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Jemperli



GlaxoSmithKline (Ireland) LimitedEU/1/21/1538/001

Main Information

Trade NameJemperli
Active SubstancesDostarlimab
Dosage FormConcentrate for solution for infusion
Licence HolderGlaxoSmithKline (Ireland) Limited
Licence NumberEU/1/21/1538/001

Group Information

ATC CodeL01XC Monoclonal antibodies
L01XC40 dostarlimab

Status

License statusAuthorised
Licence Issued21/04/2021
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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