Summary of Community decisions on marketing authorizations in respect of medicinal products from 1.10.2006 to 31.10.2006 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
Date: 2006-11-24
Institutions: European Commission
Subjects: market approval, marketing standard, medicinal product, pharmaceutical legislation

C 287/12

EN

Official Journal of the European Union

24.11.2006

Summary of Community decisions on marketing authorizations in respect of medicinal products
from 1.10.2006 to 31.10.2006

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

(2006/C 287/04)

— 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

Date of
notification

11.10.2006 Doxastad (doxazosin) Art 29

See Annex I

See Annex I

13.10.2006

11.10.2006 Doxazosin Winthrop (doxazosin) Art 29 -

See Annex II

See Annex II

13.10.2006

11.10.2006

Cardoreg (doxazosin) Art 29

See Annex III

See Annex III

13.10.2006

11.10.2006 Doxagamma (doxazosin) Art 29

See Annex IV

See Annex IV

13.10.2006

11.10.2006 Doxazosin Retard Arrow (doxazosin) Art 29

See Annex V

See Annex V

13.10.2006

13.10.2006

Cobactan DC Art 39

See Annex VI

See Annex VI

16.10.2006

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

24.11.2006

EN

Official Journal of the European Union

C 287/13

ANNEX I

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

Member State

Marketing Authorisation
Holder

Applicant

Invented name

Strength

Pharmaceutical Form

Route of
administ-
ration

Estonia

Latvia

Lithuania

Netherlands

Spain

Sweden

United
Kingdom

STADA Arzneimittel AG
Stadastr. 2-18,
D.61118 Bad Vilbel
Tél: 0049 6101 603301
Fax: 0049 6101 603151

4 mg

Doxalfa
prolongeeritult
tabletid

toimeainet
vabastavad

4 mg

Prolonged-release
tablet

Oral

Doxalfa
4 mg
darbības tabletes

ilgstošās

4 mg

Prolonged-release
tablet

Oral

Doxalfa 4 mg pailginto atpa-
laidavimo tabletės

4 mg

Prolonged-release
tablet

Oral

Doxazosine retard CF 4mg,
tabletten met
gereguleerde
afgifte

4 mg

Prolonged-release
tablet

Oral

DOXAZOSINA NEO STADA
4 mg comprimidos de libera-
ción prolongada EEG

4 mg

Prolonged-release
tablet

Oral

Doxastad 4mg depottablett

4 mg

Prolonged-release
tablet

Oral

Doxadura XL 4 mg

4 mg

Prolonged-release
tablet

Oral

STADA Arzneimittel AG
Stadastr. 2-18,
D-61118 Bad Vilbel
Tél: 0049 6101 603301
Fax: 0049 6101 603151

STADA Arzneimittel AG
Stadastr. 2-18,
D-61118 Bad Vilbel
Tél:: 0049 6101 603301
Fax: 0049 6101 603151

STADA Arzneimittel AG
Stadastr. 2-18,
D-61118 Bad Vilbel
Tél: 0049 6101 603301
Fax: 0049 6101 603151

Cerntrafarm Services
B.V. Nieuwe Donk 9
4879 AC Etten-Leur
Nederland
Tél: 0031 765 081000
Fax: 0031 765 035614

Laboratorio STADA,
S.L. Frederic Mompou, 5
08960 Sant Just Desvern
E-Barcelone
Tél: 0034 93 47 38889
Fax: 0034 93 47 37495

Genus Pharmaceuticals
Benham Valence, Speen
Newbury
Berkshire RG20 8LU
United Kingdom
Tél: 01635 568400
Fax: 01635 568401

C 287/14

EN

Official Journal of the European Union

24.11.2006

ANNEX II

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

Member State

Marketing Authorisation
Holder

Applicant

Name

Strength

Pharmaceutical Form

Route of
administ-
ration

Denmark

Germany

Hungary

Poland

Slovakia

Spain

United
Kingdom

Doxazosin ‘Winthrop’

4 mg

Prolonged release
tablets

Oral

Winthrop Pharmaceuticals
UK Ltd
1 Onslow Street
Guildford
Surrey GU1 4YS
Royaume-Uni
Tél: 00 44 (0)
1483 55 48 31
Fax: 00 44 (0)
1483 55 48 31

Doxazosin Winthrop 4 mg
Retardtabletten

4 mg

Prolonged release
tablets

Oral

Doxazosin Winthrop 4mg
Tablettes

4 mg

Prolonged release
tablets

Oral

DOXAWIN XL

4 mg

Prolonged release
tablets

Oral

Doxazosin Winthrop XL
4 mg

4 mg

Prolonged release
tablets

Oral

Doxazosina WINTHROP
de
4 mg
liberación prolongada EFG

comprimidos

4 mg

Prolonged release
tablets

Oral

Slocinx XL 4mg Tablets

4 mg

Prolonged release
tablets

Oral

Winthrop Arzneimittel
GmbH
Industriestrasse 10 82256
D-Furstenfeldbruck
Tél: 0049 (0) 81 41 3572
324
Fax: 0049 (0) 81 41 3572
329

Chinoin Pharmaceuticals
and Chemical Works Co
Ltd 1045 H-Budapest, To
utca 1-5
Tél: 0036 1 505 0000
Fax: 0036 1 505 0005

Winthrop Medicaments
1-13 Bd Romain Rolland
F-75014, Paris
Tél: 0033 (0) 1 57 63 33
33
Fax: 0033 (0) 1 57 63 33
30

Winthrop Médicaments
1-13 Bd Romain Rolland
F-75014 Paris
Tél: 0033 (0) 1 57 63 33
33
Fax: 0033 (0) 1 57 63 33
30

Winthrop Pharmaceuticals
UK Ltd
1 Onslow Street
Guildford
Surrey GU1 4YS
United Kingdom
Tél: 00 44 (0)
1483 55 48 31
Fax: 00 44 (0)
1483 55 48 31

Winthrop Pharmaceuticals
UK Ltd
1 Onslow Street
Guildford
Surrey GU1 4YS
United Kingdom

24.11.2006

EN

Official Journal of the European Union

C 287/15

ANNEX III

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

Member State

Marketing Authorisation
Holder

Applicant

Invented name

Strength

Pharmaceutical Form

Route of
administ-
ration

Pharmcom Oy
Keijumaki 6B 30
FIN-02130 Espoo
Tél: 00358 407 075670
Fax: 00358 94524872

Czech Republic

Denmark

Hungary

Poland

Slovakia

United Kingdom

Ratiopharm GmBH
Graf-Arco-Strasse 3
D-89079 Ulm
Tél: 0049 731 40202
Fax: 0049 731 4027330

Ratiopharm Hungaria Kft.
Uzoki utca 36/a
H-1145 Budapest
Tél: 0036 1 2732730
Fax: 0036 1 2732731

Ratiopharm GmBH
Graf-Arco-Strasse 3
D-89079 Ulm
Tél: 0049 731 40202
Fax: 0049 731 4027330

Ratiopharm GmBH
Graf-Arco-Strasse 3
D-89079 Ulm
Tél: 0049 731 40202
Fax:0049 731 4027330

Ratiopharm GmBH
Graf-Arco-Strasse 3
D-89079 Ulm
Tél: 0049 731 40202
Fax: 0049 731 4027330

Lansoprazol-ratiopharm
4 mg Hartkapseln

4 mg

Prolonged release
tablets

Oral

Cardoreg 4 mg depotta-
bletter

4 mg

Prolonged release
tablets

Oral

Doxazosin-ratiopharm
retard 4 mg tabletta

4 mg

Prolonged release
tablets

Oral

Doxazosin-ratiopharm
retard PR4

4 mg

Prolonged release
tablets

Oral

Doxazosin-ratiopharm
retard 4 mg

4 mg

Prolonged release
tablets

Oral

DoxaCard
prolonged release tablets

XL

4 mg

4 mg

Prolonged release
tablets

Oral

C 287/16

EN

Official Journal of the European Union

24.11.2006

ANNEX IV

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

MEMBER STATES

Member State

Marketing Authorisation
Holder

Applicant

Invented name

Strength

Pharmaceutical Form

Route of
administrati-
on

Generics [UK] Ltd.
Station Close
Potters Bar
Herts EN6 1TL.
United Kingdom
Tél: 00 44 1707 853000
Fax: 00 44 1707 650734

Denmark

United
Kingdom

Doxagamma

4mg

Prolonged-release
tablet

oral

Doxzogen XL 4mg Tablets 4mg

Prolonged-release
tablet

oral

Generics [UK] Ltd.,
Station Close, Potters Bar,
Herts,EN6 1TL.
United Kingdom
Tél: 00 44 1707 853000
Fax: 00 44 1707 650734

24.11.2006

EN

Official Journal of the European Union

C 287/17

ANNEX V

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

Member State

Marketing Authorisation Holder

Applicant

Name

Strength

Pharmaceutical Form

Route of
administ-
ration

Arrow Generics UK Ltd
Unit 2 Eastman Way
Stevenage
Hertfordshire, SG1 4SZ
United Kingdom
Tél.: 00 44 207 612 7612
Fax: 00 44 207 612 7620

Denmark

Portugal

Slovenia

United
Kingdom

Doxazosin
4mg depottabletter

‘Arrow’,

4 mg

Prolonged release
tablets

Oral

Doxazosin
Arrow
4mg comprimido de
libertaçao prolongada

4 mg

Prolonged release
tablets

Oral

Doksazosin
Arrow
4mg tablete s podal-
jšanim sproščanjem

4 mg

Prolonged release
tablets

Oral

Cardozin XL 4mg

4 mg

Prolonged release
tablets

Oral

Arrowblue Produtos Farnda-
cêuticos S.A.
Torre Fernão Magalhães
10o Esq., Av. D. João II — P-
Lisbonne
Tél.: 00 351 21 896 51 05
Fax: 00 351 21896 51 05

Arrow Generics UK Ltd
Unit 2 Eastman Way
Stevenage
Hertfordshire, SG1 4SZ
United Kingdom
Tél.: 00 44 207 612 7612
Fax: 00 44 207 612 7620

Arrow Generics UK Ltd
Unit 2 Eastman Way
Stevenage
Hertfordshire, SG1 4SZ
United Kingdom
Tél.: 00 44 207 612 7612
Fax: 00 44 207 612 7620

ANNEX VI

LIST OF NAMES, PHARMACEUTICAL FORM OF THE MEDICINAL PRODUCTS, ANIMAL SPECIES,
ROUTE OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER
STATES

Member State

Marketing Authorisation
Holder

Belgium

Intervet International B.V.
Wim de Körverstraat 35
NL -5831 AN Boxmeer

Product invented name

Pharmaceutical form

Animal species

Frequency

Recommended dose

Cobactan DC

Intramammary ointment

Dairy cows

Single dose

150 mg cefquinome

Czech Republic

Intervet International B.V.
Wim de Körverstraat 35
NL -5831 AN Boxmeer

Cobactan DC intramam
susp. Ad us. Vet

Intramammary ointment

Dairy cows

Single dose

150 mg cefquinome

Germany

Estonia

Greece

Spain

France

Ireland

Italy

Intervet Deutschland
GmbH
Feldstr. 1a
D-85716 Unterschleis-
sheim

Intervet International B.V.
Wim de Körverstraat 35
NL -5831 AN Boxmeer

Intervet International B.V.
Wim de Körverstraat 35
NL -5831 AN Boxmeer

Intervet International B.V.
Wim de Körverstraat 35
NL -5831 AN Boxmeer

Cobactan DC

Intramammary ointment

Dairy cows

Single dose

150 mg cefquinome

Cobactan DC

Intramammary ointment

Dairy cows

Single dose

150 mg cefquinome

Cobactan DC

Intramammary ointment

Dairy cows

Single dose

150 mg cefquinome

Cobactan DC

Intramammary ointment

Dairy cows

Single dose

150 mg cefquinome

Intervet International B.V.
Wim de Körverstraat 35
NL -5831 AN Boxmeer

Cobactan DC suspen-
sion intramammaire

Intramammary ointment

Dairy cows

Single dose

150 mg cefquinome

Intervet Ireland
Magna Drive
Magna Business Park
Citywest Road
IE-Dublin 24

Intervet International B.V.
Wim de Körverstraat 35
NL -5831 AN Boxmeer

Cephaguard DC

Intramammary ointment

Dairy cows

Single dose

150 mg cefquinome

Cobactan DC

Intramammary ointment

Dairy cows

Single dose

150 mg cefquinome

Withdrawal period
(meat and milk)

Meat and offal: 2 days
Milk: 49 days

Meat and offal: 2 days
Milk: 49 days

Meat and offal: 2 days
Milk: 49 days

Meat and offal: 2 days
Milk: 49 days

Meat and offal: 2 days
Milk: 49 days

Meat and offal: 2 days
Milk: 49 days

Meat and offal: 2 days
Milk: 49 days

Meat and offal: 2 days
Milk: 49 days

Meat and offal: 2 days
Milk: 49 days

C

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7
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Member State

Marketing Authorisation
Holder

Product invented name

Pharmaceutical form

Animal species

Frequency

Recommended dose

Cobactan DC

Intramammary ointment

Dairy cows

Single dose

150 mg cefquinome

Withdrawal period
(meat and milk)

Meat and offal: 2 days
Milk: 49 days

.

2
4
1
1
2
0
0
6

.

Cyprus

Latvia

Lithuania

Luxembourg

Austria

Poland

Portugal

Slovenia

Slovakia

United Kingdom

Intervet International B.V.
Wim de Körverstraat 35
NL -5831 AN Boxmeer

Intervet International B.V.
Wim de Körverstraat 35
NL -5831 AN Boxmeer

Intervet International B.V.
Wim de Körverstraat 35
NL -5831 AN Boxmeer

Intervet International B.V.
Wim de Körverstraat 35
NL -5831 AN Boxmeer

Intervet Gesmbh Siemens-
strasse 107
A -1210 Vienne

Intervet International B.V.
Wim de Körverstraat 35
NL -5831 AN Boxmeer

Intervet Portugal, Lda.
Estrada Nacional 249
PT-2725-397 Mem Martins

Intervet International B.V.
Wim de Körverstraat 35
NL -5831 AN Boxmeer

Intervet International B.V.
Wim de Körverstraat 35
NL -5831 AN Boxmeer

Intervet International B.V.
Wim de Körverstraat 35
NL -5831 AN Boxmeer

Cobactan DC

Intramammary ointment

Dairy cows

Single dose

150 mg cefquinome

Meat and offal: 2 days
Milk: 49 days

E
N

Cobactan DC

Intramammary ointment

Dairy cows

Single dose

150 mg cefquinome

Cobactan DC

Intramammary ointment

Dairy cows

Single dose

150 mg cefquinome

Cobactan DC

Intramammary ointment

Dairy cows

Single dose

150 mg cefquinome

Cobactan DC

Intramammary ointment

Dairy cows

Single dose

150 mg cefquinome

Cobactan DC

Intramammary ointment

Dairy cows

Single dose

150 mg cefquinome

Cobactan DC

Intramammary ointment

Dairy cows

Single dose

150 mg cefquinome

Cobactan DC

Intramammary ointment

Dairy cows

Single dose

150 mg cefquinome

Cobactan DC

Intramammary ointment

Dairy cows

Single dose

150 mg cefquinome

Meat and offal: 2 days
Milk: 49 days

Meat and offal: 2 days
Milk: 49 days

Meat and offal: 2 days
Milk: 49 days

Meat and offal: 2 days
Milk: 49 days

Meat and offal: 2 days
Milk: 49 days

Meat and offal: 2 days
Milk: 49 days

Meat and offal: 2 days
Milk: 49 days

Meat and offal: 2 days
Milk: 49 days

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