Basic Information
SCEMBLIX FILM-COATED TABLET 20 MG
TABLET, FILM COATED
Regulatory Information
SIN16539P
July 5, 2022
Prescription Only
Therapeutic
ORAL
August 10, 2023
May 30, 2025
XL01EA06
Company Information
Active Ingredients
Strength: 20mg
Detailed Information
Contraindications
**5 Contraindications** Hypersensitivity to the active substance or to any of the excipients listed in section 2 Description and composition – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.
Indication Information
**3 Indications** Scemblix® is indicated for the treatment of adult patients with: - Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP) previously treated with two or more tyrosine kinase inhibitors (see section 12 Clinical studies – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). - Ph+ CML in CP harboring the T315I mutation.