EMEA-000391-PIP01-08-M01 - paediatric investigation plan

nevirapine

Key facts

• Invented name:
  • Viramune
  • Viramune
• Active substance:
  nevirapine
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/26/2010
• PIP number:
  EMEA-000391-PIP01-08-M01
• Pharmaceutical form(s):
  • Prolonged-release tablet
  • Tablet
  • 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:
  03/03/2010
• Compliance check done:
  Да
• Compliance procedure number:
  EMEA-C-000391-PIP01-08-M01
• Compliance opinion date:
  06/08/2010
• Compliance outcome:
  Positive

Decision

P/26/2010: European Medicines Agency decision of of 3 March 2010 on the acceptance of a modification of an agreed Paediatric Investigation Plan for nevirapine (Viramune) (EMEA-000391-PIP01-08-M01) in accordance with Regu...

Adopted Reference Number: EMA/116975/2010