EMEA-001120-PIP01-10 - paediatric investigation plan

Budesonide

Key facts

• Invented name:
  Budiair and associated names
• Active substance:
  Budesonide
• Therapeutic area:
  Neonatology-Paediatric Intensive Care
• Decision number:
  P/285/2011
• PIP number:
  EMEA-001120-PIP01-10
• Pharmaceutical form(s):
  Pressurised inhalation (solution)
• Condition(s) / indication(s):
  Prevention of bronchopulmonary dysplasia
• Route(s) of administration:
  Inhalation use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  30/11/2011
• Compliance check done:
  No

Decision

P/285/2011: EMA decision of 30 November 2011 on the agreement of a paediatric investigation plan and on the granting of a waiver for budesonide (Budiair and associated names) (EMEA-001120-PIP01-10)

Adopted Reference Number: EMA/910691/2011