EMEA-003405-PIP01-23 - paediatric investigation plan

CX-000359 mRNA encoding the UL128 protein in the CMV glycoprotein complex pentamer

CX- 000594 mRNA encoding the gL protein in the CMV glycoprotein complex pentamer

CX- 000712 mRNA encoding the UL130 protein in the CMV glycoprotein complex pentamer

CX-005128 mRNA encoding the UL131A protein in the CMV glycoprotein complex pentamer

CX-005282 m-RNA encoding the gH protein in the CMV glycoprotein complex pentamer

CX-000667 mRNA encoding CMV gB (mRNA- 1647)

Key facts

• Active Substance:
  • CX-000359 mRNA encoding the UL128 protein in the CMV glycoprotein complex pentamer
  • CX- 000594 mRNA encoding the gL protein in the CMV glycoprotein complex pentamer
  • CX- 000712 mRNA encoding the UL130 protein in the CMV glycoprotein complex pentamer
  • CX-005128 mRNA encoding the UL131A protein in the CMV glycoprotein complex pentamer
  • CX-005282 m-RNA encoding the gH protein in the CMV glycoprotein complex pentamer
  • CX-000667 mRNA encoding CMV gB (mRNA- 1647)
• Therapeutic area:
  Infections and infestations
• Decision number:
  P/0097/2024
• PIP number:
  EMEA-003405-PIP01-23
• Pharmaceutical form(s):
  Powder for suspension for injection
• Condition(s) / indication(s):
  Prevention of cytomegalovirus infection
• Route(s) of administration:
  Intramuscular use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  12/04/2024

Decision

P/0097/2024: EMA decision of 12 April 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for CX-000359 mRNA encoding the UL128 protein in the CMV glycoprotein complex pentamer /

AdoptedReference Number: EMA/137691/2024