Authorised

Product identification

Medicine name:
Acecare 2 mg/ml Solution for Injection for Dogs and Cats
Active substance:
  • Acepromazine maleate
Target species:
  • Dog
  • Cat
Route of administration:
  • Intramuscular use
  • Intravenous use
  • Subcutaneous use

Product details

Active substance and strength:
  • Acepromazine maleate
    2.71
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Dog
    • Cat
  • Intravenous use
    • Dog
    • Cat
  • Subcutaneous use
    • Dog
    • Cat
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QN05AA04
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • United Kingdom (Northern Ireland)
Available in:
  • United Kingdom (Northern Ireland)
Package description:
  • 20 ml clear glass (Type II) vial. Closed with a grey bromobutyl coated rubber bung and aluminium crimped seal.

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:
  • Animalcare Limited
Marketing authorisation date:
Manufacturing sites for batch release:
  • Produlab Pharma B.V.
Responsible authority:
  • The Veterinary Medicines Directorate
Authorisation number:
  • VM 10347/4037
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0459/001
Concerned member states:
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 28/01/2022
Download
Source URL: https://medicines.health.europa.eu/veterinary/600000050443