Desvenlafaxine succinate monohydrate - paediatric investigation plan

Desvenlafaxine succinate monohydrate

Key facts

• Active Substance:
  Desvenlafaxine succinate monohydrate
• Therapeutic area:
  Psychiatry
• Decision number:
  P/158/2009
• PIP number:
  Desvenlafaxine succinate monohydrate
• Pharmaceutical form(s):
  Prolonged-release tablet
• Condition(s) / indication(s):
  Treatment of major depressive disorder
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Laboratorios Almirall S.A.

  E-mail: [e-mail]; Country: Spain; Phone: [phone]; Fax: [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  11/08/2009

Decision

P/158/2009: European Medicines Agency decision of 11 August 2009 on the granting of a product specific waiver for desvenlafaxine succinate monohydrate (EMEA-000523-PIP01-08) in accordance with Regulation (EC) No 1901/200...

AdoptedReference Number: EMEA/495247/200