Veterinary Medicines

Cefenicol CA 5 mg/ml eye drops, solution for dogs and cats

Authorised
  • Chloramphenicol
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Product identification

Medicine name:
Cefenicol CA 5 mg/ml eye drops, solution for dogs and cats
CEFENICOL 5 MG/ML COLLYRE EN SOLUTION POUR CHIENS ET CHATS
Active substance:
  • Chloramphenicol
Target species:
  • Dog
  • Cat
Route of administration:
  • Ocular use

Product details

Active substance and strength:
  • Chloramphenicol
    5.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Eye drops, solution
Withdrawal period by route of administration:
  • Ocular use
    • Dog
    • Cat
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QS01AA01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • France
Package description:
  • (ID1) 10 millilitre(s): Box (Cardboard) with 1 Bottle (Low Density PolyEthylene) with 10 millilitre(s), closed with Screw cap (High Density PolyEthylene)

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Hybrid application – bioavailability studies cannot be used to demonstrate bioequivalence (Article 19(1)(b) of Regulation (EU) 2019/6)
Marketing authorisation holder:
  • CP-Pharma Handelsgesellschaft mbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • CP-Pharma Handelsgesellschaft mbH
Responsible authority:
  • French Agency For Food, Environmental And Occupational Health & Safety
Authorisation number:
  • FR/V/0094563 3/2024
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0344/001
Concerned member states:
  • Austria
  • Belgium
  • Denmark
  • Estonia
  • Finland
  • France
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Spain
  • Sweden
  • 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.
French (PDF)
Published on: 13/09/2024
Download

Package Leaflet and Labelling

This document does not exist in this language (English). You can find it in another language below.
French (PDF)
Published on: 13/09/2024
Download

2402485-paren-20240710.pdf

English (PDF)
Published on: 23/10/2024
Download
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