EMEA-003398-PIP01-23 - paediatric investigation plan

salbutamol sulfate

Key facts

• Active substance:
  salbutamol sulfate
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  P/0223/2023
• PIP number:
  EMEA-003398-PIP01-23
• Pharmaceutical form(s):
  Inhalation powder
• Condition(s) / indication(s):
  Treatment of asthma
• Route(s) of administration:
  Inhalation use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  26/06/2023
• Compliance check done:
  No

Decision

P/0223/2023 : EMA decision of 26 June 2023 on the refusal of a paediatric investigation plan and on the granting of a waiver for salbutamol (sulfate) (EMEA-003398-PIP01-23)

Reference Number: EMA/234995/2023