Kraj: Singapur
Język: angielski
Źródło: HSA (Health Sciences Authority)
Imatinib mesilate 119.5mg eqv. Imatinib
LOTUS INTERNATIONAL PTE. LTD.
L01EA01
TABLET, FILM COATED
Imatinib mesilate 119.5mg eqv. Imatinib 100.0 mg
ORAL
Prescription Only
Remedica Ltd (Buildings 5 &10)
ACTIVE
2018-02-28
Page 1 of 30 1. NAME OF THE MEDICINAL PRODUCT ALVOTINIB 100 mg film-coated tablets ALVOTINIB 400 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 100 mg film-coated tablets: Each film-coated tablet contains 100 mg imatinib (as imatinib mesilate). 400 mg film-coated tablets: Each film-coated tablet contains 400 mg imatinib (as imatinib mesilate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM 100 mg film-coated tablet: Dark yellow to brownish-orange, round shaped, film-coated tablets of 10.1 mm (± 5%) diameter with a break-line on one side and ‘100’ on the other side. The tablet can be divided into equal doses. 400 mg film-coated tablets: Dark yellow to brownish-orange, ovaloid shaped, film-coated tablets, 21.6 mm long & 10.6mm wide (± 5%) with a break-line on one side and ‘400’ on the other side. The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Imatinib is indicated for the • treatment of adult and paediatric patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukaemia (Ph+ CML) (for paediatric use see section 4.2). • treatment of adult and paediatric patients with Ph+ CML in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy (for paediatric use see section 4.2). • treatment of paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) integrated with chemotherapy. • treatment of adult patients with relapsed or refractory Ph+ ALL as monotherapy. • treatment of adult patients with Kit+ (CD117) unresectable and/or metastatic malignant gastrointestinal stromal tumours (GIST). • adjuvant treatment of adult patients following complete gross resection of Kit+ GIST. Page 2 of 30 The effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in CML, and on haematological and cytogenetic response rates in relapsed or refracto Przeczytaj cały dokument