EMEA-001307-PIP01-12 - paediatric investigation plan

lopinavir

ritonavir

lamivudine

Key facts

• Active substance:
  • lopinavir
  • ritonavir
  • lamivudine
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0268/2012
• PIP number:
  EMEA-001307-PIP01-12
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of human immunodeficiency virus (HIV-1) infection
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  20/11/2012
• Compliance check done:
  No

Decision

P/0268/2012: EMA decision of 20 November 2012 on the granting of a product-specific waiver for lopinavir / ritonavir / lamivudine (EMEA-001307-PIP01-12)

Adopted Reference Number: EMA/646961/2012