Atorvastatin calcium - paediatric investigation plan | European Medicines Agency (EMA)
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Atorvastatin calcium - paediatric investigation plan
Atorvastatin calcium
PIPHuman
Key facts
Invented name
Sortis and associated names
Active Substance
Atorvastatin calcium
Therapeutic area
Endocrinology-Gynaecology-Fertility-Metabolism
Decision number
P/53/2008
PIP number
Atorvastatin calcium
Pharmaceutical form(s)
Film-coated tablet
Age-appropriate oral formulation
Condition(s) / indication(s)
Pure hypercholesterolaemia (heterozygous, homozygous, or otherwise primary hypercholesterolaemia), combined (mixed) hyperlipidaemia; prevention of cardiovascular events
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Decision date
Compliance procedure number
EMEA-C-000073-PIP01-07
Compliance opinion date
Compliance outcome
Positive
Decision
P/53/2008: European medicines agency decision of 20 July 2008 on the application for agreement of a Paediatric Investigation Plan for Atorvastatin calcium (Sortis and associated names) EMEA-000073-PIP01-07 in accordance ...