Veterinary Medicines

OFTALMOVET 3,0 mg/ml + 2,2 mg/ml + 5,0 mg/ml COLIRIO EN SOLUCIÓN PARA PERROS Y GATOS

Authorised
  • Lidocaine hydrochloride monohydrate
  • Chloramphenicol
  • Prednisolone
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Product identification

Medicine name:
OFTALMOVET 3,0 mg/ml + 2,2 mg/ml + 5,0 mg/ml COLIRIO EN SOLUCIÓN PARA PERROS Y GATOS
Active substance:
  • Lidocaine hydrochloride monohydrate
  • Chloramphenicol
  • Prednisolone
Target species:
  • Cat
  • Dog
Route of administration:
  • Ocular use

Product details

Active substance and strength:
  • Lidocaine hydrochloride monohydrate
    5.80
    milligram(s)
    /
    1.00
    millilitre(s)
  • Chloramphenicol
    3.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • Prednisolone
    2.20
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Eye drops, solution
Withdrawal period by route of administration:
  • Ocular use
    • Cat
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QS03CA02
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Spain
Available in:
  • Spain
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Hybrid application - change in active substance(s) (Article 19(1)(a) of Regulation (EU) 2019/6)
Marketing authorisation holder:
  • Fatro Iberica S.L.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Labiana Pharmaceuticals S.L.U
Responsible authority:
  • Spanish Agency For Medicines And Health Products
Authorisation number:
  • 4246 ESP
Date of authorisation status change:

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 7/03/2024
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 15/12/2023
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 15/12/2023
Download

es-PUAR-4246 esp-np-oftalmovet-3-0-mg-ml-+-2-2-mg-ml-+-5-0-mg-ml-colirio-en-solución-para-perros-y-gatos-es.pdf

Spanish (PDF)
Published on: 15/12/2023
Download
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