EMEA-001530-PIP01-13 - paediatric investigation plan

4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide (JNJ-54781532-AAD)

Key facts

• Active Substance:
  4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide (JNJ-54781532-AAD)
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0221/2014
• PIP number:
  EMEA-001530-PIP01-13
• Pharmaceutical form(s):
  • Film-coated tablet
  • Age-appropriate oral dosage form
• Condition(s) / indication(s):
  Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, ankylosing spondyloarthritis, psoriatic arthritis and juvenile idiopathic arthritis)
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Janssen Cilag International NV (Belgium)

  Belgium ; E-mail: [e-mail] ; 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:
  03/09/2014

Decision

P/0221/2014: EMA decision of 3 September 2014 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H...

AdoptedReference Number: EMA/454986/2014