EMEA-002694-PIP02-21 - paediatric investigation plan

mixture of 2 synthetic double-stranded N-Acetyl-galactosamine conjugated siRNA oligonucleotides that are directed against hepatitis B virus (JNJ-73763989)

Key facts

• Active substance:
  mixture of 2 synthetic double-stranded N-Acetyl-galactosamine conjugated siRNA oligonucleotides that are directed against hepatitis B virus (JNJ-73763989)
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0228/2022
• PIP number:
  EMEA-002694-PIP02-21
• Pharmaceutical form(s):
  • Age appropriate dosage form for parenteral use
  • Age appropriate formulation
• Condition(s) / indication(s):
  Treatment of chronic hepatitis D infection
• Route(s) of administration:
  • Subcutaneous use
  • Oral use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  08/07/2022
• Compliance check done:
  No

Decision

P/0228/2022: EMA decision of 8 July 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for mixture of 2 synthetic double-stranded N-Acetyl-galactosamine conjugated siRNA oligonucleoti

Reference Number: EMA/609177/2022