MICAFUNGIN-AFT (AFT Pharmaceuticals Pty Ltd)
Product name
MICAFUNGIN-AFT
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
118 (255 working days)
Active ingredients
Micafungin sodium
Registration type
New generic medicine
Indication
Micafungin-AFT is indicated for:
- Treatment of invasive candidiasis in children and adults
- Treatment of oesophageal candidiasis in adults, adolescents ≥ 16 years of age and the elderly patients for whom intravenous therapy is appropriate
- Prophylaxis of Candida infection in children and adult patients undergoing allogeneic haematopoietic stem cell transplantation or patients who are expected to have neutropenia (absolute neutrophil count < 500 cells/μL) for 10 or more days