{ "id": "mirapex-pramipexole", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-06", "status": "published_traceable_archive" }, "names": { "brand": "MIRAPEX / MIRAPEX ER", "generic": "盐酸普拉克索", "aliases": [ "Mirapex", "Mirapex ER", "pramipexole", "pramipexole dihydrochloride", "普拉克索", "盐酸普拉克索", "盐酸普拉克索片", "盐酸普拉克索缓释片", "MIRAPEX", "MIRAPEX ER", "森福罗" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": { "value": "森福罗®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_a92ef31704391cdb", "label": "烟台市人民政府：2024 年市直机关医院药品记录中的森福罗／盐酸普拉克索片 0.25 mg×30 片记录", "url": "https://www.yantai.gov.cn/art/2023/12/29/art_67240_3168957.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "government_medicine_listing", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" } } }, "identity": { "therapeuticArea": "神经与认知", "sourceArchiveMarket": "美国：MIRAPEX 普通片 NDA 020667 与 MIRAPEX ER 缓释片 NDA 022421 的历史品牌、规格、批准与停止销售记录；当前通用名标签作为安全阅读语境。页面不把历史 RLD、仍可访问的说明书或纸盒样稿写成当前库存，也不外推中国大陆、欧盟、日本或其他市场的商品名、批准、包装、供应及可替代性。", "dosageFormClass": "MIRAPEX 口服普通片历史规格为 0.125、0.25、0.5、0.75、1、1.25、1.5 mg；MIRAPEX ER 口服缓释片为 0.375、0.75、1.5、2.25、3、3.75、4.5 mg。普通片与缓释片的释放、标签用途和使用路径不同，不能只按总 mg 自行换算、拼接、掰分、轮换或替换。", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1997（MIRAPEX 普通片美国首次批准）；2010（MIRAPEX ER 美国批准）", "archiveSponsorText": "Boehringer Ingelheim（美国历史原品牌申请主体）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "MIRAPEX", "MIRAPEX ER", "pramipexole", "pramipexole dihydrochloride", "普拉克索", "盐酸普拉克索" ], "excludedProductCues": [ "ropinirole", "REQUIP", "rotigotine", "NEUPRO", "levodopa", "SINEMET", "STALEVO", "RYTARY", "CREXONT" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-mirapex-ir-2021-0-125mg", "marketCode": "US", "labelVersion": { "zh": "美国 FDA 2021-07 历史说明书，第 3 节；规格核对于 2026-09-10", "en": "U.S. FDA July 2021 historical label, section 3; strengths checked 2026-09-10" }, "dosageForm": { "zh": "盐酸普拉克索普通片", "en": "Pramipexole immediate-release tablet" }, "route": { "zh": "口服", "en": "Oral" }, "routeCodes": [ "oral" ], "productCode": null, "pouchCode": null, "applicationNumber": "NDA 020667", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "0.125 mg／片（盐酸普拉克索一水合物；历史标签含量，不是服药片数）", "en": "0.125 mg per tablet (pramipexole dihydrochloride monohydrate; historical label strength, not a tablet-count instruction)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸普拉克索一水合物", "en": "Pramipexole dihydrochloride monohydrate" }, "value": 0.125, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片", "en": "Per tablet" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-10", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_3204a292a1e803fe", "label": "FDA：MIRAPEX 盐酸普拉克索普通片处方信息（NDA 020667；2021-07 版本）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020667s044lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-mirapex-ir-2021-0-25mg", "marketCode": "US", "labelVersion": { "zh": "美国 FDA 2021-07 历史说明书，第 3 节；规格核对于 2026-09-10", "en": "U.S. FDA July 2021 historical label, section 3; strengths checked 2026-09-10" }, "dosageForm": { "zh": "盐酸普拉克索普通片", "en": "Pramipexole immediate-release tablet" }, "route": { "zh": "口服", "en": "Oral" }, "routeCodes": [ "oral" ], "productCode": null, "pouchCode": null, "applicationNumber": "NDA 020667", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "0.25 mg／片（盐酸普拉克索一水合物；历史标签含量，不是服药片数）", "en": "0.25 mg per tablet (pramipexole dihydrochloride monohydrate; historical label strength, not a tablet-count instruction)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸普拉克索一水合物", "en": "Pramipexole dihydrochloride monohydrate" }, "value": 0.25, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片", "en": "Per tablet" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-10", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_3204a292a1e803fe", "label": "FDA：MIRAPEX 盐酸普拉克索普通片处方信息（NDA 020667；2021-07 版本）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020667s044lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-mirapex-ir-2021-0-5mg", "marketCode": "US", "labelVersion": { "zh": "美国 FDA 2021-07 历史说明书，第 3 节；规格核对于 2026-09-10", "en": "U.S. FDA July 2021 historical label, section 3; strengths checked 2026-09-10" }, "dosageForm": { "zh": "盐酸普拉克索普通片", "en": "Pramipexole immediate-release tablet" }, "route": { "zh": "口服", "en": "Oral" }, "routeCodes": [ "oral" ], "productCode": null, "pouchCode": null, "applicationNumber": "NDA 020667", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "0.5 mg／片（盐酸普拉克索一水合物；历史标签含量，不是服药片数）", "en": "0.5 mg per tablet (pramipexole dihydrochloride monohydrate; historical label strength, not a tablet-count instruction)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸普拉克索一水合物", "en": "Pramipexole dihydrochloride monohydrate" }, "value": 0.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片", "en": "Per tablet" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-10", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_3204a292a1e803fe", "label": "FDA：MIRAPEX 盐酸普拉克索普通片处方信息（NDA 020667；2021-07 版本）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020667s044lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-mirapex-ir-2021-0-75mg", "marketCode": "US", "labelVersion": { "zh": "美国 FDA 2021-07 历史说明书，第 3 节；规格核对于 2026-09-10", "en": "U.S. FDA July 2021 historical label, section 3; strengths checked 2026-09-10" }, "dosageForm": { "zh": "盐酸普拉克索普通片", "en": "Pramipexole immediate-release tablet" }, "route": { "zh": "口服", "en": "Oral" }, "routeCodes": [ "oral" ], "productCode": null, "pouchCode": null, "applicationNumber": "NDA 020667", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "0.75 mg／片（盐酸普拉克索一水合物；历史标签含量，不是服药片数）", "en": "0.75 mg per tablet (pramipexole dihydrochloride monohydrate; historical label strength, not a tablet-count instruction)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸普拉克索一水合物", "en": "Pramipexole dihydrochloride monohydrate" }, "value": 0.75, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片", "en": "Per tablet" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-10", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_3204a292a1e803fe", "label": "FDA：MIRAPEX 盐酸普拉克索普通片处方信息（NDA 020667；2021-07 版本）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020667s044lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-mirapex-ir-2021-1mg", "marketCode": "US", "labelVersion": { "zh": "美国 FDA 2021-07 历史说明书，第 3 节；规格核对于 2026-09-10", "en": "U.S. FDA July 2021 historical label, section 3; strengths checked 2026-09-10" }, "dosageForm": { "zh": "盐酸普拉克索普通片", "en": "Pramipexole immediate-release tablet" }, "route": { "zh": "口服", "en": "Oral" }, "routeCodes": [ "oral" ], "productCode": null, "pouchCode": null, "applicationNumber": "NDA 020667", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "1 mg／片（盐酸普拉克索一水合物；历史标签含量，不是服药片数）", "en": "1 mg per tablet (pramipexole dihydrochloride monohydrate; historical label strength, not a tablet-count instruction)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸普拉克索一水合物", "en": "Pramipexole dihydrochloride monohydrate" }, "value": 1, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片", "en": "Per tablet" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-10", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_3204a292a1e803fe", "label": "FDA：MIRAPEX 盐酸普拉克索普通片处方信息（NDA 020667；2021-07 版本）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020667s044lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-mirapex-ir-2021-1-5mg", "marketCode": "US", "labelVersion": { "zh": "美国 FDA 2021-07 历史说明书，第 3 节；规格核对于 2026-09-10", "en": "U.S. FDA July 2021 historical label, section 3; strengths checked 2026-09-10" }, "dosageForm": { "zh": "盐酸普拉克索普通片", "en": "Pramipexole immediate-release tablet" }, "route": { "zh": "口服", "en": "Oral" }, "routeCodes": [ "oral" ], "productCode": null, "pouchCode": null, "applicationNumber": "NDA 020667", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "1.5 mg／片（盐酸普拉克索一水合物；历史标签含量，不是服药片数）", "en": "1.5 mg per tablet (pramipexole dihydrochloride monohydrate; historical label strength, not a tablet-count instruction)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸普拉克索一水合物", "en": "Pramipexole dihydrochloride monohydrate" }, "value": 1.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片", "en": "Per tablet" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-10", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_3204a292a1e803fe", "label": "FDA：MIRAPEX 盐酸普拉克索普通片处方信息（NDA 020667；2021-07 版本）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020667s044lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-mirapex-er-2021-0-375mg", "marketCode": "US", "labelVersion": { "zh": "美国 FDA 2021-07 历史说明书，第 3 节；规格核对于 2026-09-10", "en": "U.S. FDA July 2021 historical label, section 3; strengths checked 2026-09-10" }, "dosageForm": { "zh": "盐酸普拉克索缓释片", "en": "Pramipexole extended-release tablet" }, "route": { "zh": "口服", "en": "Oral" }, "routeCodes": [ "oral" ], "productCode": null, "pouchCode": null, "applicationNumber": "NDA 022421", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "0.375 mg／片（盐酸普拉克索一水合物；历史标签含量，不是服药片数）", "en": "0.375 mg per tablet (pramipexole dihydrochloride monohydrate; historical label strength, not a tablet-count instruction)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸普拉克索一水合物", "en": "Pramipexole dihydrochloride monohydrate" }, "value": 0.375, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片", "en": "Per tablet" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-10", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_023f34bc5fd4ce38", "label": "FDA：MIRAPEX ER 盐酸普拉克索缓释片处方信息（NDA 022421；2021-07 版本）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022421s022lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-mirapex-er-2021-0-75mg", "marketCode": "US", "labelVersion": { "zh": "美国 FDA 2021-07 历史说明书，第 3 节；规格核对于 2026-09-10", "en": "U.S. FDA July 2021 historical label, section 3; strengths checked 2026-09-10" }, "dosageForm": { "zh": "盐酸普拉克索缓释片", "en": "Pramipexole extended-release tablet" }, "route": { "zh": "口服", "en": "Oral" }, "routeCodes": [ "oral" ], "productCode": null, "pouchCode": null, "applicationNumber": "NDA 022421", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "0.75 mg／片（盐酸普拉克索一水合物；历史标签含量，不是服药片数）", "en": "0.75 mg per tablet (pramipexole dihydrochloride monohydrate; historical label strength, not a tablet-count instruction)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸普拉克索一水合物", "en": "Pramipexole dihydrochloride monohydrate" }, "value": 0.75, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片", "en": "Per tablet" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-10", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_023f34bc5fd4ce38", "label": "FDA：MIRAPEX ER 盐酸普拉克索缓释片处方信息（NDA 022421；2021-07 版本）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022421s022lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-mirapex-er-2021-1-5mg", "marketCode": "US", "labelVersion": { "zh": "美国 FDA 2021-07 历史说明书，第 3 节；规格核对于 2026-09-10", "en": "U.S. FDA July 2021 historical label, section 3; strengths checked 2026-09-10" }, "dosageForm": { "zh": "盐酸普拉克索缓释片", "en": "Pramipexole extended-release tablet" }, "route": { "zh": "口服", "en": "Oral" }, "routeCodes": [ "oral" ], "productCode": null, "pouchCode": null, "applicationNumber": "NDA 022421", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "1.5 mg／片（盐酸普拉克索一水合物；历史标签含量，不是服药片数）", "en": "1.5 mg per tablet (pramipexole dihydrochloride monohydrate; historical label strength, not a tablet-count instruction)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸普拉克索一水合物", "en": "Pramipexole dihydrochloride monohydrate" }, "value": 1.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片", "en": "Per tablet" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-10", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_023f34bc5fd4ce38", "label": "FDA：MIRAPEX ER 盐酸普拉克索缓释片处方信息（NDA 022421；2021-07 版本）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022421s022lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-mirapex-er-2021-2-25mg", "marketCode": "US", "labelVersion": { "zh": "美国 FDA 2021-07 历史说明书，第 3 节；规格核对于 2026-09-10", "en": "U.S. FDA July 2021 historical label, section 3; strengths checked 2026-09-10" }, "dosageForm": { "zh": "盐酸普拉克索缓释片", "en": "Pramipexole extended-release tablet" }, "route": { "zh": "口服", "en": "Oral" }, "routeCodes": [ "oral" ], "productCode": null, "pouchCode": null, "applicationNumber": "NDA 022421", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "2.25 mg／片（盐酸普拉克索一水合物；历史标签含量，不是服药片数）", "en": "2.25 mg per tablet (pramipexole dihydrochloride monohydrate; historical label strength, not a tablet-count instruction)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸普拉克索一水合物", "en": "Pramipexole dihydrochloride monohydrate" }, "value": 2.25, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片", "en": "Per tablet" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-10", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_023f34bc5fd4ce38", "label": "FDA：MIRAPEX ER 盐酸普拉克索缓释片处方信息（NDA 022421；2021-07 版本）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022421s022lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-mirapex-er-2021-3mg", "marketCode": "US", "labelVersion": { "zh": "美国 FDA 2021-07 历史说明书，第 3 节；规格核对于 2026-09-10", "en": "U.S. FDA July 2021 historical label, section 3; strengths checked 2026-09-10" }, "dosageForm": { "zh": "盐酸普拉克索缓释片", "en": "Pramipexole extended-release tablet" }, "route": { "zh": "口服", "en": "Oral" }, "routeCodes": [ "oral" ], "productCode": null, "pouchCode": null, "applicationNumber": "NDA 022421", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "3 mg／片（盐酸普拉克索一水合物；历史标签含量，不是服药片数）", "en": "3 mg per tablet (pramipexole dihydrochloride monohydrate; historical label strength, not a tablet-count instruction)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸普拉克索一水合物", "en": "Pramipexole dihydrochloride monohydrate" }, "value": 3, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片", "en": "Per tablet" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-10", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_023f34bc5fd4ce38", "label": "FDA：MIRAPEX ER 盐酸普拉克索缓释片处方信息（NDA 022421；2021-07 版本）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022421s022lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-mirapex-er-2021-3-75mg", "marketCode": "US", "labelVersion": { "zh": "美国 FDA 2021-07 历史说明书，第 3 节；规格核对于 2026-09-10", "en": "U.S. FDA July 2021 historical label, section 3; strengths checked 2026-09-10" }, "dosageForm": { "zh": "盐酸普拉克索缓释片", "en": "Pramipexole extended-release tablet" }, "route": { "zh": "口服", "en": "Oral" }, "routeCodes": [ "oral" ], "productCode": null, "pouchCode": null, "applicationNumber": "NDA 022421", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "3.75 mg／片（盐酸普拉克索一水合物；历史标签含量，不是服药片数）", "en": "3.75 mg per tablet (pramipexole dihydrochloride monohydrate; historical label strength, not a tablet-count instruction)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸普拉克索一水合物", "en": "Pramipexole dihydrochloride monohydrate" }, "value": 3.75, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片", "en": "Per tablet" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-10", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_023f34bc5fd4ce38", "label": "FDA：MIRAPEX ER 盐酸普拉克索缓释片处方信息（NDA 022421；2021-07 版本）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022421s022lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-mirapex-er-2021-4-5mg", "marketCode": "US", "labelVersion": { "zh": "美国 FDA 2021-07 历史说明书，第 3 节；规格核对于 2026-09-10", "en": "U.S. FDA July 2021 historical label, section 3; strengths checked 2026-09-10" }, "dosageForm": { "zh": "盐酸普拉克索缓释片", "en": "Pramipexole extended-release tablet" }, "route": { "zh": "口服", "en": "Oral" }, "routeCodes": [ "oral" ], "productCode": null, "pouchCode": null, "applicationNumber": "NDA 022421", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "4.5 mg／片（盐酸普拉克索一水合物；历史标签含量，不是服药片数）", "en": "4.5 mg per tablet (pramipexole dihydrochloride monohydrate; historical label strength, not a tablet-count instruction)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸普拉克索一水合物", "en": "Pramipexole dihydrochloride monohydrate" }, "value": 4.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片", "en": "Per tablet" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-10", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_023f34bc5fd4ce38", "label": "FDA：MIRAPEX ER 盐酸普拉克索缓释片处方信息（NDA 022421；2021-07 版本）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022421s022lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "暂不展示 MIRAPEX 包装图：有历史纸盒文件，但尚未保留可与全部准确规格一一对应的公开图片集", "en": "MIRAPEX pack images withheld: a historical carton document exists, but a complete exact presentation-matched public image set has not been retained" }, "summary": { "zh": "FDA 2020 文件包含 MIRAPEX 0.25 mg、NDC 0597-0184-61、100 片纸盒版面，但该单一历史纸盒不能代表七种普通片、七种 ER 缓释片、当前通用药或其他市场。为避免把纸盒样稿、再包装图片或另一规格误作准确当前包装，页面先不展示包装图，也不冒充原品牌当前外观；只保留官方文件入口。", "en": "An FDA 2020 document contains the historical MIRAPEX 0.25 mg, NDC 0597-0184-61, 100-tablet carton layout. That single historical carton cannot represent seven immediate-release strengths, seven ER strengths, current generics or another market. To avoid treating a dieline, repackaged image or another strength as an exact current pack, the page withholds pack imagery and does not present a supposed current originator appearance; it retains the official-document route instead." }, "source": { "id": "src_822acc19cb7aac1d", "label": "FDA：MIRAPEX 普通片 0.25 mg、NDC 0597-0184-61、100 片历史纸盒标签（2020 批准文件）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020667Orig1s039lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_regulatory_record", "documentKind": "carton_and_container_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "MIRAPEX／普拉克索说明书放大阅读：先分普通片与 ER，再看突然入睡、血压、行为和肾功能", "en": "MIRAPEX / pramipexole enlarged label: separate IR from ER, then review sudden sleep, blood pressure, behaviour and kidney function" }, "summary": { "zh": "说明书把突然入睡、嗜睡、体位性低血压、冲动控制、幻觉／精神病样行为、运动障碍、姿势异常、肾功能和停药反应列为重点。老人发生幻觉的风险更高，肾清除又可能随年龄下降；网页只提供核对路线，不计算个人剂量、频次、减量或换剂型。", "en": "The labels prioritise sudden sleep, somnolence, orthostatic hypotension, impulse-control problems, hallucinations/psychotic-like behaviour, dyskinesia, postural deformity, renal function and withdrawal symptoms. Hallucination risk is higher in older people and renal clearance may decline with age. The page provides a review route, not an individual dose, frequency, taper or formulation switch." }, "checks": [ { "zh": "可能在没有明显预警的情况下于日常活动中突然入睡。出现开车、吃饭、谈话或其他活动中睡着、异常嗜睡、意识异常或事故风险时，应停止危险活动并尽快联系临床团队；严重急性情况使用当地急救。", "en": "Sudden sleep can occur during daily activities without clear warning. Falling asleep while driving, eating, talking or another activity, unusual somnolence, altered awareness or accident risk requires stopping hazardous activity and prompt clinical contact; severe acute situations require local emergency help." }, { "zh": "开始或增加时可能出现体位性低血压、头晕或晕厥。老人、脱水、降压药或其他会导致嗜睡／低血压的药同处药单时，要优先核对跌倒风险；不要自行补服、停药或改时间。", "en": "Orthostatic hypotension, dizziness or fainting can occur during initiation or escalation. Older age, dehydration, antihypertensives or other sedating/hypotensive medicines requires priority fall-risk review; do not self-catch up, stop or reschedule." }, { "zh": "照护者也应留意赌博、购物、进食、性行为或其他难以控制的冲动，以及幻觉、妄想、混乱或明显行为变化。老人发生幻觉风险更高；这不是羞耻或意志问题，应尽快把变化与完整药单告诉开方团队。", "en": "Caregivers should also watch for gambling, shopping, eating, sexual or other difficult-to-control urges, and for hallucinations, delusions, confusion or marked behavioural change. Hallucination risk is higher in older adults; this is not a moral failing and should be reported promptly with the complete medicine list." }, { "zh": "普拉克索主要经肾脏排泄，肾功能会影响清除。老人或肾功能变化者不能照搬别人的 mg、片数或频次；网页不从年龄、肌酐或估算肾小球滤过率自动生成方案。", "en": "Pramipexole is eliminated mainly by the kidneys, so renal function affects clearance. Older people or those with changing kidney function cannot copy another person's milligrams, tablet count or frequency; the site does not generate a plan from age, creatinine or eGFR." }, { "zh": "与左旋多巴合用时可能加重运动障碍；普通片、ER 缓释片、罗匹尼罗、罗替戈汀贴剂及其他多巴胺相关药不能按共同机制或 mg 自行叠加、轮换或替换。多巴胺拮抗药也可能影响作用，应让药师核对完整药单。", "en": "Levodopa co-use can worsen dyskinesia. Immediate-release and ER pramipexole, ropinirole, rotigotine patches and other dopaminergic medicines cannot be self-combined, rotated or substituted by shared mechanism or milligrams. Dopamine antagonists may also affect response, so a pharmacist should review the full list." }, { "zh": "说明书列出停药相关症状并要求专业渐减；突然停药或快速减量可能出现发热、意识改变、肌强直、焦虑、抑郁、疲劳、疼痛、失眠等。不要按网页自行停药或照搬减量表。", "en": "The labels describe withdrawal symptoms and clinician-directed gradual discontinuation. Abrupt stopping or rapid reduction can be associated with fever, altered consciousness, rigidity, anxiety, depression, fatigue, pain, insomnia and other symptoms. Do not self-stop or copy a taper from the page." } ], "source": { "id": "src_762310eefa903362", "label": "DailyMed（NLM）：盐酸普拉克索普通片当前美国通用名标签（2026-03-31 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=60167d7c-469f-455a-a113-561841af5e59&version=22", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "普拉克索怎样起作用：作用于多巴胺 D2 受体家族，对 D3 亲和力较高", "en": "How pramipexole works: a dopamine D2-family agonist with higher affinity for D3" }, "summary": { "zh": "FDA 标签将普拉克索描述为非麦角类多巴胺受体激动剂，对 D2 受体家族具有较高选择性，并对 D3 的亲和力高于 D2 或 D4。帕金森病中的精确作用机制仍未完全确定；机制不能替代诊断、疗效评估或个人用药决定。", "en": "The FDA label describes pramipexole as a non-ergot dopamine-receptor agonist selective for the D2 family, with higher affinity for D3 than D2 or D4. Its precise mechanism in Parkinson's disease remains incompletely defined. Mechanism cannot replace diagnosis, benefit assessment or an individual treatment decision." }, "checks": [ { "zh": "多巴胺作用相近不等于药物相同。普拉克索不能与左旋多巴／卡比多巴、罗匹尼罗、罗替戈汀、阿扑吗啡或其他帕金森病药按 mg 自行换算、叠加或轮换。", "en": "Related dopamine action does not make medicines identical. Pramipexole cannot be self-converted, combined or rotated by milligrams with levodopa/carbidopa, ropinirole, rotigotine, apomorphine or another Parkinson's medicine." }, { "zh": "普通片和 ER 缓释片含共同成分，但释放结构不同。即使历史标签含专业转换说明，也不构成按总 mg 自行换剂型、掰片或改变频次的许可；ER 片应整片吞服。", "en": "Immediate-release and ER tablets share an ingredient but differ in release structure. Even when a historical label includes clinician-directed conversion information, it does not permit self-switching by total milligrams, splitting or changing frequency; ER tablets are swallowed whole." }, { "zh": "无须把“作用于 D3”理解为需要做全基因组筛查。当前标签并未把全基因筛查作为所有人使用前的常规要求；肾功能、症状、耐受性和完整药单更需要针对实际问题核对。", "en": "D3 activity does not imply a need for whole-genome screening. The current label does not make whole-genome screening a routine prerequisite for everyone; kidney function, symptoms, tolerability and the complete medicine list require review for the actual question." } ], "source": { "id": "src_3204a292a1e803fe", "label": "FDA：MIRAPEX 盐酸普拉克索普通片处方信息（NDA 020667；2021-07 版本）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020667s044lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "MIRAPEX / MIRAPEX ER", "generic": "盐酸普拉克索", "dosageFormClass": "MIRAPEX 口服普通片历史规格为 0.125、0.25、0.5、0.75、1、1.25、1.5 mg；MIRAPEX ER 口服缓释片为 0.375、0.75、1.5、2.25、3、3.75、4.5 mg。普通片与缓释片的释放、标签用途和使用路径不同，不能只按总 mg 自行换算、拼接、掰分、轮换或替换。" }, "labelSource": { "id": "src_762310eefa903362", "label": "DailyMed（NLM）：盐酸普拉克索普通片当前美国通用名标签（2026-03-31 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=60167d7c-469f-455a-a113-561841af5e59&version=22", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "productRoutes": [ { "source": { "id": "src_762310eefa903362", "label": "DailyMed（NLM）：盐酸普拉克索普通片当前美国通用名标签（2026-03-31 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=60167d7c-469f-455a-a113-561841af5e59&version=22", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-06", "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_3204a292a1e803fe", "label": "FDA：MIRAPEX 盐酸普拉克索普通片处方信息（NDA 020667；2021-07 版本）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020667s044lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "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": "2026-09-06", "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_023f34bc5fd4ce38", "label": "FDA：MIRAPEX ER 盐酸普拉克索缓释片处方信息（NDA 022421；2021-07 版本）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022421s022lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "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": "2026-09-06", "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_3d17358ce65b1cf8", "label": "FDA Orange Book 第 46 版（2026）：MIRAPEX NDA 020667 与 MIRAPEX ER NDA 022421 的规格、RLD 与停止销售状态", "url": "https://www.fda.gov/media/71474/download", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "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": "2026-09-02", "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": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-06", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "MIRAPEX／MIRAPEX ER 是盐酸普拉克索的历史美国品牌。药盒上的 mg 表示每片标签含量，不是每天片数；普通片与 ER 缓释片不能仅凭共同成分和总毫克数自行互换。老人尤其要先看突然入睡、体位性低血压、幻觉、冲动控制、跌倒与肾功能；与左旋多巴或其他多巴胺相关药同处药单时，不能根据网页自行叠加、减量、停药或错开。", "history": "FDA Orange Book 记录 MIRAPEX 普通片 NDA 020667 于 1997-07-01 获批，0.5 mg 于 1998 年、0.75 mg 于 2007 年形成后续规格；MIRAPEX ER NDA 022421 的首批缓释规格于 2010-02-19 获批，2.25 mg 与 3.75 mg 于 2011-06-17 获批。品牌记录目前均列为停止销售，因此本页把历史品牌身份、当前通用名标签和实时供应严格分开。", "sourceDocuments": [ { "id": "src_762310eefa903362", "label": "DailyMed（NLM）：盐酸普拉克索普通片当前美国通用名标签（2026-03-31 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=60167d7c-469f-455a-a113-561841af5e59&version=22", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, { "id": "src_3204a292a1e803fe", "label": "FDA：MIRAPEX 盐酸普拉克索普通片处方信息（NDA 020667；2021-07 版本）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020667s044lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, { "id": "src_023f34bc5fd4ce38", "label": "FDA：MIRAPEX ER 盐酸普拉克索缓释片处方信息（NDA 022421；2021-07 版本）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022421s022lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, { "id": "src_822acc19cb7aac1d", "label": "FDA：MIRAPEX 普通片 0.25 mg、NDC 0597-0184-61、100 片历史纸盒标签（2020 批准文件）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020667Orig1s039lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_regulatory_record", "documentKind": "carton_and_container_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, { "id": "src_3d17358ce65b1cf8", "label": "FDA Orange Book 第 46 版（2026）：MIRAPEX NDA 020667 与 MIRAPEX ER NDA 022421 的规格、RLD 与停止销售状态", "url": "https://www.fda.gov/media/71474/download", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } ], "applicationNumber": "MIRAPEX NDA 020667；MIRAPEX ER NDA 022421", "approvalTimeline": [ { "date": "1997-07-01", "title": { "zh": "MIRAPEX 普通片在美国首次批准", "en": "Initial U.S. approval of MIRAPEX immediate-release tablets" }, "detail": { "zh": "Orange Book 将 0.125、0.25、1、1.25 与 1.5 mg 的最初批准日期列为 1997-07-01，并将多个规格保留为历史 RLD。", "en": "The Orange Book lists 1 July 1997 for the initial 0.125, 0.25, 1, 1.25 and 1.5 mg approvals and retains several strengths as historical RLD products." }, "source": { "id": "src_3d17358ce65b1cf8", "label": "FDA Orange Book 第 46 版（2026）：MIRAPEX NDA 020667 与 MIRAPEX ER NDA 022421 的规格、RLD 与停止销售状态", "url": "https://www.fda.gov/media/71474/download", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, { "date": "2010-02-19", "title": { "zh": "MIRAPEX ER 缓释片在美国批准", "en": "U.S. approval of MIRAPEX ER" }, "detail": { "zh": "NDA 022421 的 0.375、0.75、1.5、3 与 4.5 mg 缓释片于该日批准；2.25 与 3.75 mg 后于 2011 年批准。", "en": "The 0.375, 0.75, 1.5, 3 and 4.5 mg ER tablets under NDA 022421 were approved on this date; 2.25 and 3.75 mg followed in 2011." }, "source": { "id": "src_3d17358ce65b1cf8", "label": "FDA Orange Book 第 46 版（2026）：MIRAPEX NDA 020667 与 MIRAPEX ER NDA 022421 的规格、RLD 与停止销售状态", "url": "https://www.fda.gov/media/71474/download", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, { "date": "2021-07", "title": { "zh": "FDA 更新普通片与 ER 的行为、幻觉和停药警示", "en": "FDA updated behavioural, hallucination and withdrawal warnings for IR and ER" }, "detail": { "zh": "两份标签均保留突然入睡、体位性低血压、冲动控制与幻觉，并新增或强化停药相关警示。", "en": "Both labels retain sudden-sleep, orthostatic-hypotension, impulse-control and hallucination warnings and add or strengthen withdrawal information." }, "source": { "id": "src_3204a292a1e803fe", "label": "FDA：MIRAPEX 盐酸普拉克索普通片处方信息（NDA 020667；2021-07 版本）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020667s044lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" } }, { "date": "2026-03-31", "title": { "zh": "当前美国通用名标签更新", "en": "Current U.S. generic label updated" }, "detail": { "zh": "当前 DailyMed 普通片标签用于补充现行安全阅读，不替代历史 MIRAPEX 品牌身份。", "en": "The current DailyMed immediate-release generic label supplies current safety reading without replacing historical MIRAPEX brand identity." }, "source": { "id": "src_762310eefa903362", "label": "DailyMed（NLM）：盐酸普拉克索普通片当前美国通用名标签（2026-03-31 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=60167d7c-469f-455a-a113-561841af5e59&version=22", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" } } ], "marketStatus": [ { "market": { "zh": "美国 MIRAPEX 普通片", "en": "United States — MIRAPEX immediate-release" }, "status": { "zh": "历史原研/RLD，当前品牌行停止销售", "en": "Historical originator/RLD; brand rows currently discontinued" }, "detail": { "zh": "七个规格均为历史品牌记录；仍可访问的标签和纸盒文件不证明当前品牌库存。", "en": "All seven strengths are historical brand records. Accessible labels and carton documents do not establish current brand stock." } }, { "market": { "zh": "美国 MIRAPEX ER", "en": "United States — MIRAPEX ER" }, "status": { "zh": "历史缓释片 RLD，当前品牌行停止销售", "en": "Historical ER RLD; brand rows currently discontinued" }, "detail": { "zh": "七个缓释规格属于独立 NDA 022421；不能与普通片按名称或总 mg 自动合并。", "en": "Seven ER strengths belong to separate NDA 022421 and cannot be automatically merged with immediate-release tablets by name or total milligrams." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "准确市场产品记录待逐项建立", "en": "Exact market-product records not yet established" }, "detail": { "zh": "不从美国 NDA、历史商品名、规格或共同通用名推定当地批准、包装、供应、原研/仿制关系或可替代性。", "en": "No local approval, pack, supply, originator/generic relationship or interchangeability is inferred from U.S. NDAs, historical trade names, strengths or a shared generic name." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "0.25 mg 是一天吃两片 0.125 mg 吗？", "en": "Does 0.25 mg mean two 0.125 mg tablets per day?" }, "answer": { "zh": "网页不能这样换算。mg 是每片标签含量；个人片数、频次、普通片或 ER 剂型必须依据准确处方、适应证、肾功能、症状和完整药单由专业人员确认。", "en": "The page cannot make that conversion. Milligrams are the labelled amount per tablet; individual tablet count, frequency and IR/ER form require professional confirmation from the exact prescription, indication, kidney function, symptoms and full medicine list." } }, { "question": { "zh": "普通片可以换成同总 mg 的 MIRAPEX ER 吗？", "en": "Can immediate-release tablets be switched to the same total milligrams of MIRAPEX ER?" }, "answer": { "zh": "不能由网页授权。两者释放结构、标签用途和使用路径不同；历史说明书里的专业转换内容也不是患者自行换剂型的许可。", "en": "A webpage cannot authorise this. Release structure, labelled use and administration pathway differ. Clinician-directed conversion content in a historical label is not permission to self-switch formulations." } }, { "question": { "zh": "出现幻觉、突然入睡或异常冲动怎么办？", "en": "What if hallucinations, sudden sleep or unusual urges occur?" }, "answer": { "zh": "停止驾驶和其他危险活动，尽快联系开方团队，并让照护者一同说明变化和完整药单。严重意识异常、事故、跌倒受伤或其他急性危险应使用当地急救；不要自行突然停药。", "en": "Stop driving and other hazardous activities, contact the prescribing team promptly, and have a caregiver describe changes and the full medicine list. Severe altered awareness, an accident, fall injury or another acute danger requires local emergency help; do not abruptly stop the medicine yourself." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label", "medicine-list-review-for-older-adults" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/mirapex-pramipexole/", "en": "https://origindrug.com/en/drugs/mirapex-pramipexole/" }, "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." ] }