EMEA-001657-PIP01-14-M01 - paediatric investigation plan

Glucagon

Key facts

• Invented name:
  Baqsimi
• Active substance:
  Glucagon
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0301/2020
• PIP number:
  EMEA-001657-PIP01-14-M01
• Pharmaceutical form(s):
  Nasal powder
• Condition(s) / indication(s):
  Treatment of hypoglycaemia
• Route(s) of administration:
  Intranasal use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  12/08/2020
• Compliance check done:
  Yes
• Compliance procedure number:
  EMA/PE/0000223458
• Compliance opinion date:
  18/10/2024
• Compliance outcome:
  Positive

Decision

P/0301/2020: EMA decision of 12 August 2020 on the acceptance of a modification of an agreed paediatric investigation plan for glucagon (Baqsimi), (EMEA-001657-PIP01-14-M01)

Adopted Reference Number: EMA/371376/2020