EMA/PE/0000239193 - paediatric investigation plan

hafnium oxide

Key facts

• Active substance:
  hafnium oxide
• Therapeutic area:
  Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Decision number:
  EMA/PE/0000239193
• PIP number:
  EMA/PE/0000239193
• Pharmaceutical form(s):
  Suspension for injection
• Condition(s) / indication(s):
  Treatment of head and neck epithelial malignant neoplasms
• Route(s) of administration:
  • Intratumoral use
  • Intralesional use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  14/04/2025
• Compliance check done:
  Nej

Decision

EMA/PE/0000239193: EMa decision of 14 April 2025 on the granting of a product specific waiver for hafnium oxide

Adopted Reference Number: EMADOC-1700519818-2035628