EMEA-001743-PIP01-14 - paediatric investigation plan

Carvedilol

ivabradine hydrochloride

Key facts

• Active Substance:
  • Carvedilol
  • ivabradine hydrochloride
• Decision number:
  P/0178/2015
• PIP number:
  EMEA-001743-PIP01-14
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  • Treatment of heart failure
  • Treatment of ischaemic coronary artery disorders
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Les Laboratoires Servier

  France; Email: [e-mail]; Tel.: [phone]; Fax: [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  07/08/2015

Decision

P/0178/2015: EMA decision of 7 August 2015 on the granting of a product-specific waiver for carvedilol / ivabradine (hydrochloride) (EMEA-001743-PIP01-14)

AdoptedReference Number: EMA/473695/2015