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Ultomiris



Alexion Europe S.A.S.EU/1/19/1371/004

Main Information

Trade NameUltomiris
Active SubstancesRAVULIZUMAB
Dosage FormSolution for injection
Licence HolderAlexion Europe S.A.S.
Licence NumberEU/1/19/1371/004

Group Information

ATC CodeL04AA43 ravulizumab

Status

License statusAuthorised
Licence Issued31/05/2023
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

Educational Materials - HCP

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