Atopica 10 mg soft capsules for dogs
Atopica 10 mg soft capsules for dogs
Authorised
- Ciclosporin
Product identification
Medicine name:
Atopica 10 mg soft capsules for dogs
Atoplus 10 mg capsule molli per cani
Active substance:
- Ciclosporin
Target species:
-
Dog
Route of administration:
-
Oral use
Product details
Active substance and strength:
-
Ciclosporin10.00/milligram(s)1.00Capsule
Pharmaceutical form:
-
Capsule, soft
Withdrawal period by route of administration:
-
Oral use
- Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QL04AD01
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised 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/0880/001
Concerned member states:
-
Belgium
-
Denmark
-
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
Combined File of all Documents
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Italian (PDF)
Published on: 7/06/2024
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