Veterinary Medicines

Atopica 100 mg/ml oral solution for cats and dogs

Authorised
  • Ciclosporin
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Product identification

Medicine name:
Atopica 100 mg/ml oral solution for cats and dogs
Atopica 100 mg/ml mixtúra, lausn handa köttum og hundum
Active substance:
  • Ciclosporin
Target species:
  • Dog
  • Cat
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Ciclosporin
    100.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Oral solution
Withdrawal period by route of administration:
  • Oral use
    • Dog
    • Cat
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QL04A
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Iceland
Package description:
  • Multi-dose type III amber glass bottle containing 50 ml oral solution closed with a chlorobutyl rubber stopper and sealed with an aluminium tear-off cap. Each bottle is provided with two dispenser sets (consisting of a PE dip tube and a 1 ml or 4 ml polypropylene syringe) packed in a cardboard box. A polypropylene child-resistant screw cap is provided for closure of the bottle during the in-use period. Pack sizes1 x 50 ml bottle and two dispenser sets
  • Multi-dose type III amber glass bottle containing 17 ml oral solution closed with a rubber stopper and sealed with a polypropylene child-resistant screw cap. One bottle and a dispenser set ( consisting of a PE dip tube and a 1 ml polypropylene syringe) packed in a cardboard box. Pack sizes1 x 17 ml and one dispenser set
  • Multi-dose type III amber glass bottle containing 5 ml oral solution closed with a rubber stopper and sealed with a polypropylene child-resistant screw cap. One bottle and a dispenser set (consisting of a PE dip tube and a 1 ml polypropylene syringe) packed in a cardboard box. Pack sizes1 x 5 ml and one dispenser set

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:
  • Icelandic Medicines Agency
Authorisation number:
  • IS/2/11/023/01
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0881/001
Concerned member states:
  • Austria
  • Belgium
  • Denmark
  • Finland
  • France
  • Germany
  • Iceland
  • Italy
  • Luxembourg
  • Netherlands
  • Norway
  • Portugal
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 8/03/2023
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