Veterinary Medicines

Buprelab 0.3 mg/ml solution for injection for dogs and cats

Authorised
  • Buprenorphine hydrochloride
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Product identification

Medicine name:
Buprelab 0.3 mg/ml solution for injection for dogs and cats
Active substance:
  • Buprenorphine hydrochloride
Target species:
  • Dog
  • Cat
Route of administration:
  • Intravenous use
  • Intramuscular 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:
  • Intravenous use
    • Dog
    • Cat
  • Intramuscular use
    • Dog
    • Cat
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QN02AE01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Luxembourg
Package description:
  • Box with 1 vial of 10 ml
  • Box with 5 vials of 10 ml
  • Box with 10 vials of 10 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:
  • Labiana Life Sciences S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Labiana Life Sciences S.A.
Responsible authority:
  • Ministere De La Sante Division De La Pharmacie Et Des Medicaments
Authorisation number:
  • V/006/08/01/2024
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0430/001
Concerned member states:
  • Belgium
  • Cyprus
  • Estonia
  • Finland
  • France
  • Hungary
  • Latvia
  • Lithuania
  • Luxembourg
  • Romania
  • Sweden

Documents

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
French (PDF)
Published on: 19/02/2024
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Summary of Product Characteristics

English (PDF)
Published on: 27/06/2024
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eu-PUAR-esv0430001-mrp-buprelab-0-3-mg-ml-solution-for-injection-for-dogs-and-cats-en.pdf

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