EMEA-001835-PIP01-15-M05 - paediatric investigation plan

Liquid ethanolic extract 30 per cent (w/w) of Allium cepa L. (fresh bulb) and Citrus limon (L.) Burm. f. (fresh fruit)

Paullinia cupana Kunth

Theobroma cacao L.

Key facts

• Active substance:
  • Liquid ethanolic extract 30 per cent (w/w) of Allium cepa L. (fresh bulb) and Citrus limon (L.) Burm. f. (fresh fruit)
  • Paullinia cupana Kunth
  • Theobroma cacao L.
• Therapeutic area:
  Dermatology
• Decision number:
  P/0220/2021
• PIP number:
  EMEA-001835-PIP01-15-M05
• Pharmaceutical form(s):
  Cutaneous solution
• Condition(s) / indication(s):
  Treatment of alopecia
• Route(s) of administration:
  Cutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  09/06/2021
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-001835-PIP01-15-M05
• Compliance opinion date:
  26/04/2023
• Compliance outcome:
  Positive

Decision

P/0220/2021 : EMA decision of 9 June 2021 on the acceptance of a modification of an agreed paediatric investigation plan for liquid ethanolic extract 30 per cent (w/w) of Allium cepa L. (fresh bulb) and Citrus limon (L.)....(EMEA-001835-PIP01-15-M05)

Adopted Reference Number: EMA/245659/2021