Veterinary Medicines

Sedastop 5 mg/ml Solution for Injection for Cats and Dogs

Authorised
  • Atipamezole hydrochloride
Download as PDF

Product identification

Medicine name:
Narcostop 5 mg/ml, solution for injection for cats and dogs
Sedastop 5 mg/ml Solution for Injection for Cats and Dogs
Active substance:
  • Atipamezole hydrochloride
Target species:
  • Dog
  • Cat
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Atipamezole hydrochloride
    5.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QV03AB90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • United Kingdom (Northern Ireland)
Package description:
  • Cardboard box with 5 vials containing 10 ml. Clear glass (type I) vial with bromobutylrubber stopper (type I) containing 10 ml solution for injection.
  • Cardboard box with 10 vials containing 10 ml. Clear glass (type I) vial with bromobutylrubber stopper (type I) containing 10 ml solution for injection.
  • Cardboard box with 1 vial containing 10 ml. Clear glass (type I) vial with bromobutylrubber stopper (type I) containing 10 ml solution for injection.

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:
  • Le Vet. B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Produlab Pharma B.V.
Responsible authority:
  • The Veterinary Medicines Directorate
Authorisation number:
  • VM 19994/4014
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0139/001
Concerned member states:
  • Austria
  • Belgium
  • Czechia
  • Denmark
  • Finland
  • France
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Luxembourg
  • Poland
  • Portugal
  • Slovakia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)