EMEA-000653-PIP01-09-M05

Key facts

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 immune thrombocytopenia (idiopathic thrombocytopenic purpura)
Route(s) of administration
Subcutaneous use
Contact for public enquiries
Amgen Europe BV
United Kingdom
E-mail: pipenquiry@amgen.com
Tel. +44 (0)1223 420305
Decision type
PM: decision on the application for modification of an agreed PIP

Decision

How useful was this page?

Add your rating