Rosuvastatin (calcium) - paediatric investigation plan

rosuvastatin calcium
PIPHuman

Key facts

Invented name
Crestor and associated names
Active Substance
rosuvastatin calcium
Therapeutic area
Cardiovascular diseases
Decision number
P/229/2010
PIP number
Rosuvastatin (calcium)
Pharmaceutical form(s)
Film-coated tablet
Condition(s) / indication(s)
  • Homozygous Familial Hypercholesterolaemia
  • Prevention of cardiovascular events
  • Primary combined (mixed) dyslipidaemia
  • Primary hypercholesterolaemia
Route(s) of administration
Oral use
Contact for public enquiries

AstraZeneca AB (UK)

Tel. +44 2073045345
E-mail: paediatrics@astrazeneca.com

Decision type
PM: decision on the application for modification of an agreed PIP
Decision date
Compliance procedure number
EMEA-C-000022-PIP01-07-M04
Compliance opinion date
Compliance outcome
Positive

Decision

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