Veterinary Medicines

Alphafluben 44 mg/ml oral gel for dogs

Authorised
  • Flubendazole
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Product identification

Medicine name:
Alphafluben 44 mg/ml oral gel for dogs
Alphafluben, 44mg/ml, Perorální gel
Active substance:
  • Flubendazole
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Flubendazole
    44.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Oral gel
Withdrawal period by route of administration:
  • Oral use
    • Dog
      • Meat and offal
        no withdrawal period
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP52AC12
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Czechia
Package description:
  • 7.5 ml gel in a linear low density polyethylene (LLDPE) plastic oral syringe, with polystyrene plunger packaged in carton.

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:
  • Alphavet Zrt.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Alphavet Zrt.
Responsible authority:
  • Institute For State Control Of Veterinary Biologicals And Medicaments
Authorisation number:
  • 96/001/22-C
Date of authorisation status change:
Reference member state:
  • Portugal
Procedure number:
  • PT/V/0139/001
Concerned member states:
  • Austria
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Estonia
  • Greece
  • Hungary
  • Italy
  • Latvia
  • Lithuania
  • Poland
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Czech (PDF)
Published on: 20/03/2025
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Czech (PDF)
Published on: 20/03/2025
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Czech (PDF)
Published on: 8/04/2025
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Combined File of all Documents

English (PDF)
Published on: 6/01/2026
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