EMEA-003210-PIP01-22 - paediatric investigation plan

Doxecitine

Doxribtimine

Key facts

• Active substance:
  • Doxecitine
  • Doxribtimine
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0287/2022
• PIP number:
  EMEA-003210-PIP01-22
• Pharmaceutical form(s):
  Powder for oral solution
• Condition(s) / indication(s):
  Treatment of thymidine kinase 2 deficiency
• Route(s) of administration:
  • Oral use
  • Gastric use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  11/08/2023
• Compliance check done:
  No

Decision

P/0287/2022 : EMA decision on 11 August 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral for doxecitine / doxribtimine (EMEA-003210-PIP01-22)

Adopted Reference Number: EMA/629449/2022