Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 April 2007 to 30 April 2007 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
Date: 2007-05-25
Institutions: European Commission
Subjects: EU Member State, market approval, marketing standard, medicinal product, pharmaceutical legislation, veterinary drug, withdrawal from the market

C 115/10

EN

Official Journal of the European Union

25.5.2007

Summary of Community decisions on marketing authorizations in respect of medicinal products
from 1 April 2007 to 30 April 2007

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

(2007/C 115/04)

— 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

13.4.2007

Alendronate Hexal

See Annex I

See Annex I

18.4.2007

13.4.2007

Gadovist

See Annex II

See Annex II

19.4.2007

13.4.2007

Gadograf

See Annex III

See Annex III

19.4.2007

17.4.2007

Dolovet

See Annex IV

See Annex IV

20.4.2007

17.4.2007

Suvaxyn Parvo E

See Annex V

See Annex V

20.4.2007

19.4.2007

Suvaxyn Ery

See Annex VI

See Annex VI

20.4.2007

— 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

Date of notification

2.4.2007

Equimectin

See Annex VII

See Annex VII

3.4.2007

13.4.2007

Mefecur

See Annex VIII

See Annex VIII

19.4.2007

13.4.2007

Mefecomb

See Annex IX

See Annex IX

20.4.2007

13.4.2007

Mefelor

See Annex X

See Annex X

19.4.2007

13.4.2007

Mefesan

See Annex XI

See Annex XI

19.4.2007

13.4.2007

Metofelosan

See Annex XII

See Annex XII

20.4.2007

13.4.2007

Metoprolol/Felodipin
‘YES’

See Annex XIII

See Annex XIII

18.4.2007

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

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

ANNEX I

Member State

Marketing Authorisation Holder

Applicant

Invented name
Name

Strength

Pharmaceutical form

Route of
administration

Content (concentration)

HEXAL A/S
Kanalholmen 8-12
DK-2650 Hvidovre

Sweden

Belgium

Denmark

Greece

HEXAL A/S
Kanalholmen 8-12
DK-2650 Hvidovre

HEXAL A/S
Kanalholmen 8-12
DK-2650 Hvidovre

HEXAL A/S
Kanalholmen 8-12
DK-2650 Hvidovre

Alendronat HEXAL

10 mg

Tablets

Oral use

10 mg per tablet

Alendronate Sandoz
10 mg tabletten

10 mg

Tablets

Oral use

10 mg per tablet

Alendonicht

10 mg

Tablets

Oral use

10 mg per tablet

Forosa

10 mg

Tablets

Oral use

10 mg per tablet

.

.

2
5
5
2
0
0
7

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
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a
n
U
n
o
n

i

C

1
1
5
/
1
1

C 115/12

EN

Official Journal of the European Union

25.5.2007

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

ANNEX II

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Austria

Austria

Belgium

Belgium

Denmark

Denmark

Germany

Germany

Greece

Greece

Spain

Spain

Schering Austria GmbH
Wienerbergstraße 41
Euro Plaza-Gebäude F/PF45
A-1121 Wien

Schering Austria GmbH
Wienerbergstraße 41
Euro Plaza-Gebäude F/PF45
A-1121 Wien

NV Schering S.A.
J.E. Mommaertslaan, 14
B-1831 Machelen (Diegem)

NV Schering S.A.
J.E. Mommaertslaan, 14
B-1831 Machelen (Diegem)

Schering AG
Müllerstr. 178
D-13342 Berlin-Mitte

Schering AG
Müllerstr. 178
D-13342 Berlin-Mitte

Schering Deutschland GmbH
Max-Dohrn-Strasse 10
D-10589 Berlin

Schering Deutschland GmbH
Max-Dohrn-Strasse 10
D-10589 Berlin

Schering Hellas SA
466 Irakliou Ave. & 12-14
Kyprou Str.
Neo Iraklio
GR-14122 Athens

Schering Hellas SA
466 Irakliou Ave. &12-14
Kyprou Str.
Neo Iraklio
GR-14122 Athens

Schering España, S.A.
c/ Mendez Alvaro, 55
E-28045 Madrid

Schering España, S.A.
c/ Mendez Alvaro, 55
E-28045 Madrid

Gadovist

1 mmol/ml

Solution for injection

Intravenous use

Gadovist

1 mmol/ml

Solution
prefilled syringe

for

Injection

in

Intravenous use

Gadovist

1 mmol/ml

Solution for injection

Intravenous use

Gadovist

1 mmol/ml

Solution
prefilled syringe

for

Injection

in

Intravenous use

Gadovist

1 mmol/ml

Solution for injection

Intravenous use

Gadovist

1 mmol/ml

Solution
prefilled syringe

for

Injection

in

Intravenous use

Gadovist

1 mmol/ml

Solution for injection

Intravenous use

Gadovist

1 mmol/ml

Solution
prefilled syringe

for

Injection

in

Intravenous use

Gadovist

1 mmol/ml

Solution for injection

Intravenous use

Gadovist

1 mmol/ml

Solution
prefilled syringe

for

Injection

in

Intravenous use

Gadovist

1 mmol/ml

Solution for injection

Intravenous use

Gadovist

1 mmol/ml

Solution
prefilled syringe

for

Injection

in

Intravenous use

25.5.2007

EN

Official Journal of the European Union

C 115/13

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Finland

Finland

France

France

Ireland

Ireland

Italy

Italy

Luxembourg

Luxembourg

Netherlands

Netherlands

Norway

Norway

Schering Oy
Pansiontie 47
Post Box 415
FIN-20101 Turku

Schering Oy
Pansiontie 47
Post Box 415
FIN-20101 Turku

Schering SA
Z.I. Roubaix-Est
rue de Toufflers
BP 69
F-59452 Lys-Lez-Lannoy
Cedex

Schering SA
Z.I. Roubaix-Est
rue de Toufflers
BP 69
F-59452 Lys-Lez-Lannoy
Cedex

HE Clissmann T/A Schering
72 Heather Road
Dublin 18
Ireland

HE Clissmann T/A Schering
72 Heather Road
Dublin 18
Ireland

Schering S.p.A.
Via E. Schering, 21
I-20090 Segrate (MI)

Schering S.p.A.
Via E. Schering, 21
I-20090 Segrate (MI)

NV Schering S.A.
J.E. Mommaertslaan, 14
B-1831 Machelen (Diegem)

NV Schering S.A.
J.E. Mommaertslaan, 14
B-1831 Machelen (Diegem)

Schering Nederland B.V
Van Houten Industriepark 1
Postbus 116
1380 AC Weesp
Nederland

Schering Nederland B.V
Van Houten Industriepark 1
Postbus 116
1380 AC Weesp
Nederland

Schering AG
Müllerstr. 178
D-13342 Berlin-Mitte

Schering AG
Müllerstr. 178
D-13342 Berlin-Mitte

Gadovist

1 mmol/ml

Solution for injection

Intravenous use

Gadovist

1 mmol/ml

Solution
prefilled syringe

for

Injection

in

Intravenous use

Gadovist

1 mmol/ml

Solution for injection

Intravenous use

Gadovist

1 mmol/ml

Solution
prefilled syringe

for

Injection

in

Intravenous use

Gadovist

1 mmol/ml

Solution for injection

Intravenous use

Gadovist

1 mmol/ml

Solution
prefilled syringe

for

Injection

in

Intravenous use

Gadovist

1 mmol/ml

Solution for injection

Intravenous use

Gadovist

1 mmol/ml

Solution
prefilled syringe

for

Injection

in

Intravenous use

Gadovist

1 mmol/ml

Solution for injection

Intravenous use

Gadovist

1 mmol/ml

Solution
prefilled syringe

for

Injection

in

Intravenous use

Gadovist

1 mmol/ml

Solution for injection

Intravenous use

Gadovist

1 mmol/ml

Solution
prefilled syringe

for

Injection

in

Intravenous use

Gadovist

1 mmol/ml

Solution for injection

Intravenous use

Gadovist

1 mmol/ml

Solution
prefilled syringe

for

Injection

in

Intravenous use

C 115/14

EN

Official Journal of the European Union

25.5.2007

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Portugal

Sweden

Sweden

United
Kingdom

United
Kingdom

Schering Lusitana, Lda
Estrada Nacional 249, km 15
P.O. Box 16
P-2725-397 Mem Martins

Schering AG
Müllerstr. 178
D-13342 Berlin-Mitte

Schering AG
Müllerstr. 178
D-13342 Berlin-Mitte
Allemagne

Schering Health Care Limited
The Brow
Burgess Hill
West Sussex RH1F 9NE
United Kingdom

Schering Health Care Limited
The Brow
Burgess Hill
West Sussex RH1F 9NE
United Kingdom

Gadovist

1 mmol/ml

Solution for injection

Intravenous use

Gadovist

1 mmol/ml

Solution for injection

Intravenous use

Gadovist

1 mmol/ml

Solution
prefilled syringe

for

Injection

in

Intravenous use

Gadovist

1 mmol/ml

Solution for injection

Intravenous use

Gadovist

1 mmol/ml

Solution
prefilled syringe

for

Injection

in

Intravenous use

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

ANNEX III

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Germany

Germany

Spain

Spain

Schering Deutschland GmbH
Max-Dohrn-Strasse 10
D-10589 Berlin

Schering Deutschland GmbH
Max-Dohrn-Strasse 10
D-10589 Berlin

Schering España, S.A.
c/ Mendez Alvaro, 55
E-28045 Madrid

Schering España, S.A.
c/ Mendez Alvaro, 55
E-28045 Madrid

Gadograf

1 mmol/ml

Solution for injection

Intravenous use

Gadograf

1 mmol/ml

Solution
prefilled syringe

for

Injection

in

Intravenous use

Gadograf

1 mmol/ml

Solution for injection

Intravenous use

Gadograf

1 mmol/ml

Solution
prefilled syringe

for

Injection

in

Intravenous use

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

ANNEX IV

Member State

Applicant or
Marketing
Authorisation Holder

Product invented
name

Pharmaceutical form

Strength

Animal species

Frequency and route of
administration

Recommended dose

Belgium,
Republic,
Czech
Denmark, Spain, Finland, Italy,
Luxembourg, The Netherlands,
Norway, Poland and Slovakia

Vetcare Ltd.
P. O. Box 99
FIN-24101 Salo

Dolovet vet 2,4 g

Powder

2.4g ketoprofen per sachet
of 15g powder

Cattle
(adult animals weighing
about 600 kg)

One bag of 15g once daily
for 1 — 3 days. This
corresponds to 4mg keto-
profen per kg body weight

One bag of 15g once
daily for 1 — 3 days.
The powder
should be
mixed with water e.g. in
a bottle using ½ litres of
water, shaked well and
administered immediately
per orally to an animal

Austria and Hungary

As above

Rifen 2,4 g

As above

As above

As above

As above

As above

.

.

2
5
5
2
0
0
7

E
N

O

f
f
i
c
i
a
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J
o
u
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n
a
l

o
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t
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E
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1
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NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ANIMAL SPECIES,
ROUTES OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDER

ANNEX V

Member State

Marketing Authorisation Holder

Applicant

Product invented
name

Pharmaceutic-
al form

Strength

Animal species

Frequency and route of
administration

Recomme-
nded dose

Austria

Belgium

France

Wyeth Lederle Pharma GmbH, Fort
Dodge
Waidhausengasse 19/9
A-1140 Vienna
Contact: Dr. Attila Romváry
Tel: +43 1 912 28 40
Fax: +43 1 911 51 00
Email: romvara@fdah.com

Fort Dodge Animal Health Holland
C.J. van Houtenlaan 36
1381 CP Weesp
The Netherlands
Contact: Dr. Durk Stellingwerf
Tel: (31-35) 699 33 72
Fax: (31-35) 699 33 80
Email: stellid@fdah.com

Fort Dodge Santé Animale S.A.
24, Avenue Marcel Dassault
BP 440
F-37204 Tours Cedex 3
Contact: Mr. Yves Dehon
Tel: +33 2 4774 8979
Fax: +33 2 47748999
Email: dehony@ahp.com

Wyeth Lederle Pharma
GmbH, Fort Dodge

Suvaxyn Parvo/E

Emulsion
for injection

Porcine

— PPV inducing a HIA
titre of at least 160
(in rabbits).

— E. rhusiopathiae: RP
≥ 1 in accordance
with the EP

2 ml

From 5 months: 2 inj. 3-4
wks apart. 2nd dose at least
4 wks before mating.

Annual Revacc-ination: 1
dose during each lacta-tion
period 3 to 4 wks before
mating.

Intramuscular injection

Fort Dodge Animal
Health Holland

Suvaxyn Parvo/E

Emulsion
for injection

Porcine

— PPV inducing a HIA
titre of at least 160
(in rabbits).

— E. rhusiopathiae: RP
≥ 1 in accordance
with the EP

2 ml

From 5 months: 2 inj. 3-4
wks apart. 2nd dose at least
4 wks before mating.

Annual Revacc-ination: 1
dose during each lacta-tion
period 3 to 4 wks before
mating.

Intramuscular injection

Dodge

Fort
Animale S.A.

Santé

Suvaxyn Parvo/E

Emulsion
for injection

Porcine

— PPV inducing a HIA
titre of at least 160
(in rabbits).

— E. rhusiopathiae: RP
≥ 1 in accordance
with the EP

2 ml

From 5 months: 2 inj. 3-4
wks apart. 2nd dose at least
4 wks before mating.

Annual Revacc-ination: 1
dose during each lacta-tion
period 3 to 4 wks before
mating.

Intramuscular injection

C

1
1
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
5
5
2
0
0
7

Member State

Marketing Authorisation Holder

Applicant

Product invented
name

Pharmaceutic-
al form

Strength

Animal species

Frequency and route of
administration

Recomme-
nded dose

Germany

Fort Dodge Veterinär GmbH
Adenauerstrasse 20
D-52146 Würselen
Contact: Dr. Elisabeth Stangl
Tel: (49-240) 545 42 16
Fax: (49-240) 545 44 61
Email: stangle@fdah.com

Fort Dodge Veterinär
GmbH

Suvaxyn Parvo/E

Emulsion
for injection

Porcine

— PPV inducing a HIA
titre of at least 160
(in rabbits).

— E. rhusiopathiae: RP
≥ 1 in accordance
with the EP

2 ml

From 5 months: 2 inj. 3-4
wks apart. 2nd dose at least
4 wks before mating.

Annual Revacc-ination: 1
dose during each lacta-tion
period 3 to 4 wks before
mating.

Intramuscular injection

Greece

Ireland

Wyeth Lederle Pharma GmbH, Fort
Dodge
Waidhausengasse 19/9
A-1140 Vienna
Contact: Dr. Eusebio Uruburu
Tel: (34-915) 98 13 44
Fax: (34-915) 97 24 34
Email: urubure@fdah.com

Fort Dodge Animal Health Limited
Flanders Road
Hedge End
Southampton S030 4QH
United Kingdom
Contact: Dr. Germán Lastra
Tel: (44-14) 89 77 42 21
Fax: (44-14) 89 77 42 51
Email: lastrag@fdah.com

Wyeth Lederle Pharma
GmbH, Fort Dodge

Suvaxyn Parvo/E

Emulsion
for injection

Porcine

— PPV inducing a HIA
titre of at least 160
(in rabbits).

— E. rhusiopathiae: RP
≥ 1 in accordance
with the EP

2 ml

From 5 months: 2 inj. 3-4
wks apart. 2nd dose at least
4 wks before mating.

Annual Revacc-ination: 1
dose during each lacta-tion
period 3 to 4 wks before
mating.

Intramuscular injection

Fort Dodge Animal
Health Limited

Suvaxyn Parvo/E

Emulsion
for injection

Porcine

— PPV inducing a HIA
titre of at least 160
(in rabbits).

— E. rhusiopathiae: RP
≥ 1 in accordance
with the EP

2 ml

From 5 months: 2 inj. 3-4
wks apart. 2nd dose at least
4 wks before mating.

Annual Revacc-ination: 1
dose during each lacta-tion
period 3 to 4 wks before
mating.

Intramuscular injection

.

.

2
5
5
2
0
0
7

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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a
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U
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1
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Member State

Marketing Authorisation Holder

Applicant

Product invented
name

Pharmaceutic-
al form

Strength

Animal species

Frequency and route of
administration

Recomme-
nded dose

Luxembourg

Fort Dodge Animal Health Holland
C.J. van Houtenlaan 36
1381 CP Weesp
The Netherlands
Contact: Dr. Durk Stellingwerf
Tel: (31-35) 699 33 72
Fax: (31-35) 699 33 80
Email: stellid@fdah.com

Fort Dodge Animal
Health Holland

Suvaxyn Parvo/E

Emulsion
for injection

Porcine

— PPV inducing a HIA
titre of at least 160
(in rabbits).

— E. rhusiopathiae: RP
≥ 1 in accordance
with the EP

2 ml

From 5 months: 2 inj. 3-4
wks apart. 2nd dose at least
4 wks before mating.

Annual Revacc-ination: 1
dose during each lacta-tion
period 3 to 4 wks before
mating.

Intramuscular injection

Netherlands

Fort Dodge Animal Health Holland
C.J. van Houtenlaan 36
1381 CP Weesp
The Netherlands
Contact: Dr. Durk Stellingwerf
Tel: (31-35) 699 33 72
Fax: (31-35) 699 33 80
Email: stellid@fdah.com

Fort Dodge Animal
Health Holland

Suvaxyn Parvo/E

Emulsion
for injection

Porcine

— PPV inducing a HIA
titre of at least 160
(in rabbits).

— E. rhusiopathiae: RP
≥ 1 in accordance
with the EP

2 ml

From 5 months: 2 inj. 3-4
wks apart. 2nd dose at least
4 wks before mating.

Annual Revacc-ination: 1
dose during each lacta-tion
period 3 to 4 wks before
mating.

Intramuscular injection

Norway

Fort Dodge Veterinaria S.A.
c/ Camprodón s/n ‘La Riba’
Vall de Bianya (Girona), Spain
Contact: Dr. Germán Lastra
Tel: +44 1489774221
Fax: +44 1489 774 251
Email: lastrag@fdah.com

Fort Dodge Veterinaria
S.A.

Suvaxyn Parvo/E

Emulsion
for injection

Porcine

— PPV inducing a HIA
titre of at least 160
(in rabbits).

— E. rhusiopathiae: RP
≥ 1 in accordance
with the EP

2 ml

From 5 months: 2 inj. 3-4
wks apart. 2nd dose at least
4 wks before mating.

Annual Revacc-ination: 1
dose during each lacta-tion
period 3 to 4 wks before
mating.

Intramuscular injection

C

1
1
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
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a
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U
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i

.

.

2
5
5
2
0
0
7

Member State

Marketing Authorisation Holder

Applicant

Product invented
name

Pharmaceutic-
al form

Strength

Animal species

Frequency and route of
administration

Recomme-
nded dose

Sweden

Fort Dodge Animal Health Holland
C.J. van Houtenlaan 36
1381 CP Weesp
The Netherlands
Contact: Dr. Germán Lastra
Tel: +44 1489774221
Fax: +44 1489 774 251
Email: lastrag@fdah.com

United Kingdom Fort Dodge Animal Health Limited
Flanders Road
Hedge End
Southampton S030 4QH
United Kingdom
Tel: (44-14) 89 77 42 21
Fax: (44-14) 89 77 42 51
Email: lastrag@fdah.com

Spain

Fort Dodge Veterinaria S.A. Ctra.
Camprodón s/n ‘La Riba’
E-17813 Vall de Bianya (Girona)
Tel: (34) 915 98 13 36
Fax: (34) 915 97 24 34
Email: rodrigv2@fdah.com

Fort Dodge Animal
Health Holland

Suvaxyn
vet

Parvo/E

Emulsion
for injection

Fort Dodge Animal
Health Limited

Suvaxyn Parvo/E

Emulsion
for injection

Fort Dodge Veterinaria
S.A.

Suvaxyn Parvo/E

Emulsion
for injection

Porcine

— PPV inducing a HIA
titre of at least 160
(in rabbits).

— E. rhusiopathiae: RP
≥ 1 in accordance
with the EP

Porcine

— PPV inducing a HIA
titre of at least 160
(in rabbits).

— E. rhusiopathiae: RP
≥ 1 in accordance
with the EP

Porcine

— PPV inducing a HIA
titre of at least 160
(in rabbits).

— E. rhusiopathiae: RP
≥ 1 in accordance
with the EP

2 ml

2 ml

2 ml

From 5 months: 2 inj. 3-4
wks apart. 2nd dose at least
4 wks before mating.

Annual Revacc-ination: 1
dose during each lacta-tion
period 3 to 4 wks before
mating.

Intramuscular injection

From 5 months: 2 inj. 3-4
wks apart. 2nd dose at least
4 wks before mating.

Annual Revacc-ination: 1
dose during each lacta-tion
period 3 to 4 wks before
mating.

Intramuscular injection

From 5 months: 2 inj. 3-4
wks apart. 2nd dose at least
4 wks before mating.

Annual Revacc-ination: 1
dose during each lacta-tion
period 3 to 4 wks before
mating.

Intramuscular injection

.

.

2
5
5
2
0
0
7

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
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E
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9

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

ANNEX VI

Member State

Marketing Authorisation Holder

Applicant

Product invented
name

Pharmaceu-
tical form

Strength

Animal species

Frequency and route of admin-
istration

Recom-
mende-
d dose

2 ml

Wyeth Lederle Pharma
GmbH, Fort Dodge

Suvaxyn Ery

Emulsion
for injection

— E. rhusiopathiae: RP
≥ 1 in accordance
with the EP

Porcine

From 5 months: 2 inj. 3-4
wks apart. 2nd dose at
least 4 wks before mating.

Annual Revacc-ination: 1
dose during each lacta-tion
period 3 to 4 wks before
mating.

Intramuscular injection

Austria

Belgium

Wyeth Lederle Pharma GmbH, Fort
Dodge
Waidhausengasse 19/9
A-1140 Vienna
Contact: Dr. Attila Romváry
Tel: (43-1) 912 28 40
Fax: (43-1) 911 51 00
Email: romvara@fdah.com

Fort Dodge Animal Health Benelux B.V.
Van Houten Industriepark 25
1381 MZ Weesp
The Netherlands
Contact: Dr. Durk Stellingwerf
Tel: (31-35) 699 33 72
Fax: (31-35) 699 33 80
Email: stellid@fdah.com

Czech Republic

Fort Dodge Animal Health Holland
C.J van Houtenlaan 36
1381 CP Weesp
The Netherlands
Contact: Dr. Durk Stellingwerf
Tel: (31-35) 699 33 72
Fax: (31-35) 699 33 80
Email: stellid@fdah.com

Fort Dodge Animal
Health Benelux B.V.

Suvaxyn Ery

Emulsion
for injection

— E. rhusiopathiae: RP
≥ 1 in accordance
with the EP

Porcine

Fort Dodge Animal
Health Holland

Suvaxyn Ery

Emulsion
for injection

— E. rhusiopathiae: RP
≥ 1 in accordance
with the EP

Porcine

2 ml

From 5 months: 2 inj. 3-4
wks apart. 2nd dose at
least 4 wks before mating.

Annual Revacc-ination: 1
dose during each lacta-tion
period 3 to 4 wks before
mating.

Intramuscular injection

2 ml

From 5 months: 2 inj. 3-4
wks apart. 2nd dose at
least 4 wks before mating.

Annual Revacc-ination: 1
dose during each lacta-tion
period 3 to 4 wks before
mating.

Intramuscular injection

C

1
1
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
5
5
2
0
0
7

Member State

Marketing Authorisation Holder

Applicant

Product invented
name

Pharmaceu-
tical form

Strength

Animal species

Frequency and route of admin-
istration

Fort Dodge Animal
Health Holland

Suvaxyn Ery

Emulsion
for injection

— E. rhusiopathiae: RP
≥ 1 in accordance
with the EP

Porcine

From 5 months: 2 inj. 3-4
wks apart. 2nd dose at
least 4 wks before mating.

Annual Revacc-ination: 1
dose during each lacta-tion
period 3 to 4 wks before
mating.

Intramuscular injection

Recom-
mende-
d dose

2 ml

Estonia

France

Fort Dodge Animal Health Holland
C.J van Houtenlaan 36
1381 CP Weesp
The Netherlands
Contact: Dr. Durk Stellingwerf
Tel: (31-35) 699 33 72
Fax: (31-35) 699 33 80
Email: stellid@fdah.com

Fort Dodge Santé Animale S.A.
24, Avenue Marcel Dassault
BP 440
F-37204 Tours Cedex 3
Contact: Mr. Yves Dehon
Tel: +33 2 47 74 89 79
Fax: +33 2 47 74 89 71
Email: dehonyv@fdah.com

Dodge

Fort
Animale S.A.

Santé

Suvaxyn Ery

Emulsion
for injection

— E. rhusiopathiae: RP
≥ 1 in accordance
with the EP

Porcine

Germany

Fort Dodge Veterinär GmbH
Adenauerstrasse 20
D-52146 Würselen
Contact: Dr. Elisabeth Stangl
Tel: (49-240) 545 42 16
Fax: (49 24) 545 44 61
Email: stangle@fdah.com

Fort Dodge Veterinär
GmbH

Suvaxyn Ery

Emulsion
for injection

— E. rhusiopathiae: RP
≥ 1 in accordance
with the EP

Porcine

.

.

2
5
5
2
0
0
7

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

1
1
5
/
2
1

2 ml

From 5 months: 2 inj. 3-4
wks apart. 2nd dose at
least 4 wks before mating.

Annual Revacc-ination: 1
dose during each lacta-tion
period 3 to 4 wks before
mating.

Intramuscular injection

2 ml

From 5 months: 2 inj. 3-4
wks apart. 2nd dose at
least 4 wks before mating.

Annual Revacc-ination: 1
dose during each lacta-tion
period 3 to 4 wks before
mating.

Intramuscular injection

Member State

Marketing Authorisation Holder

Applicant

Product invented
name

Pharmaceu-
tical form

Strength

Animal species

Frequency and route of admin-
istration

Fort Dodge Animal
Health Holland

Suvaxyn Ery

Emulsion
for injection

— E. rhusiopathiae: RP
≥ 1 in accordance
with the EP

Porcine

From 5 months: 2 inj. 3-4
wks apart. 2nd dose at
least 4 wks before mating.

Annual Revacc-ination: 1
dose during each lacta-tion
period 3 to 4 wks before
mating.

Intramuscular injection

Recom-
mende-
d dose

2 ml

Fort Dodge Animal
Health Limited

Suvaxyn Ery

Emulsion
for injection

— E. rhusiopathiae: RP
≥ 1 in accordance
with the EP

Porcine

Greece

Ireland

Fort Dodge Animal Health Holland
C.J van Houtenlaan 36
1381 CP Weesp
The Netherlands
Contact: Dr. Germán Lastra
Tel: (44-14) 89 77 42 21
Fax: (44-14) 89 77 42 51
Email: lastrag@fdah.com

Fort Dodge Animal Health Limited
Flanders Road
Hedge End
Southampton S030 4QH
United Kingdom
Contact: Dr. Germán Lastra
Tel: (44-14) 89 77 42 21
Fax: (44-14) 89 77 42 51
Email: lastrag@fdah.com

Italy

Fort Dodge Animal Health SpA
Via Nettunense 90
I-04011 Aprilia
Tel: (39-06) 927 151
Fax: (39-06) 23 32 55 55
Email: bollaa@fdah.com

Fort Dodge Animal
Health SpA

Suvaxyn Ery

Emulsion
for injection

— E. rhusiopathiae: RP
≥ 1 in accordance
with the EP

Porcine

C

1
1
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
5
5
2
0
0
7

2 ml

From 5 months: 2 inj. 3-4
wks apart. 2nd dose at
least 4 wks before mating.

Annual Revacc-ination: 1
dose during each lacta-tion
period 3 to 4 wks before
mating.

Intramuscular injection

2 ml

From 5 months: 2 inj. 3-4
wks apart. 2nd dose at
least 4 wks before mating.

Annual Revacc-ination: 1
dose during each lacta-tion
period 3 to 4 wks before
mating.

Intramuscular injection

Member State

Marketing Authorisation Holder

Applicant

Product invented
name

Pharmaceu-
tical form

Strength

Animal species

Frequency and route of admin-
istration

Lithuania

Fort Dodge Animal Health Holland
C.J van Houtenlaan 36
1381 CP Weesp
The Netherlands
Contact: Dr. Durk Stellingwerf
Tel: (31-35) 699 33 72
Fax: (31-35) 699 33 80
Email: stellid@fdah.com

Fort Dodge Animal
Health Holland

Suvaxyn Ery

Emulsion
for injection

— E. rhusiopathiae: RP
≥ 1 in accordance
with the EP

Porcine

From 5 months: 2 inj. 3-4
wks apart. 2nd dose at
least 4 wks before mating.

Annual Revacc-ination: 1
dose during each lacta-tion
period 3 to 4 wks before
mating.

Intramuscular injection

Recom-
mende-
d dose

2 ml

Luxembourg

Fort Dodge Animal Health Benelux B.V.
Van Houten Industriepark 25
1381 MZ Weesp
The Netherlands
Contact: Dr. Durk Stellingwerf
Tel: (31-35) 699 33 72
Fax: (31-35) 699 33 80
Email: stellid@fdah.com

Fort Dodge Animal
Health Benelux B.V.

Suvaxyn Ery

Emulsion
for injection

— E. rhusiopathiae: RP
≥ 1 in accordance
with the EP

Porcine

Malta

Fort Dodge Animal Health Holland
C.J van Houtenlaan 36
1381 CP Weesp
The Netherlands
Contact: Dr. Durk Stellingwerf
Tel: (31-35) 699 33 72
Fax: (31-35) 699 33 80
Email: stellid@fdah.com

Fort Dodge Animal
Health Holland

Suvaxyn Ery

Emulsion
for injection

— E. rhusiopathiae: RP
≥ 1 in accordance
with the EP

Porcine

2 ml

From 5 months: 2 inj. 3-4
wks apart. 2nd dose at
least 4 wks before mating.

Annual Revacc-ination: 1
dose during each lacta-tion
period 3 to 4 wks before
mating.

Intramuscular injection

2 ml

From 5 months: 2 inj. 3-4
wks apart. 2nd dose at
least 4 wks before mating.

Annual Revacc-ination: 1
dose during each lacta-tion
period 3 to 4 wks before
mating.

Intramuscular injection

.

.

2
5
5
2
0
0
7

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

1
1
5
/
2
3

Member State

Marketing Authorisation Holder

Applicant

Product invented
name

Pharmaceu-
tical form

Strength

Animal species

Frequency and route of admin-
istration

Netherlands

Fort Dodge Animal Health Benelux B.V.
Van Houten Industriepark 25
1381 MZ Weesp
The Netherlands
Contact: Dr. Durk Stellingwerf
Tel: (31-35) 699 33 72
Fax: (31-35) 699 33 80
Email: stellid@fdah.com

Fort Dodge Animal
Health Benelux B.V.

Suvaxyn Ery

Emulsion
for injection

— E. rhusiopathiae: RP
≥ 1 in accordance
with the EP

Porcine

From 5 months: 2 inj. 3-4
wks apart. 2nd dose at
least 4 wks before mating.

Annual Revacc-ination: 1
dose during each lacta-tion
period 3 to 4 wks before
mating.

Intramuscular injection

Recom-
mende-
d dose

2 ml

Norway

Fort Dodge Veterinär GmbH
Adenauerstrasse 20
D-52146 Würselen
Contact: Dr. Germán Lastra
Tel: (44-14) 89 77 42 21
Fax: (44-14) 89 77 42 51
Email: lastrag@fdah.com

Fort Dodge Veterinär
GmbH

Suvaxyn Ery

Emulsion
for injection

— E. rhusiopathiae: RP
≥ 1 in accordance
with the EP

Porcine

Portugal

Fort Dodge Veterinària Lda.
Rua Dr. António Loureiro Borges, n.o 2,
Arquiparque-Miraflores
P-1495-131 Algés
Contact: Dr. Virginia Rodríguez
Tel: (34-91) 598 13 43
Fax: (34-91) 597 24 34
Email: rodrigv2@fdah.com

Fort Dodge Veterinària
Lda.

Suvaxyn Ery

Emulsion
for injection

— E. rhusiopathiae: RP
≥ 1 in accordance
with the EP

Porcine

2 ml

From 5 months: 2 inj. 3-4
wks apart. 2nd dose at
least 4 wks before mating.

Annual Revacc-ination: 1
dose during each lacta-tion
period 3 to 4 wks before
mating.

Intramuscular injection

2 ml

From 5 months: 2 inj. 3-4
wks apart. 2nd dose at
least 4 wks before mating.

Annual Revacc-ination: 1
dose during each lacta-tion
period 3 to 4 wks before
mating.

Intramuscular injection

C

1
1
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
5
5
2
0
0
7

Member State

Marketing Authorisation Holder

Applicant

Product invented
name

Pharmaceu-
tical form

Strength

Animal species

Frequency and route of admin-
istration

Slovak Republic

Fort Dodge Animal Health Holland
C.J van Houtenlaan 36
1381 CP Weesp
The Netherlands
Contact: Dr. Durk Stellingwerf
Tel: (31-35) 699 33 72
Fax: (31-35) 699 33 80
Email: stellid@fdah.com

Fort Dodge Animal
Health Holland

Suvaxyn Ery

Emulsion
for injection

— E. rhusiopathiae: RP
≥ 1 in accordance
with the EP

Porcine

From 5 months: 2 inj. 3-4
wks apart. 2nd dose at
least 4 wks before mating.

Annual Revacc-ination: 1
dose during each lacta-tion
period 3 to 4 wks before
mating.

Intramuscular injection

Recom-
mende-
d dose

2 ml

United Kingdom Fort Dodge Animal Health Limited
Flanders Road
Hedge End
Southampton S030 4QH
United Kingdom
Contact: Dr. Germán Lastra
Tel: (44-14) 89 77 42 21
Fax: (44-14) 89 77 42 51
Email: lastrag@fdah.com

Hungary

Fort Dodge Animal Health Holland
C.J van Houtenlaan 36
1381 CP Weesp
The Netherlands
Contact: Dr. Durk Stellingwerf
Tel: (31-35) 699 33 72
Fax: (31-35) 699 33 80
Email: stellid@fdah.com

Fort Dodge Animal
Health Limited

Suvaxyn Ery

Emulsion
for injection

— E. rhusiopathiae: RP
≥ 1 in accordance
with the EP

Porcine

Fort Dodge Animal
Health Holland

Suvaxyn Ery

Emulsion
for injection

— E. rhusiopathiae: RP
≥ 1 in accordance
with the EP

Porcine

2 ml

From 5 months: 2 inj. 3-4
wks apart. 2nd dose at
least 4 wks before mating.

Annual Revacc-ination: 1
dose during each lacta-tion
period 3 to 4 wks before
mating.

Intramuscular injection

2 ml

From 5 months: 2 inj. 3-4
wks apart. 2nd dose at
least 4 wks before mating.

Annual Revacc-ination: 1
dose during each lacta-tion
period 3 to 4 wks before
mating.

Intramuscular injection

.

.

2
5
5
2
0
0
7

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

1
1
5
/
2
5

Member State

Marketing Authorisation Holder

Applicant

Product invented
name

Pharmaceu-
tical form

Strength

Animal species

Frequency and route of admin-
istration

Spain

Fort Dodge Veterinaria, S.A.
Ctra. Camprodón s/n ‘La Riba’
E-17813 Vall de Bianya (Girona)
Contact: Dra Virginia Rodríguez
Tel: (34-91) 598 13 36
Fax: (34-91) 597 24 34
Email: rodrigv2@fdah.com

Fort Dodge Veterinaria,
S.A.

Suvaxyn Ery

Emulsion
for injection

— E. rhusiopathiae: RP
≥ 1 in accordance
with the EP

Porcine

From 5 months: 2 inj. 3-4
wks apart. 2nd dose at
least 4 wks before mating.

Annual Revacc-ination: 1
dose during each lacta-tion
period 3 to 4 wks before
mating.

Intramuscular injection

Recom-
mende-
d dose

2 ml

C

1
1
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
5
5
2
0
0
7

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

ANNEX VII

Member State

Applicant or
Marketing Authorisa-
tion Holder

Product invented
name

Pharmaceutical form

Strength

Animal
species

Frequency and route of administration

Recommended dose

Austria,

Netherlands,
Belgium,
Denmark, Finland, France, Germany,
Greece, Hungary,
Italy,
Luxembourg,
Poland,
Portugal and Spain

Norway,

Ireland,

Le Vet B.V.
The Netherlands

Equimectine

Oral gel

12 mg/g

Horses

Oral use. A single administration of
0.2 mg ivermectin per kg of body-
weight. Retreatment should be done
according to the epidemiological situa-
less than 30 days
tion, but not at
interval

A single administration of 0.2 mg
ivermectin per kg of bodyweight

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

ANNEX VIII

Member State

Marketing Authorisation Holder

Applicant

Invented name

Strength

Pharmaceutical Form

Route of administration

Denmark

Germany

Sandoz Pharmaceuticals GmbH
Carl-Zeiss-Ring 3
D-85737 Ismaning

Mefecur

50/5 mg

Prolonged-release tablet

Sandoz Pharmaceuticals GmbH
Carl-Zeiss-Ring 3
D-85737 Ismaning

Felodipin Metoprolol
5 mg/47,5 mg Retardtabletten

Sandoz

50/5 mg

Prolonged-release tablet

oral

oral

.

.

2
5
5
2
0
0
7

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

1
1
5
/
2
7

C 115/28

EN

Official Journal of the European Union

25.5.2007

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

ANNEX IX

Member State

Marketing Authorisation
Holder

Applicant

Invented name

Strength

Pharmaceutical Form

Route of
administration

Denmark

Germany

Finland

Luxembourg

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

Mefecomb 50 mg/5 mg

50/5 mg

Prolonged-release
tablet

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

Metoprololtartrat/Felodipin-
ratiopharm 50 mg/5 mg
Retardtabletten

50/5 mg

Prolonged-release
tablet

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

Mefecomb 50 mg/5 mg
depot-tabletti

50/5 mg

Prolonged-release
tablet

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

Metoprololtartrat/Felodipin-
ratiopharm 50 mg/5 mg
Retardtabletten

50/5 mg

Prolonged-release
tablet

oral

oral

oral

oral

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

ANNEX X

Member State

Marketing
Authorisation Holder

Denmark

Germany

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

Applicant

Invented name

Strength

Pharmaceutical Form

Mefelor

50/5 mg

Prolonged-release
tablet

AbZ-Pharma GmbH
Dr.-Georg-Spohn-Str. 7
D-89143 Blaubeuren

Metoprololtartrat/Felodipin
AbZ 50 mg/5 mg Retardta-
bletten

50/5 mg

Prolonged-release
tablet

Route of
administration

oral

oral

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

ANNEX XI

Member State

Marketing Authorisation
Holder

CT Arzneimittel GmbH
Lengeder Str. 42a
D-13407 Berlin

Denmark

Germany

Applicant

Invented name

Strength

Pharmaceutical Form

Mefesan

50/5 mg

Prolonged-release
tablet

CT Arzneimittel GmbH
Lengeder Str. 42a
D-13407 Berlin

Metoprololtartrat/Felodipin-
CT 50 mg/5 mg Retardta-
bletten

50/5 mg

Prolonged-release
tablet

Route of
administration

oral

oral

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

ANNEX XII

Member State

Marketing Authorisation Holder

Applicant

Invented name

Strength

Pharmaceutical Form

Route of
administration

Denmark

Germany

YES Pharmaceutical Development
Services GmbH
Bahnstraße 42-46
D-61381 Friedrichsdorf

Metofelosan

50/5 mg

Prolonged-release tablet

oral

ALIUD PHARMA GmbH & Co. KG
Gottlieb-Daimler-Str. 19
D-89150 Laichingen

Metocomb AL 50 mg/5 mg Retardtable-
tten

50/5 mg

Prolonged-release tablet

oral

.

.

2
5
5
2
0
0
7

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

1
1
5
/
2
9

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

ANNEX XIII

Member State

Marketing Authorisation Holder

Applicant

Invented name

Strength

Pharmaceutical Form

Route of
administration

Denmark

Belgium

Germany

Finland

Luxembourg

YES Pharmaceutical Development
Services GmbH
Bahnstraße 42-46
D-61381 Friedrichsdorf

Metoprolol/Felodipin ‘YES’

50/5 mg

Prolonged-release tablet

oral

Eurogenerics N.V.
Heizel Esplanade Heysel b22
B-1020 Brussels

STADApharm GmbH
Stadastr. 2-18
D-61118 Bad Vilbel

STADA Arzneimittel AG
Stadastr. 2-18
D-61118 Bad Vilbel

Eurogenerics N.V.
Heizel Esplanade Heysel b22
B-1020 Brussels

Co-Metoprolol EG 50/5 mg tablets
(prolonged release)

50/5 mg

Prolonged-release tablet

Metoplus STADA 50 mg/5 mg Retardta-
bletten

50/5 mg

Prolonged-release tablet

Metoprololitartraatti/Felodipiini STADA
50 mg/5 mg depottabletti

50/5 mg

Prolonged-release tablet

Co-Metoprolol EG 50/5 mg tablets
(prolonged release)

50/5 mg

Prolonged-release tablet

oral

oral

oral

oral

C

1
1
5
/
3
0

E
N

O

f
f
i
c
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