Veterinary Medicines

Temprace 0.5 mg/ml Solution for Injection for Dogs and Cats

Authorised
  • Acepromazine maleate
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Product identification

Medicine name:
Temprace 0.5 mg/ml Solution for Injection for Dogs and Cats
Temprace vet - injeksjonsvæske, oppløsning - 0,5 mg/ml
Active substance:
  • Acepromazine maleate
Target species:
  • Dog
  • Cat
Route of administration:
  • Intravenous use

Product details

Active substance and strength:
  • Acepromazine maleate
    0.68
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QN05AA04
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Norway
Package description:
  • Clear type I glass vial of 10 ml closed with a coated bromobutyl rubber stopper and aluminium cap in a carton box
  • Clear type I glass vial of 20 ml closed with a coated bromobutyl rubber stopper and aluminium cap in a carton box
  • Clear type I glass vial of 100 ml closed with a coated bromobutyl rubber stopper and aluminium cap in a carton box

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Hybrid application (Article 13(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Le Vet. Beheer B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Produlab Pharma B.V.
Responsible authority:
  • Norwegian Medical Products Agency
Authorisation number:
  • 16-11368
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0321/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

English (PDF)
Published on: 29/04/2025
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