EMEA-001168-PIP01-11-M03 - paediatric investigation plan

Serelaxin

Key facts

• Active Substance:
  Serelaxin
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0292/2016
• PIP number:
  EMEA-001168-PIP01-11-M03
• Pharmaceutical form(s):
  Solution for infusion
• Condition(s) / indication(s):
  Treatment of acute heart failure
• Route(s) of administration:
  Intravenous use
• Contact for public enquiries:

  Novartis Europharm Ltd

  United Kingdom; E-mail: [e-mail]; Tel. [phone]; Fax [phone]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  04/11/2016

Decision

P/0292/2016: EMA decision of 4 November 2016 on the acceptance of a modification of an agreed paediatric investigation plan for serelaxin (EMEA-001168-PIP01-11-M03)

Reference Number: EMA/666205/2016