File downloaded on 2025-12-29
Source URL: https://medicines.health.europa.eu/veterinary/en/600000050434
Authorised

Product identification

Medicine name:
Acecare 2 mg/ml Solution for Injection for Dogs and Cats
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
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QN05AA04
Authorisation status:
  • Valid
Authorised in:
  • Ireland
Available in:
  • 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
Marketing authorisation holder:
  • Ecuphar
Marketing authorisation date:
Manufacturing sites for batch release:
  • Produlab Pharma B.V.
Responsible authority:
  • Health Products Regulatory Authority
Authorisation number:
  • VPA10491/009/001
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: 22/12/2024
Download

Combined File of all Documents

English (PDF)
Published on: 22/12/2024
Download