Страна: Армения
Язык: английский
Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
imatinib (imatinib mesylate)
Novartis Pharma Stein AG
L01XE01
imatinib (imatinib mesylate)
400mg
tablets film-coated
(30/3x10/) in blister
Prescription
Registered
2015-12-23
1 ANNEX I BRIEF DESCRIPTION OF THE MEDICINAL PRODUCT 2 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 receive adjuvant treatment. • the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (DFSP) and adult patients with recurrent and/or metastatic DFSP who are not eligible for surg Прочитать полный документ