My HPRA: Register

NPLATE 500 MICROGRAMS

500 Microgram Pdr for Soln for Injection

Amgen Europe B.V.EU/1/08/497/2,4

Main Information

Trade NameNPLATE 500 MICROGRAMS
Active SubstancesROMIPLOSTIM
Strength500 Microgram
Dosage FormPdr for Soln for Injection
Licence HolderAmgen Europe B.V.
Licence NumberEU/1/08/497/2,4

Group Information

ATC CodeB02BX04 Other systemic hemostatics

Status

Authorised/WithdrawnAuthorised
Licence Issued04/02/2009
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

Educational Materials - HCP

Dosing Calculator
« Back
Follow medicine

Print