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Nplate 250 micrograms /500 micrograms

Amgen Europe B.V.EU/1/08/497/5-8

Main Information

Trade NameNplate 250 micrograms /500 micrograms
Active SubstancesRomiplostim
Dosage FormPowder and solvent for solution for injection
Licence HolderAmgen Europe B.V.
Licence NumberEU/1/08/497/5-8

Group Information

ATC CodeB02BX Other systemic hemostatics
B02BX04 romiplostim


License statusAuthorised
Licence Issued11/01/2010
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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