Rozlytrek
·
- Prescription status not stated
- Cancer treatments and immune-system medicines
- Active substance
- Entrectinib
- Made by
- Roche Registration GmbH
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
- Rozlytrek as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age and older with solid tumours expressing a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and who have not received a prior NTRK inhibitor who have no satisfactory treatment options. Rozlytrek as monotherapy is indicated for the treatment of adult patients with ROS1 positive, advanced non small cell lung cancer (NSCLC) not previously treated with ROS1 inhibitors.
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
SpainNo exact match for this strength and form
CanadaNo exact match for this strength and form
NetherlandsNo exact match for this strength and form
SwitzerlandNo exact match for this strength and form
Details
| Made by | Roche Registration GmbH |
|---|---|
| Active substance | Entrectinib |
| Used in | Cancer treatments and immune-system medicines |
| Classification | L01EX14 · Cancer treatments and immune-system medicines |
| Additional monitoring ▼ | Yes — under additional monitoring (black triangle). Report suspected side effects. |
| Authorised on | 2020-07-31 |
| Last updated by the regulator | 2026-07-15 |
| EMA product number | EMEA/H/C/004936 |
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).