Summary of Community decisions on marketing authorisations in respect of medicinal products from 15 October to 15 November 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)
Date: 2002-11-29
Institutions: European Commission
Subjects: market approval, marketing, medicinal product, pharmaceutical product, preparation for market

C 297/8

EN

Official Journal of the European Communities

29.11.2002

Summary of Community decisions on marketing authorisations in respect of medicinal products
from 15 October to 15 November 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 (2))

— Issuing, maintenance or modification of a national marketing authorisation

(2002/C 297/04)

Date of the decision

Name(s) of the
medicinal product

Holder(s) of the
marketing authorisation

Member State concerned

Date of
notification

17.10.2002

Domperidone

See Annex 1

See Annex 1

18.10.2002

25.10.2002

Bupropion

See Annex 2

See Annex 2

28.10.2002

12.11.2002

Clozapine

See Annex 3

See Annex 3

13.11.2002

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

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

ANNEX 1

Marketing authorisation
holder's address
(contact person)

AUSTRIA
Janssen-Cilag Pharma GmbH
Pfarrgasse 75
A-1232 Wien

Trade name/name

Strengths

Pharmaceutical forms

Routes
of adminis-
tration

Packaging

Content/concentration

Package sizes

Motilium

10 mg

Film-coated tablet Oral

Blister

10 mg/tablet

10, 50 tablets

1 mg/ml

Oral suspension

Oral

Suppository

Suppository

Suppository

Rectal

Rectal

Rectal

Flask

Strip

Strip

Strip

1 mg/ml

200 ml

10 mg/suppository

6 suppositories

30 mg/suppository

6 suppositories

60 mg/suppository

6 suppositories

10 mg

30 mg

60 mg

10 mg

10 mg

10 mg

1 mg/ml

10 mg

30 mg

60 mg

Tablet

Oral

Instant melt tablet Oral

Blister

Blister

10 mg/tablet

30, 100 tablets

10 mg/tablet

10, 20, 30
tablets

Effervescent
granule

Drinkable
suspension

Suppository

Suppository

Suppository

Oral

Sachet

10 mg/sachet

20 sachets

Oral

Bottle

1 mg/ml

100 ml, 200 ml

Rectal

Rectal

Rectal

Strip

Strip

Strip

10 mg/suppository

6 suppositories

30 mg/suppository

6 suppositories

60 mg/suppository

6 suppositories

BELGIUM
Janssen-Cilag NV
Roderveldlaan 1
B-2600 Berchem

Motilium

29.11.2002

EN

Official Journal of the European Communities

C 297/9

Marketing authorisation
holder's address
(contact person)

DENMARK
Janssen-Cilag A/S
Hammerbakken 19
DK-3460 Birkerød

FRANCE
Janssen-Cilag
1, rue Camille-Desmoulins
TSA 91003
F-92787 Issy Les Moulineaux
Cedex 9

Pierre Fabre Medicament
45, place Abel-Gance
F-92100 Boulogne

GERMANY
Byk Gulden Lomberg
Chemische Fabrik GmbH
Byk-Gulden-Straße 2
D-78467 Konstanz

GREECE
Janssen-Cilag
Pharmaceutical SACI
56 Eirinis Avenue
GR-151 21 Pefki
Athens

IRELAND
Janssen-Cilag Limited
Saunderton
High Wycombe
Buckinghamshire
HP14 4HJ
United Kingdom

Trade name/name

Strengths

Pharmaceutical forms

Routes
of adminis-
tration

Packaging

Content/concentration

Package sizes

Motilium

10 mg

Tablet

Oral

Strips

10 mg/tablet

30 tablets

30 mg

Suppository

Rectal

Strips

30 mg/suppository

6 suppositories

60 mg

Suppository

Rectal

Strips

60 mg/suppository

6 suppositories

Motilium

10 mg

Tablet

10 mg

Effervescent
granule

Oral

Oral

Blister

10 mg/tablet

40 tablets

Sachet

10 mg per sachet
of 3 g

30 sachets

1 mg/ml

Oral suspension

Oral

Flask

1 mg/ml

200 ml

10 mg

Suppository

Rectal

Strips

10 mg/suppository

5 suppositories

30 mg

Suppository

Rectal

Strips

30 mg suppository

5 suppositories

60 mg

Suppository

Rectal

Strips

60 mg suppository

5 suppositories

10 mg

Oral Lyophilisate Oral

Blister

10 mg/lyophilisate

10, 30, 40
Lyophilisates

Peridys

10 mg

Tablet

Oral

Blister

10 mg/tablet

40 tablets

1 mg/ml

Oral suspension

Oral

Flask

1 mg/ml

200 ml

Motilium

10 mg

Tablet

Oral

Blister

10 mg/tablet

20, 50, 100, 400
tablets

10 mg/ml

Suspension

Oral

Motilium K

10 mg/ml

Suspension

Oral

Dropper
bottle

Dropper
bottle

10 mg/ml

10 mg/ml

30 and 100 ml

Motilium
Granulat

10 mg

Effervescent
granule

Oral

Sachets

10 mg/sachet

Cilroton

10 mg

Film-coated tablet Oral

Blisters

10 mg/tablet

HP
1 × 10 × 30 ml

10 ml
20, 50, 100
sachets

Box of 30
(Blister 3 × 10)

5 mg/5 ml

Oral solution

10 mg

Effervescent
granule

Oral

Oral

Bottle

1 mg/ml

200 ml

Sachets

10 mg/sachet

30 sachets

60 mg

Suppository

Rectal

Foil

60 mg/suppository

6 suppositories

Motilium

10 mg

Suppository

Rectal

Blister

10 mg/tablet

6 suppositories

30 mg

Suppository

Rectal

Blister

30 mg/suppository

6 suppositories

10 mg

Tablet

Oral

Blister

10 mg/tablet

10, 20 and 100
tablets

60 mg

Suppository

Rectal

Blister
Strips

60 mg/suppository

6 suppositories

1 mg/ml

Oral suspension

Oral

Bottle

1 mg/ml

200 ml

C 297/10

EN

Official Journal of the European Communities

29.11.2002

Marketing authorisation
holder's address
(contact person)

ITALY
Italchimici SpA
v. Pontina Km 29, Civ.5
I-00040 Pomezia (Roma)

Janssen-Cilag SpA
v. M. Buonarroti 23
I-20093 Cologno Monzese
(MI)

Trade name/name

Strengths

Pharmaceutical forms

Peridon

10 mg

Tablet

1 mg/ml

Oral solution

60 mg

30 mg

10 mg

Gastronorm

5 mg

Suppository

Suppository

Effervescent
granule

Effervescent
granule

Gastronorm (1)

5 mg

Chewable tablet

Motilium

10 mg

Tablet

1 mg/ml

Oral solution

Routes
of adminis-
tration

Oral

Oral

Rectal

Rectal

Oral

Packaging

Content/concentration

Package sizes

Blister

Bottle

Strip

Strip

10 mg/tablet

30 tablets

1 mg/ml

200 ml

60 mg/suppository

6 suppositories

30 mg/suppository

6 suppositories

Sachets

10 mg/sachet

30 sachets

Oral

Sachet

5 mg/sachet

20 sachets

Oral

Oral

Oral

Oral

Blister

Blister

5 mg/tablet

10 mg/tablet

Glass bottle 1 mg/ml

10 tablets

30 tablets

200 ml

Sachets

10 mg/sachet

30 sachets

LUXEMBOURG
Janssen-Cilag NV
Roderveldlaan 1
B-2600 Berchem

Motilium

10 mg

10 mg

10 mg

10 mg

1 mg/ml

10 mg

30 mg

60 mg

Effervescent
granule

Effervescent
granule

Drinkable
suspension

Suppository

Suppository

Suppository

Tablet

Oral

Instant melt tablet Oral

Oral

Blister

Blister

Sachet

10 mg/tablet

30, 100 tablets

10 mg/tablet

20, 30 tablets

10 mg/sachet

20, 30, 40
sachets

Oral

Glass bottle 1 mg/ml

100 ml, 200 ml

Rectal

Rectal

Rectal

Strip

Strip

Strip

10 mg/suppository

6 suppositories

30 mg/suppository

6 suppositories

60 mg/suppository

6 suppositories

NETHERLANDS
Janssen-Cilag BV
Postbus 90240
5000 LT Tilburg
Nederland

Taxandria Pharmaceutica BV
Postbus 90241
5000 LV Tilburg
Nederland

PORTUGAL
Janssen Farmacêutica
Portugal, Lda

Motilium

10 mg

Film coated tablet Oral

Blister

10 mg/tablet

60 tablets, 50
tablets (hospital)

10 mg

Lingual tablet

Oral

Blister

1 mg/ml

oral suspension

Oral

10 mg

30 mg

60 mg

Suppository

Suppository

Suppository

Rectal

Rectal

Rectal

Bottle

Blister

Blister

Blister

10 mg/lingual
tablet

1 mg/ml

10 and
30 tablets

200 ml

10 mg/suppository

6 suppositories

30 mg/suppository

6 suppositories

60 mg/suppository

6 suppositories

Gastrocure

10 mg

Film-coated tablet Oral

Blister

10 mg/tablet

10 tablets

Motilium

10 mg

Tablet

Oral

Blister

10 mg/tablet

20 and
60 tablets

10 mg

30 mg

60 mg

Suppository

Suppository

Suppository

1 mg/ml

oral solution

10 mg

Effervescent
granule

Rectal

Rectal

Rectal

Oral

Oral

Strips

Strips

Strips

Bottles

Sachets

10 mg/suppository

6 suppositories

30 mg/suppository

6 suppositories

60 mg/suppository

6 suppositories

1 mg/ml

100, 200 ml

10 mg/sachet

10, 20 Sachets

Motilium
Rapid

10 mg

Oral lyophilisate

Oral

Blister

10 mg/sachet

10, 30, 40
tablets

29.11.2002

EN

Official Journal of the European Communities

C 297/11

Marketing authorisation
holder's address
(contact person)

SPAIN
Janssen-Cilag SA
Paseo de Las Doce
Estrellas, 5-7
E-28042 Madrid

Dr. Esteve SA
Av. Mare de Deu de Mont-
serrat, 221
E-08041 Barcelona

UNITED KINGDOM
Sanofi Winthrop Ltd
1 Onslow Street
Guildford
Surrey GU1 4YS
United Kingdom

Trade name/name

Strengths

Pharmaceutical forms

Routes
of adminis-
tration

Packaging

Content/concentration

Package sizes

Nauzelin

10 mg/tablet

Film coated tablet Oral

Blister

10 mg/tablet

30 tablets

1 mg/ml

Oral suspension

Oral

Bottle

1 mg/ml

200 ml

Motilium

10 mg/tablet

Film coated tablet Oral

Blister

10 mg/tablet

30 tablets

1 mg/ml

Oral suspension

Oral

Bottle

1 mg/ml

200 ml

30 mg

Suppository

Rectal

Blister

30 mg/suppository

12 suppositories

60 mg

Suppository

Rectal

Blister

60 mg/suppository

12 suppositories

Motilium

30 mg

Suppository

Rectal

Strips

30 mg/suppository

3 and 10
suppositories

5 mg

Suspension

10 mg

Tablet

Oral

Oral

Bottles

1 mg/ml

100 and 200 ml

Blisters
HDPE
containers

12,72 mg
equivalent to
10 mg
domperidone

4, 10, 28, 30
and 100 tablets
500 tablets

60 mg

Suppository

Rectal

Strips

60 mg/suppository

10 suppositories

50 mg

Suspension

Oral

Bottles

10 mg/ml

20 mg

Tablet

Oral

Blister

Domperidone
maleate 25,45 mg
equivalent to
20 mg
domperidone

Janssen-Cilag Limited
Saunderton
High Wycombe
Buckinghamshire
HP14 4HJ
United Kingdom

Domperidone

60 mg

Suppository

Rectal

Strips

60 mg/suppository

Domperidone
(Maleate)
Tablets

20 mg

Tablet

Oral

Blisters

Domperidone
maleate 25,45 mg,
equivalent to
domperidone base
20 mg

30 and 100 ml
bottles

30 and 100
tablets

10 and 21
suppositories

28, 30, 100 and
250 tablets

Domperidone

1 mg/ml

Oral suspension

Oral

Flasks

1 mg/1 ml

30 and 200 ml

Domperidone

30 mg

Suppository

Rectal

Strips

30 mg/suppository

3 or 10
suppositories

Domperidone

10 mg

Suppository

Rectal

Strips

10 mg/suppository

10 suppositories

Domperidone

10 mg

Tablet

Oral

Blisters

10 mg/tablet

28, 30, 100 and
250 tablets

Johnson & Johnson MSD
High Wycombe
Buckinghamshire
HP14 4HJ
United Kingdom

Motilium 10

10 mg

Film-coated tablet Oral

Blisters

Domperidone
Maleate
Tablets 10 mg

10 mg

Film-coated tablet Oral

Blisters

Tubs

10 tablets

Domperidone
maleate equivalent
to 10 mg
domperidone base

10, 28 and 30
tablets
84, 100 and 250
tabs

(1) Registration suspended by Ministry of Health as product not marketed within 12 months of licensing.

C 297/12

EN

Official Journal of the European Communities

29.11.2002

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 2

Member State

Marketing
authorisation holder

Invented name

Strength

Pharmaceutical
form

Route of
adminis-
tration

Packaging

Package size

AUSTRIA

DENMARK

FRANCE

GERMANY

Zyban

150 mg

Prolonged
release tablets

Oral use

Blister
(PA-Alu-PVC/Alu)

Quomem

150 mg

Prolonged
release tablets

Oral use

Blister
(PA-Alu-PVC/Alu)

Zyban

150 mg

Prolonged
release tablets

Oral use

Blister
(PA-Alu-PVC/Alu)

30, 40, 50, 60, 100
tablets
(in Austria available:
30 and 60 tablets)

30, 40, 50, 60, 100
tablets
(all sizes in Austria
presently not
available)

100 tablets on the
market
30, 40, 50 and 60
tablets approved

Zyban

150 mg

Prolonged
release tablets

Oral use

Blister
(PA-Alu-PVC/Alu)

30, 40, 50, 60, 100

Quomem

150 mg

Prolonged
release tablets

Oral use

Blister
(PA-Alu-PVC/Alu)

30, 40, 50, 60, 100

Corzen

150 mg

Prolonged
release tablets

Oral use

Blister
(PA-Alu-PVC/Alu)

100, 30, 60 (OP);
20 (UM)

Quomem

150 mg

Prolonged
release tablets

Oral use

Blister
(PA-Alu-PVC/Alu)

100, 30, 40, 50, 60
(OP); 30 (UM)

Zyban

150 mg

Prolonged
release tablets

Oral use

Blister
(PA-Alu-PVC/Alu)

100, 30, 40, 50, 60
(OP); 30 (UM)

GlaxoSmithKline
Pharma GmbH
Albert-Schweitzer-Gasse 6
A-1140 Wien
Tel. (43-1) 970 95-0
Fax (43-1) 97 07 51 98

Allen Pharmazeutika
Gesellschaft mbH
Albert-Schweitzer-Gasse 6
A-1140 Wien
Tel. (43-1) 970 95-0
Fax (43-1) 97 07 51 70

GlaxoSmithKline
Pharma A/S
Nykær 68
DK-2605 Brøndby
Tel. (45) 36 75 90 00
Fax (45) 36 75 30 08

Laboratoire GlaxoSmithKline
100, route de Versailles
F-78163 Marly le Roi
Tel. (33-1) 39 17 97 70
Fax (33-1) 39 17 17 58

Laboratoire GlaxoSmithKline
100, route de Versailles
F-78163 Marly le Roi
Tel. (33-1) 39 17 97 70
Fax (33-1) 39 17 17 58

GlaxoSmithKline
GmbH & Co. KG
Leopoldstraße 175
D-80804 München
Tel. (49-89) 360 44-0
Fax (49-89) 360 44-123

GlaxoSmithKline
GmbH & Co. KG
Leopoldstraße 175
D-80804 München
Tel. (49-89) 360 44-0
Fax (49-89) 360 44-123

GlaxoSmithKline
GmbH & Co. KG
Leopoldstraße 175
D-80804 München
Tel. (49-89) 360 44-0
Fax (49-89) 360 44-123

29.11.2002

EN

Official Journal of the European Communities

C 297/13

Member State

Marketing
authorisation holder

Invented name

Strength

Pharmaceutical
form

Route of
adminis-
tration

Packaging

Package size

GERMANY
(cont’d)

GREECE

IRELAND

ITALY

BELGIUM/
LUXEMBOURG

NETHERLANDS

GlaxoSmithKline
GmbH & Co. KG
Leopoldstraße 175
D-80804 München
Tel. (49-89) 360 44-0
Fax (49-89) 360 44-123

GlaxoSmithKline AEBE
966 Kiphisias
GR-15239 Chaland R
Athens
Tel. (30-10)
688 21 00/688 29 58
Fax (30-10)
684 71 44/684 71 64

Glaxo Laboratories Ltd
Stockley Park West
Uxbridge
Middlesex UB11 1BT
United Kingdom

Valda Laboratori
Farmaceutici SpA
Via Zambeletti
I-20021 Baranzate Di
Bollate (MI)
Tel. (39) 02 380 61
Fax (39) 02 350 18 82

GlaxoSmithKline SpA
Via A. Fleming 2
I-37135 Verona
Tel. (39) 045 921 81 11
Fax (39) 045 921 83 88

GlaxoSmithKline SpA
Via A. Fleming 2
I-37135 Verona
Tel. (39) 045 921 81 11
Fax (39) 045 921 83 88

GlaxoSmithKline SA/NV
Rue du Tilleul, 13
B-1332 Genval
Tel. (32-2) 656 21 11
Fax (32-2) 656 20 99

GlaxoSmithKline SA/NV
Rue du Tilleul, 13
B-1332 Genval
Tel. (32-2) 656 21 11
Fax (32-2) 656 20 99

GlaxoSmithKline BV
PO Box 780
3700 At Zeist
Nederland
Tel. (31-30) 693 81 00
Fax (31-30) 693 84 71

Zyntabac

150 mg

Prolonged
release tablets

Oral use

Blister
(PA-Alu-PVC/Alu)

100, 30, 40, 50, 60
(OP); 30 (UM)

Zyban

150 mg

Prolonged
release tablet

Oral use

Blister
(PA-Alu-PVC/Alu)

30, 40, 50, 60, 100

Zyban

150 mg

Prolonged
release tablet

Oral use

Blister
(PA-Alu-PVC/Alu)

30, 40, 50, 60 or
100 tablets
(but only 100
tablets are
marketed)

Corzen

150 mg

Prolonged
release tablets

Oral use

Blister
(PA-Alu-PVC/Alu)

30, 40, 50, 60, 100
tablets

Zyban

150 mg

Prolonged
release tablets

Oral use

Blister
(PA-Alu-PVC/Alu)

30, 40, 50, 60, 100
tablets

Quomen

150 mg

Prolonged
release tablets

Oral use

Blister
(PA-Alu-PVC/Alu)

30, 40, 50, 60, 100
tablets

Quomem

150 mg

Prolonged
release tablets

Oral use

Blister
(PA-Alu-PVC/Alu)

30, 40, 50, 60, 100

Zyban

150 mg

Prolonged
release tablets

Oral use

Blister
(PA-Alu-PVC/Alu)

30, 40, 50, 60, 100

Zyban

150 mg

Prolonged
release tablets

Oral use

Blister
(PA-Alu-PVC/Alu)

30, 40, 50, 60 or
100 tablets

C 297/14

EN

Official Journal of the European Communities

29.11.2002

Member State

Marketing
authorisation holder

Invented name

Strength

Pharmaceutical
form

Route of
adminis-
tration

Packaging

Package size

NETHERLANDS
(cont’d)

PORTUGAL

GlaxoSmithKline BV
PO Box 780
3700 At Zeist
Nederland
Tel. (31-30) 693 81 00
Fax (31-30) 693 84 71

GlaxoSmithKline BV
PO Box 780
3700 At Zeist
Nederland
Tel. (31-30) 693 81 00
Fax (31-30) 693 84 71

GlaxoSmithKline BV
PO Box 780
3700 At Zeist
Nederland
Tel. (31-30) 693 81 00
Fax (31-30) 693 84 71

Glaxo Wellcome
Farmacêutica, Lda
PRT Rua Dr. António
Loureiro Borges, 3
Arquiparque
Miraflores Algés
Tel. (351) . . .
Fax (351) . . .

Glaxo Wellcome
Farmacêutica, Lda
PRT Rua Dr. António
Loureiro Borges, 3
Arquiparque
Miraflores Algés
Tel. (351) . . .
Fax (351) . . .

Glaxo Wellcome
Farmacêutica, Lda
PRT Rua Dr. António
Loureiro Borges, 3
Arquiparque
Miraflores Algés
Tel. (351) . . .
Fax (351) . . .

Quomem

150 mg

Prolonged
release tablets

Oral use

Blister
(PA-Alu-PVC/Alu)

30, 40, 50, 60 or
100 tablets

Corzen

150 mg

Prolonged
release tablets

Oral use

Blister
(PA-Alu-PVC/Alu)

30, 40, 50, 60 or
100 tablets

Zyntabac

150 mg

Prolonged
release tablets

Oral use

Blister
(PA-Alu-PVC/Alu)

30, 40, 50, 60 or
100 tablets

Zyban

150 mg

Prolonged
release tablets

Oral use

Blister
(PA-Alu-PVC/Alu)

30, 40, 50, 60 and
100 tablets

Zyntabac

150 mg

Prolonged
release tablets

Oral use

Blister
(PA-Alu-PVC/Alu)

30, 40, 50, 60 and
100 tablets

Quomem

150 mg

Prolonged
release tablets

Oral use

Blister
(PA-Alu-PVC/Alu)

30, 40, 50, 60 and
100 tablets

SPAIN

Laboratorios Dr. Esteve SA
Avda.Virgen De Montserrat,
221
E-08041 Barcelona
Tel. (34) 934 46 60 00
Fax (34) 934 50 34 52

Glaxo Wellcome SA
Pque. Tecnologico Madrid
Severo Ochoa, 2
E-28760 Tres Cantos
Madrid
Tel. (34) 918 07 03 01
Fax (34) 918 07 03 10

Quomen

150 mg

Prolonged
release tablets

Oral use

Blister
(PA-Alu-PVC/Alu)

30 and 60

Zyntabac

150 mg

Prolonged
release tablets

Oral use

Blister
(PA-Alu-PVC/Alu)

30 and 60

29.11.2002

EN

Official Journal of the European Communities

C 297/15

Member State

Marketing
authorisation holder

Invented name

Strength

Pharmaceutical
form

Route of
adminis-
tration

Packaging

Package size

SWEDEN

UNITED
KINGDOM

GlaxoSmithKline AB
PO Box 263
S-431 23 Mölndal
Tel. (46-31) 67 09 00
Fax (46-31) 27 47 45

Glaxo Wellcome UK Ltd
Stockley Park West
Uxbridge
Middlesex UB11 1BT
United Kingdom
Tel. (44-208) 990 28 96
Fax (44-208) 990 43 85

Zyban

150 mg

Prolonged
release tablets

Oral use

Blister
(PA-Alu-PVC/Alu)

1 × 100 tablets
(1 × 30, 1 × 40,
1 × 50, 1 × 60
tablets; not
marketed in
Sweden)

Zyban

150 mg

Prolonged
release tablets

Oral use

Blister
(PA-Alu-PVC/Alu)

60 tablets

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

ANNEX 3

Member State

Marketing
authorisation holder

Invented name

Strength

Pharmaceutical
form

Route of
administration

Packaging

Package size

AUSTRIA

Novartis Pharma GmbH
Brunner Straße 59
Postfach 169
A-1235 Wien

Novartis Pharma GmbH
Brunner Straße 59
Postfach 169
A-1235 Wien

Leponex

25 mg

Tablets

Oral use

PVC/PVDC/aluminium
blister

50

Leponex

100 mg

Tablets

Oral use

PVC/PVDC/aluminium
blister

60

BELGIUM

Novartis Pharma SA
Medialaan 40, bus 1
B-1800 Vilvorde

Leponex

25 mg

Tablets

Oral use

PVC/PVDC/aluminium
blister

30 (unidose)

Novartis Pharma SA
Medialaan 40, bus 1
B-1800 Vilvorde

Leponex

100 mg

Tablets

Oral use

PVC/PVDC/aluminium
blister

30 (unidose)

DENMARK

Novartis Healthcare A/S
Lyngbyvej 172
DK-2100 Copenhagen

Leponex

25 mg

Tablets

Oral use

Glass bottle

100

Novartis Healthcare A/S
Lyngbyvej 172
DK-2100 Copenhagen

Novartis Healthcare A/S
Lyngbyvej 172
DK-2100 Copenhagen

Leponex

100 mg

Tablets

Oral use

ALU/PVC/PVDC/blister

50

Leponex

100 mg

Tablets

Oral use

Glass bottle

100

C 297/16

EN

Official Journal of the European Communities

29.11.2002

Member State

Marketing
authorisation holder

Invented name

Strength

Pharmaceutical
form

Route of
administration

Packaging

Package size

FINLAND

Novartis Finland Oy
Metsänneidonkuja 10
FIN-02130 Espoo

Leponex

25 mg

Tablets

Oral use

PVC/PVDC/aluminium
blister

30

Novartis Finland Oy
Metsänneidonkuja 10
FIN-02130 Espoo

Novartis Finland Oy
Metsänneidonkuja 10
FIN-02130 Espoo

Novartis Finland Oy
Metsänneidonkuja 10
FIN-02130 Espoo

Leponex

25 mg

Tablets

Oral use

Glass bottle

100

Leponex

100 mg

Tablets

Oral use

PVC/PVDC/aluminium
blister

50

Leponex

100 mg

Tablets

Oral use

Glass bottle

100

FRANCE

Novartis Pharma SA
2 & 4, rue Lionel-Terray
F-92500 Rueil-Malmaison

Leponex

25 mg

Tablets

Oral use

PVC/PVDC/alu blister
packs

7

Novartis Pharma SA
2 & 4, rue Lionel-Terray
F-92500 Rueil-Malmaison

Novartis Pharma SA
2 & 4, rue Lionel-Terray
F-92500 Rueil-Malmaison

Novartis Pharma SA
2 & 4, rue Lionel-Terray
F-92500 Rueil-Malmaison

Novartis Pharma SA
2 & 4, rue Lionel-Terray
F-92500 Rueil-Malmaison

Novartis Pharma SA
2 & 4, rue Lionel-Terray
F-92500 Rueil-Malmaison

Novartis Pharma SA
2 & 4, rue Lionel-Terray
F-92500 Rueil-Malmaison

Novartis Pharma SA
2 & 4, rue Lionel-Terray
F-92500 Rueil-Malmaison

Leponex

25 mg

Tablets

Oral use

PVC/PVDC/alu blister
packs

Leponex

25 mg

Tablets

Oral use

PVC/PVDC/alu blister
packs

Leponex

25 mg

Tablets

Oral use

PVC/PVDC/alu blister
packs

14

28

30

Leponex

100 mg

Tablets

Oral use

PVC/PVDC/alu blister
packs

7

Leponex

100 mg

Tablets

Oral use

PVC/PVDC/alu blister
packs

Leponex

100 mg

Tablets

Oral use

PVC/PVDC/alu blister
packs

Leponex

100 mg

Tablets

Oral use

PVC/PVDC/alu blister
packs

14

28

30

GERMANY

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nürnberg

Leponex

25 mg

Tablets

Oral use

PVC/PVDC blister packs 20

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nürnberg

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nürnberg

Leponex

25 mg

Tablets

Oral use

PVC/PVDC blister packs 50

Leponex

25 mg

Tablets

Oral use

PVC/PVDC blister packs 100

29.11.2002

EN

Official Journal of the European Communities

C 297/17

Member State

Marketing
authorisation holder

Invented name

Strength

Pharmaceutical
form

Route of
administration

Packaging

Package size

GERMANY
(cont’d)

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nürnberg

Leponex

25 mg

Tablets

Oral use

PVC/PVDC blister packs 500

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nürnberg

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nürnberg

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nürnberg

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nürnberg

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nürnberg

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nürnberg

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nürnberg

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nürnberg

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nürnberg

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nürnberg

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nürnberg

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nürnberg

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nürnberg

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nürnberg

Leponex

25 mg

Tablets

Oral use

PVC/PVDC blister packs 5 000

Leponex

25 mg

Tablets

Oral use

HDPE bottle

500

Leponex

50 mg

Tablets

Oral use

PVC/PVDC blister packs 20

Leponex

50 mg

Tablets

Oral use

PVC/PVDC blister packs 50

Leponex

50 mg

Tablets

Oral use

PVC/PVDC blister packs 100

Leponex

50 mg

Tablets

Oral use

PVC/PVDC blister packs 500

Leponex

50 mg

Tablets

Oral use

PVC/PVDC blister packs 5 000

Leponex

50 mg

Tablets

Oral use

HDPE bottle

500

Leponex

100 mg

Tablets

Oral use

PVC/PVDC blister packs 20

Leponex

100 mg

Tablets

Oral use

PVC/PVDC blister packs 50

Leponex

100 mg

Tablets

Oral use

PVC/PVDC blister packs 100

Leponex

100 mg

Tablets

Oral use

PVC/PVDC blister packs 500

Leponex

100 mg

Tablets

Oral use

PVC/PVDC blister packs 5 000

Leponex

100 mg

Tablets

Oral use

HDPE bottle

500

C 297/18

EN

Official Journal of the European Communities

29.11.2002

Member State

Marketing
authorisation holder

Invented name

Strength

Pharmaceutical
form

Route of
administration

Packaging

Package size

GREECE

IRELAND

Novartis (Hellas) SACI
12 Km National Road No 1
GR-14453 Metamorphosis
Athens

Novartis (Hellas) SACI
12 Km National Road No 1
GR-14453 Metamorphosis
Athens

Contact:
Novartis Ireland Limited
Beech House
Beech Hill Office Campus
Clonskeagh
Dublin 4
Ireland

MAH:
Novartis Pharmaceuticals UK
Limited
Frimley Business Park
Frimley
Camberley
Surrey GU16 7SR
United Kingdom

Novartis Pharmaceuticals UK
Limited
Frimley Business Park
Frimley
Camberley
Surrey GU16 7SR
United Kingdom

Novartis Pharmaceuticals UK
Limited
Frimley Business Park
Frimley
Camberley
Surrey GU16 7SR
United Kingdom

Novartis Pharmaceuticals UK
Limited
Frimley Business Park
Frimley
Camberley
Surrey GU16 7SR
United Kingdom

Leponex

25 mg

Tablets

Oral use

PVC/PVDC/alu blister
packs

50 (2 × 25)

Leponex

100 mg

Tablets

Oral use

PVC/PVDC/alu blister
packs

50 (5 × 10)

Clozaril

25 mg

Tablets

Oral use

PVC/PVDC blister packs 28

Clozaril

25 mg

Tablets

Oral use

PVC/PVDC blister packs 84

Clozaril

100 mg

Tablets

Oral use

PVC/PVDC blister packs 28

Clozaril

100 mg

Tablets

Oral use

PVC/PVDC blister packs 84

ITALY

Novartis Farma SpA
SS 233 (Varesina) km 20,5
I-21040 Origgio (Varese)

Leponex

25 mg

Tablets

Oral use

Opaque PVC/aluminium
blister packs

28

Novartis Farma SpA
SS 233 (Varesina) km 20,5
I-21040 Origgio (Varese)

Leponex

100 mg

Tablets

Oral use

Opaque PVC/aluminium
blister packs

28

LUXEMBOURG Novartis Pharma GmbH

Leponex

25 mg

Tablets

Oral use

PVC/PVDC blister packs 20

Roonstraße 25
D-90429 Nürnberg

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nürnberg

Leponex

25 mg

Tablets

Oral use

PVC/PVDC blister packs 50

29.11.2002

EN

Official Journal of the European Communities

C 297/19

Member State

Marketing
authorisation holder

Invented name

Strength

Pharmaceutical
form

Route of
administration

Packaging

Package size

LUXEMBOURG
(cont’d)

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nürnberg

Leponex

25 mg

Tablets

Oral use

PVC/PVDC blister packs 100

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nürnberg

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nürnberg

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nürnberg

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nürnberg

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nürnberg

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nürnberg

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nürnberg

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nürnberg

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nürnberg

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nürnberg

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nürnberg

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nürnberg

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nürnberg

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nürnberg

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nürnberg

Leponex

25 mg

Tablets

Oral use

PVC/PVDC blister packs 500

Leponex

25 mg

Tablets

Oral use

PVC/PVDC blister packs 5 000

Leponex

25 mg

Tablets

Oral use

HDPE bottle

500

Leponex

50 mg

Tablets

Oral use

PVC/PVDC blister packs 20

Leponex

50 mg

Tablets

Oral use

PVC/PVDC blister packs 50

Leponex

50 mg

Tablets

Oral use

PVC/PVDC blister packs 100

Leponex

50 mg

Tablets

Oral use

PVC/PVDC blister packs 500

Leponex

50 mg

Tablets

Oral use

PVC/PVDC blister packs 5 000

Leponex

50 mg

Tablets

Oral use

HDPE bottle

500

Leponex

100 mg

Tablets

Oral use

PVC/PVDC blister packs 20

Leponex

100 mg

Tablets

Oral use

PVC/PVDC blister packs 50

Leponex

100 mg

Tablets

Oral use

PVC/PVDC blister packs 100

Leponex

100 mg

Tablets

Oral use

PVC/PVDC blister packs 500

Leponex

100 mg

Tablets

Oral use

PVC/PVDC blister packs 5 000

Leponex

100 mg

Tablets

Oral use

HDPE bottle

500

C 297/20

EN

Official Journal of the European Communities

29.11.2002

Member State

Marketing
authorisation holder

Invented name

Strength

Pharmaceutical
form

Route of
administration

Packaging

Package size

PORTUGAL

SPAIN

SWEDEN

Novartis Farma — Produtos
Farmacéuticos SA
Rua do Centro Empresarial
Edifico 8, Quinta da Beloura
P-2710-444 Sintra

Novartis Farma — Produtos
Farmacéuticos SA
Rua do Centro Empresarial
Edifico 8, Quinta da Beloura
P-2710-444 Sintra

Novartis Farma — Produtos
Farmacéuticos SA
Rua do Centro Empresarial
Edifico 8, Quinta da Beloura
P-2710-444 Sintra

Novartis Farmaceutica SA
Gran Via de les Corts
Catalanes
E-08013 Barcelona

Novartis Farmaceutica SA
Gran Via de les Corts
Catalanes
E-08013 Barcelona

Novartis Sverige AB
Kemistvägen 1B
Box 1150
S-183 11 Täby

Novartis Sverige AB
Kemistvägen 1B
Box 1150
S-183 11 Täby

Novartis Sverige AB
Kemistvägen 1B
Box 1150
S-183 11 Täby

Novartis Sverige AB
Kemistvägen 1B
Box 1150
S-183 11 Täby

Leponex

25 mg

Tablets

Oral use

PVC/PVDC/alu blister

20

Leponex

25 mg

Tablets

Oral use

PVC/PVDC/alu blister
packs

50

Leponex

100 mg

Tablets

Oral use

PVC/PVDC/alu blister

50

Leponex

25 mg

Tablets

Oral use

PVC/PVDC blister packs 40

Leponex

100 mg

Tablets

Oral use

PVC/PVDC blister packs 40

Leponex

25 mg

Tablets

Oral use

Glass bottle

100

Leponex

100 mg

Tablets

Oral use

Alu-PVC/PVDC blister
packs

98 unit dose

Leponex

100 mg

Tablets

Oral use

Glass bottle

100

Leponex
Liam
50 mg/2 ml
5 × 10 U 17
(Nopas
103120) is
imported on
special,
named-
patient
licences (not
marketed)

THE
NETHERLANDS

Novartis Pharma BV
Raapopseweg 1
6824 DP Arnhem
Nederland

Novartis Pharma BV
Raapopseweg 1
6824 DP Arnhem
Nederland

Leponex

25 mg

Tablets

Oral use

PVC/PVDC blister packs 30

Leponex

25 mg

Tablets

Oral use

Glass bottle

100

29.11.2002

EN

Official Journal of the European Communities

C 297/21

Member State

Marketing
authorisation holder

Invented name

Strength

Pharmaceutical
form

Route of
administration

Packaging

Package size

THE
NETHERLANDS
(cont’d)

Novartis Pharma BV
Raapopseweg 1
6824 DP Arnhem
Nederland

Leponex

100 mg

Tablets

Oral use

PVC/PVDC blister packs 30

UNITED
KINGDOM

Leponex

100 mg

Tablets

Oral use

Glass bottle

100

Clozaril

25 mg

Tablets

Oral use

PVC/PVDC blister packs 14

Clozaril

25 mg

Tablets

Oral use

PVC/PVDC blister packs 28

Clozaril

25 mg

Tablets

Oral use

PVC/PVDC blister packs 84

Clozaril

25 mg

Tablets

Oral use

Type III brown glass
bottles

100

Clozaril

100 mg

Tablets

Oral use

PVC/PVDC blister packs 14

Clozaril

100 mg

Tablets

Oral use

PVC/PVDC blister packs 28

Clozaril

100 mg

Tablets

Oral use

PVC/PVDC blister packs 84

Novartis Pharma BV
Raapopseweg 1
6824 DP Arnhem
Nederland

Novartis Pharmaceuticals UK
Limited
Frimley Business Park
Frimley
Camberley
Surrey GU16 7SR
United Kingdom

Novartis Pharmaceuticals UK
Limited
Frimley Business Park
Frimley
Camberley
Surrey GU16 7SR
United Kingdom

Novartis Pharmaceuticals UK
Limited
Frimley Business Park
Frimley
Camberley
Surrey GU16 7SR
United Kingdom

Novartis Pharmaceuticals UK
Limited
Frimley Business Park
Frimley
Camberley
Surrey GU16 7SR
United Kingdom

Novartis Pharmaceuticals UK
Limited
Frimley Business Park
Frimley
Camberley
Surrey GU16 7SR
United Kingdom

Novartis Pharmaceuticals UK
Limited
Frimley Business Park
Frimley
Camberley
Surrey GU16 7SR
United Kingdom

Novartis Pharmaceuticals UK
Limited
Frimley Business Park
Frimley
Camberley
Surrey GU16 7SR
United Kingdom

C 297/22

EN

Official Journal of the European Communities

29.11.2002

Member State

Marketing
authorisation holder

Invented name

Strength

Pharmaceutical
form

Route of
administration

Packaging

Package size

UNITED
KINGDOM
(cont’d)

ICELAND

NORWAY

Novartis Pharmaceuticals UK
Limited
Frimley Business Park
Frimley
Camberley
Surrey GU16 7SR
United Kingdom

Novartis Healthcare A/S
Lyngbyvej 172
DK-2100 Copenhagen

Novartis Healthcare A/S
Lyngbyvej 172
DK-2100 Copenhagen

Novartis Healthcare A/S
Lyngbyvej 172
DK-2100 Copenhagen

Novartis Norge AS
Brynsalléen 4
POBox 237 Oekern
N-0510 Oslo

Novartis Norge AS
Brynsalléen 4
POBox 237 Oekern
N-0510 Oslo

Clozaril

100 mg

Tablets

Oral use

Type III brown glass
bottles

100

Leponex

25 mg

Tablets

Oral use

Glass bottle

100

Leponex

100 mg

Tablets

Oral use

ALU/PVC/PVDC/
aluminium blister

50

Leponex

100 mg

Tablets

Oral use

Glass bottle

100

Leponex

25 mg

Tablets

Oral use

Glass bottle

100

Leponex

100 mg

Tablets

Oral use

Glass bottle

100

Non-opposition to a notified concentration

(Case COMP/M.2938 — SNPE/MBDA/JV)

(2002/C 297/05)

(Text with EEA relevance)

On 30 October 2002, the Commission decided not to oppose the above notified concentration and to
declare it compatible with the common market. This decision is based on Article 6(1)(b) of Council
Regulation (EEC) No 4064/89. The full text of the decision is only available in English and will be
made public after it is cleared of any business secrets it may contain. It will be available:

— as a paper version through the sales offices of the Office for Official Publications of the European

Communities (see list on the last page),

— in electronic form in the ‘CEN’ version of the CELEX database, under document No 302M2938. CELEX

is the computerised documentation system of European Community law.

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