Norofol 10 mg/ml Emulsion for Injection for Cats and Dogs
Norofol 10 mg/ml Emulsion for Injection for Cats and Dogs
Authorised
- Propofol
Product identification
Medicine name:
Norofol 10 mg/ml Emulsion for Injection for Cats and Dogs
Active substance:
- Propofol
Target species:
-
Dog
-
Cat
Route of administration:
-
Intravenous use
Product details
Active substance and strength:
-
Propofol10.00/milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Emulsion for injection
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QN01AX10
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
United Kingdom (Northern Ireland)
Package description:
- (ID1) 20 millilitre(s): Box (cardboard) with 1 Vial (clear glass (Glass typ I)) with 20 millilitre(s), closed with Stopper (bromobutyl rubber) and Cap`` (aluminium)
- (ID2) 50 millilitre(s): Box (cardboard) with 1 Vial (clear glass (Glass typ I)) with 50 millilitre(s), closed with Stopfen (bromobutyl rubber) and Cap`` (aluminium)
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Generic application (Article 13(1) of Directive No 2001/82/EC)
Marketing authorisation holder:
- Norbrook Laboratories Limited
Marketing authorisation date:
Manufacturing sites for batch release:
- Norbrook Laboratories (Ireland) Limited
- Norbrook Laboratories Limited
Responsible authority:
- The Veterinary Medicines Directorate
Authorisation number:
- Vm 02000/4275
Date of authorisation status change:
Reference member state:
-
Germany
Procedure number:
- DE/V/0317/001
Concerned member states:
-
Austria
-
Bulgaria
-
Cyprus
-
Czechia
-
Estonia
-
Finland
-
Latvia
-
Lithuania
-
Portugal
-
Romania
-
Slovakia
-
Slovenia
-
Spain
-
United Kingdom (Northern Ireland)
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
