EMEA-003104-PIP01-21 - paediatric investigation plan

Favezelimab

Pembrolizumab

Key facts

• Active Substance:
  • Favezelimab
  • Pembrolizumab
• Therapeutic area:
  Oncology
• Decision number:
  P/0009/2022
• PIP number:
  EMEA-003104-PIP01-21
• Pharmaceutical form(s):
  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 neoplasms and melanoma)
• Route(s) of administration:
  Intravenous use
• Contact for public enquiries:

  Merck, Sharp & Dohme (Europe) Inc.

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

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  31/01/2022

Decision

P/0009/2022 : EMA decision of 31 January 2022 on the granting of a product-specific waiver for favezelimab / pembrolizumab (EMEA-003104-PIP01- 21)

AdoptedReference Number: EMA/782285/2021