EMEA-003304-PIP01-22 - paediatric investigation plan

Mocravimod

Key facts

• Active substance:
  Mocravimod
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0310/2023
• PIP number:
  EMEA-003304-PIP01-22
• Pharmaceutical form(s):
  Capsule, hard
• Condition(s) / indication(s):
  Treatment in haematopoietic stem cell transplantation in patients with acute myeloid leukaemia
• 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:
  07/08/2023
• Compliance check done:
  No

Decision

P/0310/2023 : EMA decision of 7 August 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for mocravimod (EMEA-003304-PIP01-22)

Reference Number: EMA/344819/2023