/200 ml

Solution for infusion

Intravenous use

2 mg/ml

250 mg

500 mg

750 mg

500 mg

Film-coated tablets

Film-coated tablets

Film-coated tablets

Oral use

Oral use

Oral use

Modified release tablets

Oral use

250 mg

500 mg

750 mg

500 mg

Ciproxina OD

1 000 mg

Modified release tablets

Oral use

1 000 mg

Ciproxina

Ciproxina

Ciproxina

Ciproxina

10 g/100 ml

Oral suspension

5 g/100 ml

Oral suspension

Oral use

Oral use

100 mg/ ml

50 mg/ml

200 mg/100 ml

Solution for infusion

Intravenous use

2 mg/ml

400 mg/200 ml

Solution for infusion

Intravenous use

2 mg/ml

.

2
8
1
1
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

3
0
5
/
7
9

Member State

Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical Form

Route of administration

Romania

Bayer HealthCare AG
D-51368 Leverkusen

Slovak Republic

Bayer HealthCare AG
D-51368 Leverkusen

Slovenia

Bayer Pharma d.o.o.
Bravničarjeva 13
SLO-1000 Ljubljana

Spain

Quimica farmacéutica Bayer, S.L.
Av. Baix Llobregat, 3-5
E-08970 Sant Joan Despí Barcelona

Ciprobay

Ciprobay

Ciprobay

Ciprobay XR

Ciprobay XR

Ciproxin

Ciproxin

Ciprobay

Ciprobay

Ciprobay

Ciprobay

Ciprobay

Ciprobay

Ciprobay

Ciprobay

Ciprobay

Ciprobay

Ciprobay

BAYCIP

BAYCIP

BAYCIP

BAYCIP

BAYCIP

BAYCIP

500 mg

Film-coated tablets

Oral use

200 mg/ 100 ml

Solution for infusion

Intravenous use

400 mg/ 200 ml

Solution for infusion

Intravenous use

500 mg

Modified release tablets

1 000 mg

Modified release tablets

5 g/100 ml

Oral suspension

10 g/100 ml

Oral suspension

250 mg

500 mg

750 mg

Film-coated tablet

Film-coated tablet

Film-coated tablet

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

100 mg/50 ml

Solution for infusion

Intravenous use

200 mg/100 ml

Solution for infusion

Intravenous use

400 mg/200 ml

Solution for infusion

Intravenous use

250 mg

500 mg

750 mg

Film-coated tablet

Film-coated tablet

Film-coated tablet

Oral use

Oral use

Oral use

200 mg/100 ml

Solution for infusion

Intravenous use

400 mg/200 ml

Solution for infusion

Intravenous use

250 mg

500 mg

750 mg

250 mg

500 mg

Film-coated tablets

Film-coated tablets

Film-coated tablets

Oral suspension (in single dose
sachets)

Oral suspension (in single dose
sachets)

10 g/100 ml

Oral suspension

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Content
(concentration)

500 mg

2 mg/ml

2 mg/ml

500 mg

1 000 mg

50 mg/ml

100 mg/ml

250 mg

500 mg

750 mg

2 mg/ml

2 mg/ml

2 mg/ml

250 mg

500 mg

750 mg

2 mg/ml

2 mg/ml

250 mg

500 mg

750 mg

250 mg

500 mg

100 mg/ml

C

3
0
5
/
8
0

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

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

i

.

2
8
1
1
2
0
0
8

.

Member State

Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical Form

Route of administration

Sweden

Bayer HealthCare AG
D-51368 Leverkusen

United Kingdom

Bayer plc
Bayer House
Newbury
Berkshire RG14 1JA
United Kingdom
Trading as: Bayer plc
Bayer Schering Pharma

Ciproxin

Ciproxin

Ciproxin

Ciproxin

Ciproxin

Ciproxin

Ciproxin

Ciproxin

Ciproxin

Ciproxin

Ciproxin

Ciproxin

Ciproxin

Ciproxin

Ciproxin

Ciproxin

250 mg

500 mg

750 mg

Film-coated tablet

Film-coated tablet

Film-coated tablet

5 g/100 ml

Oral suspension

10 g/100 ml

Oral suspension

Oral use

Oral use

Oral use

Oral use

Oral use

200 mg/100 ml

Solution for infusion

Intravenous use

400 mg/200 ml

Solution for infusion

Intravenous use

100 mg

250 mg

500 mg

750 mg

Film-coated tablet

Film-coated tablet

Film-coated tablet

Film-coated tablet

250 mg/5 ml

Oral suspension

500 mg/5 ml

Oral suspension

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

100 mg/50 ml

Solution for infusion

Intravenous use

200 mg/100 ml

Solution for infusion

Intravenous use

400 mg/200 ml

Solution for infusion

Intravenous use

Content
(concentration)

250 mg

500 mg

750 mg

50 mg/ml

100 mg/ml

2 mg/ml

2 mg/ml

100 mg

250 mg

500 mg

750 mg

50 mg/ml

100 mg/ml

2 mg/ml

2 mg/ml

2 mg/ml

.

2
8
1
1
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

3
0
5
/
8
1

ANNEX V

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

Member State

MAH name and address

INN

Product Name

Strength

Pharmaceutical Form

Route of
administration

Austria

Austria

Austria

Bulgaria

Belgium

Belgium

Belgium

Cyprus

Bayer HealthCare AG
D-51368 Leverkusen

Bayer HealthCare AG
D-51368 Leverkusen

Bayer Austria GmbH
Herbststraße 6-10
A-1160 Wien

Bayer AG
D-51368 Leverkusen

Bayer AG
D-51368 Leverkusen

Bayer S.A.-N.V.
Avenue Louise 143/Louizalaan 143
B-1050 Bruxelles/Brussel

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

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

Moxifloxacin hydrochloride

Actira 400 mg — Filmtabletten

400 mg

Film-coated tablet

Oral use

Moxifloxacin hydrochloride

Octegra 400 mg — Filmtabletten

400 mg

Film-coated tablet

Oral use

Moxifloxacin hydrochloride

Avelox 400 mg — Filmtabletten

400 mg

Film-coated tablet

Oral use

Moxifloxacin

Avelox

400 mg

Film-coated tablet

Oral use

Moxifloxacin hydrochloride

Actira 400 mg

400 mg

Film-coated tablet

Oral use

Moxifloxacin hydrochloride

Avelox 400 mg

400 mg

Film-coated tablet

Oral use

Moxifloxacin hydrochloride

Proflox 400 mg

400 mg

Film-coated tablet

Oral use

Moxifloxacin hydrochloride

Avelox

400 mg

Film-coated tablet

Oral use

Czech Republic

Bayer HealthCare AG
D-51368 Leverkusen

Germany

Germany

Bayer Vital GmbH
D-51368 Leverkusen

Bayer HealthCare AG
D-51368 Leverkusen

Moxifloxacin hydrochloride

Avelox

400 mg

Film-coated tablet

Oral use

Moxifloxacin hydrochloride

Avalox 400 mg Filmtabletten

400 mg

Film-coated tablet

Oral use

Moxifloxacin hydrochloride

Octegra 400 mg Filmtabletten

400 mg

Film-coated tablet

Oral use

C

3
0
5
/
8
2

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

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

i

.

2
8
1
1
2
0
0
8

.

Member State

MAH name and address

INN

Product Name

Strength

Pharmaceutical Form

Route of
administration

Germany

Germany

Denmark

Denmark

Denmark

Denmark

Estonia

Greece

Greece

Greece

Spain

Bayer HealthCare AG
D-51368 Leverkusen

Bayer HealthCare AG
D-51368 Leverkusen

Bayer HealthCare AG
D-51368 Leverkusen

Bayer HealthCare AG
D-51368 Leverkusen

Teva Denmark A/S
Parallelvej 10
DK-2800 Kongens Lyngby

Teva UK limited
Brampton Road
Eastbourne
East Sussex BN22 9AG
United Kingdom

Bayer HealthCare AG
D-51368 Leverkusen

Elpen SA Pharmaceutical Industry
95, Marathonos Avenue
GR-19009 Pikermi

Bayer Hellas Abee
Sorou 18-20
GR-15125 Maroussi — Athens

Bayer plc, Pharmaceutical
Bayer House
Strawberry Hill
Newbury
Berkshire RG14 1JA
United Kingdom

Química Farmaceutica Bayer, S.A.
Av. Baix Llobregat, 3-5
E-08970 Sant Joan Despi, Barcelona

Moxifloxacin hydrochloride

Actira 400 mg Filmtabletten

400 mg

Film-coated tablet

Oral use

Moxifloxacin hydrochloride

Actimax 400 mg Filmtabletten

400 mg

Film-coated tablet

Oral use

Moxifloxacin hydrochloride

Actira

400 mg

Film-coated tablet

Oral use

Moxifloxacin hydrochloride

Avelox

400 mg

Film-coated tablet

Oral use

Moxifloxacin

Infekt

400 mg

Film-coated tablet

Oral use

Moxifloxacin

Moxiflaxacine ‘Teva’

400 mg

Film-coated tablet

Oral use

Moxifloxacin hydrochloride

Avelox

400 mg

Film-coated tablet

Oral use

Moxifloxacin

Octegra

400 mg

Film-coated tablet

Oral use

Moxifloxacin

Avelox

400 mg

Film-coated tablet

Oral use

Moxifloxacin

Proflox

400 mg

Film-coated tablet

Oral use

Moxifloxacin hydrochloride

Actira 400 mg comprimidos recu-
biertos con película

400 mg

Film-coated tablet

Oral use

.

2
8
1
1
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

3
0
5
/
8
3

Member State

MAH name and address

INN

Product Name

Strength

Pharmaceutical Form

Route of
administration

Spain

Spain

Spain

Finland

Finland

France

France

Hungary

Iceland

Italy

Italy

Procter and Gamble Pharmaceuticals
Iberia, SL
WTC Almeda park, Edif 1, 2a planta
E-08940 Cornellá de Llobregat, Barcelona

Recordati Espaňa, SL
Carretera De Zeneta, 149
E-30588 Beniel (Murcia)

Laboratorios Dr Esteve, SA
Avda. Mare de Déu de Montserrat, 221
E-08041 Barcelona

Bayer HealthCare AG
D-51368 Leverkusen

Bayer HealthCare AG
D-51368 Leverkusen

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

Moxifloxacin hydrochloride

Octegra 400 mg comprimidos
recubiertos con película

400 mg

Film-coated tablet

Oral use

Moxifloxacin hydrochloride

Havelox 400 mg comprimidos
recubiertos con película

400 mg

Film-coated tablet

Oral use

Moxifloxacin hydrochloride

Proflox 400 mg comprimidos
recubiertos con película

400 mg

Film-coated tablet

Oral use

Moxifloxacin hydrochloride

Actira

400 mg

Film-coated tablet

Oral use

Moxifloxacin hydrochloride

Avelox

400 mg

Film-coated tablet

Oral use

Moxifloxacin hydrochloride

Izilox 400 mg, comprimé pelliculé

400 mg

Film-coated tablet

Oral use

Bayer Healthcare AG
D-51368 Leverkusen

Moxifloxacin hydrochloride

Octegra 400 mg, comprimé pelli-
culé

400 mg

Film-coated tablet

Oral use

Bayer Hungária Kft
Alkotás u.50.
H-1123 Budapest

Bayer Healthcare AG
D-51368 Leverkusen

Bayer Spa
Viale Certosa 130
I-20156 Milano

Bayer AG
D-51368 Leverkusen

Moxifloxacin hydrochloride

Avelox

400 mg

Film-coated tablet

Oral use

Moxifloxacin hydrochloride

Avelox

400 mg

Film-coated tablet

Oral use

Moxifloxacin hydrochloride

Avalox

400 mg

Film-coated tablet

Oral use

Moxifloxacin hydrochloride

Proflox

400 mg

Film-coated tablet

Oral use

C

3
0
5
/
8
4

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

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

i

.

2
8
1
1
2
0
0
8

.

Member State

MAH name and address

INN

Product Name

Strength

Pharmaceutical Form

Route of
administration

Moxifloxacin hydrochloride

Octegra

400 mg

Film-coated tablet

Oral use

Moxifloxacin hydrochloride

Actira

400 mg

Film-coated tablet

Oral use

E
N

Moxafloxacin hydrochloride

Avelox

400 mg

Film-coated tablet

Oral use

Italy

Italy

Ireland

Innova pharma Spa
Via M. Civitali 1
I-20148 Milano

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

Bayer Limited
The Atrium
Blackthorn Road
Dublin 18
Ireland

Lithuania

Bayer HealthCare AG
D-51368 Leverkusen

Luxembourg

Bayer HealthCare AG
D-51368 Leverkusen

Luxembourg

Luxembourg

Latvia

Malta

Netherlands

Bayer S.A.-N.V.
Avenue Louise 143/Louizalaan 143
B-1050 Bruxelles/Brussel

Therabel Pharma
Rue Egide Van Ochem 110
B-1180 Bruxelles

Bayer HealthCare AG
D-51368 Leverkusen

Bayer Vital GmbH
D-51368 Leverkusen

Bayer BV
Energieweg 1
3641 RT Mijdrecht
Nederland

Moxifloxacin hydrochloride

Avelox

400 mg

Film-coated tablet

Oral use

Moxifloxacin hydrochloride

Actira

400 mg

Film-coated tablet

Oral use

Moxifloxacin hydrochloride

Avelox

400 mg

Film-coated tablet

Oral use

Moxifloxacin hydrochloride

Proflox

400 mg

Film-coated tablet

Oral use

Moxifloxacin hydrochloride

Avelox

400 mg

Film-coated tablet

Oral use

Moxifloxacin hydrochloride

Avalox

400 mg

Film-coated tablet

Oral use

Moxifloxacin hydrochloride

Avelox 400 mg tabletten

400 mg

Film-coated tablet

Oral use

Netherlands

Bayer HealthCare AG
D-51368 Leverkusen

Moxifloxacin hydrochloride

Octegra 400 mg tabletten

400 mg

Film-coated tablet

Oral use

.

2
8
1
1
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

3
0
5
/
8
5

Member State

MAH name and address

INN

Product Name

Strength

Pharmaceutical Form

Route of
administration

Poland

Portugal

Portugal

Portugal

Romania

Sweden

Sweden

Sweden

Slovenia

Slovakia

United Kingdom

Bayer HealthCare AG
D-51368 Leverkusen

Bayer AG
D-51368 Leverkusen

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

Bialfar-Produtos
A Av. da Siderurgia Nacional
P.O. Box 56
P-4745-457 S. Mamede do Coronado

Bayer HealthCare AG
D-51368 Leverkusen

Bayer HealthCare AG
D-51368 Leverkusen

Bayer HealthCare AG
D-51368 Leverkusen

Bayer HealthCare AG
D-51368 Leverkusen

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

Bayer HealthCare AG
D-51368 Leverkusen

Bayer plc, Pharmaceutical
Bayer House
Strawberry Hill
Newbury
Berkshire RG14 1JA
United Kingdom

Moxifloxacin hydrochloride

Avelox

400 mg

Film-coated tablet

Oral use

Moxifloxacin hydrochloride

Actira

400 mg

Film-coated tablet

Oral use

Moxifloxacin hydrochloride

Avelox

400 mg

Film-coated tablet

Oral use

Moxifloxacin hydrochloride

Proflox

400 mg

Film-coated tablet

Oral use

Moxifloxacin hydrochloride

Avelox

400 mg

Film-coated tablet

Oral use

Moxifloxacin hydrochloride

Avelox

400 mg

Film-coated tablet

Oral use

Moxifloxacin hydrochloride

Actira

400 mg

Film-coated tablet

Oral use

Moxifloxacin hydrochloride

Octegra

400 mg

Film-coated tablet

Oral use

Moxifloxacin hydrochloride

Avelox 400 mg filmsko obložene
tablete

400 mg

Film-coated tablet

Oral use

Moxifloxacin hydrochloride

Avelox 400

400 mg

Film-coated tablet

Oral use

Moxifloxacin hydrochloride

Avelox 400 mg tablets

400 mg

Film-coated tablet

Oral use

C

3
0
5
/
8
6

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

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

i

.

2
8
1
1
2
0
0
8

.

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE
OF ADMINISTRATION, APPLICANT IN THE MEMBER STATES

ANNEX VI

Member State

Marketing Authorisation
Holder

Applicant

Name

Strength

Pharmaceutical Form

Route of
administration

.

2
8
1
1
2
0
0
8

.

Denmark

France

Germany

Greece

iQur Pharmaceuticals Ltd
20-22 Bedford Row
London WC1R 4JS
United Kingdom

iQur Pharmaceuticals Ltd
20-22 Bedford Row
London WC1R 4JS
United Kingdom

iQur Pharmaceuticals Ltd
20-22 Bedford Row
London WC1R 4JS
United Kingdom

iQur Pharmaceuticals Ltd
20-22 Bedford Row
London WC1R 4JS
United Kingdom

iQur Pharmaceuticals Ltd
20-22 Bedford Row
London WC1R 4JS
United Kingdom

iQur Pharmaceuticals Ltd
20-22 Bedford Row
London WC1R 4JS
United Kingdom

iQur Pharmaceuticals Ltd
20-22 Bedford Row
London WC1R 4JS
United Kingdom

iQur Pharmaceuticals Ltd
20-22 Bedford Row
London WC1R 4JS
United Kingdom

Ribavirin IQUR Capsules

200 mg

Capsule, hard

Oral use

Ribavirin IQUR Tablets

200/400/600 mg

Film-coated tablet

Oral use

Ribavirin IQUR Capsules

200 mg

Capsule, hard

Oral use

Ribavirin IQUR Tablets

200/400/600 mg

Film-coated tablet

Oral use

Ribavirin IQUR Capsules

200 mg

Capsule, hard

Oral use

Ribavirin IQUR Tablets

200/400/600 mg

Film-coated tablet

Oral use

Ribavirin IQUR Capsules

200 mg

Capsule, hard

Oral use

Ribavirin IQUR Tablets

200/400/600 mg

Film-coated tablet

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

3
0
5
/
8
7

Member State

Marketing Authorisation
Holder

Applicant

Name

Strength

Pharmaceutical Form

Route of
administration

Ireland

Italy

Poland

iQur Pharmaceuticals Ltd
20-22 Bedford Row
London WC1R 4JS
United Kingdom

iQur Pharmaceuticals Ltd
20-22 Bedford Row
London WC1R 4JS
United Kingdom

iQur Pharmaceuticals Ltd
20-22 Bedford Row
London WC1R 4JS
United Kingdom

iQur Pharmaceuticals Ltd
20-22 Bedford Row
London WC1R 4JS
United Kingdom

iQur Pharmaceuticals Ltd
20-22 Bedford Row
London WC1R 4JS
United Kingdom

iQur Pharmaceuticals Ltd
20-22 Bedford Row
London WC1R 4JS
United Kingdom

Ribavirin IQUR capsules

200 mg

Capsule, hard

Oral use

Ribavirin IQUR tablets

200/400/600 mg

Film-coated tablet

Oral use

Ribavirin IQUR

200 mg

Capsule, hard

Oral use

Ribavirin IQUR

200/400/600 mg

Film-coated tablet

Oral use

Ribavirin IQUR

200 mg

Capsule, hard

Oral use

Ribavirin IQUR

200/400/600 mg

Film-coated tablet

Oral use

C

3
0
5
/
8
8

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

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

i

.

2
8
1
1
2
0
0
8

.