Active substance
Simvastatin
- SFDA 25
- US FDA 20
- Health Canada 57
- US price lines 7
- NHS prices 6
- WHO EML 1
- Safety 11
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| SIMCOR 10 MG F-C TABLETS | 10 mg | Film-coated tablet · Oral use | 30 Blister | SAR 43.55 | Generic · Prescription | Pharma International Co. | Valid |
| SIMCOR 20 MG F-C TABLETS | 20 mg | Film-coated tablet · Oral use | 30 Blister | SAR 48.20 | Generic · Prescription | Pharma International Co. | Valid |
| SIMVA 10 MG COATED TABLET | 10 mg | Film-coated tablet · Oral use | 30 Blister | SAR 56.90 | Generic · Prescription | Jamjoom Pharmaceuticals Factory Company | Valid |
| SIMVA 20 MG COATED TABLET | 20 mg | Film-coated tablet · Oral use | 30 Blister | SAR 56.90 | Generic · Prescription | Jamjoom Pharmaceuticals Factory Company | Valid |
| SIMVA 40 MG COATED TABLET | 40 mg | Film-coated tablet · Oral use | 30 Blister | SAR 65.15 | Generic · Prescription | Jamjoom Pharmaceuticals Factory Company | Valid |
| SIMVAGEN 10 mg film-coated tablet | 10 mg | Film-coated tablet · Oral use | 30 Blister | SAR 66.95 | Generic · Prescription | RIYADH PHARMA | Valid |
| SIMVAGEN 20 mg film-coated tablet | 20 mg | Film-coated tablet · Oral use | 30 Blister | SAR 66.95 | Generic · Prescription | RIYADH PHARMA | Valid |
| SIMVAGEN 40 mg film-coated tablet | 40 mg | Film-coated tablet · Oral use | 30 Blister | SAR 66.95 | Generic · Prescription | RIYADH PHARMA | Valid |
| VASTA 10MG F.C TAB | 10 mg | Film-coated tablet · Oral use | 30 Blister | SAR 66.95 | Generic · Prescription | Tabuk Pharmaceutical Manufacturing Company | Valid |
| VASTA 20MG F.C TAB | 20 mg | Film-coated tablet · Oral use | 30 Blister | SAR 66.95 | Generic · Prescription | Tabuk Pharmaceutical Manufacturing Company | Valid |
| VASTA 40MG F.C. TABLETS | 40 mg | Film-coated tablet · Oral use | 30 Blister | SAR 66.95 | Generic · Prescription | Tabuk Pharmaceutical Manufacturing Company | Valid |
| VISCOR 20MG F.C. TABLETS | 20 mg | Film-coated tablet · Oral use | 30 Blister | SAR 48.20 | Generic · Prescription | National Pharmaceutical Industries Co. (SAOG) | Valid |
| ZOCOR 10MG TAB | 10 mg | Film-coated tablet · Oral use | 30 Blister | SAR 66.95 | NCE · Prescription | Organon Pharma UK Limited | Valid |
| ZOCOR 20MG TAB | 20 mg | Film-coated tablet · Oral use | 28 Blister | SAR 66.95 | NCE · Prescription | Organon Pharma UK Limited | Valid |
| ZOCOR 40MG TAB | 40 mg | Film-coated tablet · Oral use | 30 Blister | SAR 66.95 | NCE · Prescription | Organon Pharma UK Limited | Valid |
| SIMVAHEXAL 10MG F.C. TABLETS | 10 mg | Film-coated tablet · Oral use | 30 Blister | SAR 39.20 | Generic · Prescription | HEXAL | Withdrawn by MAH · Not Marketed |
| SIMVAHEXAL 20MG F.C. TABLETS | 20 mg | Film-coated tablet · Oral use | 30 Blister | SAR 43.40 | Generic · Prescription | HEXAL | Withdrawn by MAH · Not Marketed |
| SIMVAHEXAL 40MG F.C. TABLETS | 40 mg | Film-coated tablet · Oral use | 30 Blister | SAR 58.65 | Generic · Prescription | HEXAL | Withdrawn by MAH · Not Marketed |
| SIMVAST | 20 mg | Film-coated tablet · Oral use | 28 Blister | SAR 68.55 | Generic · Prescription | Gulf Pharmaceutical Industries (Julphar) | Withdrawn by MAH · Not Marketed |
| SIMVAST 10MG TAB | 10 mg | Film-coated tablet · Oral use | 28 Blister | SAR 62.00 | Generic · Prescription | Gulf Pharmaceutical Industries (Julphar) | Withdrawn by MAH · Not Marketed |
| SIMVAST 40 MG TABLETS | 40 mg | Film-coated tablet · Oral use | 30 Blister | SAR 80.45 | Generic · Prescription | Gulf Pharmaceutical Industries (Julphar) | Withdrawn by MAH · Not Marketed |
| SIMVATEN 10MG F.C.TABLET | 10 mg | Film-coated tablet · Oral use | 30 Blister | SAR 53.80 | Generic · Prescription | SAJA-SAUDI ARABIAN JAPANESE PHARMACEUTICAL CO | Withdrawn by MAH · Not Marketed |
| SIMVATEN 20MG F.C.TABLET | 20 mg | Film-coated tablet · Oral use | 30 Blister | SAR 59.50 | Generic · Prescription | SAJA-SAUDI ARABIAN JAPANESE PHARMACEUTICAL CO | Withdrawn by MAH · Not Marketed |
| SIMVATEN 40MG F.C.TABLET | 40 mg | Film-coated tablet · Oral use | 30 Blister | SAR 89.40 | Generic · Prescription | SAJA-SAUDI ARABIAN JAPANESE PHARMACEUTICAL CO | Withdrawn by MAH · Not Marketed |
| VASTA 80MG F.C. TABLETS | 80 mg | Film-coated tablet · Oral use | 30 Blister | SAR 118.75 | Generic · Prescription | Tabuk Pharmaceutical Manufacturing Company | Withdrawn by MAH · Not Marketed |
Indications — CHI Daman Drug Formulary
ANTIPHOSPHOLIPID SYNDROME; CORONARY ARTERY DISEASE; DYSLIPIDEMIA; METACHROMATIC LEUKODYSTROPHY; NON-ST WAVE ELEVATED MYOCARDIAL INFARCTION (NSTEMI); ST-WAVE ELEVATED MYOCARDIAL INFARCTION (STEMI)
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| ZOCOR | 5MG; 10MG; 20MG; 40MG | tablet · oral | ORGANON | Prescription | 23 Dec 1991 |
| SIMVASTATIN | 5MG; 10MG; 20MG; 40MG; 80MG | tablet · oral | AUROBINDO PHARMA | Prescription | 20 Dec 2006 |
| SIMVASTATIN | 10MG; 20MG; 40MG; 80MG; 5MG | tablet · oral | RISING | Prescription | 20 Dec 2006 |
| SIMVASTATIN | 5MG; 10MG; 20MG; 40MG; 80MG | tablet · oral | ZYDUS PHARMS USA | Prescription | 20 Dec 2006 |
| SIMVASTATIN | 5MG; 10MG; 20MG; 40MG; 80MG | tablet · oral | BIOCON PHARMA | Prescription | 20 Dec 2006 |
| SIMVASTATIN | 10MG; 20MG; 40MG; 80MG; 5MG | tablet · oral | LUPIN | Prescription | 11 May 2007 |
| SIMVASTATIN | 80MG; 10MG; 20MG; 40MG; 5MG | tablet · oral | ACCORD HLTHCARE | Prescription | 26 Feb 2008 |
| SIMVASTATIN | 5MG; 10MG; 20MG; 40MG; 80MG | tablet · oral | OXFORD PHARMS | Prescription | 30 Aug 2010 |
| SIMVASTATIN | 5MG; 10MG; 20MG; 40MG; 80MG | tablet · oral | HETERO LABS LTD III | Prescription | 25 Nov 2014 |
| FLOLIPID | 20MG/5ML; 40MG/5ML | suspension · oral | SALERNO PHARMS | Prescription | 21 Apr 2016 |
| SIMVASTATIN | 10MG; 20MG; 40MG; 80MG; 5MG | tablet · oral | INVAGEN PHARMS | Prescription | 13 Nov 2017 |
| SIMVASTATIN | 10MG; 20MG; 40MG; 80MG | tablet · oral | YILING | Prescription | 27 Nov 2024 |
| ZOCOR | 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | tablet · oral | ORGANON | Discontinued | 23 Dec 1991 |
| SIMVASTATIN | 5MG; 10MG; 20MG; 40MG; 80MG | tablet · oral | IVAX SUB TEVA PHARMS | Discontinued | 23 Jun 2006 |
| SIMVASTATIN | 5MG; 10MG; 20MG; 40MG; 80MG | tablet · oral | SUN PHARM INDS LTD | Discontinued | 23 Jun 2006 |
| SIMVASTATIN | 5MG; 10MG; 20MG; 40MG; 80MG | tablet · oral | WATSON LABS TEVA | Discontinued | 20 Dec 2006 |
| SIMVASTATIN | 5MG; 10MG; 20MG; 40MG; 80MG | tablet · oral | CHARTWELL RX | Discontinued | 20 Dec 2006 |
| SIMVASTATIN | 10MG; 20MG; 40MG; 80MG | tablet, orally disintegrating · oral | SYNTHON PHARMS | Discontinued | 9 Oct 2007 |
| SIMVASTATIN | 5MG; 10MG; 20MG; 40MG; 80MG | tablet · oral | PHARMOBEDIENT | Discontinued | 8 Jun 2010 |
| SIMVASTATIN | 5MG; 10MG; 20MG; 40MG; 80MG | tablet · oral | MICRO LABS | Discontinued | 16 Sep 2011 |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| APO-SIMVASTATIN | 02247011 | 5 MG | TABLET · ORAL | APOTEX INC |
| APO-SIMVASTATIN | 02247012 | 10 MG | TABLET · ORAL | APOTEX INC |
| APO-SIMVASTATIN | 02247013 | 20 MG | TABLET · ORAL | APOTEX INC |
| APO-SIMVASTATIN | 02247014 | 40 MG | TABLET · ORAL | APOTEX INC |
| APO-SIMVASTATIN | 02247015 | 80 MG | TABLET · ORAL | APOTEX INC |
| AURO-SIMVASTATIN | 02405148 | 5 MG | TABLET · ORAL | AURO PHARMA INC |
| AURO-SIMVASTATIN | 02405156 | 10 MG | TABLET · ORAL | AURO PHARMA INC |
| AURO-SIMVASTATIN | 02405164 | 20 MG | TABLET · ORAL | AURO PHARMA INC |
| AURO-SIMVASTATIN | 02405172 | 40 MG | TABLET · ORAL | AURO PHARMA INC |
| AURO-SIMVASTATIN | 02405180 | 80 MG | TABLET · ORAL | AURO PHARMA INC |
| JAMP-SIMVASTATIN | 02375591 | 5 MG | TABLET · ORAL | JAMP PHARMA CORPORATION |
| JAMP-SIMVASTATIN | 02375605 | 10 MG | TABLET · ORAL | JAMP PHARMA CORPORATION |
| JAMP-SIMVASTATIN | 02375613 | 20 MG | TABLET · ORAL | JAMP PHARMA CORPORATION |
| JAMP-SIMVASTATIN | 02375621 | 40 MG | TABLET · ORAL | JAMP PHARMA CORPORATION |
| JAMP-SIMVASTATIN | 02375648 | 80 MG | TABLET · ORAL | JAMP PHARMA CORPORATION |
| MINT-SIMVASTATIN | 02372932 | 5 MG | TABLET · ORAL | MINT PHARMACEUTICALS INC |
| MINT-SIMVASTATIN | 02372940 | 10 MG | TABLET · ORAL | MINT PHARMACEUTICALS INC |
| MINT-SIMVASTATIN | 02372959 | 20 MG | TABLET · ORAL | MINT PHARMACEUTICALS INC |
| MINT-SIMVASTATIN | 02372967 | 40 MG | TABLET · ORAL | MINT PHARMACEUTICALS INC |
| MINT-SIMVASTATIN | 02372975 | 80 MG | TABLET · ORAL | MINT PHARMACEUTICALS INC |
| PHARMA-SIMVASTATIN | 02469979 | 5 MG | TABLET · ORAL | PHARMASCIENCE INC |
| PHARMA-SIMVASTATIN | 02469987 | 10 MG | TABLET · ORAL | PHARMASCIENCE INC |
| PHARMA-SIMVASTATIN | 02469995 | 20 MG | TABLET · ORAL | PHARMASCIENCE INC |
| PHARMA-SIMVASTATIN | 02470004 | 40 MG | TABLET · ORAL | PHARMASCIENCE INC |
| PHARMA-SIMVASTATIN | 02470012 | 80 MG | TABLET · ORAL | PHARMASCIENCE INC |
32 more — full table
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | SIMVASTATIN 10 MG TABLET | $0.02807 | per EA | 23 Sep 2026 |
| US NADAC | SIMVASTATIN 20 MG TABLET | $0.03215 | per EA | 23 Sep 2026 |
| US NADAC | SIMVASTATIN 40 MG TABLET | $0.05376 | per EA | 23 Sep 2026 |
| US NADAC | SIMVASTATIN 5 MG TABLET | $0.03136 | per EA | 23 Sep 2026 |
| US NADAC | SIMVASTATIN 80 MG TABLET | $0.09376 | per EA | 23 Sep 2026 |
| US NADAC | ZOCOR 20 MG TABLET | $9.7276 | per EA | 1 Jan 2026 |
| US NADAC | ZOCOR 40 MG TABLET | $9.72936 | per EA | 1 Jan 2026 |
| NHS Drug Tariff | Simvastatin 10mg tablets | £0.64 | 28 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Simvastatin 20mg tablets | £0.73 | 28 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Simvastatin 20mg/5ml oral suspension sugar free | £227.66 | 150 ml | 1 Oct 2026 |
| NHS Drug Tariff | Simvastatin 40mg tablets | £0.93 | 28 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Simvastatin 40mg/5ml oral suspension sugar free | £319.63 | 150 ml | 1 Oct 2026 |
| NHS Drug Tariff | Simvastatin 80mg tablets | £1.41 | 28 tablet | 1 Oct 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
WHO WHO Model List of Essential Medicines (2025)
- 12.6. Lipid-lowering agents · core
Mixed hyperlipidaemia; Coronary atherosclerosis
Oral > Solid: 5 mg; 10 mg; 20 mg; 40 mg
Safety signals and safety-related labeling changes
- US FDA 28 Mar 2024 VYTORIN — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 9 Aug 2023 ZOCOR — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - EMA PRAC 11 Feb 2021 PRAC signal: Bullous pemphigoid
Action for MAH: update of the product information: No - US FDA 25 Sep 2020 FLOLIPID — safety-related labeling change
Labeling sections changed: Warnings and Precautions - EMA PRAC 3 Sep 2020 PRAC signal: Bullous pemphigoid
Action for MAH: update of the product information: No - EMA PRAC 11 Jun 2015 PRAC signal: Lichenoid drug eruption
Action for MAH: update of the product information: No - MHRA 11 Dec 2014 Simvastatin: dose limitations with concomitant amlodipine or diltiazem
The maximum recommended dose for simvastatin in conjunction with amlodipine and diltiazem is now 20 mg/day. - MHRA 11 Dec 2014 Simvastatin: updated advice on drug interactions
Updated contraindications and maximum dose recommendations when taken with a number of other medicines. - MHRA 11 Dec 2014 Simvastatin: increased risk of myopathy at high dose (80 mg)
There is an increased risk of myopathy associated with high-dose (80 mg) simvastatin. The 80-mg dose should be considered only in patients with severe hypercholesterolaemia and high risk of cardiovascular complications who have not achieved their treatment goals on lower doses, when the benefits are expected to outweigh the potential risks - EMA PRAC 10 Apr 2014 PRAC signal: Risk of myopathy and rhabdomyolysis associated with high doses
Action for MAH: update of the product information: Yes - EMA PRAC 7 Nov 2013 PRAC signal: Risk of myopathy and rhabdomyolysis associated with high doses
Action for MAH: update of the product information: No
Combinations containing Simvastatin
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.