EMEA-003515-PIP01-23 - paediatric investigation plan

2-(3,5-dichloro-1-methyl-indazol-4-yl)-1-[(1S,3R)-3-(hydroxymethyl)-5-(1-hydroxy-1-methyl-ethyl)- 1-methyl-3,4-dihydro-1H-isoquinolin-2-yl]ethanone monohydrate

Key facts

• Active Substance:
  2-(3,5-dichloro-1-methyl-indazol-4-yl)-1-[(1S,3R)-3-(hydroxymethyl)-5-(1-hydroxy-1-methyl-ethyl)- 1-methyl-3,4-dihydro-1H-isoquinolin-2-yl]ethanone monohydrate
• Therapeutic area:
  Nervous system disorders
• Decision number:
  P/0056/2024
• PIP number:
  EMEA-003515-PIP01-23
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of Parkinson's disease
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  08/03/2024

Decision

P/0056/2024 : EMA decision of 8 March 2024 on the granting of a product-specific waiver for 2-(3,5-dichloro-1-methyl-indazol-4-yl)-1-[(1S,3R)-3- (hydroxymethyl)-5-(1-hydroxy-1-methyl-ethyl)-1-methyl... (EMEA-003515-PIP01-23)

Reference Number: EMA/62600/2024