Rozlytrek 50 mg film-coated granules in sachet
- Licence status
- Active substances
- Entrectinib
- Dosage Form
- Film-coated granules
- Licence number
- EU/1/20/1460/003
- Licence holder
- Roche Registration GmbH
Product documents
- Package Leaflet
- Summary of Product Characteristics
- Public Assessment Report
Licence information
- ATC code
- L01EX14 entrectinib
- Legal supply status
- Product subject to prescription which may not be renewed (A)
- Place of sale
- Supply through pharmacies only
- Conditions of Licence
- Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2)
- Marketing availability
- Unknown
- Advertising conditions
- Advertising to healthcare professionals only
- Licence issued
- 27/06/2024