Atorvastatin calcium
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) |
|
Condition(s) / indication(s) |
Pure hypercholesterolaemia (heterozygous, homozygous, or otherwise primary hypercholesterolaemia), combined (mixed) hyperlipidaemia; prevention of cardiovascular events
|
Route(s) of administration |
Oral use
|
Contact for public enquiries |
Pfizer Limited
|
Decision type |
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
|
Compliance procedure number |
EMEA-C-000073-PIP01-07
|
Compliance opinion date |
13/11/2009
|
Compliance outcome |
positive
|