EMEA-002116-PIP01-17-M01 - paediatric investigation plan

Insulin human (NTRA-2112)

Key facts

• Active substance:
  Insulin human (NTRA-2112)
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0458/2022
• PIP number:
  EMEA-002116-PIP01-17-M01
• Pharmaceutical form(s):
  Powder for oral solution
• Condition(s) / indication(s):
  Treatment of intestinal malabsorption in preterm infants
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  28/10/2022
• Compliance check done:
  Nein

Decision

P/0458/2022 : EMA decision of 28 October 2022 on the acceptance of a modification of an agreed paediatric investigation plan for insulin human (NTRA-2112/ELGN-2112) (EMEA-002116-PIP01-17-M01)

Adopted Reference Number: EMA/776153/2022