EMEA-003591-PIP01-24 - paediatric investigation plan
fenofibrate
rosuvastatin calcium
PIPHuman
Key facts
- Active Substance
- fenofibrate
- rosuvastatin calcium
- Therapeutic area
- Metabolism and nutrition disorders
- Decision number
- P/0200/2024
- PIP number
- EMEA-003591-PIP01-24
- Pharmaceutical form(s)
- Tablet.
- Condition(s) / indication(s)
- Treatment of elevated cholesterol with elevated triglycerides
- 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