EMEA-001364-PIP01-12

Key facts

Active substance
  • Atorvastatin calcium
  • Amlodipine besilate
Therapeutic area
Endocrinology, -gynacology-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

Decision

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