EMEA-001364-PIP01-12

Adopted

First published: 23/04/2013
Last updated: 23/04/2013
EMA/23839/2013

Active substance	Atorvastatin calcium Amlodipine besilate
Therapeutic area	Endocrinology-Gynaecology-Fertility-Metabolism
Decision number	P/0034/2013
PIP number	EMEA-001364-PIP01-12
Pharmaceutical form(s)	Film-coated tablet
Condition(s) / indication(s)	Prevention of cardiovascular events in hypertensive patients and diabetes mellitus type II patients with multiple risk factors for cardiovascular disease Treatment of concomitant angina and dyslipidaemia Treatment of concomitant hypertension and dyslipidaemia
Route(s) of administration	Oral use
Contact for public enquiries	HCS bvba E-mail: info@hcsbvba.be Country: Belgium Tel. + 32 475591545 Fax + 32 33215069
Decision type	W: decision granting a waiver in all age groups for all conditions or indications