{
  "fetchedAt": "2026-10-05T13:22:41.937Z",
  "readOnly": true,
  "rule": "Regulator records only. Where a record cannot be read, status is not-established and is never inferred from news, a sponsor, or another regulator's decision. The E3 coder treats a not-established Saudi status as in scope and marks every such code provisional.",
  "entries": [
    {
      "agent": "sab-142",
      "set": "investigational",
      "market": "Saudi Arabia",
      "status": "not-established",
      "approvedOn": null,
      "recordAsOf": "2026-02-02",
      "regulator": "Saudi Food and Drug Authority (New SFDA Drug Approvals list)",
      "url": "https://www.sfda.gov.sa/en/new-sfda-drug-approvals",
      "qualifying": "No row naming SAB-142 / SAB142 among 462 rows on 47 pages, approval dates 2025-02-01 to 2026-02-02. The list covers only that approval window, so absence from it does not show non-registration. The SFDA drugs-list search (https://www.sfda.gov.sa/en/drugs-list) is a POST form behind reCAPTCHA and was not submitted; the Saudi Drug Information site (sdi.sfda.gov.sa) did not complete a TLS handshake from this network."
    },
    {
      "agent": "sab-142",
      "set": "investigational",
      "market": "US",
      "status": "not-approved",
      "approvedOn": null,
      "recordAsOf": "2026-10-02",
      "regulator": "FDA (Drugs@FDA via openFDA; CBER approved cellular and gene therapy products)",
      "url": "https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22SAB-142%22+OR+openfda.brand_name:%22SAB-142%22+OR+products.brand_name:%22SAB-142%22+OR+products.active_ingredients.name:%22SAB-142%22&limit=20",
      "qualifying": "Drugs@FDA (dataset last_updated 2026-10-02): \"SAB-142\": NOT_FOUND; \"SAB142\": NOT_FOUND. Not on CBER's approved cellular and gene therapy products list (content current as of 2026-09-17). Other licensed biologics (FDA Purple Book) were not queried."
    },
    {
      "agent": "sab-142",
      "set": "investigational",
      "market": "EU",
      "status": "not-approved",
      "approvedOn": null,
      "recordAsOf": "2026-10-05",
      "regulator": "EMA / European Commission (EMA medicines dataset)",
      "url": "https://www.ema.europa.eu/en/documents/report/medicines-output-medicines_json-report_en.json",
      "qualifying": "No human-medicine record whose name, INN or active substance contains SAB-142 / SAB142 among 2746 records (dataset timestamp 2026-10-05T06:02:03Z); the dataset holds centrally authorised medicines, withdrawn ones and pending CHMP opinions. A new active substance for diabetes falls under the mandatory centralised procedure (Regulation (EC) 726/2004, Annex point 3)."
    },
    {
      "agent": "mtx-101",
      "set": "investigational",
      "market": "Saudi Arabia",
      "status": "not-established",
      "approvedOn": null,
      "recordAsOf": "2026-02-02",
      "regulator": "Saudi Food and Drug Authority (New SFDA Drug Approvals list)",
      "url": "https://www.sfda.gov.sa/en/new-sfda-drug-approvals",
      "qualifying": "No row naming MTX-101 / MTX101 among 462 rows on 47 pages, approval dates 2025-02-01 to 2026-02-02. The list covers only that approval window, so absence from it does not show non-registration. The SFDA drugs-list search (https://www.sfda.gov.sa/en/drugs-list) is a POST form behind reCAPTCHA and was not submitted; the Saudi Drug Information site (sdi.sfda.gov.sa) did not complete a TLS handshake from this network."
    },
    {
      "agent": "mtx-101",
      "set": "investigational",
      "market": "US",
      "status": "not-approved",
      "approvedOn": null,
      "recordAsOf": "2026-10-02",
      "regulator": "FDA (Drugs@FDA via openFDA; CBER approved cellular and gene therapy products)",
      "url": "https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22MTX-101%22+OR+openfda.brand_name:%22MTX-101%22+OR+products.brand_name:%22MTX-101%22+OR+products.active_ingredients.name:%22MTX-101%22&limit=20",
      "qualifying": "Drugs@FDA (dataset last_updated 2026-10-02): \"MTX-101\": NOT_FOUND; \"MTX101\": NOT_FOUND. Not on CBER's approved cellular and gene therapy products list (content current as of 2026-09-17). Other licensed biologics (FDA Purple Book) were not queried."
    },
    {
      "agent": "mtx-101",
      "set": "investigational",
      "market": "EU",
      "status": "not-approved",
      "approvedOn": null,
      "recordAsOf": "2026-10-05",
      "regulator": "EMA / European Commission (EMA medicines dataset)",
      "url": "https://www.ema.europa.eu/en/documents/report/medicines-output-medicines_json-report_en.json",
      "qualifying": "No human-medicine record whose name, INN or active substance contains MTX-101 / MTX101 among 2746 records (dataset timestamp 2026-10-05T06:02:03Z); the dataset holds centrally authorised medicines, withdrawn ones and pending CHMP opinions. A new active substance for diabetes falls under the mandatory centralised procedure (Regulation (EC) 726/2004, Annex point 3)."
    },
    {
      "agent": "retogatein",
      "set": "investigational",
      "market": "Saudi Arabia",
      "status": "not-established",
      "approvedOn": null,
      "recordAsOf": "2026-02-02",
      "regulator": "Saudi Food and Drug Authority (New SFDA Drug Approvals list)",
      "url": "https://www.sfda.gov.sa/en/new-sfda-drug-approvals",
      "qualifying": "No row naming retogatein / Diamyd / GAD-alum / rhGAD65 among 462 rows on 47 pages, approval dates 2025-02-01 to 2026-02-02. The list covers only that approval window, so absence from it does not show non-registration. The SFDA drugs-list search (https://www.sfda.gov.sa/en/drugs-list) is a POST form behind reCAPTCHA and was not submitted; the Saudi Drug Information site (sdi.sfda.gov.sa) did not complete a TLS handshake from this network."
    },
    {
      "agent": "retogatein",
      "set": "investigational",
      "market": "US",
      "status": "not-approved",
      "approvedOn": null,
      "recordAsOf": "2026-10-02",
      "regulator": "FDA (Drugs@FDA via openFDA; CBER approved cellular and gene therapy products)",
      "url": "https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22retogatein%22+OR+openfda.brand_name:%22retogatein%22+OR+products.brand_name:%22retogatein%22+OR+products.active_ingredients.name:%22retogatein%22&limit=20",
      "qualifying": "Drugs@FDA (dataset last_updated 2026-10-02): \"retogatein\": NOT_FOUND; \"Diamyd\": NOT_FOUND; \"GAD-alum\": NOT_FOUND; \"rhGAD65\": NOT_FOUND. Not on CBER's approved cellular and gene therapy products list (content current as of 2026-09-17). Other licensed biologics (FDA Purple Book) were not queried."
    },
    {
      "agent": "retogatein",
      "set": "investigational",
      "market": "EU",
      "status": "not-approved",
      "approvedOn": null,
      "recordAsOf": "2026-10-05",
      "regulator": "EMA / European Commission (EMA medicines dataset)",
      "url": "https://www.ema.europa.eu/en/documents/report/medicines-output-medicines_json-report_en.json",
      "qualifying": "No human-medicine record whose name, INN or active substance contains retogatein / Diamyd / GAD-alum / rhGAD65 among 2746 records (dataset timestamp 2026-10-05T06:02:03Z); the dataset holds centrally authorised medicines, withdrawn ones and pending CHMP opinions. A new active substance for diabetes falls under the mandatory centralised procedure (Regulation (EC) 726/2004, Annex point 3)."
    },
    {
      "agent": "crg-002",
      "set": "investigational",
      "market": "Saudi Arabia",
      "status": "not-established",
      "approvedOn": null,
      "recordAsOf": "2026-02-02",
      "regulator": "Saudi Food and Drug Authority (New SFDA Drug Approvals list)",
      "url": "https://www.sfda.gov.sa/en/new-sfda-drug-approvals",
      "qualifying": "No row naming CRG-002 / CRG002 among 462 rows on 47 pages, approval dates 2025-02-01 to 2026-02-02. The list covers only that approval window, so absence from it does not show non-registration. The SFDA drugs-list search (https://www.sfda.gov.sa/en/drugs-list) is a POST form behind reCAPTCHA and was not submitted; the Saudi Drug Information site (sdi.sfda.gov.sa) did not complete a TLS handshake from this network."
    },
    {
      "agent": "crg-002",
      "set": "investigational",
      "market": "US",
      "status": "not-approved",
      "approvedOn": null,
      "recordAsOf": "2026-10-02",
      "regulator": "FDA (Drugs@FDA via openFDA; CBER approved cellular and gene therapy products)",
      "url": "https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22CRG-002%22+OR+openfda.brand_name:%22CRG-002%22+OR+products.brand_name:%22CRG-002%22+OR+products.active_ingredients.name:%22CRG-002%22&limit=20",
      "qualifying": "Drugs@FDA (dataset last_updated 2026-10-02): \"CRG-002\": NOT_FOUND; \"CRG002\": NOT_FOUND. Not on CBER's approved cellular and gene therapy products list (content current as of 2026-09-17). Other licensed biologics (FDA Purple Book) were not queried."
    },
    {
      "agent": "crg-002",
      "set": "investigational",
      "market": "EU",
      "status": "not-approved",
      "approvedOn": null,
      "recordAsOf": "2026-10-05",
      "regulator": "EMA / European Commission (EMA medicines dataset)",
      "url": "https://www.ema.europa.eu/en/documents/report/medicines-output-medicines_json-report_en.json",
      "qualifying": "No human-medicine record whose name, INN or active substance contains CRG-002 / CRG002 among 2746 records (dataset timestamp 2026-10-05T06:02:03Z); the dataset holds centrally authorised medicines, withdrawn ones and pending CHMP opinions. A new active substance for diabetes falls under the mandatory centralised procedure (Regulation (EC) 726/2004, Annex point 3)."
    },
    {
      "agent": "ct-868",
      "set": "investigational",
      "market": "Saudi Arabia",
      "status": "not-established",
      "approvedOn": null,
      "recordAsOf": "2026-02-02",
      "regulator": "Saudi Food and Drug Authority (New SFDA Drug Approvals list)",
      "url": "https://www.sfda.gov.sa/en/new-sfda-drug-approvals",
      "qualifying": "No row naming CT-868 / CT868 among 462 rows on 47 pages, approval dates 2025-02-01 to 2026-02-02. The list covers only that approval window, so absence from it does not show non-registration. The SFDA drugs-list search (https://www.sfda.gov.sa/en/drugs-list) is a POST form behind reCAPTCHA and was not submitted; the Saudi Drug Information site (sdi.sfda.gov.sa) did not complete a TLS handshake from this network."
    },
    {
      "agent": "ct-868",
      "set": "investigational",
      "market": "US",
      "status": "not-approved",
      "approvedOn": null,
      "recordAsOf": "2026-10-02",
      "regulator": "FDA (Drugs@FDA via openFDA; CBER approved cellular and gene therapy products)",
      "url": "https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22CT-868%22+OR+openfda.brand_name:%22CT-868%22+OR+products.brand_name:%22CT-868%22+OR+products.active_ingredients.name:%22CT-868%22&limit=20",
      "qualifying": "Drugs@FDA (dataset last_updated 2026-10-02): \"CT-868\": NOT_FOUND; \"CT868\": NOT_FOUND. Not on CBER's approved cellular and gene therapy products list (content current as of 2026-09-17). Other licensed biologics (FDA Purple Book) were not queried."
    },
    {
      "agent": "ct-868",
      "set": "investigational",
      "market": "EU",
      "status": "not-approved",
      "approvedOn": null,
      "recordAsOf": "2026-10-05",
      "regulator": "EMA / European Commission (EMA medicines dataset)",
      "url": "https://www.ema.europa.eu/en/documents/report/medicines-output-medicines_json-report_en.json",
      "qualifying": "No human-medicine record whose name, INN or active substance contains CT-868 / CT868 among 2746 records (dataset timestamp 2026-10-05T06:02:03Z); the dataset holds centrally authorised medicines, withdrawn ones and pending CHMP opinions. A new active substance for diabetes falls under the mandatory centralised procedure (Regulation (EC) 726/2004, Annex point 3)."
    },
    {
      "agent": "hdv-insulin-lispro",
      "set": "investigational",
      "market": "Saudi Arabia",
      "status": "not-established",
      "approvedOn": null,
      "recordAsOf": "2026-02-02",
      "regulator": "Saudi Food and Drug Authority (New SFDA Drug Approvals list)",
      "url": "https://www.sfda.gov.sa/en/new-sfda-drug-approvals",
      "qualifying": "No row naming HDV-insulin / HDV-LIS / hepatocyte directed vesicle / hepatic-directed vesicle among 462 rows on 47 pages, approval dates 2025-02-01 to 2026-02-02. The list covers only that approval window, so absence from it does not show non-registration. The SFDA drugs-list search (https://www.sfda.gov.sa/en/drugs-list) is a POST form behind reCAPTCHA and was not submitted; the Saudi Drug Information site (sdi.sfda.gov.sa) did not complete a TLS handshake from this network."
    },
    {
      "agent": "hdv-insulin-lispro",
      "set": "investigational",
      "market": "US",
      "status": "not-approved",
      "approvedOn": null,
      "recordAsOf": "2026-10-02",
      "regulator": "FDA (Drugs@FDA via openFDA; CBER approved cellular and gene therapy products)",
      "url": "https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22HDV-insulin%22+OR+openfda.brand_name:%22HDV-insulin%22+OR+products.brand_name:%22HDV-insulin%22+OR+products.active_ingredients.name:%22HDV-insulin%22&limit=20",
      "qualifying": "Drugs@FDA (dataset last_updated 2026-10-02): \"HDV-insulin\": NOT_FOUND; \"HDV-LIS\": NOT_FOUND; \"hepatocyte directed vesicle\": NOT_FOUND; \"hepatic-directed vesicle\": NOT_FOUND. Not on CBER's approved cellular and gene therapy products list (content current as of 2026-09-17). Other licensed biologics (FDA Purple Book) were not queried."
    },
    {
      "agent": "hdv-insulin-lispro",
      "set": "investigational",
      "market": "EU",
      "status": "not-approved",
      "approvedOn": null,
      "recordAsOf": "2026-10-05",
      "regulator": "EMA / European Commission (EMA medicines dataset)",
      "url": "https://www.ema.europa.eu/en/documents/report/medicines-output-medicines_json-report_en.json",
      "qualifying": "No human-medicine record whose name, INN or active substance contains HDV-insulin / HDV-LIS / hepatocyte directed vesicle / hepatic-directed vesicle among 2746 records (dataset timestamp 2026-10-05T06:02:03Z); the dataset holds centrally authorised medicines, withdrawn ones and pending CHMP opinions. A new active substance for diabetes falls under the mandatory centralised procedure (Regulation (EC) 726/2004, Annex point 3)."
    },
    {
      "agent": "gzr33",
      "set": "investigational",
      "market": "Saudi Arabia",
      "status": "not-established",
      "approvedOn": null,
      "recordAsOf": "2026-02-02",
      "regulator": "Saudi Food and Drug Authority (New SFDA Drug Approvals list)",
      "url": "https://www.sfda.gov.sa/en/new-sfda-drug-approvals",
      "qualifying": "No row naming GZR33 / GZR-33 / GZR101 / GZR-101 among 462 rows on 47 pages, approval dates 2025-02-01 to 2026-02-02. The list covers only that approval window, so absence from it does not show non-registration. The SFDA drugs-list search (https://www.sfda.gov.sa/en/drugs-list) is a POST form behind reCAPTCHA and was not submitted; the Saudi Drug Information site (sdi.sfda.gov.sa) did not complete a TLS handshake from this network."
    },
    {
      "agent": "gzr33",
      "set": "investigational",
      "market": "US",
      "status": "not-approved",
      "approvedOn": null,
      "recordAsOf": "2026-10-02",
      "regulator": "FDA (Drugs@FDA via openFDA; CBER approved cellular and gene therapy products)",
      "url": "https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22GZR33%22+OR+openfda.brand_name:%22GZR33%22+OR+products.brand_name:%22GZR33%22+OR+products.active_ingredients.name:%22GZR33%22&limit=20",
      "qualifying": "Drugs@FDA (dataset last_updated 2026-10-02): \"GZR33\": NOT_FOUND; \"GZR-33\": NOT_FOUND; \"GZR101\": NOT_FOUND; \"GZR-101\": NOT_FOUND. Not on CBER's approved cellular and gene therapy products list (content current as of 2026-09-17). Other licensed biologics (FDA Purple Book) were not queried."
    },
    {
      "agent": "gzr33",
      "set": "investigational",
      "market": "EU",
      "status": "not-approved",
      "approvedOn": null,
      "recordAsOf": "2026-10-05",
      "regulator": "EMA / European Commission (EMA medicines dataset)",
      "url": "https://www.ema.europa.eu/en/documents/report/medicines-output-medicines_json-report_en.json",
      "qualifying": "No human-medicine record whose name, INN or active substance contains GZR33 / GZR-33 / GZR101 / GZR-101 among 2746 records (dataset timestamp 2026-10-05T06:02:03Z); the dataset holds centrally authorised medicines, withdrawn ones and pending CHMP opinions. A new active substance for diabetes falls under the mandatory centralised procedure (Regulation (EC) 726/2004, Annex point 3)."
    },
    {
      "agent": "prv-101",
      "set": "investigational",
      "market": "Saudi Arabia",
      "status": "not-established",
      "approvedOn": null,
      "recordAsOf": "2026-02-02",
      "regulator": "Saudi Food and Drug Authority (New SFDA Drug Approvals list)",
      "url": "https://www.sfda.gov.sa/en/new-sfda-drug-approvals",
      "qualifying": "No row naming PRV-101 / PRV101 among 462 rows on 47 pages, approval dates 2025-02-01 to 2026-02-02. The list covers only that approval window, so absence from it does not show non-registration. The SFDA drugs-list search (https://www.sfda.gov.sa/en/drugs-list) is a POST form behind reCAPTCHA and was not submitted; the Saudi Drug Information site (sdi.sfda.gov.sa) did not complete a TLS handshake from this network."
    },
    {
      "agent": "prv-101",
      "set": "investigational",
      "market": "US",
      "status": "not-approved",
      "approvedOn": null,
      "recordAsOf": "2026-10-02",
      "regulator": "FDA (Drugs@FDA via openFDA; CBER approved cellular and gene therapy products)",
      "url": "https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22PRV-101%22+OR+openfda.brand_name:%22PRV-101%22+OR+products.brand_name:%22PRV-101%22+OR+products.active_ingredients.name:%22PRV-101%22&limit=20",
      "qualifying": "Drugs@FDA (dataset last_updated 2026-10-02): \"PRV-101\": NOT_FOUND; \"PRV101\": NOT_FOUND. Not on CBER's approved cellular and gene therapy products list (content current as of 2026-09-17). Other licensed biologics (FDA Purple Book) were not queried."
    },
    {
      "agent": "prv-101",
      "set": "investigational",
      "market": "EU",
      "status": "not-approved",
      "approvedOn": null,
      "recordAsOf": "2026-10-05",
      "regulator": "EMA / European Commission (EMA medicines dataset)",
      "url": "https://www.ema.europa.eu/en/documents/report/medicines-output-medicines_json-report_en.json",
      "qualifying": "No human-medicine record whose name, INN or active substance contains PRV-101 / PRV101 among 2746 records (dataset timestamp 2026-10-05T06:02:03Z); the dataset holds centrally authorised medicines, withdrawn ones and pending CHMP opinions. A new active substance for diabetes falls under the mandatory centralised procedure (Regulation (EC) 726/2004, Annex point 3)."
    },
    {
      "agent": "cnty-813",
      "set": "investigational",
      "market": "Saudi Arabia",
      "status": "not-established",
      "approvedOn": null,
      "recordAsOf": "2026-02-02",
      "regulator": "Saudi Food and Drug Authority (New SFDA Drug Approvals list)",
      "url": "https://www.sfda.gov.sa/en/new-sfda-drug-approvals",
      "qualifying": "No row naming CNTY-813 / CNTY813 among 462 rows on 47 pages, approval dates 2025-02-01 to 2026-02-02. The list covers only that approval window, so absence from it does not show non-registration. The SFDA drugs-list search (https://www.sfda.gov.sa/en/drugs-list) is a POST form behind reCAPTCHA and was not submitted; the Saudi Drug Information site (sdi.sfda.gov.sa) did not complete a TLS handshake from this network."
    },
    {
      "agent": "cnty-813",
      "set": "investigational",
      "market": "US",
      "status": "not-approved",
      "approvedOn": null,
      "recordAsOf": "2026-10-02",
      "regulator": "FDA (Drugs@FDA via openFDA; CBER approved cellular and gene therapy products)",
      "url": "https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22CNTY-813%22+OR+openfda.brand_name:%22CNTY-813%22+OR+products.brand_name:%22CNTY-813%22+OR+products.active_ingredients.name:%22CNTY-813%22&limit=20",
      "qualifying": "Drugs@FDA (dataset last_updated 2026-10-02): \"CNTY-813\": NOT_FOUND; \"CNTY813\": NOT_FOUND. Not on CBER's approved cellular and gene therapy products list (content current as of 2026-09-17). Other licensed biologics (FDA Purple Book) were not queried."
    },
    {
      "agent": "cnty-813",
      "set": "investigational",
      "market": "EU",
      "status": "not-approved",
      "approvedOn": null,
      "recordAsOf": "2026-10-05",
      "regulator": "EMA / European Commission (EMA medicines dataset)",
      "url": "https://www.ema.europa.eu/en/documents/report/medicines-output-medicines_json-report_en.json",
      "qualifying": "No human-medicine record whose name, INN or active substance contains CNTY-813 / CNTY813 among 2746 records (dataset timestamp 2026-10-05T06:02:03Z); the dataset holds centrally authorised medicines, withdrawn ones and pending CHMP opinions. A new active substance for diabetes falls under the mandatory centralised procedure (Regulation (EC) 726/2004, Annex point 3)."
    },
    {
      "agent": "tipifarnib",
      "set": "investigational",
      "market": "Saudi Arabia",
      "status": "not-established",
      "approvedOn": null,
      "recordAsOf": "2026-02-02",
      "regulator": "Saudi Food and Drug Authority (New SFDA Drug Approvals list)",
      "url": "https://www.sfda.gov.sa/en/new-sfda-drug-approvals",
      "qualifying": "No row naming tipifarnib among 462 rows on 47 pages, approval dates 2025-02-01 to 2026-02-02. The list covers only that approval window, so absence from it does not show non-registration. The SFDA drugs-list search (https://www.sfda.gov.sa/en/drugs-list) is a POST form behind reCAPTCHA and was not submitted; the Saudi Drug Information site (sdi.sfda.gov.sa) did not complete a TLS handshake from this network."
    },
    {
      "agent": "tipifarnib",
      "set": "investigational",
      "market": "US",
      "status": "not-approved",
      "approvedOn": null,
      "recordAsOf": "2026-10-02",
      "regulator": "FDA (Drugs@FDA via openFDA; CBER approved cellular and gene therapy products)",
      "url": "https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22tipifarnib%22+OR+openfda.brand_name:%22tipifarnib%22+OR+products.brand_name:%22tipifarnib%22+OR+products.active_ingredients.name:%22tipifarnib%22&limit=20",
      "qualifying": "Drugs@FDA (dataset last_updated 2026-10-02): \"tipifarnib\": NOT_FOUND. Not on CBER's approved cellular and gene therapy products list (content current as of 2026-09-17). Other licensed biologics (FDA Purple Book) were not queried."
    },
    {
      "agent": "tipifarnib",
      "set": "investigational",
      "market": "EU",
      "status": "not-approved",
      "approvedOn": null,
      "recordAsOf": "2026-10-05",
      "regulator": "EMA / European Commission (EMA medicines dataset)",
      "url": "https://www.ema.europa.eu/en/documents/report/medicines-output-medicines_json-report_en.json",
      "qualifying": "No human-medicine record whose name, INN or active substance contains tipifarnib among 2746 records (dataset timestamp 2026-10-05T06:02:03Z); the dataset holds centrally authorised medicines, withdrawn ones and pending CHMP opinions. A new active substance for diabetes falls under the mandatory centralised procedure (Regulation (EC) 726/2004, Annex point 3)."
    },
    {
      "agent": "sotagliflozin",
      "set": "indication",
      "market": "Saudi Arabia",
      "status": "not-established",
      "approvedOn": null,
      "recordAsOf": "2026-02-02",
      "regulator": "Saudi Food and Drug Authority (New SFDA Drug Approvals list)",
      "url": "https://www.sfda.gov.sa/en/new-sfda-drug-approvals",
      "qualifying": "No row naming sotagliflozin / Zynquista / Inpefa among 462 rows on 47 pages, approval dates 2025-02-01 to 2026-02-02. The list covers only that approval window, so absence from it does not show non-registration. The SFDA drugs-list search (https://www.sfda.gov.sa/en/drugs-list) is a POST form behind reCAPTCHA and was not submitted; the Saudi Drug Information site (sdi.sfda.gov.sa) did not complete a TLS handshake from this network."
    },
    {
      "agent": "sotagliflozin",
      "set": "indication",
      "market": "US",
      "status": "approved",
      "approvedOn": "2023-05-26",
      "recordAsOf": "2026-10-02",
      "regulator": "FDA (Drugs@FDA via openFDA; CBER approved cellular and gene therapy products)",
      "url": "https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22sotagliflozin%22+OR+openfda.brand_name:%22sotagliflozin%22+OR+products.brand_name:%22sotagliflozin%22+OR+products.active_ingredients.name:%22sotagliflozin%22&limit=20",
      "qualifying": "earliest ORIG approval NDA216203 INPEFA 20230526; NDA216203 INPEFA (\"sotagliflozin\": 1 application(s); \"Zynquista\": NOT_FOUND; \"Inpefa\": 1 application(s))"
    },
    {
      "agent": "sotagliflozin",
      "set": "indication",
      "market": "EU",
      "status": "not-approved",
      "approvedOn": null,
      "recordAsOf": "2026-10-05",
      "regulator": "EMA / European Commission (EMA medicines dataset)",
      "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zynquista",
      "qualifying": "Zynquista: Withdrawn"
    },
    {
      "agent": "tirzepatide",
      "set": "indication",
      "market": "Saudi Arabia",
      "status": "not-established",
      "approvedOn": null,
      "recordAsOf": "2026-02-02",
      "regulator": "Saudi Food and Drug Authority (New SFDA Drug Approvals list)",
      "url": "https://www.sfda.gov.sa/en/new-sfda-drug-approvals",
      "qualifying": "No row naming tirzepatide / Mounjaro / Zepbound among 462 rows on 47 pages, approval dates 2025-02-01 to 2026-02-02. The list covers only that approval window, so absence from it does not show non-registration. The SFDA drugs-list search (https://www.sfda.gov.sa/en/drugs-list) is a POST form behind reCAPTCHA and was not submitted; the Saudi Drug Information site (sdi.sfda.gov.sa) did not complete a TLS handshake from this network."
    },
    {
      "agent": "tirzepatide",
      "set": "indication",
      "market": "US",
      "status": "approved",
      "approvedOn": "2022-05-13",
      "recordAsOf": "2026-10-02",
      "regulator": "FDA (Drugs@FDA via openFDA; CBER approved cellular and gene therapy products)",
      "url": "https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22tirzepatide%22+OR+openfda.brand_name:%22tirzepatide%22+OR+products.brand_name:%22tirzepatide%22+OR+products.active_ingredients.name:%22tirzepatide%22&limit=20",
      "qualifying": "earliest ORIG approval NDA215866 MOUNJARO 20220513; NDA215866 MOUNJARO, NDA217806 ZEPBOUND (\"tirzepatide\": 2 application(s); \"Mounjaro\": 1 application(s); \"Zepbound\": 1 application(s))"
    },
    {
      "agent": "tirzepatide",
      "set": "indication",
      "market": "EU",
      "status": "approved",
      "approvedOn": "2022-09-15",
      "recordAsOf": "2026-10-05",
      "regulator": "EMA / European Commission (EMA medicines dataset)",
      "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/mounjaro",
      "qualifying": "Mounjaro (tirzepatide): \"Authorised\" 15/09/2022"
    },
    {
      "agent": "semaglutide",
      "set": "indication",
      "market": "Saudi Arabia",
      "status": "approved",
      "approvedOn": "2026-02-01",
      "recordAsOf": "2026-02-02",
      "regulator": "Saudi Food and Drug Authority (New SFDA Drug Approvals list)",
      "url": "https://www.sfda.gov.sa/en/new-sfda-drug-approvals",
      "qualifying": "Approved: a product naming semaglutide / Ozempic / Wegovy / Rybelsus is on the list; the date is the earliest approval on the list, and registrations before its window are not shown.  | New Registration | Generic (Multisource) Drug | Glucentra | Semaglutide | 1.34 mg/ml | Solution for injection in pre-filled pen | 2026-02-01 | SFDA Approved Use |  ¦  | New Registration | Generic(Multisource) Drug | Tasylev | semaglutide | 0.25 mg | Solution for injection in pre-filled pen | SFDA Approved Use |  (462 rows on 47 pages, approval dates 2025-02-01 to 2026-02-02)"
    },
    {
      "agent": "semaglutide",
      "set": "indication",
      "market": "US",
      "status": "approved",
      "approvedOn": "2017-12-05",
      "recordAsOf": "2026-10-02",
      "regulator": "FDA (Drugs@FDA via openFDA; CBER approved cellular and gene therapy products)",
      "url": "https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22semaglutide%22+OR+openfda.brand_name:%22semaglutide%22+OR+products.brand_name:%22semaglutide%22+OR+products.active_ingredients.name:%22semaglutide%22&limit=20",
      "qualifying": "earliest ORIG approval NDA209637 OZEMPIC 20171205; NDA209637 OZEMPIC, NDA213051 OZEMPIC, NDA213182 RYBELSUS, NDA215256 WEGOVY, NDA218316 WEGOVY (\"semaglutide\": 6 application(s); \"Ozempic\": 2 application(s); \"Wegovy\": 2 application(s); \"Rybelsus\": 2 application(s))"
    },
    {
      "agent": "semaglutide",
      "set": "indication",
      "market": "EU",
      "status": "approved",
      "approvedOn": "2018-02-08",
      "recordAsOf": "2026-10-05",
      "regulator": "EMA / European Commission (EMA medicines dataset)",
      "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ozempic",
      "qualifying": "Wegovy (semaglutide): \"Authorised\" 06/01/2022; Ozempic (semaglutide): \"Authorised\" 08/02/2018; Rybelsus (semaglutide): \"Authorised\" 03/04/2020; Kayshild (semaglutide): \"Authorised\" 26/03/2026; Kyinsu (insulin icodec;semaglutide): \"Authorised\" 24/11/2025"
    },
    {
      "agent": "bcg",
      "set": "indication",
      "market": "Saudi Arabia",
      "status": "not-established",
      "approvedOn": null,
      "recordAsOf": "2026-02-02",
      "regulator": "Saudi Food and Drug Authority (New SFDA Drug Approvals list)",
      "url": "https://www.sfda.gov.sa/en/new-sfda-drug-approvals",
      "qualifying": "No row naming BCG / Bacillus Calmette among 462 rows on 47 pages, approval dates 2025-02-01 to 2026-02-02. The list covers only that approval window, so absence from it does not show non-registration. The SFDA drugs-list search (https://www.sfda.gov.sa/en/drugs-list) is a POST form behind reCAPTCHA and was not submitted; the Saudi Drug Information site (sdi.sfda.gov.sa) did not complete a TLS handshake from this network."
    },
    {
      "agent": "bcg",
      "set": "indication",
      "market": "US",
      "status": "approved",
      "approvedOn": null,
      "recordAsOf": "2026-10-02",
      "regulator": "FDA CBER (licensed biologic product page)",
      "url": "https://www.fda.gov/vaccines-blood-biologics/vaccines/tice-bcg",
      "qualifying": "Licensed by CBER: https://www.fda.gov/vaccines-blood-biologics/vaccines/tice-bcg (STN 102821); https://www.fda.gov/vaccines-blood-biologics/vaccines/bcg-vaccine (STN 103050). Original licence date not printed on the page. Drugs@FDA: \"BCG\": NOT_FOUND; \"Bacillus Calmette\": NOT_FOUND."
    },
    {
      "agent": "bcg",
      "set": "indication",
      "market": "EU",
      "status": "not-established",
      "approvedOn": null,
      "recordAsOf": "2026-10-05",
      "regulator": "EMA / European Commission (EMA medicines dataset)",
      "url": "https://www.ema.europa.eu/en/documents/report/medicines-output-medicines_json-report_en.json",
      "qualifying": "No centrally authorised human medicine whose name, INN or active substance contains BCG / Bacillus Calmette among 2746 records (dataset timestamp 2026-10-05T06:02:03Z). National authorisations are outside the dataset and were not checked country by country."
    },
    {
      "agent": "fenofibrate",
      "set": "indication",
      "market": "Saudi Arabia",
      "status": "not-established",
      "approvedOn": null,
      "recordAsOf": "2026-02-02",
      "regulator": "Saudi Food and Drug Authority (New SFDA Drug Approvals list)",
      "url": "https://www.sfda.gov.sa/en/new-sfda-drug-approvals",
      "qualifying": "No row naming fenofibrate / fenofibric acid among 462 rows on 47 pages, approval dates 2025-02-01 to 2026-02-02. The list covers only that approval window, so absence from it does not show non-registration. The SFDA drugs-list search (https://www.sfda.gov.sa/en/drugs-list) is a POST form behind reCAPTCHA and was not submitted; the Saudi Drug Information site (sdi.sfda.gov.sa) did not complete a TLS handshake from this network."
    },
    {
      "agent": "fenofibrate",
      "set": "indication",
      "market": "US",
      "status": "approved",
      "approvedOn": "1993-12-31",
      "recordAsOf": "2026-10-02",
      "regulator": "FDA (Drugs@FDA via openFDA; CBER approved cellular and gene therapy products)",
      "url": "https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22fenofibrate%22+OR+openfda.brand_name:%22fenofibrate%22+OR+products.brand_name:%22fenofibrate%22+OR+products.active_ingredients.name:%22fenofibrate%22&limit=20",
      "qualifying": "earliest ORIG approval NDA019304 TRICOR (MICRONIZED) 19931231; NDA019304 TRICOR (MICRONIZED), NDA021203 TRICOR, ANDA075868 FENOFIBRATE (MICRONIZED), ANDA076433 FENOFIBRATE, ANDA076635 FENOFIBRATE, NDA022224 TRILIPIX (\"fenofibrate\": 20 application(s); \"fenofibric acid\": 13 application(s))"
    },
    {
      "agent": "fenofibrate",
      "set": "indication",
      "market": "EU",
      "status": "approved",
      "approvedOn": "2011-04-14",
      "recordAsOf": "2026-10-05",
      "regulator": "EMA / European Commission (EMA medicines dataset)",
      "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/pravafenix",
      "qualifying": "Cholib (fenofibrate;simvastatin): \"Authorised\" 26/08/2013; Pravafenix (fenofibrate;pravastatin): \"Authorised\" 14/04/2011"
    }
  ]
}