Augtyro
·
- Prescription status not stated
- Cancer treatments and immune-system medicines
- Active substance
- Repotrectinib
- Made by
- Bristol-Myers Squibb Pharma EEIG
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
- Augtyro as monotherapy is indicated for the treatment of adult patients with ROS1-positive advanced non-small cell lung cancer (NSCLC). Augtyro as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age and older with advanced solid tumours expressing a NTRK gene fusion, and who have received a prior NTRK inhibitor, or have not received a prior NTRK inhibitor and treatment options not targeting NTRK provide limited clinical benefit, or have been exhausted (see sections 4.4 and 5.1)
From the official label · 2026-09-30 · European Medicines Agency
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
United StatesNo exact match for this strength and form
NetherlandsNo exact match for this strength and form
Details
| Made by | Bristol-Myers Squibb Pharma EEIG |
|---|---|
| Active substance | Repotrectinib |
| Used in | Cancer treatments and immune-system medicines |
| Classification | L01EX28 · Cancer treatments and immune-system medicines |
| Additional monitoring ▼ | Yes — under additional monitoring (black triangle). Report suspected side effects. |
| Authorised on | 2025-01-13 |
| Last updated by the regulator | 2025-01-28 |
| EMA product number | EMEA/H/C/006005 |
Source: European Medicines Agency — medicine data · 2026-09-30 · not reviewed by a clinician
Source: European Medicines Agency (EMA). Product information as published by EMA. Reuse terms: EMA legal notice (reproduction authorised).