Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1783256
Name of medicinal product: ALUNBRIG
Active substances:
Brigatinib
Estonian, English, Latin
ATC code: L01ED04
Dosage form: film-coated tablet
Route of administration: oral use
Strengh: 90mg
Amount in package: 28TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
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
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Last imported to Estonia: April 26, 2024
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 
Percent Valid from Valid until Valid Diagnosis Doctor's speciality Primary Age Other
100  05.04.2024     Yes  C34-C34  Onkoloog  No     anaplastilise lümfoomkinaas-positiivse kaugelearenenud varem ravimata mitteväikerakk-kopsuvähi raviks heas üldseisundis (ECOG 0-2) täiskasvanud patsientidele 
100  05.04.2024     Yes  C34-C34  Onkoloog  No  until 4 years  anaplastilise lümfoomkinaas-positiivse kaugelearenenud varem ravimata mitteväikerakk-kopsuvähi raviks heas üldseisundis (ECOG 0-2) täiskasvanud patsientidele 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: November 24, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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