EMEA-000653-PIP01-09-M05

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Overview

Product details for Nplate
Invented nameNplate
Active substance

Romiplostim

Decision numberP/0233/2017
PIP numberEMEA-000653-PIP01-09-M05
Pharmaceutical form(s)Powder for solution for injection, Powder and solvent for solution for injection
Condition(s)/indication(s)

Treatment of disease-related thrombocytopenia in myelodysplastic syndrome

Treatment of immune thrombocytopenia (idiopathic thrombocytopenic purpura)

Route(s) of administrationSubcutaneous use
PIP applicant

Amgen Europe BV
United Kingdom
E-mail: pipenquiry@amgen.com
Tel. +44 (0)1223 420305

Decision typePM: decision on the application for modification of an agreed PIP

Decision