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Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 March 2008 to 31 March 2008 (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 )

OJ C 104, 25.4.2008, p. 12–22 (BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

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Official Journal

25.4.2008

Official Journal of the European Union

C 104/12

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 March 2008 to 31 March 2008

(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) )

(2008/C 104/06)

— Issuing, maintenance or modification of a national marketing authorisation

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

3.3.2008

Equibactin vet.

See Annex I

4.3.2008

11.3.2008

Trimethoprim/sulfadiazine

See Annex II

12.3.2008

18.3.2008

Revlimid

Celgene Europe Limited

8 The Square

Stockley Park

Uxbridge

Middlesex UB11 1FW

United Kingdom

This Decision is addressed to the Member States

19.3.2008

— Revocation of a national marketing authorization

Date of the decision	Name(s) of the medicinal product	Holder(s) of the marketing authorization	Member State concerned	Date of notification
6.3.2008	Lumiracoxib	See Annex III	See Annex III	7.3.2008

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

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

ANNEX I

NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTES OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDER

Applicant or Marketing Authorisation Holder

Product invented name

Pharmaceutical form

Strength

Animal species

Frequency and route of administration

Recommended dose

Le Vet B.V.

Willeskop 212

3421 GW Oudewater

Nederland

Equibactin vet. (333 mg/g + 67 mg/g) oral paste for horses

Paste

333,3 mg/g sulfadiazine and 66,7 mg/g trimethoprim

Horse

Oral

5 mg trimethoprim and 25 mg sulfadiazine per kg body weight per day to a maximum of 5 days

ANNEX II

NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTES OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDER/APPLICANT

Member State/Marketing Authorisation Number

Marketing Authorisation Holder

Product invented name

Pharmaceutical form

Strength/Active substance (INN)

Animal species

Therapeutic indication

Recommended dose

Netherlands

NL 10351

AST Beheer BV

Sulfatrim Oral Doser

Oral paste

Active substances per gram:

Trimethoprim 66,7 mg

Sulfadiazine 333,3 mg

Horses

Respiratory tract infections associated with Streptococcus spp. and Staphylococcus aureus; gastrointestinal infections associated with E. Coli; urogenital infections associated with beta-hemolytic streptococci; wound infections and abscesses associated with Streptococcus spp. and Staphylococcus aureus

5 mg trimethoprim and 25 mg sulfadiazine per kg body weight per day to a maximum of 5 days.

One syringe is intended for 600 kg bodyweight and each syringe is subdivided into 12 markings. The equivalent of one marking is sufficient to treat 50 kg of bodyweight

Netherlands

NL 10437

AST Farma BV

Sultrisan Orale Paste voor paarden

Oral paste

Active substances per gram:

Trimethoprim 66,7 mg

Sulfadiazine 333,3 mg

Horses

Respiratory tract infections associated with Streptococcus spp. and Staphylococcus aureus; gastrointestinal infections associated with E. coli; urogenital infections associated with beta-hemolytic streptococci; wound infections and abscesses associated with Streptococcus spp. and Staphylococcus aureus

5 mg trimethoprim and 25 mg sulfadiazine per kg body weight per day to a maximum of 5 days.

One syringe is intended for 600 kg bodyweight and each syringe is subdivided into 12 markings. The equivalent of one marking is sufficient to treat 50 kg of bodyweight

Belgium

282IS20F7

Schering-Plough NV/SA

(Belgium)

Tribrissen Pâte orale

Oral paste

Pro 100 g:

Trimethoprim 6,66 g

Sulfadiazine 33,34 g

Horses

Tribrissen Oral Paste is indicated for the treatment of horses with bacterial infections caused by sensitive bacteria, including:

—	gastro-intestinal infections,

—	infections of respiratory tracts,

—	infections of urogenital tracts,

—	wound infections and cellulitis,

—	salmonellosis,

—	as profylacticum for post-operative infections

The dose is 30 mg/kg body weight per day.

The dose is reached by setting the drive screw on the plunger according to the weight of the horse. Each unit on the scale on the plunger provides sufficient paste for 50 kg body weight.

For horses, the following dosages can be applied according to the nature and seriousness of the ailment:

—	Gastro-intestinal infections: 30 mg/kg/day over 2 applications of 15 mg/kg body weight/day or 1 application of 30 mg/kg/day, during minimal 5 days or until 2 days after the symptoms have disappeared.

—

Serious acute infections outside of the intestinal tracts (respiratory-urinal tracts): first an injection of Tribrissen 48 % or Duoprim, followed by a daily administration of Tribrissen Oral Paste at 30 mg/kg/day over 2 applications of 15 mg/kg body weight/day or 1 administrations of 30 mg/kg/day, during minimal 5 days or until 2 days after the symptoms have disappeared.

—	Infections of the genital tracts. Next to an oral treatment during 5 days or until 2 days after the symptoms have disappeared, an intra-uterine treatment will be administered with 10 ml Tribrissen 48 %, diluted in an isotonic solution of 100 ml during 3 days.

—	Wound infections. Next to an oral treatment during 5 days or until 2 days after the symptoms have disappeared, a local treatment with Tribrissen Dispersible Powder will be administered.

For the treatment of Salmonellosis, it is necessary to administer a double dose at 60 mg/kg/day. This dose needs to be administered in 2 times. The treatment must be given during 10 days

Netherlands

NL 5055

Schering-Plough NV

(Belgium)

Tribrissen Oral Paste

Oral paste

Per 30 mg paste:

Sulfadiazine 10 mg

Trimethoprim 2 mg

Horses

—	respiratory infections caused by Streptococcus spp., Staphylococcus aureus,

—	gastro-intestinal infections caused by E. coli,

—	urogenital infections caused by bèta-haemolytic streptococci,

—	wounds and abscesses by Streptococcus spp., Staphylococcus aureus

25 mg sulfadiazine and 5 mg trimethoprim per kg BW per day, during maximum 5 days

Sweden

10893

Schering-Plough A/S

(Denmark)

Tribrissen vet

Oral paste

Sulfadiazine 333 mg

Trimethoprim 67 mg

Horses

Bacterial infections, for instance infections in wounds, respiratory tract, GI-tract or urogenital system

30 mg of combined active ingredients per kg bodyweight 1-2 times daily, which correspond to 37,5 g paste (one tube) per os to a 500 kg horse 1-2 times daily. Preferably, horses should be treated with an initial injection of Tribrissen Injection, followed by administration of oral paste during 5 days or until no symptoms have been seen for at least 2 days. Treated animals should have free access to water

Iceland

MT nr 880040

Schering-Plough A/S

(Denmark)

Tribrissen vet

Oral paste

Sulfadiazine 333 mg/g

Trimethoprim 67 mg/g

Horses

Bacterial infections, for instance infections in wounds, respiratory tract, GI-tract or urogenital system

United Kingdom

Vm 00201/4064

Schering-Plough Limited

(UK)

Tribrissen Oral Paste

Oral paste

Active constituents % w/w:

Sulfadiazine 33,3 % w/w

Trimethoprim 6,7 % w/w

Horses

The product is recommended for the treatment of bacterial diseases in horses including:

—	alimentary tract infections,

—	upper and lower respiratory tract infections, including strangles,

—	infected wounds and cellulitis,

—	salmonellosis,

—	antibacterial medication in surgical cases where asepsis cannot be guaranteed

30 mg of combined active ingredients per kg bodyweight daily. This dose is provided by adjusting the screw-gauge on the plunger of the syringe according to the bodyweight of the horse. Each division on the plunger provides sufficient paste to medicate 50 kg bodyweight. Each syringe provides a daily dose for a 500 kg horse.

The dose may be administered once daily, or the daily dose may be divided and administered at 12 hourly intervals, for five days or until two days after symptoms have subsided, to a maximum of five days

Ireland

VPA 10277/41/1

Schering-Plough Limited

(UK)

Tribrissen Oral Paste

Oral paste

Each gram contains:

Sulfadiazine 333 mg

Trimethoprim 67 mg

Horses

The product is recommended for the treatment of bacterial diseases in horses including:

—	alimentary tract infections,

—	upper and lower respiratory tract infections, including strangles,

—	infected wounds and cellulitis,

—	salmonellosis,

—	antibacterial medication in surgical cases where asepsis cannot be guaranteed

Preferably, horses should be treated initially with an initial injection of Tribrissen Injection 48 % or Trivetrin Injection followed by daily administration of Tribrissen Oral Paste.

For the treatment of salmonellosis, it is necessary to give double the above dose rate, i.e. 60 mg of combined active ingredients per kg bodyweight per day. This should be given as two equally divided doses per day. Treatment should be continued for at least ten days

Denmark

18146

ScanVet Animal Health A/S

Norodine Vet Oral Paste

Oral paste

Trimethoprim 58 mg/g

Sulfadiazine 288,3 mg/g

Horses

Infections in horses caused by micro-organisms sensitive to trimethoprim + sulphonamide

The paste is presented in a syringe of plastic with the dose to treat 50 kg of horse.

The daily dose is 30 mg combined active ingredients per kg body weight the equivalent to the contents of one syringe for a 500 kg horse

Ireland

VPA 10999/23/1

Norbrook Laboratories Ltd

Norodine Equine Oral Paste

Oral paste

Each 4,31 g dose contains:

Trimethoprim 5,8 % w/w

Sulfadiazine 28,83 % w/w

Horses

Norodine Equine Paste is indicated in the treatment of bacterial infections In horses caused by sensitive micro-organisms including:

—	Escherichia coli,

—	Staphylococcus spp.,

—	Streptococcus spp.

The daily dose is 30 mg of combined actives per kg bodyweight by oral administration. Treatment should be continued until 2 days after symptoms have resolved, up to a maximum of 5 days

Norway

96-1182

ScanVet Animal Health AS

Norodine Vet Oralpasta

Oral paste

1 g contains:

Trimethoprim 58,00 mg

Sulfadiazine 288,30 mg

Horses

Infections in horses caused by micro-organisms sensitive to trimethoprim + sulphonamide

The equivalent of one syringe is to treat 50 kg of body weight, from 50 kg to 500 kg.

The daily dose is 0,09 g oral paste (5 mg trimetoprim + 25 mg sulfadiazin) per kg body weight. This is equivalent to the contents of one syringe for a 500 kg horse

Sweden

10966

Norbrook Laboratories Ltd

Hippotrim Vet

Oral paste

1 g contain:

Sulfadiazine 288,3 mg

Trimethoprim 58,0 mg

Horses

Infections in horses caused by micro-organisms sensitive to trimetoprim + sulphonamide, e.g. infections in the airways, GI-tract, urogenital-tract and wound infections

45 g/500 kg horse alternatively 52 g/600 kg (equal to 30 mg/kg of the combined active substances) 1-2 times a day. The treatment should continue in 5 days or until 2 days with no symptoms have passed. The dosing-device is graded and each grade equals a dose for 50 kg bodyweight

United Kingdom

Vm 02000/4098

Norbrook Laboratories Ltd

Norodine Equine Paste

Oral paste

Each 45 g syringe contains:

Trimethoprim 2,6 g and Sulfadiazine 13,0 g

Horses

Infections in horses caused by micro-organisms sensitive to trimetoprim + sulphonamide, e.g. infections in the airways, GI-tract, urogenital-tract and wound infections

The daily dose is 30 mg of combined actives per kg bodyweight by oral administration. Treatment should be continued for up to 5 days or until 2 days after symptoms have resolved.

Each syringe provides one daily dose for a 500 kg horse.

Each division on the dial-a-dose plunger provides sufficient product to treat 50 kg of bodyweight

United Kingdom

Vm 00015/4028

Boehringer Ingelheim Ltd

Equitrim Equine Oral Paste

Oral paste

Trimethoprim 5,78 % w/w

Sulfadiazine 28,89 % w/w

Horses

Treatment of bacterial infections in horses caused by sensitive microorganisms including: Escherichia coli, Staphylococcus spp., Streptococcus spp. The product may be effective in alimentary tract infection such as diarrhoea; respiratory infections including pneumonia, pleurisy, strangles; wounds, septicaemia and general infections

The daily dose is 30 mg combined active ingredients per kg body weight. Each syringe contains one daily dose for a 500 kg horse. Each division the dial-a-dose plunger provides sufficient medication to treat 50 kg of body weight.

Treatment should be continued for up to 5 days or until 2 days after symptoms have resolved, up to a maximum of 5 days

United Kingdom

Fort Dodge Animal Health

Duphatrim Equine Formula

Oral paste

Each 45 g syringe contains:

Trimetophrim 2,6 g and Sulphadiazine 13 g

Horses

The product is indicated in the treatment of bacterial infections in horses caused by sensitive micro-organisms including:

—	Escherichia coli,

—	Corynebacterium equi,

—	Staphylococcus spp.,

—	Streptococcus spp.

When sensitive organisms are present, the combination may be effective in treating alimentary tract infections including diarrhoea; respiratory tract infections including pneumonia, pleurisy and strangles; wounds; septicaemia and general infections

The daily dose is 30 mg of combined actives per kg bodyweight by oral administration. Treatment should be continued for up to 5 days or until 2 days after the symptoms have resolved. Each syringe provides one daily dose for a 500 kg horse

ANNEX III

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

Member State

Marketing Authorisation Holder

(Invented) name

Strength

Pharmaceutical form

Route of administration

Austria

Novartis Pharma GmbH

Brunner Straße 59

A-1235 Wien

Prexige

100 mg

Film-coated tablet

Oral use

Austria

Novartis Pharma GmbH

Brunner Straße 59

A-1235 Wien

Frexocel

100 mg

Film-coated tablet

Oral use

Belgium

Novartis Pharma NV

Medialaan 40 bus 1

B-1800 Vilvoorde

Prexigem

100 mg

Film-coated tablet

Oral use

Belgium

Novartis Pharma NV

Medialaan 40 bus 1

B-1800 Vilvoorde

Stellige

100 mg

Film-coated tablet

Oral use

Czech Republic

Novartis s.r.o.

Pharma

Nagano III.

U Nákladového nádraží 10

CZ-130 00 Prague 3

Prexige

100 mg

Film-coated tablet

Oral use

Cyprus

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Prexige

100 mg

Film-coated tablet

Oral use

Denmark

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 København Ø

Prexige

100 mg

Film-coated tablet

Oral use

Estonia

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Prexige

100 mg

Film-coated tablet

Oral use

Finland

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Prexige

100 mg

Film-coated tablet

Oral use

Germany

Novartis Pharma GmbH

Roonstr. 25

D-90429 Nürnberg

Prexige

100 mg

Film-coated tablet

Oral use

Germany

Novartis Pharma GmbH

Roonstr. 25

D-90429 Nürnberg

Frexocel

100 mg

Film-coated tablet

Oral use

Germany

Novartis Pharma GmbH

Roonstr. 25

D-90429 Nürnberg

Hirzia

100 mg

Film-coated tablet

Oral use

Germany

Novartis Pharma GmbH

Roonstr. 25

D-90429 Nürnberg

Stellige

100 mg

Film-coated tablet

Oral use

Greece

Novartis Hellas Aebe

National Road a, 12 th Km

Metamorphosi Attikis

GR-144 51

Prexige

100 mg

Film-coated tablet

Oral use

Greece

Novartis Hellas Aebe

National Road a, 12 th Km

Metamorphosi Attikis

GR-144 51

Frexocel

100 mg

Film-coated tablet

Oral use

Hungary

Novartis Hungária Kft.

H-1114 Budapest

Bartók Béla út 43-47

Prexige

100 mg

Film-coated tablet

Oral use

Iceland

Novartis Healthcare A/S, c/o

Vistor hf., Hörgatúni 2

IS-210 Garðabær

Prexige

100 mg

Film-coated tablet

Oral use

Latvia

Novartis Finland Oy,

Metsänneidonkuja 10

FIN-02130 Espoo

Prexige

100 mg

Film-coated tablet

Oral use

Lithuania

Novartis Finland Oy,

Metsänneidonkuja 10

FIN-02130 Espoo

Prexige

100 mg

Film-coated tablet

Oral use

Luxembourg

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nürnberg

Prexige

100 mg

Film-coated tablet

Oral use

Malta

Novartis Pharmaceuticals UK Ltd

Frimley Business Park,

Frimley, Camberly

GU16 7SR Surrey

United Kingdom

Prexige

100 mg

Film coated tablet

Oral use

Netherlands

Novartis Pharma B.V.

Raapopseweg 1

6824 DP Arnhem

Nederland

Prexige

100 mg

Film-coated tablet

Oral use

Norway

Novartis Norge AS

Brynsalléen 4

N-0667 Oslo

Prexige

100 mg

Film-coated tablet

Oral use

Poland

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nürnberg

Stellige

100 mg

Film-coated tablet

Oral use

Poland

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nürnberg

Prexige

100 mg

Film-coated tablet

Oral use

Portugal

Laboratório Normal

Produtos Farmacêuticos, SA

Rua do Centro Empresarial

Edifício 8 — Quinta da Beloura

P-2710-444 Sintra

Frexocel

100 mg

Film-coated tablet

Oral use

Portugal

Sociedade de Produtos Farmacêuticos Wander, Lda

Rua do Centro Empresarial

Edifício 8 — Quinta da Beloura

P-2710-444 Sintra

Hirzia

100 mg

Film-coated tablet

Oral use

Portugal

Novartis Farma, Produtos Farmacêuticos, SA

Rua do Centro Empresarial

Edifício 8 — Quinta da Beloura

P-2710-444 Sintra

Prexige

100 mg

Film-coated tablet

Oral use

Portugal

Sanabo-Produtos

Farmacêuticos, Lda.

Rua do Centro Empresarial

Edificio 8 — Quinta da Beloura

P-2710-444 Sintra

Stellige

100 mg

Film-coated tablet

Oral use

Slovakia

Novartis s.r.o., Nagano III.

U Nákladového nádraží 10

CZ-130 00 Praha 3

Prexige

100 mg

Film-coated tablet

Oral use

Slovenia

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nürnberg

Frexocel

100 mg

Film -coated tablet

Oral use

Slovenia

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nürnberg

Prexige

100 mg

Film-coated tablet

Oral use

Spain

Novartis Farmacéutica SA

Gran Via de les Corts Catalanes

E-764 08013 Barcelona

Prexige

100 mg

Film-coated tablet

Oral use

Spain

Novartis Farmacéutica SA

Gran Via de les Corts Catalanes

E-764 08013 Barcelona

Stellige

100 mg

Film-coated tablet

Oral use

Sweden

Novartis Sverige AB

Box 1150

S-183 11 Täby

Prexige

100 mg

Film-coated tablet

Oral use

United Kingdom

Novartis Pharmaceuticals UK Limited

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Lumiracoxib 100 mg tablets

100 mg

Film-coated tablet

Oral use

United Kingdom

Novartis Pharmaceuticals UK Limited

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Prexige

100 mg

Film-coated tablet

Oral use

United Kingdom

Novartis Pharmaceuticals UK Limited

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Frexocel

100 mg

Film-coated tablet

Oral use

United Kingdom

Novartis Pharmaceuticals UK Limited

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Stellige

100 mg

Film-coated tablet

Oral use

United Kingdom

Novartis Pharmaceuticals UK Limited

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Hirzia

100 mg

Film-coated tablet

Oral use

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