Summary of Community decisions on marketing authorizations in respect of medicinal products from 15 November 2003 to 15 December 2003 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
Date: 2004-01-10
Institutions: European Commission
Subjects: market approval, marketing, medicinal product

10.1.2004

EN

Official Journal of the European Union

C 6/3

— Modification of a marketing authorization (Article 34 of Regulation (EEC) No 2309/93):

Accepted

Date of the
decision

Name of the
medicinal product

Holder of the
marketing authorization

1.12.2003

Doxirobe Gel

1.12.2003

Pirsue

Pfizer Ltd
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

Pfizer Ltd
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

Number of the
entry in the
Community Register

Date of
notification

EU/2/99/012/001-002

3.12.2003

EU/2/00/027/001-003

3.12.2003

Anyone wishing to consult the public assessment report on the medicinal products in question and the
decisions relating thereto is invited to contact:

The European Agency for the Evaluation of Medicinal products
7 Westferry Circus
Canary Wharf
London E14 4HB
United Kingdom

Summary of Community decisions on marketing authorizations in respect of medicinal products
from 15 November 2003 to 15 December 2003

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

— Issuing, maintenance or modification of a national marketing authorisation

(2004/C 6/03)

Date of the decision

Name(s) of the
medicinal product

Holder(s) of the marketing
authorization

Member State concerned

Date of
notification

1.12.2003

Calcichew D3

See Annex I

See Annex I

3.12.2003

1.12.2003

Calcitugg

See Annex II

See Annex II

3.12.2003

1.12.2003

Fluconazole

See Annex III

See Annex III

3.12.2003

1.12.2003

Beriate P

See Annex IV

See Annex IV

3.12.2003

4.12.2003

Perindopril

See Annex V

See Annex V

8.12.2003

12.12.2003

Mononine

See Annex VI

See Annex VI

16.12.2003

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

ANNEX I

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS, ROUTES OF ADMINISTRATION,
MARKETING AUTHORISATION HOLDERS, PACKAGING AND PACKAGE SIZES OF THE MEDICINAL
PRODUCT IN THE MEMBER STATES

Article 30 Referral for Calcichew-D3 (and related names) Chewable tablets (Calcium 500 mg plus cholecalciferol
10 µg)

Member State

MAH

Invented name

Strength

Pharmaceutical form Route of administration

Packaging

Package size

Austria

Nycomed Austria GmbH

Cal — D — or

500 mg/10 µg

Chewable tablet Oral

Polyethylene (PEHD)
bottle

20, 60, 120

Belgium

Christiaens Pharma

Steovit D3
500 mg/400 I.E

500 mg/10 µg

Chewable tablet Oral

Polyethylene (PEHD)
bottle
Unit dose (blister):
PVC/PVdC/PE/Al

20, 30, 50, 60, 90, 100, 180
Unit dose (blister): 50

Denmark

Nycomed Danmark A/S

CaviD

500 mg/10 µg

Chewable tablet Oral

Polyethylene (PEHD)
bottle

100

Finland

Oy Leiras Finland Ab

Calcichew-D3 Forte
500 mg/400 IU purut-
abletti

500 mg/10 µg

Chewable tablet Oral

Germany

Jenapharm GmbH & Co.
KG

Calcilac KT

500 mg/10 µg

Chewable tablet Oral

Polyethylene (PEHD)
bottle
Unit dose (blister):
PVC/PVdC/PE/Al

Polyethylene (PEHD)
bottle
Unit dose (blister):
PVC/PVdC/PE/Al

20, 30, 50, 60, 90, 100, 180
Unit dose (blister): 50

20, 30, 50, 60, 90, 100, 180
Unit dose (blister): 50

Orion Pharma GmbH

Calcimagon-D3

500 mg/10 µg

Chewable tablet Oral

Polyethylene (PEHD)
bottle

20, 50, 100 and 10 × 20

Greece

Nycomed Hellas SA

Calcioral D3

500 mg/10 µg

Chewable tablet Oral

Polyethylene (PEHD)
bottle
Unit dose (blister):
PVC/PVdC/PE/Al

20, 30, 50, 60, 90, 100, 180
Unit dose (blister): 50

C

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Member State

MAH

Invented name

Strength

Pharmaceutical form Route of administration

Packaging

Package size

Luxembourg

Christiaens Pharma

Steovit D3
500 mg/400 I.E

500 mg/10 µg

Chewable tablet Oral

Netherlands

Christiaens BV

Calcichew-D3
500 mg/400 I.E

500 mg/10 µg

Chewable tablet Oral

Polyethylene (PEHD)
bottle
Unit dose (blister):
PVC/PVdC/PE/Al

Polyethylene (PEHD)
bottle
Unit dose (blister):
PVC/PVdC/PE/Al

20, 30, 50, 60, 90, 100, 180
Unit dose (blister): 50

Bottle: 20, 30, 50, 60, 90, 100,
180
Unit dose (blister): 50

Norway

Nycomed Pharma AS,
Norway

Calcigran Forte

500 mg/10 µg

Chewable tablet Oral

Polyethylene (PEHD)
bottle

60, 100

Portugal

Laboratoires Theramex

Orocal-D3

500 mg/10 µg

Chewable tablet Oral

Polyethylene (PEHD)
bottle

20, 60

Sweden

Nycomed Pharma AS,
Norway

Calcichew-D3

500 mg/10 µg

Chewable tablet Oral

Polyethylene (PEHD)
bottle
Unit dose (blister):
PVC/PVdC/PE/Al

20, 30, 50, 60, 90, 100, 180
Unit dose (blister): 50

Nycomed Pharma AS,
Norway

Calcichew-D3 Spearmint

500 mg/10 µg

Chewable tablet Oral

Polyethylene (PEHD)
bottle

20, 30, 60, 100, 120, 180

.

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ANNEX II

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS, ROUTES OF ADMINISTRATION,
MARKETING AUTHORISATION HOLDERS, PACKAGING AND PACKAGE SIZES OF THE MEDICINAL
PRODUCT IN THE MEMBER STATES

Article 30 Referral for Calcitugg (and associated names) Chewable tablets (Calcium carbonate)

Member State

MAH

Invented name

Strength

Pharmaceutical form Route of Administration

Packaging

Package size

Belgium

Christiaens Pharma

Calcichew

500 mg

Chewable tablet Oral

Polyethylene (PEHD)
bottle

20, 50, 100

Finland

Oy Leiras Finland Ab

Calcichew 500 mg
purutabletti

500 mg

Chewable tablet Oral

Polyethylene (PEHD)
bottle

20, 100

Oy Leiras Finland Ab

Calcichew Spearmint
500 mg purutabletti

500 mg

Chewable tablet Oral

Polyethylene (PEHD)
bottle

20, 100

Germany

Orion Pharma GmbH

Calcimagon 500 mg

500 mg

Chewable tablet Oral

Polyethylene (PEHD)
bottle

20, 50, 100 and 10 × 100

Greece

Nycomed Hellas SA

Calcioral

500 mg

Chewable tablet Oral

Luxembourg

Christiaens Pharma

Calcichew

500 mg

Chewable tablet Oral

Netherlands

Christiaens BV

Calcichew 500 mg

500 mg

Chewable tablet Oral

Christiaens BV

Calcichew 1 000 mg

1 000 mg

Chewable tablet Oral

Polyethylene (PEHD)
bottle

20

Polyethylene (PEHD)
bottle

20, 50, 100

Bottle: Polyethylene
(PEHD)
Unit dose (blister):
PVC/PVdC/PE/Al

Polyethylene (PEHD)
bottle
Unit dose (blister):
PVC/PVdC/PE/Al

Bottle: 15, 30, 60, 90
Unit dose (blister): 50

30, 60, 90, 100
Unit dose (blister): 50

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Member State

MAH

Invented name

Strength

Pharmaceutical form Route of Administration

Packaging

Package size

Spain

Altana Pharma SA

Mastical

500 mg

Chewable tablet Oral

Sweden

Nycomed AB

Calcitugg

500 mg

Chewable tablet Oral

Nycomed AB

Calcitugg 1 000 mg

1 000 mg

Chewable tablet Oral

Polyethylene (PEHD)
bottle

60, 90

Polyethylene (PEHD)
bottle

60, 100

Polyethylene (PEHD)
bottle
Unit dose (blister):
PVC/PVdC/PE/Al

30, 60, 90, 100
Unit dose (blister): 50

.

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LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF
ADMINISTRATION, MARKETING AUTHORISATION HOLDER, APPLICANT, PACKAGING AND PACKAGE
SIZES IN THE MEMBER STATES

ANNEX III

Member State

Marketing Authorisation
Holder/Applicant

Invented name

Strength

Pharmaceutical
Form

Route of administration

Packaging

Package-size

Germany

Alfred E. Tiefenbacher
(GmbH & Co.)

Sweden

Alfred E. Tiefenbacher
(GmbH & Co.)

Fluconazol
Tiefenbacher 50 mg
Hartkapseln

Fluconazol
Tiefenbacher 100 mg
Hartkapseln

Fluconazol
Tiefenbacher 150 mg
Hartkapseln

Fluconazol
Tiefenbacher 200 mg
Hartkapseln

Fluconazol
Tiefenbacher 50 mg
kapsler, hårda

Fluconazol
Tiefenbacher 100 mg
kapsler, hårda

Fluconazol
Tiefenbacher 150 mg
kapsler, hårda

Fluconazol
Tiefenbacher 200 mg
kapsler, hårda

50 mg

Capsule, hard

Oral use

PVC/PVdC/Alu Blister

3, 7, 10, 14, 20, 28, 30, 42,
50, 100

100 mg

Capsule, hard

Oral use

PVC/PVdC/Alu Blister

7, 10, 14, 20, 28, 30, 50, 60,
100

150 mg

Capsule, hard

Oral use

PVC/PVdC/Alu Blister

1, 2, 4, 6, 10, 20

200 mg

Capsule, hard

Oral use

PVC/PVdC/Alu Blister

7, 10, 14, 20, 28, 30, 50, 100

50 mg

Capsule, hard

Oral use

PVC/PVdC/Alu Blister

3, 7, 10, 14, 20, 28, 30, 42,
50, 100

100 mg

Capsule, hard

Oral use

PVC/PVdC/Alu Blister

7, 10, 14, 20, 28, 30, 50, 60,
100

150 mg

Capsule, hard

Oral use

PVC/PVdC/Alu Blister

1, 2, 4, 6, 10, 20

200 mg

Capsule, hard

Oral use

PVC/PVdC/Alu Blister

7, 10, 14, 20, 28, 30, 50, 100

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LIST OF THE MARKETING AUTHORISATION HOLDER,
INVENTED NAME, STRENGTHS, PHAR-
MACEUTICAL FORM, ROUTE OF ADMINISTRATION, PACKAGING AND PACKAGE SIZE OF THE
MEDICINAL PRODUCT IN THE MEMBER STATES

ANNEX IV

.

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Member State

Marketing Authorisation
Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Packaging

Content (Concentration)

Package-size

Austria

Aventis Behring GmbH
PO Box 1230
D-35002 Marburg

Beriate P

250 IU

Powder and solvent
for
solution for injection or
infusion

Intravenous use

Beriate P

500 IU

Powder and solvent
for
solution for injection or
infusion

Intravenous use

Beriate P

1 000 IU

Powder and solvent
for
solution for injection or
infusion

Intravenous use

Germany

Aventis Behring GmbH
PO Box 1230
D-35002 Marburg

Beriate P

250 IU

Powder and solvent
for
solution for injection or
infusion

Intravenous use

Beriate P

500 IU

for
Powder and solvent
solution for injection or
infusion

Intravenous use

Beriate P

1 000 IU

Powder and solvent
for
solution for injection or
infusion

Intravenous use

Italy

Aventis Behring GmbH
PO Box 1230
D-35002 Marburg

Beriate P

250 IU

Powder and solvent
for
solution for injection or
infusion

Intravenous use

Powder:
vial (glass)
Solvent:
vial (glass)

Powder:
vial (glass)
Solvent:
vial (glass)

Powder:
vial (glass)
Solvent:
vial (glass)

Powder:
vial (glass)
Solvent:
vial (glass)

Powder:
vial (glass)
Solvent:
vial (glass)

Powder:
vial (glass)
Solvent:
vial (glass)

Powder:
vial (glass)
Solvent:
vial (glass)

Powder: 250 IU
Solvent: 2,5 ml
(100 IU/ml)

1 vial +
1 vial +
1 set of administration
devices (*)

Powder: 500 IU
Solvent: 5 ml
(100 IU/ml)

1 vial +
1 vial +
1 set of administration
devices (*)

Powder: 1 000 IU
Solvent: 10 ml
(100 IU/ml)

1 vial +
1 vial +
1 set of administration
devices (*)

Powder: 250 IU
Solvent: 2,5 ml
(100 IU/ml)

1 vial +
1 vial +
1 set of administration
devices (*)

Powder: 500 IU
Solvent: 5 ml
(100 IU/ml)

1 vial +
1 vial +
1 set of administration
devices (*)

Powder: 1 000 IU
Solvent: 10 ml
(100 IU/ml)

1 vial +
1 vial +
1 set of administration
devices (*)

Powder: 250 IU
Solvent: 2,5 ml
(100 IU/ml)

1 vial +
1 vial +
1 set of administration
devices (*)

E
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Member State

Marketing Authorisation
Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Packaging

Content (Concentration)

Package-size

Italy
(cont’d)

Beriate P

500 IU

for
Powder and solvent
solution for injection or
infusion

Intravenous use

Beriate P

1 000 IU

Powder and solvent
for
solution for injection or
infusion

Intravenous use

Portugal

Aventis Behring GmbH
PO Box 1230
D-35002 Marburg

Beriate P

250 IU

Powder and solvent
for
solution for injection or
infusion

Intravenous use

Beriate P

500 IU

Powder and solvent
for
solution for injection or
infusion

Intravenous use

Beriate P

1 000 IU

for
Powder and solvent
solution for injection or
infusion

Intravenous use

Spain

Aventis Behring GmbH
PO Box 1230
D-35002 Marburg

Beriate P

250 IU

Powder and solvent
for
solution for injection or
infusion

Intravenous use

Beriate P

500 IU

Powder and solvent
for
solution for injection or
infusion

Intravenous use

Beriate P

1 000 IU

Powder and solvent
for
solution for injection or
infusion

Intravenous use

Powder:
vial (glass)
Solvent:
vial (glass)

Powder:
vial (glass)
Solvent:
vial (glass)

Powder:
vial (glass)
Solvent:
vial (glass)

Powder:
vial (glass)
Solvent:
vial (glass)

Powder:
vial (glass)
Solvent:
vial (glass)

Powder:
vial (glass)
Solvent:
vial (glass)

Powder:
vial (glass)
Solvent:
vial (glass)

Powder:
vial (glass)
Solvent:
vial (glass)

Powder: 500 IU
Solvent: 5 ml
(100 IU/ml)

1 vial +
1 vial +
1 set of administration
devices (*)

Powder: 1 000 IU
Solvent: 10 ml
(100 IU/ml)

1 vial +
1 vial +
1 set of administration
devices (*)

Powder: 250 IU
Solvent: 2,5 ml
(100 IU/ml)

1 vial +
1 vial +
1 set of administration
devices (*)

Powder: 500 IU
Solvent: 5 ml
(100 IU/ml)

1 vial +
1 vial +
1 set of administration
devices (*)

Powder: 1 000 IU
Solvent: 10 ml
(100 IU/ml)

1 vial +
1 vial +
1 set of administration
devices (*)

Powder: 250 IU
Solvent: 2,5 ml
(100 IU/ml)

1 vial +
1 vial +
1 set of administration
devices (*)

Powder: 500 IU
Solvent: 5 ml
(100 IU/ml)

1 vial +
1 vial +
1 set of administration
devices (*)

Powder: 1 000 IU
Solvent: 10 ml
(100 IU/ml)

1 vial +
1 vial +
1 set of administration
devices (*)

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Member State

Marketing Authorisation
Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Packaging

Content (Concentration)

Package-size

Sweden

Aventis Behring GmbH
PO Box 1230
D-35002 Marburg

Beriate P

250 IU

Powder and solvent
for
solution for injection or
infusion

Intravenous use

Beriate P

500 IU

for
Powder and solvent
solution for injection or
infusion

Intravenous use

Beriate P

1 000 IU

Powder and solvent
for
solution for injection or
infusion

Intravenous use

United
Kingdom

Aventis Behring GmbH
PO Box 1230
D-35002 Marburg

Beriate P

250 IU

Powder and solvent
for
solution for injection or
infusion

Intravenous use

Beriate P

500 IU

Powder and solvent
for
solution for injection or
infusion

Intravenous use

Beriate P

1 000 IU

Powder and solvent
for
solution for injection or
infusion

Intravenous use

(*) 1 transfer set.

1 disposable filter spike.

Powder:
vial (glass)
Solvent:
vial (glass)

Powder:
vial (glass)
Solvent:
vial (glass)

Powder:
vial (glass)
Solvent:
vial (glass)

Powder:
vial (glass)
Solvent:
vial (glass)

Powder:
vial (glass)
Solvent:
vial (glass)

Powder:
vial (glass)
Solvent:
vial (glass)

Powder: 250 IU
Solvent: 2,5 ml
(100 IU/ml)

1 vial +
1 vial +
1 set of administration
devices (*)

Powder: 500 IU
Solvent: 5 ml
(100 IU/ml)

1 vial +
1 vial +
1 set of administration
devices (*)

Powder: 1 000 IU
Solvent: 10 ml
(100 IU/ml)

1 vial +
1 vial +
1 set of administration
devices (*)

Powder: 250 IU
Solvent: 2,5 ml
(100 IU/ml)

1 vial +
1 vial +
1 set of administration
devices (*)

Powder: 500 IU
Solvent: 5 ml
(100 IU/ml)

1 vial +
1 vial +
1 set of administration
devices (*)

Powder: 1 000 IU
Solvent: 10 ml
(100 IU/ml)

1 vial +
1 vial +
1 set of administration
devices (*)

.

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1
0
1
2
0
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4

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

ANNEX V

Member State

Marketing Authorisation Holder
Address

Marketing Authorisation Holder
Tel. and Fax

Invented name

Strength

Pharmaceutical
form

Route of administration

Packaging

Package sizes

Austria

Servier Austria GmbH
Mariahilfer Straße 20/5
A-1070 Wien

Tel. (43-1) 524 39 99
Fax (43-1) 524 39 99

COVERSUM
2 mg

2 mg

Tablets

Oral use

PVC/aluminium blister strip
in carton box

30 tablets

COVERSUM
4 mg

4 mg

Tablets

Oral use

30 tablets

Belgium

Servier Benelux SA
Bvd. International 57
B-1070 Bruxelles

Tel. (32-2) 529 43 11
Fax (32-2) 529 43 15

COVERSYL
2 mg

2 mg

Tablets

Oral use

NOT MARKETED

COVERSYL
4 mg

4 mg

Tablets

Oral use

PVC/aluminium blister strip
in carton box

30 tablets & 30 tablets
(unit dose)
(Only packages of 30
tablets are marketed)

Denmark

Les Laboratoires Servier
22, rue Garnier
B-92200 Neuilly-sur-Seine

Tel. (33-1) 55 72 60 00
Fax (33-1) 55 72 60 11

COVERSYL

2 mg

Tablets

Oral use

PVC/aluminium blister strip
in carton box

30 tablets

COVERSYL

4 mg

Tablets

Oral use

30 & 90 tablets

Finland

Les Laboratoires Servier
22, rue Garnier
F-92200 Neuilly-sur-Seine

Tel. (33-1) 55 72 60 00
Fax (33-1) 55 72 60 11

COVERSYL
2 mg

2 mg

Tablets

Oral use

NOT MARKETED
blister 30 & 90

COVERSYL
4 mg

ACERTIL
2 mg

ACERTIL
4 mg

4 mg

Tablets

Oral use

PVC/aluminium blister strip
in carton box

30 & 90 tablets

2 mg

Tablets

Oral use

4 mg

Tablets

Oral use

NOT MARKETED
blister 30 & 90

NOT MARKETED
blister 30 & 90

C

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Member State

Marketing Authorisation Holder
Address

Marketing Authorisation Holder
Tel. and Fax

Invented name

Strength

Pharmaceutical
form

Route of administration

Packaging

Package sizes

France

Les Laboratoires Servier
22, rue Garnier
F-92200 Neuilly-sur-Seine

Tel. (33-1) 55 72 60 00
Fax (33-1) 55 72 60 11

COVERSYL
2 mg

2 mg

Tablets

Oral use

PVC/aluminium blister strip
in carton box

tablets & 100

30
tablets (unit dose)

.

.

1
0
1
2
0
0
4

4 mg

Tablets

Oral use

tablets & 100

30
tablets (unit dose)

E
N

COVERSYL
4 mg

ELECTAN
2 mg

ELECTAN
4 mg

PROCAPTAN
2 mg

PROCAPTAN
4 mg

2 mg

Tablets

Oral use

NOT MARKETED

4 mg

Tablets

Oral use

NOT MARKETED

2 mg

Tablets

Oral use

NOT MARKETED

4 mg

Tablets

Oral use

NOT MARKETED

Germany

Les Laboratoires Servier
22, rue Garnier
F-92200 Neuilly-sur-Seine

Tel. (33-1) 55 72 60 00
Fax (33-1) 55 72 60 11

COVERSUM
COR 2 mg

2 mg

Tablets

Oral use

PVC/aluminium blister strip
in carton box

30, 50 & 100 tablets

COVERSUM
4 mg

COVERAX
COR 2 mg

COVERAX
4 mg

4 mg

Tablets

Oral use

30, 50 & 100 tablets

2 mg

Tablets

Oral use

NOT MARKETED

4 mg

Tablets

Oral use

NOT MARKETED

Greece

Servier Hellas
Pharmaceuticals SA
181 Syngrou Ave.
GR-171 21 N. Smyrni

(30-2) 109 39 10 00

Tel.
Fax (30-2) 109 39 10 01

COVERSYL

2 mg

Tablets

Oral use

PVC/aluminium blister strip
in carton box

30 tablets

COVERSYL

4 mg

Tablets

Oral use

30 tablets

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

6
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1
3

Member State

Marketing Authorisation Holder
Address

Marketing Authorisation Holder
Tel. and Fax

Invented name

Strength

Pharmaceutical
form

Route of administration

Packaging

Package sizes

Ireland

Les Laboratoires Servier
22, rue Garnier
F-92200 Neuilly-sur-Seine

Tel. (33-1) 55 72 60 00
Fax (33-1) 55 72 60 11

COVERSYL
tablets 2 mg

2 mg

Tablets

Oral use

NOT MARKETED

4 mg

Tablets

Oral use

PVC/aluminium blister strip
in carton box

30 tablets

2 mg

Tablets

Oral use

NOT MARKETED

4 mg

Tablets

Oral use

NOT MARKETED

2 mg

Tablets

Oral use

NOT MARKETED

4 mg

Tablets

Oral use

NOT MARKETED

COVERSYL
tablets 4 mg

Perindopril
2 mg tablets

Perindopril
4 mg tablets

Perindopril
Servier
2 mg tablets

Perindopril
Servier
4 mg tablets

Italy

Les Laboratoires Servier
22, rue Garnier
F-92200 Neuilly-sur-Seine

Tel. (33-1) 55 72 60 00
Fax (33-1) 55 72 60 11

COVERSYL

4 mg

Tablets

Oral use

PVC/aluminium blister strip
in carton box

14 tablets

Luxembourg

Servier Benelux SA
Bvd. International 57
B-1070 Bruxelles

Tel. (32-2) 529 43 11
Fax (32-2) 529 43 15

COVERSYL
2 mg

2 mg

Tablets

Oral use

NOT MARKETED

COVERSYL
4 mg

4 mg

Tablets

Oral use

PVC/aluminium blister strip
in carton box

30 tablets

Netherlands

Les Laboratoires Servier
22, rue Garnier
F-92200 Neuilly-sur-Seine

Tel. (33-1) 55 72 60 00
Fax (33-1) 55 72 60 11

COVERSYL
2 mg

2 mg

Tablets

Oral use

PVC/aluminium blister strip
in carton box

14 & 50 tablets

COVERSYL
4 mg

4 mg

Tablets

Oral use

30 & 50 tablets

C

6
/
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

.

.

1
0
1
2
0
0
4

Member State

Marketing Authorisation Holder
Address

Marketing Authorisation Holder
Tel. and Fax

Invented name

Strength

Pharmaceutical
form

Route of administration

Packaging

Package sizes

Portugal

Spain

Sweden

Servier Portugal — Especial-
idades Farmacêuticas, Lda
Av. Antonio Augusto Aguiar
P-128 — 1069-133 Lisboa

(35-1) 213 12 20 00

Tel.
Fax (35-1) 213 12 20 90

COVERSYL

2 mg

Tablets

Oral use

NOT MARKETED

COVERSYL

4 mg

Tablets

Oral use

PVC/aluminium blister strip
in carton box

14, 30, 60 tablets

Les Laboratoires Servier
22, rue Garnier
F-92200 Neuilly-sur-Seine

Les Laboratoires Servier
22, rue Garnier
F-92200 Neuilly-sur-Seine

Tel. (33-1) 55 72 60 00
Fax (33-1) 55 72 60 11

COVERSYL
4 mg

4 mg

Tablets

Oral use

PVC/aluminium blister strip
in carton box

30 & 500 tablets

Tel. (33-1) 55 72 60 00
Fax (33-1) 55 72 60 11

COVERSYL

2 mg

Tablets

Oral use

NOT MARKETED
PVC/aluminium blister strip in carton box 30 tablets

COVERSYL

4 mg

Tablets

Oral use

NOT MARKETED
PVC/aluminium blister in carton box
30 & 90 tablets

United
Kingdom

Les Laboratoires Servier
22, rue Garnier
F-92200 Neuilly-sur-Seine

Tel. (33-1) 55 72 60 00
Fax (33-1) 55 72 60 11

COVERSYL
2 mg

2 mg

Tablets

Oral use

PVC/aluminium blister strip
in carton box

7, 14, 28, 30, 56, 112
tablets

COVERSYL
4 mg

Perindopril
tablets 2 mg

Perindopril
tablets 4 mg

4 mg

Tablets

Oral use

2 mg

Tablet

Oral use

4 mg

Tablet

Oral use

Iceland

Norway

Les Laboratoires Servier
22, rue Garnier
F-92200 Neuilly-sur-Seine

Tel. (33-1) 55 72 60 00
Fax (33-1) 55 72 60 11

COVERSYL

2 mg

Tablets

Oral use

PVC/aluminium blister strip
in carton box

30 tablets

COVERSYL

4 mg

Tablets

Oral use

30 & 90 tablets

Les Laboratoires Servier
22, rue Garnier
F-92200 Neuilly-sur-Seine

Tel. (33-1) 55 72 60 00
Fax (33-1) 55 72 60 11

COVERSYL
2 mg

2 mg

Tablets

Oral use

COVERSYL
4 mg

4 mg

Tablets

Oral use

NOT MARKETED YET
30 tablets (blister)

NOT MARKETED YET
30 & 90 tablets (blister)

.

.

1
0
1
2
0
0
4

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
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U
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i

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1
5

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF
ADMINISTRATION, MARKETING AUTHORISATION HOLDERS, PACKAGING AND PACKAGE SIZES IN THE
MEMBER STATES

ANNEX VI

Member States

Marketing Authorisation
Holder

Belgium

Aventis Behring GmbH
PO Box 1230
D-35002 Marburg

Invented name

Strengths

Pharmaceutical form

Route of administration

Packaging

Content concentration

Package sizes

Mononine

250 IU

Powder and solvent for
solution for injection

Intravenous use

Mononine

500 IU

Powder and solvent for
solution for injection

Intravenous use

Mononine

1 000 IU

Powder and solvent for
solution for injection

Intravenous use

C

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
u
r
o
p
e
a
n
U
n
o
n

i

.

.

1
0
1
2
0
0
4

Powder:
vial (glass)
Solvent:
vial (glass)

Powder:
vial (glass)
Solvent:
vial (glass)

Powder:
vial (glass)
Solvent:
vial (glass)

Powder:
vial (glass)
Solvent:
vial (glass)

Powder:
vial (glass)
Solvent:
vial(glas)

Powder:
vial (glass)
Solvent:
vial (glass)

Powder:
vial (glass)
Solvent:
vial (glass)

Powder: 250 IU
Solvent: 2,5 ml

Powder: 500 IU
Solvent: 5 ml

Powder: 1 000 IU
Solvent: 10 ml

Powder: 250 IU
Solvent: 2,5 ml

Powder: 500 IU
Solvent: 5 ml

Powder: 1 000 IU
Solvent: 10 ml

Powder: 250 IU
Solvent: 2,5 ml

1 vial +
1 vial +
1 set of administration
devices (*)

1 vial +
1 vial +
1 set of administration
devices (*)

1 vial +
1 vial +
1 set of administration
devices (*)

1 vial +
1 vial +
1 set of administration
devices (*)

1 vial +
1 vial +
1 set of administration
devices (*)

1 vial +
1 vial +
1 set of administration
devices (*)

1 vial +
1 vial +
1 set of administration
devices (*)

Denmark

Aventis Behring GmbH
PO Box 1230
D-35002 Marburg

Mononine

250 IU

Powder and solvent for
solution for injection

Intravenous use

Mononine

500 IU

Powder and solvent for
solution for injection

Intravenous use

Mononine

1 000 IU

Powder and solvent for
solution for injection

Intravenous use

France

Aventis Behring GmbH
PO Box 1230
D-35002 Marburg

Mononine

250 IU

Powder and solvent for
solution for injection

Intravenous use

Member States

Marketing Authorisation
Holder

Invented name

Strengths

Pharmaceutical form

Route of administration

Packaging

Content concentration

Package sizes

.

.

1
0
1
2
0
0
4

France
(cont’d)

Mononine

500 IU

Powder and solvent for
solution for injection

Intravenous use

Mononine

1 000 IU

Powder and solvent for
solution for injection

Intravenous use

Germany

Aventis Behring GmbH
PO Box 1230
D-35002 Marburg

Mononine

250 IU

Powder and solvent for
solution for injection

Intravenous use

Mononine

500 IU

Powder and solvent for
solution for injection

Intravenous use

Mononine

1 000 IU

Powder and solvent for
solution for injection

Intravenous use

Greece

GEROLYMATOS P.N.
AEBE
Asclipiou 10 st.
GR-14565 Kryoneri,
Attiki

Mononine

250 IU

Powder and solvent for
solution for injection

Intravenous use

Mononine

500 IU

Powder and solvent for
solution for injection

Intravenous use

Mononine

1 000 IU

Powder and solvent for
solution for injection

Intravenous use

Powder:
vial (glass)
Solvent:
vial (glass)

Powder:
vial (glass)
Solvent:
vial (glass)

Powder:
vial (glass)
Solvent:
vial (glass)

Powder:
vial (glass)
Solvent:
vial (glass)

Powder:
vial (glass)
Solvent:
vial (glass)

Powder:
vial (glass)
Solvent:
vial (glass)

Powder:
vial (glass)
Solvent:
vial (glass)

Powder:
vial (glass)
Solvent:
vial (glass)

Powder: 500 IU
Solvent: 5 ml

Powder: 1 000 IU
Solvent: 10 ml

Powder: 250 IU
Solvent: 2,5 ml

Powder: 500 IU
Solvent: 5 ml

Powder: 1 000 IU
Solvent: 10 ml

Powder: 250 IU
Solvent: 2,5 ml

Powder: 500 IU
Solvent: 5 ml

Powder: 1 000 IU
Solvent: 10 ml

1 vial +
1 vial +
1 set of administration
devices (*)

1 vial +
1 vial +
1 set of administration
devices (*)

1 vial +
1 vial +
1 set of administration
devices (*)

1 vial +
1 vial +
1 set of administration
devices (*)

1 vial +
1 vial +
1 set of administration
devices (*)

1 vial +
1 vial +
1 set of administration
devices (*)

1 vial +
1 vial +
1 set of administration
devices (*)

1 vial +
1 vial +
1 set of administration
devices (*)

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

6
/
1
7

Invented name

Strengths

Pharmaceutical form

Route of administration

Packaging

Content concentration

Package sizes

Member States

Marketing Authorisation
Holder

Ireland

Aventis Behring Ltd.
Aventis House
Market Place
Haywards Heath
West Sussex RH16 1DB
United Kingdom

Mononine

250 IU

Powder and solvent for
solution for injection

Intravenous use

Mononine

500 IU

Powder and solvent for
solution for injection

Intravenous use

Mononine

1 000 IU

Powder and solvent for
solution for injection

Intravenous use

Italy

Aventis Behring GmbH
PO Box 1230
D-35002 Marburg

Mononine

250 IU

Powder and solvent for
solution for injection

Intravenous use

Mononine

500 IU

Powder and solvent for
solution for injection

Intravenous use

Mononine

1 000 IU

Powder and solvent for
solution for injection

Intravenous use

Luxembourg

Aventis Behring NV/SA
Astra Gardens
Belgicastraat 11
B-1930 Zaventem

Mononine

250 IU

Powder and solvent for
solution for injection

Intravenous use

Mononine

500 IU

Powder and solvent for
solution for injection

Intravenous use

Powder:
vial (glass)
Solvent:
vial (glass)

Powder:
vial (glass)
Solvent:
vial (glass)

Powder:
vial (glass)
Solvent:
vial (glass)

Powder:
vial (glass)
Solvent:
vial (glass)

Powder:
vial (glass)
Solvent:
vial (glass)

Powder:
vial (glass)
Solvent:
vial (glass)

Powder:
vial (glass)
Solvent:
vial (glass)

Powder:
vial (glass)
Solvent:
vial (glass)

Powder: 250 IU
Solvent: 2,5 ml

Powder: 500 IU
Solvent: 5 ml

Powder: 1 000 IU
Solvent: 10 ml

Powder: 250 IU
Solvent: 2,5 ml

Powder: 500 IU
Solvent: 5 ml

Powder: 1 000 IU
Solvent: 10 ml

Powder: 250 IU
Solvent: 2,5 ml

Powder: 500 IU
Solvent: 5 ml

1 vial +
1 vial +
1 set of administration
devices (*)

1 vial +
1 vial +
1 set of administration
devices (*)

1 vial +
1 vial +
1 set of administration
devices (*)

1 vial +
1 vial +
1 set of administration
devices (*)

1 vial +
1 vial +
1 set of administration
devices (*)

1 vial +
1 vial +
1 set of administration
devices (*)

1 vial +
1 vial +
1 set of administration
devices (*)

1 vial +
1 vial +
1 set of administration
devices (*)

C

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
u
r
o
p
e
a
n
U
n
o
n

i

.

.

1
0
1
2
0
0
4

Member States

Marketing Authorisation
Holder

Invented name

Strengths

Pharmaceutical form

Route of administration

Packaging

Content concentration

Package sizes

.

.

1
0
1
2
0
0
4

Luxembourg
(cont’d)

Mononine

1 000 IU

Powder and solvent for
solution for injection

Intravenous use

Netherlands

Aventis Behring GmbH
PO Box 1230
D-35002 Marburg

Mononine

250 IU

Powder and solvent for
solution for injection

Intravenous use

Mononine

500 IU

Powder and solvent for
solution for injection

Intravenous use

Mononine

1 000 IU

Powder and solvent for
solution for injection

Intravenous use

Portugal

Aventis Behring GmbH
PO Box 1230
D-35002 Marburg

Mononine

250 IU

Powder and solvent for
solution for injection

Intravenous use

Mononine

500 IU

Powder and solvent for
solution for injection

Intravenous use

Mononine

1 000 IU

Powder and solvent for
solution for injection

Intravenous use

Spain

Aventis Behring GmbH
PO Box 1230
D-35002 Marburg

Mononine

250 IU

Powder and solvent for
solution for injection

Intravenous use

Powder:
vial (glass)
Solvent:
vial (glass)

Powder:
vial (glass)
Solvent:
vial (glass)

Powder:
vial (glass)
Solvent:
vial (glass)

Powder:
vial (glass)
Solvent:
vial (glass)

Powder:
vial (glass)
Solvent:
vial (glass)

Powder:
vial (glass)
Solvent:
vial (glass)

Powder:
vial (glass)
Solvent:
vial (glass)

Powder:
vial (glass)
Solvent:
vial (glass)

Powder: 1 000 IU
Solvent: 10 ml

Powder: 250 IU
Solvent: 2,5 ml

Powder: 500 IU
Solvent: 5 ml

Powder: 1 000 IU
Solvent: 10 ml

Powder: 250 IU
Solvent: 2,5 ml

Powder: 500 IU
Solvent: 5 ml

Powder: 1 000 IU
Solvent: 10 ml

Powder: 250 IU
Solvent: 2,5 ml

1 vial +
1 vial +
1 set of administration
devices (*)

1 vial +
1 vial +
1 set of administration
devices (*)

1 vial +
1 vial +
1 set of administration
devices (*)

1 vial +
1 vial +
1 set of administration
devices (*)

1 vial +
1 vial +
1 set of administration
devices (*)

1 vial +
1 vial +
1 set of administration
devices (*)

1 vial +
1 vial +
1 set of administration
devices (*)

1 vial +
1 vial +
1 set of administration
devices (*)

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

6
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1
9

Member States

Marketing Authorisation
Holder

Invented name

Strengths

Pharmaceutical form

Route of administration

Packaging

Content concentration

Package sizes

Spain
(cont’d)

Mononine

500 IU

Powder and solvent for
solution for injection

Intravenous use

Mononine

1 000 IU

Powder and solvent for
solution for injection

Intravenous use

Sweden

Aventis Behring GmbH
PO Box 1230
D-35002 Marburg

Mononine

250 IU

Powder and solvent for
solution for injection

Intravenous use

Mononine

500 IU

Powder and solvent for
solution for injection

Intravenous use

Mononine

1 000 IU

Powder and solvent for
solution for injection

Intravenous use

United
Kingdom

Aventis Behring Ltd.
Aventis House
Market Place
Haywards Heath
West Sussex RH16 1DB
United Kingdom

Mononine

250 IU

Powder and solvent for
solution for injection

Intravenous use

Mononine

500 IU

Powder and solvent for
solution for injection

Intravenous use

Mononine

1 000 IU

Powder and solvent for
solution for injection

Intravenous use

Powder:
vial (glass)
Solvent:
vial (glass)

Powder:
vial (glass)
Solvent:
vial (glass)

Powder:
vial (glass)
Solvent:
vial (glass)

Powder:
vial (glass)
Solvent:
vial (glass)

Powder:
vial (glass)
Solvent:
vial (glass)

Powder:
vial (glass)
Solvent:
vial (glass)

Powder:
vial (glass)
Solvent:
vial (glass)

Powder:
vial (glass)
Solvent:
vial (glass)

Powder: 500 IU
Solvent: 5 ml

Powder: 1 000 IU
Solvent: 10 ml

Powder: 250 IU
Solvent: 2,5 ml

Powder: 500 IU
Solvent: 5 ml

Powder: 1 000 IU
Solvent: 10 ml

Powder: 250 IU
Solvent: 2,5 ml

Powder: 500 IU
Solvent: 5 ml

Powder: 1 000 IU
Solvent: 10 ml

1 vial +
1 vial +
1 set of administration
devices (*)

1 vial +
1 vial +
1 set of administration
devices (*)

1 vial +
1 vial +
1 set of administration
devices (*)

1 vial +
1 vial +
1 set of administration
devices (*)

1 vial +
1 vial +
1 set of administration
devices (*)

1 vial +
1 vial +
1 set of administration
devices (*)

1 vial +
1 vial +
1 set of administration
devices (*)

1 vial +
1 vial +
1 set of administration
devices (*)

(*) 1 set of administration devices contains:

sterile double ended transfer needle, sterile vented filter spike, sterile appropriate plastic syringe, sterile winged infusion set, disposable alcohol swabs, sterile plaster dressing, plastic disposal bag.

C

6
/
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

.

.

1
0
1
2
0
0
4