PRUCALOPRIDE MEDICIANZ; PRUCALOPRIDE MEDSURGE; ROSPRIDE (Medicianz Healthcare Pty Ltd)
Product name
PRUCALOPRIDE MEDICIANZ; PRUCALOPRIDE MEDSURGE; ROSPRIDE
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
155 (255 working days)
Active ingredients
prucalopride succinate
Registration type
New generic medicine
Indication
PRUCALOPRIDE MEDICIANZ; PRUCALOPRIDE MEDSURGE; ROSPRIDE (tablet) is indicated for the treatment of chronic functional constipation in adults in whom laxatives fail to provide adequate relief.
- Before prucalopride 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 is not effective within four weeks, the benefit of continuing treatment should be reconsidered.
Registration process
First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine