EMEA-000222-PIP01-08-M09 - paediatric investigation plan

Etravirine

Key facts

• Invented name:
  • Intelence
  • Intelence
• Active Substance:
  Etravirine
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0121/2019
• PIP number:
  EMEA-000222-PIP01-08-M09
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Treatment of human immunodeficiency virus (HIV-1) infection
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Janssen-Cilag International NV

  Tel. [phone]

  E-mail: [e-mail]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  17/04/2019

Decision

P/0121/2019: EMA decision of 17 April 2019 on the acceptance of a modification of an agreed paediatric investigation plan for etravirine (Intelence), (EMEA-000222-PIP01-08-M09)

AdoptedReference Number: EMA/182544/2019Summary: