CARBOPROST-REACH (Reach Pharmaceuticals Pty Ltd)
Product name
CARBOPROST-REACH
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
125 (255 working days)
Active ingredients
, carboprost trometamol
Registration type
New generic medicine
Indication
CARBOPROST-REACH is indicated for the treatment of postpartum haemorrhage due to uterine atony which has not responded to conventional methods of management.
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.
First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine