EMEA-003582-PIP01-24 - paediatric investigation plan
rosuvastatin
ezetimibe
PIPHuman
Key facts
- Active substance
- rosuvastatin
- ezetimibe
- Therapeutic area
- Cardiac disorders
- Decision number
- P/0210/2024
- PIP number
- EMEA-003582-PIP01-24
- 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
Verisfield Single Member S.A.
Email: pharmacovigilance@verisfield.gr; economou@verisfield.gr
Tel: +30 2107475196- Decision type
- W: decision granting a waiver in all age groups for all conditions or indications
- Decision date
- Compliance check done
- No