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

Authorised
  • Buprenorphine hydrochloride
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Product identification

Medicine name:
Bupredine Multidose 0.3 mg/ml Solution for Injection for Dogs, Cats and Horses
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
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QN02AE01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Netherlands
Available in:
  • Netherlands
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:
  • Medicines Evaluation Board
Authorisation number:
  • REG NL 116390
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)

Documents

Combined File of all Documents

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Dutch (PDF)
Published on: 19/01/2022
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