Atopica 100 mg/ml oral solution for cats and dogs
Atopica 100 mg/ml oral solution for cats and dogs
Authorised
- Ciclosporin
Product identification
Medicine name:
Atopica 100 mg/ml oral solution for cats and dogs
Atopica 100 mg/ml Drank
Atopica 100 mg/ml Solution buvable
Atopica 100 mg/ml Lösung zum Einnehmen
Active substance:
- Ciclosporin
Target species:
-
Dog
-
Cat
Route of administration:
-
Oral use
Product details
Active substance and strength:
-
Ciclosporin100.00/milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Oral solution
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QL04A
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Belgium
Available in:
-
Belgium
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:
- Federal Agency For Medicines And Health Products
Authorisation number:
- BE-V397905
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)
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Package Leaflet
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Labelling
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