Summary of Community decisions on marketing authorisations in respect of medicinal products from 15 August to 15 September 2002 (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: 2002-10-02
Institutions: European Commission
Subjects: market approval, marketing, medicinal product, pharmaceutical legislation, pharmaceutical product, preparation for market

C 237/10

EN

Official Journal of the European Communities

2.10.2002

Summary of Community decisions on marketing authorisations in respect of medicinal products
from 15 August to 15 September 2002

(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))

(2002/C 237/04)

— Issuing, maintenance or modification of a national marketing authorisation

Date of the decision

Name(s) of the
medicinal product

Holder(s) of the
marketing authorisation

Member State concerned

Date of notification

21.8.2002

Dacarbazine Faulding

See Annex 1

See Annex 1

22.8.2002

Captopril/
hydrochlorothiazide

See Annex 2

See Annex 2

9.9.2002

Captopril

See Annex 3

See Annex 3

12.9.2002

Bovimectin Injection

See Annex 4

See Annex 4

12.9.2002

Porcimectin Injection

See Annex 5

See Annex 5

22.8.2002

22.8.2002

10.9.2002

16.9.2002

16.9.2002

— Withdrawal of a national marketing authorisation

Date of the decision

Name(s) of the
medicinal product

Holder(s) of the
marketing authorisation

Member State concerned

Date of notification

22.8.2002

Cerivastatin

See Annex 6

See Annex 6

22.8.2002

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

2.10.2002

EN

Official Journal of the European Communities

C 237/11

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

ANNEX I

Member State

Marketing authorisation
holder

Name

Strength

Pharmaceutical
form

Route of
administration

Packaging

Content

Package
size

UNITED
KINGDOM

Faulding Pharmaceuticals plc
Queensway
Royal Leamington SpA
Warwickshire CV31 3RW
United Kingdom

Faulding Pharmaceuticals plc
Queensway
Royal Leamington SpA
Warwickshire CV31 3RW
United Kingdom

Faulding Pharmaceuticals plc
Queensway
Royal Leamington SpA
Warwickshire CV31 3RW
United Kingdom

Dacarbazine
Faulding

100 mg

Powder for solution
for injection

Intravenous use Vial (glass) 10 ml

1 vial

Dacarbazine
Faulding

200 mg

Powder for solution
for injection

Intravenous use Vial (glass) 20 ml

1 vial

Dacarbazine
Faulding

600 mg

Powder for solution
for injection

Intravenous use Vial (glass) 100 ml

1 vial

FRANCE

Faulding Pharmaceuticals SA
93, rue de Magenta
F-92600 Asnières

Dacarbazine
Faulding

100 mg

Powder for solution
for injection

Intravenous use Vial (glass) 10 ml

1 vial

SPAIN

Faulding Pharmaceuticals SA
93, rue de Magenta
F-92600 Asnières

Faulding Pharmaceuticals SA
93, rue de Magenta
F-92600 Asnières

Faulding Pharmaceuticals plc
Queensway
Royal Leamington SpA
Warwickshire CV31 3RW
United Kingdom

Faulding Pharmaceuticals plc
Queensway
Royal Leamington SpA
Warwickshire CV31 3RW
United Kingdom

Faulding Pharmaceuticals plc
Queensway
Royal Leamington SpA
Warwickshire CV31 3RW
United Kingdom

Dacarbazine
Faulding

200 mg

Powder for solution
for injection

Intravenous use Vial (glass) 20 ml

1 vial

Dacarbazine
Faulding

600 mg

Powder for solution
for injection

Intravenous use Vial (glass) 100 ml

1 vial

Dacarbazine
Faulding

100 mg

Powder for solution
for injection

Intravenous use Vial (glass) 10 ml

1 vial

Dacarbazine
Faulding

200 mg

Powder for solution
for injection

Intravenous use Vial (glass) 20 ml

1 vial

Dacarbazine
Faulding

600 mg

Powder for solution
for injection

Intravenous use Vial (glass) 100 ml

1 vial

ANNEX 2

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

Article 11 referral initiated by France for Ecazide

Member State

MAH address
(contact person)

MAH telephone

MAH fax

Trade name

Strength

Pharma-
ceutical form

Route of
administration

Packaging

Package size

AUSTRIA

Bristol-Myers Squibb GesmbH
Columbusgasse 4
A-1211 Wien

(43-1) 60 14 30

(43-1) 60 14 32 29 Capozide

25/25

Tablets

Oral

PVC/Alu blister

30 tablets

Capozide forte

50/25

Capozide mite

25/12,5

AT Mayrhofer Pharmazeutika
Herrenst. 2
A-4010 Linz

(43) 73 27 65 90

(43)
732 76 54 91 00

Captopril
‘Mayrhofer’
compositum
forte-Tabletten

50 mg/25 ml

Tablets

Oral

PVC/Alu blister

20, 50

BELGIUM

Bristol-Myers Squibb
Belgium SA/NV
Chaussée de La Hulpe 185
B-1170 Bruxelles

DENMARK

Bristol-Myers Squibb AB
PO Box 15200
S-167 15 Bromma

FRANCE

Bristol-Myers Squibb
1, parvis de la Défense
La grande Arche Nord
F-92800 Puteaux

Laboratoires Aventis France
46, quai de la Rapée
F-75601 Paris Cedex
M. Alain Saint-Pierre

(32-2) 352 74 60

(32-2) 352 74 14

Volupril

50/25

Tablets

Oral

—

28 and 42 tablets

(46-8) 704 71 00

(46-8) 704 89 43

Capozid

50/25

Tablets

Oral

Amber glass
bottle

30 and 100 tablets

(33) 140 90 66 99 (33) 140 90 91 62 Ecazide

50/25

Tablets

Oral

PVC/Alu blister

28 tablets

(33) 155 71 55 71 (33) 155 71 55 55 Captea

50 mg

Tablets

Oral

PVC/PVDC/Alu
blister

28 tablets

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2
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2

Member State

MAH address
(contact person)

MAH telephone

MAH fax

Trade name

Strength

Pharma-
ceutical form

Route of
administration

Packaging

Package size

GERMANY

Squibb- von Heyden GmbH
Sapporobogen 6-8
D-80809 München

(49-89) 12 14 20

(49-89)
12 14 23 92

Capozide 25

25/25

Tablets

Oral

Capozide 50

25/25

Capozide mite

25/12,5

Cap/HCT

25/12,5

Hydrocap

25/12,5

Lopirin comp.

25/12,5

PVC/Alu blister
Amber glass
bottle

Capozide 25, 50, mite:

PVC/Alu blister: 20, 50,
100 and 400 tablets

Glass bottle: 500 tablets

E
N

Cap/HCT, Hydrocap,
Lopirin comp:

PVC/Alu blister: 20, 50,
100 and 200 tablets

Schwarz Pharma AG
Alfred-Nobel-Straße 10
D-40789 Monheim

(49) 2 17 34 80

(49)
21 73 48 16 08

Tensobon
comp mite

25 mg/25 mg
25 mg/12,5 mg
50 mg/25 mg

Tablets

Oral

PP/PP blister
wide-necked
glass bottle
with screw cap

10, 30, 50, 98, 100,
350, 500

GREECE

Bristol-Myers Squibb AEBE
102 Tatoiou and Kolokotroni
Street
GR-146 71 Nea Erythrea Attikis

(30-10) 624 93 99 (30-10) 624 93 70 Superace 50/25 25/25

Tablets

Oral

Opaque
PVC/Alu blister

20 tablets

Superace 50/15 50/15

Ketazide 50/25
(Mead Johnson)

50/25

Menarini Apharmaceutical SA
7 an Dambergi Street
GR-10455 Athens

(30-10)
831 61 11 13

(30-10) 831 73 43 Uresan

50 + 25 mg

Tablets

Oral

Blister

36

(30) 284 93 06

(30) 284 93 04

Ketazide

50 + 25 mg

Tablets

Oral

Blister

48

Mead Johnson AEBE
11th km National Road,

Athens-Lamia Metamorfosi
GR-14451 Attiki
PO Box 3711 Athens

.

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Member State

MAH address
(contact person)

MAH telephone

MAH fax

Trade name

Strength

Pharma-
ceutical form

Route of
administration

Packaging

Package size

IRELAND

Bristol-Myers Squibb
Pharmaceuticals Ltd
Swords County Dublin
Ireland

(353-1) 813 91 11 (353-1) 840 71 93 Capozide

50/25

Tablets

Oral

Half Capozide

25/12,5

PVC/PVDC/Alu
blister
Amber glass
bottle
HDPE bottle
Foil strips

Capozide 50/25:

PVC/PVDC/Alu blister:
28 tablets

Half Capozide 25/12,5:

PVC/PVDC/Alu blister:
28 tablets

Amber glass or HDPE
bottle: 100 tablets

ITALY

Bristol-Myers Squibb SpA
Via Virgilio Maroso, 50
I-00142 Rome

(39) 06 50 39 61

(39)
06 50 39 62 16

Aceplus

50/25

Tablets

Oral

Opaque
PVC/Alu blister

12 tablets

Aceplus Mite

50/15

A. Menarini Industrie Sud
Via del Murillo Km 2,800
Sermoneta Latina
Dr Ryli

(39)
05 55 68 05 00

(39)
05 55 68 05 00

Acediur

50 mg/25 mg
50 mg/15 mg

Tablets

Oral

PVC/Alu blister

NETHERLANDS Bristol-Myers Squibb BV

(31-348) 57 42 22 (31-348) 42 38 48 Capozide

50/25
25/12,5

Tablets

Oral

PVC/PVDC/Alu
blister

PVC/PVDC/Alu blister:
30 tablets

Aceplus

50/25

(351) 214 40 70 00 (351) 214 40 70 90 Lopiretic
Capozide
(Heyden
Farmacêutica
Portuguesa)

50/25

Tablets

Oral

PVC/Alu blister

20, 30 and 60 tablets

(351) 214 40 70 00 (351) 214 40 70 90 Capozide

50 mg/25 mg

Tablets

Oral

PVC/Alu blister

10, 20, 30, 60 units

Vijzelmolenlaan 9
3447 GX Woerden
PO Box 514
3440 AM Woerden
Nederland

PORTUGAL

Bristol-Myers Squibb
Edifício de Fernão de Magalhães

Quinta da Fonte
P-2780-730 Paço de Arcos

Heyden Farmacêutica
Portuguesa Lda
Edifício Fernão de Magalhães,
Piso 1

Quinta da Fonte
P-2780-730 Porto Salvo

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2
0
0
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Member State

MAH address
(contact person)

MAH telephone

MAH fax

Trade name

Strength

Pharma-
ceutical form

Route of
administration

Packaging

Package size

SPAIN

Grupo Bristol-Myers Squibb
C/Almansa 101
E-28040 Madrid

UNITED
KINGDOM

E.R. Squibb & Sons Limited
141-149 Staines Road
Hounslow
Middlesex
TW3 3JA
United Kingdom

(34) 914 56 53 00 (34) 914 56 55 01 Ecazide

50/25

Tablets

Oral

PVC/Alu blister

30 tablets

Captopril Hidro-
clorotiazid a
Apothecon
50/25 mg
(generic Apo-
thecon) Decreso
(Searle Ib)

(44)
80 07 31 17 36

(44)
20 87 54 37 89

Capozide

50/25

Tablets

Oral

Capozide LS

25/12,5

Acezide

50/25

PVC/PVDC/Alu
blister
Amber glass
bottle
HDPE bottle
Foil strips

Capozide/Capozide
LS/Acezide:

PVC/PVDC/Alu blister
and foil strips:
28 tablets

Capozide/Capozide LS:

Amber glass and HDPE
bottle: 100 tablets

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2
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LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCT, ROUTE OF
ADMINISTRATION, MARKETING AUTHORISATION HOLDERS (MAH), PACKAGING AND PACKAGE SIZES
IN THE MEMBER STATES

ANNEX 3

MAH telephone

MAH fax

Trade name

Strength

Pharma-
ceutical form

Route of
administration

Packaging

Content concentration

Package size

(43-1) 60 14 30 (43-1)

60 14 32 29

Lopirin
Captopril
BMS

12,5 mg
25 mg
50 mg

Tablets

Oral use

PVC/Alu blister

Country

AUSTRIA

MAH address
(contact person)

Bristol-Myers Squibb
GesmbH
Columbusgasse 4
A-1101 Wien

BELGIUM

Bristol-Myers Squibb
Belgium SA/NV
Chaussée de La Hulpe 185
B-1170 Bruxelles

(32-2) 352 74 60 (32-2) 352 74 14 Capoten

Captopril
BMS

12,5 mg
25 mg
50 mg
100 mg

25 mg
50 mg
100 mg

Tablets

Oral use

PVC/Alu blister

DENMARK

Bristol-Myers Squibb AB
PO Box 15200
S-167 15 Bromma

(46-8) 704 71 00 (46-8) 704 89 43 Capoten

Tablets

Oral use

12,5 mg
25 mg
50 mg

PVC/Alu blister
Glass and HDPE
bottles

Captopril, micro-
crystalline cellulose,
corn starch, stearic
acid, lactose
monohydrate

FINLAND

Bristol-Myers Squibb AB
PO Box 15200
S-167 15 Bromma

(46-8) 704 71 00 (46-8) 704 89 43 Capoten

Tablets

Oral use

12,5 mg
25 mg
50 mg

PVC/Alu blister
Amber glass
bottles

Captopril, micro-
crystalline cellulose,
corn starch, stearic
acid, lactose
monohydrate

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2
1
0
2
0
0
2

Captopril, micro-
crystalline cellulose,
corn starch, stearic
acid, lactose
monohydrate,
colloidal silica

Captopril, micro-
crystalline cellulose,
corn starch, stearic
acid, lactose
monohydrate

30 and 60 tablets

Capoten:

12,5 mg: 30, 45
and 90 tablets
25 and 50 mg: 30,
45, 60 and 100
tablets
100 mg: 30, 45 and
60 tablets

Captopril BMS:

25 and 50 mg: 30,
45, 60, 90 and 100
tablets
100 mg: 30, 45 and
60 tablets

PVC/Alu blister
12,5 mg: 30, 56,
60, 84 and 100
tablets
PVC/Alu blister
25/50 mg: 30, 56,
84 and 100 tablets
Glass and plastic
bottles: 100 and
200 tablets

PVC/Alu blister
12,5/25 mg: 30 and
100 tablets

PVC/Alu blister
50 mg: 100 tablets

Amber glass bottle:
200 tablets

Country

MAH address
(contact person)

MAH telephone

MAH fax

Trade name

Strength

Pharma-
ceutical form

Route of
administration

Packaging

Content concentration

Package size

FRANCE

Bristol-Myers Squibb
1, parvis de la Défense
La grande Arche Nord
F-92800 Puteaux

(33)
140 90 66 99

(33)
140 90 91 62

Lopril
Captopril
RPG

25 mg
50 mg
100 mg

Tablets

Oral use

PVC/Alu blister

GERMANY

Squibb- von Heyden GmbH
Sapporobogen 6-8
D-80809 München

(49-89) 12 14 20 (49-89)

Capoten

12 14 23 92

Lopiten

Tablets

Oral use

PVC/Alu blister
Amber glass
bottle

6,25 mg
37,5 mg
75 mg

6,25 mg
12,5 mg
25 mg
37,5 mg
50 mg
75 mg

Captopril, micro-
crystalline cellulose,
corn starch, stearic
acid, lactose
monohydrate

Captopril, micro-
crystalline cellulose,
corn starch, stearic
acid, lactose
monohydrate,
colloidal silica

Lopirin Cor

12,5 mg

Lopirin

Lopicor

6,25 mg
25 mg
37,5 mg
50 mg
75 mg

12,5 mg
25 mg
50 mg

30 and 45 tablets

Capoten:
PVC/Alu: 20, 50,
100, 400 tablets
Lopiten (6,25, 37,5,
75):
PVC/Alu: 20, 50,
100, 400 tablets
Lopiten (12,5, 25,
50):
PVC/Alu: 20, 50,
100, 500 tablets
Lopirin Cor:
PVC/Alu: 20, 50,
100, 400 (20 × 20)
Amber glass bottles:
500 tablets
Lopirin (6,25, 12,5,
25, 50, 75):
PVC/Alu: 20, 50,
100, 400 (20 × 20)
Amber glass bottles:
500 tablets
Lopirin (37,5):
PVC/Alu: 20, 50,
100, 400 tablets
Lopicor:
PVC/Alu: 20, 50,
100, 500 tablets

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Country

MAH address
(contact person)

MAH telephone

MAH fax

Trade name

Strength

Pharma-
ceutical form

Route of
administration

Packaging

Content concentration

Package size

(30-10)
624 93 99

(30-10)
624 93 70

Capoten

25 mg
50 mg

Tablets

Oral use

PVC/Alu blister

GREECE

Bristol-Myers Squibb AEBE
102 Tatoiou and
Kolokotroni Street
GR-146 71 Nea Erythrea
Attikis

ICELAND

Bristol-Myers Squibb AB
PO Box 15200
S-167 15 Bromma

(46-8) 704 71 00 (46-8) 704 89 43 Capoten

Tablets

Oral use

PVC/Alu blister

14 tablets

Captopril, micro-
crystalline cellulose,
corn starch, stearic
acid, lactose
monohydrate

Captopril, micro-
crystalline cellulose,
corn starch, stearic
acid, lactose
monohydrate

12,5 mg: 30 and
100 tablets
25/50 mg: 100
tablets

IRELAND

Bristol-Myers Squibb
Pharmaceuticals Ltd
Swords County Dublin
Ireland

(353-1)
813 91 11

(353-1)
840 71 93

Capoten

ITALY

Bristol-Myers Squibb SpA
Via Virgilio Maroso, 50
I-00142 Rome

(39) 06 50 39 61 (39)

06 50 39 62 16

Capoten
Acepress
UPSA
Captopril
UPSA

LUXEMBOURG

Bristol-Myers Squibb
Belgium SA/NV
Chaussée de La Hulpe 185
B-1170 Bruxelles

(32-2) 352 74 60 (32-2) 352 74 14 Capoten

Tablets

Oral use

PVC/Alu blister
HDPE bottles
Amber glass
bottle

Captopril, micro-
crystalline cellulose,
corn starch, stearic
acid, lactose
monohydrate

Tablets

Oral use

PVC/Alu blister

Captopril, micro-
crystalline cellulose,
corn starch, stearic
acid, lactose
monohydrate

PVC/Alu: 28, 56,
60, 84 and 90
tablets

HDPE bottles: 100
tablets

Amber glass bottle:
100 tablets

25 mg: 50 tablets
50 mg: 24 tablets

Tablets

Oral use

PVC/Alu blister

Captopril, micro-
crystalline cellulose,
corn starch, stearic
acid, lactose
monohydrate

25 mg: 45, 60 and
100 tablets
50 mg: 45 and 60
tablets
100 mg: 30 and 60
tablets

12,5 mg
25 mg
50 mg

12,5 mg
25 mg
50 mg

25 mg
50 mg

25 mg
50 mg
100 mg

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Country

MAH address
(contact person)

MAH telephone

MAH fax

Trade name

Strength

NETHERLANDS

Bristol-Myers Squibb BV
Vijzelmolenlaan 9
3447 GX Woerden
PO Box 514
3440 AM Woerden
Nederland

(31-348)
57 42 22

(31-348)
42 38 48

Capoten

12,5 mg
25 mg
50 mg

Pharma-
ceutical form

Route of
administration

Tablets

Oral use

PVC/Alu blister
PVC/PVDC/Alu
blister
Amber glass
bottle

Captopril, micro-
crystalline cellulose,
corn starch, stearic
acid, lactose
monohydrate

Packaging

Content concentration

Package size

NORWAY

Bristol-Myers Squibb AB
PO Box 15200
S-167 15 Bromma

(46-8) 704 71 00 (46-8) 704 89 43 Capoten

Tablets

Oral use

12,5 mg
25 mg
50 mg

PVC/Alu blister
Amber glass
bottle

Captopril, micro-
crystalline cellulose,
corn starch, stearic
acid, lactose
monohydrate

12,5 mg: 60 tablets
25/50 mg: 30
tablets
12,5/25/50: 50
tablets (hospital
pack)

25/50 mg: amber
glass bottle

PVC/Alu blister
12,5/25 mg: 30 and
100 tablets

PVC/Alu blister
50 mg: 100 tablets

Amber glass bottle:
200 tablets

PORTUGAL

Bristol-Myers Squibb
Edifício de Fernão de
Magalhães
Quinta da Fonte
P-2780-730 Paço de Arcos

(351)
214 40 70 00

(351)
214 40 70 90

Capoten
Captopril
generico

12,5 mg
25 mg
50 mg

Tablets

Oral use

PVC/Alu blister

SPAIN

Grupo Bristol-Myers Squibb
C/ Almansa 101
E-28040 Madrid

(34)
914 56 53 00
(34)
914 56 54 74

(34)
914 56 55 01

Capoten
Captopril
Apothecon

12,5 mg
25 mg
50 mg
100 mg

Tablets

Oral use

PVC/Alu blister

Captopril, micro-
crystalline cellulose,
corn starch, stearic
acid, lactose
monohydrate

12,5 mg: 60 tablets
25 mg: 20 and 60
tablets
50 mg: 60 tablets

Captopril, micro-
crystalline cellulose,
corn starch, stearic
acid, lactose
monohydrate

12,5 mg: 20 tablets
25 mg: 60 tablets
50 mg: 30 tablets
100 mg: 15 tablets

.

.

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1
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2
0
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2

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Country

MAH address
(contact person)

MAH telephone

MAH fax

Trade name

Strength

SWEDEN

Bristol-Myers Squibb AB
PO Box 15200
S-167 15 Bromma

(46-8) 704 71 00 (46-8) 704 89 43 Capoten

12,5 mg
25 mg
50 mg

Pharma-
ceutical form

Route of
administration

Tablets

Oral use

Packaging

Content concentration

Package size

PVC/Alu blister
Amber glass
bottle

Captopril, micro-
crystalline cellulose,
corn starch, stearic
acid, lactose
monohydrate

UNITED
KINGDOM

E.R. Squibb & Sons Limited
141-149 Staines Road
Hounslow
Middlesex TW3 3JA
United Kingdom

(44)
800 731 17 36

(44)
208 754 37 89

Capoten
Acepril

Tablets

Oral use

12,5 mg
25 mg
50 mg

PVC/Alu blister
Amber glass
bottle
HDPE bottle

Captopril, micro-
crystalline cellulose,
corn starch, stearic
acid, lactose
monohydrate

PVC/Alu blister
12,5/25 mg: 30 and
100 tablets

PVC/Alu blister
50 mg: 100 tablets

Amber glass bottle:
200 tablets

PVC/Alu: 28, 56,
60, 84 and 90
tablets

Amber glass bottle:
100 tablets

HDPE bottles: 100
tablets

C

2
3
7
/
2
0

E
N

O

f
f
i
c
i
a
l

J
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n
a
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o
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t
h
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E
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m
m
u
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i
t
i
e
s

.

.

2
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2
0
0
2

2.10.2002

EN

Official Journal of the European Communities

C 237/21

LIST OF THE PHARMACEUTICAL FORMS, STRENGTHS, ROUTES OF ADMINISTRATION, PACKAGING
AND PACKAGE SIZES OF THE VETERINARY MEDICINAL PRODUCT IN THE MEMBER STATES

ANNEX 4

Marketing authorisation holder (name and address)

Reference Member State:

IRELAND
Cross Vetpharm Group Ltd (Bimeda)
Broomhill Road
Tallaght
Dublin 24
Ireland

Concerned Member State:

BELGIUM
Cross Vetpharm Group Ltd (Bimeda)
Broomhill Road
Tallaght
Dublin 24
Ireland

Member State

Invented name

Strength

Pharmaceutical
form

Target species Route of administration

Packaging

Content

Package
size

IRELAND

Bovimectin
Injection

Bovimectin
Injection

Bovimectin
Injection

1 % w/v

(10 mg/ml)

1 % w/v

(10 mg/ml)

1 % w/v

(10 mg/ml)

BELGIUM

Bovimec B

1 % w/v

(10 mg/ml)

Bovimec B

1 % w/v

(10 mg/ml)

Bovimec B

1 % w/v

(10 mg/ml)

Solution for
injection

Cattle

Subcutaneous
injection

Bottle
(polyethylene)

50 ml

1 bottle

Solution for
injection

Cattle

Subcutaneous
injection

Bottle
(polyethylene)

250 ml

1 bottle

Solution for
injection

Cattle

Subcutaneous
injection

Bottle
(polyethylene)

500 ml

1 bottle

Solution for
injection

Cattle

Subcutaneous
injection

Bottle
(polyethylene)

50 ml

1 bottle

Solution for
injection

Cattle

Subcutaneous
injection

Bottle
(polyethylene)

250 ml

1 bottle

Solution for
injection

Cattle

Subcutaneous
injection

Bottle
(polyethylene)

500 ml

1 bottle

C 237/22

EN

Official Journal of the European Communities

2.10.2002

LIST OF THE PHARMACEUTICAL FORMS, STRENGTHS, ROUTES OF ADMINISTRATION, PACKAGING
AND PACKAGE SIZES OF THE VETERINARY MEDICINAL PRODUCT IN THE MEMBER STATES

ANNEX 5

Marketing authorisation holder (name and address)

Reference Member State:

IRELAND
Cross Vetpharm Group Ltd (Bimeda)
Broomhill Road
Tallaght
Dublin 24
Ireland

Concerned Member State:

BELGIUM
Cross Vetpharm Group Ltd (Bimeda)
Broomhill Road
Tallaght
Dublin 24
Ireland

Member State

Invented name

Strength

Pharmaceutical
form

Target species Route of administration

Packaging

Content

Package
size

IRELAND

Porcimectin
Injection

Porcimectin
Injection

Porcimectin
Injection

1 % w/v

(10 mg/ml)

1 % w/v

(10 mg/ml)

1 % w/v

(10 mg/ml)

BELGIUM

Porcimec P

1 % w/v

(10 mg/ml)

Porcimec P

1 % w/v

(10 mg/ml)

Porcimec P

1 % w/v

(10 mg/ml)

Solution for
injection

Pigs

Subcutaneous
injection

Bottle
(polyethylene)

50 ml

1 bottle

Solution for
injection

Pigs

Subcutaneous
injection

Bottle
(polyethylene)

250 ml

1 bottle

Solution for
injection

Pigs

Subcutaneous
injection

Bottle
(polyethylene)

500 ml

1 bottle

Solution for
injection

Pigs

Subcutaneous
injection

Bottle
(polyethylene)

50 ml

1 bottle

Solution for
injection

Pigs

Subcutaneous
injection

Bottle
(polyethylene)

250 ml

1 bottle

Solution for
injection

Pigs

Subcutaneous
injection

Bottle
(polyethylene)

500 ml

1 bottle

2.10.2002

EN

Official Journal of the European Communities

C 237/23

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 6

Member State

Marketing authorisation holder

Invented name

Strength

Pharmaceutical
form

Route of
adminis-
tration

Packaging

Package size

AUSTRIA

Bayer Austria Gesellschaft GmbH
Lerchenfelder Gürtel 9-11
A-1164 Wien

Lipobay

0,1 mg

Film-coated
tablet

Oral use

Blister

Bayer Austria Gesellschaft GmbH
Lerchenfelder Gürtel 9-11
A-1164 Wien

Lipobay

0,2 mg

Bayer Austria Gesellschaft GmbH
Lerchenfelder Gürtel 9-11
A-1164 Wien

Lipobay

0,3 mg

Bayer Austria Gesellschaft GmbH
Lerchenfelder Gürtel 9-11
A-1164 Wien

Lipobay

0,4 mg

Bayer Austria Gesellschaft GmbH
Lerchenfelder Gürtel 9-11
A-1164 Wien

Liposterol

0,4 mg

Film-coated
tablet

Film-coated
tablet

Film-coated
tablet

Film-coated
tablet

Film-coated
tablet

Lipobay

0,1 mg

Oral use

Blister

Lipobay

0,2 mg

Film-coated
tablet

Oral use

Blister

BELGIUM

DENMARK

Bayer NV
Louizalaan 143
B-1050 Brussel

Bayer NV
Louizalaan 143
B-1050 Brussel

Bayer NV
Louizalaan 143
B-1050 Brussel

Bayer NV
Louizalaan 143
B-1050 Brussel

Bayer NV
Louizalaan 143
B-1050 Brussel

Bayer AG
Monheim
D-51368 Leverkusen

Bayer AG
Monheim
D-51368 Leverkusen

Bayer AG
Monheim
D-51368 Leverkusen

Bayer AG
Monheim
D-51368 Leverkusen

Lipobay

0,3 mg

Lipobay

0,4 mg

Cholstat

0,4 mg

Lipobay

0,1 mg

Lipobay

0,2 mg

Lipobay

0,3 mg

Lipobay

0,4 mg

Film-coated
tablet

Film-coated
tablet

Film-coated
tablet

Film-coated
tablet

Film-coated
tablet

Film-coated
tablet

Film-coated
tablet

14, 20, 28, 30, 50,
98, 100 and 160
tablets

14, 20, 28, 30, 50,
98, 100 and 160
tablets

Oral use

Blister

Oral use

Blister

30 tablets

Oral use

Blister

30 tablets

Oral use

Blister

30 tablets

14, 20, 28, 30, 50,
98, 100 and 160
tablets

14, 20, 28, 30, 50,
98, 100 and 160
tablets

14, 20, 28, 30, 50,
98, 100 and 160
tablets

14, 20, 28, 30, 50,
98, 100 and 160
tablets

14, 20, 28, 30, 50,
98, 100 and 160
tablets

Oral use

Blister

Oral use

Blister

Oral use

Blister

Oral use

Blister

28 tablets

Oral use

Blister

28 and 98 tablets

Oral use

Blister

28 and 98 tablets

Oral use

Blister

28 and 98 tablets

C 237/24

EN

Official Journal of the European Communities

2.10.2002

Member State

Marketing authorisation holder

Invented name

Strength

Pharmaceutical
form

Route of
adminis-
tration

Packaging

Package size

FINLAND

Bayer AG
Monheim
D-51368 Leverkusen

Lipobay

0,1 mg

Film-coated
tablet

Oral use

Blister

FRANCE

Bayer AG
Monheim
D-51368 Leverkusen

Bayer AG
Monheim
D-51368 Leverkusen

Bayer AG
Monheim
D-51368 Leverkusen

Fournier
9, rue Petitot
F-21000 Dijon

Fournier
9, rue Petitot
F-21000 Dijon

Fournier
9, rue Petitot
F-21000 Dijon

Fournier
9, rue Petitot
F-21000 Dijon

Bayer Pharma
13, rue Jean-Jaurès
F-92807 Puteaux Cedex

Bayer Pharma
13, rue Jean-Jaurès
F-92807 Puteaux Cedex

Bayer Pharma
13, rue Jean-Jaurès
F-92807 Puteaux Cedex

Bayer Pharma
13, rue Jean-Jaurès
F-92807 Puteaux Cedex

Lipobay

0,2 mg

Film-coated
tablet

Oral use

Blister

Lipobay

0,3 mg

Film-coated
tablet

Oral use

Blister

Lipobay

0,4 mg

Film-coated
tablet

Oral use

Blister

Cholstat

0,1 mg

Film-coated
tablet

Oral use

Blister

Cholstat

0,2 mg

Film-coated
tablet

Oral use

Blister

Cholstat

0,3 mg

Film-coated
tablet

Oral use

Blister

Cholstat

0,4 mg

Film-coated
tablet

Oral use

Blister

Staltor

0,1 mg

Film-coated
tablet

Oral use

Blister

Staltor

0,2 mg

Film-coated
tablet

Oral use

Blister

Staltor

0,3 mg

Film-coated
tablet

Oral use

Blister

Staltor

0,4 mg

Film-coated
tablet

Oral use

Blister

14, 20, 28, 30, 50,
98, 100 and 160
tablets

14, 20, 28, 30, 50,
98, 100 and 160
tablets

14, 20, 28, 30, 50,
98, 100 and 160
tablets

14, 20, 28, 30, 50,
98, 100 and 160
tablets

14, 20, 28, 30, 50,
98, 100 tablets
160 tablets (hospital)

14, 20, 28 and 30
tablets
50, 98, 100 and 160
tablets (hospital)

14, 20, 28 and 30
tablets
50, 98, 100 and 160
tablets (hospital)

14, 20, 28 and 30
tablets
50, 98, 100 and 160
tablets (hospital)

14, 20, 28, 30, 50,
98, 100 tablets
160 tablets (hospital)

14, 20, 28, 30, 50,
98, 100 tablets
160 tablets (hospital)

14, 20, 28 and 30
tablets
50, 98, 100 and 160
tablets (hospital)

14, 20, 28 and 30
tablets
50, 98, 100 and 160
tablets (hospital)

GERMANY

Bayer Vital GmbH & Co. KG
Geb. D162
D-51368 Leverkusen

Lipobay

0,1 mg

Film-coated
tablet

Oral use

Blister

30, 50, 100 (OP)
10 × 16 (AP)

2.10.2002

EN

Official Journal of the European Communities

C 237/25

Member State

Marketing authorisation holder

Invented name

Strength

Pharmaceutical
form

Route of
adminis-
tration

Packaging

Package size

GERMANY
(cont’d)

Bayer Vital GmbH & Co. KG
Geb. D162
D-51368 Leverkusen

Lipobay

0,2 mg

Film-coated
tablet

Oral use

Blister

30, 50, 100 (OP)
10 × 16 (AP)

Bayer Vital GmbH & Co. KG
Geb. D162
D-51368 Leverkusen

Bayer Vital GmbH & Co. KG
Geb. D162
D-51368 Leverkusen

Lipobay

0,3 mg

Film-coated
tablet

Oral use

Blister

30, 50, 100 (OP)
10 × 16 (AP)

Lipobay

0,4 mg

Film-coated
tablet

Oral use

Blister

20, 30, 50, 100 (OP)
160 (AP)
20 (UM)

Bayer AG Pharma Deutschland
D-51368 Leverkusen

Vazqol

0,1 mg

Bayer AG Pharma Deutschland
D-51368 Leverkusen

Vazqol

0,2 mg

Bayer AG Pharma Deutschland
D-51368 Leverkusen

Vazqol

0,3 mg

Bayer AG Pharma Deutschland
D-51368 Leverkusen

Vazqol

0,4 mg

Film-coated
tablet

Film-coated
tablet

Film-coated
tablet

Film-coated
tablet

Oral use

Blister

30, 50, 100 (OP)
10 × 16 (AP)

Oral use

Blister

30, 50, 100 (OP)
10 × 16 (AP)

Oral use

Blister

30, 50, 100 (OP)
10 × 16 (AP)

Oral use

Blister

20, 30, 50, 100 (OP)
160 (AP)
20 (UM)

Fournier Pharma GmbH
Justus-von-Liebig-Straße 16
D-66280 Sulzbach

Fournier Pharma GmbH
Justus-von-Liebig-Straße 16
D-66280 Sulzbach

Fournier Pharma GmbH
Justus-von-Liebig-Straße 16
D-66280 Sulzbach

Fournier Pharma GmbH
Justus-von-Liebig-Straße 16
D-66280 Sulzbach

Zenas

0,1 mg

Film-coated
tablet

Oral use

Blister

30, 50, 100 (OP)
10 × 16 (AP)

Zenas

0,2 mg

Film-coated
tablet

Oral use

Blister

30, 50, 100 (OP)
10 × 16 (AP)

Zenas

0,3 mg

Film-coated
tablet

Oral use

Blister

30, 50, 100 (OP)
10 × 16 (AP)

Zenas

0,4 mg

Film-coated
tablet

Oral use

Blister

20, 30, 50, 100 (OP)
20 (UM)

GREECE

Bayer Hellas ABEE
Ακακίων 54Α
GR-15125 Μαρούσι Αθήνα

Lipoban

0,1 mg

Film-coated
tablet

Oral use

Blister

14, 28, 30, 50, 98
and 100 tablets

Bayer Hellas ABEE
Ακακίων 54Α
GR-15125 Μαρούσι Αθήνα

Bayer Hellas ABEE
Ακακίων 54Α
GR-15125 Μαρούσι Αθήνα

Bayer Hellas ABEE
Ακακίων 54Α
GR-15125 Μαρούσι Αθήνα

Lipoban

0,2 mg

Film-coated
tablet

Oral use

Blister

14, 28, 30, 50, 98
and 100 tablets

Lipoban

0,3 mg

Film-coated
tablet

Oral use

Blister

14, 28, 30, 50, 98
and 100 tablets

Lipoban

0,4 mg

Film-coated
tablet

Oral use

Blister

14, 20, 28, 30, 50,
98, 100 and 160
tablets

C 237/26

EN

Official Journal of the European Communities

2.10.2002

Member State

Marketing authorisation holder

Invented name

Strength

Pharmaceutical
form

Route of
adminis-
tration

Packaging

Package size

GREECE
(cont’d)

Elpen AE
21ο χλµ Λεωφ. Μαραθώνα
GR-19009 Πικέρµι Αττική

Eltina

0,1 mg

Film-coated
tablet

Oral use

Blister

14, 28, 30, 50, 98
and 100 tablets

Elpen AE
21ο χλµ Λεωφ. Μαραθώνα
GR-19009 Πικέρµι Αττική

Elpen AE
21ο χλµ Λεωφ. Μαραθώνα
GR-19009 Πικέρµι Αττική

Elpen AE
21ο χλµ Λεωφ. Μαραθώνα
GR-19009 Πικέρµι Αττική

Eltina

0,2 mg

Film-coated
tablet

Oral use

Blister

14, 28, 30, 50, 98
and 100 tablets

Eltina

0,3 mg

Film-coated
tablet

Oral use

Blister

14, 28, 30, 50, 98
and 100 tablets

Eltina

0,4 mg

Film-coated
tablet

Oral use

Blister

14, 20, 28, 30, 50,
98, 100 and 160
tablets

ICELAND

Bayer AG
Bayerwerk
D-51368 Leverkusen

Lipobay

0,1 mg

Film-coated
tablet

Oral use

Blister

28 and 98 tablets

IRELAND

Bayer AG
Bayerwerk
D-51368 Leverkusen

Bayer AG
Bayerwerk
D-51368 Leverkusen

Bayer AG
Bayerwerk
D-51368 Leverkusen

Bayer plc
Bayer House
Strawberry Hill
Newbury
Berkshire RG14 1JA
United Kingdom

Bayer plc
Bayer House
Strawberry Hill
Newbury
Berkshire RG14 1JA
United Kingdom

Bayer plc
Bayer House
Strawberry Hill
Newbury
Berkshire RG14 1JA
United Kingdom

Bayer plc
Bayer House
Strawberry Hill
Newbury
Berkshire RG14 1JA
United Kingdom

Lipobay

0,2 mg

Film-coated
tablet

Oral use

Blister

28 tablets

Lipobay

0,3 mg

Film-coated
tablet

Oral use

Blister

98 tablets

Lipobay

0,4 mg

Film-coated
tablet

Oral use

Blister

28 and 98 tablets

Lipobay

0,1 mg

Film-coated
tablet

Oral use

Blister

14, 20, 28, 30, 50,
98, 100 and 160
tablets

Lipobay

0,2 mg

Film-coated
tablet

Oral use

Blister

14, 20, 28, 30, 50,
98, 100 and 160
tablets

Lipobay

0,3 mg

Film-coated
tablet

Oral use

Blister

14, 20, 28, 30, 50,
98, 100 and 160
tablets

Lipobay

0,4 mg

Film-coated
tablet

Oral use

Blister

14, 20, 28, 30, 50,
98, 100 and 160
tablets

2.10.2002

EN

Official Journal of the European Communities

C 237/27

Member State

Marketing authorisation holder

Invented name

Strength

Pharmaceutical
form

Route of
adminis-
tration

Packaging

Package size

ITALY

Bayer SpA
Viale Certosa, 130
I-20156 Milano

Bayer SpA
Viale Certosa, 130
I-20156 Milano

Bayer SpA
Viale Certosa, 130
I-20156 Milano

Bayer SpA
Viale Certosa, 130
I-20156 Milano

Fournier Pharma SpA
Via Cassanese, 224
I-2090 Segrate Milano

Fournier Pharma SpA
Via Cassanese, 224
I-2090 Segrate Milano

Fournier Pharma SpA
Via Cassanese, 224
I-2090 Segrate Milano

Fournier Pharma SpA
Via Cassanese, 224
I-2090 Segrate Milano

Chiesi Farmaceutici SpA
Via Palermo, 26/A
I-43100 Parma

Chiesi Farmaceutici SpA
Via Palermo, 26/A
I-43100 Parma

Chiesi Farmaceutici SpA
Via Palermo, 26/A
I-43100 Parma

Chiesi Farmaceutici SpA
Via Palermo, 26/A
I-43100 Parma

143, avenue Louise
B-1050 Bruxelles

Bayer Belgium
143, avenue Louise
B-1050 Bruxelles

Lipobay

0,1 mg

Film-coated
tablet

Oral use

Blister

14, 28 and 98
tablets

Lipobay

0,2 mg

Film-coated
tablet

Oral use

Blister

14, 28 and 98
tablets

Lipobay

0,3 mg

Film-coated
tablet

Oral use

Blister

14, 28 and 98
tablets

Lipobay

0,4 mg

Film-coated
tablet

Oral use

Blister

14, 20, 28, 30, 50,
98, 100 and 160
tablets

Cervasta

0,1 mg

Film-coated
tablet

Oral use

Blister

14, 28 and 98
tablets

Cervasta

0,2 mg

Film-coated
tablet

Oral use

Blister

14, 28 and 98
tablets

Cervasta

0,3 mg

Film-coated
tablet

Oral use

Blister

14, 28 and 98
tablets

Cervasta

0,4 mg

Film-coated
tablet

Oral use

Blister

14, 20, 28, 30, 50,
98, 100 and 160
tablets

Stativa

0,1 mg

Film-coated
tablet

Oral use

Blister

14, 28 and 98
tablets

Stativa

0,2 mg

Film-coated
tablet

Oral use

Blister

14, 28 and 98
tablets

Stativa

0,3 mg

Film-coated
tablet

Oral use

Blister

14, 28 and 98
tablets

Stativa

0,4 mg

Film-coated
tablet

Oral use

Blister

14, 20, 28, 30, 50,
98, 100 and 160
tablets

14, 20, 28, 30, 50,
98, 100 and 160
tablets

14, 20, 28, 30, 50,
98, 100 and 160
tablets

LUXEMBOURG Bayer Belgium

Lipobay

0,1 mg

Film-coated
tablet

Oral use

Blister

Lipobay

0,2 mg

Film-coated
tablet

Oral use

Blister

C 237/28

EN

Official Journal of the European Communities

2.10.2002

Member State

Marketing authorisation holder

Invented name

Strength

Pharmaceutical
form

Route of
adminis-
tration

Packaging

Package size

LUXEMBOURG
(cont’d)

Bayer Belgium
143, avenue Louise
B-1050 Bruxelles

Lipobay

0,3 mg

Film-coated
tablet

Oral use

Blister

Bayer Belgium
143, avenue Louise
B-1050 Bruxelles

Fournier Pharma
16b, rue des Trois Arbres
B-1180 Bruxelles

Fournier Pharma
16b, rue des Trois Arbres
B-1180 Bruxelles

Fournier Pharma
16b, rue des Trois Arbres
B-1180 Bruxelles

Fournier Pharma
16b, rue des Trois Arbres
B-1180 Bruxelles

Bayer BV
Nijverheidsweg 26
3641 RR Mijdrecht
Nederland

Bayer BV
Nijverheidsweg 26
3641 RR Mijdrecht
Nederland

Bayer BV
Nijverheidsweg 26
3641 RR Mijdrecht
Nederland

Bayer BV
Nijverheidsweg 26
3641 RR Mijdrecht
Nederland

NETHER-
LANDS

Lipobay

0,4 mg

Film-coated
tablet

Oral use

Blister

Cholstat

0,1 mg

Film-coated
tablet

Oral use

Blister

Cholstat

0,2 mg

Film-coated
tablet

Oral use

Blister

Cholstat

0,3 mg

Film-coated
tablet

Oral use

Blister

Lipobay

0,1 mg

Film-coated
tablet

Oral use

Blister

Lipobay

0,2 mg

Film-coated
tablet

Oral use

Blister

Lipobay

0,3 mg

Film-coated
tablet

Oral use

Blister

Lipobay

0,4 mg

Film-coated
tablet

Oral use

Blister

PORTUGAL

Fournier Farmacêutica Portugal
Lda PRT
Avenida Eng. Duarte Pacheco
Amoreiras
P-1070 Lisboa

Cholstat

0,4 mg

Film-coated
tablet

Oral use

Blister

14, 20, 28, 30, 50,
98, 100 and 160
tablets

14, 20, 28, 30, 50,
98, 100 and 160
tablets

14, 20, 28, 30, 50,
98, 100 and 160
tablets

14, 20, 28, 30, 50,
98, 100 and 160
tablets

14, 20, 28, 30, 50,
98, 100 and 160
tablets

14, 20, 28, 30, 50,
98, 100 and 160
tablets

14, 20, 28, 30, 50,
98, 100 and 160
tablets

14, 20, 28, 30, 50,
98, 100 and 160
tablets

14, 20, 28, 30, 50,
98, 100 and 160
tablets

14, 20, 28, 30, 50,
98, 100 and 160
tablets

Cholstat

0,4 mg

Film-coated
tablet

Oral use

Blister

14, 20, 28, 30, 50,
98 and 100 tablets

Bayer Portugal SA PRT
Rua da Quinta do Pinheiro, 5
P-2795 Carnaxide-Lisboa

Lipobay

0,1 mg

Film-coated
tablet

Oral use

Blister

14 and 28 tablets

Bayer Portugal SA PRT
Rua da Quinta do Pinheiro, 5
P-2795 Carnaxide-Lisboa

Lipobay

0,2 mg

Film-coated
tablet

Oral use

Blister

14, 28 and 56
tablets

2.10.2002

EN

Official Journal of the European Communities

C 237/29

Member State

Marketing authorisation holder

Invented name

Strength

Pharmaceutical
form

Route of
adminis-
tration

Packaging

Package size

PORTUGAL
(cont’d)

Bayer Portugal SA PRT
Rua da Quinta do Pinheiro, 5
P-2795 Carnaxide-Lisboa

Lipobay

0,3 mg

Film-coated
tablet

Oral use

Blister

14, 28 and 56
tablets

Bayer Portugal SA PRT
Rua da Quinta do Pinheiro, 5
P-2795 Carnaxide-Lisboa

Lipobay

0,4 mg

Film-coated
tablet

Oral use

Blister

14, 20, 28, 30, 50,
98, 100 and 160
tablets

SPAIN

Química Farmacéutica Bayer SA
Calabria 268
E-08029 Barcelona

Lipobay

0,1 mg

Film-coated
tablet

Oral use

Blister

28 tablets

Química Farmacéutica Bayer SA
Calabria 268
E-08029 Barcelona

Lipobay

0,2 mg

Film-coated
tablet

Oral use

Blister

28 tablets

Química Farmacéutica Bayer SA
Calabria 268
E-08029 Barcelona

Lipobay

0,3 mg

Film-coated
tablet

Oral use

Blister

28 tablets

Química Farmacéutica Bayer SA
Calabria 268
E-08029 Barcelona

Lipobay

0,4 mg

Film-coated
tablet

Oral use

Blister

28 tablets

Laboratorios Fournier SA
Ronda de Poniente 16
E-28760 Tres Cantos

Laboratorios Fournier SA
Ronda de Poniente 16
E-28760 Tres Cantos

Laboratorios Fournier SA
Ronda de Poniente 16
E-28760 Tres Cantos

Laboratorios Fournier SA
Ronda de Poniente 16
E-28760 Tres Cantos

Zenas micro

0,1 mg

Film-coated
tablet

Oral use

Blister

28 tablets

Zenas micro

0,2 mg

Film-coated
tablet

Oral use

Blister

28 tablets

Zenas micro

0,3 mg

Film-coated
tablet

Oral use

Blister

28 tablets

Zenas micro

0,4 mg

Film-coated
tablet

Oral use

Blister

28 tablets

SWEDEN

Bayer AG
Monheim
D-51368 Leverkusen

Lipobay

0,1 mg

Film-coated
tablet

Oral use

Blister

Bayer AG
Monheim
D-51368 Leverkusen

Bayer AG
Monheim
D-51368 Leverkusen

Bayer AG
Monheim
D-51368 Leverkusen

Lipobay

0,2 mg

Film-coated
tablet

Oral use

Blister

Lipobay

0,3 mg

Film-coated
tablet

Oral use

Blister

Lipobay

0,4 mg

Film-coated
tablet

Oral use

Blister

14, 20, 28, 30, 50,
98, 100 and 160
tablets

14, 20, 28, 30, 50,
98, 100 and 160
tablets

14, 20, 28, 30, 50,
98, 100 and 160
tablets

14, 20, 28, 30, 50,
98, 100 and 160
tablets

C 237/30

EN

Official Journal of the European Communities

2.10.2002

Member State

Marketing authorisation holder

Invented name

Strength

Pharmaceutical
form

Route of
adminis-
tration

Packaging

Package size

UNITED
KINGDOM

Bayer plc
Bayer House
Strawberry Hill
Newbury
Berkshire RG14 1JA
United Kingdom

Bayer plc
Bayer House
Strawberry Hill
Newbury
Berkshire RG14 1JA
United Kingdom

Bayer plc
Bayer House
Strawberry Hill
Newbury
Berkshire RG14 1JA
United Kingdom

Bayer plc
Bayer House
Strawberry Hill
Newbury
Berkshire RG14 1JA
United Kingdom

Bayer plc
Bayer House
Strawberry Hill
Newbury
Berkshire RG14 1JA
United Kingdom

Bayer plc
Bayer House
Strawberry Hill
Newbury
Berkshire RG14 1JA
United Kingdom

Bayer plc
Bayer House
Strawberry Hill
Newbury
Berkshire RG14 1JA
United Kingdom

Bayer plc
Bayer House
Strawberry Hill
Newbury
Berkshire RG14 1JA
United Kingdom

Bayer plc
Bayer House
Strawberry Hill
Newbury
Berkshire RG14 1JA
United Kingdom

Bayer plc
Bayer House
Strawberry Hill
Newbury
Berkshire RG14 1JA
United Kingdom

Lipobay

0,1 mg

Film-coated
tablet

Oral use

Blister

Lipobay

0,2 mg

Film-coated
tablet

Oral use

Blister

Lipobay

0,3 mg

Film-coated
tablet

Oral use

Blister

Lipobay

0,4 mg

Film-coated
tablet

Oral use

Blister

Vaslip

0,1 mg

Film-coated
tablet

Oral use

Blister

Vaslip

0,2 mg

Film-coated
tablet

Oral use

Blister

Vaslip

0,3 mg

Film-coated
tablet

Oral use

Blister

Vaslip

0,4 mg

Film-coated
tablet

Oral use

Blister

Liposterol

0,1 mg

Film-coated
tablet

Oral use

Blister

Liposterol

0,2 mg

Film-coated
tablet

Oral use

Blister

14, 20, 28, 30, 50,
98, 100 and 160
tablets

14, 20, 28, 30, 50,
98, 100 and 160
tablets

14, 20, 28, 30, 50,
98, 100 and 160
tablets

14, 20, 28, 30, 50,
98, 100 and 160
tablets

14, 20, 28, 30, 50,
98, 100 and 160
tablets

14, 20, 28, 30, 50,
98, 100 and 160
tablets

14, 20, 28, 30, 50,
98, 100 and 160
tablets

14, 20, 28, 30, 50,
98, 100 and 160
tablets

14, 20, 28, 30, 50,
98, 100 and 160
tablets

14, 20, 28, 30, 50,
98, 100 and 160
tablets

2.10.2002

EN

Official Journal of the European Communities

C 237/31

Member State

Marketing authorisation holder

Invented name

Strength

Pharmaceutical
form

Route of
adminis-
tration

Packaging

Package size

UNITED
KINGDOM
(cont’d)

Bayer plc
Bayer House
Strawberry Hill
Newbury
Berkshire RG14 1JA
United Kingdom

Bayer plc
Bayer House
Strawberry Hill
Newbury
Berkshire RG14 1JA
United Kingdom

Bayer plc
Bayer House
Strawberry Hill
Newbury
Berkshire RG14 1JA
United Kingdom

Bayer plc
Bayer House
Strawberry Hill
Newbury
Berkshire RG14 1JA
United Kingdom

Bayer plc
Bayer House
Strawberry Hill
Newbury
Berkshire RG14 1JA
United Kingdom

Bayer plc
Bayer House
Strawberry Hill
Newbury
Berkshire RG14 1JA
United Kingdom

Liposterol

0,3 mg

Film-coated
tablet

Oral use

Blister

14, 20, 28, 30, 50,
98, 100 and 160
tablets

Liposterol

0,4 mg

Film-coated
tablet

Oral use

Blister

14, 20, 28, 30, 50,
98, 100 and 160
tablets

Zenas

0,1 mg

Film-coated
tablet

Oral use

Blister

14, 20, 28, 30, 50,
98, 100 and 160
tablets

Zenas

0,2 mg

Film-coated
tablet

Oral use

Blister

14, 20, 28, 30, 50,
98, 100 and 160
tablets

Zenas

0,3 mg

Film-coated
tablet

Oral use

Blister

14, 20, 28, 30, 50,
98, 100 and 160
tablets

Zenas

0,4 mg

Film-coated
tablet

Oral use

Blister

14, 20, 28, 30, 50,
98, 100 and 160
tablets

Conclusion of the Memorandum of Understanding with Slovenia on its participation in the
Community programmes SAVE and Altener

(2002/C 237/05)

The Memorandum of Understanding between the European Commission, on behalf of the European
Community, and the Government of Slovenia on its participation in the Community programmes SAVE
and Altener has been signed.

The full text of the Memorandum of Understanding can be found on the following web page:

http://europa.eu.int/comm/energy/en/pfs_4_en.html