PLERIXAFOR APOTEX (Accelagen Pty Ltd)
Product name
PLERIXAFOR APOTEX
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
202 working days (255)
Active ingredients
plerixafor
Registration type
New generic medicine
Indication
PLERIXAFOR APOTEX (solution for injection) is indicated in combination with granulocyte-colony stimulating factor (G-CSF) to mobilise haematopoietic stem cells (HSCs) to the peripheral blood for collection and subsequent autologous transplantation in patients with lymphoma and multiple myeloma (MM).
Registration process
First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine