EMEA-000298-PIP01-08-M06 - paediatric investigation plan

peginterferon alfa-2a

Key facts

• Invented name:
  • Pegasys
  • Pegasys
• Active substance:
  peginterferon alfa-2a
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0143/2018
• PIP number:
  EMEA-000298-PIP01-08-M06
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  • Treatment of chronic hepatitis B
  • Treatment of chronic hepatitis C
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  07/05/2018
• Compliance check done:
  Kyllä
• Compliance procedure number:
  EMEA-C-000298-PIP01-08-M06
• Compliance opinion date:
  29/05/2019
• Compliance outcome:
  Positive

Decision

P/0143/2018: EMA decision of 7 May 2018 on the acceptance of a modification of an agreed paediatric investigation plan for peginterferon alfa-2a (Pegasys), (EMEA-000298-PIP01-08-M06)

Adopted Reference Number: EMA/201224/2018