EMEA-001553-PIP01-13-M02 - paediatric investigation plan

Nanobody directed towards the fusion protein of human respiratory syncytial virus (ALX-0171)

Key facts

• Active Substance:
  Nanobody directed towards the fusion protein of human respiratory syncytial virus (ALX-0171)
• Therapeutic area:
  Neonatology-Paediatric Intensive Care
• Decision number:
  P/0367/2018
• PIP number:
  EMEA-001553-PIP01-13-M02
• Pharmaceutical form(s):
  Nebuliser solution
• Condition(s) / indication(s):
  Treatment of lower respiratory tract disease caused by human respiratory syncytial virus (RSV)
• Route(s) of administration:
  Inhalation use
• Contact for public enquiries:

  Ablynx NV

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  07/12/2018

Decision

P/0367/2018: EMA decision of 7 December 2018 on the acceptance of a modification of an agreed paediatric investigation plan for nanobody directed towards the fusion protein of human respiratory syncytial virus (ALX-0171) (EMEA-001553-PIP01-13-M02)

AdoptedReference Number: EMA/796427/2018