EMEA-002866-PIP01-20 - paediatric investigation plan

N-[(1R)-1-(1H-indol-3-ylmethyl)pentyl]-2-(4-methylpiperazin-1-yl)thiazole-5-carboxamide (UCB0599)

Key facts

• Active Substance:
  N-[(1R)-1-(1H-indol-3-ylmethyl)pentyl]-2-(4-methylpiperazin-1-yl)thiazole-5-carboxamide (UCB0599)
• Therapeutic area:
  Neurology
• Decision number:
  P/0484/2020
• PIP number:
  EMEA-002866-PIP01-20
• Pharmaceutical form(s):
  Capsule (hard)
• Condition(s) / indication(s):
  Treatment of Parkinson's disease
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  UCB Pharma S.A.

  Tel. + 353 14632371; E-mail: [e-mail]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  21/12/2020

Decision

P/0484/2020 : EMA decision of 21 December 2020 on the granting of a product specific waiver for N-[(1R)-1-(1H-indol-3-ylmethyl)pentyl]-2-(4- methylpiperazin-1-yl)thiazole-5-carboxamide (UCB0599) (EMEA-002866-PIP01-20)

AdoptedReference Number: EMA/632012/2020