APREPITANT APOTEX (Apotex Pty Ltd)
Product name
APREPITANT APOTEX
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
122 working days (255)
Active ingredients
aprepitant
Registration type
New generic medicine
Indication
APREPITANT APOTEX (capsules), in combination with other antiemetic agents, is indicated for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of:
- highly emetogenic cancer chemotherapy.
- moderately emetogenic cancer chemotherapy.
APREPITANT APOTEX is indicated for the prevention of postoperative nausea and vomiting.
Registration process
First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine