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SCEMBLIX (Novartis Pharmaceuticals Australia Pty Ltd)
Product name
SCEMBLIX
Date registered
Evaluation commenced
Decision date
Approval time
139 (255 working days)
Active ingredients
asciminib hydrochloride
Registration type
EOI
Indication
SCEMBLIX is now also indicated for the treatment of patients 18 years of age and above with wewly diagnosed Philadelphia chromosome-positive chronic myeloid leukaemia (Ph+ CML) in chronic phase (CP)
Registration process
Priority review
Involves faster TGA evaluation of vital and life-saving medicines for which a complete data dossier is available