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
Buprelab Vet 0,3 mg/ml injektionsvätska, lösning för hund och katt
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
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QN02AE01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Sweden
Available in:
  • Sweden
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:
  • Swedish Medical Products Agency
Authorisation number:
  • 65059
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0430/001
Concerned member states:
  • Belgium
  • Cyprus
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Hungary
  • Ireland
  • Latvia
  • Lithuania
  • Luxembourg
  • Romania
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 24/04/2025
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Swedish (PDF)
Published on: 5/11/2025
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Package Leaflet

English (PDF)
Published on: 24/04/2025
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Swedish (PDF)
Published on: 15/04/2025
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Labelling

English (PDF)
Published on: 24/04/2025
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Swedish (PDF)
Published on: 22/01/2024
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Combined File of all Documents

English (PDF)
Published on: 24/07/2025
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eu-PUAR-esv0430001-mrp-buprelab-0-3-mg-ml-solution-for-injection-for-dogs-and-cats-en_30_10_2025_20.pdf

English (PDF)
Published on: 30/10/2025
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