GENRX IMATINIB

Quốc gia: Úc

Ngôn ngữ: Tiếng Anh

Nguồn: Department of Health (Therapeutic Goods Administration)

Thành phần hoạt chất:

imatinib mesilate, Quantity: 119.5 mg

Sẵn có từ:

Arrotex Pharmaceuticals Pty Ltd

INN (Tên quốc tế):

imatinib mesilate

Dạng dược phẩm:

Tablet, film coated

Thành phần:

Excipient Ingredients: crospovidone; colloidal anhydrous silica; hypromellose; hyprolose; macrogol 8000; iron oxide red; iron oxide yellow; magnesium stearate

Tuyến hành chính:

Oral

Các đơn vị trong gói:

180, 60

Loại thuốc theo toa:

(S4) Prescription Only Medicine

Chỉ dẫn điều trị:

- treatment of patients with chronic myeloid leukaemia (CML) - treatment of adult patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (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, where conventional therapies have failed - treatment of adult patients with aggressive systemic mastocytosis (ASM), where conventional therapies have failed - treatment of adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) - adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP).

Tóm tắt sản phẩm:

Visual Identification: Brownish orange, round biconvex, bevelled-edge, film-coated tablets. Engraved "IMA" over score "100" on one side, "APO" on the other side; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Tình trạng ủy quyền:

Licence status A

Ngày ủy quyền:

2013-04-18