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LEDAGA (Recordati Rare Diseases Australia Pty Ltd)
Product name
LEDAGA
Date registered
Evaluation commenced
Decision date
Approval time
170 (255 working days)
Active ingredients
chlormethine hydrochloride
Registration type
NCE/NBE
Indication
LEDAGA (gel) is indicated for the topical treatment of mycosis fungoides-type cutaneous T-cell lymphoma (MF-type CTCL) in adult patients.
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.