EMEA-002921-PIP01-20 - paediatric investigation plan

Argon

oxygen

Key facts

• Active Substance:
  • Argon
  • oxygen
• Therapeutic area:
  Neurology
• Decision number:
  P/0187/2021
• PIP number:
  EMEA-002921-PIP01-20
• Pharmaceutical form(s):
  Medicinal gas (compressed)
• Condition(s) / indication(s):
  Treatment of acute ischaemic stroke due to large intracranial vessel occlusion as add-on to thrombectomy
• Route(s) of administration:
  Inhalation use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  07/05/2021

Decision

P/0187/2021 : EMA decision of 7 May 2021 on the granting of a product specific waiver for argon / oxygen (EMEA-002921-PIP01-20)

AdoptedReference Number: EMA/151826/2021