EMA/PE/0000221101 - paediatric investigation plan

esepapogene zalarnarepvec

Key facts

• Active substance:
  esepapogene zalarnarepvec
• Therapeutic area:
  Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Decision number:
  EMA/PE/0000221101
• PIP number:
  EMA/PE/0000221101
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of human papillomavirus (HPV) 16 positive oropharyngeal squamous cell carcinoma
• Route(s) of administration:
  Intravenous use
• Compliance check done:
  No

Decision

EMA/PE/0000221101 : EMA decision of 5 December 2024 on the granting of a product specific waiver for esepapogene zalarnarepvec

Adopted Reference Number: EMADOC-1700519818-1791979