EMEA-000196-PIP01-08-M04 - paediatric investigation plan

telaprevir

Key facts

• Invented name:
  • Incivo
  • Incivo
• Active substance:
  telaprevir
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0093/2017
• PIP number:
  EMEA-000196-PIP01-08-M04
• Pharmaceutical form(s):
  • Film-coated tablet
  • Chewable tablet
• Condition(s) / indication(s):
  Treatment of chronic hepatitis C
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  12/04/2017
• Compliance check done:
  No

Decision

P/0093/2017: EMA decision of 11 April 2017 on the acceptance of a modification of an agreed paediatric investigation plan for telaprevir (EMEA- 000196-PIP01-08-M04)

Adopted Reference Number: EMA/181808/2017