EMEA-002674-PIP01-19 - paediatric investigation plan

3-(4-acetamidophenyl)-2-(S)-methoxypropionic acid, or (S)-3-(4-acetamidophenyl)-2- methoxypropanoic acid (N-Acetyl-GED-0507-34-LEVO)

Key facts

• Active substance:
  3-(4-acetamidophenyl)-2-(S)-methoxypropionic acid, or (S)-3-(4-acetamidophenyl)-2- methoxypropanoic acid (N-Acetyl-GED-0507-34-LEVO)
• Therapeutic area:
  Skin and subcutaneous tissue disorders
• Decision number:
  P/0516/2023
• PIP number:
  EMEA-002674-PIP01-19
• Pharmaceutical form(s):
  Gel
• Condition(s) / indication(s):
  Treatment of acne vulgaris
• Route(s) of administration:
  Cutaneous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  29/12/2023
• Compliance check done:
  No

Decision

P/0516/2023 : EMA decision of 29 December 2023 on the agreement of a paediatric investigation plan and on the granting of a waiver for 3-(4- acetamidophenyl)-2-(S)-methoxypropionic acid, or (S)-3-(4-acetamidophenyl)-2.....(EMEA-002674-PIP01-19)

Reference Number: EMA/555066/2023