Temprace 0.5 mg/ml Solution for Injection for Dogs and Cats
Temprace 0.5 mg/ml Solution for Injection for Dogs and Cats
Authorised
- Acepromazine maleate
Product identification
Medicine name:
Temprace 0.5 mg/ml Solution for Injection for Dogs and Cats
Active substance:
- Acepromazine maleate
Target species:
-
Dog
-
Cat
Route of administration:
-
Intravenous use
Product details
Active substance and strength:
-
Acepromazine maleate0.68/milligram(s)1.00millilitre(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:
-
Belgium
Available in:
-
Belgium
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:
- Federal Agency For Medicines And Health Products
Authorisation number:
- BE-V533351
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)
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Summary of Product Characteristics
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Package Leaflet
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Combined File of all Documents
English (PDF)
Download Published on: 29/04/2025
Labelling
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