EMEA-000065-PIP01-07-M05 - paediatric investigation plan

telbivudine

Key facts

• Invented name:
  • Sebivo
  • Sebivo
• Active substance:
  telbivudine
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0152/2017
• PIP number:
  EMEA-000065-PIP01-07-M05
• 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:
  07/06/2017
• Compliance check done:
  No

Decision

P/0152/2017: EMA decision of 7 June 2017 on the acceptance of a modification of an agreed paediatric investigation plan for telbivudine (Sebivo), (EMEA-000065-PIP01-07-M05)

Adopted Reference Number: EMA/305258/2017