EMEA-000339-PIP02-09-M03 - paediatric investigation plan

Entecavir

Key facts

• Invented name:
  • Baraclude
  • Baraclude
• Active substance:
  Entecavir
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0125/2014
• PIP number:
  EMEA-000339-PIP02-09-M03
• Pharmaceutical form(s):
  • Film-coated tablet
  • Oral solution
• Condition(s) / indication(s):
  Treatment of chronic hepatitis B
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  16/05/2014
• Compliance check done:
  Sim
• Compliance procedure number:
  EMEA-C-000339-PIP02-09-M03
• Compliance opinion date:
  20/06/2014
• Compliance outcome:
  Positive

Decision

P/0125/2014: EMA decision of 16 May 2014 on the acceptance of a modification of an agreed paediatric investigation plan for entecavir (monohydrate) (Baraclude), (EMEA-000339-PIP02-09-M03)

Adopted Reference Number: EMA/280408/2014