EMEA-002519-PIP02-18 - paediatric investigation plan

2-(2-(3-Butoxy-phenyl)-ethylamino)-N,N-dimethyl-acetamide hydrochloride

Key facts

• Active substance:
  2-(2-(3-Butoxy-phenyl)-ethylamino)-N,N-dimethyl-acetamide hydrochloride
• Therapeutic area:
  Psychiatry
• Decision number:
  P/0215/2019
• PIP number:
  EMEA-002519-PIP02-18
• Pharmaceutical form(s):
  Capsule, hard
• Condition(s) / indication(s):
  Treatment of schizophrenia
• Route(s) of administration:
  Oral use
• Decision type:
  RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
• Decision date:
  14/06/2019
• Compliance check done:
  No

Decision

P/0215/2019: EMA decision of 14 June 2019 on the refusal of a product specific waiver for 2-(2-(3-Butoxy-phenyl)-ethylamino)-N,N-dimethyl-acetamide hydrochloride (EMEA-002519-PIP02-18)

Adopted Reference Number: EMA/299172/2019