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THIOTEPA REACH (Reach Pharmaceuticals Pty Ltd)

Product name
THIOTEPA REACH
Sponsor
Reach Pharmaceuticals Pty Ltd
Date registered
Evaluation commenced
Decision date
Approval time
193 (255 working days)
Active ingredients
thiotepa
Registration type
EOI
Indication

THIOTEPA-REACH (powder for injection) is now also 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 5.2 Clinical trials)

    • Registration process

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