EMEA-002460-PIP01-18 - paediatric investigation plan

amantadine (hydrochloride)

Key facts

• Active substance:
  amantadine (hydrochloride)
• Therapeutic area:
  Neurology
• Decision number:
  P/0033/2019
• PIP number:
  EMEA-002460-PIP01-18
• Pharmaceutical form(s):
  Prolonged-release capsule (hard)
• Condition(s) / indication(s):
  Treatment of Parkinson's disease and parkinsonism
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  29/01/2019
• Compliance check done:
  No

Decision

P/0033/2019: EMA decision of 29 January 2019 on the granting of a product specific waiver for amantadine (hydrochloride) (EMEA-002460-PIP01-18)

Reference Number: EMA/887206/2018