EMEA-002755-PIP01-19-M01 - paediatric investigation plan

Fully human IgG1 RB-1 YTE anti-RSV F monoclonal antibody (MK-1654)

Key facts

• Active Substance:
  Fully human IgG1 RB-1 YTE anti-RSV F monoclonal antibody (MK-1654)
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0554/2021
• PIP number:
  EMEA-002755-PIP01-19-M01
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Prevention of lower respiratory tract infection caused by respiratory syncytial virus
• Route(s) of administration:
  Intramuscular use
• Contact for public enquiries:

  Merck Sharp & Dohme (Europe), Inc.

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  31/12/2021

Decision

P/0554/2021 : EMA decision of 31 December 2021 on the acceptance of a modification of an agreed paediatric investigation plan for fully human IgG1 RB- 1 YTE anti-RSV F monoclonal antibody (MK-1654), (EMEA-002755-PIP01-19-M01)

AdoptedReference Number: EMA/709698/2021