EMEA-001608-PIP02-21 - paediatric investigation plan

Doxylamine (succinate)

pyridoxine (hydrochloride)

Key facts

• Active substance:
  • Doxylamine (succinate)
  • pyridoxine (hydrochloride)
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0410/2021
• PIP number:
  EMEA-001608-PIP02-21
• Pharmaceutical form(s):
  Prolonged-release tablet
• Condition(s) / indication(s):
  Treatment of nausea and vomiting in pregnancy
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  29/10/2021
• Compliance check done:
  No

Decision

P/0410/2021 : EMA decision of 29 October 2021 on the granting of a product specific waiver for doxylamine (succinate) / pyridoxine (hydrochloride) (Xonvea), (EMEA-001608-PIP02-21)

Adopted Reference Number: EMA/533708/2021