EMEA-003403-PIP01-23 - paediatric investigation plan

therapeutic DNA plasmid vaccine targeting HPV16 E6 and E7 proteins (VB10.16)

Key facts

• Active substance:
  therapeutic DNA plasmid vaccine targeting HPV16 E6 and E7 proteins (VB10.16)
• Therapeutic area:
  Oncology
• Decision number:
  P/0256/2023
• PIP number:
  EMEA-003403-PIP01-23
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  Treatment of human papilloma virus (HPV) type 16 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:
  14/07/2023
• Compliance check done:
  No

Decision

P/0256/2023 : EMA decision of 14 July 2023 on the granting of a product specific waiver for therapeutic DNA plasmid vaccine targeting HPV16 E6 and E7 proteins (VB10.16) (EMEA-003403-PIP01-23)

Reference Number: EMA/304362/2023