{ "id": "creon", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-23", "status": "published_traceable_archive" }, "names": { "brand": "CREON", "generic": "胰酶", "aliases": [ "CREON", "pancrelipase", "胰酶", "胰酶肠溶胶囊", "creon 10000", "creon 25000" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "消化系统", "sourceArchiveMarket": "美国：DailyMed 有日期公开处方药标签（页面 2024-02-28 更新；本档案分别建立五种准确延迟释放胶囊瓶装身份；不代表当前供应或可得性）。本页不从这一美国文件推定中国大陆、欧盟、日本或其他市场的商品名、批准、供应、可售资格或可替代性。", "dosageFormClass": "胰酶延迟释放口服胶囊：每粒以脂肪酶、蛋白酶及淀粉酶 USP 单位共同标示；本档案只建立五种准确瓶装身份，不以数字推定个人粒数、换算或疗程。", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2009（DailyMed 标签所列美国初始批准年份）", "archiveSponsorText": "AbbVie Inc. / DailyMed（NLM）美国公开标签" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "pancrelipase bulk ingredient", "other pancreatic enzyme product", "其他胰酶制剂" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-creon-pancrelipase-delayed-release-capsule-3000-usp-lipase-70-bottle-ndc-0032120370", "marketCode": "US", "labelVersion": { "zh": "DailyMed 有日期美国公开标签（页面 2024-02-28 更新）；仅为所引标签的准确包装展示面，不代表当前供应或可得性", "en": "Dated U.S. DailyMed public label (page updated 28 Feb 2024); exact cited package panel only, not current supply or availability" }, "dosageForm": { "zh": "CREON 胰酶延迟释放口服胶囊", "en": "CREON pancrelipase delayed-release oral capsule" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0032-1203-70", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒：脂肪酶 3,000 USP 单位；蛋白酶 9,500 USP 单位；淀粉酶 15,000 USP 单位；70 粒瓶装", "en": "Per capsule: lipase 3,000 USP units; protease 9,500 USP units; amylase 15,000 USP units; 70-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=creon-pancrelipase-delayed--release-caps-04.jpg&setid=073201aa-556d-4a70-918e-84e9616fd88d&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "脂肪酶", "en": "lipase" }, "value": 3000, "unit": "USP units", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示的酶活性；不是个人粒数、每餐安排、换算、联用或换药指令", "en": "labelled enzyme activity per capsule; 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unscored" }, "imprint": "CREON 1203", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_c0b1683acb6c584e", "label": "DailyMed（NLM）：CREON 胰酶延迟释放口服胶囊美国公开标签（AbbVie；页面 2024-02-28 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=073201aa-556d-4a70-918e-84e9616fd88d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-creon-pancrelipase-delayed-release-capsule-6000-usp-lipase-100-bottle-ndc-0032120601", "marketCode": "US", "labelVersion": { "zh": "DailyMed 有日期美国公开标签（页面 2024-02-28 更新）；仅为所引标签的准确包装展示面，不代表当前供应或可得性", "en": "Dated U.S. DailyMed public label (page updated 28 Feb 2024); exact cited package panel only, not current supply or availability" }, "dosageForm": { "zh": "CREON 胰酶延迟释放口服胶囊", "en": "CREON pancrelipase delayed-release oral capsule" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0032-1206-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒：脂肪酶 6,000 USP 单位；蛋白酶 19,000 USP 单位；淀粉酶 30,000 USP 单位；100 粒瓶装", "en": "Per capsule: lipase 6,000 USP units; protease 19,000 USP units; amylase 30,000 USP units; 100-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=creon-pancrelipase-delayed--release-caps-05.jpg&setid=073201aa-556d-4a70-918e-84e9616fd88d&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "脂肪酶", "en": "lipase" }, "value": 6000, "unit": "USP units", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示的酶活性；不是个人粒数、每餐安排、换算、联用或换药指令", "en": "labelled enzyme activity per capsule; not an individual's capsule count, meal plan, conversion, co-use or switching instruction" } }, { "ingredient": { "zh": "蛋白酶", "en": "protease" }, "value": 19000, "unit": "USP units", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示的酶活性；须与脂肪酶和淀粉酶标示一起核对", "en": "labelled enzyme activity per capsule; check together with the lipase and amylase wording" } }, { "ingredient": { "zh": "淀粉酶", "en": "amylase" }, "value": 30000, "unit": "USP units", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示的酶活性；须与脂肪酶和蛋白酶标示一起核对", "en": "labelled enzyme activity per capsule; check together with the lipase and protease wording" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": false, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "橙色不透明胶囊帽与蓝色不透明胶囊体", "en": "orange opaque cap and blue opaque body" }, "shape": { "zh": "两节胶囊；无刻痕", "en": "two-piece capsule; unscored" }, "imprint": "CREON 1206", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_c0b1683acb6c584e", "label": "DailyMed（NLM）：CREON 胰酶延迟释放口服胶囊美国公开标签（AbbVie；页面 2024-02-28 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=073201aa-556d-4a70-918e-84e9616fd88d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-creon-pancrelipase-delayed-release-capsule-12000-usp-lipase-250-bottle-ndc-0032121207", "marketCode": "US", "labelVersion": { "zh": "DailyMed 有日期美国公开标签（页面 2024-02-28 更新）；仅为所引标签的准确包装展示面，不代表当前供应或可得性", "en": "Dated U.S. DailyMed public label (page updated 28 Feb 2024); 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not an individual's capsule count, meal plan, conversion, co-use or switching instruction" } }, { "ingredient": { "zh": "蛋白酶", "en": "protease" }, "value": 38000, "unit": "USP units", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示的酶活性；须与脂肪酶和淀粉酶标示一起核对", "en": "labelled enzyme activity per capsule; check together with the lipase and amylase wording" } }, { "ingredient": { "zh": "淀粉酶", "en": "amylase" }, "value": 60000, "unit": "USP units", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示的酶活性；须与脂肪酶和蛋白酶标示一起核对", "en": "labelled enzyme activity per capsule; check together with the lipase and protease wording" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 250, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": false, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 250, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "棕色不透明胶囊帽与无色透明胶囊体", "en": "brown opaque cap and colorless transparent body" }, "shape": { "zh": "两节胶囊；无刻痕", "en": "two-piece capsule; 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protease 76,000 USP units; amylase 120,000 USP units; 100-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=creon-pancrelipase-delayed--release-caps-07.jpg&setid=073201aa-556d-4a70-918e-84e9616fd88d&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "脂肪酶", "en": "lipase" }, "value": 24000, "unit": "USP units", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示的酶活性；不是个人粒数、每餐安排、换算、联用或换药指令", "en": "labelled enzyme activity per capsule; not an individual's capsule count, meal plan, conversion, co-use or switching instruction" } }, { "ingredient": { "zh": "蛋白酶", "en": "protease" }, "value": 76000, "unit": "USP units", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示的酶活性；须与脂肪酶和淀粉酶标示一起核对", "en": "labelled enzyme activity per capsule; check together with the lipase and amylase wording" } }, { "ingredient": { "zh": "淀粉酶", "en": "amylase" }, "value": 120000, "unit": "USP units", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示的酶活性；须与脂肪酶和蛋白酶标示一起核对", "en": "labelled enzyme activity per capsule; check together with the lipase and protease wording" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": false, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "橙色不透明胶囊帽与无色透明胶囊体", "en": "orange opaque cap and colorless transparent body" }, "shape": { "zh": "两节胶囊；无刻痕", "en": "two-piece capsule; unscored" }, "imprint": "CREON 1224", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_c0b1683acb6c584e", "label": "DailyMed（NLM）：CREON 胰酶延迟释放口服胶囊美国公开标签（AbbVie；页面 2024-02-28 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=073201aa-556d-4a70-918e-84e9616fd88d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-creon-pancrelipase-delayed-release-capsule-36000-usp-lipase-100-bottle-ndc-0032301613", "marketCode": "US", "labelVersion": { "zh": "DailyMed 有日期美国公开标签（页面 2024-02-28 更新）；仅为所引标签的准确包装展示面，不代表当前供应或可得性", "en": "Dated U.S. DailyMed public label (page updated 28 Feb 2024); exact cited package panel only, not current supply or availability" }, "dosageForm": { "zh": "CREON 胰酶延迟释放口服胶囊", "en": "CREON pancrelipase delayed-release oral capsule" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0032-3016-13", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒：脂肪酶 36,000 USP 单位；蛋白酶 114,000 USP 单位；淀粉酶 180,000 USP 单位；100 粒瓶装", "en": "Per capsule: lipase 36,000 USP units; protease 114,000 USP units; amylase 180,000 USP units; 100-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=creon-pancrelipase-delayed--release-caps-0a.jpg&setid=073201aa-556d-4a70-918e-84e9616fd88d&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "脂肪酶", "en": "lipase" }, "value": 36000, "unit": "USP units", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示的酶活性；不是个人粒数、每餐安排、换算、联用或换药指令", "en": "labelled enzyme activity per capsule; not an individual's capsule count, meal plan, conversion, co-use or switching instruction" } }, { "ingredient": { "zh": "蛋白酶", "en": "protease" }, "value": 114000, "unit": "USP units", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示的酶活性；须与脂肪酶和淀粉酶标示一起核对", "en": "labelled enzyme activity per capsule; check together with the lipase and amylase wording" } }, { "ingredient": { "zh": "淀粉酶", "en": "amylase" }, "value": 180000, "unit": "USP units", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示的酶活性；须与脂肪酶和蛋白酶标示一起核对", "en": "labelled enzyme activity per capsule; check together with the lipase and protease wording" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": false, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "蓝色不透明胶囊帽与无色透明胶囊体", "en": "blue opaque cap and colorless transparent body" }, "shape": { "zh": "两节胶囊；无刻痕", "en": "two-piece capsule; unscored" }, "imprint": "CREON 1236", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_c0b1683acb6c584e", "label": "DailyMed（NLM）：CREON 胰酶延迟释放口服胶囊美国公开标签（AbbVie；页面 2024-02-28 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=073201aa-556d-4a70-918e-84e9616fd88d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-creon-pancrelipase-delayed-release-capsule-12000-usp-lipase-250-bottle-ndc-0032121207", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=creon-pancrelipase-delayed--release-caps-06.jpg&setid=073201aa-556d-4a70-918e-84e9616fd88d&type=img", "alt": "CREON 胰酶延迟释放胶囊：脂肪酶 12,000 USP 单位、NDC 0032-1212-07、250 粒瓶装在美国 DailyMed 公开标签中的展示面", "archiveMarket": "美国", "labelVersion": "DailyMed 有日期公开标签（页面 2024-02-28 更新）", "presentation": "CREON 胰酶延迟释放胶囊：每粒脂肪酶 12,000 USP 单位、蛋白酶 38,000 USP 单位、淀粉酶 60,000 USP 单位，NDC 0032-1212-07，250 粒瓶装展示面。", "notice": "此图只对应美国 DailyMed 有日期公开标签中的 CREON、胰酶延迟释放胶囊、每粒脂肪酶 12,000 USP 单位、蛋白酶 38,000 USP 单位、淀粉酶 60,000 USP 单位、NDC 0032-1212-07 与 250 粒瓶装。它只帮助核对品牌、通用名、三项酶活性单位、剂型、NDC、包装数量、外观线索与来源；不用于鉴定真伪，也不证明其他强度、其他包装、其他市场、原研身份、当前供应、可得性、可替代性或任何个人的粒数、用餐安排、转换、联用或换药方案。", "source": { "id": "src_c0b1683acb6c584e", "label": "DailyMed（NLM）：CREON 胰酶延迟释放口服胶囊美国公开标签（AbbVie；页面 2024-02-28 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=073201aa-556d-4a70-918e-84e9616fd88d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "CREON 说明书放大阅读：单位、缓释颗粒和“能否打开胶囊”必须先分开看", "en": "CREON label reading: units, delayed-release pellets and whether a capsule can be opened must be read separately" }, "summary": { "zh": "本模块以 AbbVie 的 DailyMed 美国公开标签为阅读入口，帮助核对 CREON、胰酶、延迟释放胶囊、每粒脂肪酶 USP 单位与目标市场。它不提供个人粒数、每餐/加餐方案、加减量、同类替换或购买结论。", "en": "This module uses AbbVie's U.S. DailyMed public label to check CREON, pancrelipase, delayed-release capsules, lipase USP units per capsule and target market. It does not provide an individual's capsule count, meal/snack plan, dose adjustment, same-class substitution or purchase conclusion." }, "checks": [ { "zh": "先核对 CREON、胰酶、延迟释放胶囊和每粒脂肪酶 USP 单位。3,000、6,000、12,000、24,000、36,000 不是 mg，也不是可以靠数字自行把不同胶囊互换、拼凑或减少的规则；标签把用量与个人情况和饮食等因素一起处理。", "en": "First check CREON, pancrelipase, delayed-release capsule and lipase USP units per capsule. 3,000, 6,000, 12,000, 24,000 and 36,000 are not milligrams and are not a rule for self-exchanging, assembling or reducing different capsules; the label handles use together with individual factors and diet." }, { "zh": "“延迟释放”说明胶囊内有肠溶颗粒。标签中针对该准确产品的处理文字包括完整吞咽、不得压碎或咀嚼；对吞咽困难另有受限情形的文字。它不是任何胶囊都能掰半、研碎、咀嚼、把颗粒分成两次、保存混合物或用另一胰酶产品替代的授权。", "en": "“Delayed release” means the capsule contains enteric-coated pellets. The label's handling text for this exact product includes swallowing whole and not crushing or chewing, with separate limited wording for swallowing difficulty. It is not permission to split, crush, chew, divide pellets for later use, store a mixture or replace with another pancreatic enzyme product." }, { "zh": "标签明确提示不要把其他胰酶产品当作 CREON 的自行替代。家中同时有不同强度、旧药盒、其他胰酶、营养补充剂或多种慢病药时，请把每一盒实际包装、处方和完整药单交给药师或开方团队；不要按“都是胰酶”、颜色或单位数字自行合并、轮换或换算。", "en": "The label explicitly cautions against treating another pancreatic enzyme product as a self-substitute for CREON. With different strengths, older packs, another enzyme product, supplements or multiple chronic medicines at home, have a pharmacist or prescribing team review every actual pack, prescription and complete medicine list; do not self-combine, alternate or convert from “all are enzymes,” colour or unit numbers." }, { "zh": "持续或明显腹痛、腹胀、呕吐、皮疹/呼吸困难、口腔疼痛或其他急性严重不适，应使用当地紧急医疗或既有照护渠道；不要等待网页，也不要因担心症状自行停止、补用、改变胶囊内容物或更换产品。", "en": "With persistent or marked abdominal pain, bloating, vomiting, rash/breathing trouble, mouth pain or another acute serious concern, use local urgent or established care; do not wait for a webpage or self-stop, make up, alter capsule contents or change products because of a concern." } ], "source": { "id": "src_c0b1683acb6c584e", "label": "DailyMed（NLM）：CREON 胰酶延迟释放口服胶囊美国公开标签（AbbVie；页面 2024-02-28 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=073201aa-556d-4a70-918e-84e9616fd88d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "胰酶怎样起作用：标签描述脂肪酶、蛋白酶和淀粉酶帮助分解食物成分", "en": "How pancrelipase works: the label describes lipase, protease and amylase helping digest food components" }, "summary": { "zh": "标签把胰酶描述为含脂肪酶、蛋白酶和淀粉酶的酶制剂，并说明这些酶在小肠近端参与食物脂肪、蛋白质和淀粉的分解。这个机制说明不决定任何个人是否需要此药、应使用多少、能否与其他产品同用或何时改用。", "en": "The label describes pancrelipase as an enzyme preparation containing lipase, protease and amylase, and says these enzymes participate in digesting dietary fats, proteins and starches in the proximal small intestine. This mechanism explanation does not decide whether an individual needs it, how much to use, whether it can be combined with another product or when to change." }, "checks": [ { "zh": "“帮助消化”不等于任何腹胀、腹泻、体重变化或饭后不适都可以自行用胰酶处理；这些症状可能有不同原因，网页不能诊断或替代评估。", "en": "“Helps digestion” does not mean every bloating, diarrhoea, weight change or post-meal concern can be self-treated with pancrelipase; such symptoms may have different causes, and a webpage cannot diagnose or replace assessment." }, { "zh": "脂肪酶 USP 单位描述的是标签中的酶活性标示，不等于毫克，也不能从另一种胰酶、另一强度、另一剂型或另一市场包装自行推算替换关系。", "en": "Lipase USP units describe labelled enzyme activity, not milligrams, and do not allow a self-derived substitution across another enzyme product, strength, form or market pack." }, { "zh": "延迟释放颗粒与酶活性相关的术语不能预测个人症状、营养状态或联用风险。出现严重不适或不确定如何使用时，应让药师或开方团队结合实际药盒、完整药单与现行标签核对。", "en": "Terms about delayed-release pellets and enzyme activity cannot predict an individual's symptoms, nutritional status or combination risk. With a serious concern or uncertainty about use, have a pharmacist or prescribing team review the actual pack, complete medicine list and current label." } ], "source": { "id": "src_c0b1683acb6c584e", "label": "DailyMed（NLM）：CREON 胰酶延迟释放口服胶囊美国公开标签（AbbVie；页面 2024-02-28 更新；Clinical Pharmacology）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=073201aa-556d-4a70-918e-84e9616fd88d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "CREON", "generic": "胰酶", "dosageFormClass": "胰酶延迟释放口服胶囊：每粒以脂肪酶、蛋白酶及淀粉酶 USP 单位共同标示；本档案只建立五种准确瓶装身份，不以数字推定个人粒数、换算或疗程。" }, "labelSource": { "id": "src_c0b1683acb6c584e", "label": "DailyMed（NLM）：CREON 胰酶延迟释放口服胶囊美国公开标签（AbbVie；页面 2024-02-28 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=073201aa-556d-4a70-918e-84e9616fd88d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "productRoutes": [ { "source": { "id": "src_c0b1683acb6c584e", "label": "DailyMed（NLM）：CREON 胰酶延迟释放口服胶囊美国公开标签（AbbVie；页面 2024-02-28 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=073201aa-556d-4a70-918e-84e9616fd88d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "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": "2026-08-23", "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": "2026-08-23", "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": "CREON 是胰酶延迟释放胶囊。标签上的 3,000、6,000、12,000、24,000、36,000 是每粒脂肪酶的 USP 单位，且同一粒还含蛋白酶和淀粉酶单位；本页把这些三项单位、NDC 与包装数量逐一对应到五个准确瓶装面板。它们不是网页可以换算成“吃几粒”的答案。不同强度、每餐/加餐安排、体重、饮食与疾病情况需要由开方团队逐项确认。", "history": "所引 DailyMed 美国公开标签列示 Initial U.S. Approval: 2009、AbbVie Inc. 为包装方，并显示页面更新日期为 2024-02-28。本页仅保留其中五个准确延迟释放胶囊瓶装面板；每个面板都须把三项酶活性单位、NDC、粒数和胶囊文字一同核对。该来源还把胶囊定义为延迟释放颗粒制剂，并写有与完整吞咽、不得压碎或咀嚼及特定处理相关的产品文字。来源日期和历史节点只定位所引文件，不能替代手中实际产品的现行说明书、处方判断或目标市场记录。", "sourceDocuments": [ { "id": "src_c0b1683acb6c584e", "label": "DailyMed（NLM）：CREON 胰酶延迟释放口服胶囊美国公开标签（AbbVie；页面 2024-02-28 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=073201aa-556d-4a70-918e-84e9616fd88d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } ], "applicationNumber": "DailyMed 公开标签所列 Biologic Licensing Application 记录（本档案不另行断言具体申请号）", "approvalTimeline": [ { "date": "2009", "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: 2009。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: 2009. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_c0b1683acb6c584e", "label": "DailyMed: CREON pancrelipase delayed-release capsule public label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=073201aa-556d-4a70-918e-84e9616fd88d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } }, { "date": "2024-02-28", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2024-02-28 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 2024-02-28 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_c0b1683acb6c584e", "label": "DailyMed: CREON pancrelipase delayed-release capsule public label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=073201aa-556d-4a70-918e-84e9616fd88d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/creon/", "en": "https://origindrug.com/en/drugs/creon/" }, "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." ] }