País: Armênia
Língua: inglês
Origem: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
imatinib (imatinib mesylate)
Novartis Pharma Produktions GmbH
L01EA01
imatinib (imatinib mesylate)
400mg
tablets film-coated
(30/3x10/) in blister
Prescription
Registered
2021-07-26
1 ANNEX I BRIEF DESCRIPTION OF THE MEDICINAL PRODUCT 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. 1. NAME OF MEDICAL PRODUCT GLIVEC ® 100 mg and 400 mg Film-coated tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _ _ _active substance:_ imatinib; 1 tablet contains imatinib mesylate equivalent to imatinib - 100 or 400 mg; _excipients:_ For a complete list of excipients, see Section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets. 4. CLINICAL DATA 4.1 INDICATIONS. Glivec is indicated for the treatment of • adult and paediatric patients with newly diagnosed Philadelphia chromosome (bcr-abl) positive (Ph+) chronic myeloid leukaemia (CML) for whom bone marrow transplantation is not considered as the first line of treatment. • adult and paediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis. • adult and paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy. • adult patients with relapsed or refractory Ph+ ALL as monotherapy. • adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements. • adult patients with advanced hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) with FIP1L1-PDGFR α rearrangement. The effect of Glivec on the outcome of bone marrow transplantation has not been determined. Glivec is indicated for • the treatment of adult patients with Kit (CD 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (GIST). • the adjuvant treatment of adult patients who are at significant risk of relapse following resection of Kit (CD117)-positive GIST. Patients who have a low or very low risk of recurrence should not recei Leia o documento completo