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Ultomiris

300 milligram(s) Concentrate for solution for infusion

Alexion Europe SASEU/1/19/1371/001

Main Information

Trade NameUltomiris
Active SubstancesRAVULIZUMAB
Strength300 milligram(s)
Dosage FormConcentrate for solution for infusion
Licence HolderAlexion Europe SAS
Licence NumberEU/1/19/1371/001

Group Information

ATC CodeL04AA Selective immunosuppressants

Status

Authorised/WithdrawnAuthorised
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
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