Veterinary Medicines

ALZANE 5 mg/ml Solution for injection for dogs and cats

Authorised
  • Atipamezole hydrochloride
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Product identification

Medicine name:
ALZANE 5 mg/ml Solution for injection for dogs and cats
Alzane vet 5 mg/ml Injektionsvätska, lösning
Active substance:
  • Atipamezole hydrochloride
Target species:
  • Dog
  • Cat
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Atipamezole hydrochloride
    5.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QV03AB90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Sweden
Package description:
  • box containing 10 vials of 10 ml
  • box containing 5 vials of 10 ml
  • box containing 1 vial 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:
  • Laboratorios Syva S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Laboratorios Syva S.A.
Responsible authority:
  • Swedish Medical Products Agency
Authorisation number:
  • 42704
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0147/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Package Leaflet

English (PDF)
Published on: 6/04/2023
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Swedish (PDF)
Published on: 27/05/2025
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Summary of Product Characteristics

English (PDF)
Published on: 6/04/2023
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Swedish (PDF)
Published on: 27/05/2025
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Labelling

English (PDF)
Published on: 6/04/2023
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Swedish (PDF)
Published on: 27/05/2025
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Combined File of all Documents

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