PYRAZINAMIDE-AFT (AFT Pharmaceuticals Pty Ltd)
Product name
PYRAZINAMIDE-AFT
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
196 (255 working days)
Active ingredients
pyrazinamide
Registration type
NCE/ NBE
Indication
Pyrazinamide-AFT is indicated in adult patients of more than 12 years of age with active drug-sensitive tuberculosis caused by Mycobacterium tuberculosis. Pyrazinamide-AFT is an anti-tuberculosis agent used in combination with other anti- tuberculosis agents and is commonly used in the first 2 months of treatment.
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.