EMEA-001965-PIP01-16 - paediatric investigation plan

Olodaterol (hydrochloride)

Key facts

• Invented name:
  • Striverdi
  • Respimat
• Active Substance:
  Olodaterol (hydrochloride)
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  P/0112/2017
• PIP number:
  EMEA-001965-PIP01-16
• Pharmaceutical form(s):
  Inhalation solution
• Condition(s) / indication(s):
  Treatment of cystic fibrosis
• 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:
  11/04/2017

Decision

P/0112/2017: EMA decision of 11 April 2017 on the agreement of a paediatric investigation plan and on the granting of a waiver for olodaterol (hydrochloride) (Striverdi Respimat), (EMEA-001965-PIP01-16)

AdoptedReference Number: EMA/181827/2017