Product class: Authorized package
Medicinal product class: For human use
Package code: 1758708
Name of medicinal product: ALECENSA
Active substances:
Alectinib
Estonian, English, Latin
ATC code: L01ED03
Dosage form: capsule, hard
Route of administration: oral use
Strengh: 150mg
Amount in package: 240TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Alecensa as monotherapy is indicated for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC). Alecensa as monotherapy is indicated for the treatment of adult patients with ALK-positive advanced NSCLC previously treated with crizotinib.
Safety features: Yes
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: Roche Registration GmbH 
Marketing authorization number: EU/1/16/1169 
Marketing authorization issued on: 20 February 2017 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Centralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: 01 September 2022
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription