Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: ALUNBRIG
Active substances:
Brigatinib
Estonian, English, Latin
ATC code: L01ED04
Dosage form: film-coated tablet
Strength: 90mg
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Indication: Alunbrig is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor. Alunbrig is indicated as monotherapy for the treatment of adult patients with ALK-positive advanced NSCLC previously treated with crizotinib.
Safety features: Yes
Marketing authorization holder: Takeda Pharma A/S 
Marketing authorization number: EU/1/18/1264 
Marketing authorization issued on: November 26, 2018 
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
1783245  ALUNBRIG  film-coated tablet  90mg 7TK  Prescription           
1783256  ALUNBRIG  film-coated tablet  90mg 28TK  Prescription  100%    31.05.2024     
1783267  ALUNBRIG  film-coated tablet  90mg 30TK  Prescription           
3046384  ALUNBRIG  film-coated tablet  90mg 7TK  Prescription          pudel 
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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