EMEA-003472-PIP01-23 - paediatric investigation plan
Rosuvastatin
Ezetimibe
PIPHuman
Key facts
- Active Substance
- Rosuvastatin
- Ezetimibe
- Therapeutic area
- Cardiovascular diseases
- Decision number
- P/0490/2023
- PIP number
- EMEA-003472-PIP01-23
- 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
- Decision type
- W: decision granting a waiver in all age groups for all conditions or indications
- Decision date