Atorvastatin calcium

Key facts

Invented name
Sortis and associated names
Active substance
Atorvastatin calcium
Therapeutic area
Endocrinology, -gynacology-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
Route(s) of administration
Oral use
Contact for public enquiries
Pfizer Limited
E-mail: PIP_Enquiries@pfizer.com
Country: United Kingdom
Phone: +44 1304646607
Fax: +44 1304657750
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

Decision

Topics

How useful was this page?

Add your rating