EMEA-000653-PIP01-09-M05

Adopted

First published: 02/10/2017
Last updated: 02/10/2017
EMA/460032/2017

Invented name	Nplate
Active substance	romiplostim
Therapeutic area	Haematology-Hemostaseology
Decision number	P/0233/2017
PIP number	EMEA-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 idiopathic thrombocytopenic purpura as a model for immunomodulation
Route(s) of administration	Subcutaneous use
Contact for public enquiries	Amgen Europe BV E-mail: medinfointernational@amgen.com Tel. +44 (0)1223 420305
Decision type	PM: decision on the application for modification of an agreed PIP
Compliance procedure number	EMEA-C-000653-PIP01-09-M05
Compliance opinion date	27/03/2020
Compliance outcome	positive