EMEA-000043-PIP01-07 - paediatric investigation plan

indacaterol maleate

Key facts

• Active Substance:
  indacaterol maleate
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  P/2/2008
• PIP number:
  EMEA-000043-PIP01-07
• Pharmaceutical form(s):
  • Inhalation powder
  • Capsule (hard)
• Condition(s) / indication(s):
  Chronic obstructive pulmonary disease
• Route(s) of administration:
  Inhalation use
• Contact for public enquiries:

  Novartis Europharm Limited

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

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  01/02/2008

Decision

P/2/2008: European medicines agency decision of 1 February 2008 on the application for a product specific waiver for Indacaterol maleate EMEA-000043-PIP01-07 in accordance with Regulation (EC) No 1901/2006 of the Europea...

AdoptedReference Number: EMEA/43267/2008