What this pack is
MEVALOTIN is the brand name in this record; pravastatin sodium is the generic name. Read both together with the dosage form (oral tablet).
PACK CHECK · MARKET FIRST
MEVALOTINGeneric namepravastatin sodium
How this medicine works
PMDA material classifies pravastatin as an HMG-CoA reductase inhibitor and describes inhibition of cholesterol synthesis in the liver and small intestine. This mechanism helps explain the class but cannot decide which statin, strength, alternate-day switch or whole-genome testing an individual needs.
Read source: Japan ↗Current regulatory record · reviewed 2026-08-30More about its action and precautions →Check the market, names, dosage form and route together
A medicine may use different brand names across markets. Keep the market, brand, generic name, dosage form and route together; one matching field does not prove that two packs are the same or interchangeable.
Open the complete product-identity record
Use these fields when the pack, market name or package image needs closer checking. They are evidence boundaries, not substitution instructions.
- International brand name
- MEVALOTIN
- Generic name
- pravastatin sodium
- Dosage-form class
- Japan PMDA: pravastatin sodium 5 mg and 10 mg oral tablets; 0.5% and 1% oral fine granules (review the four product identities separately)
- Route
- Oral
- Package-image status
- No exact original-brand package image is shown This is deliberate: do not use a retailer, repackager or another-market image to identify the pack in hand. See why and what to check instead →
No source-verifiable mainland-China trade-name cue has been established for this record. This does not establish whether the medicine exists, is approved or is available in mainland China. Check pack text and current CDE/NMPA records item by item.
FOR EVERYDAY QUESTIONS
After the leaflet, continue with the question you still need to check
What this page can show
This is a source-traceable public record. It helps you read the product identity and its listed source documents; each market still needs its own current record check.
What to bring to the next conversation
Bring the actual pack, the label or prescription, and a complete medicine list when you speak with a pharmacist or clinician.
NEXT SAFE STEP
Choose the next safe check
A question about changing, combining or splitting?Put the exact packs on one list before a pharmacist or prescriber checks the full context.Open the family medicine list →A question about cost, reimbursement or availability?First lock the market, exact presentation and date. Use local official reimbursement, hospital or pharmacy channels for a current answer rather than a web estimate.Open regulator and market-record entry points →Unsure about a pack or a cross-border product?Photo reading can return possible record matches only. Check the actual product against the current regulator record for its market.Identify pack text locally →Saw a recall, approval or procurement headline?Open the original publisher, then match its product, market and date. Do not make a stop or switch decision from a headline.Read primary-source news →
PRODUCT PRESENTATION IDENTITY
Strength, pack and device identity
Package strength is not an individual dose. These fields help identify the exact labelled product; they do not calculate how much, how often, a missed-use action, splitting, switching or conversion.
How to read a score line: ‘scored’ or ‘unscored’ first identifies this labelled presentation. A score line by itself does not permit self-splitting, reducing or changing the product. Only an explicit statement in the current label for this exact presentation, checked with a pharmacist against the prescription, can support any further handling.
4 source-backed strength, pack or device records — open the full list
First match the market, dosage form and labelled amount on the pack in hand. The number of tablets, sachets or devices in a pack is not a personal dose or schedule.
JP · Current Japanese PMDA electronic label (revised Jul 2023)
Pravastatin sodium 5 mg per tablet
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- PMDA approval no. 21300AMZ00549
- Form and route
- MEVALOTIN pravastatin sodium 5 mg oral tablet · oral (exact product-identity field)
- Listing review
- Cited public label display reviewed 2026-08-30; actual marketing, stock and availability are not established.
- pravastatin sodium
- 5 mglabelled amount per tablet; not an individual's tablet count, frequency, switching or splitting instruction
- Labelled appearance
- white · round uncoated unscored tablet · imprint SANKYO 231Unscored in this labelled presentation
JP · Current Japanese PMDA electronic label (revised Jul 2023)
Pravastatin sodium 10 mg per tablet
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- PMDA approval no. 20300AMZ00671
- Form and route
- MEVALOTIN pravastatin sodium 10 mg oral tablet · oral (exact product-identity field)
- Listing review
- Cited public label display reviewed 2026-08-30; actual marketing, stock and availability are not established.
- pravastatin sodium
- 10 mglabelled amount per tablet; not an individual's tablet count, frequency, switching or splitting instruction
- Labelled appearance
- pale red · round uncoated scored tablet; the score is not permission to self-split · imprint SANKYO 232Scored appearance; this is not a self-splitting instruction
JP · Current Japanese PMDA electronic label (revised Jul 2023)
Pravastatin sodium 5 mg per 1 g of fine granules (0.5%)
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- PMDA approval no. 21300AMZ00548
- Form and route
- MEVALOTIN pravastatin sodium 0.5% fine granules · oral (exact product-identity field)
- Listing review
- Cited public label display reviewed 2026-08-30; actual marketing, stock and availability are not established.
- pravastatin sodium
- 5 mglabelled amount per 1 g of fine granules; not an individual's gram amount, frequency or tablet conversion
- Labelled appearance
- white · fine granules; not identifiable by tablet appearanceNot applicable to this dosage form
JP · Current Japanese PMDA electronic label (revised Jul 2023)
Pravastatin sodium 10 mg per 1 g of fine granules (1%)
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- PMDA approval no. 20300AMZ00672
- Form and route
- MEVALOTIN pravastatin sodium 1% fine granules · oral (exact product-identity field)
- Listing review
- Cited public label display reviewed 2026-08-30; actual marketing, stock and availability are not established.
- pravastatin sodium
- 10 mglabelled amount per 1 g of fine granules; not an individual's gram amount, frequency or tablet conversion
- Labelled appearance
- pale red · fine granules; not identifiable by tablet appearanceNot applicable to this dosage form
LOOK CLOSER · CHECK THE SOURCE
Official product-appearance references
- Check the name and strengthMatch the full medicine name, mg, form and country on your pack to the image title.
- Enlarge to read the markingsFor tablets, read the imprint; for sachets, check the name and strength. Similar colour or shape alone is not enough.
- Compare with the official guideOpen the source below the image. If details differ or are unclear, show the actual pack to a pharmacist.
Scope: dated Japanese PMDA patient-guide images—not an exact outer package, not a China or U.S. pack. Appearance cannot establish authenticity, availability, interchangeability or how much to take.
Japan · PMDA patient guide
MEVALOTIN (pravastatin sodium) 5 mg tablet blister detail
Not an exact outer-package image, not a China-market pack, not authentication, and not an individual amount or self-splitting instruction.
Open the official PMDA patient guide ↗Japan · PMDA patient guide
MEVALOTIN (pravastatin sodium) 10 mg tablet blister detail
Not an exact outer-package image, not a China-market pack, not authentication, and not an individual amount or self-splitting instruction.
Open the official PMDA patient guide ↗Japan · PMDA patient guide
MEVALOTIN (pravastatin sodium) 0.5% fine granules
Not an exact outer-package image, not a China-market pack, not authentication, and not an individual amount or self-splitting instruction.
Open the official PMDA patient guide ↗Japan · PMDA patient guide
MEVALOTIN (pravastatin sodium) 1% fine granules
Not an exact outer-package image, not a China-market pack, not authentication, and not an individual amount or self-splitting instruction.
Open the official PMDA patient guide ↗PACKAGE-VISUAL STATUS
Official guide appearance references are available; exact outer-package images remain withheld
This page separately shows unaltered 5 mg and 10 mg blister details and 0.5% and 1% fine-granule images from the July 2023 Japan PMDA patient guide, with enlargement. An exact outer-carton principal display panel has not been verified, so outer-package images remain withheld. Guide appearances do not establish identity, authenticity, availability or individual suitability for China or another market.
LABEL READING · NOT A PRESCRIPTION
MEVALOTIN label reading: 5 mg, 10 mg, 0.5% and 1% do not share one measurement basis
Reading level: drug-specific label reading. This record has been expanded around its dosage form or a higher-risk reading question; the current target-market label and professional review still apply.
The current PMDA record separates MEVALOTIN into 5 mg per tablet, 10 mg per tablet, 5 mg per 1 g of fine granules (0.5%), and 10 mg per 1 g (1%). This module helps check the exact form, amount per labelled unit, pregnancy/breastfeeding boundary, liver function and serious muscle-injury warning. It provides no individual tablet or gram count, frequency, switching or stopping plan.
- The 5 mg and 10 mg tablets state an amount per tablet; the 0.5% and 1% granules state 5 mg or 10 mg per 1 g of granules. Percent, per-gram and per-tablet units cannot be directly converted from numbers on a webpage or used to calculate an individual's amount.
- The PMDA label places pregnancy, possible pregnancy and breastfeeding within contraindication/important-use boundaries. When planning pregnancy, possibly pregnant, pregnant or breastfeeding, do not self-continue, stop, alternate days or switch statins from this page; contact the prescribing team or pharmacist promptly.
- Unexplained muscle pain, tenderness, weakness or cramps, especially with marked fatigue, fever or dark urine, may need prompt medical assessment. The label includes serious muscle-injury warnings such as rhabdomyolysis. Do not wait for a webpage to decide whether a medicine caused the symptoms.
- Liver or kidney problems, thyroid conditions, previous muscle reactions and a complete medicine list including fibrates, immunosuppressants or other lipid-lowering medicines may affect professional judgement. The site does not decide suitability, need for genetic testing or how to switch statins from one medicine name or laboratory result.
- The score on the 10 mg tablet is a PMDA appearance field, not permission for everyone to self-split; the 5 mg tablet is unscored and the fine granules are another dosage form. Before changing form, splitting, crushing, mixing with food or combining strengths, check the actual pack and current prescription.
PHARMACOVIGILANCE · OFFICIAL ROUTES
Check safety information in the right market
Start with the public label or product record linked to this dossier, then use the official safety routes below for the market that applies to the medicine in hand.
Match five details before using a safety record
- Brand and generic nameBoth must match the medicine named by the record.
- Dosage form and strengthTablet, capsule, injection, inhaler, patch and eye drop are not interchangeable.
- Market and notice dateA record applies only to the country or region and date it names.
- Lot, pack and manufacturerRecord these only when the official notice specifically names them.
- Current product informationA historical record may have been superseded by the current label.
This checklist only helps organise the right question. It does not create a personal conclusion about stopping, switching, dose, combination or suitability.
This dossier’s product-level source checkPMDA · Japan · Regulatory product record · 2026-08-30
This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk.
Markets actually represented by the reviewed product documents
- Japan · 2
This is a document-coverage summary, not a claim that the medicine is authorised, supplied, interchangeable or actively monitored in every listed market today.
This record’s label or product-record routePMDA: current Japanese product page for MEVALOTIN 5 mg / 10 mg tablets and 0.5% / 1% fine granules ↗Current regulatory record · reviewed 2026-08-30
Other official market or version documents for this record
These are separately reviewed product documents for the same dossier. Their market, date, dosage form and document status must stay attached to each link; they do not establish interchangeability between products, strengths, packs, indications or countries.
- PMDA · Japan · Regulatory product record · 2026-08-30PMDA: current Japanese electronic label for MEVALOTIN (pravastatin sodium), revised Jul 2023 ↗Current regulatory record · reviewed 2026-08-30
This is not a conclusion that the medicine has no risk, warning, recall or newer notice in another market. Start with the checked product-level label above, then use the official market gateways below for the product in hand.
See the reviewed safety-record directory →Global official safety gateways
- NMPA Centre for Drug Reevaluation · Mainland ChinaPrimary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item.Drug-vigilance bulletins and safety notices ↗reviewed 2026-08-22
- FDA · United StatesPrimary FDA pages for important new safety issues, labelling changes and risk communications.Drug Safety Communications ↗reviewed 2026-08-22
- FDA MedWatch · United StatesU.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality.Safety information and serious-problem reporting ↗reviewed 2026-08-22
- EMA · European Union / European Economic AreaOfficial EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment.Pharmacovigilance overview and EudraVigilance ↗reviewed 2026-08-22
- MHRA · United KingdomPrimary UK MHRA medicine-safety updates for professionals and the public.Drug Safety Update ↗reviewed 2026-08-22
- PMDA · JapanPMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents.Medicine safety information ↗reviewed 2026-08-22
- MFDS · Republic of KoreaMFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case.Medicine safety letters ↗reviewed 2026-08-22
- HSA · SingaporeHSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information.Adverse-event reporting and medicine-safety information ↗reviewed 2026-08-22
- Health Canada · CanadaHealth Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item.MedEffect Canada: advisories, warnings and recalls ↗reviewed 2026-08-22
- TGA · AustraliaPrimary Australian TGA safety alerts, advisories and monitoring information for therapeutic products.Medicine safety alerts ↗reviewed 2026-08-22
- Swissmedic · SwitzerlandOfficial Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality.Pharmacovigilance and suspected adverse-reaction reporting ↗reviewed 2026-08-22
- Medsafe · New ZealandNew Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information.Medicine safety communications ↗reviewed 2026-08-22
- SAHPRA · South AfricaSAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information.Medicine safety information, alerts and pharmacovigilance ↗reviewed 2026-08-22
- WHO · GlobalWHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market.Medicine and vaccine safety-alert archive ↗reviewed 2026-08-22
- Anvisa · BrazilAnvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item.Pharmacovigilance, alerts and VigiMed ↗reviewed 2026-08-22
This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline.
For severe or rapidly worsening symptoms, suspected overdose, a severe allergic reaction, loss of consciousness or another emergency, use local emergency services. Do not wait for an online alert search or change a medicine from this page.
PRIVATE FAMILY LIST
Bring this record into a local medicine list
Only the brand, generic name, dosage form and route are added, and they stay in this browser. Copy strength, label directions, start/stop history and any concern from the actual pack; this tool does not calculate a dose or decide combination, switching or stopping.
Add to the family medicine list →PACK · LABEL · MEDICINE LIST
Six checks for this medicine pack
Use this card to organise questions about MEVALOTIN (pravastatin sodium). Keep the exact pack, its current label and the full medicine list together.
Identify the exact product
MEVALOTIN is the brand in this record and pravastatin sodium is the active-ingredient name. Check both with the dosage form (Japan PMDA: pravastatin sodium 5 mg and 10 mg oral tablets; 0.5% and 1% oral fine granules (review the four product identities separately)) and the market on the actual pack.
Read the labelled strength in context
mg, mcg, mg/mL or a percentage describes the labelled amount in one tablet, capsule, measured volume, spray or other unit. It is not an answer to how many units a person should take.
Check before splitting or opening
Before splitting, crushing, chewing or opening anything, find an explicit instruction for this exact product in its current label and ask a pharmacist. A score line or a previous pack is not enough by itself.
Put every product on one list
Include prescriptions, over-the-counter products, eye drops, creams, vitamins, minerals, herbs and supplements. A pharmacist or prescriber needs the whole list before any combination, alternation, switch or stop is considered.
Ask a specific pharmacogenetics question
Ask which medicine, which gene and what clinical decision a result could change. A gene–drug association does not mean broad genetic testing is needed for everyone and must not be used to change treatment without professional review.
Know when to seek urgent help
For a suspected overdose, a severe allergic reaction, fainting or difficulty breathing, use the local emergency or poison-information service now. Do not wait for a website reply or alter several medicines to test what caused it.
This card does not calculate a dose, decide whether medicines can be combined, or replace a clinician or pharmacist. Market-specific current labels and the person's full context still need review.
MARKET DOCUMENTS · READ SEPARATELY
Enlarged market leaflets and regulator documents
Each link retains its own market, date, dosage form and document status. These documents support larger-print reading and item-by-item checking; they do not make products, strengths, packs, indications or use between countries or regions interchangeable.
- PMDA: MEVALOTIN patient medication guide, updated Jul 2023 ↗Current regulatory record · reviewed 2026-09-08
- PMDA: current Japanese product page for MEVALOTIN 5 mg / 10 mg tablets and 0.5% / 1% fine granules ↗Current regulatory record · reviewed 2026-08-30
- PMDA: current Japanese electronic label for MEVALOTIN (pravastatin sodium), revised Jul 2023 ↗Current regulatory record · reviewed 2026-08-30
HOW IT WORKS · NOT A TREATMENT PLAN
How pravastatin works: inhibiting HMG-CoA reductase does not make all statins interchangeable
- A shared statin class does not make MEVALOTIN, atorvastatin, rosuvastatin or simvastatin milligram-equivalent, self-switchable day by day or combinable. Strength, interactions, liver/kidney function, indication and prescribing goal need separate review.
- Mechanism cannot turn symptoms, age or one cholesterol result into an individual medicine decision. Complete history, laboratory data, medicine list and the current target-market label are the basis for discussion with the prescribing team.
- Genetic information can sometimes inform interpretation of specific medicine risks, but the word “statin” does not mean everyone needs whole-genome screening. Whether to test, what to test and how to interpret it require a qualified professional using the actual medicine and clinical context.
SOURCE EVIDENCE REGISTER
Source evidence map
Every public link is labelled with its market, document status and document type. A historical public record is not a current label, and an official lookup entry is not a product-specific record.
- PMDA: current Japanese product page for MEVALOTIN 5 mg / 10 mg tablets and 0.5% / 1% fine granules ↗Current regulatory record · reviewed 2026-08-30
- PMDA: current Japanese electronic label for MEVALOTIN (pravastatin sodium), revised Jul 2023 ↗Current regulatory record · reviewed 2026-08-30
- PMDA: MEVALOTIN patient medication guide, updated Jul 2023 ↗Current regulatory record · reviewed 2026-09-08
- Daiichi Sankyo: Sankyo research history and MEVALOTIN global-launch record ↗reviewed 2026-08-30
SOURCE-TRACEABLE ARCHIVE
MEVALOTINpravastatin sodium
This page links to public primary-source material for MEVALOTIN. The archive is historical or documentary evidence only; it does not by itself establish originator status, product quality, current labelling, availability or sale eligibility.
DOCUMENT TIMELINE
Document timeline
MEVALOTIN global-launch history milestone
Daiichi Sankyo's history page lists MEVALOTIN as a groundbreaking HMG-CoA reductase inhibitor developed by Sankyo and records its global launch. This history milestone does not replace current market approval records.
Daiichi Sankyo: Sankyo research history and MEVALOTIN global-launch record ↗Revision date of the electronic label currently linked by PMDA
The current PMDA product page links a label and patient guide revised in Jul 2023, covering 5 mg and 10 mg tablets and 0.5% and 1% fine granules. The date identifies the document version; it does not establish another market's status or anyone's start date.
PMDA: current Japanese electronic label for MEVALOTIN (pravastatin sodium), revised Jul 2023 ↗Current PMDA product-page access review
This review confirmed that the PMDA product page still lists four MEVALOTIN products and Daiichi Sankyo. Page availability does not establish stock, purchase availability or individual suitability.
PMDA: current Japanese product page for MEVALOTIN 5 mg / 10 mg tablets and 0.5% / 1% fine granules ↗
MARKET SCOPE
Market-record boundary
Japan
Current PMDA product page, electronic label and patient guide linkedThe four Japanese product identities are recorded separately; label availability does not establish stock, price, prescription eligibility or individual suitability.
Mainland China, United States, EU and other markets
Current product records require market-by-market reviewJapan MEVALOTIN, Daiichi Sankyo development history and the pravastatin generic name do not establish current approval, strength, packaging, supply, originator/generic status or interchangeability for PRAVACHOL or another market.
How to read this record
Read each document in its stated market, date and dosage-form context. A historical record is not a current label and does not support individual medical, substitution or purchasing conclusions.
RECORD FAQ
Record questions
Do a 5 mg tablet and 0.5% fine granules mean the same thing?
They do not use the same labelled basis. A 5 mg tablet contains 5 mg per tablet; the 0.5% granules in this label contain 5 mg per 1 g of granules. Form, unit and actual prescription must be checked together; matching numbers do not make them interchangeable.
Can pravastatin be taken one day and atorvastatin or rosuvastatin the next?
A webpage cannot confirm such alternating use for an individual. Statins are not directly milligram-equivalent, and indication, intensity, interactions, liver/kidney function and prescribing goals may differ. Do not self-alternate, combine or stop them; take the actual packs, prescription, laboratory data and complete medicine list to the prescribing team or pharmacist.
Does the score on the 10 mg tablet mean it can be self-split into 5 mg?
A score alone does not decide this. It is a label appearance field. Whether the actual product may be divided, the accuracy and stability after splitting, and whether that matches the individual prescription require the exact label and pharmacist or prescriber review.
READ NEXT
Related reading
Evidence status
The listed links are public sources selected for traceability. They must be rechecked against the current target-market record before any use beyond reading and research.