Kapsul Pralsetinib | China Drugs ListPralsetinib capsules | China Drugs List
Maklumat rujukan awam, bukan nasihat perubatan, preskripsi atau tawaran membekalkan ubat. Sahkan kelulusan semasa, ketersediaan dan kesesuaian dengan profesional berlesen.
Lain-lain
- Jenama
- Gavreto
- Syarikat
- Rigel Pharmaceuticals, Inc. (label AS)Rigel Pharmaceuticals, Inc. (US label)
- Jenis ubat
- Ubat kimiaChemical medicine
- Bidang terapeutik
- OnkologiOncology
- Indikasi dalam sumber awam
- Maklumat preskripsi AS: orang dewasa dengan kanser paru-paru bukan sel kecil metastatik positif fusi RET yang dikenal pasti melalui ujian yang diluluskan FDA. Juga orang dewasa dan kanak-kanak berumur 12 tahun ke atas dengan kanser tiroid lanjut atau metastatik positif fusi RET yang memerlukan terapi sistemik dan refraktori terhadap iodin radioaktif apabila bersesuaian; indikasi tiroid ini mendapat kelulusan dipercepat. Indikasi AS ini tidak menetapkan kelulusan di China. Kebenaran EU ditarik balik pada Oktober 2024 atas sebab komersial.US prescribing information: adults with metastatic RET fusion-positive non-small cell lung cancer identified by an FDA-approved test. Also adults and children aged 12 years and older with advanced or metastatic RET fusion-positive thyroid cancer requiring systemic therapy and refractory to radioactive iodine when appropriate; this thyroid indication has accelerated approval. These US indications do not establish Chinese approval. The EU authorization was withdrawn in October 2024 for commercial reasons.
- Sumber dan skop indikasi
- Disemak semula 12/2025; berkuat kuasa 2025-12-30. Indikasi luar negara terpilih; tidak menetapkan skop yang diluluskan di China.Revised 12/2025; effective 2025-12-30. Selected overseas indications; does not establish the Chinese approved scope.
- Batasan maklumat preskripsi
- Maklumat preskripsi rasmi luar negara dipautkan; label China semasa yang lengkap belum disahkan.Overseas official prescribing information linked; a complete current Chinese label has not been verified.
- Status ketersediaan China
- Kelulusan di China, indikasi semasa di China dan ketersediaan berterusan di pasaran tidak disahkan secara bebas dalam semakan sumber bahasa Inggeris ini.Chinese approval, current Chinese indications and continuous market availability were not independently verified in this English-source review.
- Status luar negara
- Lihat bukti daripada pengawal selia / pengilang luar negara yang dipautkan. Kelulusan dan indikasi khusus mengikut bidang kuasa; bekalan semasa belum dipastikan.See the linked overseas regulator / manufacturer evidence. Approval and indications are jurisdiction-specific; current supply is not established.
- Klasifikasi insurans
- Belum disahkanNot yet verified
- Edisi insurans
- Semakan insurans kesihatan kebangsaan China belum selesaiChinese national insurance review pending
- Nota pengesahan insurans
- Tiada keputusan pembayaran balik dibuat bagi penambahan ini; maklumat yang tiada bukan bukti pengecualian.No reimbursement determination was made for this addition; missing information is not proof of exclusion.
Sumber
- https://www.dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=16edd46e-28b8-f06d-e063-6394a90ae31b&type=display
- Gavreto — maklumat preskripsi AS lengkap Rigel di DailyMedGavreto — Rigel full US prescribing information on DailyMed
Official prescribing information · Revised 12/2025; effective 2025-12-30
Label pengilang AS lengkap dibuka, termasuk bahagian indikasi dan mekanisme. Indikasi tiroid merupakan kelulusan dipercepat; tiada indikasi kanser tiroid medular disimpulkan.Complete US manufacturer label opened, including indication and mechanism sections. Thyroid indication is accelerated approval; no medullary thyroid cancer indication is inferred.
- Gavreto — notis penarikan balik EMAGavreto — EMA withdrawal notice
Regulatory authorization status · Withdrawal 2024-10-24; page updated 2025-01-17
Kebenaran EU ditarik balik atas permintaan pemegangnya atas sebab komersial; maklumat produk EU terdahulu tidak dipersembahkan sebagai kebenaran semasa.EU authorization withdrawn at the holder request for commercial reasons; historical EU product information is not presented as a current authorization.
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