Veterinary Medicines

BUTE GEL 4 g/100 g Gel ad uso topico per equidi non destinati alla produzione di alimenti per il consumo umano

Authorised
  • Phenylbutazone
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Product identification

Medicine name:
BUTE GEL 4 g/100 g Gel ad uso topico per equidi non destinati alla produzione di alimenti per il consumo umano
Active substance:
  • Phenylbutazone
Target species:
  • Horse (non food-producing)
Route of administration:
  • Topical use

Product details

Active substance and strength:
  • Phenylbutazone
    8.00
    gram(s)
    /
    200.00
    gram(s)
Pharmaceutical form:
  • Gel
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QM01AA01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Italy
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Acme S.r.l.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Labiana Life Sciences S.A.
Responsible authority:
  • Ministry Of Health
Authorisation number:
  • 100143
Date of authorisation status change:

Documents

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Italian (PDF)
Published on: 18/04/2025
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