Veterinary Medicines

Atopica 50 mg soft capsules for dogs

Authorised
  • Ciclosporin
Download as PDF

Product identification

Medicine name:
Atopica 50 mg soft capsules for dogs
ATOPICA 50 MG
Active substance:
  • Ciclosporin
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Ciclosporin
    50.00
    milligram(s)
    /
    1.00
    Capsule
Pharmaceutical form:
  • Capsule, soft
Withdrawal period by route of administration:
  • Oral use
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QL04AD01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • France
Available in:
  • France
Package description:
  • Aluminium/Aluminium blisters containing 5 soft capsules. Cardboard box containing 60 soft capsules in 12 blister packs.
  • Aluminium/Aluminium blisters containing 5 soft capsules. Cardboard box containing 30 soft capsules in 6 blister packs.
  • Aluminium/Aluminium blisters containing 5 soft capsules. Cardboard box containing 15 soft capsules in 3 blister packs.

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:
  • Elanco GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • Elanco France S.A.S.
Responsible authority:
  • French Agency For Food, Environmental And Occupational Health & Safety
Authorisation number:
  • FR/V/9504825 5/2002
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0880/003
Concerned member states:
  • Austria
  • Belgium
  • Denmark
  • Finland
  • France
  • Germany
  • Italy
  • Luxembourg
  • Netherlands
  • Norway
  • Portugal
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 3/05/2024
Download
French (PDF)
Published on: 30/11/2023
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: 15/10/2025
Download
How useful was this page?:
No votes yet
"Please do not include any personal data, such as your name or contact details. If you do, you consent to the processing of that data in accordance with EMA’s Privacy Statement concerning requests for information or access to documents. If you would like a reply from EMA, please Send a question to EMA instead."