EMA/PE/0000291645 - paediatric investigation plan

mRNA encoding Human cytomegalovirus UL128

mRNA encoding Human cytomegalovirus UL130

mRNA encoding Human cytomegalovirus UL131A

mRNA encoding Human cytomegalovirus glycoprotein H

mRNA encoding Human cytomegalovirus glycoprotein B

mRNA encoding Human cytomegalovirus glycoprotein L

Key facts

• Active substance:
  • mRNA encoding Human cytomegalovirus UL128
  • mRNA encoding Human cytomegalovirus UL130
  • mRNA encoding Human cytomegalovirus UL131A
  • mRNA encoding Human cytomegalovirus glycoprotein H
  • mRNA encoding Human cytomegalovirus glycoprotein B
  • mRNA encoding Human cytomegalovirus glycoprotein L
• Therapeutic area:
  Infections and infestations
• Decision number:
  EMA/PE/0000291645
• PIP number:
  EMA/PE/0000291645
• Pharmaceutical form(s):
  Powder for suspension for injection
• Condition(s) / indication(s):
  Prevention of cytomegalovirus infection
• Route(s) of administration:
  Intramuscular use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  29/01/2026
• Compliance check done:
  Ne

Decision

EMA/PE/0000291645 : EMA decision of 29 January 2026 on the acceptance of a modification of an agreed paediatric investigation plan for mRNA encoding Human cytomegalovirus glycoprotein...

Adopted Reference Number: EMADOC-1700519818-2827694