Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 January 2008 to 31 January 2008 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC )
Date: 2008-02-29
Institutions: European Commission
Subjects: EU Member State, market approval, marketing standard, medicinal product, pharmaceutical legislation

C 56/14

EN

Official Journal of the European Union

29.2.2008

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

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

(2008/C 56/08)

— Issuing, maintenance or modification of a national marketing authorisation

Date of the
decision

Name(s) of the medicinal
product

Holder(s) of the marketing
authorization

Member State concerned

11.1.2008

Methotaxol-T

See Annex I

See Annex I

17.1.2008

Ivermectin

See Annex II

See Annex II

18.1.2008

Ciprofloxacin Nycomed

See Annex III

See Annex III

— Suspension of a national marketing authorization

Date of the
decision

Name(s) of the medicinal
product

Holder(s) of the marketing
authorization

Member State concerned

25.1.2008

Lumiracoxib

See Annex IV

See Annex IV

— Revocation of a national marketing authorization

Date of the
decision

10.1.2008

Name(s) of the medicinal
product

Holder(s) of the marketing
authorization

Member State concerned

Cetirizine
Dermapharm 10 mg

dihydrochloride

See Annex V

See Annex V

Date of
notification

15.1.2008

18.1.2008

21.1.2008

Date of
notification

29.1.2008

Date of
notification

11.1.2008

10.1.2008

Cetirizine
Copypharm 10 mg

dihydrochloride

10.1.2008

Cetirizine
Apex 10 mg

dihydrochloride

10.1.2008

Cetirizine
Nordic Drugs 10 mg

dihydrochloride

See Annex VI

See Annex VI

11.1.2008

See Annex VII

See Annex VII

11.1.2008

See Annex VIII

See Annex VIII

11.1.2008

10.1.2008

Clobutinol

See Annex IX

See Annex IX

11.1.2008

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

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

ANNEX I

.

.

2
9
2
2
0
0
8

Product invented name

Pharmaceutical form

Strength

Indication

Recommended dose
Frequency and route of administration

E
N

Member State

Applicant or marketing
authorisation holder

The Netherlands

Eurovet Animal Health
Handelsweg 25
P.O. Box 179
5530 AD Bladel
Nederland

Methoxasol-T

Solution for oral
administration

Trimethoprim 20 mg/ml
Sulfamethoxazole 100 mg/ml
N-Methyl-2-pyrrolidone

Germany

Eurovet Animal Health
Handelsweg 25
P.O. Box 179
5530 AD Bladel
Nederland

Methoxasol-T

As for The Netherlands

As for The Netherlands

Austria

Eurovet Animal Health
Handelsweg 25
P.O. Box 179
5530 AD Bladel
Nederland

Methoxasol — Lösung
für Schweine und Hühner

As for The Netherlands

As for The Netherlands

Oral, via the drinking water
Pigs: 2,5-5 mg trimethoprim and
12,5-25 mg sulfamethoxasole per
kg body weight per day
for
3-5 days
Chickens: 5-12 mg trimethoprim
and 25-58 mg sulfamethoxasole
per kg body weight per day for
3-5 days

Oral, via the drinking water
Methoxasol-T should be adminis-
tered daily in drinking water over
a period of 3-4 days
Pigs: 20,8 mg sulfamethoxasole
+ 4,2 mg trimethoprim per kg
body weight per day for 3-4 days
Broilers: 27,5 mg sulfamethoxasole
+ 5,5 mg trimethoprim per kg
body weight per day for 3-4 days

As for Germany

infections caused by

Pigs:
Bronchial
Pasteurella multocida
Intestinal
infections caused by
Escherichia coli and Salmonella spp.
Urogenital
infections caused by
Escherichia coli
Non-egg-laying chickens:
Bronchial
infections caused by
Escherichia coli, Salmonella spp.
and Pasteurella spp.

infec-
Therapeutic treatment of
tions
caused by trimethoprim
and sulfamethoxasole susceptible
bacteria
Pigs:
Pasteurella multocida, Actinobacillus
pleuropneumoniae,
Staphylococcus
hyicus, E. coli, Haemophilus spp.,
Pasteurella haemolytica, Salmonella
cholerasuis,
thyphi-
murium, Streptococcus spp., Staphy-
lococcus aureus, Staphylococcus spp.
Broilers:
Staphylococcus aureus, Salmonella
enteritidis, E. coli

Salmonella

infections,

For the treatment of respiratory
tract
urogenital,
gastrointestinal and skin infec-
tions caused by pathogens sensi-
tive to trimethoprim and sulfa-
methoxasole in pigs and poultry
(broilers)

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

5
6
/
1
5

Member State

Applicant or marketing
authorisation holder

Product invented name

Pharmaceutical form

Strength

Indication

Poland

Eurovet Animal Health
Handelsweg 25
P.O. Box 179
5530 AD Bladel
Nederland

Methoxasol

As for The Netherlands

As for The Netherlands

of

treatment

For
infections
caused by organisms sensitive to
combination
trimethoprim
of
and sulfamethoxasole
Pigs:
Infections of the respiratory tract
caused by Pasteurella multocida,
Actinobacillus pleuropneumoniae
Infections of the digestive system
caused by Escherichia coli, Salmo-
nella spp.
Infections of the urinary system
caused by Escherichia coli
Hens:
Infections of the respiratory tract
caused by Escherichia coli, Salmo-
nella spp., Pasteurella multocida
Infections of the digestive system
caused by Salmonella spp.
Polyarthritis caused by suscep-
tible Escherichia coli

Recommended dose
Frequency and route of administration

Oral, via the drinking water
Pigs: 24 mg/kg b.w., equivalent to
1 litre of
the drug in 500 l
drinking water, for 3-4 days
Hens: 33 mg/kg b.w., equivalent to
1 litre of
the drug in 750 l
drinking water, for 3-4 days

Hungary and
Lithuania

Eurovet Animal Health
Handelsweg 25
P.O. Box 179
5530 AD Bladel
Nederland

Methoxasol

As for The Netherlands

As for The Netherlands

For the treatment of pigs and
non-egg-laying chickens suffering
from infectious diseases of
the
system caused by
respiratory
to sulfame-
bacteria
thoxasole
trimethoprim
(e.g. porcine A. pleuropneumoniae
and gallinaceous E. coli) and for
prophylactic use

sensitive
and

Oral, via the drinking water
Pigs: 24 mg of active ingredient
compound per kilogram of body
weight or 200 ml of the medicine
per 1 000 kg of body weight per
day
Poultry: 33 mg of active ingredient
compound per kilogram of body
weight or 275 ml of the medicine
per 1 000 kg of body weight per
day

C

5
6
/
1
6

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
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p
e
a
n
U
n
o
n

i

.

.

2
9
2
2
0
0
8

NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ANIMAL SPECIES,
ROUTES OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDER/APPLICANT(S)

ANNEX II

Member State

Marketing authorisation
holder/applicant

Product invented name

Pharmaceutical form

Strength

Animal species

Frequency and route of
administration

Recommended dose

Ireland

ECO Animal Health Ltd
78 Coombe Road
New Malden
Surrey
KT3 4QS
United Kingdom

Ecomectin 18,7 mg/g
Oral paste for horses

Oral paste
A white homogenous
paste

Ivermectin 18,7 mg/g

Horses

The paste is given by
oral route

One syringe division of paste
per 100 kg body weight
(based on a recommended
dosage of 200 microgram
ivermectin
body
per
weight)

kg

Belgium

As above

Cyprus

As above

Czech Republic

As above

Denmark

As above

Finland

As above

France

As above

Germany

As above

Greece

As above

Hungary

As above

Ivermax 18,7 mg/g
Oral paste for horses

Tizoval 18,7 mg/g
Oral paste for horses

Vetimec 18,7 mg/g
Oral paste for horses

Ecomectin 18,7 mg/g
Oral paste for horses

Ecomectin 18,7 mg/g
Oral paste for horses

Divamectin 18,7 mg/g
Oral paste for horses

Tizoval 18,7 mg/g
Oral paste for horses

Tizoval 18,7 mg/g
Oral paste for horses

Ecomectin 18,7 mg/g
Oral paste for horses

As above

As above

As above

As above

As above

As above

As above

As above

As above

As above

As above

As above

As above

As above

As above

As above

As above

As above

As above

As above

As above

As above

As above

As above

As above

As above

As above

As above

As above

As above

As above

As above

As above

As above

As above

As above

As above

As above

As above

As above

As above

As above

As above

As above

As above

.

.

2
9
2
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

5
6
/
1
7

Member State

Marketing authorisation
holder/applicant

Product invented name

Pharmaceutical form

Strength

Animal species

Frequency and route of
administration

Recommended dose

Italy

As above

The Netherlands

As above

Norway

As above

Portugal

As above

Spain

As above

Sweden

As above

United Kingdom As above

Tizoval 18,7 mg/g
Oral paste for horses

Ivermax 18,7 mg/g
Oral paste for horses

Tizoval 18,7 mg/g
Oral paste for horses

Ecomectin 18,7 mg/g
Oral paste for horses

Ecomectin 18,7 mg/g
Oral paste for horses

Ecomectin 18,7 mg/g
Oral paste for horses

Animec 18,7 mg/g
Oral paste for horses

As above

As above

As above

As above

As above

As above

As above

As above

As above

As above

As above

As above

As above

As above

As above

As above

As above

As above

As above

As above

As above

As above

As above

As above

As above

As above

As above

As above

As above

As above

As above

As above

As above

As above

As above

C

5
6
/
1
8

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
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r
o
p
e
a
n
U
n
o
n

i

.

.

2
9
2
2
0
0
8

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

ANNEX III

Member State

Marketing authorisation
holder

Applicant

Invented name
Name

Strength

Pharmaceutical form

Route of administration

Content
(Concentration)

United Kingdom

Nycomed Danmark ApS
Langebjerg 1
DK-4000 Roskilde

Ciprofloxacin

2 mg/ml

Solution for infusion

Intravenous use

50 ml, 100 ml, 200 ml

Denmark

Finland

Norway

Sweden

Nycomed Danmark ApS
Langebjerg 1
DK-4000 Roskilde

Nycomed Danmark ApS
Langebjerg 1
DK-4000 Roskilde

Nycomed Pharma AS
Drammernsveien 852
N-1372 Asker

Nycomed AB
Tegeluddvägen 17-21
S-102 53 Stockholm

Ciprofloxacin
Nycomed

Ciprofloxacin
Nycomed

Ciprofloxacin
Nycomed

Ciprofloxacin
Nycomed

2 mg/ml

Solution for infusion

Intravenous use

50 ml, 100 ml, 200 ml

2 mg/ml

Solution for infusion

Intravenous use

50 ml, 100 ml, 200 ml

2 mg/ml

Solution for infusion

Intravenous use

50 ml, 100 ml, 200 ml

2 mg/ml

Solution for infusion

Intravenous use

50 ml, 100 ml, 200 ml

.

.

2
9
2
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

5
6
/
1
9

C 56/20

EN

Official Journal of the European Union

29.2.2008

ANNEX IV

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

Member State

Marketing authorisation holder

Invented name

Strength

Pharmaceutical form

Route of administration

Austria

Austria

Belgium

Belgium

Czech Republic

Cyprus

Denmark

Estonia

Finland

Germany

Germany

Germany

Germany

Novartis Pharma GmbH
Brunner Straße 59
A-1235 Wien

Novartis Pharma GmbH
Brunner Straße 59
A-1235 Wien

Novartis Pharma NV
Medialaan 40 bus 1
B-1800 Vilvoorde

Novartis Pharma NV
Medialaan 40 bus 1
B-1800 Vilvoorde

Novartis s.r.o.
Pharma
Nagano III.
U Nákladového nádraží 10
CZ-130 00 Prague 3

Novartis Pharmaceuticals UK Ltd
Frimley Business Park
Frimley
Camberley
Surrey GU-167-SR
United Kingdom

Novartis Healthcare A/S
Lyngbyvej 172
DK-2100 København Ø

Novartis Finland Oy
Metsänneidonkuja 10
FI-02130 Espoo

Novartis Finland Oy
Metsänneidonkuja 10
FI-02130 Espoo

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nuernberg

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nuernberg

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nuernberg

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nuernberg

Prexige

100 mg

Film-coated tablet

Oral use

Frexocel

100 mg

Film-coated tablet

Oral use

Prexigem

100 mg

Film-coated tablet

Oral use

Stellige

100 mg

Film-coated tablet

Oral use

Prexige

100 mg

Film-coated tablet

Oral use

Prexige

100 mg

Film-coated tablet

Oral use

Prexige

100 mg

Film-coated tablet

Oral use

Prexige

100 mg

Film-coated tablet

Oral use

Prexige

100 mg

Film-coated tablet

Oral use

Prexige

100 mg

Film-coated tablet

Oral use

Frexocel

100 mg

Film-coated tablet

Oral use

Hirzia

100 mg

Film-coated tablet

Oral use

Stellige

100 mg

Film-coated tablet

Oral use

29.2.2008

EN

Official Journal of the European Union

C 56/21

Member State

Marketing authorisation holder

Invented name

Strength

Pharmaceutical form

Route of administration

Greece

Greece

Hungary

Iceland

Latvia

Lithuania

Luxembourg

Malta

Netherlands

Norway

Poland

Poland

Novartis Hellas Aebe
National Road a, 12 th Km
Metamorphosi Attikis
GR-14451

Novartis Hellas Aebe
National Road a, 12 th Km
Metamorphosi Attikis
GR-14451

Novartis Hungária Kft.
Bartók Béla út 43-47
H-1114 Budapest

Novartis Healthcare A/S, c/o
Vistor hf.
Hörgatúni 2
IS-210 Garðabær

Novartis Finland Oy
Metsänneidonkuja 10
FI-02130 Espoo

Novartis Finland Oy
Metsanneidonkuja 10
FI-02130 Espoo

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nürnberg

Novartis Pharmaceuticals UK Ltd.
Frimley Business Park
Frimley
Camberly
GU16 7SR Surrey
United Kingdom

Novartis Pharma B.V.
Raapopseweg 1
6824 DP Arnhem
Nederland

Novartis Norge AS
Brynsalléen 4
N-0667 Oslo

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nurnberg

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nurnberg

Prexige

100 mg

Film-coated tablet

Oral use

Frexocel

100 mg

Film-coated tablet

Oral use

Prexige

100 mg

Film-coated tablet

Oral use

Prexige

100 mg

Film-coated tablet

Oral use

Prexige

100 mg

Film-coated tablet

Oral use

Prexige

100 mg

Film-coated tablet

Oral use

Prexige

100 mg

Film-coated tablet

Oral use

Prexige

100 mg

Film-coated tablet

Oral use

Prexige

100 mg

Film-coated tablet

Oral use

Prexige

100 mg

Film-coated tablet

Oral use

Stellige

100 mg

Film-coated tablet

Oral use

Prexige

100 mg

Film-coated tablet

Oral use

C 56/22

EN

Official Journal of the European Union

29.2.2008

Member State

Marketing authorisation holder

Invented name

Strength

Pharmaceutical form

Route of administration

Portugal

Portugal

Portugal

Portugal

Slovakia

Slovenia

Slovenia

Spain

Spain

Sweden

United Kingdom

Frexocel

100 mg

Film-coated tablet

Oral use

Hirzia

100 mg

Film-coated tablet

Oral use

Prexige

100 mg

Film-coated tablet

Oral use

Stellige

100 mg

Film-coated tablet

Oral use

Prexige

100 mg

Film-coated tablet

Oral use

Frexocel

100 mg

Film-coated tablet

Oral use

Prexige

100 mg

Film-coated tablet

Oral use

Prexige

100 mg

Film-coated tablet

Oral use

Stellige

100 mg

Film-coated tablet

Oral use

Prexige

100 mg

Film-coated tablet

Oral use

Lumiracoxib
100 mg tablets

100 mg

Film-coated tablet

Oral use

Laboratório Normal
Produtos Farmacêuticos S.A
Rua do Centro Empresarial
Edificio 8 — Quinta da Beloura
P-2710-444 Sintra

Sociedade de Produtos Farmacêu-
ticos Wander Lda.
Rua do Centro Empresarial
Edificio 8 — Quinta da Beloura
P-2710-444 Sintra

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

Sanabo-Produtos
Farmacêuticos Lda.
Rua do Centro Empresarial
Edificio 8 — Quinta da Beloura
P-2710-444 Sintra

Novartis s.r.o., Nagano III.
U Nákladového nádraží 10
CZ-130 00 Praha 3

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nürnberg

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nürnberg

Novartis Farmacéutica S.A.
Gran Via de les Corts Catalanes
E-764 08013 Barcelona

Novartis Farmacéutica S.A.
Gran Via de les Corts Catalanes
E-764 08013 Barcelona

Novartis Sverige AB
Box 1150
S-183 11 Täby

Novartis Pharmaceuticals
UK Limited
Frimley Business Park
Frimley
Camberley
Surrey GU16 7SR
United Kingdom

29.2.2008

EN

Official Journal of the European Union

C 56/23

Member State

Marketing authorisation holder

Invented name

Strength

Pharmaceutical form

Route of administration

United Kingdom

United Kingdom

United Kingdom

United Kingdom

Novartis Pharmaceuticals
UK Limited
Frimley Business Park
Frimley
Camberley
Surrey GU16 7SR
United Kingdom

Novartis Pharmaceuticals
UK Limited
Frimley Business Park
Frimley
Camberley
Surrey GU16 7SR
United Kingdom

Novartis Pharmaceuticals
UK Limited
Frimley Business Park
Frimley
Camberley
Surrey GU16 7SR
United Kingdom

Novartis Pharmaceuticals
UK Limited
Frimley Business Park
Frimley
Camberley
Surrey GU16 7SR
United Kingdom

Prexige

100 mg

Film-coated tablet

Oral use

Frexocel

100 mg

Film-coated tablet

Oral use

Stellige

100 mg

Film-coated tablet

Oral use

Hirzia

100 mg

Film-coated tablet

Oral use

C 56/24

EN

Official Journal of the European Union

29.2.2008

ANNEX V

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

Cetirizine dihydrochloride Dermapharm 10 mg and associated names

Member State

Marketing authorisation
holder

Austria

Belgium

Germany

Netherlands

Dermapharm GmbH
Türkenstr. 25/12
A-1090 Wien

Dermapharm AG
Luise-Ullrich-Str. 6
D-82031 Grünwald

Dermapharm AG
Luise-Ullrich-Str. 6
D-82031 Grünwald

Dermapharm AG
Luise-Ullrich-Str. 6
D-82031 Grünwald

Product name

Strength

Pharmaceutical form

Route of administration

Cetiderm 10 mg Filmtabletten

10 mg

Film-coated tablet

Oral

Cetirizine dihydrochloride Dermapharm
10 mg filmomhulde tabletten

10 mg

Film-coated tablet

Oral

Cetiderm 10 mg Filmtabletten

10 mg

Film-coated tablet

Oral

Cetirizine dihydrochloride Dermapharm
10 mg tabletten

10 mg

Film-coated tablet

Oral

ANNEX VI

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

Cetirizine dihydrochloride Copyfarm 10 mg and associated names

Member State

Marketing authorisation
holder

Denmark

Netherlands

Norway

Sweden

Copyfarm A/S,
Energivej 15,
POB 69
DK-5260 Odense S

Copyfarm A/S
Energivej 15
POB 69
DK-5260 Odense S

Copyfarm A/S
Energivej 15,
POB 69,
DK-5260 Odense S

Copyfarm A/S
Energivej 15,
POB 69,
DK-5260 Odense S

Product name

Strength

Pharmaceutical form

Route of administration

Cetirizin ‘Copyfarm’

10 mg

Film-coated tablet

Oral

Cetirizine dihydrochloride Copyfarm 10 mg

10 mg

Film-coated tablet

Oral

Cetirizin Copyfarm

10 mg

Film-coated tablet

Oral

Cetirizin Copyfarm

10 mg

Film-coated tablet

Oral

29.2.2008

EN

Official Journal of the European Union

C 56/25

ANNEX VII

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

Cetirizine dihydrochloride APEX 10 mg and associated names

Member State Marketing authorisation holder

Product name

Strength

Pharmaceutical form

Route of administration

Belgium

Luxembourg

Netherlands

Docpharma N.V.
Ambachtenlaan 13 H
B-3001 Heverlee

Docpharma N.V.
Ambachtenlaan 13 H
B-3001 Heverlee

Apex Pharmaceuticals Ltd
2nd Floor, Devlin House
36 Saint George Street
Mayfair
W1S 2FW London
United Kingdom

Doccetiri

10 mg

Film-coated tablet

Oral

Doccetiri —10

10 mg

Film-coated tablet

Oral

Cetirizine dihydrochloride —
APEX 10 mg

10 mg

Film-coated tablet

Oral

ANNEX VIII

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

Cetirizine dihydrochloride Nordic Drugs 10 mg and associated names

Member State

Marketing authorisation
holder

Denmark

Finland

Netherlands

Norway

Sweden

Nordic Drugs AB
Box 300 35
S-200 61 Limhamn

Nordic Drugs AB
Box 300 35
S-200 61 Limhamn

Nordic Drugs AB
Box 300 35
S-200 61 Limhamn

Nordic Drugs AB
Box 30035
S-200 61 Limhamn

Nordic Drugs AB
Box 300 35
S-200 61 Limhamn

Product name

Strength

Pharmaceutical form

Route of administration

Gardex

10 mg

Film-coated tablet

Gardex

10 mg

Film-coated tablet

Cetirizine dihydrochloride
Nordic Drugs 10 mg

10 mg

Film-coated tablet

Acura

Acura

10 mg

Film-coated tablet

10 mg

Film-coated tablet

Oral

Oral

Oral

Oral

Oral

C 56/26

EN

Official Journal of the European Union

29.2.2008

ANNEX IX

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

Clobutinol containing medicinal products with marketing authorisation in the European Union

Member State

Marketing authorisation holder

Invented name

Strength

Pharmaceutical form

Route of
administration

Austria

Austria

Austria

Belgium

Belgium

Belgium

Boehringer Ingelheim Austria GmbH
Dr. Boehringer-Gasse 5-11
A-1121 Wien

Boehringer Ingelheim Austria GmbH
Dr. Boehringer-Gasse 5-11
A-1121 Wien

Boehringer Ingelheim Austria GmbH
Dr. Boehringer-Gasse 5-11
A-1121 Wien

SCS Boehringer Ingelheim Comm.V.,
Avenue Ariane 16
B-1200 Bruxelles

SCS Boehringer Ingelheim Comm.V.,
Avenue Ariane 16
B-1200 Bruxelles

SCS Boehringer Ingelheim Comm.V.,
Avenue Ariane 16
B-1200 Bruxelles

Silomat — Dragees

40 mg

Coated tablet

Oral use

Silomat — Hustensaft

40 mg/10 ml

Oral solution

Oral use

Silomat — Tropfen

60 mg/ml

Oral drops,
solution

Oral use

Silomat

40 mg

Tablets

Oral use

Silomat

60 mg

Oral solution

Oral use

Silomat

20 mg/5 ml

Syrup

Oral use

Czech Republic

SCS Boehringer Ingelheim Comm.V.,
Avenue Ariane 16
B-1200 Bruxelles

Silomat

20 mg/2 ml

Solution for
injection

Intramuscular
or intravenous use

Czech Republic

SCS Boehringer Ingelheim Comm.V.,
Avenue Ariane 16
B-1200 Bruxelles

Silomat

40 mg/10 ml

Syrup

Oral use

Czech Republic

Boehringer Ingelheim GmbH
Binger Straße 173
D-55216 Ingelheim am Rhein

Silomat

900 mg /15 ml Oral drops,

Oral use

solution

Germany

Germany

Boehringer Ingelheim Pharma GmbH &
Co.KG
Binger Str. 173
D-55216 Ingelheim

Clobutinol
Kapseln 80 mg

80 mg

Capsule, hard

Oral use

Boehringer Ingelheim Pharma GmbH &
Co.KG
Binger Str. 173
D-55216 Ingelheim

Clobutinol -Tropfen TH

40 mg/0,67 ml

Oral drops,
solution

Oral use

29.2.2008

EN

Official Journal of the European Union

C 56/27

Member State

Marketing authorisation holder

Invented name

Strength

Pharmaceutical form

Route of
administration

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Boehringer Ingelheim Pharma GmbH &
Co.KG
Binger Str. 173
D-55216 Ingelheim

Boehringer Ingelheim Pharma GmbH &
Co.KG
Binger Str. 173
D-55216 Ingelheim

Silomat Ampullen
gegen Reizhusten

20 mg/2 ml

Solution for
injection

Intramuscular
or intravenous use

Silomat Dragees gegen
Reizhusten

40 mg

Coated tablet

Oral use

Boehringer Ingelheim Pharma GmbH &
Co.KG
Binger Str. 173
D-55216 Ingelheim

Silomat Saft gegen
Reizhusten

40 mg/10 ml

Solution

Oral use

Boehringer Ingelheim Pharma GmbH &
Co.KG
Binger Str. 173
D-55216 Ingelheim

Chephasaar Chemisch-Pharmazeutische
Fabrik GmbH
Mühlstr. 50
D-66386 Sankt Ingbert

Chephasaar Chemisch-Pharmazeutische
Fabrik GmbH
Mühlstr. 50
D-66386 Sankt Ingbert

Silomat Tropfen gegen
Reizhusten

40 mg/0,67 ml

Oral drops,
solution

Oral use

Clobutinol-Chephasaar
Kapsel 40 mg

40 mg

Capsule, hard

Oral use

Clobutinol-Chephasaar
Saft 4mg/ml

4 mg/1 ml

Oral solution

Oral use

Chephasaar Chemisch-Pharmazeutische
Fabrik GmbH
Mühlstr. 50
D-66386 Sankt Ingbert

Clobutinol-MIP
Kapsel 40 mg

Chephasaar Chemisch-Pharmazeutische
Fabrik GmbH
Mühlstr. 50
D-66386 Sankt Ingbert

Clobutinol-MIP
Tropfen 80 mg/ml

40 mg

Capsule, hard

Oral use

80 mg/1 ml

Oral solution

Oral use

Chephasaar Chemisch-Pharmazeutische
Fabrik GmbH
Mühlstr. 50
D-66386 Sankt Ingbert

Chephasaar Chemisch-Pharmazeutische
Fabrik GmbH
Mühlstr. 50
D-66386 Sankt Ingbert

Chephasaar Chemisch-Pharmazeutische
Fabrik GmbH
Mühlstr. 50
D-66386 Sankt Ingbert

Chephasaar Chemisch-Pharmazeutische
Fabrik GmbH
Mühlstr. 50
D-66386 Sankt Ingbert

Rofatuss forte

80 mg

Capsule, hard

Oral use

Rofatuss N

40 mg

Capsule, hard

Oral use

Rofatuss Saft

400 mg/100 ml Oral solution

Oral use

Rofatuss Tropfen

80 mg/1 ml

Oral drops,
solution

Oral use

C 56/28

EN

Official Journal of the European Union

29.2.2008

Member State

Marketing authorisation holder

Invented name

Strength

Pharmaceutical form

Route of
administration

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Greece

EMRA-MED Arzneimittel GmbH
Otto Hahn-Str. 11
D-22946 Trittau

Silomat Dragees gegen
Reizhusten

40 mg

Coated tablet

Oral use

EMRA-MED Arzneimittel GmbH
Otto Hahn-Str. 11
D-22946 Trittau

Silomat Saft

40 mg/10 ml

Oral solution

Oral use

HEXAL AG
Industriestr. 25
D-83607 Holzkirchen

HEXAL AG
Industriestr. 25
D-83607 Holzkirchen

HEXAL AG
Industriestr. 25
D-83607 Holzkirchen

HEXAL AG
Industriestr. 25
D-83607 Holzkirchen

Clobutinol Tropfen

40 mg/0,67 ml

Oral drops,
solution

Oral use

Tussed Hustenstiller
Dragees

40 mg

Coated tablet

Oral use

Tussed Hustenstiller Saft

40 mg/10 ml

Oral solution

Oral use

Tussed Hustenstiller
Tropfen

40 mg/0,67 ml

Solution

Oral use

Hofmann & Sommer GmbH & Co.KG
Chemisch-pharmazeutische Fabrik
Lindenstr. 11
D-07426 Königsee

Nullatuss Clobutinol
Hustentropfen

6 g/100 g

Oral drops,
solution

Oral use

kohlpharma GmbH
Im Holzhau 8
D-66663 Merzig

Pharma Westen GmbH
Fixheider Str. 4
D-51381 Leverkusen

Pharma Westen GmbH
Fixheider Str. 4
D-51381 Leverkusen

ratiopharm GmbH
Graf Arco-Str. 3
D-89079 Ulm

ratiopharm GmbH
Graf Arco-Str. 3
D-89079 Ulm

ratiopharm GmbH
Graf Arco-Str. 3
D-89079 Ulm

Silomat Tropfen gegen
Reizhusten

40 mg/0,67 ml

Oral solution

Oral use

Silomat Dragees gegen
Reizhusten

40 mg

Coated tablet

Oral use

Silomat Saft gegen
Reizhusten

40 mg/10 ml

Oral solution

Oral use

Hustenstiller-ratiopharm
Clobutinol

20 mg/5 ml

Oral solution

Oral use

Hustenstiller-ratiopharm
Clobutinol Kapseln

80 mg

Capsule, hard

Oral use

Hustenstiller-ratiopharm
Clobutinol Tropfen

80 mg/1 ml

Oral solution

Oral use

Boehringer Ingelheim Hellas S.A.
2 Ellinikou str.
GR-16777 Athens

Silomat Compositum
(Clobutinol HCl + Orci-
prenaline Sulfate)

20+5 mg/5ml

Syrup

Oral use

29.2.2008

EN

Official Journal of the European Union

C 56/29

Member State

Marketing authorisation holder

Invented name

Strength

Pharmaceutical form

Route of
administration

Greece

Greece

Finland

Finland

Finland

France

France

France

France

Boehringer Ingelheim Hellas S.A.
2 Ellinikou str.
GR-16777 Athens

Boehringer Ingelheim Hellas S.A.
2 Ellinikou str.
GR-16777 Athens

Boehringer Ingelheim Finland Oy
Tammisaarenkatu 5
FI-00180 Helsinki

Boehringer Ingelheim Finland Oy
Tammisaarenkatu 5
FI-00180 Helsinki

Orion Corporation, ORION PHARMA
Tengströminkatu 8
P.O. Box 425
FI-20101 Turku

BOEHRINGER INGELHEIM FRANCE
37-39, rue Boissière
F-75116 Paris

BOEHRINGER INGELHEIM FRANCE
37-39, rue Boissière
F-75116 Paris

BOEHRINGER INGELHEIM FRANCE
37-39, rue Boissière
F-75116 Paris

BOEHRINGER INGELHEIM FRANCE
37-39, rue Boissière
F-75116 Paris

Silomat

60 mg/ml

Oral solution,
drops

Oral use

Silomat

20 mg/5ml

Syrup

Oral use

Silomat

4 mg/ml

Oral solution

Oral use

Silomat

40 mg

Coated tablet

Oral use

Mixtus

4 mg/ml

Oral solution

Oral use

Silomat

0,40 %

Syrup

Oral use

Silomat

20 mg/2 ml

Solution for
injection

Intramuscular
or intravenous use

Silomat

40 mg

Coated tablet

Oral use

Silomat

6 %

Oral drops,
solution

Oral use