EMEA-003023-PIP01-21 - paediatric investigation plan

5’-capped mRNA encoding HPV16 oncoprotein E6 and E7

Key facts

• Active Substance:
  5’-capped mRNA encoding HPV16 oncoprotein E6 and E7
• Therapeutic area:
  Oncology
• Decision number:
  P/0401/2021
• PIP number:
  EMEA-003023-PIP01-21
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  Treatment of head and neck squamous cell carcinoma (HNSCC)
• 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:
  30/09/2021

Decision

P/0401/2021 : EMA decision of 30 September 2021 on the granting of a product specific waiver for 5’-capped mRNA encoding HPV16 oncoprotein E6 and E7 (EMEA-003023-PIP01-21)

AdoptedReference Number: EMA/522104/2021