EMEA-002424-PIP02-19 - paediatric investigation plan

7-(2-Methoxy-3,5-dimethylpyridin-4-yl)-1-[(3S)-tetrahydrofuran-3-yl]-1,5-dihydro-4H-pyrazolo[4,3-c]quinolin-4-one maleate

Key facts

• Active Substance:
  7-(2-Methoxy-3,5-dimethylpyridin-4-yl)-1-[(3S)-tetrahydrofuran-3-yl]-1,5-dihydro-4H-pyrazolo[4,3-c]quinolin-4-one maleate
• Therapeutic area:
  Neurology
• Decision number:
  P/0354/2019
• PIP number:
  EMEA-002424-PIP02-19
• Pharmaceutical form(s):
  Capsule (hard)
• Condition(s) / indication(s):
  Treatment of dementia with Lewy bodies
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Eisai 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:
  04/10/2019

Decision

P/0354/2019: EMA decision of 4 October 2019 on the granting of a product specific waiver for 7-(2-Methoxy-3,5-dimethylpyridin-4-yl)-1-[(3S)- tetrahydrofuran-3-yl]-1,5-dihydro-4H-pyrazolo[4,3- c]quinolin-4-one maleate (EMEA-002424-PIP02- 19)

AdoptedReference Number: EMA/523335/2019