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SCEMBLIX (Novartis Pharmaceuticals Australia Pty Ltd)
Product name
SCEMBLIX
Date registered
Evaluation commenced
Decision date
Approval time
171 (255 working days)
Active ingredients
asciminib hydrochloride
Registration type
NCE/NBE
Indication
SCEMBLIX is indicated for the treatment of patients 18 years of age and above with:
- Philadelphia chromosome-positive chronic myeloid leukaemia (Ph+ CML) in chronic phase (CP) previously treated with two or more tyrosine kinase inhibitors (see section 5.1 Clinical trials).
- Ph+ CML in CP with the T315I mutation.