EMEA-001943-PIP01-16-M05

Table of contents

Key facts

Invented name
Ultomiris
Active substance
ravulizumab
Therapeutic area
  • Haematology-Hemostaseology
  • Uro-nephrology
Decision number
P/0400/2020
PIP number
EMEA-001943-PIP01-16-M05
Pharmaceutical form(s)
  • Concentrate for solution for infusion
  • Solution for infusion
Condition(s) / indication(s)
Treatment of atypical haemolytic uremic syndrome
Route(s) of administration
  • Intravenous use
  • Subcutaneous use
Contact for public enquiries
Alexion Europe SAS

Tel. +33 147100615
E-mail: pip.enquiries@alexion.com

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

Decision

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