EMEA-000628-PIP01-09-M04 - paediatric investigation plan

ivabradine hydrochloride

Key facts

• Invented name:
  • Procoralan
  • Procoralan
• Active Substance:
  ivabradine hydrochloride
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0102/2013
• PIP number:
  EMEA-000628-PIP01-09-M04
• Pharmaceutical form(s):
  • Film-coated tablet
  • Solution for injection
  • Oral solution
• Condition(s) / indication(s):
  • Treatment of angina pectoris
  • Treatment of chronic heart failure
  • Treatment of coronary artery disease
• Route(s) of administration:
  • Intravenous use
  • Oral use
• Contact for public enquiries:

  Les Laboratoires Servier

  E-mail: [e-mail]; Country: France; Tel. + 33 155726000; Fax: [phone]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  30/04/2013
• Compliance procedure number:
  EMEA-C-000628-PIP01-09-M04
• Compliance opinion date:
  10/10/2014
• Compliance outcome:
  Positive

Decision

P/0102/2013: EMA decision of 30 April 2013 on the acceptance of a modification of an agreed paediatric investigation plan for ivabradine (hydrochloride) (Procoralan) (EMEA-000628-PIP01-09-M04)

AdoptedReference Number: EMA/203739/2013