EMEA-002600-PIP04-22 - paediatric investigation plan

Pegcetacoplan

Key facts

• Invented name:
  Aspaveli
• Active Substance:
  Pegcetacoplan
• Therapeutic area:
  Neurology
• Decision number:
  P/0403/2022
• PIP number:
  EMEA-002600-PIP04-22
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of amyotrophic lateral sclerosis
• Route(s) of administration:
  Subcutaneous use
• Contact for public enquiries:

  Apellis Netherlands B.V.

  email: [e-mail]; tel: [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  09/09/2022

Decision

P/0403/2022 : EMA decision of 9 September 2022 on the granting of a product specific waiver for pegcetacoplan (Aspaveli), (EMEA-002600-PIP04-22)

AdoptedReference Number: EMA/709243/2022