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ANIDULAFUNGIN GX; ANIDULAFUNGIN GA; ANIDULAFUNGIN ISL; ANIDULAFUNGIN JUNO; ANIDULAFUNGIN MEDIS; ANIDULAFUNGIN ZP (Medis Pharma Pty Ltd)
Product name
ANIDULAFUNGIN GX; ANIDULAFUNGIN GA; ANIDULAFUNGIN ISL; ANIDULAFUNGIN JUNO; ANIDULAFUNGIN MEDIS; ANIDULAFUNGIN ZP
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
127 (255 working days)
Active ingredients
anidulafungin
Registration type
New generic medicine
Indication
ANIDULAFUNGIN GX; ANIDULAFUNGIN GA; ANIDULAFUNGIN ISL; ANIDULAFUNGIN JUNO; ANIDULAFUNGIN MEDIS; ANIDULAFUNGIN ZP (powder for injection) is indicated as a treatment of invasive candidiasis, including candidaemia in adult and in paediatric patients one month and older (see Section 5.1 Pharmacodynamic Properties).
Registration process
First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine