EMEA-002755-PIP01-19-M02 - 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/0523/2023
• PIP number:
  EMEA-002755-PIP01-19-M02
• 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
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  29/12/2023
• Compliance check done:
  No

Decision

P/0523/2023 : EMA decision of 29 December 2023 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-M02)

Reference Number: EMA/553405/2023