EMA/PE/0000230564 - paediatric investigation plan
ezetimibe
rosuvastatin
PIPHuman
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Key facts
- Active substance
- ezetimibe
- rosuvastatin
- Therapeutic area
- Cardiac disorders
- Decision number
- EMA/PE/0000230564
- PIP number
- EMA/PE/0000230564
- Pharmaceutical form(s)
- Film-coated tablet
- Condition(s) / indication(s)
- Treatment of cardiovascular disease
- Route(s) of administration
- Oral use
- Contact for public enquiries
Sun Pharmaceutical Industries (Europe) B.V.
Email: eu.regulatorynew@sunpharma.com
Tel.: +31 (0)645818462- Decision type
- W: decision granting a waiver in all age groups for all conditions or indications
- Decision date
- Compliance check done
- Ne