EMEA-001468-PIP01-13 - paediatric investigation plan

(E)-4-[(5-Phenyl-1,3,4-thiadiazol-2-yl)oxy]-1-azoniatricyclo[3.3.1.13,7] decane 3,4-dicarboxy-3-hydroxybutanoate hydrate (ABT-126)

Key facts

• Active substance:
  (E)-4-[(5-Phenyl-1,3,4-thiadiazol-2-yl)oxy]-1-azoniatricyclo[3.3.1.13,7] decane 3,4-dicarboxy-3-hydroxybutanoate hydrate (ABT-126)
• Therapeutic area:
  Neurology
• Decision number:
  P/0081/2014
• PIP number:
  EMEA-001468-PIP01-13
• Pharmaceutical form(s):
  • Capsule
  • Coated tablet
• Condition(s) / indication(s):
  Treatment of schizophrenia
• Route(s) of administration:
  Oral use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  02/04/2014
• Compliance check done:
  No

Decision

P/0081/2014: EMA decision of 2 April 2014 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for (E)-4-[(5-Phenyl-1,3,4-thiadiazol-2-yl)oxy]-1-azoniatric...

Adopted Reference Number: EMA/122563/2014