EMEA-000628-PIP01-09-M04

Key facts

Invented name
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 chronic heart failure
  • Treatment of angina pectoris
  • Treatment of coronary artery disease
Route(s) of administration
  • Intravenous use
  • Oral use
Contact for public enquiries
Les Laboratoires Servier
E-mail: mail.pip.enquiries@fr.netgrs.com
Country: France
Tel. + 33 155726000
Fax: +32 155725044
Decision type
PM: decision on the application for modification of an agreed PIP
Compliance procedure number
EMEA-C-000628-PIP01-09-M04
Compliance opinion date
10/10/2014
Compliance outcome
positive

Decision

How useful was this page?

Add your rating