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KYNTHEUM (PREVIOUSLY KNOWN BRODALUMAB)

210mg(140mg/ml) Milligram Solution for injection in pre-filled syringe

LEO Pharma A/SEU/1/16/1155/001

Main Information

Trade NameKYNTHEUM (PREVIOUSLY KNOWN BRODALUMAB)
Active SubstancesBRODALUMAB
Strength210mg(140mg/ml) Milligram
Dosage FormSolution for injection in pre-filled syringe
Licence HolderLEO Pharma A/S
Licence NumberEU/1/16/1155/001

Group Information

ATC CodeL04AC12 Broadlumab

Status

Authorised/WithdrawnAuthorised
Licence Issued17/07/2017
Supply StatusSupply through pharmacies only
Dispensing StatusProduct subject to prescription which may not be renewed (A)
Marketing Status--Unknown--
Promotion StatusPromotion to Healthcare Professionals only
Conditions of LicenceMedicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).

Documents

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