{ "id": "mevalotin-pravastatin", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-30", "status": "published_traceable_archive" }, "names": { "brand": "MEVALOTIN", "generic": "普伐他汀钠", "aliases": [ "Mevalotin", "メバロチン", "pravastatin", "pravastatin sodium", "普伐他汀", "普伐他汀钠" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "日本 PMDA 当前 MEVALOTIN 5 mg／10 mg 片及 0.5%／1% 细粒产品页、电子说明书与患者用药指南", "dosageFormClass": "日本 PMDA：普伐他汀钠 5 mg、10 mg 口服片；0.5%、1% 口服细粒（四个产品身份须分别核对）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1989（第一三共历史页记载 MEVALOTIN 全球上市）", "archiveSponsorText": "第一三共株式会社（PMDA 当前日本产品页所列制造销售方）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "MEVALOTIN", "メバロチン錠5", "メバロチン錠10", "メバロチン細粒0.5%", "メバロチン細粒1%" ], "excludedProductCues": [ "PRAVACHOL", "PRAVACHOL 40 mg", "pravastatin 20 mg", "pravastatin 40 mg", "pravastatin 80 mg", "普伐他汀 20 mg", "普伐他汀 40 mg", "普伐他汀 80 mg" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "jp-mevalotin-pravastatin-tablet-5mg-current", "marketCode": "JP", "labelVersion": { "zh": "PMDA 当前日本电子说明书（2023-07 修订）", "en": "Current Japanese PMDA electronic label (revised Jul 2023)" }, "dosageForm": { "zh": "MEVALOTIN（メバロチン）普伐他汀钠 5 mg 口服片", "en": "MEVALOTIN pravastatin sodium 5 mg oral tablet" }, "route": { "zh": "口服（准确产品身份字段）", "en": "oral (exact product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "PMDA approval no. 21300AMZ00549", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片含普伐他汀钠 5 mg", "en": "Pravastatin sodium 5 mg per tablet" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "普伐他汀钠", "en": "pravastatin sodium" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、换药或掰片指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, switching or splitting instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形素片、无刻痕", "en": "round uncoated unscored tablet" }, "imprint": "SANKYO 231", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_2d10a23407238f30", "label": "PMDA：メバロチン（普伐他汀钠）当前日本电子说明书（2023-07 修订）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/430574_2189010C1032_2_15", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "jp-mevalotin-pravastatin-tablet-10mg-current", "marketCode": "JP", "labelVersion": { "zh": "PMDA 当前日本电子说明书（2023-07 修订）", "en": "Current Japanese PMDA electronic label (revised Jul 2023)" }, "dosageForm": { "zh": "MEVALOTIN（メバロチン）普伐他汀钠 10 mg 口服片", "en": "MEVALOTIN pravastatin sodium 10 mg oral tablet" }, "route": { "zh": "口服（准确产品身份字段）", "en": "oral (exact product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "PMDA approval no. 20300AMZ00671", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片含普伐他汀钠 10 mg", "en": "Pravastatin sodium 10 mg per tablet" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "普伐他汀钠", "en": "pravastatin sodium" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、换药或掰片指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, switching or splitting instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": { "color": { "zh": "微红色", "en": "pale red" }, "shape": { "zh": "圆形素片、有刻痕；刻痕不是自行掰片许可", "en": "round uncoated scored tablet; the score is not permission to self-split" }, "imprint": "SANKYO 232", "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_2d10a23407238f30", "label": "PMDA：メバロチン（普伐他汀钠）当前日本电子说明书（2023-07 修订）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/430574_2189010C1032_2_15", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "jp-mevalotin-pravastatin-fine-granules-0-5pct-current", "marketCode": "JP", "labelVersion": { "zh": "PMDA 当前日本电子说明书（2023-07 修订）", "en": "Current Japanese PMDA electronic label (revised Jul 2023)" }, "dosageForm": { "zh": "MEVALOTIN（メバロチン）普伐他汀钠细粒 0.5%", "en": "MEVALOTIN pravastatin sodium 0.5% fine granules" }, "route": { "zh": "口服（准确产品身份字段）", "en": "oral (exact product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "PMDA approval no. 21300AMZ00548", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_g", "primaryDisplay": { "zh": "每 1 g 细粒含普伐他汀钠 5 mg（0.5%）", "en": "Pravastatin sodium 5 mg per 1 g of fine granules (0.5%)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "普伐他汀钠", "en": "pravastatin sodium" }, "value": 5, "unit": "mg", "basisCode": "per_g", "basisLabel": { "zh": "每 1 g 细粒的标签标示量；不是个人克数、频率或片剂换算", "en": "labelled amount per 1 g of fine granules; not an individual's gram amount, frequency or tablet conversion" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "细粒剂；不能用片剂外观核对", "en": "fine granules; not identifiable by tablet appearance" }, "imprint": null, "scoreStatus": "not_applicable", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_2d10a23407238f30", "label": "PMDA：メバロチン（普伐他汀钠）当前日本电子说明书（2023-07 修订）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/430574_2189010C1032_2_15", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "jp-mevalotin-pravastatin-fine-granules-1pct-current", "marketCode": "JP", "labelVersion": { "zh": "PMDA 当前日本电子说明书（2023-07 修订）", "en": "Current Japanese PMDA electronic label (revised Jul 2023)" }, "dosageForm": { "zh": "MEVALOTIN（メバロチン）普伐他汀钠细粒 1%", "en": "MEVALOTIN pravastatin sodium 1% fine granules" }, "route": { "zh": "口服（准确产品身份字段）", "en": "oral (exact product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "PMDA approval no. 20300AMZ00672", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_g", "primaryDisplay": { "zh": "每 1 g 细粒含普伐他汀钠 10 mg（1%）", "en": "Pravastatin sodium 10 mg per 1 g of fine granules (1%)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "普伐他汀钠", "en": "pravastatin sodium" }, "value": 10, "unit": "mg", "basisCode": "per_g", "basisLabel": { "zh": "每 1 g 细粒的标签标示量；不是个人克数、频率或片剂换算", "en": "labelled amount per 1 g of fine granules; not an individual's gram amount, frequency or tablet conversion" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": { "color": { "zh": "微红色", "en": "pale red" }, "shape": { "zh": "细粒剂；不能用片剂外观核对", "en": "fine granules; not identifiable by tablet appearance" }, "imprint": null, "scoreStatus": "not_applicable", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_2d10a23407238f30", "label": "PMDA：メバロチン（普伐他汀钠）当前日本电子说明书（2023-07 修订）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/430574_2189010C1032_2_15", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [ { "id": "jp-mevalotin-tablet-5mg-pmda-guide-2023", "marketCode": "JP", "visualKind": "official_patient_guide_dosage_form_appearance", "title": { "zh": "MEVALOTIN（普伐他汀钠）5 mg 片剂泡罩局部", "en": "MEVALOTIN (pravastatin sodium) 5 mg tablet blister detail" }, "imageUrl": "/evidence/medicine/mevalotin-pravastatin/mevalotin-tablet-5mg-pmda-guide-2023.jpeg", "alt": { "zh": "日本 PMDA 指南中的 MEVALOTIN 5 mg 片剂泡罩局部原图", "en": "Original Japan PMDA guide image of MEVALOTIN 5 mg tablet blister detail" }, "description": { "zh": "2023 年 7 月版日本 PMDA 患者指南第 4 页：5 mg 片剂泡罩局部。图片按原样提取，2026 年 9 月 8 日核对。", "en": "Page 4 of the July 2023 Japan PMDA patient guide: 5 mg tablet blister detail. Extracted without image alteration; checked 8 September 2026." }, "exclusions": { "zh": "不是整盒包装图，不是中国市场包装，不是真伪证明，也不是个人用量或自行掰片的依据。", "en": "Not an exact outer-package image, not a China-market pack, not authentication, and not an individual amount or self-splitting instruction." }, "source": { "id": "src_50147f1d11000ec1", "label": "PMDA：メバロチン患者用药指南（2023-07 更新）", "url": "https://www.info.pmda.go.jp/downfiles/guide/ph/430574_2189010C1032_2_00G.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "patient_medication_guide", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-08", "reviewedAt": "2026-09-08" }, "scope": "official_dosage_form_appearance_only_not_outer_package_authentication_or_personal_use" }, { "id": "jp-mevalotin-tablet-10mg-pmda-guide-2023", "marketCode": "JP", "visualKind": "official_patient_guide_dosage_form_appearance", "title": { "zh": "MEVALOTIN（普伐他汀钠）10 mg 片剂泡罩局部", "en": "MEVALOTIN (pravastatin sodium) 10 mg tablet blister detail" }, "imageUrl": "/evidence/medicine/mevalotin-pravastatin/mevalotin-tablet-10mg-pmda-guide-2023.jpeg", "alt": { "zh": "日本 PMDA 指南中的 MEVALOTIN 10 mg 片剂泡罩局部原图", "en": "Original Japan PMDA guide image of MEVALOTIN 10 mg tablet blister detail" }, "description": { "zh": "2023 年 7 月版日本 PMDA 患者指南第 4 页：10 mg 片剂泡罩局部。图片按原样提取，2026 年 9 月 8 日核对。", "en": "Page 4 of the July 2023 Japan PMDA patient guide: 10 mg tablet blister detail. Extracted without image alteration; checked 8 September 2026." }, "exclusions": { "zh": "不是整盒包装图，不是中国市场包装，不是真伪证明，也不是个人用量或自行掰片的依据。", "en": "Not an exact outer-package image, not a China-market pack, not authentication, and not an individual amount or self-splitting instruction." }, "source": { "id": "src_50147f1d11000ec1", "label": "PMDA：メバロチン患者用药指南（2023-07 更新）", "url": "https://www.info.pmda.go.jp/downfiles/guide/ph/430574_2189010C1032_2_00G.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "patient_medication_guide", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-08", "reviewedAt": "2026-09-08" }, "scope": "official_dosage_form_appearance_only_not_outer_package_authentication_or_personal_use" }, { "id": "jp-mevalotin-fine-granules-0-5pct-pmda-guide-2023", "marketCode": "JP", "visualKind": "official_patient_guide_dosage_form_appearance", "title": { "zh": "MEVALOTIN（普伐他汀钠）0.5% 细粒", "en": "MEVALOTIN (pravastatin sodium) 0.5% fine granules" }, "imageUrl": "/evidence/medicine/mevalotin-pravastatin/mevalotin-fine-granules-0-5pct-pmda-guide-2023.jpeg", "alt": { "zh": "日本 PMDA 指南中的 MEVALOTIN 0.5% 细粒原图", "en": "Original Japan PMDA guide image of MEVALOTIN 0.5% fine granules" }, "description": { "zh": "2023 年 7 月版日本 PMDA 患者指南第 4 页：0.5% 细粒。图片按原样提取，2026 年 9 月 8 日核对。", "en": "Page 4 of the July 2023 Japan PMDA patient guide: 0.5% fine granules. Extracted without image alteration; checked 8 September 2026." }, "exclusions": { "zh": "不是整盒包装图，不是中国市场包装，不是真伪证明，也不是个人用量或自行掰片的依据。", "en": "Not an exact outer-package image, not a China-market pack, not authentication, and not an individual amount or self-splitting instruction." }, "source": { "id": "src_50147f1d11000ec1", "label": "PMDA：メバロチン患者用药指南（2023-07 更新）", "url": "https://www.info.pmda.go.jp/downfiles/guide/ph/430574_2189010C1032_2_00G.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "patient_medication_guide", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-08", "reviewedAt": "2026-09-08" }, "scope": "official_dosage_form_appearance_only_not_outer_package_authentication_or_personal_use" }, { "id": "jp-mevalotin-fine-granules-1pct-pmda-guide-2023", "marketCode": "JP", "visualKind": "official_patient_guide_dosage_form_appearance", "title": { "zh": "MEVALOTIN（普伐他汀钠）1% 细粒", "en": "MEVALOTIN (pravastatin sodium) 1% fine granules" }, "imageUrl": "/evidence/medicine/mevalotin-pravastatin/mevalotin-fine-granules-1pct-pmda-guide-2023.jpeg", "alt": { "zh": "日本 PMDA 指南中的 MEVALOTIN 1% 细粒原图", "en": "Original Japan PMDA guide image of MEVALOTIN 1% fine granules" }, "description": { "zh": "2023 年 7 月版日本 PMDA 患者指南第 4 页：1% 细粒。图片按原样提取，2026 年 9 月 8 日核对。", "en": "Page 4 of the July 2023 Japan PMDA patient guide: 1% fine granules. Extracted without image alteration; checked 8 September 2026." }, "exclusions": { "zh": "不是整盒包装图，不是中国市场包装，不是真伪证明，也不是个人用量或自行掰片的依据。", "en": "Not an exact outer-package image, not a China-market pack, not authentication, and not an individual amount or self-splitting instruction." }, "source": { "id": "src_50147f1d11000ec1", "label": "PMDA：メバロチン患者用药指南（2023-07 更新）", "url": "https://www.info.pmda.go.jp/downfiles/guide/ph/430574_2189010C1032_2_00G.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "patient_medication_guide", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-08", "reviewedAt": "2026-09-08" }, "scope": "official_dosage_form_appearance_only_not_outer_package_authentication_or_personal_use" } ], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "已有官方指南外观参考；仍不展示无法逐包装对应的整盒图", "en": "Official guide appearance references are available; exact outer-package images remain withheld" }, "summary": { "zh": "本页另列 2023 年 7 月版日本 PMDA 患者指南中的 5 mg、10 mg 泡罩局部及 0.5%、1% 细粒原图，可点击放大。仍未核验逐包装对应的整盒主展示面，因此不展示整盒包装图。指南外观不能证明中国或其他市场药盒的身份、真伪、供应或个人适用性。", "en": "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." }, "source": { "id": "src_2d10a23407238f30", "label": "PMDA：メバロチン（普伐他汀钠）当前日本电子说明书（2023-07 修订）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/430574_2189010C1032_2_15", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "MEVALOTIN 说明书放大阅读：5 mg、10 mg、0.5% 与 1% 不是同一种计量基准", "en": "MEVALOTIN label reading: 5 mg, 10 mg, 0.5% and 1% do not share one measurement basis" }, "summary": { "zh": "PMDA 当前档案把 MEVALOTIN 分为每片 5 mg、每片 10 mg，以及每 1 g 细粒含 5 mg（0.5%）或 10 mg（1%）。本模块帮助核对准确剂型、每单位标示量、妊娠/哺乳边界、肝功能与严重肌肉损伤警示；不提供个人片数、克数、频率、换药或停药方案。", "en": "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." }, "checks": [ { "zh": "5 mg／10 mg 片说的是每片标示量；0.5%／1% 细粒说的是每 1 g 细粒所含 5 mg／10 mg。百分比、每克和每片不能在网页上凭数字直接互换，更不能据此推算个人吃多少。", "en": "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." }, { "zh": "PMDA 说明书把妊妇、可能妊娠者及哺乳期列入禁忌/重要边界。正在备孕、可能怀孕、怀孕或哺乳时，不要凭网页自行继续、停用、隔天吃或换成另一种他汀，应尽快联系开方团队或药师。", "en": "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." }, { "zh": "无法解释的肌肉痛、压痛、无力、抽筋，尤其伴明显乏力、发热或深色尿，可能需要尽快医疗评估；说明书列有横纹肌溶解等严重肌肉损伤警示。不要等待网页判断是否由药物引起。", "en": "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." }, { "zh": "肝功能问题、肾功能问题、甲状腺问题、既往肌肉不良反应以及贝特类、免疫抑制剂或其他降脂药等完整药单都可能影响专业判断。网页不会根据一个药名或一次化验自动决定是否适合、是否需要基因筛查或怎样换他汀。", "en": "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." }, { "zh": "10 mg 片有刻痕仅是 PMDA 外观字段，不等于任何人都能自行掰半；5 mg 片无刻痕，细粒又是另一剂型。改变剂型、掰片、研磨、混合食物或用另一规格拼接前，应核对实际包装和现行处方。", "en": "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." } ], "source": { "id": "src_50147f1d11000ec1", "label": "PMDA：メバロチン患者用药指南（2023-07 更新）", "url": "https://www.info.pmda.go.jp/downfiles/guide/ph/430574_2189010C1032_2_00G.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "patient_medication_guide", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-08", "reviewedAt": "2026-09-08" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "普伐他汀怎样起作用：抑制 HMG-CoA 还原酶，不等于所有他汀可以轮换", "en": "How pravastatin works: inhibiting HMG-CoA reductase does not make all statins interchangeable" }, "summary": { "zh": "PMDA 资料将普伐他汀归为 HMG-CoA 还原酶抑制剂，并说明其通过抑制肝脏和小肠中的胆固醇合成发挥作用。这个机制帮助理解药物类别，但不能决定某个人应使用哪一种他汀、多少强度、是否隔天轮换或是否需要全基因筛查。", "en": "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." }, "checks": [ { "zh": "同属他汀不表示 MEVALOTIN、阿托伐他汀、瑞舒伐他汀、辛伐他汀可按毫克数自行等量替换、每天轮换或叠加。强度、相互作用、肝肾功能、适应症和处方目标都要分别核对。", "en": "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." }, { "zh": "药物作用机制不能从症状、年龄或一项胆固醇结果直接推导个人用药。完整病史、化验、药单和目标市场现行说明书才是与开方团队讨论的基础。", "en": "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." }, { "zh": "基因信息有时可参与特定药物风险解释，但“他汀”三个字不等于人人需要全基因组筛查。是否检测、检测哪一项及怎样解释必须由合格专业人员结合实际药物和临床背景决定。", "en": "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": { "id": "src_2d10a23407238f30", "label": "PMDA：メバロチン（普伐他汀钠）当前日本电子说明书（2023-07 修订）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/430574_2189010C1032_2_15", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "MEVALOTIN", "generic": "普伐他汀钠", "dosageFormClass": "日本 PMDA：普伐他汀钠 5 mg、10 mg 口服片；0.5%、1% 口服细粒（四个产品身份须分别核对）" }, "labelSource": { "id": "src_232ce8a63d78c6f2", "label": "PMDA：メバロチン錠 5／10、细粒 0.5%／1% 当前日本产品页", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/2189010C1032_2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "productRoutes": [ { "source": { "id": "src_232ce8a63d78c6f2", "label": "PMDA：メバロチン錠 5／10、细粒 0.5%／1% 当前日本产品页", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/2189010C1032_2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "status": "product_level_public_record_verified", "authority": { "zh": "PMDA", "en": "PMDA" }, "market": { "zh": "日本", "en": "Japan" }, "recordType": { "zh": "监管产品记录", "en": "Regulatory product record" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "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." } }, { "source": { "id": "src_2d10a23407238f30", "label": "PMDA：メバロチン（普伐他汀钠）当前日本电子说明书（2023-07 修订）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/430574_2189010C1032_2_15", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "status": "product_level_public_record_verified", "authority": { "zh": "PMDA", "en": "PMDA" }, "market": { "zh": "日本", "en": "Japan" }, "recordType": { "zh": "监管产品记录", "en": "Regulatory product record" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "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." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "PMDA", "en": "PMDA" }, "market": { "zh": "日本", "en": "Japan" }, "recordType": { "zh": "监管产品记录", "en": "Regulatory product record" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "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." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary 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." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’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." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’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." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health 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." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’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." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’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." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "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." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "MEVALOTIN（メバロチン）是日本 PMDA 当前列示的普伐他汀钠品牌档案，覆盖 5 mg、10 mg 口服片和 0.5%、1% 细粒。页面把“每片 mg”和“每 1 g 细粒所含 mg”分开，帮助普通读者核对品牌、通用名、剂型、强度、外观文字与说明书；不从包装数字计算个人片数、克数、频率，也不把它与阿托伐他汀、瑞舒伐他汀或另一市场的普伐他汀自行换算。", "history": "第一三共历史资料记录其三共前身在他汀研发中的历史，并将 MEVALOTIN 的全球上市列为重要节点；PMDA 当前产品页列示四个日本产品及第一三共为制造销售方。历史和当前日本记录用于来源定位，不能外推其他市场。", "sourceDocuments": [ { "id": "src_232ce8a63d78c6f2", "label": "PMDA：メバロチン錠 5／10、细粒 0.5%／1% 当前日本产品页", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/2189010C1032_2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_2d10a23407238f30", "label": "PMDA：メバロチン（普伐他汀钠）当前日本电子说明书（2023-07 修订）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/430574_2189010C1032_2_15", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_50147f1d11000ec1", "label": "PMDA：メバロチン患者用药指南（2023-07 更新）", "url": "https://www.info.pmda.go.jp/downfiles/guide/ph/430574_2189010C1032_2_00G.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "patient_medication_guide", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-08", "reviewedAt": "2026-09-08" }, { "id": "src_6cc8d719b40c0755", "label": "第一三共：三共研发历史与 MEVALOTIN 全球上市记录", "url": "https://www.daiichisankyo.com/about_us/mission-strength/history/sankyo/index.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_product_history", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } ], "applicationNumber": "日本承认番号 21300AMZ00549／20300AMZ00671／21300AMZ00548／20300AMZ00672", "approvalTimeline": [ { "date": "1989", "title": { "zh": "MEVALOTIN 全球上市历史节点", "en": "MEVALOTIN global-launch history milestone" }, "detail": { "zh": "第一三共历史页把 MEVALOTIN 列为三共研发的突破性 HMG-CoA 还原酶抑制剂，并记录其全球上市。该历史节点不替代当前市场批准记录。", "en": "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." }, "source": { "id": "src_6cc8d719b40c0755", "label": "第一三共：三共研发历史与 MEVALOTIN 全球上市记录", "url": "https://www.daiichisankyo.com/about_us/mission-strength/history/sankyo/index.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_product_history", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, { "date": "2023-07", "title": { "zh": "PMDA 当前链接电子说明书修订", "en": "Revision date of the electronic label currently linked by PMDA" }, "detail": { "zh": "PMDA 当前产品页链接 2023-07 修订的电子说明书和患者用药指南，覆盖 5 mg、10 mg 片与 0.5%、1% 细粒。日期定位文件版本，不表示其他市场状态或任何人的开始用药日期。", "en": "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." }, "source": { "id": "src_2d10a23407238f30", "label": "PMDA：メバロチン（普伐他汀钠）当前日本电子说明书（2023-07 修订）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/430574_2189010C1032_2_15", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, { "date": "2026-08-30", "title": { "zh": "PMDA 当前产品页访问复核", "en": "Current PMDA product-page access review" }, "detail": { "zh": "本次复核确认 PMDA 产品页仍列示四个 MEVALOTIN 产品并指向第一三共。页面存在不等于任何地点有库存、可购买或适合个人。", "en": "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." }, "source": { "id": "src_232ce8a63d78c6f2", "label": "PMDA：メバロチン錠 5／10、细粒 0.5%／1% 当前日本产品页", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/2189010C1032_2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } } ], "marketStatus": [ { "market": { "zh": "日本", "en": "Japan" }, "status": { "zh": "已链接 PMDA 当前产品页、电子说明书和患者指南", "en": "Current PMDA product page, electronic label and patient guide linked" }, "detail": { "zh": "四个日本产品身份分别记录；没有从说明书存在推定库存、价格、处方资格或个人适用性。", "en": "The four Japanese product identities are recorded separately; label availability does not establish stock, price, prescription eligibility or individual suitability." } }, { "market": { "zh": "中国大陆、美国、欧盟及其他市场", "en": "Mainland China, United States, EU and other markets" }, "status": { "zh": "现行产品记录待逐市场建立", "en": "Current product records require market-by-market review" }, "detail": { "zh": "不从日本 MEVALOTIN、第一三共研发历史或普伐他汀通用名推定 PRAVACHOL 或其他市场的当前批准、规格、包装、供应、原研/仿制关系和可替代性。", "en": "Japan 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." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "5 mg 片和 0.5% 细粒是不是一个意思？", "en": "Do a 5 mg tablet and 0.5% fine granules mean the same thing?" }, "answer": { "zh": "不是同一种标示基准。5 mg 片是每片含 5 mg；0.5% 细粒在该说明书中是每 1 g 细粒含 5 mg。剂型、计量单位和实际处方必须一起核对，不能只看数字相同就互换。", "en": "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." } }, { "question": { "zh": "可以一天吃普伐他汀、一天吃阿托伐他汀或瑞舒伐他汀吗？", "en": "Can pravastatin be taken one day and atorvastatin or rosuvastatin the next?" }, "answer": { "zh": "网页不能为个人确认这种轮换。不同他汀不是按毫克数直接等量，适应症、强度、相互作用、肝肾功能和处方目标都可能不同。不要自行轮换、叠加或停用，应把实际药盒、处方、化验和完整药单交给开方团队或药师核对。", "en": "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." } }, { "question": { "zh": "10 mg 片有刻痕，是不是可以自己掰成 5 mg？", "en": "Does the score on the 10 mg tablet mean it can be self-split into 5 mg?" }, "answer": { "zh": "不能只凭刻痕作决定。刻痕是说明书外观字段，是否可以分割、分割后的剂量准确性、稳定性和是否符合个人处方，需要核对实际产品说明书并由药师或开方团队确认。", "en": "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." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "statin-gene-testing-what-labels-can-and-cannot-say" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/mevalotin-pravastatin/", "en": "https://origindrug.com/en/drugs/mevalotin-pravastatin/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }