EMEA-003302-PIP01-22 - paediatric investigation plan

Humanised VHH-type bispecific antibody against complement component 5 and serum albumin (ALXN1720)

Key facts

• Active Substance:
  Humanised VHH-type bispecific antibody against complement component 5 and serum albumin (ALXN1720)
• Therapeutic area:
  Neurology
• Decision number:
  P/0198/2023
• PIP number:
  EMEA-003302-PIP01-22
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of myasthenia gravis
• Route(s) of administration:
  Subcutaneous use
• Contact for public enquiries:

  Alexion Europe SAS

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

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  22/05/2023

Decision

P/0198/2023 : EMA decision of 22 May 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for humanised VHH-type bispecific antibody against complement.....(EMEA-003302-PIP01-22)

AdoptedReference Number: EMA/220354/2023