EMEA-001288-PIP01-12 - paediatric investigation plan

1-(2R,5R)-5-ethynyl-5-(hydroxymethyl)-2,5-dihydro-2-furanyl)-5-methyl-2,4(1H,3H)-pyrimidinedione (BMS-986001)

Key facts

• Active substance:
  1-(2R,5R)-5-ethynyl-5-(hydroxymethyl)-2,5-dihydro-2-furanyl)-5-methyl-2,4(1H,3H)-pyrimidinedione (BMS-986001)
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0082/2013
• PIP number:
  EMEA-001288-PIP01-12
• Pharmaceutical form(s):
  • Film-coated tablet
  • Age appropriate oral solid dosage form
• Condition(s) / indication(s):
  Treatment of human immunodeficiency virus (HIV-1) infection
• Route(s) of administration:
  Oral use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  27/03/2013
• Compliance check done:
  No

Decision

P/0082/2013: EMA decision of 27 March 2013 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for 1-(2R,5R)-5-ethynyl-5-(hydroxymethyl)-2,5-dihydro-2-fur...

Adopted Reference Number: EMA/192018/2013