Carprofen Norbrook 50 mg/ml solution for injection for cattle
Carprofen Norbrook 50 mg/ml solution for injection for cattle
Authorised
- Carprofen
Product identification
Medicine name:
Carprofen Norbrook 50 mg/ml solution for injection for cattle
Carprofen Norbrook 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
-
Milk0day
-
-
-
Subcutaneous use
-
Cattle
-
Meat and offal21day
-
Milk0day
-
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QM01AE91
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Ireland
Package description:
- 50 ml multidose type I amber glass vial, sealed with 20 mm bromobutyl rubber stopper and 20 mm aluminium seals in a cardboard box. Cardboard box containing 1 vial of 50 ml
- 50 ml multidose type I amber glass vials, sealed with 20 mm bromobutyl rubber stopper and 20 mm aluminium seals in a cardboard box. Cardboard box containing 5 vials of 50 ml. For multi-vial pack sizes, each vial will be packed in an individual carton within an outer cardboard box.
- 50 ml multidose type I amber glass vials, sealed with 20 mm bromobutyl rubber stopper and 20 mm aluminium seals in a cardboard box. Cardboard box containing 6 vials of 50 ml. For multi-vial pack sizes, each vial will be packed in an individual carton within an outer cardboard box.
- 50 ml multidose type I amber glass vials, sealed with 20 mm bromobutyl rubber stopper and 20 mm aluminium seals in a cardboard box. Cardboard box containing 12 vials of 50 ml. For multi-vial pack sizes, each vial will be packed in an individual carton within an outer cardboard box.
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Generic application (Article 18 of Regulation (EU) 2019/6)
Marketing authorisation holder:
- Norbrook Laboratories (Ireland) Limited
Marketing authorisation date:
Manufacturing sites for batch release:
- Norbrook Laboratories Limited
- Norbrook Manufacturing Limited
Responsible authority:
- Health Products Regulatory Authority
Authorisation number:
- VPA22664/152/001
Date of authorisation status change:
Reference member state:
-
Ireland
Procedure number:
- IE/V/0612/001
Concerned member states:
-
Austria
-
Belgium
-
Croatia
-
Czechia
-
Denmark
-
Finland
-
France
-
Germany
-
Greece
-
Italy
-
Netherlands
-
Norway
-
Portugal
-
Romania
-
Slovakia
-
Slovenia
-
Spain
-
United Kingdom (Northern Ireland)
Generic of:
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
