EMEA-001474-PIP01-13-M01 - paediatric investigation plan

anti-PD1 humanized monoclonal antibody of the IgG4/kappa class (MK-3475) (pembrolizumab)

Key facts

• Invented name:
  Keytruda
• Active substance:
  anti-PD1 humanized monoclonal antibody of the IgG4/kappa class (MK-3475) (pembrolizumab)
• Therapeutic area:
  Oncology
• Decision number:
  P/0043/2018
• PIP number:
  EMEA-001474-PIP01-13-M01
• Pharmaceutical form(s):
  • Powder for concentrate for solution for infusion
  • Concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of all conditions included in the category of malignant neoplasms (except nervous system, haematopoietic and lymphoid tissue)
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  16/02/2018
• Compliance check done:
  Ja
• Compliance procedure number:
  EMEA-C-001474-PIP01-13-M01
• Compliance opinion date:
  01/02/2019
• Compliance outcome:
  Positive

Decision

P/0043/2018: EMA decision of 16 February 2018 on the acceptance of a modification of an agreed paediatric investigation plan for pembrolizumab (Keytruda), (EMEA-001474-PIP01-13-M01)

Adopted Reference Number: EMA/75530/2018