EMEA-000059-PIP01-07 - paediatric investigation plan

indacaterol maleate

glycopyrronium bromide

Key facts

• Active substance:
  • indacaterol maleate
  • glycopyrronium bromide
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  P/5/2008
• PIP number:
  EMEA-000059-PIP01-07
• Pharmaceutical form(s):
  • Inhalation powder
  • Capsule, hard
• Condition(s) / indication(s):
  Chronic obstructive pulmonary disease
• Route(s) of administration:
  Inhalation use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  01/02/2008
• Compliance check done:
  No

Decision

P/5/2008: European medicines agency decision of 1 February 2008 on the application for product specific waiver for Indacaterol maleate, Glycopyrronium bromide EMEA-000059-PIP01-07 in accordance with Regulation (EC) No 19...

Adopted Reference Number: EMEA/43543/2008