Active substance
Pravastatin
- SFDA 2
- US FDA 20
- Health Canada 51
- US price lines 4
- NHS prices 3
- WHO EML 1
- Safety 6
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| LIPOSTAT 10MG TAB | 10 mg | Tablet · Oral use | 30 Blister | SAR 64.30 | NCE · Prescription | SPIMACO ADDWAEIH | Withdrawn by MAH · Not Marketed |
| LIPOSTAT 20MG TAB | 20 mg | Tablet · Oral use | 30 Blister | SAR 103.85 | NCE · Prescription | SPIMACO ADDWAEIH | Withdrawn by MAH · Not Marketed |
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| PRAVASTATIN SODIUM | 10MG; 20MG; 40MG | tablet · oral | AUROBINDO PHARMA USA | Prescription | 24 Apr 2006 |
| PRAVASTATIN SODIUM | 10MG; 20MG; 40MG; 80MG | tablet · oral | APOTEX | Prescription | 23 Oct 2006 |
| PRAVASTATIN SODIUM | 10MG; 20MG; 40MG; 80MG | tablet · oral | DR REDDYS LABS INC | Prescription | 23 Oct 2006 |
| PRAVASTATIN SODIUM | 80MG; 40MG; 20MG; 10MG | tablet · oral | WATSON LABS | Prescription | 23 Oct 2006 |
| PRAVASTATIN SODIUM | 10MG; 20MG; 40MG; 80MG | tablet · oral | CIPLA | Prescription | 23 Oct 2006 |
| PRAVASTATIN SODIUM | 10MG; 20MG; 40MG; 80MG | tablet · oral | GLENMARK PHARMS LTD | Prescription | 11 May 2007 |
| PRAVASTATIN SODIUM | 10MG; 20MG; 40MG; 80MG | tablet · oral | CHARTWELL RX | Prescription | 8 Jan 2008 |
| PRAVASTATIN SODIUM | 80MG | tablet · oral | AUROBINDO PHARMA USA | Prescription | 15 Jan 2008 |
| PRAVASTATIN SODIUM | 80MG; 10MG; 20MG; 40MG; 30MG; 60MG | tablet · oral | SENORES PHARMS | Prescription | 11 Feb 2008 |
| PRAVASTATIN SODIUM | 20MG; 40MG; 80MG | tablet · oral | ZYDUS PHARMS USA | Prescription | 30 Apr 2008 |
| PRAVASTATIN SODIUM | 10MG; 20MG; 40MG; 80MG | tablet · oral | ACCORD HLTHCARE | Prescription | 17 Nov 2016 |
| PRAVASTATIN SODIUM | 10MG; 20MG; 40MG; 80MG | tablet · oral | AUROBINDO PHARMA | Prescription | 2 Feb 2017 |
| PRAVASTATIN SODIUM | 10MG; 20MG; 40MG; 80MG | tablet · oral | BIOCON PHARMA | Prescription | 13 Apr 2018 |
| PRAVACHOL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | tablet · oral | BRISTOL MYERS SQUIBB | Discontinued | 31 Oct 1991 |
| PRAVASTATIN SODIUM | 10MG; 20MG; 40MG; 80MG | tablet · oral | PHARMOBEDIENT | Discontinued | 23 Oct 2006 |
| PRAVASTATIN SODIUM | 10MG | tablet · oral | ZYDUS PHARMS USA | Discontinued | 30 Apr 2008 |
| PRAVASTATIN SODIUM | 10MG; 20MG; 40MG; 80MG | tablet · oral | PHARMOBEDIENT | Discontinued | 27 May 2010 |
| PRAVASTATIN SODIUM | 20MG; 40MG; 80MG | tablet · oral | HISUN PHARM HANGZHOU | Discontinued | 23 Nov 2018 |
| PRAVASTATIN SODIUM | 10MG; 20MG; 40MG; 80MG | tablet · oral | RANBAXY LABS LTD | Discontinued | |
| PRAVASTATIN SODIUM | 10MG; 20MG; 30MG; 40MG | tablet · oral | PLIVA HRVATSKA DOO | Discontinued |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| AG-PRAVASTATIN | 02476142 | 10 MG | TABLET · ORAL | ANGITA PHARMA INC. |
| AG-PRAVASTATIN | 02476150 | 20 MG | TABLET · ORAL | ANGITA PHARMA INC. |
| AG-PRAVASTATIN | 02476169 | 40 MG | TABLET · ORAL | ANGITA PHARMA INC. |
| AG-PRAVASTATIN TABLETS | 02562286 | 10 MG | TABLET · ORAL | ANGITA PHARMA INC. |
| AG-PRAVASTATIN TABLETS | 02562294 | 20 MG | TABLET · ORAL | ANGITA PHARMA INC. |
| AG-PRAVASTATIN TABLETS | 02562308 | 40 MG | TABLET · ORAL | ANGITA PHARMA INC. |
| APO-PRAVASTATIN | 02243506 | 10 MG | TABLET · ORAL | APOTEX INC |
| APO-PRAVASTATIN | 02243507 | 20 MG | TABLET · ORAL | APOTEX INC |
| APO-PRAVASTATIN | 02243508 | 40 MG | TABLET · ORAL | APOTEX INC |
| AURO-PRAVASTATIN | 02458977 | 10 MG | TABLET · ORAL | AURO PHARMA INC |
| AURO-PRAVASTATIN | 02458985 | 20 MG | TABLET · ORAL | AURO PHARMA INC |
| AURO-PRAVASTATIN | 02458993 | 40 MG | TABLET · ORAL | AURO PHARMA INC |
| BIO-PRAVASTATIN | 02446251 | 10 MG | TABLET · ORAL | BIOMED PHARMA |
| BIO-PRAVASTATIN | 02446278 | 20 MG | TABLET · ORAL | BIOMED PHARMA |
| BIO-PRAVASTATIN | 02446286 | 40 MG | TABLET · ORAL | BIOMED PHARMA |
| JAMP PRAVASTATIN TABLETS | 02558084 | 10 MG | TABLET · ORAL | JAMP PHARMA CORPORATION |
| JAMP PRAVASTATIN TABLETS | 02558092 | 20 MG | TABLET · ORAL | JAMP PHARMA CORPORATION |
| JAMP PRAVASTATIN TABLETS | 02558106 | 40 MG | TABLET · ORAL | JAMP PHARMA CORPORATION |
| JAMP-PRAVASTATIN | 02330954 | 10 MG | TABLET · ORAL | JAMP PHARMA CORPORATION |
| JAMP-PRAVASTATIN | 02330962 | 20 MG | TABLET · ORAL | JAMP PHARMA CORPORATION |
| JAMP-PRAVASTATIN | 02330970 | 40 MG | TABLET · ORAL | JAMP PHARMA CORPORATION |
| M-PRAVASTATIN | 02476274 | 10 MG | TABLET · ORAL | MANTRA PHARMA INC |
| M-PRAVASTATIN | 02476282 | 20 MG | TABLET · ORAL | MANTRA PHARMA INC |
| M-PRAVASTATIN | 02476290 | 40 MG | TABLET · ORAL | MANTRA PHARMA INC |
| MAR-PRAVASTATIN | 02432048 | 10 MG | TABLET · ORAL | MARCAN PHARMACEUTICALS INC |
26 more — full table
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | PRAVASTATIN SODIUM 10 MG TAB | $0.05549 | per EA | 23 Sep 2026 |
| US NADAC | PRAVASTATIN SODIUM 20 MG TAB | $0.05797 | per EA | 23 Sep 2026 |
| US NADAC | PRAVASTATIN SODIUM 40 MG TAB | $0.0828 | per EA | 23 Sep 2026 |
| US NADAC | PRAVASTATIN SODIUM 80 MG TAB | $0.14329 | per EA | 23 Sep 2026 |
| NHS Drug Tariff | Pravastatin 10mg tablets | £1.00 | 28 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Pravastatin 20mg tablets | £1.08 | 28 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Pravastatin 40mg tablets | £1.38 | 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
Therapeutic equivalent to simvastatin for Mixed hyperlipidaemia; Therapeutic equivalent to simvastatin for Coronary atherosclerosis
Safety signals and safety-related labeling changes
- EMA PRAC 13 Jan 2023 PRAC signal: Myasthenia gravis
Action for MAH: update of the product information: Yes - EMA PRAC 7 Jul 2022 PRAC signal: Myasthenia gravis
Action for MAH: update of the product information: No - US FDA 31 May 2022 PRAVACHOL — 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 - EMA PRAC 11 Feb 2021 PRAC signal: Bullous pemphigoid
Action for MAH: update of the product information: No - 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
Combinations containing Pravastatin
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.