EMEA-001996-PIP02-16-M01 - paediatric investigation plan

Glutamine

Key facts

• Active Substance:
  Glutamine
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0068/2022
• PIP number:
  EMEA-001996-PIP02-16-M01
• Pharmaceutical form(s):
  Oral powder
• Condition(s) / indication(s):
  Treatment of sickle cell disease
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  11/03/2022

Decision

P/0068/2022 : EMA decision of 11 March 2022 on the acceptance of a modification of an agreed paediatric investigation plan for glutamine (EMEA- 001996-PIP02-16-M01)

AdoptedReference Number: EMA/68911/2022