EMEA-001267-PIP01-12 - paediatric investigation plan

N-{4-chloro-2-[(1-oxido-4-pyridinyl)carbonyl]phenyl}-4-(1,1-dimethylethyl) benzenesulfonamide, sodium salt

Key facts

• Active Substance:
  N-{4-chloro-2-[(1-oxido-4-pyridinyl)carbonyl]phenyl}-4-(1,1-dimethylethyl) benzenesulfonamide, sodium salt
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0048/2013
• PIP number:
  EMEA-001267-PIP01-12
• Pharmaceutical form(s):
  • Capsule (hard)
  • Age-appropriate dosage form, other
• Condition(s) / indication(s):
  Treatment of Crohn's disease
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Glaxo Group Limited

  E-mail: [e-mail]; Country: United Kingdom; Tel. + [phone]; Fax + [phone]

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  01/03/2013

Decision

P/0048/2013: EMA decision of 1 March 2013 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for N-{4-chloro-2-[(1-oxido-4-pyridinyl)carbonyl]phenyl}-4-(...

AdoptedReference Number: EMA/120296/2013