EMEA-003279-PIP01-22 - paediatric investigation plan

albaconazole

Key facts

• Active Substance:
  albaconazole
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0168/2023
• PIP number:
  EMEA-003279-PIP01-22
• Pharmaceutical form(s):
  Capsule (hard)
• Condition(s) / indication(s):
  Treatment of acute vulvovaginal candidiasis
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Palau Pharma, S.L.; E-mail: [e-mail] ; Tel: [phone]

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  15/05/2023

Decision

P/0168/2023 : EMA decision of 15 May 2023 on the agreement of a paediatric investigation plan and on the granting of a waiver for albaconazole (EMEA-003279-PIP01-22)

AdoptedReference Number: EMA/160497/2023