EMEA-002652-PIP01-19 - paediatric investigation plan

betahistine

Key facts

• Active Substance:
  betahistine
• Therapeutic area:
  • Neurology
  • Oto-rhino-laryngology
• Decision number:
  P/0228/2020
• PIP number:
  EMEA-002652-PIP01-19
• Pharmaceutical form(s):
  Nasal spray (solution)
• Condition(s) / indication(s):
  Treatment of peripheral vertigo
• Route(s) of administration:
  Intranasal use
• Contact for public enquiries:

  Auris Medical Ltd

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

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  17/06/2020

Decision

P/0228/2020: EMA decision of 17 June 2020 on the granting of a product specific waiver for betahistine (dihydrochloride) (EMEA-002652-PIP01-19)

AdoptedReference Number: EMA/304245/2020