EMEA-003514-PIP02-23 - paediatric investigation plan
Obicetrapib
Ezetimibe
PIPHuman
Key facts
- Active Substance
- Obicetrapib
- Ezetimibe
- Therapeutic area
- Metabolism and nutrition disorders
- Decision number
- P/0035/2024
- PIP number
- EMEA-003514-PIP02-23
- Pharmaceutical form(s)
- Tablet
- Condition(s) / indication(s)
- Treatment of elevated cholesterol
- Route(s) of administration
- Oral use
- Contact for public enquiries
NewAmsterdam Pharma B.V.
Email: Marc.ditmarsch@newamsterdampharma.com
Tel. +31 352062971- Decision type
- W: decision granting a waiver in all age groups for all conditions or indications
- Decision date