Entrectinib 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
- Rozlytrek
- Company
- Roche Registration GmbH (EU authorization holder)
- Medicine type
- Chemical medicine
- Therapeutic area
- Oncology
- Indications recorded in the public source
- Selected EU indications: For adults with ROS1-positive advanced non-small cell lung cancer who have not previously received a ROS1 inhibitor. NTRK fusion-positive solid-tumor indications are also described in the linked regulator overview, with age, prior-treatment and alternative-treatment requirements. This summary does not establish the approved indications in China.
- Indication source and scope
- Web page accessed 2026-11-02. Selected overseas indications; does not establish the Chinese approved scope.
- Prescribing-information limitations
- Regulatory product information / approval evidence is linked; a complete current prescribing-information document has not been verified in this review.
- 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.ema.europa.eu/en/medicines/human/EPAR/rozlytrek
- Rozlytrek — EMA European public assessment report
Regulatory medicine overview · Web page accessed 2026-11-02
English primary regulatory source opened and reviewed. Selected EU indications and the EU authorization holder are reported; this is not evidence of Chinese approval. The webpage overview and its older therapeutic-indication block display different pediatric age thresholds; this selected summary therefore states the consistent adult ROS1 indication and does not infer an unverified pediatric threshold. An attempted full-label fetch returned HTTP 429, so labelUrl is blank.
Evidence reviewed:
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