EMEA-001444-PIP01-13 - paediatric investigation plan

zolpidem (tartrate)

Key facts

• Active substance:
  zolpidem (tartrate)
• Therapeutic area:
  Psychiatry
• Decision number:
  P/0150/2013
• PIP number:
  EMEA-001444-PIP01-13
• Pharmaceutical form(s):
  Sublingual tablet
• Condition(s) / indication(s):
  Treatment of insomnia
• Route(s) of administration:
  Sublingual use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  03/07/2013
• Compliance check done:
  No

Decision

P/0150/2013: EMA decision of 3 July 2013 on the granting of a product-specific waiver for zolpidem tartrate (EMEA-001444-PIP01-13)

Adopted Reference Number: EMA/316665/2013