EMEA-003562-PIP01-23 - paediatric investigation plan
ezetimibe
fenofibrate
rosuvastatin calcium
PIPHuman
Key facts
- Active Substance
- ezetimibe
- fenofibrate
- rosuvastatin calcium
- Therapeutic area
- Congenital, familial and genetic disorders
- Decision number
- P/0161/2024
- PIP number
- EMEA-003562-PIP01-23
- Pharmaceutical form(s)
- Film-coated tablet
- Condition(s) / indication(s)
- Treatment of hyperlipidaemia
- Route(s) of administration
- Oral use
- Contact for public enquiries
Althera Laboratories Ltd
Email: regulatory.eu@altheralabs.com
Tel: +353 861838865- Decision type
- W: decision granting a waiver in all age groups for all conditions or indications
- Decision date