Norocarp 50 mg/ml Solution for Injection for Cattle
Norocarp 50 mg/ml Solution for Injection for Cattle
Authorised
- Carprofen
Product identification
Medicine name:
Norocarp 50 mg/ml Solution for Injection for Cattle
Active substance:
- Carprofen
Target species:
-
Cattle
Route of administration:
-
Intravenous use
-
Subcutaneous use
Product details
Active substance and strength:
-
Carprofen50.00/milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Solution for injection
Withdrawal period by route of administration:
-
Intravenous use
-
Cattle
-
Meat and offal21day
-
Milk0hour
-
-
-
Subcutaneous use
-
Cattle
-
Meat and offal21day
-
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QM01AE91
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Belgium
Package description:
- Norocarp Injection for Cattle in 12 x 50ml multidose amber glass (Type I) vials, sealed with 20mm bromobutyl bungs and 20mm aluminium seals.
- Norocarp Injection for Cattle in 10 x 50ml multidose amber glass (Type I) vials, sealed with 20mm bromobutyl bungs and 20mm aluminium seals.
- Norocarp Injection for Cattle in 6 x 50ml multidose amber glass (Type I) vials, sealed with 20mm bromobutyl bungs and 20mm aluminium seals.
- Norocarp Injection for Cattle in 5 x 50ml multidose amber glass (Type I) vials, sealed with 20mm bromobutyl bungs and 20mm aluminium seals.
- Norocarp Injection for Cattle in 1 x 50ml multidose amber glass (Type I) vial, sealed with 20mm bromobutyl bung and 20mm aluminium seal.
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Well-established use application (Article 13a of Directive No 2001/82/EC)
Marketing authorisation holder:
- Norbrook Laboratories (Ireland) Limited
Marketing authorisation date:
Manufacturing sites for batch release:
- Norbrook Manufacturing Limited
- Norbrook Laboratories Limited
Responsible authority:
- Federal Agency For Medicines And Health Products
Authorisation number:
- BE-V346674
Date of authorisation status change:
Reference member state:
-
Ireland
Procedure number:
- IE/V/0230/001
Concerned member states:
-
Austria
-
Belgium
-
Denmark
-
Finland
-
France
-
Germany
-
Italy
-
Norway
-
Portugal
-
Spain
-
United Kingdom (Northern Ireland)
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Package Leaflet
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Combined File of all Documents
English (PDF)
Download Published on: 29/12/2024
Labelling
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