EMEA-001170-PIP01-11 - paediatric investigation plan

4-[[9-[(3S)-tetrahydro-3-furanyl]-8-[(2,4,6-trifluorophenyl)amino]-9H-purin-2-yl]amino]-transcyclohexanol (CC-930)

Key facts

• Active Substance:
  4-[[9-[(3S)-tetrahydro-3-furanyl]-8-[(2,4,6-trifluorophenyl)amino]-9H-purin-2-yl]amino]-transcyclohexanol (CC-930)
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  P/258/2011
• PIP number:
  EMEA-001170-PIP01-11
• Pharmaceutical form(s):
  Capsule (hard)
• Condition(s) / indication(s):
  Treatment of idiopathic pulmonary fibrosis
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Celgene Europe Limited

  Switzerland; [e-mail]; [phone]; [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  26/10/2011

Decision

P/258/2011: EMA decision of 26 October 2011 on the granting of a product specific waiver for 4-[[9-[(3S)-tetrahydro-3-furanyl]-8-[(2,4,6- trifluorophenyl)amino]-9H-purin-2-yl]amino]-trans-cyclohexanol (CC-930) (EMEA-001...

AdoptedReference Number: EMA/751564/2011