国家: 台湾
语言: 中文
来源: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)
IMATINIB MESYLATE
瑞士商愛爾康大藥廠股份有限公司台灣分公司 台北市中正區仁愛路二段99號11樓 (20916488)
L01EA01
膜衣錠
IMATINIB MESYLATE (1013000710) (eq. to Imatinib 100mg)MG
鋁箔盒裝
製 劑
須由醫師處方使用
NOVARTIS PHARMA PRODUKTIONS GMBH OEFLINGERSTRASSE 44, 79664 WEHR, GERMANY DE
imatinib
治療正值急性轉化期(blast crisis)、加速期或經ALPHA-干擾素治療無效之慢性期的慢性骨髓性白血病(CML)患者。治療成年人無法手術切除或轉移的惡性胃腸道基質瘤。用於治療初診斷為慢性骨髓性白血病(CML)的病人。‧治療初診斷為費城染色體陽性急性淋巴性白血病(Ph+ALL)且併用化療之成年及兒童患者。‧做為治療成人復發性或難治性費城染色體陽性急性淋巴性白血病(Ph+ALL)之單一療法。‧治療患有與血小板衍生生長因子受體(PDGFR)基因重組相關之骨髓發育不全症候群(MDS)/骨髓增生疾病(MPD)之成人患者。‧治療患有系統性肥大細胞增生症(SM),限具FIPILI-PDGFR基因變異且不具有c-Kit基因D816V突變之成人患者。‧治療嗜伊紅性白血球增加症候群(HES)與/或慢性嗜伊紅性白血病(CEL)且有血小板衍生生長因子受體(PDGFR)基因重組之成人患者。‧作為成人KIT(CD 117)陽性胃腸道基質瘤完全切除後(complete gross resection)之術後輔助治療。‧治療無法手術切除、復發性或轉移性且有血小板衍生生長因子受體(PDGFR)基因重組之隆突性皮膚纖維肉瘤(DFSP)之成人患者。
註銷日期: 2021/02/19; 註銷理由: 自請註銷; 有效日期: 2024/08/25; 英文品名: Vativio film-coated tablets 100mg
已註銷
2014-08-25
VATIVIO 100 MG FILM-COATED TABLETS DESCRIPTION AND COMPOSITION PHARMACEUTICAL FORM(S) Film-coated tablets 100 MG TABLETS, DIVISIBLE Very dark yellow to brownish orange film-coated tablets, round with imprint “NVR” on one side and “SA” and score on the other side. ACTIVE SUBSTANCE(S) FILM-COATED TABLETS Each tablet contains 100 mg imatinib (as mesylate beta crystals). EXCIPIENTS 100 MG (DIVISIBLE) FILM-COATED TABLETS Tablet content: Cellulose microcrystalline, Crospovidone, Hypromellose, Magnesium stearate, Silica colloidal anhydrous. Coating content: Hypromellose, Macrogol, Talc, Iron oxide, red (E 172), Iron oxide, yellow (E 172). INDICATIONS Imatinib ® is indicated for the treatment of adult and pediatric patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) (for pediatric use see section 4 Dosage and administration), treatment of adult and pediatric patients with Ph+ CML in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy (for pediatric use see section 4 Dosage and administration), treatment of adult and pediatric 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 myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements, treatment of adult patients with systemic mastocytosis (SM) without the D816V c-Kit mutation or with c-Kit mutational status unknown, treatment of adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL), treatment of adult patients with Kit+ (CD117) unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST). adjuvant treatment of adult patients following resection of Kit+ GIST, treatment of adult patients with unresectable 阅读完整的文件