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PHELINUN (Link Medical Products Pty Ltd T/A Link Pharmaceuticals)

Product name
PHELINUN
Date registered
Evaluation commenced
Decision date
Approval time
245 (255 working days)
Active ingredients
melphalan hydrochloride
Registration type
EOI
Indication

High dose PHELINUN used alone or in combination with other cytotoxic agents and/or Total Body Irradiation (TBI) for the treatment of malignant disease in adult patients, as part of autologous or allogeneic conditioning regimens. PHELINUN used alone or in combination with other cytotoxic agents and/or TBI in paediatric HSCT conditioning regimens.

Registration process

Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.