Summary of Community decisions on marketing authorisations in respect of medicinal products from 15 May to 15 June 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: 2002-07-02
Institutions: European Commission
Subjects: market approval, marketing, medicinal product

C 157/6

EN

Official Journal of the European Communities

2.7.2002

Summary of Community decisions on marketing authorisations in respect of medicinal products
from 15 May to 15 June 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 157/03)

— 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

30.5.2002

Fluvoxamine

See Annex I

30.5.2002

Cisapride

See Annex II

See Annex I

See Annex II

Date of
notification

3.6.2002

3.6.2002

(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 I

Member State

Marketing authorisation
holder

Invented names

Strength

Pharmaceutical form

Route of
adminis-
tration

Packaging

Package sizes

AUSTRIA

BELGIUM

DENMARK

Solvay Pharma GesmbH.
Donaustraße 106
A-3400 Klosterneuburg

Solvay Pharma & Cie.,
SNC-VOF
Bd. Em. Bockstaellaan 122
B-1020 Brussels

Solvay Pharma & Cie.,
SNC-VOF
Bd. Em. Bockstaellaan 122
B-1020 Brussels

Solvay Pharma & Cie.,
SNC-VOF
Bd. Em. Bockstaellaan 122
B-1020 Brussels

Solvay Pharmaceuticals BV
C.J. van Houtenlaan 36
1381 CP Weesp
The Netherlands

Floxyfral

50 mg
100 mg

Film coated,
breakable tablets

Oral use

PVC/PVDC blisters

Floxyfral

100 mg

Film coated,
breakable tablets

Oral use

PVC/PVDC blisters

Dumirox

100 mg

Film coated,
breakable tablets

Oral use

PVC/PVDC blisters

Maleate de
Fluvoxamine

100 mg

Film coated,
breakable tablets

Oral use

PVC/PVDC blisters

50 mg — 5, 30
and 60
100 mg — 15
and 30

20, 30 and 60
Hospital pack of
100 (UD)

30 and 60
Hospital pack of
100 (UD)

30 and 60
Hospital pack of
100 (UD)

Fevarin

50 mg
100 mg

Tablets

Oral use

PVC/PVDC-A1
blisters

30, 60 and 90

2.7.2002

EN

Official Journal of the European Communities

C 157/7

Member State

Marketing authorisation
holder

Invented names

Strength

Pharmaceutical form

Route of
adminis-
tration

Packaging

Package sizes

Fevarin

50 mg
100 mg

Film coated
tablets

Oral use

PVC/PVDC-A1
blisters

30, 60 and 90

FINLAND

FRANCE

Solvay Pharmaceuticals BV
C.J. van Houtenlaan 36
1381 CP Weesp
The Netherlands

Solvay Pharma
42, rue Rouget de Lisle
BP 22
F-92151 Suresnes

Floxyfral

50 mg
100 mg

Film coated,
breakable tablets

Oral use

PVC/PVDC/Alu
blisters

GERMANY

Solvay Arzneimittel GmbH
Hans-Boeckler-Allee 20
D-30173 Hannover

Fevarin

50 mg
100 mg

Film coated
tablets

Oral use

PVC/PVDC blisters

Solvay Arzneimittel GmbH
Hans-Boeckler-Allee 20
D-30173 Hannover

Fevarin Tabs

50 mg
100 mg

Film coated,
breakable tablets

Oral use

PVC/PVDC blisters

GREECE

Solvay Pharma MEPE
Ag. Dimitriou 63
GR-17456 Alimos

Dumyrox

50 mg
100 mg

Film coated
tablets and
enteric coated
tablets

Oral use

PVC/PVDC blisters

30

Famar ABE
P. Marinopoulou 7
GR-174 56 Alimos

Luvox

50 mg
100 mg

Enteric coated
tablets

Oral use

PVC/PVDC blisters

30

Solvay Healthcare Limited
Mansbridge Road
West End
Southampton SO18 3JD
United Kingdom

Faverin Tablets
50 mg and
Faverin Tablets
100 mg

50 mg
100 mg

Coated tablets

Oral use

Blister strip

50 mg — 60
100 mg — 30

Fevarin

50 mg
100 mg

Film coated,
breakable tablets

Oral use

PVC/PVDC/alu
opaque blisters

15 and 30

IRELAND

ITALY

LUXEMBOURG

Solvay Pharmaceuticals BV
C.J. van Houtenlaan 36
1381 CP Weesp
The Netherlands

Solvay Pharma SpA
Via della Libertà 30
I-10095 Grugliasco (TO)

Farmades SpA
Via di Tor Cervara 282
I-00155 Roma

Solvay Pharma & Cie.,
SNC-VOF
Bd. Em. Bockstaellaan 122
B-1020 Brussels

Solvay Pharma & Cie.,
SNC-VOF
Bd. Em. Bockstaellaan 122
B-1020 Brussels

Dumirox

50 mg
100 mg

Film coated,
breakable tablets

Oral use

PVC/PVDC/alu
opaque blisters

Maveral

50 mg
100 mg

Film coated,
breakable tablets

Oral use

PVC/PVDC/alu
opaque blisters

Floxyfral

100 mg

Film coated,
breakable tablets

Oral use

PVC/PVDC blisters

Dumirox

100 mg

Film coated,
breakable tablets

Oral use

PVC/PVDC blisters

20, 30 and 50
Hospital pack of
100

20, 50 and 100
Hospital pack of
250 (5 × 50)

20, 50 and 100
Hospital pack of
250 (5 × 50)

30

30

20, 30 and 60
Hospital pack of
100 (UD)

30 and 60
Hospital pack of
100 (UD)

50 mg — 30, 50
and 60
100 mg — 30
and 50

THE
NETHERLANDS

Solvay Pharmaceuticals BV
C.J. van Houtenlaan 36
1381 CP Weesp
Nederland

Fevarin

50 mg
100 mg

Film coated,
tablets

Oral use

PVC/PVDC-A1
blisters

C 157/8

EN

Official Journal of the European Communities

2.7.2002

Member State

Marketing authorisation
holder

Invented names

Strength

Pharmaceutical form

Route of
adminis-
tration

Packaging

Package sizes

NORWAY

PORTUGAL

SPAIN

SWEDEN

UNITED
KINGDOM

Solvay Pharmaceuticals BV
C.J. van Houtenlaan 36
1381 CP Weesp
The Netherlands

Solvay Farma Lda
Av. Marechal Gomes da
Costa, 33
P-1800-255 Lisboa

Fevarin

50 mg
100 mg

Film coated
tablets

Oral use

PVC/PVDC-A1
blisters

30 and 90

Dumyrox

50 mg
100 mg

Film coated,
breakable tablets

Oral use

PVC/PVDC/Alu
blisters

50 mg — 20 and
60
100 mg — 30

Solvay Pharma SA
Av. Diagonal, 507
E-08029 Barcelona

Dumirox 50
and Dumirox
100

50 mg
100 mg

Film coated,
breakable tablets

Oral use

PVC/PVDC-A1
blisters

30

Solvay Pharmaceuticals BV
C.J. van Houtenlaan 36
1381 CP Weesp
The Netherlands

Fevarin

50 mg
100 mg

Film coated
tablets

Oral use

PVC/PVDC-A1
blisters

30, 60 and 90

Solvay Healthcare Limited
Mansbridge Road
West End
Southampton SO18 3JD
United Kingdom

Faverin Tablets
50 mg and
Faverin Tablets
100 mg

50 mg
100 mg

Coated tablets

Oral use

Blister strip

50 mg — 60
100 mg — 30

ANNEX II

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

CISAPRIDE-CONTAINING MEDICINAL PRODUCTS WITH MARKETING AUTHORISATION IN THE EUROPEAN
UNION

Member State

Marketing authorisation
holder

Product name

Strength

Pharmaceutical form

Route of
adminis-
tration

Packaging

Package sizes

AUSTRIA

Janssen-Cilag Pharma
GmbH
Pfarrg. 75
A-1232 Wien

Janssen-Cilag Pharma
GmbH
Pfarrg. 75
A-1232 Wien

Janssen-Cilag Pharma
GmbH
Pfarrg. 75
A-1232 Wien

Janssen-Cilag Pharma
GmbH
Pfarrg. 75
A-1232 Wien

Prepulsid
1 mg/ml — orale
suspension

Prepulsid
1 mg/ml — orale
suspension

1 mg/ml Oral suspension Oral use

Bottle

100 ml

1 mg/ml Oral suspension Oral use

Sachet

20 sachets of 5 ml
50 sachets of 5 ml
20 sachets of 10 ml
50 sachets of 10 ml

Prepulsid 5 mg
Tabletten

5 mg

Tablet

Oral use

Blister

Prepulsid 10 mg
Tabletten

10 mg

Tablet

Oral use

Blister

10
20
30
50

10
20
30
50

2.7.2002

EN

Official Journal of the European Communities

C 157/9

Member State

Marketing authorisation
holder

Product name

Strength

Pharmaceutical form

Route of
adminis-
tration

Packaging

Package sizes

AUSTRIA
(cont’d)

BELGIUM

DENMARK

Janssen-Cilag Pharma
GmbH
Pfarrg. 75
A-1232 Wien

Prepulsid 20 mg
Tabletten

20 mg

Tablet

Oral use

Blister

20

Janssen-Cilag NV
Roderveldlaan
B-2600 Berchem

Janssen-Cilag NV
Roderveldlaan
B-2600 Berchem

Janssen-Cilag NV
Roderveldlaan
B-2600 Berchem

Janssen-Cilag NV
Roderveldlaan
B-2600 Berchem

Janssen-Cilag NV
Roderveldlaan
B-2600 Berchem

Janssen-Cilag NV
Roderveldlaan
B-2600 Berchem

Janssen-Cilag NV
Roderveldlaan
B-2600 Berchem

Janssen-Cilag NV
Roderveldlaan
B-2600 Berchem

Janssen-Cilag A/S
Postboks 149
Hammerbakken 19
DK-3460 Birkerød

Janssen-Cilag A/S
Postboks 149
Hammerbakken 19
DK-3460 Birkerød

Janssen-Cilag A/S
Postboks 149
Hammerbakken 19
DK-3460 Birkerød

Janssen-Cilag A/S
Postboks 149
Hammerbakken 19
DK-3460 Birkerød

Prepulsid

5 mg

Tablet

Oral use

Strip

30 UD

Prepulsid

1 mg/ml Oral suspension
(adults)

Oral use

Bottle

100 ml

Prepulsid

1 mg/ml Oral suspension Oral use

Sachet

20 sachets of 5 ml

Prepulsid

10 mg

Tablet

Oral use

Strip

100

Prepulsid

20 mg

Tablet

Oral use

Strip

50
100 U.D.

Prepulsid

10 mg

Effervescent
tablet

Oral use

20
100

Prepulsid

1 mg/ml Oral suspension

Oral use

Bottle

100 ml

(paediatric)

Prepulsid

1 mg/ml Oral suspension Oral use

Sachet

50 sachets of 10 ml

Prepulsid

1 mg/ml Oral solution

Oral use

Bottle (glass)

200 ml

Prepulsid

10 mg

Tablet

Oral use

Prepulsid

20 mg

Tablet

Oral use

Blister
PVC-PE-
PVDC/ALU

Blister
PVC-PE-
PVDC/ALU

50
100

50
100

Prepulsid

10 mg

Oral lyophilisate Oral use

Blister
PVC-PE/ALU

Not applicable since
it is not marketed

C 157/10

EN

Official Journal of the European Communities

2.7.2002

Member State

Marketing authorisation
holder

Product name

Strength

Pharmaceutical form

Route of
adminis-
tration

Packaging

Package sizes

DENMARK
(cont’d)

FINLAND

Janssen-Cilag A/S
Postboks 149
Hammerbakken 19
DK-3460 Birkerød

Janssen-Cilag Oy
Metsänneidonkuja 8
FIN-02130 Espoo

Janssen-Cilag Oy
Metsänneidonkuja 8
FIN-02130 Espoo

Janssen-Cilag Oy
Metsänneidonkuja 8
FIN-02130 Espoo

Janssen-Cilag Oy
Metsänneidonkuja 8
FIN-02130 Espoo

Janssen-Cilag Oy
Metsänneidonkuja 8
FIN-02130 Espoo

Janssen-Cilag Oy
Metsänneidonkuja 8
FIN-02130 Espoo

Janssen-Cilag Oy
Metsänneidonkuja 8
FIN-02130 Espoo

Janssen-Cilag Oy
Metsänneidonkuja 8
FIN-02130 Espoo

Prepulsid

20 mg

Oral lyophilisate Oral use

Blister
PVC-PE/ALU

Not applicable since
it is not marketed

Prepulsid

5 mg

Tablet

Oral use

Blister
ALU/PVC/PVDC

30

Prepulsid

10 mg

Tablet

Oral use

Blister
ALU/PVC/PVDC

50
100

Prepulsid

20 mg

Tablet

Oral use

Blister
ALU/PVC/PVDC

60

Prepulsid

1 mg/ml Oral suspension Oral use

Bottle (glass)

100 ml
200 ml

Prepulsid

30 mg

Suppository

Rectal
use

PVC/HDPE
Blister

Prepulsid
Quicklet

Prepulsid
Quicklet

Prepulsid
Quicklet

5 mg

Oral lyophilisate Oral use

Blister aclar/alu

10 mg

Oral lyophilisate Oral use

Blister aclar/alu

20 mg

Oral lyophilisate Oral use

Blister aclar/alu

6

28
56

28
56

28
56

40

FRANCE

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

Prepulsid 10 mg,
comprimé

10 mg

Tablet

Oral use

PVC/PVDC/
Aluminium/
Polythylene
blister

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

Prepulsid adultes
1 mg/ml
suspension
buvable en
flacon

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

Prepulsid enfants
et nourrissons
1 mg/ml
suspension
buvable en
flacon

1 mg/ml Oral suspension Oral use Glass vial

200 ml

1 mg/ml Oral suspension Oral use Glass vial

100 ml

2.7.2002

EN

Official Journal of the European Communities

C 157/11

Member State

Marketing authorisation
holder

Product name

Strength

Pharmaceutical form

Route of
adminis-
tration

Packaging

Package sizes

FRANCE
(cont’d)

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

Prepulsid 5 mg/
5 ml suspension
buvable en
sachet

5 mg/
5 ml

Oral suspension Oral use

Sachet paper/
alu/poly-
ethelene/surlyn

20
40
Sachets of 5 ml

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

10 mg/
10 ml

Prepulsid 10 mg/
10 ml
suspension
buvable en
sachet

Oral suspension Oral use

Sachet paper/
alu/poly-
ethelene/surlyn

20
40
Sachets of 10 ml

GERMANY

Janssen-Cilag
Raiffeisenstraße 8
D-41470 Neuss

Alimix

1 mg/ml Oral suspension Oral use

Bottle (amber
glass)

Janssen-Cilag
Raiffeisenstraße 8
D-41470 Neuss

Alimix 5 mg,
Tabletten

5 mg

Tablet

Oral use

Janssen-Cilag
Raiffeisenstraße 8
D-41470 Neuss

Alimix 10 mg,
Tabletten

10 mg

Tablet

Oral use

Janssen-Cilag
Raiffeisenstraße 8
D-41470 Neuss

Alimix 5 mg,
Tabletten

20 mg

Tablet

Oral use

Janssen-Cilag
Raiffeisenstraße 8
D-41470 Neuss

Cisaprid-Janssen
5 mg, Tabletten

5 mg

Tablet

Oral use

Janssen-Cilag
Raiffeisenstraße 8
D-41470 Neuss

Janssen-Cilag
Raiffeisenstraße 8
D-41470 Neuss

Propulsin

1 mg/ml Oral suspension Oral use

Propulsin 5 mg,
Tabletten

5 mg

Tablet

Oral use

PVC-PE-PVDC/
Alu blister

Alu/Alu blister

PVC-PE-PVDC/
Alu blister

Alu/Alu blister

PVC-PE-PVDC/
Alu blister

Alu/Alu blister

PVC-PE-PVDC/
Alu blister

Alu/Alu blister

Bottle (amber
glass)

PVC-PE-PVDC/
Alu blister

Alu/Alu blister

100 ml, 200 ml,
5 × 100 ml (hospital
pack), 5 × 200 ml
(hospital pack),
100 ml (sample
pack not for sale)

100
20
50
200 (10 × 20)
(hospital pack)
20 (sample pack not
for sale)

100
20
50
200 (10 × 20)
(hospital pack)
20 (sample pack not
for sale)

100
20
50
200 (10 × 20)
(hospital pack)
20 (sample pack not
for sale)

100
20
50
200 (10 × 20)
(hospital pack)
20 (sample pack not
for sale)

100 ml, 200 ml,
5 × 100 ml (hospital
pack), 5 × 200 ml
(hospital pack),
100 ml (sample
pack not for sale)

100
20
50
200 (10 × 20)
(hospital pack)
20 (sample pack not
for sale)

C 157/12

EN

Official Journal of the European Communities

2.7.2002

Member State

Marketing authorisation
holder

Product name

Strength

Pharmaceutical form

Route of
adminis-
tration

Packaging

Package sizes

GERMANY
(cont’d)

Janssen-Cilag
Raiffeisenstraße 8
D-41470 Neuss

Propulsin 10 mg,
Tabletten

10 mg

Tablet

Oral use

Janssen-Cilag
Raiffeisenstraße 8
D-41470 Neuss

Propulsin 20 mg,
Tabletten

20 mg

Tablet

Oral use

PVC-PE-PVDC/
Alu blister

Alu/Alu blister

PVC-PE-PVDC/
Alu blister

Alu/Alu blister

Janssen-Cilag
Raiffeisenstraße 8
D-41470 Neuss

Janssen-Cilag
Raiffeisenstraße 8
D-41470 Neuss

Propulsin Beutel
5 ml

5 mg/
5 ml

Oral suspension Oral use

Propulsin Beutel
10 ml

10 mg/
10 ml

Oral suspension Oral use

Janssen-Cilag
Raiffeisenstraße 8
D-41470 Neuss

Propulsin lingual,
5 mg,
Lutschtabletten

5 mg

Lozenge

Oral use Aclar/Alu

blister
Alu/Alu blister

Janssen-Cilag
Raiffeisenstraße 8
D-41470 Neuss

Propulsin lingual,
10 mg,
Lutschtabletten

10 mg

Lozenge

Oral use Aclar/Alu

blister
Alu/Alu blister

Janssen-Cilag
Raiffeisenstraße 8
D-41470 Neuss

Propulsin lingual,
20 mg,
Lutschtabletten

20 mg

Lozenge

Oral use Aclar/Alu

blister
Alu/Alu blister

100
20
50
200 (10 × 20)
(hospital pack)
20 (sample pack not
for sale)

100
20
50
200 (10 × 20)
(hospital pack)
20 (sample pack not
for sale)

20 × 5 ml,
50 × 5 ml,
20 × 5 ml (sample
pack not for sale)

20 × 10 ml,
50 × 10 ml,
20 × 10 ml (sample
pack not for sale)

20
48
20 (sample pack not
for sale

20
48
20 (sample pack not
for sale

20
48
20 (sample pack not
for sale

Janssen-Cilag
Raiffeisenstraße 8
D-41470 Neuss

Propulsin
Lösungstabletten
10 mg

10 mg

Effervescent
tablet

Oral use

20

GREECE

Cosmopharm Ltd
PO Box 42
GR-20100 Korinthos

Evifix

10 mg

Tablet

Oral use

Blister

50 (5 × 10)

Help Ltd
14 Valaoritou Street
GR-14452 Metamorhosi
— Athens

Help Ltd
14 Valaoritou Street
GR-14452 Metamorhosi
— Athens

Lirebin

5 mg/
5 ml

Oral suspension Oral use

Bottle

100 ml
200 ml

Lirebin

5 mg

Tablet

Oral use

Blister

30
500 (10 × 50)

2.7.2002

EN

Official Journal of the European Communities

C 157/13

Member State

Marketing authorisation
holder

Product name

Strength

Pharmaceutical form

Route of
adminis-
tration

Packaging

Package sizes

GREECE
(cont’d)

Help Ltd
14 Valaoritou Street
GR-14452 Metamorhosi
— Athens

Biomedica — Chemica SA
25 G. Lyra Street
GR-14564 Kiphisia

Lirebin

10 mg

Tablet

Oral use

Blister

50 (2 × 25)

Systilan

10 mg

Tablet

Oral use

Blister

50 (5 × 10)

Biomedica — Chemica SA
25 G. Lyra Street
GR-14564 Kiphisia

Systilan

5 mg/
5 ml

Oral suspension Oral use

Bottle

100 ml
200 ml

Biomedica — Chemica SA
25 G. Lyra Street
GR-14564 Kiphisia

Circocric

10 mg

Tablet

Oral use

Blister

50 (5 × 10)

Biomedica — Chemica SA
25 G. Lyra Street
GR-14564 Kiphisia

Circocric

Uni-Pharma
14th Km Athens-Lamia
GR-14564 Kifisia —
Athens

Oferin

5 mg/
5 ml

5 mg/
5 ml

Oral suspension Oral use

Bottle

100 ml
200 ml

Oral suspension Oral use

Bottle

200 ml

Uni-Pharma
14th Km Athens-Lamia
GR-14564 Kifisia —
Athens

Chrispa
16th Km Marathona
GR-15344 Palini —
Athens

Janssen-Cilag
56 Irinis Ave.
GR-15121 Perxi — Athens

Janssen-Cilag
56 Irinis Ave.
GR-15121 Perxi — Athens

Oferin

10 mg

Tablet

Oral use

Blister

50 (5 × 10)

Bozaxtral

10 mg

Tablet

Oral use

Blister

50 (5 × 10)

Alimix

5 mg

Tablet

Oral use

Blister

30

Alimix

10 mg

Tablet

Oral use

Blister

50 (2 × 25)

Janssen-Cilag
56 Irinis Ave.
GR-15121 Perxi — Athens

Alimix

Janssen-Cilag
56 Irinis Ave.
GR-15121 Perxi — Athens

Alimix

5 mg/
5 ml

5 mg/
5 ml

Oral suspension Oral use

Bottle

100 ml
200 ml

Oral suspension Oral use

Sachet

20 sachets of 5 ml
50 sachets of 5 ml
20 sachets of 10 ml
50 sachets of 10 ml

Janssen-Cilag
56 Irinis Ave.
GR-15121 Perxi — Athens

Alimix

30 mg

Suppository

Rectal
use

Blister

6

C 157/14

EN

Official Journal of the European Communities

2.7.2002

Member State

Marketing authorisation
holder

Product name

Strength

Pharmaceutical form

Route of
adminis-
tration

Packaging

Package sizes

GREECE
(cont’d)

Janssen-Cilag
56 Irinis Ave.
GR-15121 Perxi — Athens

Alimix

20 mg

Tablet

Oral use

Blister

60 (3 × 20)

Alimix

10 mg

Tablet

Oral use

Blister

20
56

Ruvetine

10 mg

Tablet

Oral use

Blister

50 (2 × 25)

Ruvetine

5 mg/
5 ml

Oral suspension Oral use

Bottle

100 ml
200 ml

Ruvetine

20 mg

Tablet

Oral use

Blister

60 (3 × 20)

Janssen-Cilag
56 Irinis Ave.
GR-15121 Perxi — Athens

Rafarm AEBE
Kapodistriov and 12
Kopinthou Street
GR-15451 N. Psychiko —
Athens

Rafarm AEBE
Kapodistriov and 12
Kopinthou Street
GR-15451 N. Psychiko —
Athens

Rafarm AEBE
Kapodistriov and 12
Kopinthou Street
GR-15451 N. Psychiko —
Athens

Genepharm SA
18th Km Athens
Marathona Ave.
GR-15344 Palini — Attikis

Dolyzinax

5 mg/
5 ml

Oral suspension Oral use

Bottle

150 ml

Genepharm SA
18th Km Athens
Marathona Ave.
GR-15344 Palini — Attikis

Dolyzinax

10 mg

Tablet

Oral use

Blister

50 (5 × 10)

BROS Ltd
Galinis and 15 Argis Street
GR-15464 N. Kiphisia

Lamafer

5 mg/
5 ml

Oral suspension Oral use

Bottle

100 ml
200 ml

BROS Ltd
Galinis and 15 Argis Street
GR-15464 N. Kiphisia

BROS Ltd
Galinis and 15 Argis Street
GR-15464 N. Kiphisia

Kleva Ltd
189 Parnithos Ave.
GR-13671 Acharnai —
Attiki

Kleva Ltd
189 Parnithos Ave.
GR-13671 Acharnai —
Attiki

Lamafer

5 mg

Tablet

Oral use

Blister

30 (3 × 10)

Lamafer

10 mg

Tablet

Oral use

Blister

50 (5 × 10)

Kinussen

5 mg

Tablet

Oral use

Blister

30 (3 × 10)

Kinussen

10 mg

Tablet

Oral use

Blister

50 (5 × 10)

2.7.2002

EN

Official Journal of the European Communities

C 157/15

Member State

Marketing authorisation
holder

Product name

Strength

Pharmaceutical form

Route of
adminis-
tration

Packaging

Package sizes

GREECE
(cont’d)

Kleva Ltd
189 Parnithos Ave.
GR-13671 Acharnai —
Attiki

Kleva Ltd
189 Parnithos Ave.
GR-13671 Acharnai —
Attiki

Faran ABEE
Achaias and Trizinias
GR-14564 N. Kiphisia —
Athens

Faran ABEE
Achaias and Trizinias
GR-14564 N. Kiphisia —
Athens

Kinussen

5 mg/
5 ml

Oral suspension Oral use

Bottle

200 ml

Kinussen

20 mg

Tablet

Oral use

Blister

60 (3 × 20)

Cefanyl

5 mg

Tablet

Oral use

Blister

30 (3 × 10)

Cefanyl

10 mg

Tablet

Oral use

Blister

50 (5 × 10)

Faran ABEE
Achaias and Trizinias
GR-14564 N. Kiphisia —
Athens

Cefanyl

5 mg/
5 ml

5 mg/
5 ml

Nastilox

Oral suspension Oral use

Bottle

Oral suspension Oral use

Bottle

200 ml

Farmaten Ltd
68 Menaorou Street
GR-10432 Athens

Farmaten Ltd
68 Menaorou Street
GR-10432 Athens

Farmaten Ltd
68 Menaorou Street
GR-10432 Athens

Finifarm Ltd
5 Anavritis Street
GR-11143 Athens

Finifarm Ltd
5 Anavritis Street
GR-11143 Athens

Anfarm Hellas SA
442 Acharnon Street
GR-11143 Athens

Anfarm Hellas SA
442 Acharnon Street
GR-11143 Athens

Elpen SA Pharmaceutical
Industry
21st Km Marathona Ave.
GR-19009 Pikermi —
Attiki

100 ml
200 ml

30 (3 × 10)
250
500
1 000

50 (5 × 10)
250
500
1 000

Nastilox

5 mg

Tablet

Oral use

Nastilox

10 mg

Tablet

Oral use

Blister
Bottle

Blister
Bottle

Spabucol

10 mg

Tablet

Oral use

Blister

50 (5 × 10)

Spabucol

5 mg/
5 ml

Oral suspension Oral use

Bottle

200 ml

Minsk

10 mg

Tablet

Oral use

Blister

50 (5 × 10)

Minsk

Elpegon

5 mg/
5 ml

5 mg/
5 ml

Oral suspension Oral use

Bottle

200 ml

Oral suspension Oral use

Bottle

100 ml
200 ml

C 157/16

EN

Official Journal of the European Communities

2.7.2002

Member State

Marketing authorisation
holder

Product name

Strength

Pharmaceutical form

Route of
adminis-
tration

Packaging

Package sizes

Elpegon

5 mg

Tablet

Oral use

Blister

30 (3 × 10)

Elpegon

10 mg

Tablet

Oral use

Blister

50 (5 × 10)

Zenopar

5 mg

Tablet

Oral use

Blister

30 (3 × 10)

Zenopar

10 mg

Tablet

Oral use

Blister

50 (5 × 10)

Zenopar

5 mg/
5 ml

Oral suspension Oral use

Bottle

100 ml
200 ml

Cevilor

10 mg

Tablet

Oral use

Blister

50 (5 × 10)

Epasan

5 mg/
5 ml

Oral suspension Oral use

Bottle

200 ml

Epasan

10 mg

Tablet

Oral use

Blister

50 (5 × 10)

Cisapride/Hexal

5 mg

Tablet

Oral use

Blister

30 (3 × 10)

Cisapride/Hexal

10 mg

Tablet

Oral use

Blister

50 (5 × 10)

GREECE
(cont’d)

Elpen SA Pharmaceutical
Industry
21st Km Marathona Ave.
GR-19009 Pikermi —
Attiki

Elpen SA Pharmaceutical
Industry
21st Km Marathona Ave.
GR-19009 Pikermi —
Attiki

Remedina ABEE
25 Gounari
GR-13451 Kamatero —
Attiki

Remedina ABEE
25 Gounari
GR-13451 Kamatero —
Attiki

Remedina ABEE
25 Gounari
GR-13451 Kamatero —
Attiki

Antor Ltd
4 Omirou
GR-15126 Marousi

Zikides NG
45 Victoros Ougo
GR-10437 Athens

Zikides NG
45 Victoros Ougo
GR-10437 Athens

Hexal Hellas
189 Parnithos Ave.
GR-13671 Athens

Hexal Hellas
189 Parnithos Ave.
GR-13671 Athens

Hexal Hellas
189 Parnithos Ave.
GR-13671 Athens

Cisapride/Hexal

5 mg/
5 ml

1 mg/
1 ml

Oral suspension Oral use

Bottle

200 ml

Oral suspension Oral use

Bottle

200 ml

Gastridol

Medichrom SA
26th Km Markopoulou
Ave.
GR-19003 Koropi —
Attiki

2.7.2002

EN

Official Journal of the European Communities

C 157/17

Member State

Marketing authorisation
holder

Product name

Strength

Pharmaceutical form

Route of
adminis-
tration

Packaging

Package sizes

GREECE
(cont’d)

IRELAND

ITALY

Medichrom SA
26th Km Markopoulou
Ave.
GR-19003 Koropi —
Attiki

Komep SA
Pireos and 64 Aristovoulou
Street
GR-11853 Athens

Komep SA
Pireos and 64 Aristovoulou
Street
GR-11853 Athens

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

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

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

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

J. C. Healthcare SRL
Via Michelangelo
Buonarroti, 23
I-20093 Cologno Monzese
MI

J. C. Healthcare SRL
Via Michelangelo
Buonarroti, 23
I-20093 Cologno Monzese
MI

Italchimici SpA
Via G. Winckelmann, 2
I-20146 Milano (MI)

Gastridol

10 mg

Tablet

Oral use

Blister

50 (5 × 10)

Saprimix

1 mg/
1 ml

Oral suspension Oral use

Bottle

100 ml
200 ml

Saprimix

10 mg

Tablet

Oral use

Blister

50 (5 × 10)

Prepulsid
Suspension

1 mg/ml Oral suspension Oral use Amber glass

Bottle

200 ml
500 ml

Prepulsid
Paediatric
Suspension

1 mg/ml Oral suspension Oral use Amber glass

100 ml

Bottle

Prepulsid Tablets
5 mg

5 mg

Tablet

Oral use ALU/PVC/PE/
PVDC blister

Prepulsid Tablets
10 mg

10 mg

Tablet

Oral use ALU/PVC/PE/
PVDC blister

6
10
60
84

10
30
60
84
90
100
112
120

Alimix

5 mg/
5 ml

Oral suspension Oral use

Sachet

30 sachets of 5 ml

Alimix

10 mg/
10 ml

Oral suspension Oral use

Sachet

30 sachets of 10 ml

Cipril

10 mg

Tablet

Oral use

Blister

30

C 157/18

EN

Official Journal of the European Communities

2.7.2002

Member State

Marketing authorisation
holder

Product name

Strength

Pharmaceutical form

Route of
adminis-
tration

Packaging

Package sizes

ITALY
(cont’d)

Italchimici SpA
Via G. Winckelmann, 2
I-20146 Milano (MI)

Cipril

1 mg/
1 ml

Oral suspension Oral use

Bottle

100 ml
200 ml

Italchimici SpA
Via G. Winckelmann, 2
I-20146 Milano (MI)

Italchimici SpA
Via G. Winckelmann, 2
I-20146 Milano (MI)

Italchimici SpA
Via G. Winckelmann, 2
I-20146 Milano (MI)

Cipril

10 mg

Effervescent
granules

Oral use

Sachet

Cipril

5 mg

Chewable tablet Oral use

Cipril

10 mg

Chewable tablet Oral use

30

28

28

Italchimici SpA
Via G. Winckelmann, 2
I-20146 Milano (MI)

Cipril

Prepulsid

Janssen Cilag SpA
Via Michelangelo
Buonarroti, 23
I-20093 Cologno Monzese
MI

5 mg/
5 ml

1 mg/
1 ml

Oral suspension Oral use

Sachet

30 sachets of 5 ml

Oral suspension Oral use

Bottle

100 ml
200 ml

Janssen Cilag SpA
Via Michelangelo
Buonarroti, 23
I-20093 Cologno Monzese
MI

Janssen Cilag SpA
Via Michelangelo
Buonarroti, 23
I-20093 Cologno Monzese
MI

Janssen Cilag SpA
Via Michelangelo
Buonarroti, 23
I-20093 Cologno Monzese
MI

Janssen Cilag SpA
Via Michelangelo
Buonarroti, 23
I-20093 Cologno Monzese
MI

Janssen Cilag SpA
Via Michelangelo
Buonarroti, 23
I-20093 Cologno Monzese
MI

Prepulsid

10 mg

Effervescent
granules

Oral use

Sachet

30

Prepulsid

5 mg

Chewable tablet Oral use

Blister

28

Prepulsid

10 mg

Chewable tablet Oral use

Blister

28

Prepulsid

5 mg/
5 ml

Oral supsension Oral use

Sachet

30 sachets of 5 ml

Prepulsid

10 mg/
10 ml

Oral suspension Oral use

Sachet

30 sachets of 10 ml

LUXEMBOURG

Janssen-Cilag NV
Uitbreidingstraat 2
B-2600 Berchem

Cyprid

5 mg

Tablet

Oral use

Strip

20
30

2.7.2002

EN

Official Journal of the European Communities

C 157/19

Member State

Marketing authorisation
holder

Product name

Strength

Pharmaceutical form

Route of
adminis-
tration

Packaging

Package sizes

LUXEMBOURG
(cont’d)

Janssen-Cilag NV
Uitbreidingstraat 2
B-2600 Berchem

Cyprid

1 mg/ml Oral solution

Oral use

Bottle

100 ml

Janssen-Cilag NV
Uitbreidingstraat 2
B-2600 Berchem

Janssen-Cilag NV
Uitbreidingstraat 2
B-2600 Berchem

Janssen-Cilag NV
Uitbreidingstraat 2
B-2600 Berchem

Janssen-Cilag NV
Uitbreidingstraat 2
B-2600 Berchem

Janssen-Cilag NV
Uitbreidingstraat 2
B-2600 Berchem

Janssen-Cilag NV
Uitbreidingstraat 2
B-2600 Berchem

Janssen-Cilag NV
Uitbreidingstraat 2
B-2600 Berchem

Janssen-Cilag NV
Uitbreidingstraat 2
B-2600 Berchem

Janssen-Cilag NV
Uitbreidingstraat 2
B-2600 Berchem

Janssen-Cilag NV
Uitbreidingstraat 2
B-2600 Berchem

Cyprid

5 mg/
5 ml

Oral solution

Oral use

Sachet

20 sachets of 5 ml

Cyprid

5 mg

Tablet

Oral use

Blister

20

Prepulsid

10 mg

Tablet

Oral use

Strip

Prepulsid

20 mg

Tablet

Oral use

Strip

40
100

50
100

Prepulsid

1 mg/ml Oral solution

Oral use

Bottle

100 ml

Prepulsid

30 mg

Suppository

Rectal
use

Strip

6

Prepulsid

10 mg

Effervescent
tablet

Oral use

20
100

Prepulsid

10 mg/
10 ml

Oral solution

Oral use

Sachet

50 sachets of 10 ml

Prepulsid
Quicklet

Prepulsid
Quicklet

10 mg

Tablet

Oral use

Blister

20 mg

Tablet

Oral use

Blister

20
56
100

20
56
100

THE NETHER-
LANDS

Janssen-Cilag BV
Dr. Paul Janssenweg 150
5026 RH Tilburg
Nederland

Prepulsid
suspensie voor
oraal gebruik
1 mg/ml

1 mg/ml Oral suspension Oral use

Bottle

Janssen-Cilag BV
Dr. Paul Janssenweg 150
5026 RH Tilburg
Nederland

Prepulsid
Tabletten 5 mg

5 mg

Tablet

Oral use

Strip

Janssen-Cilag BV
Dr. Paul Janssenweg 150
5026 RH Tilburg
Nederland

Prepulsid
Tabletten 10 mg

10 mg

Tablet

Oral use

Strip

C 157/20

EN

Official Journal of the European Communities

2.7.2002

Member State

Marketing authorisation
holder

Product name

Strength

Pharmaceutical form

Route of
adminis-
tration

Packaging

Package sizes

THE NETHER-
LANDS
(cont’d)

Janssen-Cilag BV
Dr. Paul Janssenweg 150
5026 RH Tilburg
Nederland

Prepulsid
Tabletten 20 mg

20 mg

Tablet

Oral use

Strip

PORTUGAL

Janssen-Cilag BV
Dr. Paul Janssenweg 150
5026 RH Tilburg
Nederland

Laboratório B A Farma,
Lda
Rua Prof. Sousa da
Câmara, n.o 207 a 211
Apartado 15087
P-1074-803 Lisboa

Laboratório B A Farma,
Lda
Rua Prof. Sousa da
Câmara, n.o 207 a 211
Apartado 15087
P-1074-803 Lisboa

Laboratório Azevedos —
Indústria Farmacêutica, SA
Estrada Nacional 117
2 Alfragide
P-2724-503 Amadora

Laboratório Azevedos —
Indústria Farmacêutica, SA
Estrada Nacional 117
2 Alfragide
P-2724-503 Amadora

Laboratório Azevedos —
Indústria Farmacêutica, SA
Estrada Nacional 117
2 Alfragide
P-2724-503 Amadora

Laboratório Azevedos —
Indústria Farmacêutica, SA
Estrada Nacional 117
2 Alfragide
P-2724-503 Amadora

Labesfal — Laboratórios
Almiro, SA
Campo de Besteiros
Apartado 7
P-3465-051 Tondela

Labesfal — Laboratórios
Almiro, SA
Campo de Besteiros
Apartado 7
P-3465-051 Tondela

Prepulsid
Zetpillen 30 mg

30 mg

Suppository

Rectal
use

Strip

Ciside

10 mg

Tablet

Oral use

PVC/aluminium
Blister

10
60

Ciside

1 mg/ml Oral suspension Oral use Amber-coloured

200 ml

glass bottle

Clotioride

5 mg

Tablet

Oral use

PVC/aluminium
blister

10
60

Clotioride

10 mg

Tablet

Oral use

PVC/aluminium
blister

60

Clotioride

30 mg

Suppository

Rectal
use

PVC poly-
ethylene alveole

10

Clotioride

1 mg/ml Oral suspension Oral use Amber-coloured

200 ml

glass bottle,
PVC/alum. cap

Hagasical

10 mg

Tablet

Oral use

PVC/aluminium
blister

60

Hagasical

1 mg/ml Oral suspension Oral use Amber-coloured

200 ml

glass bottle

2.7.2002

EN

Official Journal of the European Communities

C 157/21

Member State

Marketing authorisation
holder

Product name

Strength

Pharmaceutical form

Route of
adminis-
tration

Packaging

Package sizes

PORTUGAL
(cont’d)

Janssen Farmacêutica
Portugal, Lda
Estrada Consiglieri Pedroso,
69-a,
Queluz de Baixo
P-2749-503 Barcarena

Janssen Farmacêutica
Portugal, Lda
Estrada Consiglieri Pedroso,
69-a,
Queluz de Baixo
P-2749-503 Barcarena

Janssen Farmacêutica
Portugal, Lda
Estrada Consiglieri Pedroso,
69-a,
Queluz de Baixo
P-2749-503 Barcarena

Janssen Farmacêutica
Portugal, Lda
Estrada Consiglieri Pedroso,
69-a,
Queluz de Baixo
P-2749-503 Barcarena

Janssen Farmacêutica
Portugal, Lda
Estrada Consiglieri Pedroso,
69-a,
Queluz de Baixo
P-2749-503 Barcarena

Janssen Farmacêutica
Portugal, Lda
Estrada Consiglieri Pedroso,
69-a,
Queluz de Baixo
P-2749-503 Barcarena

Janssen Farmacêutica
Portugal, Lda
Estrada Consiglieri Pedroso,
69-a,
Queluz de Baixo
P-2749-503 Barcarena

Janssen Farmacêutica
Portugal, Lda
Estrada Consiglieri Pedroso,
69-a,
Queluz de Baixo
P-2749-503 Barcarena

Janssen Farmacêutica
Portugal, Lda
Estrada Consiglieri Pedroso,
69-a,
Queluz de Baixo
P-2749-503 Barcarena

Prepulsid

5 mg

Tablet

Oral use

Prepulsid

10 mg

Tablet

Oral use

PVC/PVDC/
PE/Aluminium
blister

10
20
60

PVC/PVDC/
PE/Aluminium
blister

10
60

Prepulsid

10 mg

Effervescent
tablet

Oral use

Sachet
Aluminium/
Aluminium

20
56

Prepulsid

10 mg

Effervescent
granules

Oral use

Polyethylene,
aluminium and
paper sachet

20

Prepulsid

20 mg

Tablet

Oral use

PVC/PVDC/
PE/Aluminium
blister

60

Prepulsid

30 mg

Suppository

Rectal
use

PVC and
polyethylene

6

Prepulsid

1 mg/ml Oral suspension Oral use Amber-coloured

glass bottles

100 ml
200 ml

Prepulsid

5 mg/
5 ml

Oral suspension Oral use

Polyethylene/
aluminium/
paper/ionomer
sachet

20 and 50 sachets
of 5 ml

Prepulsid

10 mg/
10 ml

Oral suspension Oral use

Polyethylene/
aluminium/
paper/ionomer
sachet

20 and 50 sachets
of 10 ml

C 157/22

EN

Official Journal of the European Communities

2.7.2002

Member State

Marketing authorisation
holder

Product name

Strength

Pharmaceutical form

Route of
adminis-
tration

Packaging

Package sizes

PORTUGAL
(cont’d)

SPAIN

Janssen Farmacêutica
Portugal, Lda
Estrada Consiglieri Pedroso,
69-a,
Queluz de Baixo
P-2749-503 Barcarena

Janssen Farmacêutica
Portugal, Lda
Estrada Consiglieri Pedroso,
69-a,
Queluz de Baixo
P-2749-503 Barcarena

Janssen Farmacêutica
Portugal, Lda
Estrada Consiglieri Pedroso,
69-a,
Queluz de Baixo
P-2749-503 Barcarena

Lab. Dr. Esteve SA
Avda. Mare de Deu de
Montserrat, 221
E-0841 Barcelona

Lab. Dr. Esteve SA
Avda. Mare de Deu de
Montserrat, 221
E-0841 Barcelona

Lab. Dr. Esteve SA
Avda. Mare de Deu de
Montserrat, 221
E-0841 Barcelona

Lab. Dr. Esteve SA
Avda. Mare de Deu de
Montserrat, 221
E-0841 Barcelona

Lab. Dr. Esteve SA
Avda. Mare de Deu de
Montserrat, 221
E-0841 Barcelona

SALVAT, SA
Gall, 30-36
E-08950 Esplugues de
Llobregat (Barcelona)

SALVAT, SA
Gall, 30-36
E-08950 Esplugues de
Llobregat (Barcelona)

SALVAT, SA
Gall, 30-36
E-08950 Esplugues de
Llobregat (Barcelona)

Prepulsid
Quicklet

5 mg

Dipersible tablet Oral use

Blister Aclar/
Aluminium

Prepulsid
Quicklet

10 mg

Dipersible tablet Oral use

Blister Aclar/
Aluminium

Prepulsid
Quicklet

20 mg

Dipersible tablet Oral use

Blister Aclar/
Aluminium

16
28
56

16
28
56

16
28
56

Arcasín

10 mg

Tablet

Oral use

Blister

50

Arcasín

10 mg/
10 ml

Oral suspension Oral use

Sachet (paper)

50

Arcasín

20 mg

Tablet

Oral use

Blister

30

Arcasín

1 mg/
1 ml

Oral suspension Oral use

Bottle

100 ml
200 ml

Arcasín

5 mg

Tablet

Oral use

Blister

Fisiogastrol

10 mg

Tablet

Oral use

PVC/AL blister

Fisiogastrol

10 mg/
10 ml

Oral suspension Oral use

Sachet

30
60

50
500

50
500

Fisiogastrol

1 mg/
1 ml

Oral suspension Oral use

Bottle

100 ml
200 ml

2.7.2002

EN

Official Journal of the European Communities

C 157/23

Member State

Marketing authorisation
holder

Product name

Strength

Pharmaceutical form

Route of
adminis-
tration

Packaging

Package sizes

SPAIN
(cont’d)

SALVAT, SA
Gall, 30-36
E-08950 Esplugues de
Llobregat (Barcelona)

Fisiogastrol

5 mg

Tablet

Oral use

PVC/AL blister

30
60
500

Quimifar, SA
Comandran, 37
E-08210 Barcelona

Quimifar, SA
Comandran, 37
E-08210 Barcelona

Quimifar, SA
Comandran, 37
E-08210 Barcelona

Janssen Cilag, SA
Paseo de las doce estrellas,
5-7
E-28042 Madrid

Janssen Cilag, SA
Paseo de las doce estrellas,
5-7
E-28042 Madrid

Janssen Cilag, SA
Paseo de las doce estrellas,
5-7
E-28042 Madrid

Janssen Cilag, SA
Paseo de las doce estrellas,
5-7
E-28042 Madrid

Janssen Cilag, SA
Paseo de las doce estrellas,
5-7
E-28042 Madrid

Janssen Cilag AB
Rotebergsvägen 1
Box 7073
S-19207 Sollentuna

Janssen Cilag AB
Rotebergsvägen 1
Box 7073
S-19207 Sollentuna

Janssen Cilag AB
Rotebergsvägen 1
Box 7073
S-19207 Sollentuna

Kelosal

10 mg

Tablet

Oral use

PVC/PVDC/AL
blister

50

Kelosal

5 mg

Tablet

Oral use

PVC/PVDC/AL
blister

30
60

Kelosal

1 mg/
1 ml

Oral suspension Oral use

Bottle (glass)

100 ml
200 ml

Prepulsid

10 mg

Tablet

Oral use

Blister

50

Prepulsid

10 mg/
10 ml

Oral suspension Oral use

Sachet

50

Prepulsid

20 mg

Tablet

Oral use

Blister

30

Prepulsid

1 mg/
1 ml

Oral suspension Oral use

Bottle (plastic)

Prepulsid

5 mg

Tablet

Oral use

Blister

100 ml
200 ml

30
60

Prepulsid

10 mg

Tablet

Oral use

PVC/ALU blister 50

100
250
100 (single dose
package)

Prepulsid

20 mg

Tablet

Oral use

PVC/ALU blister 100

Prepulsid

1 mg/ml Oral suspension Oral use

Bottle (glass)

200 ml

SWEDEN

C 157/24

EN

Official Journal of the European Communities

2.7.2002

Member State

Marketing authorisation
holder

Product name

Strength

Pharmaceutical form

Route of
adminis-
tration

Packaging

Package sizes

UNITED
KINGDOM

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

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

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

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

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

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

Prepulsid Tablets 5 mg

Tablet

Oral use ALU/PE/PVC/
PVDC blister

Prepulsid Tablets 10 mg

Tablet

Oral use ALU/PE/PVC/
PVDC blister

Prepulsid
Suspension
1 mg/ml

1 mg/ml Oral suspension Oral use

Bottle (glass)

Prepulsid
Quicklet Tablets

5 mg

Quicklet tablet

Oral use ALU/aclar foil

blister

Prepulsid
Quicklet Tablets

10 mg

Quicklet tablet

Oral use ALU/aclar foil

blister

Prepulsid
Quicklet Tablets

20 mg

Quicklet tablet

Oral use ALU/aclar foil

blister

6
10
60
84

10
30
60
84
90
100
112
120

200 ml
500 ml

8
16
28
56
120

8
16
28
56
120

8
16
28
56
120