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80 milligram(s) Film-coated tablet

AstraZeneca ABEU/1/16/1086/002

Main Information

Trade NameTagrisso
Active SubstancesOsimertinib mesylate
Strength80 milligram(s)
Dosage FormFilm-coated tablet
Licence HolderAstraZeneca AB
Licence NumberEU/1/16/1086/002

Group Information

ATC CodeL01XE Protein kinase inhibitors
L01XE35 ZZZ Osimertinib


Licence Issued02/02/2016
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceMedicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Marketing StatusUnknown


Summary of Product CharacteristicsSearch EMA website
Package LeafletSearch EMA website
Public Assessment ReportSearch EMA website
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