基利克膠囊100毫克

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)

有效成分:

IMATINIB MESYLATE

可用日期:

台灣諾華股份有限公司 台北市中山區民生東路三段2號8樓 (01516589)

ATC代码:

L01EA01

药物剂型:

膠囊劑

组成:

IMATINIB MESYLATE (1013000710) MG

每包单位数:

盒裝

类:

製　劑

处方类型:

須由醫師處方使用

厂商:

NOVARTIS PHARMA AG CH-4056 BASEL SWITZERLAND CH

治疗领域:

imatinib

疗效迹象:

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)/骨髓增生性疾病(MPD)之成人患者。治療患有系統性肥大細胞增生症(SM)，限具FIP1L1-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(complete gross resection)後之術後輔助治療。治療患有無法手術切除、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。

產品總結:

註銷日期: 2021/05/07; 註銷理由: 自請註銷; 有效日期: 2021/10/03; 英文品名: GLIVEC CAPSULES 100MG

授权状态:

已註銷

授权日期:

2001-10-03

资料单张

GLIVEC
 100 MG HARD CAPSULES
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORM(S)
100 MG CAPSULES
White to yellow powder in an orange to greyish-orange opaque capsule,
marked “NVR SI”.
ACTIVE SUBSTANCE(S)
HARD CAPSULES
Each
capsule
contains
50 or
100
mg
imatinib
(as
mesylate
beta
crystals).
EXCIPIENTS
100 MG CAPSULES
Capsule content: Cellulose microcrystalline; Crospovidone; Magnesium
stearate; Silica colloidal, anhydrous.
Capsule shell: Gelatin; Iron oxide, red (E 172); Iron oxide, yellow (E
172);
Titanium dioxide (E 171).
Printing ink:
Shellac E904
、
Red iron oxide E172
、
Propylene Glycol
、
Strong Ammonia Solution
、
Potassium hydroxide
、
Isopropyl alcohol
、
Dehydrated alcohol
、
Butyl alcohol
、
Purified water.
Information might differ in some countries.
INDICATIONS
Glivec
®
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