EMEA-001127-PIP02-11-M02 - paediatric investigation plan

Hepatitis B (rDNA) surface antigen adjuvanted

Key facts

• Invented name:
  Heplisav B
• Active substance:
  Hepatitis B (rDNA) surface antigen adjuvanted
• Therapeutic area:
  Vaccines
• Decision number:
  P/0245/2022
• PIP number:
  EMEA-001127-PIP02-11-M02
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Prevention of hepatitis B virus infection
• Route(s) of administration:
  Intramuscular use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  08/07/2022
• Compliance check done:
  Nej

Decision

P/0245/2022 : EMA decision of 8 July 2022 on the acceptance of a modification of an agreed paediatric investigation plan for hepatitis B (rDNA) surface antigen adjuvanted (HEPLISAV B), (EMEA-001127-PIP02-11-M02)

Reference Number: EMA/595941/2022