EMEA-002559-PIP01-19 - paediatric investigation plan

anti-neonatal Fc receptor human monoclonal antibody

Key facts

• Active substance:
  anti-neonatal Fc receptor human monoclonal antibody
• Therapeutic area:
  Other
• Decision number:
  P/0288/2019
• PIP number:
  EMEA-002559-PIP01-19
• Pharmaceutical form(s):
  • Concentrate for solution for infusion
  • Solution for injection
• Condition(s) / indication(s):
  Prevention of haemolytic disease of the foetus and newborn
• Route(s) of administration:
  • Intravenous use
  • Subcutaneous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  16/08/2019
• Compliance check done:
  No

Decision

P/0288/2019: EMA decision of 16 August 2019 on the granting of a product specific waiver for anti-neonatal Fc receptor human monoclonal antibody (EMEA-002559-PIP01-19)

Adopted Reference Number: EMA/436685/2019