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AMPHOTERICIN LIPOSOMAL RMB (Southern XP IP Pty Ltd)

Product name
AMPHOTERICIN LIPOSOMAL RMB
Sponsor
Southern XP IP Pty Ltd
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.