{ "id": "coversyl", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-29", "status": "published_traceable_archive" }, "names": { "brand": "COVERSYL", "generic": "培哚普利", "aliases": [ "Coversyl", "雅施达", "perindopril", "perindopril arginine", "perindopril erbumine", "培哚普利", "培哚普利精氨酸盐", "培哚普利叔丁胺盐", "COVERSYL", "ARTG 101564", "ARTG 101568", "ARTG 101569", "DIN 02123282" ], "marketBrandNames": [ { "name": "COVERSYL", "market": { "zh": "澳大利亚", "en": "Australia" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "TGA 当前 ARTG：精氨酸盐 2.5、5、10 mg 片瓶装。", "en": "Current TGA ARTG records: perindopril arginine 2.5, 5 and 10 mg tablet bottles." }, "source": { "id": "src_55e9c1ef40b3e7fb", "label": "澳大利亚 TGA：COVERSYL 培哚普利精氨酸盐 10 mg 片瓶装（ARTG 101569）", "url": "https://www.tga.gov.au/resources/artg/101569", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "name": "COVERSYL", "market": { "zh": "加拿大", "en": "Canada" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "Health Canada 当前 DIN 02123282：叔丁胺盐 4 mg 片，Servier Canada。", "en": "Current Health Canada DIN 02123282: perindopril erbumine 4 mg tablet, Servier Canada." }, "source": { "id": "src_f569b57eee87a182", "label": "Health Canada：药品产品数据库（DPD）当前访问页；在库内核对 COVERSYL 4 mg／DIN 02123282", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "CA", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" } }, { "name": "雅施达®", "market": { "zh": "中国大陆（企业产品页名称线索）", "en": "Mainland China (company product-page name cue)" }, "evidenceStatus": "company_product_page_name_and_strength_cue", "note": { "zh": "施维雅中国高血压产品页列示雅施达®／培哚普利叔丁胺片 8 mg。该页面只建立中文商品名、通用名与规格线索，不替代 NMPA 批准记录、现行说明书、准确包装、供应或可售资格核验。", "en": "Servier China's hypertension product page lists 雅施达®, perindopril tert-butylamine tablets, 8 mg. It establishes only a Chinese trade-name, generic-name and strength cue; it does not replace an NMPA approval record, current leaflet, exact pack, supply or sale-eligibility check." }, "source": { "id": "src_724bcbaddf3b0641", "label": "施维雅中国：高血压产品页列示雅施达®／培哚普利叔丁胺片 8 mg（2026-08-31 复核）", "url": "https://www.servier.com.cn/hypertension/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "first_party_product_page", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "澳大利亚 TGA 当前 ARTG 分别列示 COVERSYL 培哚普利精氨酸盐 2.5、5、10 mg 片瓶装，Licence status 均为 A；加拿大 Health Canada 当前数据库列示 COVERSYL 培哚普利叔丁胺盐 4 mg 片（DIN 02123282）为 Marketed，产品专论另列 2、4、8 mg 片剂与包装说明。两国盐型、强度数字和包装记录必须分开核对。", "dosageFormClass": "培哚普利口服片；澳大利亚为精氨酸盐 2.5/5/10 mg，加拿大专论为叔丁胺盐 2/4/8 mg；页面不提供盐型或毫克数换算", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1994（加拿大当前记录的上市起始节点）；2005（澳大利亚三项 ARTG 登记节点）", "archiveSponsorText": "Servier Laboratories (Aust) Pty Ltd（澳大利亚 ARTG）；Servier Canada Inc.（加拿大 DIN）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "COVERSYL PLUS", "COVERAM", "perindopril and indapamide", "perindopril and amlodipine", "培哚普利吲达帕胺", "培哚普利氨氯地平", "other perindopril product", "其他培哚普利产品" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "au-coversyl-perindopril-arginine-2-5mg-tablet-bottle-artg-101564", "marketCode": "AU", "labelVersion": { "zh": "TGA ARTG 101564（2026-08-29 核验）", "en": "TGA ARTG 101564 (verified 29 Aug 2026)" }, "dosageForm": { "zh": "COVERSYL 培哚普利精氨酸盐口服片", "en": "COVERSYL perindopril arginine oral tablet" }, "route": { "zh": "口服（产品身份字段）", "en": "oral (product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "ARTG 101564", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片培哚普利精氨酸盐 2.5 mg；瓶装（澳大利亚 TGA）", "en": "Perindopril arginine 2.5 mg per tablet; bottle (Australian TGA)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "培哚普利精氨酸盐", "en": "perindopril arginine" }, "value": 2.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片澳大利亚产品标签标示量；不是与另一盐型、市场或强度的换算式", "en": "Australian labelled amount per tablet; not a conversion to another salt, market or strength" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装（TGA 产品名未列包装片数）", "en": "bottle (pack count not stated in the TGA product name)" }, "fill": null, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "active_regulatory_record", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_58e9c6a83bb3e01c", "label": "澳大利亚 TGA：COVERSYL 培哚普利精氨酸盐 2.5 mg 片瓶装（ARTG 101564）", "url": "https://www.tga.gov.au/resources/artg/101564", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "au-coversyl-perindopril-arginine-5mg-tablet-bottle-artg-101568", "marketCode": "AU", "labelVersion": { "zh": "TGA ARTG 101568（2026-08-29 核验）", "en": "TGA ARTG 101568 (verified 29 Aug 2026)" }, "dosageForm": { "zh": "COVERSYL 培哚普利精氨酸盐口服片", "en": "COVERSYL perindopril arginine oral tablet" }, "route": { "zh": "口服（产品身份字段）", "en": "oral (product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "ARTG 101568", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片培哚普利精氨酸盐 5 mg；瓶装（澳大利亚 TGA）", "en": "Perindopril arginine 5 mg per tablet; bottle (Australian TGA)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "培哚普利精氨酸盐", "en": "perindopril arginine" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片澳大利亚产品标签标示量；不是与另一盐型、市场或强度的换算式", "en": "Australian labelled amount per tablet; not a conversion to another salt, market or strength" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装（TGA 产品名未列包装片数）", "en": "bottle (pack count not stated in the TGA product name)" }, "fill": null, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "active_regulatory_record", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_54e9c05c3fb3e668", "label": "澳大利亚 TGA：COVERSYL 培哚普利精氨酸盐 5 mg 片瓶装（ARTG 101568）", "url": "https://www.tga.gov.au/resources/artg/101568", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "au-coversyl-perindopril-arginine-10mg-tablet-bottle-artg-101569", "marketCode": "AU", "labelVersion": { "zh": "TGA ARTG 101569（2026-08-29 核验）", "en": "TGA ARTG 101569 (verified 29 Aug 2026)" }, "dosageForm": { "zh": "COVERSYL 培哚普利精氨酸盐口服片", "en": "COVERSYL perindopril arginine oral tablet" }, "route": { "zh": "口服（产品身份字段）", "en": "oral (product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "ARTG 101569", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片培哚普利精氨酸盐 10 mg；瓶装（澳大利亚 TGA）", "en": "Perindopril arginine 10 mg per tablet; bottle (Australian TGA)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "培哚普利精氨酸盐", "en": "perindopril arginine" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片澳大利亚产品标签标示量；不是与另一盐型、市场或强度的换算式", "en": "Australian labelled amount per tablet; not a conversion to another salt, market or strength" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装（TGA 产品名未列包装片数）", "en": "bottle (pack count not stated in the TGA product name)" }, "fill": null, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "active_regulatory_record", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_55e9c1ef40b3e7fb", "label": "澳大利亚 TGA：COVERSYL 培哚普利精氨酸盐 10 mg 片瓶装（ARTG 101569）", "url": "https://www.tga.gov.au/resources/artg/101569", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "已建立三个澳大利亚官方文字产品身份；未用零售图或其他市场包装冒充准确药盒", "en": "Three official Australian text identities are established; no retail or other-market pack is presented as the exact pack" }, "summary": { "zh": "TGA 产品页可核对商品名、盐型、每片强度、ARTG、剂型和瓶装，但未提供可与三个产品一一对应的公开包装主展示图。加拿大专论提供片剂颜色、形状与包装文字线索，但不能反向冒充澳大利亚产品外观。因此页面透明显示图片缺口，只展示来源可追溯身份卡。", "en": "TGA product pages verify brand, salt, strength per tablet, ARTG, form and bottle presentation but do not provide a public principal-display image mapped one-to-one to all three products. The Canadian monograph supplies tablet colour, shape and packaging text clues, but these cannot stand in for Australian appearance. The page therefore discloses the image gap and shows traceable identity cards only." }, "source": { "id": "src_55e9c1ef40b3e7fb", "label": "澳大利亚 TGA：COVERSYL 培哚普利精氨酸盐 10 mg 片瓶装（ARTG 101569）", "url": "https://www.tga.gov.au/resources/artg/101569", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "COVERSYL 说明书放大阅读：先分清精氨酸盐 2.5/5/10 mg 与叔丁胺盐 2/4/8 mg", "en": "COVERSYL label reading: separate arginine 2.5/5/10 mg from erbumine 2/4/8 mg first" }, "summary": { "zh": "澳大利亚和加拿大都使用 COVERSYL 品牌，但官方记录中的盐型与毫克数字不同。共同品牌或共同活性母体不表示可以按数字自行换算；网页只帮助核对准确药盒、目标市场和现行说明书，不计算个人片数、频率、开始、停用、加药或换药。", "en": "Australia and Canada both use the COVERSYL brand, but their official records use different salts and milligram numbers. A shared brand or active moiety does not permit self-conversion from the numbers. This page only helps check the exact pack, market and current label; it calculates no individual's tablet count, frequency, start, stop, addition or switch." }, "checks": [ { "zh": "澳大利亚 5 mg 精氨酸盐与加拿大 4 mg 叔丁胺盐不是网页提供的互换公式。不要用两片 2.5 mg 自行拼成处方、把 4 mg 改成 5 mg，或按网上换算表换药；请让药师或开方团队按准确盐型、市场标签、处方和实际药盒核对。", "en": "Australian 5 mg arginine and Canadian 4 mg erbumine are not an interchange formula supplied by this site. Do not assemble a prescription from two 2.5 mg tablets, change 4 mg to 5 mg, or switch from an online conversion table. Have a pharmacist or prescriber check the exact salt, market label, prescription and pack." }, { "zh": "COVERSYL PLUS 含培哚普利与吲达帕胺，COVERAM 含培哚普利与氨氯地平；它们不是本页单方 COVERSYL。若药单同时出现复方、单方培哚普利、其他 ACE 抑制剂、利尿药或降压药，应先核对重复成分，不要自行加药或停药。", "en": "COVERSYL PLUS contains perindopril and indapamide, while COVERAM contains perindopril and amlodipine; neither is the single-ingredient COVERSYL dossier here. If a combination, single-ingredient perindopril, another ACE inhibitor, diuretic or blood-pressure medicine appears together, check duplication first and do not self-add or stop a medicine." }, { "zh": "加拿大专论列示 4 mg 浅绿色棒状有刻痕片和 8 mg 绿色圆片等外观线索。刻痕只是身份核对线索，不是所有人都能掰片或把片剂换算成另一规格的许可；实际能否分割必须回到手中产品和专业指示。", "en": "The Canadian monograph lists appearance clues including a light-green rod-shaped scored 4 mg tablet and a green round 8 mg tablet. A score is an identity clue, not universal permission to split a tablet or convert it into another strength; any splitting decision must return to the exact product and professional instruction." }, { "zh": "面、唇、舌或喉部突然肿胀，呼吸或吞咽困难，晕厥或其他严重过敏表现可能是急症，应立即使用当地急救服务。不要等待网页核实，也不要自行再次服用来“观察”。", "en": "Sudden swelling of the face, lips, tongue or throat, trouble breathing or swallowing, fainting or another severe allergic feature may be an emergency. Use local emergency services immediately; do not wait for web verification or take another tablet to ‘see what happens’." }, { "zh": "老年人、脱水、肾功能问题或同时使用 NSAID 止痛药、利尿药、保钾产品、补钾剂、锂或其他影响血压/肾功能的药物时，需要完整药单和监测计划核对。网页不凭两个药名判断能否同服、是否错开或怎样调整。", "en": "Older age, dehydration, kidney problems, or co-use of NSAID pain medicines, diuretics, potassium-sparing products, potassium supplements, lithium or other medicines affecting blood pressure or kidney function calls for full-list and monitoring review. The site does not decide co-use, separation or adjustment from two names alone." }, { "zh": "加拿大专论列有与沙库巴曲/缬沙坦相关的明确时间边界，但这不是网页可执行的自行停换药倒计时。涉及 ENTRESTO 或其他肾素-血管紧张素系统药物时，应由开方团队安排转换与监测。", "en": "The Canadian monograph contains a specific time boundary involving sacubitril/valsartan, but this is not a self-directed stop-and-switch countdown. When ENTRESTO or another renin-angiotensin-system medicine is involved, the prescribing team must coordinate the transition and monitoring." } ], "source": { "id": "src_13efa0864075ceda", "label": "Health Canada：COVERSYL 培哚普利叔丁胺盐当前产品专论与患者用药信息（2022-10-21）", "url": "https://pdf.hres.ca/dpd_pm/00067894.PDF", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "培哚普利怎样起作用：ACE 抑制路径不能变成个人换药或剂量规则", "en": "How perindopril works: the ACE-inhibition pathway is not a personal switching or dose rule" }, "summary": { "zh": "培哚普利在体内转化为活性代谢物培哚普利拉，抑制血管紧张素转换酶，减少血管紧张素 II 与醛固酮相关作用。该机制可帮助理解为何需要核对血压、肾功能、钾和完整药单，但不能从机制或血压数字替个人选择盐型、规格、片数、停药或联用。", "en": "Perindopril is converted to the active metabolite perindoprilat and inhibits angiotensin-converting enzyme, reducing angiotensin II- and aldosterone-related effects. This helps explain why blood pressure, kidney function, potassium and the complete medicine list matter, but neither the mechanism nor a blood-pressure number selects a salt, strength, tablet count, stop or combination for an individual." }, "checks": [ { "zh": "ACE 抑制剂是药理类别，不表示 COVERSYL、ZESTRIL、VASOTEC、ALTACE、CAPOTEN 或含共同路径的复方可以自行叠加、轮换或按 mg 换算。", "en": "ACE inhibitor is a pharmacologic class; it does not permit self-combining, alternating or milligram-converting COVERSYL, ZESTRIL, VASOTEC, ALTACE, CAPOTEN or shared-pathway combinations." }, { "zh": "血压下降机制不表示头晕就一定是药物过量，也不表示血压暂时升高就能补服。出现新症状或读数异常时，应按个人治疗计划联系医疗团队；严重胸痛、呼吸困难、晕厥或神经系统急症表现应立即使用当地急救服务。", "en": "A blood-pressure-lowering mechanism does not prove that dizziness means overdose or that a temporary higher reading permits an extra tablet. Follow the individual's care plan and contact the care team for new symptoms or unusual readings; severe chest pain, breathing difficulty, fainting or neurologic emergency features require immediate local emergency care." }, { "zh": "机制解释不能替代妊娠、肾功能、钾、脱水、药物相互作用或血管性水肿风险评估。涉及这些情况时，应尽快由医生或药师核对准确药盒和完整药单。", "en": "A mechanism explanation does not replace assessment of pregnancy, kidney function, potassium, dehydration, drug interactions or angioedema risk. When these apply, have a clinician or pharmacist promptly review the exact pack and complete medicine list." } ], "source": { "id": "src_13efa0864075ceda", "label": "Health Canada：COVERSYL 培哚普利叔丁胺盐当前产品专论与患者用药信息（2022-10-21）", "url": "https://pdf.hres.ca/dpd_pm/00067894.PDF", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "COVERSYL", "generic": "培哚普利", "dosageFormClass": "培哚普利口服片；澳大利亚为精氨酸盐 2.5/5/10 mg，加拿大专论为叔丁胺盐 2/4/8 mg；页面不提供盐型或毫克数换算" }, "labelSource": { "id": "src_13efa0864075ceda", "label": "Health Canada：COVERSYL 培哚普利叔丁胺盐当前产品专论与患者用药信息（2022-10-21）", "url": "https://pdf.hres.ca/dpd_pm/00067894.PDF", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "productRoutes": [ { "source": { "id": "src_13efa0864075ceda", "label": "Health Canada：COVERSYL 培哚普利叔丁胺盐当前产品专论与患者用药信息（2022-10-21）", "url": "https://pdf.hres.ca/dpd_pm/00067894.PDF", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "Health Canada", "en": "Health Canada" }, "market": { "zh": "加拿大", "en": "Canada" }, "recordType": { "zh": "监管产品记录或当前产品专论", "en": "Regulatory product record or current product monograph" }, "reviewedAt": "2026-08-29", "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_54e9c05c3fb3e668", "label": "澳大利亚 TGA：COVERSYL 培哚普利精氨酸盐 5 mg 片瓶装（ARTG 101568）", "url": "https://www.tga.gov.au/resources/artg/101568", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "TGA", "en": "TGA" }, "market": { "zh": "澳大利亚", "en": "Australia" }, "recordType": { "zh": "监管产品记录或公开说明书", "en": "Regulatory product record or public product information" }, "reviewedAt": "2026-08-29", "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_55e9c1ef40b3e7fb", "label": "澳大利亚 TGA：COVERSYL 培哚普利精氨酸盐 10 mg 片瓶装（ARTG 101569）", "url": "https://www.tga.gov.au/resources/artg/101569", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "TGA", "en": "TGA" }, "market": { "zh": "澳大利亚", "en": "Australia" }, "recordType": { "zh": "监管产品记录或公开说明书", "en": "Regulatory product record or public product information" }, "reviewedAt": "2026-08-29", "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_58e9c6a83bb3e01c", "label": "澳大利亚 TGA：COVERSYL 培哚普利精氨酸盐 2.5 mg 片瓶装（ARTG 101564）", "url": "https://www.tga.gov.au/resources/artg/101564", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "TGA", "en": "TGA" }, "market": { "zh": "澳大利亚", "en": "Australia" }, "recordType": { "zh": "监管产品记录或公开说明书", "en": "Regulatory product record or public product information" }, "reviewedAt": "2026-08-29", "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_fb5f8125a304c9a9", "label": "澳大利亚 TGA eBS：COVERSYL Product Information 官方入口", "url": "https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2010-PI-01940-3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "AU", "accessStatus": "public_access_requires_interaction", "accessMode": "public_document_with_terms", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "TGA", "en": "TGA" }, "market": { "zh": "澳大利亚", "en": "Australia" }, "recordType": { "zh": "监管产品记录或公开说明书", "en": "Regulatory product record or public product information" }, "reviewedAt": "2026-08-29", "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": "Health Canada", "en": "Health Canada" }, "market": { "zh": "加拿大", "en": "Canada" }, "recordType": { "zh": "监管产品记录或当前产品专论", "en": "Regulatory product record or current product monograph" }, "reviewedAt": "2026-08-29", "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": "COVERSYL 是培哚普利的跨市场品牌档案。先看盐型再看数字：澳大利亚药盒可写精氨酸盐 2.5、5、10 mg；加拿大专论写叔丁胺盐 2、4、8 mg。相近或不同的毫克数字不是自行换算表，也不能据此多片拼规格、换药或与 COVERSYL PLUS、COVERAM 等复方叠加。老年人、肾功能问题、脱水或同时使用止痛药、利尿药、降压药者，尤其应让药师或开方团队核对完整药单和实际药盒。", "history": "Health Canada 当前产品数据库将 DIN 02123282 的 COVERSYL 4 mg 片列为 Marketed，市场起始日期为 1994-12-31，持有人为 Servier Canada Inc.；当前产品专论日期为 2022-10-21。澳大利亚 TGA 将 ARTG 101564、101568、101569 的 2.5、5、10 mg 培哚普利精氨酸盐片登记日期列为 2005-06-08，当前 sponsor 为 Servier Laboratories (Aust) Pty Ltd。", "sourceDocuments": [ { "id": "src_54e9c05c3fb3e668", "label": "澳大利亚 TGA：COVERSYL 培哚普利精氨酸盐 5 mg 片瓶装（ARTG 101568）", "url": "https://www.tga.gov.au/resources/artg/101568", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_55e9c1ef40b3e7fb", "label": "澳大利亚 TGA：COVERSYL 培哚普利精氨酸盐 10 mg 片瓶装（ARTG 101569）", "url": "https://www.tga.gov.au/resources/artg/101569", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_58e9c6a83bb3e01c", "label": "澳大利亚 TGA：COVERSYL 培哚普利精氨酸盐 2.5 mg 片瓶装（ARTG 101564）", "url": "https://www.tga.gov.au/resources/artg/101564", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_fb5f8125a304c9a9", "label": "澳大利亚 TGA eBS：COVERSYL Product Information 官方入口", "url": "https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2010-PI-01940-3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "AU", "accessStatus": "public_access_requires_interaction", "accessMode": "public_document_with_terms", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_1ed2f8478a4fb3e3", "label": "澳大利亚 TGA eBS：COVERSYL Consumer Medicine Information 官方入口", "url": "https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2010-CMI-02831-3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "consumer_medicine_information", "market": "AU", "accessStatus": "public_access_requires_interaction", "accessMode": "public_document_with_terms", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_f569b57eee87a182", "label": "Health Canada：药品产品数据库（DPD）当前访问页；在库内核对 COVERSYL 4 mg／DIN 02123282", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "CA", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, { "id": "src_13efa0864075ceda", "label": "Health Canada：COVERSYL 培哚普利叔丁胺盐当前产品专论与患者用药信息（2022-10-21）", "url": "https://pdf.hres.ca/dpd_pm/00067894.PDF", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_724bcbaddf3b0641", "label": "施维雅中国：高血压产品页列示雅施达®／培哚普利叔丁胺片 8 mg（2026-08-31 复核）", "url": "https://www.servier.com.cn/hypertension/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "first_party_product_page", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } ], "applicationNumber": "澳大利亚 ARTG 101564／101568／101569；加拿大 DIN 02123282", "approvalTimeline": [ { "date": "1994-12-31", "title": { "zh": "加拿大当前数据库所列市场起始节点", "en": "Market-start node listed in the current Canadian database" }, "detail": { "zh": "Health Canada 当前页面将 DIN 02123282 的 COVERSYL 培哚普利叔丁胺盐 4 mg 片列为 Marketed。该状态不证明具体药房库存。", "en": "The current Health Canada page lists COVERSYL perindopril erbumine 4 mg tablets, DIN 02123282, as marketed. This does not establish stock at a particular pharmacy." }, "source": { "id": "src_f569b57eee87a182", "label": "Health Canada：药品产品数据库（DPD）当前访问页；在库内核对 COVERSYL 4 mg／DIN 02123282", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "CA", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" } }, { "date": "2005-06-08", "title": { "zh": "澳大利亚三个精氨酸盐强度的 ARTG 登记节点", "en": "ARTG date for three Australian arginine strengths" }, "detail": { "zh": "TGA 分别以 ARTG 101564、101568、101569 列示 2.5、5、10 mg 片瓶装，Licence status 为 A。", "en": "TGA separately lists 2.5, 5 and 10 mg tablet bottles under ARTG 101564, 101568 and 101569 with licence status A." }, "source": { "id": "src_55e9c1ef40b3e7fb", "label": "澳大利亚 TGA：COVERSYL 培哚普利精氨酸盐 10 mg 片瓶装（ARTG 101569）", "url": "https://www.tga.gov.au/resources/artg/101569", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2022-10-21", "title": { "zh": "加拿大当前产品专论日期", "en": "Current Canadian product-monograph date" }, "detail": { "zh": "专论列示叔丁胺盐 2、4、8 mg 片的外观、包装、警告、相互作用和患者信息；它不把这些数字转换为澳大利亚精氨酸盐规格。", "en": "The monograph lists appearance, packaging, warnings, interactions and patient information for erbumine 2, 4 and 8 mg tablets; it does not convert those numbers into Australian arginine strengths." }, "source": { "id": "src_13efa0864075ceda", "label": "Health Canada：COVERSYL 培哚普利叔丁胺盐当前产品专论与患者用药信息（2022-10-21）", "url": "https://pdf.hres.ca/dpd_pm/00067894.PDF", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } } ], "marketStatus": [ { "market": { "zh": "澳大利亚", "en": "Australia" }, "status": { "zh": "2.5、5、10 mg 精氨酸盐片 ARTG 当前 Licence status 为 A", "en": "ARTG licence status A for 2.5, 5 and 10 mg arginine tablets" }, "detail": { "zh": "监管记录不等于具体药房库存、购买资格、个人适用性或可自行换药。", "en": "A regulatory record does not establish pharmacy stock, purchasing eligibility, individual suitability or self-switching." } }, { "market": { "zh": "加拿大", "en": "Canada" }, "status": { "zh": "DIN 02123282 的 4 mg 叔丁胺盐片当前列为 Marketed", "en": "DIN 02123282 4 mg erbumine tablet is currently listed as marketed" }, "detail": { "zh": "当前专论覆盖 2、4、8 mg 片剂；具体供应和包装仍需按实际产品核对。", "en": "The current monograph covers 2, 4 and 8 mg tablets; actual supply and pack still require exact-product review." } }, { "market": { "zh": "中国大陆、美国、欧盟、日本及其他市场", "en": "Mainland China, United States, EU, Japan and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market record not established" }, "detail": { "zh": "不从澳大利亚或加拿大记录推定当地商品名、批准、盐型、包装、供应、原研/仿制关系或可替代性。", "en": "No local trade name, approval, salt, pack, supply, originator/generic relationship or interchangeability is inferred from Australian or Canadian records." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "澳大利亚 COVERSYL 5 mg 和加拿大 COVERSYL 4 mg 是同一规格吗？", "en": "Are Australian COVERSYL 5 mg and Canadian COVERSYL 4 mg the same strength?" }, "answer": { "zh": "不能只看品牌或数字认定。澳大利亚记录是精氨酸盐 5 mg，加拿大专论是叔丁胺盐 4 mg；网页不提供自行换算或替代规则。请按准确盐型、药盒、处方和目标市场说明书让药师或开方团队核对。", "en": "Do not decide from brand or number alone. The Australian record is 5 mg arginine, while the Canadian monograph is 4 mg erbumine. This site provides no self-conversion or substitution rule; have the exact salt, pack, prescription and target-market label reviewed." } }, { "question": { "zh": "药片有刻痕，能不能掰开？", "en": "Can a scored tablet be split?" }, "answer": { "zh": "刻痕首先是外观身份线索，不是通用分片许可。不同盐型、强度、市场和厂家可能不同；请以手中准确产品的现行说明书、药师或开方团队指示为准。", "en": "A score is first an appearance-identification clue, not universal splitting permission. Salt, strength, market and manufacturer may differ; follow the current label for the exact product and professional instruction." } }, { "question": { "zh": "COVERSYL PLUS 或 COVERAM 能当作单方 COVERSYL 吗？", "en": "Can COVERSYL PLUS or COVERAM be treated as single-ingredient COVERSYL?" }, "answer": { "zh": "不能。前者另含吲达帕胺，后者另含氨氯地平。请逐项核对完整成分，避免与单方培哚普利、利尿药、氨氯地平或其他降压药重复；不要自行拆分、叠加或替换。", "en": "No. The former also contains indapamide and the latter amlodipine. Check every ingredient to avoid duplication with single-ingredient perindopril, diuretics, amlodipine or other blood-pressure medicines; do not self-disassemble, combine or substitute." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/coversyl/", "en": "https://origindrug.com/en/drugs/coversyl/" }, "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." ] }