Basic Information
Pravafenix
Regulatory Information
EMEA/H/C/001243
April 14, 2011
11
September 23, 2024
Company Information
Belgium
Rue de la Pastorale 26-28 B-1080 Brussels
Laboratoires S.M.B. SA
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Pravafenix is indicated for the treatment of high-coronary-heart-disease (CHD)-risk adult patients with mixed dyslipidaemia characterised by high triglycerides and low HDL-cholesterol (C) levels whose LDL-C levels are adequately controlled while on a treatment with pravastatin-40-mg monotherapy.
Overview Summary
This is a summary of the European public assessment report (EPAR) for Pravafenix. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Pravafenix.