EMEA-003523-PIP01-23 - paediatric investigation plan

Interleukin-2/Interleukin-1 beta, human/Granulocyte colony-stimulating factor/Tumour necrosis factoralpha/ Interferon gamma

Key facts

• Active substance:
  Interleukin-2/Interleukin-1 beta, human/Granulocyte colony-stimulating factor/Tumour necrosis factoralpha/ Interferon gamma
• Therapeutic area:
  Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Decision number:
  P/0057/2024
• PIP number:
  EMEA-003523-PIP01-23
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of head and neck epithelial malignant neoplasms
• Route(s) of administration:
  Peritumoral and perilymphatic use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  08/03/2024
• Compliance check done:
  No

Decision

P/0057/2024 : EMA decision of 8 March 2024 on the granting of a product-specific waiver for Interleukin-2/Interleukin-1 beta, human/Granulocyte colony-stimulating factor/Tumour necrosis factor-alpha/Interferon gamma (EMEA-003523-PIP01-23)

Adopted Reference Number: EMA/62601/2024