Acticarp SA 50 mg/ml oplossing voor injectie voor honden en katten

Země: Nizozemsko

Jazyk: nizozemština

Zdroj: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Aktivní složka:

CARPROFEN

Dostupné s:

Ecuphar N.V.

ATC kód:

QM01AE91

INN (Mezinárodní Name):

CARPROFEN

Léková forma:

Oplossing voor injectie

Podání:

Intraveneus gebruik, Subcutaan gebruik

Druh předpisu:

Uitsluitend door dierenartsen te gebruiken

Terapeutické oblasti:

Carprofen

Datum autorizace:

2012-09-27

Charakteristika produktu

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COLLEGE TER BEOORDELING VAN GENEESMIDDELEN / MEDICINES EVALUATION
BOARD
GRAADT VAN ROGGENWEG 500
3531 AH UTRECHT
THE NETHERLANDS
DECENTRALISED PROCEDURE
PUBLICLY AVAILABLE ASSESSMENT REPORT FOR A VETERINARY
MEDICINAL PRODUCT
ACTICARP SA 50 MG/ML SOLUTION FOR INJECTION FOR DOGS AND CATS
7 NOVEMBER 2013
Acticarp SA 50 mg/ml solution for injection for dogs and cats
Ecuphar NV
Application for Decentralised Procedure
2/9
_ _
Publicly available assessment report
MODULE 1
PRODUCT SUMMARY
Dutch Registration number
REG NL 111313
EU Procedure number
NL/V/0170/001/DC
Name, strength and
pharmaceutical form
Acticarp SA 50 mg/ml solution for injection for
dogs and cats
Applicant
Ecuphar NV
Legeweg 157-i
8020 Oostkamp
Belgium
Active substance(s)
Carprofen
ATC Vetcode
QM01AE91
Target species
Dogs and cats
Indication for use
Dogs:
For the reduction of post-operative pain
and inflammation following orthopaedic and soft
tissue (including intra-ocular) surgery.
Cats:
For the control of post-operative pain
after small surgical procedures.
Acticarp SA 50 mg/ml solution for injection for dogs and cats
Ecuphar NV
Application for Decentralised Procedure
3/9
_ _
Publicly available assessment report
MODULE 2
The Summary of Product Characteristics (SPC) for this product is
available on the website:
http://mri.medagencies.org/veterinary/
Acticarp SA 50 mg/ml solution for injection for dogs and cats
Ecuphar NV
Application for Decentralised Procedure
4/9
_ _
Publicly available assessment report
MODULE 3
PUBLIC ASSESSMENT REPORT
Legal basis of original application
Application in accordance with Article 13(1) of
Directive 2001/82/EC as amended.
Date of completion of the original
decentralised procedure
17
th
of August 2012
Concerned Member States for original procedure
AT, BE, CZ, DE, LU, PT and SK
I.
SCIENTIFIC OVERVIEW
Acticarp SA 50 mg/ml solution for injection for dogs and cats is
produced and controlled
using validated methods and tests, which ensure the consistency of the
product released on
the market.
The product can be sa