PRUCALOPRIDE SUCCINATE (MedTAS Pty Ltd)
Product name
PRUCALOPRIDE SUCCINATE
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
134 (255 working days)
Active ingredients
Prucalopride succinate
Registration type
New generic medicine
Indication
PRUCALOPRIDE SUCCINATE is indicated for the treatment of chronic functional constipation in adults in whom laxatives fail to provide adequate relief.
Before PRUCALOPRIDE SUCCINATE is considered patients must have tried at least two different types of laxatives from different classes (at the highest tolerated recommended doses) for at least six months, but have not had adequate relief from constipation.
If treatment with prucalopride succinate is not effective within four weeks, the benefit of continuing treatment should be reconsidered.