Veterinary Medicines

Atopica 25 mg soft capsules for dogs

Authorised
  • Ciclosporin
Download as PDF

Product identification

Medicine name:
Atopica 25 mg soft capsules for dogs
Atopica Vet. 25 mg kapsler, bløde
Active substance:
  • Ciclosporin
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Ciclosporin
    25.00
    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:
  • Box containing 60 capsules in 12 aluminium/aluminium blister packs
  • Box containing 30 capsules in 6 aluminium/aluminium blister packs
  • Box containing 15 capsules in 3 aluminium/aluminium 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:
  • 35136
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0880/002
Concerned member states:
  • Austria
  • Belgium
  • Denmark
  • Finland
  • France
  • Germany
  • Italy
  • Luxembourg
  • Netherlands
  • Norway
  • Portugal
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)