{ "id": "levaquin", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-04", "status": "published_traceable_archive" }, "names": { "brand": "Levaquin", "generic": "左氧氟沙星", "aliases": [ "可乐必妥", "可乐必妥®", "CRAVIT", "クラビット", "LEVAQUIN", "TAVANIC", "levofloxacin", "左氧氟沙星", "左氧氟沙星片", "levofloxacin hydrate", "H20000655", "H20040091", "6241013F2020", "6241013F3027", "6241013C2024", "22100AMX00648", "22100AMX00649", "22100AMX00650", "NDA 020634" ], "marketBrandNames": [ { "name": "CRAVIT", "market": { "zh": "日本", "en": "Japan" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "PMDA 当前产品页列示クラビット片 250 mg、500 mg及细粒 10%，制造销售方为第一三共。", "en": "The current PMDA product page lists CRAVIT (クラビット) 250 mg and 500 mg tablets and 10% fine granules, with Daiichi Sankyo as marketing authorisation holder." }, "source": { "id": "src_c4a454dbd8713307", "label": "PMDA：クラビット片 250 mg／500 mg及细粒 10% 当前产品页", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/6241013C2024_1?user=1", "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": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "name": "可乐必妥", "market": { "zh": "中国大陆", "en": "Mainland China" }, "evidenceStatus": "dated_first_party_historical_leaflet", "note": { "zh": "第一三共中国 2021 年历史完整说明书中的商品名；仅用于有日期的品牌、规格与批准文号档案，不证明当前批准、包装、供应或可售资格。", "en": "Brand name in Daiichi Sankyo China's 2021 historical full leaflet; retained only as dated brand, strength and approval-number evidence, not current approval, pack, supply or sale eligibility." }, "source": { "id": "src_d26a8d5125a9c09d", "label": "第一三共中国：可乐必妥® 左氧氟沙星片 0.5 g 完整说明书（2021，历史公开资料）", "url": "https://www.daiichisankyo.com.cn/data/upload/file/20211112/6377230777353626337639593.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "name": "LEVAQUIN", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "historical_regulatory_record", "note": { "zh": "FDA 2019 历史口服片标签档案中的美国品牌名。", "en": "U.S. brand name in the 2019 FDA historical oral-tablet label archive." }, "source": { "id": "src_4e39fcca7a55ea86", "label": "FDA：LEVAQUIN 2019 美国口服片处方信息（NDA 020634）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020634s072lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" } }, { "name": "TAVANIC", "market": { "zh": "欧洲", "en": "Europe" }, "evidenceStatus": "first_party_brand_history", "note": { "zh": "第一三共 2009 年官方资料列出的欧洲品牌名；不替代任何国家现行批准记录。", "en": "European brand name stated in a 2009 Daiichi Sankyo first-party release; it does not replace a current country-specific approval record." }, "source": { "id": "src_6fa55085e6582599", "label": "第一三共：左氧氟沙星全球品牌名与研发来源说明（2009）", "url": "https://www.daiichisankyo.com/media/press_release/detail/index_3886.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "first_party_release", "market": "GLOBAL", "accessStatus": "public_access_with_site_controls", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "mainlandChinaTradeNameCue": { "value": "可乐必妥®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_5a8b4df02f34aa4c", "label": "第一三共中国：可乐必妥® 左氧氟沙星片 0.1 g 说明书（2021，历史公开资料）", "url": "https://www.daiichisankyo.com.cn/data/upload/file/20211112/6377230695728340551675231.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } }, "identity": { "therapeuticArea": "感染", "sourceArchiveMarket": "日本 PMDA 当前 CRAVIT 产品记录、2025-05 电子说明书包装项目及患者用药指南；美国 FDA LEVAQUIN 口服片历史标签；中国大陆第一三共可乐必妥® 0.1 g 与 0.5 g（均为 2021 年历史完整说明书）资料；欧洲 TAVANIC 品牌历史线索", "dosageFormClass": "日本 PMDA：250 mg、500 mg 片及 10% 细粒；美国历史标签：250 mg、500 mg、750 mg 口服片；中国大陆 2021 年历史完整说明书：0.1 g、0.5 g 口服片（市场与版本须分别核对）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1993（第一三共官方历史：日本 CRAVIT 上市）／1996（FDA 2019 标签所列美国初始批准）", "archiveSponsorText": "第一三共研发与全球品牌历史；PMDA 日本当前产品记录、2025 电子说明书与患者用药指南；日本厚生劳动省药价代码目录；Janssen / FDA 美国历史标签；第一三共中国历史公开说明书" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "クラビット点眼液" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "jp-cravit-tablet-250mg-100-bottle-current-2025", "marketCode": "JP", "labelVersion": { "zh": "PMDA 日本当前电子说明书（2025-05-20；第 2 版）", "en": "Current PMDA Japan electronic label (20 May 2025; version 2)" }, "dosageForm": { "zh": "クラビット（CRAVIT）左氧氟沙星水合物 250 mg 口服片", "en": "CRAVIT levofloxacin hydrate 250 mg oral tablet" }, "route": { "zh": "口服（日本当前产品身份字段）", "en": "oral (current Japan product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "6241013F2020", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片以左氧氟沙星计 250 mg；100 片塑料瓶散装（日本当前标签）", "en": "250 mg levofloxacin per tablet; 100-tablet loose-fill plastic bottle (current Japan label)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "左氧氟沙星（以左氧氟沙星水合物计）", "en": "levofloxacin (as levofloxacin hydrate)" }, "value": 250, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片日本当前标签标示量；不是个人片数、频率或疗程", "en": "current Japan labelled amount per tablet; not an individual tablet count, frequency or course" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 100, "unit": { "zh": "片/包装", "en": "tablets per pack" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_fa1bb1e9b9a9d12d", "label": "PMDA：クラビット片 250 mg／500 mg、细粒 10% 日本当前电子说明书（2025-05-20；包装项目）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/430574_6241013C2024_1_24", "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-cravit-tablet-250mg-100-ptp-current-2025", "marketCode": "JP", "labelVersion": { "zh": "PMDA 日本当前电子说明书（2025-05-20；第 2 版）", "en": "Current PMDA Japan electronic label (20 May 2025; version 2)" }, "dosageForm": { "zh": "クラビット（CRAVIT）左氧氟沙星水合物 250 mg 口服片", "en": "CRAVIT levofloxacin hydrate 250 mg oral tablet" }, "route": { "zh": "口服（日本当前产品身份字段）", "en": "oral (current Japan product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "6241013F2020", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片以左氧氟沙星计 250 mg；PTP 100 片（10 片×10）（日本当前标签）", "en": "250 mg levofloxacin per tablet; 100-tablet PTP pack (10 × 10) (current Japan label)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "左氧氟沙星（以左氧氟沙星水合物计）", "en": "levofloxacin (as levofloxacin hydrate)" }, "value": 250, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片日本当前标签标示量；不是个人片数、频率或疗程", "en": "current Japan labelled amount per tablet; not an individual tablet count, frequency or course" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 100, "unit": { "zh": "片/包装", "en": "tablets per pack" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_fa1bb1e9b9a9d12d", "label": "PMDA：クラビット片 250 mg／500 mg、细粒 10% 日本当前电子说明书（2025-05-20；包装项目）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/430574_6241013C2024_1_24", "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-cravit-tablet-250mg-500-ptp-current-2025", "marketCode": "JP", "labelVersion": { "zh": "PMDA 日本当前电子说明书（2025-05-20；第 2 版）", "en": "Current PMDA Japan electronic label (20 May 2025; version 2)" }, "dosageForm": { "zh": "クラビット（CRAVIT）左氧氟沙星水合物 250 mg 口服片", "en": "CRAVIT levofloxacin hydrate 250 mg oral tablet" }, "route": { "zh": "口服（日本当前产品身份字段）", "en": "oral (current Japan product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "6241013F2020", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片以左氧氟沙星计 250 mg；PTP 500 片（10 片×50）（日本当前标签）", "en": "250 mg levofloxacin per tablet; 500-tablet PTP pack (10 × 50) (current Japan label)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "左氧氟沙星（以左氧氟沙星水合物计）", "en": "levofloxacin (as levofloxacin hydrate)" }, "value": 250, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片日本当前标签标示量；不是个人片数、频率或疗程", "en": "current Japan labelled amount per tablet; not an individual tablet count, frequency or course" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 500, "unit": { "zh": "片/包装", "en": "tablets per pack" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_fa1bb1e9b9a9d12d", "label": "PMDA：クラビット片 250 mg／500 mg、细粒 10% 日本当前电子说明书（2025-05-20；包装项目）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/430574_6241013C2024_1_24", "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-cravit-tablet-500mg-100-bottle-current-2025", "marketCode": "JP", "labelVersion": { "zh": "PMDA 日本当前电子说明书（2025-05-20；第 2 版）", "en": "Current PMDA Japan electronic label (20 May 2025; version 2)" }, "dosageForm": { "zh": "クラビット（CRAVIT）左氧氟沙星水合物 500 mg 口服片", "en": "CRAVIT levofloxacin hydrate 500 mg oral tablet" }, "route": { "zh": "口服（日本当前产品身份字段）", "en": "oral (current Japan product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "6241013F3027", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片以左氧氟沙星计 500 mg；100 片塑料瓶散装（日本当前标签）", "en": "500 mg levofloxacin per tablet; 100-tablet loose-fill plastic bottle (current Japan label)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "左氧氟沙星（以左氧氟沙星水合物计）", "en": "levofloxacin (as levofloxacin hydrate)" }, "value": 500, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片日本当前标签标示量；不是个人片数、频率或疗程", "en": "current Japan labelled amount per tablet; not an individual tablet count, frequency or course" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 100, "unit": { "zh": "片/包装", "en": "tablets per pack" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_fa1bb1e9b9a9d12d", "label": "PMDA：クラビット片 250 mg／500 mg、细粒 10% 日本当前电子说明书（2025-05-20；包装项目）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/430574_6241013C2024_1_24", "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-cravit-tablet-500mg-50-ptp-current-2025", "marketCode": "JP", "labelVersion": { "zh": "PMDA 日本当前电子说明书（2025-05-20；第 2 版）", "en": "Current PMDA Japan electronic label (20 May 2025; version 2)" }, "dosageForm": { "zh": "クラビット（CRAVIT）左氧氟沙星水合物 500 mg 口服片", "en": "CRAVIT levofloxacin hydrate 500 mg oral tablet" }, "route": { "zh": "口服（日本当前产品身份字段）", "en": "oral (current Japan product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "6241013F3027", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片以左氧氟沙星计 500 mg；PTP 50 片（5 片×10）（日本当前标签）", "en": "500 mg levofloxacin per tablet; 50-tablet PTP pack (5 × 10) (current Japan label)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "左氧氟沙星（以左氧氟沙星水合物计）", "en": "levofloxacin (as levofloxacin hydrate)" }, "value": 500, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片日本当前标签标示量；不是个人片数、频率或疗程", "en": "current Japan labelled amount per tablet; not an individual tablet count, frequency or course" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 50, "unit": { "zh": "片/包装", "en": "tablets per pack" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_fa1bb1e9b9a9d12d", "label": "PMDA：クラビット片 250 mg／500 mg、细粒 10% 日本当前电子说明书（2025-05-20；包装项目）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/430574_6241013C2024_1_24", "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-cravit-tablet-500mg-100-ptp-current-2025", "marketCode": "JP", "labelVersion": { "zh": "PMDA 日本当前电子说明书（2025-05-20；第 2 版）", "en": "Current PMDA Japan electronic label (20 May 2025; version 2)" }, "dosageForm": { "zh": "クラビット（CRAVIT）左氧氟沙星水合物 500 mg 口服片", "en": "CRAVIT levofloxacin hydrate 500 mg oral tablet" }, "route": { "zh": "口服（日本当前产品身份字段）", "en": "oral (current Japan product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "6241013F3027", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片以左氧氟沙星计 500 mg；PTP 100 片（5 片×20）（日本当前标签）", "en": "500 mg levofloxacin per tablet; 100-tablet PTP pack (5 × 20) (current Japan label)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "左氧氟沙星（以左氧氟沙星水合物计）", "en": "levofloxacin (as levofloxacin hydrate)" }, "value": 500, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片日本当前标签标示量；不是个人片数、频率或疗程", "en": "current Japan labelled amount per tablet; not an individual tablet count, frequency or course" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 100, "unit": { "zh": "片/包装", "en": "tablets per pack" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_fa1bb1e9b9a9d12d", "label": "PMDA：クラビット片 250 mg／500 mg、细粒 10% 日本当前电子说明书（2025-05-20；包装项目）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/430574_6241013C2024_1_24", "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-cravit-tablet-500mg-500-ptp-current-2025", "marketCode": "JP", "labelVersion": { "zh": "PMDA 日本当前电子说明书（2025-05-20；第 2 版）", "en": "Current PMDA Japan electronic label (20 May 2025; version 2)" }, "dosageForm": { "zh": "クラビット（CRAVIT）左氧氟沙星水合物 500 mg 口服片", "en": "CRAVIT levofloxacin hydrate 500 mg oral tablet" }, "route": { "zh": "口服（日本当前产品身份字段）", "en": "oral (current Japan product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "6241013F3027", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片以左氧氟沙星计 500 mg；PTP 500 片（5 片×100）（日本当前标签）", "en": "500 mg levofloxacin per tablet; 500-tablet PTP pack (5 × 100) (current Japan label)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "左氧氟沙星（以左氧氟沙星水合物计）", "en": "levofloxacin (as levofloxacin hydrate)" }, "value": 500, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片日本当前标签标示量；不是个人片数、频率或疗程", "en": "current Japan labelled amount per tablet; not an individual tablet count, frequency or course" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 500, "unit": { "zh": "片/包装", "en": "tablets per pack" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_fa1bb1e9b9a9d12d", "label": "PMDA：クラビット片 250 mg／500 mg、细粒 10% 日本当前电子说明书（2025-05-20；包装项目）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/430574_6241013C2024_1_24", "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-cravit-fine-granules-10pct-100g-bottle-current-2025", "marketCode": "JP", "labelVersion": { "zh": "PMDA 日本当前电子说明书（2025-05-20；第 2 版）", "en": "Current PMDA Japan electronic label (20 May 2025; version 2)" }, "dosageForm": { "zh": "クラビット（CRAVIT）左氧氟沙星水合物 10% 细粒", "en": "CRAVIT levofloxacin hydrate 10% fine granules" }, "route": { "zh": "口服（日本当前产品身份字段）", "en": "oral (current Japan product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "6241013C2024", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_g", "primaryDisplay": { "zh": "每 1 g 细粒以左氧氟沙星计 100 mg（10%）；100 g 塑料瓶（日本当前标签）", "en": "100 mg levofloxacin per 1 g of fine granules (10%); 100 g plastic bottle (current Japan label)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "左氧氟沙星（以左氧氟沙星水合物计）", "en": "levofloxacin (as levofloxacin hydrate)" }, "value": 100, "unit": "mg", "basisCode": "per_g", "basisLabel": { "zh": "每 1 g 细粒日本当前标签标示量；不是个人克数、分包数、频率或疗程", "en": "current Japan labelled amount per 1 g of granules; not an individual gram amount, sachet count, frequency or course" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 100, "unit": { "zh": "g/瓶", "en": "g per bottle" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_fa1bb1e9b9a9d12d", "label": "PMDA：クラビット片 250 mg／500 mg、细粒 10% 日本当前电子说明书（2025-05-20；包装项目）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/430574_6241013C2024_1_24", "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-cravit-fine-granules-10pct-2-5g-100-sachets-current-2025", "marketCode": "JP", "labelVersion": { "zh": "PMDA 日本当前电子说明书（2025-05-20；第 2 版）", "en": "Current PMDA Japan electronic label (20 May 2025; version 2)" }, "dosageForm": { "zh": "クラビット（CRAVIT）左氧氟沙星水合物 10% 细粒", "en": "CRAVIT levofloxacin hydrate 10% fine granules" }, "route": { "zh": "口服（日本当前产品身份字段）", "en": "oral (current Japan product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "6241013C2024", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_g", "primaryDisplay": { "zh": "每 1 g 细粒以左氧氟沙星计 100 mg（10%）；2.5 g×100 包（日本当前标签）", "en": "100 mg levofloxacin per 1 g of fine granules (10%); 100 sachets of 2.5 g (current Japan label)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "左氧氟沙星（以左氧氟沙星水合物计）", "en": "levofloxacin (as levofloxacin hydrate)" }, "value": 100, "unit": "mg", "basisCode": "per_g", "basisLabel": { "zh": "每 1 g 细粒日本当前标签标示量；不是个人克数、分包数、频率或疗程", "en": "current Japan labelled amount per 1 g of granules; not an individual gram amount, sachet count, frequency or course" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 100, "unit": { "zh": "包/盒", "en": "sachets per box" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_fa1bb1e9b9a9d12d", "label": "PMDA：クラビット片 250 mg／500 mg、细粒 10% 日本当前电子说明书（2025-05-20；包装项目）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/430574_6241013C2024_1_24", "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": "us-levaquin-tablet-250mg-ndc-50458-920-50-historical-2019", "marketCode": "US", "labelVersion": { "zh": "FDA 美国历史口服片标签（2019-05；非现行包装或供应结论）", "en": "FDA U.S. historical oral-tablet label (May 2019; not a current-package or availability finding)" }, "dosageForm": { "zh": "左氧氟沙星胶囊形薄膜衣口服片", "en": "levofloxacin capsule-shaped coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 50458-920-50", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 250 mg；50 片瓶装（美国历史标签）", "en": "250 mg per tablet; 50-tablet bottle (U.S. historical label)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "左氧氟沙星", "en": "levofloxacin" }, "value": 250, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史标签标示量", "en": "historical labelled amount per tablet" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 50, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "赤陶粉红色", "en": "terra cotta pink" }, "shape": { "zh": "胶囊形薄膜衣片", "en": "capsule-shaped coated tablet" }, "imprint": "LEVAQUIN / 250", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_4e39fcca7a55ea86", "label": "FDA：LEVAQUIN 250 mg 口服片、50 片瓶装（NDC 50458-920-50；2019 美国历史标签）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020634s072lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-levaquin-tablet-500mg-ndc-50458-925-50-historical-2019", "marketCode": "US", "labelVersion": { "zh": "FDA 美国历史口服片标签（2019-05；非现行包装或供应结论）", "en": "FDA U.S. historical oral-tablet label (May 2019; not a current-package or availability finding)" }, "dosageForm": { "zh": "左氧氟沙星胶囊形薄膜衣口服片", "en": "levofloxacin capsule-shaped coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 50458-925-50", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 500 mg；50 片瓶装（美国历史标签）", "en": "500 mg per tablet; 50-tablet bottle (U.S. historical label)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "左氧氟沙星", "en": "levofloxacin" }, "value": 500, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史标签标示量", "en": "historical labelled amount per tablet" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 50, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "桃色", "en": "peach" }, "shape": { "zh": "胶囊形薄膜衣片", "en": "capsule-shaped coated tablet" }, "imprint": "LEVAQUIN / 500", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_4e39fcca7a55ea86", "label": "FDA：LEVAQUIN 500 mg 口服片、50 片瓶装（NDC 50458-925-50；2019 美国历史标签）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020634s072lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-levaquin-tablet-750mg-ndc-50458-930-20-historical-2019", "marketCode": "US", "labelVersion": { "zh": "FDA 美国历史口服片标签（2019-05；非现行包装或供应结论）", "en": "FDA U.S. historical oral-tablet label (May 2019; not a current-package or availability finding)" }, "dosageForm": { "zh": "左氧氟沙星胶囊形薄膜衣口服片", "en": "levofloxacin capsule-shaped coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 50458-930-20", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 750 mg；20 片瓶装（美国历史标签）", "en": "750 mg per tablet; 20-tablet bottle (U.S. historical label)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "左氧氟沙星", "en": "levofloxacin" }, "value": 750, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史标签标示量", "en": "historical labelled amount per tablet" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 20, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "胶囊形薄膜衣片", "en": "capsule-shaped coated tablet" }, "imprint": "LEVAQUIN / 750", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_4e39fcca7a55ea86", "label": "FDA：LEVAQUIN 750 mg 口服片、20 片瓶装（NDC 50458-930-20；2019 美国历史标签）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020634s072lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "cn-cravit-levofloxacin-tablet-100mg-10tablet-blister-h20000655-historical-2021", "marketCode": "CN", "labelVersion": { "zh": "第一三共中国历史公开完整说明书（2021-05 修订；非现行批准、供应或包装结论）", "en": "Daiichi Sankyo China historical public full leaflet (revised May 2021; not a current approval, supply or pack finding)" }, "dosageForm": { "zh": "左氧氟沙星片", "en": "levofloxacin tablet" }, "route": { "zh": "口服（历史说明书产品身份字段）", "en": "oral (historical-leaflet product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "H20000655", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "可乐必妥® 左氧氟沙星片：每片 0.1 g（100 mg），10 片铝塑板/盒（中国历史说明书）", "en": "CRAVIT® levofloxacin tablets: 0.1 g (100 mg) per tablet, 10-tablet blister/box (China historical leaflet)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "左氧氟沙星", "en": "levofloxacin" }, "value": 100, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史说明书标示量；不是个人片数或换算", "en": "historical leaflet amount per tablet; not an individual tablet count or conversion" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 10, "unit": { "zh": "片/铝塑板/盒", "en": "tablets per blister/box" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_5a8b4df02f34aa4c", "label": "第一三共中国：可乐必妥® 左氧氟沙星片 0.1 g、10 片铝塑板/盒（国药准字 H20000655；2021 历史完整说明书）", "url": "https://www.daiichisankyo.com.cn/data/upload/file/20211112/6377230695728340551675231.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "cn-cravit-levofloxacin-tablet-100mg-6tablet-blister-h20000655-historical-2021", "marketCode": "CN", "labelVersion": { "zh": "第一三共中国历史公开完整说明书（2021-05 修订；非现行批准、供应或包装结论）", "en": "Daiichi Sankyo China historical public full leaflet (revised May 2021; not a current approval, supply or pack finding)" }, "dosageForm": { "zh": "左氧氟沙星片", "en": "levofloxacin tablet" }, "route": { "zh": "口服（历史说明书产品身份字段）", "en": "oral (historical-leaflet product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "H20000655", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "可乐必妥® 左氧氟沙星片：每片 0.1 g（100 mg），6 片铝塑板/盒（中国历史说明书）", "en": "CRAVIT® levofloxacin tablets: 0.1 g (100 mg) per tablet, 6-tablet blister/box (China historical leaflet)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "左氧氟沙星", "en": "levofloxacin" }, "value": 100, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史说明书标示量；不是个人片数或换算", "en": "historical leaflet amount per tablet; not an individual tablet count or conversion" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 6, "unit": { "zh": "片/铝塑板/盒", "en": "tablets per blister/box" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_5a8b4df02f34aa4c", "label": "第一三共中国：可乐必妥® 左氧氟沙星片 0.1 g、6 片铝塑板/盒（国药准字 H20000655；2021 历史完整说明书）", "url": "https://www.daiichisankyo.com.cn/data/upload/file/20211112/6377230695728340551675231.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "cn-cravit-levofloxacin-tablet-500mg-4tablet-blister-h20040091-historical-2021", "marketCode": "CN", "labelVersion": { "zh": "第一三共中国历史公开完整说明书（2021-04 修订；非现行批准、供应或包装结论）", "en": "Daiichi Sankyo China historical public full leaflet (revised Apr 2021; not a current approval, supply or pack finding)" }, "dosageForm": { "zh": "左氧氟沙星片", "en": "levofloxacin tablet" }, "route": { "zh": "口服（历史说明书产品身份字段）", "en": "oral (historical-leaflet product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "H20040091", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "可乐必妥® 左氧氟沙星片：每片 0.5 g（500 mg），4 片铝塑板/盒（中国历史说明书）", "en": "CRAVIT® levofloxacin tablets: 0.5 g (500 mg) per tablet, 4-tablet blister/box (China historical leaflet)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "左氧氟沙星", "en": "levofloxacin" }, "value": 500, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史说明书标示量；不是个人片数或换算", "en": "historical leaflet amount per tablet; not an individual tablet count or conversion" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 4, "unit": { "zh": "片/铝塑板/盒", "en": "tablets per blister/box" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_d26a8d5125a9c09d", "label": "第一三共中国：可乐必妥® 左氧氟沙星片 0.5 g、4 片铝塑板/盒（国药准字 H20040091；2021 历史完整说明书）", "url": "https://www.daiichisankyo.com.cn/data/upload/file/20211112/6377230777353626337639593.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [ { "id": "jp-cravit-tablet-250mg-pmda-patient-guide-2025", "marketCode": "JP", "visualKind": "official_patient_guide_dosage_form_appearance", "title": { "zh": "CRAVIT 250 mg 片：日本官方剂型外观", "en": "CRAVIT 250 mg tablet: official Japan dosage-form appearance" }, "imageUrl": "/evidence/medicine/levaquin/cravit-tablet-250mg-pmda-patient-guide-2025.jpg", "alt": { "zh": "PMDA 患者用药指南中的 CRAVIT 250 mg 片和 PTP 泡罩外观", "en": "CRAVIT 250 mg tablet and PTP blister appearance in the PMDA patient medicine guide" }, "description": { "zh": "患者指南第 7 页所示橙色椭圆形 250 mg 片与 PTP 泡罩；仅对应日本该指南。", "en": "Orange oval 250 mg tablet and PTP blister shown on page 7 of the patient guide; Japan guide only." }, "exclusions": { "zh": "不是精确整盒包装图，也不是中国或美国包装；不能单凭外观判断真伪或决定用量。", "en": "Not an exact outer-package image and not a China or U.S. pack; appearance alone cannot authenticate the product or determine use." }, "source": { "id": "src_a2d8ff3f32ae1d1b", "label": "PMDA：クラビット片 250 mg／500 mg、细粒 10% 患者用医药品指南（2025-06-26；第 7 页外观）", "url": "https://www.info.pmda.go.jp/downfiles/ph/GUI/430574_6241013C2024_1_00G.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-24", "reviewedAt": "2026-08-24" }, "scope": "official_dosage_form_appearance_only_not_outer_package_authentication_or_personal_use" }, { "id": "jp-cravit-tablet-500mg-pmda-patient-guide-2025", "marketCode": "JP", "visualKind": "official_patient_guide_dosage_form_appearance", "title": { "zh": "CRAVIT 500 mg 片：日本官方剂型外观", "en": "CRAVIT 500 mg tablet: official Japan dosage-form appearance" }, "imageUrl": "/evidence/medicine/levaquin/cravit-tablet-500mg-pmda-patient-guide-2025.jpg", "alt": { "zh": "PMDA 患者用药指南中的 CRAVIT 500 mg 片和 PTP 泡罩外观", "en": "CRAVIT 500 mg tablet and PTP blister appearance in the PMDA patient medicine guide" }, "description": { "zh": "患者指南第 7 页所示淡橙色椭圆形 500 mg 片与 PTP 泡罩；仅对应日本该指南。", "en": "Pale-orange oval 500 mg tablet and PTP blister shown on page 7 of the patient guide; Japan guide only." }, "exclusions": { "zh": "不是精确整盒包装图，也不是中国或美国包装；250 mg 与 500 mg 外观不可混认。", "en": "Not an exact outer-package image and not a China or U.S. pack; the 250 mg and 500 mg appearances must not be confused." }, "source": { "id": "src_a2d8ff3f32ae1d1b", "label": "PMDA：クラビット片 250 mg／500 mg、细粒 10% 患者用医药品指南（2025-06-26；第 7 页外观）", "url": "https://www.info.pmda.go.jp/downfiles/ph/GUI/430574_6241013C2024_1_00G.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-24", "reviewedAt": "2026-08-24" }, "scope": "official_dosage_form_appearance_only_not_outer_package_authentication_or_personal_use" }, { "id": "jp-cravit-fine-granules-10pct-pmda-patient-guide-2025", "marketCode": "JP", "visualKind": "official_patient_guide_dosage_form_appearance", "title": { "zh": "CRAVIT 10% 细粒：日本官方分包外观", "en": "CRAVIT 10% fine granules: official Japan sachet appearance" }, "imageUrl": "/evidence/medicine/levaquin/cravit-fine-granules-10pct-pmda-patient-guide-2025.jpg", "alt": { "zh": "PMDA 患者用药指南中的 CRAVIT 10% 细粒 2.5 g 分包正反面", "en": "Front and back of the CRAVIT 10% fine-granule 2.5 g sachet in the PMDA patient medicine guide" }, "description": { "zh": "患者指南第 7 页所示 10% 细粒 2.5 g 分包正反面；仅对应日本该指南。", "en": "Front and back of the 2.5 g sachet of 10% fine granules shown on page 7; Japan guide only." }, "exclusions": { "zh": "分包上的 250 mg/包与 2.5 g 是产品身份字段，不是个人服用量或疗程指令。", "en": "The sachet's 250 mg per packet and 2.5 g are product-identity fields, not an individual amount or course instruction." }, "source": { "id": "src_a2d8ff3f32ae1d1b", "label": "PMDA：クラビット片 250 mg／500 mg、细粒 10% 患者用医药品指南（2025-06-26；第 7 页外观）", "url": "https://www.info.pmda.go.jp/downfiles/ph/GUI/430574_6241013C2024_1_00G.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-24", "reviewedAt": "2026-08-24" }, "scope": "official_dosage_form_appearance_only_not_outer_package_authentication_or_personal_use" } ], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "再包装历史标签不作为原品牌整盒图；日本官方剂型外观已单列", "en": "The repackaged historical label is not an original-brand outer package; official Japan dosage-form appearances are shown separately" }, "summary": { "zh": "DailyMed 可检索到的 LEVAQUIN 相关可见标签由 RedPharm Drug Inc. 标为再包装标签，不能被当作原品牌整盒包装图。页面因此仍不展示 LEVAQUIN、可乐必妥或 CRAVIT 的精确整盒包装；另设模块展示 PMDA 2025-06-26 患者指南中的日本 CRAVIT 250 mg 片、500 mg 片和 10% 细粒剂型外观，并明确不外推为中国或美国包装、真伪证明或个人用量。", "en": "The searchable DailyMed LEVAQUIN label is identified by RedPharm Drug Inc. as repackaged and cannot serve as an original-brand outer-package image. Exact LEVAQUIN, CRAVIT or 可乐必妥 outer packages therefore remain withheld. A separate module shows Japan-only CRAVIT 250 mg tablet, 500 mg tablet and 10% fine-granule dosage-form appearances from the PMDA patient guide dated 26 June 2025; they are not China or U.S. packs, authentication evidence or individual-use instructions." }, "source": { "id": "src_82d58501060b81b5", "label": "DailyMed（NLM）：LEVAQUIN 再包装历史标签说明", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=40a96527-f89e-4177-9224-5c79167f3e60", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "CRAVIT / 可乐必妥 / LEVAQUIN 说明书放大阅读：先确认市场、剂型与规格", "en": "CRAVIT / LEVAQUIN label reading: first confirm market, dosage form and strength" }, "summary": { "zh": "本模块首先链接 PMDA 2025-06 更新的日本 CRAVIT 患者用药指南：其首页并列 250 mg、500 mg 片和 10% 细粒，并标示左氧氟沙星水合物；美国 2019 年 LEVAQUIN 口服片历史标签仍作为另一个市场的阅读文件保留。两份文件都只帮助核对名称、剂型、强度和警告文字，不能判断感染是否需要抗菌药，也不把包装数字转换为个人的片数、疗程或换药方案。", "en": "This module first links the PMDA Japan CRAVIT patient medication guide, updated in June 2025. Its first page separately identifies 250 mg and 500 mg tablets and 10% fine granules as levofloxacin hydrate; the 2019 U.S. LEVAQUIN oral-tablet archive remains a reading document for a different market. Neither document decides whether an infection needs an antibacterial medicine or converts package numbers into a personal tablet count, course or switching plan." }, "checks": [ { "zh": "先核对包装上的完整品牌名：日本常见 CRAVIT、中国历史资料为可乐必妥®、美国历史标签为 LEVAQUIN，欧洲品牌历史线索为 TAVANIC；再核对左氧氟沙星、剂型、每单位标示强度和目标市场。品牌族谱不表示不同市场产品可自行互换。", "en": "First check the complete pack brand: CRAVIT in Japan, 可乐必妥® in the historical China material, LEVAQUIN in the U.S. historical label and TAVANIC as a European brand-history cue; then check levofloxacin, dosage form, stated strength per unit and target market. A brand family does not make products from different markets self-interchangeable." }, { "zh": "PMDA 2025-05 电子说明书的包装项目分别列出：250 mg 片的 100 片瓶装、PTP 100/500 片；500 mg 片的 100 片瓶装、PTP 50/100/500 片；10% 细粒的 100 g 瓶装及 2.5 g×100 包。包装总量、每片强度与细粒每 1 g 含量是不同字段，不能据此推导个人片数、克数、包数或疗程。", "en": "The May 2025 PMDA electronic label separately lists 250 mg tablets in a 100-tablet bottle and 100/500-tablet PTP packs; 500 mg tablets in a 100-tablet bottle and 50/100/500-tablet PTP packs; and 10% fine granules in a 100 g bottle or 100 sachets of 2.5 g. Total pack amount, per-tablet strength and amount per 1 g of granules are different fields and do not derive an individual's tablet, gram or sachet count or course." }, { "zh": "250、500、750 mg 首先是标签所列每片的标示强度，不是“今天应吃几片”的答案。片数、剩余药量、症状轻重或他人的处方都不能让读者自行把不同强度拼量、减半、替换或延长疗程。", "en": "250, 500 and 750 mg first identify the labelled strength per tablet; they are not an answer to “how many tablets today.” Tablet count, leftovers, symptom severity or someone else’s prescription do not permit self-combining strengths, halving, substituting or extending a course." }, { "zh": "PMDA 现行电子说明书与 FDA 历史标签均含严重不良反应警示。若出现突发或持续的腹部、胸部或背部疼痛，或肌腱疼痛/肿胀、麻木刺痛、明显情绪或意识变化、严重低血糖样不适、呼吸困难等，应立即使用当地紧急医疗支持；不要等待网页判断、继续使用或自行改成另一种抗菌药。", "en": "The current PMDA electronic label and historical FDA label both contain serious adverse-reaction warnings. With sudden or persistent abdominal, chest or back pain, tendon pain or swelling, numbness or tingling, marked mood or mental-status change, severe low-glucose-like symptoms, breathing trouble or a similar concern, use local urgent medical support immediately; do not wait for a website decision, continue, or self-switch to another antibacterial medicine." }, { "zh": "PMDA 现行电子说明书提示老年人更易出现肌腱障碍，且常伴肾功能下降；同时使用口服或注射糖皮质激素时，肌腱风险还可能增加。网页不能据此计算任何人的片数、间隔或疗程；请把年龄、肾功能资料、激素用药及完整药单交给开方医生或药师核对。", "en": "The current PMDA electronic label notes that older adults are more prone to tendon disorders and often have reduced renal function; oral or injected corticosteroids may further increase tendon risk. A website cannot calculate any person's tablet count, interval or course from this. Have the prescriber or pharmacist review age, renal information, corticosteroid use and the complete medicine list." }, { "zh": "抗菌药的适用性、给药途径与疗程必须由具体感染、检测资料、个人状况和目标市场现行标签共同决定。正在使用降糖药、抗凝药、抗心律失常药、矿物质补充剂或多种处方/非处方产品时，应带完整药单和实际包装请医生或药师核对；网页不能判断个人能否联用、换药或调整。", "en": "Whether an antibacterial medicine is appropriate, which route is used and how long it is used must be determined from the specific infection, testing, individual circumstances and the current target-market label. With glucose medicines, anticoagulants, antiarrhythmics, mineral supplements or multiple prescription/OTC products, bring the full medicine list and actual pack for clinician or pharmacist review; a webpage cannot decide individual combination, switching or adjustment." }, { "zh": "第一三共面向公众的“用药说明辅助资料”官方目录把 CRAVIT 250 mg 片、500 mg 片和 10% 细粒列为三条独立入口。本页同时保留这一官方目录和 PMDA 患者用药指南，方便放大阅读；三种产品不能互相代替，也不能把片剂的每片 mg、细粒的每 1 g 含量或包装数量换算成个人用量。", "en": "Daiichi Sankyo's official public patient-information directory exposes separate entries for CRAVIT 250 mg tablets, 500 mg tablets and 10% fine granules. This record retains that official directory together with the PMDA patient guide for enlarged reading. The three products do not replace one another or convert tablet strength, amount per gram of granules or package count into an individual amount to use." } ], "source": { "id": "src_a2d8ff3f32ae1d1b", "label": "PMDA：クラビット片 250 mg／500 mg、细粒 10% 患者用医药品指南（2025-06 更新；日本公开资料）", "url": "https://www.info.pmda.go.jp/downfiles/ph/GUI/430574_6241013C2024_1_00G.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-24", "reviewedAt": "2026-08-24" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "左氧氟沙星怎样起作用：它干扰细菌复制 DNA 所需的两种酶", "en": "How levofloxacin works: it interferes with two enzymes needed for bacterial DNA replication" }, "summary": { "zh": "FDA 2019 公开标签描述左氧氟沙星可抑制细菌的 DNA 旋转酶和拓扑异构酶 IV；这两种 II 型拓扑异构酶与细菌 DNA 的复制、转录、修复和重组有关。这一机制不能判断某种症状是否为细菌感染，也不能选择抗菌药、途径或疗程。", "en": "The 2019 FDA public label describes levofloxacin as inhibiting bacterial DNA gyrase and topoisomerase IV. These type II topoisomerases are involved in bacterial DNA replication, transcription, repair and recombination. This mechanism cannot determine whether symptoms are a bacterial infection or choose an antibacterial medicine, route or course." }, "checks": [ { "zh": "“影响细菌 DNA”不是感染诊断或选药结论。是否需要抗菌药，仍须由具体感染、检查资料、个人状况和目标市场的现行标签共同判断。", "en": "“Affecting bacterial DNA” is not a diagnosis of infection or a medicine-selection conclusion. Whether an antibacterial medicine is needed still depends on the specific infection, testing, individual circumstances and the current target-market label." }, { "zh": "共同机制不使 250、500、750 mg 口服片可自行换算、拼量或替代，也不使口服液或静脉制剂可从本页推导。产品身份、给药途径、强度和现行处方必须分别核对。", "en": "A shared mechanism does not make 250, 500 or 750 mg oral tablets self-convertible, combinable or substitutable, and does not derive oral solution or intravenous products from this page. Product identity, route, strength and current prescription must each be checked separately." }, { "zh": "机制页面也不能决定联用、换药、停用或疗程长短。正在使用多种药物、出现不适或考虑改变方案时，应带上实际包装和完整药单请医生或药师复核。", "en": "A mechanism page also cannot decide combination, switching, stopping or course length. With multiple medicines, symptoms or a contemplated change, take the actual pack and complete medicine list to a clinician or pharmacist for review." } ], "source": { "id": "src_4e39fcca7a55ea86", "label": "FDA：LEVAQUIN 2019 美国口服片处方信息（临床药理）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020634s072lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Levaquin", "generic": "左氧氟沙星", "dosageFormClass": "日本 PMDA：250 mg、500 mg 片及 10% 细粒；美国历史标签：250 mg、500 mg、750 mg 口服片；中国大陆 2021 年历史完整说明书：0.1 g、0.5 g 口服片（市场与版本须分别核对）" }, "labelSource": { "id": "src_a2d8ff3f32ae1d1b", "label": "PMDA：クラビット片 250 mg／500 mg、细粒 10% 患者用医药品指南（2025-06 更新；日本公开资料）", "url": "https://www.info.pmda.go.jp/downfiles/ph/GUI/430574_6241013C2024_1_00G.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-24", "reviewedAt": "2026-08-24" }, "productRoutes": [ { "source": { "id": "src_a2d8ff3f32ae1d1b", "label": "PMDA：クラビット片 250 mg／500 mg、细粒 10% 患者用医药品指南（2025-06 更新；日本公开资料）", "url": "https://www.info.pmda.go.jp/downfiles/ph/GUI/430574_6241013C2024_1_00G.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-24", "reviewedAt": "2026-08-24" }, "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": "2026-08-24", "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_c4a454dbd8713307", "label": "PMDA：クラビット片 250 mg／500 mg及细粒 10% 当前产品页", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/6241013C2024_1?user=1", "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": "2026-08-20", "reviewedAt": "2026-08-20" }, "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": "2026-08-20", "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_fa1bb1e9b9a9d12d", "label": "PMDA：クラビット片 250 mg／500 mg、细粒 10% 当前电子说明书（2025-05-20；包装项目）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/430574_6241013C2024_1_24", "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." } }, { "source": { "id": "src_c5a4566ed971349a", "label": "PMDA：クラビット片 250 mg／500 mg及细粒 10% 面向公众产品页", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/6241013C2024_1?user=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": "2026-08-20", "reviewedAt": "2026-08-20" }, "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": "2026-08-20", "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_4e39fcca7a55ea86", "label": "FDA：LEVAQUIN 2019 美国口服片处方信息（NDA 020634）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020634s072lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-09-13", "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_5a8b4df02f34aa4c", "label": "第一三共中国：可乐必妥® 左氧氟沙星片 0.1 g 说明书（2021，历史公开资料）", "url": "https://www.daiichisankyo.com.cn/data/upload/file/20211112/6377230695728340551675231.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "manufacturer_public_label_verified", "authority": { "zh": "第一三共中国", "en": "Daiichi Sankyo China" }, "market": { "zh": "中国大陆", "en": "Mainland China" }, "recordType": { "zh": "企业公开说明书", "en": "Manufacturer public leaflet" }, "reviewedAt": "2026-08-20", "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_d26a8d5125a9c09d", "label": "第一三共中国：可乐必妥® 左氧氟沙星片 0.5 g 完整说明书（2021，历史公开资料）", "url": "https://www.daiichisankyo.com.cn/data/upload/file/20211112/6377230777353626337639593.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "manufacturer_public_label_verified", "authority": { "zh": "第一三共中国", "en": "Daiichi Sankyo China" }, "market": { "zh": "中国大陆", "en": "Mainland China" }, "recordType": { "zh": "企业公开说明书", "en": "Manufacturer public leaflet" }, "reviewedAt": "2026-08-20", "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": "2026-08-24", "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": [ { "id": "who-2006-levaquin-injection-quality-alert", "issuedAt": "2006-11-28", "status": "historical_specific_product_quality_alert", "title": { "zh": "WHO 历史质量警示：特定 Levaquin 注射液批次与非正规渠道风险", "en": "WHO historical quality alert: specific LEVAQUIN injection batches and unauthorised-channel risk" }, "summary": { "zh": "该通知仅涉及 2006 年标示为 Levaquin（左氧氟沙星）注射液 25 mg/mL、20 mL 小瓶的两个特定批次及其非正规流通和储存风险；不适用于本档案中的口服片、日本 CRAVIT 或任何当前产品状态结论。", "en": "This notice concerns only two named 2006 batches of LEVAQUIN (levofloxacin) injection 25 mg/mL in 20 mL vials and their unauthorised distribution/storage risk. It does not apply to this dossier’s oral tablets, Japanese CRAVIT, or any current product-status conclusion." }, "source": { "id": "src_3817337418500658", "label": "WHO：2006-11-28 Levaquin injection quality and safety notice", "url": "https://cdn.who.int/media/docs/default-source/pvg/drug-alerts/da112---alert-112.pdf?sfvrsn=b5816e9c_6", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-2013-systemic-fluoroquinolone-peripheral-neuropathy-label-change", "issuedAt": "2013-08-15", "status": "fda_class_safety_communication", "title": { "zh": "FDA 药物安全通讯：全身用氟喹诺酮类的周围神经病变标签更新", "en": "FDA Drug Safety Communication: peripheral-neuropathy label updates for systemic fluoroquinolones" }, "summary": { "zh": "FDA 于 2013-08-15 发布药物安全通讯，要求全身用（口服或注射）氟喹诺酮类的说明书和患者用药指南更清楚说明周围神经病变风险；公告明确列出 Levaquin、Cipro 和 Avelox，并说明该风险可在开始用药后不久出现且可能持续。本记录是特定日期的美国类别监管通讯，不把同类关系变成任何个人的停药、改药、剂型转换或症状归因结论；出现疼痛、灼热、麻刺、麻木、无力或感觉异常等急性或令人担忧的不适，应使用当地医疗支持并由专业人员核对实际产品与完整药单。", "en": "On 2013-08-15, FDA issued a Drug Safety Communication requiring clearer peripheral-neuropathy information in labels and Medication Guides for systemic (oral or injectable) fluoroquinolones. The notice explicitly lists Levaquin, Cipro and Avelox, and says this risk may occur soon after treatment starts and may persist. This is a dated U.S. class communication; it does not turn class membership into an individual stop, switch, dosage-form conversion or symptom-attribution conclusion. With acute or concerning pain, burning, tingling, numbness, weakness or altered sensation, use local medical support and have a professional check the actual product and complete medicine list." }, "source": { "id": "src_15292a025a5f8cfe", "label": "FDA：2013-08-15 全身用氟喹诺酮类周围神经病变标签更新药物安全通讯", "url": "https://www.fda.gov/media/86575/download", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "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": "可乐必妥®、CRAVIT®、LEVAQUIN 与 TAVANIC 是左氧氟沙星在不同市场出现的品牌名称线索。第一三共官方资料记载其发现左氧氟沙星，并于 1993 年以 CRAVIT® 在日本上市；PMDA 当前电子说明书覆盖日本 CRAVIT 250 mg、500 mg 片和 10% 细粒，并逐项列出 9 种瓶装、PTP 与分包包装。美国 FDA 历史标签使用 LEVAQUIN，中国第一三共历史资料使用可乐必妥®。这些名称帮助找到同一活性成分的市场档案，但不同市场、剂型、规格、标签与包装必须分别核验。", "history": "第一三共一手资料把左氧氟沙星的研发起源和 1993 年日本 CRAVIT 上市连接起来，并在全球品牌说明中列出美国 LEVAQUIN 与欧洲 TAVANIC。中国第一三共历史文件把“可乐必妥®”列为左氧氟沙星片商品名。该品牌族谱只用于检索和阅读历史，不能把日本、美国、中国或欧洲的当前批准、持有人、供应、适应症与包装互相推定。DailyMed 可见 LEVAQUIN 图片属于再包装历史标签，故仍不作为原品牌包装展示。", "sourceDocuments": [ { "id": "src_bad8af583d79ad1c", "label": "第一三共：左氧氟沙星由其发现、1993 年以 CRAVIT 在日本上市（2011）", "url": "https://www.daiichisankyo.com/media/press_release/detail/index_3722.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "first_party_release", "market": "GLOBAL", "accessStatus": "public_access_with_site_controls", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_6fa55085e6582599", "label": "第一三共：左氧氟沙星全球品牌名与研发来源说明（2009）", "url": "https://www.daiichisankyo.com/media/press_release/detail/index_3886.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "first_party_release", "market": "GLOBAL", "accessStatus": "public_access_with_site_controls", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_c4a454dbd8713307", "label": "PMDA：クラビット片 250 mg／500 mg及细粒 10% 当前产品页", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/6241013C2024_1?user=1", "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": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_fa1bb1e9b9a9d12d", "label": "PMDA：クラビット片 250 mg／500 mg、细粒 10% 当前电子说明书（2025-05-20；包装项目）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/430574_6241013C2024_1_24", "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_87497e0d12a0afd1", "label": "日本厚生劳动省：クラビット片 250 mg／500 mg 当前药价基准收载代码（2026 目录）", "url": "https://www.mhlw.go.jp/topics/2026/04/dl/tp20260612-01_05.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_listing", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_c5a4566ed971349a", "label": "PMDA：クラビット片 250 mg／500 mg及细粒 10% 面向公众产品页", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/6241013C2024_1?user=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": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_a2d8ff3f32ae1d1b", "label": "PMDA：クラビット片 250 mg／500 mg、细粒 10% 患者用医药品指南（2025-06 更新；日本公开资料）", "url": "https://www.info.pmda.go.jp/downfiles/ph/GUI/430574_6241013C2024_1_00G.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-24", "reviewedAt": "2026-08-24" }, { "id": "src_2398a2855b848769", "label": "第一三共日本：クラビット片 250 mg／500 mg、细粒 10% 患者辅助资料官方目录", "url": "https://www.daiichisankyo.co.jp/healthy/kusuri_shiori/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "first_party_product_page", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, { "id": "src_4e39fcca7a55ea86", "label": "FDA：LEVAQUIN 2019 美国口服片处方信息（NDA 020634）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020634s072lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, { "id": "src_5a8b4df02f34aa4c", "label": "第一三共中国：可乐必妥® 左氧氟沙星片 0.1 g 说明书（2021，历史公开资料）", "url": "https://www.daiichisankyo.com.cn/data/upload/file/20211112/6377230695728340551675231.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_d26a8d5125a9c09d", "label": "第一三共中国：可乐必妥® 左氧氟沙星片 0.5 g 完整说明书（2021，历史公开资料）", "url": "https://www.daiichisankyo.com.cn/data/upload/file/20211112/6377230777353626337639593.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 020634", "approvalTimeline": [ { "date": "1993", "title": { "zh": "CRAVIT 在日本上市", "en": "CRAVIT launched in Japan" }, "detail": { "zh": "第一三共官方资料记载，左氧氟沙星由第一三共发现，并于 1993 年以 CRAVIT® 品牌在日本首次上市。这是研发与品牌历史证据，不替代任何市场的现行批准记录。", "en": "Daiichi Sankyo states that levofloxacin was originally discovered by the company and first launched in Japan in 1993 under the CRAVIT® brand. This is research and brand-history evidence, not a substitute for any current market approval record." }, "source": { "id": "src_bad8af583d79ad1c", "label": "第一三共：左氧氟沙星由其发现、1993 年以 CRAVIT 在日本上市（2011）", "url": "https://www.daiichisankyo.com/media/press_release/detail/index_3722.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "first_party_release", "market": "GLOBAL", "accessStatus": "public_access_with_site_controls", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "1996", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 1996。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 1996. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_4e39fcca7a55ea86", "label": "FDA: LEVAQUIN oral-tablet label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020634s072lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" } }, { "date": "2009", "title": { "zh": "全球品牌名称关系的一手说明", "en": "First-party account of global brand names" }, "detail": { "zh": "第一三共官方资料将美国品牌列为 LEVAQUIN、欧洲品牌列为 TAVANIC，并再次说明左氧氟沙星起源于第一三共。名称关系用于跨市场检索，不表示各市场的剂型、规格、标签或供应相同。", "en": "A Daiichi Sankyo release identifies LEVAQUIN as the U.S. brand and TAVANIC as the European brand and again states that levofloxacin originated at Daiichi Sankyo. The name relationship supports cross-market retrieval; it does not mean dosage forms, strengths, labels or supply are the same." }, "source": { "id": "src_6fa55085e6582599", "label": "第一三共：左氧氟沙星全球品牌名与研发来源说明（2009）", "url": "https://www.daiichisankyo.com/media/press_release/detail/index_3886.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "first_party_release", "market": "GLOBAL", "accessStatus": "public_access_with_site_controls", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2019", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2019 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2019 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_4e39fcca7a55ea86", "label": "FDA: LEVAQUIN oral-tablet label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020634s072lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" } }, { "date": "2021-04", "title": { "zh": "第一三共中国历史公开 0.5 g 完整说明书", "en": "Daiichi Sankyo China historical full 0.5 g leaflet" }, "detail": { "zh": "第一三共中国公开的 2021 年完整说明书将可乐必妥®列为左氧氟沙星片商品名，并列出 0.5 g 片剂。这是可追溯的历史资料，不构成中国大陆当前批准、持有人、标签、供应、原研关系或可售资格结论。", "en": "A full Daiichi Sankyo China public leaflet from 2021 identifies 可乐必妥® as a trade name for levofloxacin tablets and lists a 0.5 g tablet. It is a traceable historical document, not a conclusion about current Mainland China approval, holder, labeling, supply, originator status or sale eligibility." }, "source": { "id": "src_d26a8d5125a9c09d", "label": "Daiichi Sankyo China: 可乐必妥® 0.5 g full historical leaflet (2021)", "url": "https://www.daiichisankyo.com.cn/data/upload/file/20211112/6377230777353626337639593.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2021-05", "title": { "zh": "第一三共中国历史公开说明书", "en": "Daiichi Sankyo China historical public leaflet" }, "detail": { "zh": "第一三共中国公开的 2021 年说明书将可乐必妥®列为左氧氟沙星片商品名，并列出 0.1 g 片剂。这是可追溯的历史资料，不构成中国大陆当前批准、持有人、标签、供应、原研关系或可售资格结论。", "en": "A Daiichi Sankyo China public leaflet from 2021 identifies 可乐必妥® as a trade name for levofloxacin tablets and lists a 0.1 g tablet. It is a traceable historical document, not a conclusion about current Mainland China approval, holder, labeling, supply, originator status or sale eligibility." }, "source": { "id": "src_5a8b4df02f34aa4c", "label": "Daiichi Sankyo China: 可乐必妥® 0.1 g historical leaflet (2021)", "url": "https://www.daiichisankyo.com.cn/data/upload/file/20211112/6377230695728340551675231.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2025-05", "title": { "zh": "PMDA 日本当前产品页", "en": "Current Japan PMDA product page" }, "detail": { "zh": "PMDA 产品页列示クラビット片 250 mg、500 mg及细粒 10%，通用名为左氧氟沙星水合物，制造销售方为第一三共。该记录只确认日本页面所列产品，不能外推至中国、美国或欧洲。", "en": "The PMDA product page lists CRAVIT 250 mg and 500 mg tablets and 10% fine granules, with levofloxacin hydrate as the non-proprietary name and Daiichi Sankyo as marketing authorisation holder. It confirms only the products listed for Japan and cannot be extrapolated to China, the United States or Europe." }, "source": { "id": "src_c4a454dbd8713307", "label": "PMDA：クラビット片 250 mg／500 mg及细粒 10% 当前产品页", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/6241013C2024_1?user=1", "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": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "日本", "en": "Japan" }, "status": { "zh": "已链接 PMDA 当前产品页", "en": "Current PMDA product page linked" }, "detail": { "zh": "当前 PMDA 页面列示 CRAVIT 250 mg、500 mg 片和 10% 细粒，制造销售方为第一三共；仅对应日本页面所列产品。", "en": "The current PMDA page lists CRAVIT 250 mg and 500 mg tablets and 10% fine granules, with Daiichi Sankyo as marketing authorisation holder; this applies only to the products listed for Japan." } }, { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接 FDA 历史口服片标签", "en": "FDA historical oral-tablet label linked" }, "detail": { "zh": "仅对应本页所列 2019 FDA 口服片文件。", "en": "Only the 2019 FDA oral-tablet document listed on this page is linked." } }, { "market": { "zh": "中国大陆", "en": "Mainland China" }, "status": { "zh": "已链接企业历史公开完整说明书；现行官方记录待核验", "en": "First-party historical full leaflets linked; current official record unverified" }, "detail": { "zh": "第一三共中国的 2021 年 0.5 g 与 0.1 g 历史完整说明书提供可乐必妥®片剂的可追溯阅读线索；不得据此推定现行批准、持有人、规格、供应或可售资格。", "en": "Daiichi Sankyo China full historical 0.5 g and 0.1 g leaflets from 2021 provide traceable reading cues for 可乐必妥® tablets; they do not establish current approval, holder, strength, supply or sale eligibility." } }, { "market": { "zh": "欧洲", "en": "Europe" }, "status": { "zh": "已建立 TAVANIC 品牌历史线索；现行国家记录待核验", "en": "TAVANIC brand-history cue established; current country records unverified" }, "detail": { "zh": "第一三共 2009 年资料列出欧洲品牌名 TAVANIC；未据此推定任何欧洲国家的现行批准、持有人、规格、供应或可售资格。", "en": "A 2009 Daiichi Sankyo release states the European brand name TAVANIC; it is not used to infer current approval, holder, strength, supply or sale eligibility in any European country." } }, { "market": { "zh": "其他市场", "en": "Other markets" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从日本、美国、中国或欧洲的文件推定其他市场状态。", "en": "No other-market status is inferred from Japanese, U.S., China or European material." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "为什么同一档案会出现 CRAVIT、可乐必妥、LEVAQUIN 和 TAVANIC？", "en": "Why does one record show CRAVIT, 可乐必妥, LEVAQUIN and TAVANIC?" }, "answer": { "zh": "它们是左氧氟沙星在不同市场出现的品牌名称线索：第一三共资料记录日本 CRAVIT、中国历史资料为可乐必妥®、美国为 LEVAQUIN、欧洲品牌历史线索为 TAVANIC。名称关系便于检索，不表示各市场的现行批准、规格、标签、包装、供应或可售状态相同。", "en": "They are market-specific brand-name cues for levofloxacin: Daiichi Sankyo material records CRAVIT in Japan, the historical China material uses 可乐必妥®, the U.S. brand is LEVAQUIN and the European brand-history cue is TAVANIC. The relationship supports retrieval; it does not mean current approvals, strengths, labels, packages, supply or sale eligibility are the same across markets." } } ], "relatedMedicineChecks": [ { "target": { "id": "coumadin", "brand": "Coumadin", "generic": "华法林钠", "canonicalUrls": { "zh": "https://origindrug.com/drugs/coumadin/", "en": "https://origindrug.com/en/drugs/coumadin/" } }, "title": { "zh": "与 COUMADIN／华法林同在药单上时：先核对 INR 与出血监测记录", "en": "When COUMADIN / warfarin is on the same list: review INR and bleeding-monitoring records first" }, "summary": { "zh": "FDA 的 2019 年 LEVAQUIN 美国历史口服片标签将华法林列为需要核对的药物，并提示上市后报告中出现华法林作用增强、凝血酶原时间或 INR 升高及出血事件。该文件同时明确可能不是 FDA 最新批准标签，因此这张卡只作有日期、美国、成分层面的优先核对提示：请把两种实际药盒、目标市场现行说明书、最近的监测记录以及所有处方药、非处方药和补充剂尽快交给开方团队、药师或抗凝管理团队复核。它不判断个人能否同用，不提供 INR 目标、片数、给药间隔或停换药方案，也不建议自行停用、错开时间、替换或调整任何一种药。", "en": "The FDA's 2019 historical U.S. oral-tablet label for LEVAQUIN lists warfarin as a medicine requiring review and describes postmarketing reports of enhanced warfarin effect, increased prothrombin time or INR, and bleeding episodes. The document also states that it may not be FDA's latest approved label. This card is therefore only a dated, U.S., ingredient-level priority-review cue: promptly take both actual packs, current target-market labels, recent monitoring records, and every prescription, OTC product and supplement to the prescribing team, pharmacist or anticoagulation service. It does not decide individual co-use, provide an INR target, tablet count, timing interval or stop/switch plan, or advise self-stopping, time-separation, replacement or adjustment of either medicine." }, "source": { "id": "src_4e39fcca7a55ea86", "label": "FDA：LEVAQUIN 2019 美国历史口服片标签（7.2 Warfarin；文件明确可能不是最新批准标签）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020634s072lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, "scope": "review_complete_medicine_list_no_self_directed_change" } ], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/levaquin/", "en": "https://origindrug.com/en/drugs/levaquin/" }, "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." ] }