P/0096/2023 : EMA decision of 10 March 2023 on the granting of a product specific waiver for pembrolizumab (Keytruda), (EMEA-001474-PIP03-22) - paediatric investigation plan

Pembrolizumab

Key facts

• Invented name:
  Keytruda
• Active Substance:
  Pembrolizumab
• Therapeutic area:
  Oncology
• Decision number:
  P/0096/2023
• PIP number:
  P/0096/2023 : EMA decision of 10 March 2023 on the granting of a product specific waiver for pembrolizumab (Keytruda), (EMEA-001474-PIP03-22)
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of Hodgkin lymphoma, treatment of all conditions included in the category of malignant neoplasms (except nervous system, haematopoietic and lymphoid tissue)
• Route(s) of administration:
  Subcutaneous use
• Contact for public enquiries:

  Merck Sharp & Dohme (Europe), Inc

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

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  10/03/2023

Decision

P/0096/2023 : EMA decision of 10 March 2023 on the granting of a product specific waiver for pembrolizumab (Keytruda), (EMEA-001474-PIP03-22)

Reference Number: EMA/65237/2023