Summary of Community decisions on marketing authorisations in respect of medicinal products from 15 April 2003 to 15 May 2003 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
Date: 2003-06-03
Institutions: European Commission
Subjects: market approval, marketing, medicinal product, veterinary drug

C 129/22

EN

Official Journal of the European Union

3.6.2003

Summary of Community decisions on marketing authorisations in respect of medicinal products
from 15 April 2003 to 15 May 2003

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

(2003/C 129/06)

— 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

13.5.2003

Fluoxetine

See Annex I

See Annex I

14.5.2003

16.4.2003

Orbax

See Annex II

See Annex II

25.4.2003

— Suspension 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

22.4.2003

Benzathine
Benzylpenicillin

See Annex III

See Annex III

24.4.2003

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

ANNEX I

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

FLUOXETINE-CONTAINING MEDICINAL PRODUCTS — ELI LILLY MARKETING AUTHORISATIONS IN THE
EUROPEAN UNION

Member State

Marketing Authorisation Holder

Invented Name

Strength

Route of administration
+ Pharmaceutical form

Packaging/Package size

AUSTRIA

Eli Lilly Ges.mbH
Barichgasse 40-41
A-1030 Wien

Eli Lilly Ges.mbH
Barichgasse 40-41
A-1030 Wien

Eli Lilly Ges.mbH
Barichgasse 40-41
A-1030 Wien

Eli Lilly Ges.mbH
Barichgasse 40-41
A-1030 Wien

Eli Lilly Ges.mbH
Barichgasse 40-41
A-1030 Wien

Eli Lilly Ges.mbH
Barichgasse 40-41
A-1030 Wien

Fluctine

20 mg/5 ml

Oral Solution

Bottle 70 ml

Fluoxetine

20 mg/5 ml

Oral Solution

Bottle 70 ml

Fluctine

20 mg

Oral Capsule

Fluoxetine

20 mg

Oral Capsule

Blister packs 14 and
28

Blister packs 14 and
28

Fluctine

20 mg

Oral Tablet
Dispersible

Blister packs 14 and
28

Fluoxetine

20 mg

Oral Tablet
Dispersible

Blister packs 14 and
28

3.6.2003

EN

Official Journal of the European Union

C 129/23

Member State

Marketing Authorisation Holder

Invented Name

Strength

Route of administration
+ Pharmaceutical form

Packaging/Package size

BELGIUM

DENMARK

Eli Lilly Benelux SA
Rue de l'Etuve, 52-Bte 1
B-1000 Brussels

Eli Lilly Benelux SA
Rue de l'Etuve, 52-Bte 1
B-1000 Brussels

Eli Lilly Benelux SA
Rue de l'Etuve, 52-Bte 1
B-1000 Brussels

Eli Lilly Benelux SA
Rue de l'Etuve, 52-Bte 1
B-1000 Brussels

Eli Lilly Benelux SA
Rue de l'Etuve, 52-Bte 1
B-1000 Brussels

Eli Lilly Benelux SA
Rue de l'Etuve, 52-Bte 1
B-1000 Brussels

Eli Lilly Benelux SA
Rue de l'Etuve, 52-Bte 1
B-1000 Brussels

Eli Lilly Benelux SA
Rue de l'Etuve, 52-Bte 1
B-1000 Brussels

Eli Lilly Benelux SA
Rue de l'Etuve, 52-Bte 1
B-1000 Brussels

Eli Lilly Benelux SA
Rue de l'Etuve, 52-Bte 1
B-1000 Brussels

Eli Lilly Benelux SA
Rue de l'Etuve, 52-Bte 1
B-1000 Brussels

Eli Lilly Danmark A/S
Nybrovej 110
DK-2800 Lyngby

Eli Lilly Danmark A/S
Nybrovej 110
DK-2800 Lyngby

Eli Lilly Danmark A/S
Nybrovej 110
DK-2800 Lyngby

Eli Lilly Danmark A/S
Nybrovej 110
DK-2800 Lyngby

Prozac

20 mg/5 ml

Oral Solution

Fontex

20 mg

Oral Capsule

Prozac

20 mg

Oral Capsule

Prozac

30 mg

Oral Capsule

Bottles 70 and
140 ml

Blister packs 14, 28,
56
Unit-dose Pulvule

Blister packs 14, 28,
56
Unit-dose Pulvule

Blister pack 21
Unit-dose Pulvule

Fluoxetine ‘Lilly’

20 mg

Fluoxetine ‘Lilly’

20 mg

Oral Capsule
Green and Cream

Blister packs 14, 28,
56
Unit-dose Pulvule

Oral Capsule
Blue and White

Blister packs 14, 28,
56
Unit-dose Pulvule

Fluoxetine ‘Dista’

20 mg

Oral Capsule

Prozac

40 mg

Oral Capsule

Prozac

60 mg

Oral Capsule

Prozac

20 mg

Fontex

20 mg

Oral Tablet
Dispersible

Oral Tablet
Dispersible

Blister packs 14, 28,
56
Unit-dose Pulvule

Blister packs 14
Pulvule

Blister packs 14
Pulvule

Blister packs 14, 28,
56
Unit-dose

Blister packs 14, 28,
56
Unit-dose

Fontex

20 mg/5 ml

Oral Solution

Bottle 70 ml

Fontex

20 mg

Oral Capsule

N/A

Fonzac

20 mg

Oral Capsule

Blister packs 30,
100

Fontex

20 mg

Oral Tablet
Dispersible

Blister packs 30,
100

C 129/24

EN

Official Journal of the European Union

3.6.2003

Member State

Marketing Authorisation Holder

Invented Name

Strength

Route of administration
+ Pharmaceutical form

Packaging/Package size

FINLAND

FRANCE

GERMANY

Oy Eli Lilly Ab
Rajatorpantie 41 C
FIN-01640 Vantaa

Oy Eli Lilly Ab
Rajatorpantie 41 C
FIN-01640 Vantaa

Oy Eli Lilly Ab
Rajatorpantie 41 C
FIN-01640 Vantaa

Lilly France SA
203, Bureaux de la Colline
F-92213 Saint-Cloud

Lilly France SA
203, Bureaux de la Colline
F-92213 Saint-Cloud

Lilly France SA
203, Bureaux de la Colline
F-92213 Saint-Cloud

Lilly France SA
203, Bureaux de la Colline
F-92213 Saint-Cloud

Lilly France SA
203, Bureaux de la Colline
F-92213 Saint-Cloud

Lilly France SA
203, Bureaux de la Colline
F-92213 Saint-Cloud

Lilly France SA
203, Bureaux de la Colline
F-92213 Saint-Cloud

Lilly France SA
203, Bureaux de la Colline
F-92213 Saint-Cloud

Lilly France SA
203, Bureaux de la Colline
F-92213 Saint-Cloud

Lilly France SA
203, Bureaux de la Colline
F-92213 Saint-Cloud

Lilly Deutschland GmbH
Teichweig 3
D-35396 Gießen

Lilly Deutschland GmbH
Teichweig 3
D-35396 Gießen

Fontex

20 mg/5 ml

Oral Solution

Bottle 70 ml

Fontex

20 mg

Oral Capsule

Blister packs 10, 30,
100

Fontex

20 mg

Oral Tablet
Dispersible

Blister packs 14, 28,
56 and 100

Prozac

20 mg/5 ml

Oral Solution

Elindra

20 mg

Oral Capsule

Fluoxétine Elsa

20 mg

Oral Capsule

Fluoxétine RPG

20 mg

Oral Capsule

Fluoxétine Lilly

20 mg

Oral Capsule

Fontex

20 mg

Oral Capsule

Prozac

20 mg

Oral Capsule

Vials with pipette
70 ml

Blister packs 7, 14,
28 and 70

Blister packs 7, 14,
28 and 70

Blister packs 7, 14,
28 and 70

Blister packs 7, 14,
28 and 70

Blister packs 7, 14,
28 and 70

Blister packs 7, 14,
70

Fluctine

20 mg

Oral Tablet
Dispersible

Blister packs 14, 28,
70

Fluoxétine Lilly

20 mg

Oral Tablet
Dispersible

Blister packs 14, 28,
70

Prozac

20 mg

Oral Tablet
Dispersible

Blister packs 14, 28,
70

Fluctin

20 mg/5 ml

Oral Solution

Bottle 70 ml

Prozac

20 mg/5 ml

Oral Solution

Bottle 70 ml

3.6.2003

EN

Official Journal of the European Union

C 129/25

Member State

Marketing Authorisation Holder

Invented Name

Strength

Route of administration
+ Pharmaceutical form

Packaging/Package size

GERMANY
(cont’d)

Lilly Deutschland GmbH
Teichweig 3
D-35396 Gießen

Prozac

20 mg/5 ml

Oral Solution

Bottle 70 ml

Lilly Deutschland GmbH
Teichweig 3
D-35396 Gießen

Lilly Deutschland GmbH
Teichweig 3
D-35396 Gießen

Lilly Deutschland GmbH
Teichweig 3
D-35396 Gießen

Lilly Deutschland GmbH
Teichweig 3
D-35396 Gießen

Lilly Deutschland GmbH
Teichweig 3
D-35396 Gießen

Lilly Deutschland GmbH
Teichweig 3
D-35396 Gießen

Lilly Deutschland GmbH
Teichweig 3
D-35396 Gießen

Lilly Deutschland GmbH
Teichweig 3
D-35396 Gießen

Lilly Deutschland GmbH
Teichweig 3
D-35396 Gießen

Prozac

20 mg/5 ml

Oral Solution

Bottle 70 ml

Fluctin

20 mg

Oral Capsule

Prozac

20 mg

Oral Capsule

Prozac

20 mg

Oral Capsule

Prozac

20 mg

Oral Capsule

Prozac

20 mg

Oral Capsule

Prozac

20 mg

Oral Capsule

Prozac

20 mg

Oral Capsule

Blister packs 20, 50,
100

Blister packs 20, 50,
100

Blister packs 20, 50,
100

Blister packs 20, 50,
100

Blister packs 20, 50,
100

Blister packs 20, 50,
100

Blister packs 20, 50,
100

Fluctin

20 mg

Oral Tablet
Dispersible

Blister packs 20, 50,
100

GREECE

Pharmabrand SACI
15o KLM road Athens-Lamia,
GR-145 64 Kifissia

Ladose

20 mg/5 ml

Oral Solution

Bottle 70 ml

Pharmabrand SACI
15o KLM road Athens-Lamia,
GR-145 64 Kifissia

Pharmaserve-Lilly SACI
15o KLM road Athens-Lamia,
GR-145 64 Kifissia

Pharmaserve-Lilly SACI
15o KLM road Athens-Lamia,
GR-145 64 Kifissia

Pharmabrand SACI
15o KLM road Athens-Lamia,
GR-145 64 Kifissia

Ladose

20 mg

Oral Capsule

Blister 12 caps

Ladose

20 mg

Ladose

20 mg

Oral Tablet
Dispersible

Oral Tablet
Dispersible

Blister 14 tabs

Blister 28 tabs

Fonzac

20 mg/5 ml

Oral Solution

Bottle 70 ml

C 129/26

EN

Official Journal of the European Union

3.6.2003

Member State

Marketing Authorisation Holder

Invented Name

Strength

Route of administration
+ Pharmaceutical form

Packaging/Package size

GREECE
(cont’d)

ICELAND

IRELAND

ITALY

Pharmabrand SACI
15o KLM road Athens-Lamia,
GR-145 64 Kifissia

Fonzac

20 mg

Oral Capsule

Blister 12 caps

Eli Lilly Danmark A/S
Nybrovej 110
IS-2800 Lyngby

Eli Lilly Danmark A/S
Nybrovej 110
IS-2800 Lyngby

Eli Lilly Danmark A/S
Nybrovej 110
IS-2800 Lyngby

Eli Lilly Danmark A/S
Nybrovej 110
IS-2800 Lyngby

Eli Lilly Danmark A/S
Nybrovej 110
IS-2800 Lyngby

Eli Lilly and Co Ltd
Kingsclere road
Basingstoke
Hampshire RG21 6XA

Eli Lilly and Co Ltd
Kingsclere road
Basingstoke
Hampshire RG21 6XA

Eli Lilly and Co Ltd
Kingsclere road
Basingstoke
Hampshire RG21 6XA

Dista Products Ltd
Kingsclere road
Basingstoke
Hampshire RG21 6XA

Fontex

20 mg/5 ml

Oral Solution

Bottle 70 ml

Fontex

20 mg

Oral Capsule

Blisters 30, 100

Prozac

20 mg

Oral Capsule

Blisters 30, 100

Fontex

20 mg

Fluoxin

20 mg

Oral Tablet
Dispersible

Oral Tablet
Dispersible

Blisters 30, 100

Blisters 30, 100

Prozac

20 mg/5 ml

Oral Solution

Bottle 70 ml

Prozac

20 mg

Oral Capsule

Prozac

60 mg

Oral Capsule

Blister Packs 2, 28,
30, 98
Bottles 28, 30, 98

Blisters 7, 14, 28,
30, 56, 60, 98
Bottles 28

Prozac

20 mg

Oral Tablet
Dispersible

Blister strips 2, 28,
30, 100

Eli Lilly Italia SpA
Via Gramsci, 731
I-50019 Sesto Fiorentino (FI)

Eli Lilly Italia SpA
Via Gramsci, 731
I-50019 Sesto Fiorentino (FI)

Eli Lilly Italia SpA
Via Gramsci, 731
I-50019 Sesto Fiorentino (FI)

Prozac

20 mg/5 ml

Oral Solution

Bottles 60 ml

Prozac

20 mg

Oral Capsule

Blisters 12, 28

Prozac

20 mg

Oral Tablet
Dispersible

Blisters 12, 28

LUXEMBOURG

Eli Lilly Benelux SA
Rue de l'Etuve, 52-Bte 1
B-1000 Brussels

Prozac

20 mg

Oral Capsule

Blisters 14, 28, 56
pulvules, Unit-dose

3.6.2003

EN

Official Journal of the European Union

C 129/27

Member State

Marketing Authorisation Holder

Invented Name

Strength

Route of administration
+ Pharmaceutical form

Packaging/Package size

LUXEMBOURG
(cont’d)

Eli Lilly Benelux SA
Rue de l'Etuve, 52-Bte 1
B-1000 Brussels

Fontex

20 mg

Oral Capsule

Blister packs 14, 28,
56
Unit-dose Pulvule

Eli Lilly Benelux SA
Rue de l'Etuve, 52-Bte 1
B-1000 Brussels

Eli Lilly Benelux SA
Rue de l'Etuve, 52-Bte 1
B-1000 Brussels

Eli Lilly Benelux SA
Rue de l'Etuve, 52-Bte 1
B-1000 Brussels

Eli Lilly Benelux SA
Rue de l'Etuve, 52-Bte 1
B-1000 Brussels

Eli Lilly Benelux SA
Rue de l'Etuve, 52-Bte 1
B-1000 Brussels

Eli Lilly Benelux SA
Rue de l'Etuve, 52-Bte 1
B-1000 Brussels

Eli Lilly Nederland BV
Grootslag 1-5
3991 RA Houten
Netherlands

Eli Lilly Nederland BV
Grootslag 1-5
3991 RA Houten
Netherlands

Eli Lilly Nederland BV
Grootslag 1-5
3991 RA Houten
Netherlands

Eli Lilly Norway AS
Grenseveien 99
N-0601 Oslo

Eli Lilly Norway AS
Grenseveien 99
N-0601 Oslo

Lilly Farma, Produtos
Farmaceuticos, Lda
rua Dr. Antonio Borges no 4 —
Piso 3,
Arquiparque – Miraflores
1495-131 Alges

Prozac

30 mg

Oral Capsule

Blisters 21 pulvules

Prozac

40 mg

Oral Capsule

Blisters 14 pulvules

Prozac

60 mg

Oral Capsule

Blisters 14 pulvules

Prozac

20 mg

Oral Tablet
Dispersible

Blisters 14, 28
Unit-dose

Fontex

20 mg

Oral Tablet
Dispersible

Blister packs 14, 28,
56
Unit-dose

Prozac

20 mg/5 ml

Oral Solution

Prozac

20 mg/5 ml

Oral Solution

Prozac

20 mg

Oral Capsule

Bottles 70 ml,
140 ml

Bottle with pipette
70 ml

Blister Strip 30, 60,
90
EAV-packaging 50

Prozac

20 mg

Oral Tablet
Dispersible

Blister Strip. 28, 56

Fluoxetin

20 mg

Oral Capsule

30 blister
100 blister

Fontex

20 mg

Oral Tablet
Dispersible

30 blister
100 blister

Prozac

20 mg/5 ml

Oral Solution

Bottles 70 ml,
140 ml

NETHERLANDS

NORWAY

PORTUGAL

C 129/28

EN

Official Journal of the European Union

3.6.2003

Member State

Marketing Authorisation Holder

Invented Name

Strength

Route of administration
+ Pharmaceutical form

Packaging/Package size

PORTUGAL
(cont’d)

SPAIN

SWEDEN

Lilly Farma, Produtos
Farmaceuticos, Lda
rua Dr. Antonio Borges no 4 —
Piso 3,
Arquiparque – Miraflores
1495-131 Alges

Dista SA
Avda. de la Industria, 30
Zona Industrial
E-28108 Alcobendas — Madrid

Dista SA
Avda. de la Industria, 30
Zona Industrial
E-28108 Alcobendas — Madrid

Dista SA
Avda. de la Industria, 30
Zona Industrial
E-28108 Alcobendas — Madrid

Dista SA
Avda. de la Industria, 30
Zona Industrial
E-28108 Alcobendas — Madrid

Eli Lilly Sweden AB
Box 30037
S-104 25 Stockholm

Eli Lilly Sweden AB
Box 30037
S-104 25 Stockholm

Eli Lilly Sweden AB
Box 30037
S-104 25 Stockholm

Eli Lilly Sweden AB
Box 30037
S-104 25 Stockholm

Prozac

20 mg

Oral Capsule

Blister packs 14, 28

Prozac

20 mg/5 ml

Oral Solution

Bottles 70 and
140 ml

Prozac

20 mg/5 ml

Oral Powder
For Suspension

14, 28

Prozac

20 mg

Oral Capsule

Blister packs 14, 28

Prozac

20 mg

Oral Tablet
Dispersible

Blister packs 14, 28

Fontex

20 mg/5 ml

Oral Solution

Bottle 70 ml

Fontex

20 mg

Oral Capsule

Fonzac

20 mg

Oral Capsule

Blister Packs 98×1
(single-dose)

Blister Packs 30×1
100×1 (single-dose)

Fontex

20 mg

Oral Tablet
Dispersible

Blister Packs 10, 28,
100
100×1 (single-dose)

UNITED KINGDOM Eli Lilly and Co Ltd

Prozac

20 mg/5 ml

Oral Solution

Bottle 70 ml

Kingsclere road
Basingstoke
Hampshire RG21 6XA

Eli Lilly and Co Ltd
Kingsclere road
Basingstoke
Hampshire RG21 6XA

Eli Lilly and Co Ltd
Kingsclere road
Basingstoke
Hampshire RG21 6XA

Prozac

20 mg

Oral Capsule

Prozac

60 mg

Oral Capsule

Blister Strip 2, 28,
30, 98

Blister Strip 7, 14,
28, 30, 56, 98

3.6.2003

EN

Official Journal of the European Union

C 129/29

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

ANNEX II

Marketing Authorisation Holder (Name and address):

Reference Member State:

UNITED KINGDOM
Schering-Plough Ltd
Schering-Plough House
Shire Park
Welwyn Garden City
Herts AL7 1TW
United Kingdom

Concerned Member States:

AUSTRIA
Essex Tierarznei
Ndl. der Essex Pharma GmbH
Thomas-Dehler-Str. 27
D-81737 München

BELGIUM
Schering-Plough NV/SA
Rue de Stallesstraat 73
B-1180 Brussels

DENMARK
Schering-Plough A/S
Hvedemarken 12
DK-3520 Farum

FINLAND
Schering-Plough A/S
Hvedemarken 12
DK-3520 Farum

FRANCE
Schering-Plough Veterinaire
92, rue Baudin
F-92300 Levallois-Perret

GERMANY
Essex Tierarznei
Ndl. der Essex Pharma GmbH
Thomas-Dehler-Str. 27
D-81737 München

GREECE
Schering-Plough SA
63, Agiou Dimitriou Str.
G-17455 Alimos
Athens

IRELAND
Schering-Plough Ltd
Schering-Plough House
Shire Park
Welwyn Garden City
Herts AL7 1TW
United Kingdom

LUXEMBOURG
Schering-Plough NV/SA
Rue de Stallesstraat 73
B-1180 Brussels

PORTUGAL
Schering-Plough II-Veterinaria, Lda
Casal Colaride, Agualva
P-2735 Cacem

SPAIN
Schering-Plough SA
Km 36, Carretera Nacional I
E-28750 San Agustin de Guadalix
Madrid

SWEDEN
Schering-Plough A/S
Hvedemarken 12
DK-3520 Farum

THE NETHERLANDS
Schering-Plough NV/SA
Rue de Stallesstraat 73
B-1180 Brussels

C 129/30

EN

Official Journal of the European Union

3.6.2003

Presentations:

Invented Name

Strength

Pharmaceutical
Form

Target Species

Route of
administration

Packaging

Package size

Orbax

6,25 mg

Tablet

Dog

Orbax

6,25 mg

Tablet

Dog

Orbax

25 mg

Tablet

Dog

Orbax

25 mg

Tablet

Dog

Orbax

75 mg

Tablet

Dog

Orbax

75 mg

Tablet

Dog

Oral

Oral

Oral

Oral

Oral

Oral

Blister
(PVC/Alu)

Blister
(PVC/Alu)

Blister
(PVC/Alu)

Blister
(PVC/Alu)

Blister
(PVC/Alu)

Blister
(PVC/Alu)

10

100

10

100

8

80

LIST OF NAMES OF THE VETERINARY MEDICINAL PRODUCTS BASED ON BENZATHINE PENICILLIN FOR
FOOD PRODUCING ANIMALS AND MARKETING AUTHORISATION HOLDERS IN EU MEMBER STATES,
ICELAND AND NORWAY

ANNEX III

Member State

Product trade name

Strength

Company name

Address

AUSTRIA

Duphapen

Benzathine benzylpenicillin 112,5 mg/ml
Procaine benzylpenicillin 150,00 mg/ml

Wyeth-Lederle Pharma
GmbH

Storchengasse 1
A-1150 Wien

Duplocillin

Benzathine benzylpenicillin 128,75 mg/ml
Procaine benzylpenicillin 154,43 mg/ml

Intervet

Siemensstr. 105
A-1210 Wien

Serocillin Depot

Benzathine benzylpenicillin 112,5 mg/ml
Procaine benzylpenicillin 150,00 mg/ml

Norbrook Laboratories
Limited

Norocillin Long acting

Benzathine benzylpenicillin 112,5 mg/ml
Procaine benzylpenicillin 150,00 mg/ml

Norbrook Laboratories
Limited

105 Armagh Rd
Newry BT35 6PU
County Down
Northern Ireland

105 Armagh Road
Newry BT35 6PU
County Down
Northern Ireland

BELGIUM

Peni-Kel LA

Benzathine benzylpenicillin 150,000 IU/ml
Procaine benzylpenicillin 150,000 IU/ml

Kela Laboratória NV

St Lenaartseweg 48
B-2320 Hoogstraten

Retardpen

Benzathine benzylpenicillin 150,000 IU/ml
Procaine benzylpenicillin 150,000 IU/ml

V.M.D. NV

Berendonk 74
B-2370 Arendonk

Emdopen
150 + 150 LA

Benzathine benzylpenicillin 150,000 IU/ml
Procaine benzylpenicillin 150,000 IU/ml
Procaine hydrochloride 20 mg/ml

Emdoka bvba

J. Lijsenstraat 16
B-2321 Hoogstraten

Duplocilline LA

Benzathine benzylpenicillin 150,000 IU/ml
Procaine benzylpenicillin 150,000 IU/ml

Intervet Belgium

Ragheno Park
Dellingstraat 32/1
B-2800 Mechelen

3.6.2003

EN

Official Journal of the European Union

C 129/31

Member State

Product trade name

Strength

Company name

Address

BELGIUM
(cont’d)

Duphapen LA

Benzathine benzylpenicillin 150,000 IU/ml
Procaine benzylpenicillin 150,000 IU/ml

Fort Dodge Animal Health
Benelux BV

DENMARK

Duplocillin Vet

Benzathine benzylpenicillin 150,000 IU/ml
Procaine benzylpenicillin 150,000 IU/ml

Intervet International bv

Van Houten
Industriepark 25
1381 MZ Weesp
The Netherlands

Wim de Körverstraat 35
PO Box 31
5830 AA Boxmeer
The Netherlands

FINLAND

Duplocillin LA
vet inj
(150 mg/ml)

FRANCE

Uniject

Benzathine benzylpenicillin 115 mg/ml
Procaine benzylpenicillin 150 mg/ml

Intervet Oy

Tuupakantie 7 A
FIN-01740 Vantaa

Benzathine benzylpenicillin 74 mg/ml
Procaine benzylpenicillin 57 mg/ml
Dihydrostreptomycin sulphate 64 mg/ml

Virbac SA

13ème rue — LID
BP 27
F-06511 Carros Cedex

Duphapen LA

Benzathine benzylpenicillin 15 mg/ml
Procaine benzylpenicillin 15 mg/ml

Fort Dodge Santé Animal

22-24 Ave Marcel Dassault
BP 440
F-37204 Tours Cedex 3

Duplocilline

Benzathine benzylpenicillin 150,000 IU/ml
Procaine benzylpenicillin 150,000 IU/ml

Intervet

Dipene 5 + 5

Benzathine benzylpenicillin 100,000 IU/ml
Procaine benzylpenicillin 100,000 IU/ml

Virbac SA

Shotapen

Benzathine benzylpenicillin 100 mg/ml
Procaine benzylpenicillin 100,000 IU/ml
Dihydrostreptomycin sulphate 16,4 mg/ml

Virbac SA

Rue Olivier de Serres
Angers Technopole
F-49071 Beaucouzé

13ème rue — LID
BP 27
F-06511 Carros Cedex

13ème rue — LID
BP 27
F-06511 Carros Cedex

GERMANY

Strepdipend
Suspension ölig

Benzathine benzylpenicillin 91,67 mg/ml
Procaine benzylpenicillin 30,0 mg/ml
Dihydrostreptomycin sulphate
196,4 mg/ml

Serumwerk Bernburg AG

Hallesche Landstraße 105b
D-06406 Bernburg

Strepdipend
Suspension wässrig

Benzathine benzylpenicillin 91,67 mg/ml
Dihydrostreptomycin sulphate
157,15 mg/ml

Serumwerk Bernburg AG

Hallesche Landstraße 105b
D-06406 Bernburg

Veracin compositum

Benzathine benzylpenicillin 76,19 mg/ml
Procaine benzylpenicillin 120,00 mg/ml
Dihydrostreptomycin sulphate
258,0 mg/ml
Procaine hydrochloride 20,0 mg/ml

Albert Albrecht
GmbH & Co. KG

Hauptstraße 6—8
D-88326 Aulendorf

Vetripen Depot N

Benzathine benzylpenicillin 76,19 mg/ml
Procaine benzylpenicillin 118,69 mg/ml
Dihydrostreptomycin sulphate
263,15 mg/ml

CEVA Tiergesundheit GmbH Kanzlerstr. 4

D-40472 Düsseldorf

Langzeitpenicillin und
Dihydrostreptomycin ad
us. vet

Benzathine benzylpenicillin 76,19 mg/ml
Procaine benzylpenicillin 120,00 mg/ml
Dihydrostreptomycin sulphate
258,0 mg/ml

AniMedica GmbH

Im Südfeld 9
D-48308 Senden-Bösensell

C 129/32

EN

Official Journal of the European Union

3.6.2003

Member State

Product trade name

Strength

Company name

Address

GERMANY
(cont’d)

Belamycin 300

Benzathine benzylpenicillin 127,0 mg/ml
Procaine benzylpenicillin 149,9 mg/ml

Bela-Pharm

Lohner Str. 19
D-49377 Vechta

GREECE

Fatromiycine — S

Benzathine benzylpenicillin 150,000 IU/ml
Procaine benzylpenicillin 150,000 IU/ml
Dihydrostreptomycin sulphate 200 mg/ml

Fatro SpA

Via Emilia 285
I-40064 Ozzano dell'Emilia —
Bologna

Hipracillin retard

Benzathine benzylpenicillin 100,000 IU/ml
Procaine benzylpenicillin 100,000 IU/ml
Dihydrostreptomycin sulphate 250 mg/ml

Laboratorios HIPRA SA

Av. La Selva 135
E-17170 Amer (Girona)

IRELAND

Norocillin LA

Benzathine benzylpenicillin 112,5 mg/ml
Procaine benzylpenicillin 150,0 mg/ml

Norbrook Laboratories
Limited

Duphapen LA

Benzathine benzylpenicillin 112,5 mg/ml
Procaine benzylpenicillin 150,0 mg/ml

Fort Dodge Animal Health
Limited

ITALY

Rubrocillina
Forte Veterinaria

Benzathine benzylpenicillin 250,000 IU/ml
Dihydrostreptomycin sulphate 100 mg/ml

Gellini Inter-
national & Intervet Italy

105 Armagh Road
Newry BT35 6PU
County Down
Northern Ireland

Flanders Road
Hedge End
Southampton SO30 4QH
United Kingdom

Via Walter Tobagi, 7
I-20068 Peschiera
Borromeo (MI)

Liquicil
(3 different pack sizes all
with same strength)

Liquicil 5 + 5:
Benzathine benzylpenicillin 200,000 IU/ml
Streptomycin sulphate 200 mg/ml
Liquicil 20 + 20:
Benzathine benzylpenicillin 200,000 IU/ml
Streptomycin sulphate 200 mg/ml
Liquicil 50 + 50:
Benzathine benzylpenicillin 200,000 IU/ml
Streptomycin sulphate 200 mg/ml

A.C.R.A.F. SpA — Aziende
Chimiche Riunite Angelini
Francesco

P.le della Stazione snc
I-00040 S. Palomba-Pomezia
— Roma

Ritardomicina

Benzathine benzylpenicillin
6,000,000 IU/ml
Dihydrostreptomycin sulphate 20 mg/ml
Streptomycin sulphate 20 mg/ml

Azienda Farmaceutica
Italiana Srl

Via A. De Gasperi 47
I-21040 Sumirago (VA)

Fatro SpA

Via Emilia 285
I-40064 Ozzano dell'Emilia —
Bologna

Fatromicina Ritardo
(3 strengths)

Strength 1 + 1:
Benzathine benzylpenicillin 5 000 IU/ml
Sodium benzylpenicillin 30,000 IU/ml
Procaine benzylpenicillin 20,000 IU/ml
Dihydrostreptomycin sulphate
133,5 mg/ml
Strength 3 + 2,5:
Benzathine benzylpenicillin 150,000 IU/ml
Sodium benzylpenicillin 75,000 IU/ml
Procaine benzylpenicillin 75,000 IU/ml
Dihydrostreptomycin sulphate
333,7 mg/ml
Strength 6 + 5:
Benzathine benzylpenicillin 150,000 IU/ml
Sodium benzylpenicillin 90,000 IU/ml
Procaine benzylpenicillin 60,000 IU/ml
Dihydrostreptomycin sulphate
333,75 mg/ml

3.6.2003

EN

Official Journal of the European Union

C 129/33

Member State

Product trade name

Strength

Company name

Address

Fatro SpA

Via Emilia 285
I-40064 Ozzano dell'Emilia —
Bologna

ITALY
(cont’d)

Lugabiotic
(4 pack sizes — all with
same strength)

Flacone 1 + 1:
Benzathine benzylpenicillin 166,667 IU/ml
Sodium benzylpenicillin 66,667 IU/ml
Procaine benzylpenicillin 100,000 IU/ml
Streptomycin sulphate 333 mg/ml
Flacone 3 + 3:
Benzathine benzylpenicillin 166,667 IU/ml
Sodium benzylpenicillin 66,667 IU/ml
Procaine benzylpenicillin 100,000 IU/ml
Streptomycin sulphate 333 mg/ml
Flacone 6 + 6:
Benzathine benzylpenicillin 166,667 IU/ml
Sodium benzylpenicillin 66,667 IU/ml
Procaine benzylpenicillin 100,000 IU/ml
Streptomycin sulphate 333 mg/ml
Flacone 10 + 10:
Benzathine benzylpenicillin 166,667 IU/ml
Sodium benzylpenicillin 66,667 IU/ml
Procaine benzylpenicillin 100,000 IU/ml
Streptomycin sulphate 333 mg/ml

Neotardocillina 12,5 %

Benzathine benzylpenicillin 125,000 IU/ml
Streptomycin sulphate 50 mg/ml

VAAS Industria Chimica
Farmaceutica Srl

Gentaplus

Benzathine benzylpenicillin 200,000 IU/ml
Gentamicin sulphate 30 mg/ml

IZO

Bicormicina LA

Fatro SpA

Benzathine benzylpenicillin 125,000 IU/ml
Procaine benzylpenicillin 125,000 IU/ml
Dihydrostreptomicin sulphate 250 mg/ml
Dexamethasone sodium phosphate
200 µg/ml
Dexamethasone 21-isonicotinate
200 µg/ml

Via Siena, 268
I-47032 Capocolle di
Bertinoro (FC)

Via Cremona 282
I-25124 Brescia

Via Emilia 285
I-40064 Ozzano dell'Emilia —
Bologna

Liquibiotic iniettabile
(3 pack sizes with same
strength)

Tipo 5 + 5
Benzathine benzylpenicillin 200,000 IU/ml
Streptomycin sulphate 200 mg/ml
Tipo 20 + 20:
Benzathine benzylpenicillin 200,000 IU/ml
Streptomycin sulphate 200 mg/ml
Tipo 50 + 50:
Benzathine benzylpenicillin 200,000 IU/ml
Streptomycin sulphate 200 mg/ml

Industria Italiana Integratori
TREI SpA

Via Pietro Bembo, 12
I-41100 Modena

LUXEMBOURG Duplocilline LA inj.

Benzathine benzylpenicillin 150,000 IU/ml
Procaine benzylpenicillin 150,000 IU/ml

Intervet International BV
(NL)

Duphapen LA inj.

Benzathine benzylpenicillin 600,000 IU/ml Fort Dodge Animal Health

Benelux BV

Ragheno Park
Dellingstraat 32/1
B-2800 Mechelen

Van Houten Industriepark 25
1381 MZ Weesp
The Netherlands

NETHERLANDS

PORTUGAL

Bicormicina LA

Benzathine benzylpenicillin 125,000 IU/ml
Procaine benzylpenicillin 125,000 IU/ml
Dihydrostreptomicin sulphate 250 mg/ml
Dexamethasone sodium phosphate
200 µg/ml
Dexamethasone 21-isonicotinate
200 µg/ml

Univete — Técnica Pécuária
Comércio e Indústria, Lda

Rua D. Jerónimo
Osório, 5-B
P-1400-119 Lisboa

C 129/34

EN

Official Journal of the European Union

3.6.2003

Member State

Product trade name

Strength

Company name

Address

PORTUGAL
(cont’d)

Duplocilina LA

150,000 IU/ml

Intervet Portugal Saúde
Animal

Peni-Kel LA

150,000 IU/ml

Kela Laboratória NV

Shotapen LA

100,000 IU/ml

Virbac España SA

SPAIN

Ivensalpen retardado

Benzathine benzylpenicillin 200,000 IU/ml
Procaine benzylpenicillin 40,000 IU/ml
Benzylpenicillin 60,000 IU/ml

Laboratorios e Industrias
IVEN, SA

Ivensalpen E
(Ivensalpen sulfamidico)

Benzathine benzylpenicillin 50,000 IU/ml
Procaine benzylpenicillin 50,000 IU/ml
Sulphamethoxypiridazine 200 mg/ml

Laboratorios e Industrias
IVEN, SA

Zoobencil Estrepto 1
(Product currently
suspended)

(Same composition as Zoobencil Estrepto
2, different volume.)

Vétoquinol Especialidades
Veterinarias, SA

Zoobencil Estrepto 2

Benzathine benzylpenicillin
2,000,000 IU/ml
Streptomycin (sulphate) 200 mg/ml

Vétoquinol Especialidades
Veterinarias, SA

Zoobencil B12

Benzathine benzylpenicillin
3,000,000 IU/ml
Vitamin B12: 37,5 µg/ml

Vétoquinol Especialidades
Veterinarias, SA

Dipen Suspensión retard Benzathine benzylpenicillin 100,000 IU/ml

Chemical Iberica

Procaine benzylpenicillin 100,000 IU/ml
Dihydrostreptomycin 250 mg/ml

Estrada Nacional 249
Km 14,2
Mem Martins

St. Lenaartseweg 48
B-2320 Hoogstraten

Angel Guimerá 179 a 181
E-08950 Esplugues de
Llobregat, Barcelona

Luis I, 56-58
Polígono Industrial De
Vallecas
E-28031 Madrid

Luis I, 56-58
Polígono Industrial De
Vallecas
E-28031 Madrid

Edificio Italia
Parque Empresarial San
Fernando
E-28830 San Fernando de
Henares, Madrid

Edificio Italia
Parque Empresarial San
Fernando
E-28830 San Fernando de
Henares, Madrid

Edificio Italia
Parque Empresarial San
Fernando
E-28830 San Fernando de
Henares, Madrid

Crta Burgos-Portugal
km. 256
E-37448 Calzada de Don
Diego, Salamanca

Hiprabenzatina — 1

Benzathine benzylpenicillin
1,000,000 IU/ml
Dihydroxystreptomycin 1 000 mg/ml

Laboratorios HIPRA SA

Avda. La Selva, 135
E-17170 Amer (Girona)

Hipracilina retard

Benzathine benzylpenicillin 100,000 IU/ml
Procaine benzylpenicillin 100,000 IU/ml
Dihydrostreptomycin (sulphate) 50 mg/ml

Laboratorios HIPRA SA

Avda. La Selva, 135
E-17170 Amer (Girona)

Dipenisol retard

Benzathine benzylpenicillin 100,000 IU/ml
Procaine benzylpenicillin 100,000 IU/ml
Dihydrostreptomycin (sulphate)
200 mg/ml

Química Farmacéutica
Bayer, SA

Calabria, 268
E-08029 Barcelona

3.6.2003

EN

Official Journal of the European Union

C 129/35

Member State

Product trade name

Strength

Company name

Address

SPAIN
(cont’d)

Shotapen LA 250

Benzathine benzylpenicillin 100,000 IU/ml
Procaine benzylpenicillin 100,000 IU/ml
Dihydrostreptomycin (sulphate)
200 mg/ml

Virbac España SA

Angel Guimerá, 179-181
E-08950 Esplugues de
Llobregat, Barcelona

Benzatard

Benzathine benzylpenicillin 150,000 IU/ml
Procaine benzylpenicillin 150,000 IU/ml

Laboratorios SYVA, SA

Biosuspen retard

Biochoc

Benzatina E

Cyapen retard

Laboratorios SYVA, SA

Avda. Párroco Pablo Díez,
49-57
E-24010 León

Avda. Párroco Pablo Díez,
49-57
E-24010 León

Laboratorios SYVA, SA

Avda. Párroco Pablo Díez,
49-57
E-24010 León

Benzathine benzylpenicillin 75,000 IU/ml
Procaine benzylpenicillin 125,000 IU/ml
Dihydrostreptomycin (sulphate)
250 mg/ml
Dexamethasone(21-Naphosphate)
250 µg/ml

Benzathine benzylpenicillin
1,000,000 IU/ml
Procaine benzylpenicillin 1,000,000 IU/ml
Sodium benzylpenicillin 500,000 IU/ml
Dihydrostreptomycin (sulphate)
5 000 mg/ml

Benzathine benzylpenicillin 75,000 IU/ml
Potassium benzylpenicillin 25,000 IU/ml
Procaine benzylpenicillin 50,000 IU/ml
Streptomycin (sulphate) 250 mg/ml

Laboratorios Ovejero, SA

L-1 Crtra. León-Vilecha, 30
Apartado 321
E-24080 León

Benzathine benzylpenicillin 100,000 IU/ml
Procaine benzylpenicillin 100,000 IU/ml
Dihydrostreptomycin (sulphate)
200 mg/ml

Virbac España SA

Angel Guimerá, 179-181
E-08950 Esplugues de
Llobregat, Barcelona

SWEDEN

UNITED
KINGDOM

Duphapen LA

Benzathine benzylpenicillin 112,5 mg/ml
Procaine benzylpenicillin 150,00 mg/ml

Fort Dodge Animal Health
Limited

Norocillin LA

Benzathine benzylpenicillin 112,5 mg/ml
Procaine benzylpenicillin 150,00 mg/ml

Norbrook Laboratories Ltd

ICELAND

Duplocillin L.A. vet

Benzathine benzylpenicillin 115 mg/ml
Procaine benzylpenicillin 150 mg/ml

Intervet International B.V.

NORWAY

Flanders Road
Hedge End
Southampton SO30 4QH
United Kingdom

105 Armagh Road
Newry BT35 6PU
County Down
Northern Ireland

Lynghals 13
IS-110-Reykjavik