EMEA-002022-PIP02-23 - paediatric investigation plan

DNA plasmid encoding HPV type 16 consensus E6 and E7 proteins (pGX 3001)

DNA plasmid encoding HPV type 18 consensus E6 and E7 proteins (pGX3002)

Key facts

• Active substance:
  • DNA plasmid encoding HPV type 16 consensus E6 and E7 proteins (pGX 3001)
  • DNA plasmid encoding HPV type 18 consensus E6 and E7 proteins (pGX3002)
• Therapeutic area:
  Infections and infestations
• Decision number:
  P/0509/2023
• PIP number:
  EMEA-002022-PIP02-23
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of squamous intraepithelial lesions of the anus caused by HPV types 16 and 18
• Route(s) of administration:
  Intramuscular use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  29/12/2023
• Compliance check done:
  No

Decision

P/0509/2023 : EMA decision of 29 December 2023 on the granting of a product specific waiver for DNA plasmid encoding HPV type 16 consensus E6 and E7 proteins (pGX 3001) / DNA plasmid encoding HPV type 18 consensus......(pGX3002) (EMEA-002022-PIP02-23)

Reference Number: EMA/554989/2023