Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: ALECENSA
Active substances:
Estonian, English, Latin
ATC code: L01ED03
Dosage form: capsule, hard
Strength: 150mg
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
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
Marketing authorization holder: Roche Registration GmbH 
Marketing authorization number: EU/1/16/1169 
Marketing authorization issued on: February 20, 2017 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Centralised 
Assessment report:   
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
1739437  ALECENSA  capsule, hard  150mg 224TK  Prescription  100%    31.03.2024     
1758708  ALECENSA  capsule, hard  150mg 240TK  Prescription           
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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