Veterinary Medicines

Bupredine Multidose 0.3 mg/ml Solution for Injection for Dogs, Cats and Horses

Authorised
  • Buprenorphine hydrochloride
Download as PDF

Product identification

Medicine name:
Bupredine Multidose 0.3 mg/ml Solution for Injection for Dogs, Cats and Horses
Bupredine Multidose 0,3 mg/ml oldatos injekció kutyáknak,macskáknak és lovaknak
Active substance:
  • Buprenorphine hydrochloride
Target species:
  • Dog
  • Horse
  • Cat
Route of administration:
  • Intramuscular use
  • Intravenous use

Product details

Active substance and strength:
  • Buprenorphine hydrochloride
    0.32
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Dog
    • Horse
    • Cat
  • Intravenous use
    • Dog
    • Horse
    • Cat
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QN02AE01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Hungary
Package description:
  • Clear type I glass vials closed with a coated bromobutyl rubber stopper and aluminium cap in a carton box. Pack size: 20 ml.
  • Clear type I glass vials closed with a coated bromobutyl rubber stopper and aluminium cap in a carton box. Pack size: 100 ml
  • Clear type I glass vials closed with a coated bromobutyl rubber stopper and aluminium cap in a carton box. Pack size: 10 ml.
  • Clear type I glass vials closed with a coated bromobutyl rubber stopper and aluminium cap in a carton box. Pack size: 50 ml
  • Clear type I glass vials closed with a coated bromobutyl rubber stopper and aluminium cap in a carton box. Pack size: 5 ml.

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:
  • Le Vet. Beheer B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Produlab Pharma B.V.
Responsible authority:
  • Directorate Of Veterinary Medicinal Products
Authorisation number:
  • 3702/X/15 NÉBIH ÁTI
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0314/001
Concerned member states:
  • Austria
  • Belgium
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Latvia
  • Lithuania
  • Luxembourg
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)
How useful was this page?:
No votes yet
"Please do not include any personal data, such as your name or contact details. If you do, you consent to the processing of that data in accordance with EMA’s Privacy Statement concerning requests for information or access to documents. If you would like a reply from EMA, please Send a question to EMA instead."