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Crestor

Rosuvastatin

A potent statin for lowering LDL cholesterol.

Generic name
Rosuvastatin
Brand name
Crestor
Marketed by
AstraZeneca
First FDA approval
12 Aug 2003

Where Rosuvastatin is approved

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Of the three regulators tracked here, the first to approve Rosuvastatin was Canada, on 16 Feb 2003. It is approved in 2 of the 3 regulators tracked here.

USUnited States (FDA)
12 Aug 2003
Crestor
NDA021366 on Drugs@FDA
First original NDA/BLA approval
EUEuropean Union (EMA)
No centralised EU authorisation (it may be authorised nationally)
First centralised authorisation
CACanada (Health Canada)
16 Feb 2003
Crestor
Notice of Compliance 3523
First new-drug NOC

From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.

What health systems spend on Rosuvastatin

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ENNHS England
£16.2m
7,851,975 items dispensed, Aug 2025 to Jul 2026
+63% on the previous 12 months
Net ingredient cost, community prescriptions
USUS Medicaid
$45.9m
3,962,984 prescriptions in 2025 · Rosuvastatin Calcium, Rosuvastatin calcium, Rosuvastatin
+8% on 2024
Amount Medicaid reimbursed, before rebates

From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.

How Rosuvastatin works

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  • HMG-CoA reductase inhibitor Inhibitor
    Target: HMGCR 3-hydroxy-3-methylglutaryl-CoA reductase
    ✓ In ChEMBL and the Guide to Pharmacology
Other medicines acting on HMGCR
Diseases it has been tested for in clinical trials, by furthest phase
  • COVID-19Phase 3
  • Combined hyperlipidemiaPhase 3
  • HIV infectious diseasePhase 3
  • Increased body weightPhase 3
  • Acute coronary syndromePhase 3
  • Acute lung injuryPhase 3
  • Acute respiratory distress syndromePhase 3
  • AtherosclerosisPhase 3
  • Chronic kidney diseasePhase 3
  • Congestive heart failurePhase 3
76 diseases in all

Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL1496, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3), ligand 2954, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.

NICE appraisals of Rosuvastatin

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NICE, which decides whether the NHS in England should fund new medicines, has published 1 technology appraisal of Rosuvastatin. 1 is current, and 1 of it recommends it for at least some patients.

AppraisalNICE recommendationPublishedStatus
Statins for the prevention of cardiovascular events
NICE TA94
Recommended25 Jan 2006Current

NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.

Patient leaflets for Rosuvastatin

The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.

Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.

Reference identifiers for Rosuvastatin

ATC code
C10AA07
ChEMBL
CHEMBL1496
DrugBank
DB01098
PubChem CID
446157
CAS number
287714-41-4
FDA UNII
413KH5ZJ73
Wikidata
Q415159
Wikipedia
Rosuvastatin

Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.

What Crestor is used for

Rosuvastatin (Crestor) is a potent statin for lowering LDL cholesterol. It belongs to the Statin class.

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How this page is built

The facts on this page are pulled directly from official U.S. FDA datasets — they are not written from memory. Each field below names the dataset it came from, so you can check it yourself.

Plain-English summaries and drug-class explainers are written and reviewed by Sreepriya Prasannan (MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany). Data is retrieved automatically from the sources above and cross-checked with AI-assisted verification (Anthropic's Claude) — brand and generic names are matched against the exact FDA product record so that a combination product or a different formulation cannot be mistaken for the drug on this page. An editor reviews the result before publication. We describe this in full in our editorial standards and corrections policy. The FDA data on this page was last retrieved on 10 Oct 2026. How every register is built: methodology · fixes we have made: corrections log.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician — our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us — we correct promptly and log it.