File downloaded on 2026-01-18
Source URL: https://medicines.health.europa.eu/veterinary/en/600000038144
Authorised

Product identification

Medicine name:
Aceprolab 5 mg/ml Solution for injection
Aceprolab 5 mg/ml oldatos injekció A.U.V.
Active substance:
  • Acepromazine maleate
Target species:
  • Dog
  • Cat
  • Horse (non food-producing)
Route of administration:
  • Intramuscular use
  • Intravenous use

Product details

Active substance and strength:
  • Acepromazine maleate
    5.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QN05AA04
Authorisation status:
  • Valid
Authorised in:
  • Hungary
Package description:
  • box containing 1 vial of 100 ml
  • box containing 1 vial of 25 ml

Additional information

Entitlement type:
  • Marketing Authorisation
Marketing authorisation holder:
  • Labiana Life Sciences S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Labiana Life Sciences S.A.
Responsible authority:
  • Directorate Of Veterinary Medicinal Products
Authorisation number:
  • 4200/X/20 NÉBIH ÁTI
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0380/001
Concerned member states:
  • Hungary

Documents

Summary of Product Characteristics

English (PDF)
Published on: 27/06/2024
Download

Package Leaflet

English (PDF)
Published on: 27/06/2024
Download

Labelling

English (PDF)
Published on: 27/06/2024
Download

Combined File of all Documents

English (PDF)
Published on: 24/07/2025
Download

eu-PUAR-esv0380001-dcp-aceprolab-5-mg-ml-solution-for-injection-en.pdf

English (PDF)
Published on: 22/12/2023
Download