EMEA-002905-PIP01-20 - paediatric investigation plan

Brensocatib

Key facts

• Active Substance:
  Brensocatib
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  P/0403/2021
• PIP number:
  EMEA-002905-PIP01-20
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of non-cystic fibrosis bronchiectasis
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Insmed Netherlands B.V.

  E-mail: [e-mail]; Telephone: [phone]

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  01/10/2021

Decision

P/0403/2021 : EMA decision of 1 October 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for brensocatib (EMEA-002905-PIP01-20)

AdoptedReference Number: EMA/535381/2021