PALONOSETRON BAXTER (Baxter Healthcare Pty Ltd)
Product name
PALONOSETRON BAXTER
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
128 (255 working days)
Active ingredients
Palonosetron hydrochloride
Registration type
New generic medicine
Indication
- prevention of nausea and vomiting induced by cytotoxic chemotherapy.
- prevention of postoperative nausea and vomiting (PONV) for up to 24 hours following surgery.
Registration process
First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine