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Regeneron Ireland U.C.EU/1/19/1376/001

Main Information

Trade NameLibtayo
Active SubstancesCEMIPLIMAB
Dosage FormConcentrate for solution for infusion
Licence HolderRegeneron Ireland U.C.
Licence NumberEU/1/19/1376/001

Group Information

ATC CodeL01XC33 cemiplimab


License statusAuthorised
Licence Issued28/06/2019
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

Educational Materials - Patient

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