EMEA-000279-PIP01-08-M05 - paediatric investigation plan

raltegravir

Key facts

• Invented name:
  • Isentress
  • Isentress
• Active substance:
  raltegravir
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0155/2016
• PIP number:
  EMEA-000279-PIP01-08-M05
• Pharmaceutical form(s):
  • Film-coated tablet
  • Chewable tablet
  • Granules for oral suspension
• Condition(s) / indication(s):
  Treatment of human immunodeficiency virus (HIV-1) infection
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  15/06/2016
• Compliance check done:
  Igen
• Compliance procedure number:
  EMEA-C-000279-PIP01-08-M05
• Compliance opinion date:
  19/06/2017
• Compliance outcome:
  Positive

Decision

P/0155/2016: EMA decision of 15 June 2016 on the acceptance of a modification of an agreed paediatric investigation plan for raltegravir (Isentress), (EMEA-000279-PIP01-08-M05)

Adopted Reference Number: EMA/314181/2016