EMEA-001943-PIP05-21 - paediatric investigation plan

ravulizumab

Key facts

• Invented name:
  Ultomiris
• Active Substance:
  ravulizumab
• Therapeutic area:
  Neurology
• Decision number:
  P/0413/2021
• PIP number:
  EMEA-001943-PIP05-21
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of amyotrophic lateral sclerosis
• Route(s) of administration:
  Intravenous use
• Contact for public enquiries:

  Alexion Europe SAS

  E-mail: [e-mail]; Tel. [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  29/10/2021

Decision

P/0413/2021 : EMA decision of 29 October 2021 on the granting of a product specific waiver for ravulizumab (Ultomiris), (EMEA-001943-PIP05-21)

AdoptedReference Number: EMA/535289/2021