Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 April 2008 to 30 April 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: 2008-05-30
Institutions: European Commission
Subjects: EU Member State, market approval, marketing standard, medicinal product, pharmaceutical legislation

30.5.2008

EN

Official Journal of the European Union

C 132/11

Summary of Community decisions on marketing authorizations in respect of medicinal products
from 1 April 2008 to 30 April 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 132/04)

— 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

1.4.2008

Menitorix

2.4.2008

Compagel gel for
horses

See Annex I

See Annex II

See Annex I

See Annex II

Date of
notification

2.4.2008

3.4.2008

16.4.2008

Thalidomide Pharmion

17.4.2008

Solacyl 100 % powder
for oral solution

21.4.2008

Volibris

25.4.2008 Mycamine

25.4.2008

NovoSeven

Pharmion Ltd, Riverside House
Riverside Walk
Windsor SL4 1NA
United Kingdom

This Decision is addressed
to the Member States

17.4.2008

See Annex III

See Annex III

18.4.2008

Glaxo Group Ltd
Greenford
Middlesex UB6 0NN
United Kingdom

Astellas Pharma GmbH
Neumarkter Str. 61
D-81673 München

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

This Decision is addressed
to the Member States

22.4.2008

This Decision is addressed
to the Member States

28.4.2008

This Decision is addressed
to the Member States

28.4.2008

— 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

17.4.2008

Eformax

See Annex IV

See Annex IV

Date of
notification

18.4.2008

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

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

ANNEX I

Member State

Marketing Authorisation Holder

Applicant

Invented Name

Strength (*)

Pharmaceutical form

Route of administration

Content
(concen-
tration)

United Kingdom SmithKline Beecham PLC

980 Great West Road
Brentford
Middlesex TW8 9GS
United Kingdom

GlaxoSmithkline Biologicals S.A.
89, rue de l'Institut
B-1330 Rixensart

Belgium

Greece

Ireland

Poland

Spain

Menitorix

5 μg Hib PRP + 12,5 μg TT +
5 μg MenC PSC + 5 μg TT

Powder and solvent
solution for injection

for

Intramuscular
tion

injec-

0,5 ml

Menitorix

5 μg Hib PRP + 12,5 μg TT +
5 μg MenC PSC + 5 μg TT

Powder and solvent
solution for injection

for

Intramuscular
tion

injec-

0,5 ml

Menitorix

5 μg Hib PRP + 12,5 μg TT +
5 μg MenC PSC + 5 μg TT

Powder and solvent
solution for injection

for

Intramuscular
tion

injec-

0,5 ml

Menitorix

5 μg Hib PRP + 12,5 μg TT +
5 μg MenC PSC + 5 μg TT

Powder and solvent
solution for injection

for

Intramuscular
tion

injec-

0,5 ml

Menitorix

5 μg Hib PRP + 12,5 μg TT +
5 μg MenC PSC + 5 μg TT

Powder and solvent
solution for injection

for

Intramuscular
tion

injec-

0,5 ml

Menitorix

5 μg Hib PRP + 12,5 μg TT +
5 μg MenC PSC + 5 μg TT

Powder and solvent
solution for injection

for

Intramuscular
tion

injec-

0,5 ml

GlaxoSmithkline Α.Ε.Β.Ε.
266 Leof. Kifisias
GR-152 32 Halandri

GlaxoSmithKline (Ireland) Ltd
Stonemasons Way
Rathfarnham
Dublin 16
Ireland

SmithKline Beecham plc
980 Great West Road
Brentford
Middlesex TW8 9GS
United Kingdom

GlaxoSmithKline S.A.
Severo Ochoa no 2
Tres Cantos
E-28760 Madrid

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(*) Hib PRP — Haemophilus influenzae type B polyribosylribitol phosphate

TT — Tetanus toxoid
MenC PSC — Neisseria meningitidis serogroup C polysaccharide.

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

ANNEX II

Applicant or Marketing Authorisation Holder

Product invented name

Pharmaceutical
form

Strength

Animal
species

Frequency and
route of
administration

Recommended dose

Boehringer Ingelheim Vetmedica GmbH
Binger Str. 173
D-55216 Ingelheim

Compagel gel for horses

Gel

100 g gel contains:

Horse

Topical

heparin sodium 50 000 IU

levomenthol 0,5 g

hydroxyethyl salicylate 5,0 g

ANNEX III

Up to a total daily quantity of 50 g gel per
day is applied using finger tip pressure
onto the affected area according to the
veterinary surgeon's instructions until signs
and symptoms resolve.

After nerve block anaesthesia
the gel
should be applied to the skin in a layer the
thickness of
the back of a knife and
covered with a bandage

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

Applicant or Marketing
Authorisation Holder

Product invented name

Pharmaceutical
form

Strength

Animal species

Frequency and
route of
administration

Recommended dose

Eurovet animal Health B.V.

Solacyl 100 % powder for
oral solution

Powder

100 %

Calves and pigs Oral

Calves: 20 mg sodium salicylate per kg bodyweight twice daily, for 1 to 3 days.

Administration: orally in drinking water or milk (replacer).

Pigs: 35 mg sodium salicylate per kg bodyweight per day, for 3 to 5 days.

Administration: orally in drinking water.

Alternatively, Solacyl can also be administered with the drinking water as pulse
medication. Half of the calculated total daily amount of powder is mixed with
5-10 litres of clean water and stirred until evenly dispersed. This solution is then
added, whilst stirring, into an amount of drinking water that will be consumed
within approximately 3-4 hours and administered twice daily

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

ANNEX IV

Member State

Marketing Authorisation Holder

Applicant

(Invented) Name

Strength

Pharmaceutical form

Route of
administration

Content
(concentration)

Denmark

Cyprus

Czech Republic

Estonia

Germany

Norton Healthcare Ltd
(trading as IVAX Pharmaceuti-
cals UK)
IVAX Quays
Albert Basin
Royal Docks
London E16 2QJ
United Kingdom

Eformax 6 µg

6 micrograms

Inhalation powder

Inhalation use

6 micrograms

Eformax 12 µg

12 micrograms

Inhalation powder

Inhalation use

12 micrograms

Norton Healthcare Ltd
(trading as IVAX Pharmaceuti-
cals UK)
IVAX Quays
Albert Basin
Royal Docks
London E16 2QJ
United Kingdom

Eformax 6 mcg
Σκόνη για εισπνοή

Eformax 12 mcg
Σκόνη για εισπνοή

Teva Pharmaceuticals ČR, s.r.o
Radlická 3185/1c
CZ-150 00 Praha 5

Eformax 6 µg
Prášek k inhalaci

Teva Pharma B.V.
Computerweg 10
3542 DR, Utrecht
Nederland

Eformax 12 µg
Prášek k inhalaci

Eformax

Eformax

Norton Healthcare Ltd
(trading as IVAX Pharmaceuti-
cals UK)
IVAX Quays
Albert Basin
Royal Docks
London E16 2QJ
United Kingdom

Eformax 6 Mikrogramm
Pulver zur Inhalation

Eformax 12 Mikrogramm
Pulver zur Inhalation

6 micrograms

Inhalation powder

Inhalation use

6 micrograms

12 micrograms

Inhalation powder

Inhalation use

12 micrograms

6 micrograms

Inhalation powder

Inhalation use

6 micrograms

12 micrograms

Inhalation powder

Inhalation use

12 micrograms

6 micrograms

Inhalation powder

Inhalation use

6 micrograms

12 micrograms

Inhalation powder

Inhalation use

12 micrograms

6 micrograms

Inhalation powder

Inhalation use

6 micrograms

12 micrograms

Inhalation powder

Inhalation use

12 micrograms

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Member State

Marketing Authorisation Holder

Applicant

(Invented) Name

Strength

Pharmaceutical form

Route of
administration

Content
(concentration)

Latvia

Lithuania

Malta

Poland

Portugal

Slovakia

Teva Pharma B.V.
Computerweg 10
3542 DR, Utrecht
Nederland

Teva Pharma B.V.
Computerweg 10
3542 DR, Utrecht
Nederland

Norton Healthcare Ltd
(trading as IVAX Pharmaceuti-
cals UK)
IVAX Quays
Albert Basin
Royal Docks
London E16 2QJ
United Kingdom

Norton Healthcare Ltd
(trading as IVAX Pharmaceuti-
cals UK)
IVAX Quays
Albert Basin
Royal Docks
London E16 2QJ
United Kingdom

Eformax

Eformax

6 micrograms

Inhalation powder

Inhalation use

6 micrograms

12 micrograms

Inhalation powder

Inhalation use

12 micrograms

Eformax 6 mikrogramų/dozėje
inhaliaciniai milteliai

Eformax 12 mikrogramų
dozėje inhaliaciniai milteliai

Eformax 6 µg
Trab li jittieħed bin-nifs

Eformax 12 µg
Trab li jittieħed bin-nifs

Eformax 6 mcg
proszek do inhalacji

Eformax 12 mcg
proszek do inhalacji

6 micrograms

Inhalation powder

Inhalation use

6 micrograms

12 micrograms

Inhalation powder

Inhalation use

12 micrograms

6 micrograms

Inhalation powder

Inhalation use

6 micrograms

12 micrograms

Inhalation powder

Inhalation use

12 micrograms

6 micrograms

Inhalation powder

Inhalation use

6 micrograms

12 micrograms

Inhalation powder

Inhalation use

12 micrograms

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

Eformax

Eformax

Norton Healthcare Ltd
(trading as IVAX Pharmaceuti-
cals UK)
IVAX Quays
Albert Basin
Royal Docks
London E16 2QJ
United Kingdom

Eformax 6
Inhalačný prášok

Eformax 12 µg
Inhalačný prášok

6 micrograms

Inhalation powder

Inhalation use

6 micrograms

12 micrograms

Inhalation powder

Inhalation use

12 micrograms

6 micrograms

Inhalation powder

Inhalation use

6 micrograms

12 micrograms

Inhalation powder

Inhalation use

12 micrograms

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Member State

Marketing Authorisation Holder

Applicant

(Invented) Name

Strength

Pharmaceutical form

Route of
administration

Content
(concentration)

Sweden

Teva Sweden AB
P.O. Box 1070
S-25 110 Helsingborg

Eformax 6 µg
inhalationspulver

Eformax 12 µg
inhalationspulver

6 micrograms

Inhalation powder

Inhalation use

6 micrograms

12 micrograms

Inhalation powder

Inhalation use

12 micrograms

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