Key facts

Invented name
Ultomiris
Active Substance
ravulizumab
Therapeutic area
Uro-nephrology
Decision number
P/0188/2022
PIP number
EMEA-001943-PIP01-16-M07
Pharmaceutical form(s)
  • Concentrate for solution for infusion
  • Solution for injection
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

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

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

Decision

P/0188/2022 : EMA decision of 10 June 2022 on the acceptance of a modification of an agreed paediatric investigation plan for ravulizumab (Ultomiris), (EMEA-001943-PIP01-16-M07)

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