TEPADINA (Link Medical Products Pty Ltd T/A Link Pharmaceuticals)
Product name
TEPADINA
Date registered
Evaluation commenced
Decision date
Approval time
172 (255 working days)
Active ingredients
thiotepa
Registration type
EOI
Indication
TEPADINA is indicated, in combination with other chemotherapy medicinal products:
- with or without total body irradiation (TBI), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (HPCT) in haematological diseases in adult and paediatric patients;
- when high dose chemotherapy with HPCT support is appropriate for the treatment of solid tumours in adult and paediatric patients (refer to section 5.1 Clinical trials).
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.