3-(1H-indol-3-yl)-4-(2-(4-methyl-1-piperazinyl)-4-quinazolinyl)-1H-pyrrole-2,5-dione acetate(1:1) - paediatric investigation plan

3-(1H-indol-3-yl)-4-(2-(4-methyl-1-piperazinyl)-4-quinazolinyl)-1H-pyrrole-2,5-dione acetate(1:1)

Key facts

• Active Substance:
  3-(1H-indol-3-yl)-4-(2-(4-methyl-1-piperazinyl)-4-quinazolinyl)-1H-pyrrole-2,5-dione acetate(1:1)
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/112/2008
• PIP number:
  3-(1H-indol-3-yl)-4-(2-(4-methyl-1-piperazinyl)-4-quinazolinyl)-1H-pyrrole-2,5-dione acetate(1:1)
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Chronic plaque psoriasis
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Novartis Europharm Limited

  E-mail: [e-mail]; Tel.: [phone]

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  01/12/2008

Decision

P/112/2008: European Medicines Agency decision of 1 December 2008 on the application for agreement of a Paediatric Investigation Plan for 3-(1H-indol-3-yl)-4-(2-(4-methyl-1-piperazinyl)-4-quinazolinyl)-1H-pyrrole-2,5-dio...

AdoptedReference Number: EMEA/624134/2008