EMEA-002383-PIP01-18-M03 - paediatric investigation plan

glycopyrronium bromide

Key facts

• Invented name:
  Axhidrox
• Active substance:
  glycopyrronium bromide
• Therapeutic area:
  Skin and subcutaneous tissue disorders
• Decision number:
  P/0497/2023
• PIP number:
  EMEA-002383-PIP01-18-M03
• Pharmaceutical form(s):
  Cream
• Condition(s) / indication(s):
  Treatment of hyperhidrosis
• Route(s) of administration:
  Topical use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  01/12/2023
• Compliance check done:
  Yes
• Compliance procedure number:
  EMA/PE/0000233230
• Compliance opinion date:
  13/12/2024
• Compliance outcome:
  Positive

Decision

P/0497/2023: EMA decision of of 1 December 2023 on the acceptance of a modification of an agreed paediatric investigation plan for glycopyrronium bromide (Axhidrox), (EMEA-002383-PIP01-18-M03)

Adopted Reference Number: EMA/532192/2023