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Tevimbra



BeiGene Ireland LimitedEU/1/23/1758/001-002

Main Information

Trade NameTevimbra
Active SubstancesTislelizumab
Dosage FormConcentrate for solution for infusion
Licence HolderBeiGene Ireland Limited
Licence NumberEU/1/23/1758/001-002

Group Information

ATC CodeL01 ANTINEOPLASTIC AGENTS
L01FF09 tislelizumab

Status

License statusAuthorised
Licence Issued15/09/2023
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

Documents

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