EMEA-000436-PIP01-08 - paediatric investigation plan

mannitol

Key facts

• Active Substance:
  mannitol
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  P/204/2009
• PIP number:
  EMEA-000436-PIP01-08
• Pharmaceutical form(s):
  • Inhalation powder
  • Capsule (hard)
• Condition(s) / indication(s):
  Cystic fibrosis with pulmonary disease
• Route(s) of administration:
  Inhalation use
• Contact for public enquiries:

  Pharmaxis Pharmaceuticals Limited

  E-mail: [e-mail]; Tel.: [phone]

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  21/10/2009

Decision

P/204/2009: European Medicines Agency decision of 21 October 2009 on the agreement of a Paediatric Investigation Plan and on the granting of a deferral and on the granting of a waiver for mannitol (EMEA-000436-PIP01-08) ...

AdoptedReference Number: EMEA/659861/2009