EMEA-000612-PIP01-09 - paediatric investigation plan

nitric oxide

Key facts

• Invented name:
  • INOmax
  • INOmax
• Active substance:
  nitric oxide
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/256/09
• PIP number:
  EMEA-000612-PIP01-09
• Pharmaceutical form(s):
  Inhalation gas
• Condition(s) / indication(s):
  • Other pulmonary heart disease
  • Persistent Pulmonary Hypertension
• Route(s) of administration:
  Endotracheopulmonary use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  22/12/2009
• Compliance check done:
  Nem

Decision

P/256/09: EMA decision of 22 December 2009 on the granting of a product specific waiver for Nitric oxide (INOmax) (EMEA-000612-PIP01-09) in accordance with Regulation (EC) No 1901/2006 of the Europ...

Adopted Reference Number: EMA/821254/2009