Vernakalant hydrochloride - paediatric investigation plan

Vernakalant hydrochloride

Key facts

• Active Substance:
  Vernakalant hydrochloride
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/43/2008
• PIP number:
  Vernakalant hydrochloride
• Pharmaceutical form(s):
  • Encapsulated tablet
  • Concentrate for solution for infusion
• Condition(s) / indication(s):
  Atrial fibrillation
• Route(s) of administration:
  • Oral use
  • Intravenous use
• Contact for public enquiries:

  Cardiome UK Limited

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

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  24/06/2008

Decision

P/43/2008: European medicines agency decision of 24 June 2008 on the application for product specific waiver for vernakalant hydrochloride (EMEA-000226-PIP01-08) in accordance with Regulation (EC) No 1901/2006 of the E...

AdoptedReference Number: EMEA/313727/2008