EMEA-003039-PIP01-21

Table of contents

Key facts

Active substance
  • Ezetimibe
  • Rosuvastatin
Therapeutic area
Cardiovascular diseases
Decision number
P/0469/2021
PIP number
EMEA-003039-PIP01-21
Pharmaceutical form(s)
Film-coated tablet
Condition(s) / indication(s)
  • Prevention of cardiovascular events
  • Treatment of hypercholesterolaemia
Route(s) of administration
Oral use
Contact for public enquiries
Sandoz s.r.o.

Tel.: +31 365241710
E-mail: enquiries.paediatrics@sandoz.com

Decision type
W: decision granting a waiver in all age groups for all conditions or indications

Decision

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