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RIMYCIN (Alphapharm Pty Ltd)
Product name
RIMYCIN
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
97 working days (255)
Active ingredients
rifampicin
Registration type
EOI
Indication
Buruli Ulcer
RIMYCIN (hard capsule) is now also indicated for the treatment of Mycobacterium ulcerans infections (Buruli ulcer). Rifampicin must be used in combination with another anti-Mycobacterium ulcerans antibiotic.
Registration process
Priority review
Involves faster TGA evaluation of vital and life-saving medicines for which a complete data dossier is available
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.