EMA/PE/0000182462 - paediatric investigation plan

bizalimogene ralaplasmid

mavilimogene ralaplasmid

rocakinogene sifuplasmid

Key facts

• Active substance:
  • bizalimogene ralaplasmid
  • mavilimogene ralaplasmid
  • rocakinogene sifuplasmid
• Therapeutic area:
  Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Decision number:
  EMA/PE/0000182462
• PIP number:
  EMA/PE/0000182462
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  human papilloma virus (HPV) type 16 and/or type 18 positive malignancies
• Route(s) of administration:
  All routes of administration
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  06/12/2024
• Compliance check done:
  No

Decision

EMA/PE/0000182462 : EMA decision of 6 December 2024 on the granting of a product specific waiver for bizalimogene ralaplasmid / mavilimogene ralaplasmid / rocakinogene sifuplasmid

Adopted Reference Number: EMADOC-1700519818-1789264