AMPHOTERICIN LIPOSOMAL RAN (Sun Pharma ANZ Pty Ltd)
Product name
AMPHOTERICIN LIPOSOMAL RAN
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
140 (255 working days)
Active ingredients
amphotericin B (amphotericin)
Registration type
New generic medicine
Indication
Amphotericin SUN, Amphotericin RAN, and Amphotericin RBX is indicated for:
- prophylaxis in liver transplant patients at risk of systemic Candida, Aspergillus and Cryptococcus infections, and for
- the treatment of systemic fungal infections caused by organisms susceptible to amphotericin B (See section 5.1 PHARMACODYNAMIC PROPERTIES, Clinical Trials).
Amphotericin SUN, Amphotericin RAN, and Amphotericin RBX is indicated for empirical treatment of presumed fungal infections in febrile neutropaenic patients whose fever has failed to respond to broad spectrum antibiotic treatment.
Amphotericin SUN, Amphotericin RAN, and Amphotericin RBX is indicated for the treatment of visceral leishmaniasis. Clinical studies of efficacy in visceral leishmaniasis are limited to Leishmania infantum.
Registration process
First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine