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
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:
-
Luxembourg
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 Europe Limited
Marketing authorisation date:
Manufacturing sites for batch release:
- Elanco France S.A.S
Responsible authority:
- Le Ministère De La Santé Division De La Pharmacie Et Des Médicaments
Authorisation number:
- V 442/03/09/0768
Date of authorisation status change:
Reference member state:
-
Ireland
Procedure number:
- IE/V/0880/001
Concerned member states:
-
Denmark
-
Finland
-
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
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