BALVERSA 4 MG
activeLast updated: 2026-07-29
Product & certifications 1
- FDA 1C15180/63(NC)drugคงอยู่
ตัวยาสำคัญ
- ERDAFITINIB4.0 milligramต่อ 1 tablet
- ประเภทควบคุม
- ยาควบคุมพิเศษ
- ข้อบ่งใช้
- BALVERSATM is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy Select patients for therapy based on avalidated test for BALVERSA [see posology and method of administration (4.2.1) and Clinical Studies] Limitations of Use BALVERSATM is not recommended for the treatment of patients who are ellgible for and have not received prior PD-1 or PD-L1 inhibitor therapy [see clinical studies]
- รหัส ATC
- L01XE (Protein kinase inhibitors)
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- Category
- ยาสำเร็จรูป
- Trade name
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- Company / Manufacturer
- บริษัท แจนเซ่น-ซีแลก จำกัดดำเนินกิจการ
- Juristic registration number
- 0105515009044
- Producer's other permits
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Last updated: 2026-07-29 · Data aggregated from official government databases: NBTC · FDA · TISI · DBD · Dept. of Tourism · ACFSReport incorrect data