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AMPHOTERICIN LIPOSOMAL RMB (Southern XP IP Pty Ltd)
Product name
AMPHOTERICIN LIPOSOMAL RMB
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
139 (255 working days)
Active ingredients
Amphotericin B
Registration type
New generic medicine
Indication
[TRADENAME] 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).
[TRADENAME] is indicated for empirical treatment of presumed fungal infections in febrile neutropaenic patients whose fever has failed to respond to broad spectrum antibiotic treatment.
[TRADENAME] is indicated for the treatment of visceral leishmaniasis. Clinical studies of efficacy in visceral leishmaniasis are limited to Leishmania infantum.