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 )
Date: 2008-04-25
Institutions: European Commission
Subjects: EU Member State, market approval, marketing, medicinal product, pharmaceutical legislation

C 104/12

EN

Official Journal of the European Union

25.4.2008

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

3.3.2008

Equibactin vet.

See Annex I

11.3.2008

Trimethoprim/
sulfadiazine

See Annex II

See Annex I

See Annex II

Date of
notification

4.3.2008

12.3.2008

18.3.2008

Revlimid

Celgene Europe Limited
8 The Square
Stockley Park
Uxbridge
Middlesex UB11 1FW
United Kingdom

— Revocation of a national marketing authorization

This Decision is addressed
to the Member States

19.3.2008

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.

25.4.2008

EN

Official Journal of the European Union

C 104/13

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

ANNEX I

Applicant or Marketing
Authorisation Holder

Product invented
name

Pharmaceutical
form

Strength

Animal species

Frequency and
route of adminis-
tration

Recommended
dose

Le Vet B.V.
Willeskop 212
3421 GW Oudewater
Nederland

Paste

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

333,3 mg/g
sulfadi-
azine 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

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

ANNEX II

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

Netherlands
NL 10437

AST Farma BV

Sultrisan Orale
Paste voor
paarden

Oral paste

Horses

Horses

Active
substances per
gram:

Trimethoprim
66,7 mg

Sulfadiazine
333,3 mg

Active
substances per
gram:

Trimethoprim
66,7 mg

Sulfadiazine
333,3 mg

Respiratory tract infections associated with Strepto-
coccus spp. and Staphylococcus aureus; gastrointest-
inal
infections associated with E. Coli; urogenital
infections associated with beta-hemolytic strepto-
cocci; 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

Respiratory tract infections associated with Strepto-
coccus spp. and Staphylococcus aureus; gastrointest-
inal
infections associated with E. coli; urogenital
infections associated with beta-hemolytic strepto-
cocci; 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

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Belgium
282IS20F7

Schering-Plough
NV/SA
(Belgium)

Tribrissen Pâte
orale

Oral paste

Pro 100 g:

Horses

Trimethoprim
6,66 g

Sulfadiazine
33,34 g

Tribrissen Oral Paste is indicated for the treatment
of horses with bacterial infections caused by sensi-
tive 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 suffi-
cient 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.

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Member State/
Marketing
Authorisation
Number

Marketing
Authorisation
Holder

Product invented
name

Pharmaceutical
form

Strength/Active
substance (INN)

Animal
species

Therapeutic indication

Recommended dose

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— 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 symp-
toms have disappeared, a local treatment with
Tribrissen Dispersible Powder will be adminis-
tered.

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 treat-
ment must be given during 10 days

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

30 mg of combined active ingredients per kg body-
weight 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

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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-haemo-

lytic streptococci,

— wounds and abscesses by Streptococcus spp.,

Staphylococcus aureus

Sweden
10893

Schering-Plough
A/S
(Denmark)

Tribrissen vet

Oral paste

Horses

Sulfadiazine
333 mg

Trimethoprim
67 mg

infections,

in
Bacterial
wounds, respiratory tract, GI-tract or urogenital
system

instance infections

for

Member State/
Marketing
Authorisation
Number

Marketing
Authorisation
Holder

Product invented
name

Pharmaceutical
form

Strength/Active
substance (INN)

Animal
species

Therapeutic indication

Recommended dose

Iceland
MT nr 880040

Schering-Plough
A/S
(Denmark)

Tribrissen vet

Oral paste

Horses

Sulfadiazine
333 mg/g

Trimethoprim
67 mg/g

infections,

Bacterial
in
wounds, respiratory tract, GI-tract or urogenital
system

instance infections

for

30 mg of combined active ingredients per kg body-
weight 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

United Kingdom
Vm 00201/4064

Schering-Plough
Limited
(UK)

Tribrissen Oral
Paste

Oral paste

Active constitu-
ents % w/w:

Horses

Sulfadiazine
33,3 % w/w

Trimethoprim
6,7 % w/w

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
where asepsis cannot be guaranteed

cases

30 mg of combined active ingredients per kg body-
weight 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

Horses

Each gram
contains:

Sulfadiazine
333 mg

Trimethoprim
67 mg

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
where asepsis cannot be guaranteed

cases

30 mg of combined active ingredients per kg body-
weight 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.

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.

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Member State/
Marketing
Authorisation
Number

Marketing
Authorisation
Holder

Product invented
name

Pharmaceutical
form

Strength/Active
substance (INN)

Animal
species

Therapeutic indication

Recommended dose

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 ingredi-
to the
the equivalent
ents per kg body weight
contents of one syringe for a 500 kg horse

Ireland
VPA 10999/23/1

Norbrook
Laboratories Ltd

Norodine
Equine Oral
Paste

Oral paste

Horses

Each 4,31 g
dose contains:

Trimethoprim
5,8 % w/w

Sulfadiazine
28,83 % w/w

Norodine Equine Paste is indicated in the treat-
ment 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:

Horses

Trimethoprim
58,00 mg

Sulfadiazine
288,30 mg

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 trimeto-
prim + 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:

Horses

Sulfadiazine
288,3 mg

Trimethoprim
58,0 mg

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

to

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

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Member State/
Marketing
Authorisation
Number

Marketing
Authorisation
Holder

Product invented
name

Pharmaceutical
form

Strength/Active
substance (INN)

Animal
species

Therapeutic indication

Recommended dose

United Kingdom
Vm 02000/4098

Norbrook
Laboratories Ltd

Norodine
Equine Paste

Oral paste

United Kingdom
Vm 00015/4028

Boehringer
Ingelheim Ltd

Equitrim
Equine Oral
Paste

Oral paste

United Kingdom Fort Dodge

Animal Health

Duphatrim
Equine
Formula

Oral paste

Each 45 g
syringe
contains:

Trimethoprim
2,6 g and
Sulfadiazine
13,0 g

Trimethoprim
5,78 % w/w

Sulfadiazine
28,89 % w/w

Each 45 g
syringe
contains:

Trimetophrim
2,6 g and
Sulphadiazine
13 g

Horses

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

to

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

The daily dose is 30 mg combined active ingredi-
ents 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

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

Horses

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

spp., Streptococcus

Horses

The product
bacterial
micro-organisms including:

is indicated in the treatment of
infections in horses caused by sensitive

— Escherichia coli,
— Corynebacterium equi,
— Staphylococcus spp.,
— Streptococcus spp.

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

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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

Austria

Belgium

Belgium

Czech Republic

Cyprus

Denmark

Estonia

Finland

Novartis Pharma GmbH
Brunner Straße 59
A-1235 Wien

Novartis Pharma GmbH
Brunner Straße 59
A-1235 Wien

Novartis Pharma NV
Medialaan 40 bus 1
B-1800 Vilvoorde

Novartis Pharma NV
Medialaan 40 bus 1
B-1800 Vilvoorde

Novartis s.r.o.
Pharma
Nagano III.
U Nákladového nádraží 10
CZ-130 00 Prague 3

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

Novartis Healthcare A/S
Lyngbyvej 172
DK-2100 København Ø

Novartis Finland OY
Metsänneidonkuja 10
FIN-02130 Espoo

Novartis Finland OY
Metsänneidonkuja 10
FIN-02130 Espoo

Prexige

100 mg

Film-coated tablet

Oral use

Frexocel

100 mg

Film-coated tablet

Oral use

Prexigem

100 mg

Film-coated tablet

Oral use

Stellige

100 mg

Film-coated tablet

Oral use

Prexige

100 mg

Film-coated tablet

Oral use

Prexige

100 mg

Film-coated tablet

Oral use

Prexige

100 mg

Film-coated tablet

Oral use

Prexige

100 mg

Film-coated tablet

Oral use

Prexige

100 mg

Film-coated tablet

Oral use

.

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Member State

Marketing Authorisation Holder

(Invented) name

Strength

Pharmaceutical form

Route of administration

Germany

Germany

Germany

Germany

Greece

Greece

Hungary

Iceland

Latvia

Lithuania

Luxembourg

Novartis Pharma GmbH
Roonstr. 25
D-90429 Nürnberg

Novartis Pharma GmbH
Roonstr. 25
D-90429 Nürnberg

Novartis Pharma GmbH
Roonstr. 25
D-90429 Nürnberg

Novartis Pharma GmbH
Roonstr. 25
D-90429 Nürnberg

Novartis Hellas Aebe
National Road a, 12 th Km
Metamorphosi Attikis
GR-144 51

Novartis Hellas Aebe
National Road a, 12 th Km
Metamorphosi Attikis
GR-144 51

Novartis Hungária Kft.
H-1114 Budapest
Bartók Béla út 43-47

Novartis Healthcare A/S, c/o
Vistor hf., Hörgatúni 2
IS-210 Garðabær

Novartis Finland Oy,
Metsänneidonkuja 10
FIN-02130 Espoo

Novartis Finland Oy,
Metsänneidonkuja 10
FIN-02130 Espoo

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nürnberg

Prexige

100 mg

Film-coated tablet

Oral use

Frexocel

100 mg

Film-coated tablet

Oral use

Hirzia

100 mg

Film-coated tablet

Oral use

Stellige

100 mg

Film-coated tablet

Oral use

Prexige

100 mg

Film-coated tablet

Oral use

Frexocel

100 mg

Film-coated tablet

Oral use

Prexige

100 mg

Film-coated tablet

Oral use

Prexige

100 mg

Film-coated tablet

Oral use

Prexige

100 mg

Film-coated tablet

Oral use

Prexige

100 mg

Film-coated tablet

Oral use

Prexige

100 mg

Film-coated tablet

Oral use

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J
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Member State

Marketing Authorisation Holder

(Invented) name

Strength

Pharmaceutical form

Route of administration

Malta

Netherlands

Norway

Poland

Poland

Portugal

Portugal

Portugal

Portugal

Slovakia

Novartis Pharmaceuticals UK Ltd
Frimley Business Park,
Frimley, Camberly
GU16 7SR Surrey
United Kingdom

Novartis Pharma B.V.
Raapopseweg 1
6824 DP Arnhem
Nederland

Novartis Norge AS
Brynsalléen 4
N-0667 Oslo

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nürnberg

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nürnberg

Laboratório Normal
Produtos Farmacêuticos, SA
Rua do Centro Empresarial
Edifício 8 — Quinta da Beloura
P-2710-444 Sintra

Sociedade de Produtos Farmacêuticos Wander, Lda
Rua do Centro Empresarial
Edifício 8 — Quinta da Beloura
P-2710-444 Sintra

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

Sanabo-Produtos
Farmacêuticos, Lda.
Rua do Centro Empresarial
Edificio 8 — Quinta da Beloura
P-2710-444 Sintra

Novartis s.r.o., Nagano III.
U Nákladového nádraží 10
CZ-130 00 Praha 3

Prexige

100 mg

Film coated tablet

Oral use

Prexige

100 mg

Film-coated tablet

Oral use

Prexige

Stellige

Prexige

100 mg

Film-coated tablet

Oral use

100 mg

Film-coated tablet

Oral use

100 mg

Film-coated tablet

Oral use

Frexocel

100 mg

Film-coated tablet

Oral use

Hirzia

100 mg

Film-coated tablet

Oral use

Prexige

100 mg

Film-coated tablet

Oral use

Stellige

100 mg

Film-coated tablet

Oral use

Prexige

100 mg

Film-coated tablet

Oral use

.

.

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4
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O

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E
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a
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U
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Member State

Marketing Authorisation Holder

(Invented) name

Strength

Pharmaceutical form

Route of administration

Slovenia

Slovenia

Spain

Spain

Sweden

United Kingdom

United Kingdom

United Kingdom

United Kingdom

United Kingdom

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nürnberg

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nürnberg

Novartis Farmacéutica SA
Gran Via de les Corts Catalanes
E-764 08013 Barcelona

Novartis Farmacéutica SA
Gran Via de les Corts Catalanes
E-764 08013 Barcelona

Novartis Sverige AB
Box 1150
S-183 11 Täby

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

Frexocel

100 mg

Film -coated tablet

Oral use

Prexige

Prexige

Stellige

Prexige

100 mg

Film-coated tablet

Oral use

100 mg

Film-coated tablet

Oral use

100 mg

Film-coated tablet

Oral use

100 mg

Film-coated tablet

Oral use

Lumiracoxib 100 mg tablets

100 mg

Film-coated tablet

Oral use

Prexige

100 mg

Film-coated tablet

Oral use

Frexocel

100 mg

Film-coated tablet

Oral use

Stellige

100 mg

Film-coated tablet

Oral use

Hirzia

100 mg

Film-coated tablet

Oral use

C

1
0
4
/
2
2

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N

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4
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