EMEA-001811-PIP03-20 - paediatric investigation plan

ligelizumab

Key facts

• Active Substance:
  ligelizumab
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  P/0372/2021
• PIP number:
  EMEA-001811-PIP03-20
• Pharmaceutical form(s):
  • Solution for injection
  • Age-appropriate dosage form for parenteral use
• Condition(s) / indication(s):
  Treatment of food allergy
• Route(s) of administration:
  Subcutaneous use
• Contact for public enquiries:

  Novartis Europharm Limited

  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:
  08/09/2021

Decision

P/0372/2021 : EMA decision of 8 September 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for ligelizumab (EMEA-001811-PIP03-20)

AdoptedReference Number: EMA/463911/2021