EMEA-001519-PIP01-13 - paediatric investigation plan

(R)-7-Chloro-benzo[b]thiophene-2-carboxylic acid (1-aza-bicyclo[2.2.2]oct-3-yl)-amide hydrochloride hydrate (EVP-6124)

Key facts

• Active Substance:
  (R)-7-Chloro-benzo[b]thiophene-2-carboxylic acid (1-aza-bicyclo[2.2.2]oct-3-yl)-amide hydrochloride hydrate (EVP-6124)
• Therapeutic area:
  Neurology
• Decision number:
  P/0288/2014
• PIP number:
  EMEA-001519-PIP01-13
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Treatment of schizophrenia
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  FORUM Pharmaceuticals, Inc.

  United States ; 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:
  12/12/2014

Decision

P/0288/2014: EMA decision of 12 December 2014 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for (R)-7-Chloro-benzo[b]thiophene-2-carboxylic acid (1-...

AdoptedReference Number: EMA/591053/2014