EMEA-001608-PIP01-13 - paediatric investigation plan

Doxylamine (succinate)

pyridoxine (hydrochloride)

Key facts

• Active Substance:
  • Doxylamine (succinate)
  • pyridoxine (hydrochloride)
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0140/2014
• PIP number:
  EMEA-001608-PIP01-13
• Pharmaceutical form(s):
  Gastro-resistant coated tablet
• Condition(s) / indication(s):
  Treatment of nausea and vomiting in pregnancy
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Duchesnay Inc.

  Canada; E-mail: [e-mail]; Tel. [phone]; Fax [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  11/06/2014

Decision

P/0140/2014: EMA decision of 11 June 2014 on the refusal of a paediatric investigation plan and on the granting of a waiver for doxylamine (succinate) / pyridoxine (hydrochloride) (EMEA-001608-PIP01-13)

AdoptedReference Number: EMA/275220/2014