Authorised

Product identification

Medicine name:
Adrocil 5 mg/ml Colírio, solução Cães, gatos e equinos de desporto
Active substance:
  • Ketorolac trometamol
Target species:
  • Horse (non food-producing)
  • Dog
  • Cat
Route of administration:
  • Ocular use

Product details

Active substance and strength:
  • Ketorolac trometamol
    5.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Eye drops, solution
Withdrawal period by route of administration:
  • Ocular use
    • Horse (non food-producing)
    • Dog
    • Cat
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QS01BC05
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Portugal
Available in:
  • Portugal
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Well-established use application (Article 13a of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Vapp Producao E Comercializacao De Produtos Para Veterinaria Lda.
Marketing authorisation date:
Manufacturing sites for batch release:
  • EDOL
Responsible authority:
  • Directorate General For Food And Veterinary
Authorisation number:
  • 1023/01/16NFVPT
Date of authorisation status change:

Documents

Summary of Product Characteristics

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Portuguese (PDF)
Published on: 10/03/2022
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Source URL: https://medicines.health.europa.eu/veterinary/600000087026