EMEA-002749-PIP01-19-M02 - paediatric investigation plan

Adrenaline (epinephrine)

Key facts

• Active Substance:
  Adrenaline (epinephrine)
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  P/0404/2022
• PIP number:
  EMEA-002749-PIP01-19-M02
• Pharmaceutical form(s):
  Nasal spray (solution)
• Condition(s) / indication(s):
  Treatment of allergic reactions
• Route(s) of administration:
  Nasal use
• Contact for public enquiries:

  ARS Pharmaceuticals IRL, Limited

  E-mail: [e-mail]; Tel: [phone]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  09/09/2022

Decision

P/0404/2022 : EMA decision of 9 September 2022 on the acceptance of a modification of an agreed paediatric investigation plan for adrenaline (epinephrine) (EMEA-002749-PIP01-19-M02)

AdoptedReference Number: EMA/640003/2008