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
Atopica Vet. 50 mg kapsler, bløde
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:
  • Denmark
Available in:
  • Denmark
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:
  • Danish Medicines Agency
Authorisation number:
  • 35137
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
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Danish (, BLØDE KAPSLER 10, 25, 50 OG 100 MG)
Published on: 19/12/2023
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