EMEA-001251-PIP01-11-M06 - paediatric investigation plan

talimogene laherparepvec

Key facts

• Invented name:
  Imlygic
• Active Substance:
  talimogene laherparepvec
• Therapeutic area:
  Oncology
• Decision number:
  P/0275/2023
• PIP number:
  EMEA-001251-PIP01-11-M06
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of melanoma
• Route(s) of administration:
  Intralesional use
• Contact for public enquiries:

  Amgen Europe B.V.

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  14/07/2023

Decision

P/0275/2023 : EMA decision of 14 July 2023 on the acceptance of a modification of an agreed paediatric investigation plan for talimogene laherparepvec (Imlygic), (EMEA-001251-PIP01-11-M06)

Reference Number: EMA/282173/2023