EMEA-000784-PIP02-11-M01 - paediatric investigation plan

nitisinone

Key facts

• Invented name:
  • Orfadin
  • Orfadin
• Active substance:
  nitisinone
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0276/2013
• PIP number:
  EMEA-000784-PIP02-11-M01
• Pharmaceutical form(s):
  Oral suspension
• Condition(s) / indication(s):
  Treatment of tyrosinemia type 1
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  30/10/2013
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-000784-PIP02-11-M01
• Compliance opinion date:
  17/01/2014
• Compliance outcome:
  Positive

Decision

P/0276/2013: EMA decision of 30 October 2013 on the acceptance of a modification of an agreed paediatric investigation plan for nitisinone (Orfadin), (EMEA-000784-PIP02-11-M01)

Adopted Reference Number: EMA/592153/2013