MODULIS 100 MG/ML ORAL SOLUTION FOR DOGS
MODULIS 100 MG/ML ORAL SOLUTION FOR DOGS
Not authorised
- Ciclosporin
Product identification
Medicine name:
MODULIS 100 MG/ML ORAL SOLUTION FOR DOGS
Active substance:
- Ciclosporin
Target species:
-
Dog
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:
- QL04AD01
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Surrendered
Authorised in:
-
Netherlands
Package description:
- Box of one 5 mL vial and one 1 mL graduated syringe for oral administration
- Box of one 50 mL vial and one 2 mL graduated syringe for oral administration
- Box of one 30 mL vial and one 2 mL graduated syringe for oral administration
- Box of one 15 mL vial and one 1 mL graduated syringe for oral administration
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Generic application (Article 13(1) of Directive No 2001/82/EC)
Marketing authorisation holder:
- CEVA Sante Animale B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
- Ceva Sante Animale
- Laboratoires Biove
- Ceva Sante Animale
Responsible authority:
- Medicines Evaluation Board
Authorisation number:
- REG NL 114378
Date of authorisation status change:
Reference member state:
-
France
Procedure number:
- FR/V/0339/001
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
