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Kyowa Kirin Holdings B.V.EU/1/17/1262/001

Main Information

Active SubstancesRecombinant human igg1 monoclonal antibody to fibroblast growth factor 23
Dosage FormSolution for injection
Licence HolderKyowa Kirin Holdings B.V.
Licence NumberEU/1/17/1262/001

Group Information

ATC CodeM05BX Other drugs affecting bone structure and mineralization
M05BX05 burosumab


License statusAuthorised
Licence Issued
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
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