EMEA-002077-PIP01-16-M03

Table of contents

Key facts

Invented name
Ultomiris
Active substance
ravulizumab
Therapeutic area
  • Haematology-Hemostaseology
  • Uro-nephrology
Decision number
P/0399/2020
PIP number
EMEA-002077-PIP01-16-M03
Pharmaceutical form(s)
  • Concentrate for solution for infusion
  • Solution for injection
Condition(s) / indication(s)
Treatment of paroxysmal nocturnal haemoglobinuria
Route(s) of administration
  • Intravenous use
  • Subcutaneous use
Contact for public enquiries
Alexion Europe SAS

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

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

Decision

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