FOSAPREPITANT JUNO (Juno Pharmaceuticals Pty Ltd)
Product name
FOSAPREPITANT JUNO
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
135 (255 working days)
Active ingredients
fosaprepitant dimeglumine
Registration type
New generic medicine
Indication
FOSAPREPITANT JUNO, 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 (see Section 4.2 Dose and Method of Administration)
- moderately emetogenic cancer chemotherapy (see Section 4.2 Dose and Method of Administration).
Registration process
First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine