EMEA-002500-PIP01-18 - paediatric investigation plan

Budesonide

Key facts

• Active Substance:
  Budesonide
• Therapeutic area:
  Uro-nephrology
• Decision number:
  P/0049/2020
• PIP number:
  EMEA-002500-PIP01-18
• Pharmaceutical form(s):
  Modified release capsule
• Condition(s) / indication(s):
  Treatment of primary IgA nephropathy
• Route(s) of administration:
  Oral use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  29/01/2020

Decision

P/0049/2020: EMA decision of 29 January 2020 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for budesonide (EMEA-002500-PIP01-18)

AdoptedReference Number: EMA/27396/2020