Veterinary Medicines

Atopica 50 mg soft capsules for dogs

Authorised
  • Ciclosporin
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Product identification

Medicine name:
Atopica 50 mg soft capsules for dogs
ATOPLUS 50 mg capsule molli per cani
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
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QL04AD01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Italy
Available in:
  • Italy
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:
  • Ministry Of Health
Authorisation number:
  • 103635
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

Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
Italian (PDF)
Published on: 9/06/2023
Updated on: 10/06/2023
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Summary of Product Characteristics

English (PDF)
Published on: 3/05/2024
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