Pralsetinib capsules | China Drugs List
Public reference information, not medical advice, a prescription or an offer to supply a medicine. Confirm current approval, availability and suitability with licensed professionals.
Others
- Brand
- Gavreto
- Company
- Rigel Pharmaceuticals, Inc. (US label)
- Medicine type
- Chemical medicine
- Therapeutic area
- Oncology
- Indications recorded in the public source
- 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 The EU authorization was withdrawn in October 2024 for commercial reasons.
- Indication source and scope
- Revised 12/2025; effective 2025-12-30. Selected overseas indications; does not establish the Chinese approved scope.
- Prescribing-information limitations
- Overseas official prescribing information linked; a complete current Chinese label has not been verified.
- China availability status
- Chinese approval, current Chinese indications and continuous market availability were not independently verified in this English-source review.
- Overseas status
- See the linked overseas regulator / manufacturer evidence. Approval and indications are jurisdiction-specific; current supply is not established.
- Insurance classification
- Not yet verified
- Insurance edition
- Chinese national insurance review pending
- Insurance verification notes
- No reimbursement determination was made for this addition; missing information is not proof of exclusion.
Sources
- https://www.dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=16edd46e-28b8-f06d-e063-6394a90ae31b&type=display
- Gavreto — Rigel full US prescribing information on DailyMed
Official prescribing information · Revised 12/2025; effective 2025-12-30
Complete US manufacturer label opened, including indication and mechanism sections. Thyroid indication is accelerated approval; no medullary thyroid cancer indication is inferred.
- Gavreto — EMA withdrawal notice
Regulatory authorization status · Withdrawal 2024-10-24; page updated 2025-01-17
EU authorization withdrawn at the holder request for commercial reasons; historical EU product information is not presented as a current authorization.
Evidence reviewed:
Open the interactive record, public price references and discussions