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Ultomiris



Alexion Europe S.A.S.EU/1/19/1371/003

Main Information

Trade NameUltomiris
Active SubstancesRAVULIZUMAB
Dosage FormConcentrate for solution for infusion
Licence HolderAlexion Europe S.A.S.
Licence NumberEU/1/19/1371/003

Group Information

ATC CodeL04AA Selective immunosuppressants

Status

License statusAuthorised
Licence Issued02/07/2019
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

Documents

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

Educational Materials - HCP

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