EMEA-001504-PIP01-13 - paediatric investigation plan

5-(4,6-Dimethyl-1H-benzimidazol-2-yl)-4-methyl-N-[3-(1-methyl-4-piperidinyl)propyl]-2-pyrimidinamine 2,3-dihydroxybutanedioate hydrate (1:0.5:4) (JNJ-38518168)

Key facts

• Active Substance:
  5-(4,6-Dimethyl-1H-benzimidazol-2-yl)-4-methyl-N-[3-(1-methyl-4-piperidinyl)propyl]-2-pyrimidinamine 2,3-dihydroxybutanedioate hydrate (1:0.5:4) (JNJ-38518168)
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0150/2014
• PIP number:
  EMEA-001504-PIP01-13
• Pharmaceutical form(s):
  • Coated tablet
  • Age-appropriate dosage form, other
• Condition(s) / indication(s):
  Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylarthritis 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. + 44 (0)1494 567567; Fax [phone]

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  13/06/2014

Decision

P/0150/2014: EMA decision of 13 June 2014 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for 5-(4,6-dimethyl-1H-benzimidazol-2-yl)-4-methyl-N-[3-(1-m...

AdoptedReference Number: EMA/299666/2014