EMEA-002340-PIP01-18 - paediatric investigation plan

nitrous oxide

Key facts

• Active substance:
  nitrous oxide
• Therapeutic area:
  Pain
• Decision number:
  P/0217/2018
• PIP number:
  EMEA-002340-PIP01-18
• Pharmaceutical form(s):
  Medicinal gas (liquefied)
• Condition(s) / indication(s):
  Sedation
• Route(s) of administration:
  Inhalation use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  19/07/2018
• Compliance check done:
  No

Decision

P/0217/2018: EMA decision of 19 July 2018 on the granting of a product specific waiver for nitrous oxide (EMEA-002340-PIP01-18)

Adopted Reference Number: EMA/421241/2018