EMEA-001716-PIP02-17 - paediatric investigation plan

Venglustat

Key facts

• Active Substance:
  Venglustat
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0066/2018
• PIP number:
  EMEA-001716-PIP02-17
• Pharmaceutical form(s):
  Capsule, hard
• 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:
  16/03/2018

Decision

P/0066/2018: EMA decision of 16 March 2018 on the granting of a product- specific waiver for venglustat (EMEA-001716-PIP02-17)

AdoptedReference Number: EMA/87971/2018