EMEA-003248-PIP01-22 - paediatric investigation plan

Suvecaltamide (hydrochloride)

Key facts

• Active Substance:
  Suvecaltamide (hydrochloride)
• Therapeutic area:
  Neurology
• Decision number:
  P/0372/2022
• PIP number:
  EMEA-003248-PIP01-22
• Pharmaceutical form(s):
  Capsule (hard)
• Condition(s) / indication(s):
  Treatment of essential tremor
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Jazz Pharmaceuticals Ireland Ltd.

  E-mail: [e-mail]; Telephone: [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  09/09/2022

Decision

P/0372/2022 : EMA decision of 9 September 2022 on the granting of a product specific waiver for suvecaltamide (hydrochloride) (EMEA-003248-PIP01- 22)

AdoptedReference Number: EMA/698313/2022