专论编号 | 物质名称 | 证书持有人 | 持有人ORG-ID和LOC-ID | 证书编号 | 发布日期 | 证书状态 | 到期续期 | 证书结束日期 | 证书类型 | 上一程序的结束日期 | 历史数据 程序类型|结论|日期 |
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823 | Etoposide | MAC CHEM PRODUCTS (INDIA) PVT. LTD. Mumbai IN | 100023737;100061579 | CEP 2020-074 - Rev 01 | 2024/04/30 | Valid | 25/07/2027 | Chemical | 2024/04/30 | Administrative procedure|CEP granted|30/04/2024; New application|CEP granted|25/07/2022 |
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2787 | Esomeprazole magnesium dihydrate, Micronised | KRKA, d.d., Novo mesto Novo mesto SI | 100000627;100009540 | CEP 2018-035 - Rev 03 | 2024/04/30 | Valid | Chemical | 2024/04/30 | Renewal|CEP granted|30/04/2024; Notification|CEP granted|05/01/2023; Notification|CEP granted|26/01/2022; Minor revision|Accepted - CEP remains valid|15/12/2020 |
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2465 | Irbesartan | ZHEJIANG TIANYU PHARMACEUTICAL CO., LTD. Taizhou City CN | 100012174;100018701 | CEP 2012-233 - Rev 03 | 2024/04/30 | Valid | Chemical | 2024/04/30 | Minor revision|CEP granted|30/04/2024; Minor revision|Accepted - CEP remains valid|01/09/2023; Notification|Accepted - CEP remains valid|12/05/2023; Minor revision|Accepted - CEP remains valid|03/06/2022; Minor revision|CEP granted|23/07/2021; Minor revision|Accepted - CEP remains valid|21/07/2020 |
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809 | Betamethasone dipropionate | TIANJIN TIANYAO PHARMACEUTICALS CO., LTD. Tianjin CN | 100011805;100018616 | CEP 2022-342 - Rev 00 | 2024/04/30 | Valid | 30/04/2029 | Chemical | 2024/04/30 | New application|CEP granted|30/04/2024 | |
2536 | Milbemycin oxime for veterinary use | Zhejiang Hisun Pharmaceutical Co., Ltd. Taizhou City CN | 100011825;100018687 | CEP 2021-391 - Rev 02 | 2024/04/30 | Valid | 26/07/2028 | Chemical | 2024/04/30 | Administrative procedure|CEP granted|30/04/2024; Minor revision|CEP granted|20/11/2023; New application|CEP granted|26/07/2023 |
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2125 | Doxazosin mesilate, Form-I | Chemische Fabrik Berg GmbH Bitterfeld-Wolfen DE | 100014200;100020038 | CEP 2022-316 - Rev 00 | 2024/04/29 | Valid | 29/04/2029 | Chemical | 2024/04/29 | New application|CEP granted|29/04/2024 | |
2923 | Esomeprazole sodium | SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN | 100008538;100018201 | CEP 2020-393 - Rev 01 | 2024/04/29 | Valid | 24/11/2027 | Chemical | 2024/04/29 | Minor revision|CEP granted|29/04/2024; Minor revision|Accepted - CEP remains valid|28/08/2023; New application|CEP granted|24/11/2022 |
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1120 | Lisinopril dihydrate, Process II | HETERO DRUGS LIMITED Hyderabad IN | 100008415;100014434 | CEP 2016-197 - Rev 01 | 2024/04/29 | Valid | Chemical | 2024/04/29 | Minor revision|CEP granted|29/04/2024; Minor revision|Accepted - CEP remains valid|09/06/2023; Renewal|CEP granted|28/04/2022; Minor revision|CEP granted|22/10/2020 |
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2866 | Gefitinib | SHANDONG ANHONG PHARMACEUTICAL CO., LTD. Dezhou City CN | 100014777;100050265 | CEP 2017-028 - Rev 01 | 2024/04/29 | Valid | Chemical | 2024/04/29 | Minor revision|CEP granted|29/04/2024; Renewal|CEP granted|22/03/2023; Notification|CEP granted|07/02/2020 |
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1695 | Granisetron hydrochloride | WAVELENGTH ENTERPRISES LTD. Petah Tikva IL | 100018877;100050444 | CEP 2007-217 - Rev 04 | 2024/04/29 | Valid | Chemical | 2024/04/29 | Minor revision|CEP granted|29/04/2024; Minor revision|Accepted - CEP remains valid|23/02/2023; Notification|Accepted - CEP remains valid|14/06/2022; Minor revision|CEP granted|30/03/2021 |
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1882 | Passionflower herb dry extract, DER: 4-6.5:1 | EUROMED S.A. Mollet del Vallès ES | 100014852;100023498 | CEP 2015-351 - Rev 01 | 2024/04/29 | Valid | Herbal | 2024/04/29 | Monograph revision|CEP granted|29/04/2024; Renewal|CEP granted|17/08/2021; Monograph revision|CEP granted|24/02/2021 |
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633 | Pilocarpine hydrochloride | SPERA NEXUS, INC. Shizuoka JP | 100045481;100074964 | CEP 2015-343 - Rev 02 | 2024/04/29 | Valid | Chemical | 2024/04/29 | Renewal|CEP granted|29/04/2024; Notification|CEP granted|06/08/2021 |
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2135 | Repaglinide | ZHEJIANG HISOAR CHUANNAN PHARMACEUTICAL CO., LTD. Taizhou City CN | 100039329;100061908 | CEP 2008-201 - Rev 06 | 2024/04/29 | Valid | Chemical | 2024/04/29 | Notification|CEP granted|29/04/2024; Minor revision|CEP granted|12/03/2024; Notification|CEP granted|25/01/2022; Major revision|CEP granted|15/12/2021 |
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1655 | Mitomycin | HUBEI HONCH PHARMACEUTICAL CO., LTD. Huanggang CN | 100036821;100058182 | CEP 2022-400 - Rev 01 | 2024/04/26 | Valid | 17/04/2029 | Chemical | 2024/04/26 | Notification|CEP granted|26/04/2024; New application|CEP granted|17/04/2024 |
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1120 | Lisinopril dihydrate, Process-III | HETERO DRUGS LIMITED Hyderabad IN | 100008415;100014434 | CEP 2022-434 - Rev 01 | 2024/04/26 | Valid | 04/05/2028 | Chemical | 2024/04/26 | Minor revision|CEP granted|26/04/2024; New application|CEP granted|04/05/2023 |
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2191 | Atorvastatin calcium, Form-I | HETERO LABS LIMITED Hyderabad IN | 100011681;100018664 | CEP 2018-049 - Rev 02 | 2024/04/26 | Valid | 02/04/2025 | Chemical | 2024/04/26 | Major revision|CEP granted|26/04/2024; Monograph revision|CEP granted|24/03/2023; Major revision|Rejected|28/03/2022 |
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2357 | Dydrogesterone, Micronised | ABBOTT HEALTHCARE PRODUCTS B.V. Weesp NL | 100002995;100005756 | CEP 2019-114 - Rev 01 | 2024/04/26 | Valid | 17/06/2026 | Chemical | 2024/04/26 | Minor revision|CEP granted|26/04/2024; Notification|Accepted - CEP remains valid|14/06/2023; Notification|Accepted - CEP remains valid|04/04/2023; Monograph revision|Accepted - CEP remains valid|01/07/2022 |
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2780 | Temozolomide | FORMOSA LABORATORIES, INC. Taoyuan TW | 100011879;100018688 | CEP 2017-245 - Rev 01 | 2024/04/26 | Valid | Chemical | 2024/04/26 | Renewal|CEP granted|26/04/2024; Notification|Accepted - CEP remains valid|07/07/2022 |
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1244 | Morphine hemisulfate 2.5-hydrate | FRANCOPIA Paris FR | 100041331;100069306 | CEP 2000-126 - Rev 07 | 2024/04/26 | Valid | Chemical | 2024/04/26 | Monograph revision|CEP granted|26/04/2024; Notification|CEP granted|01/03/2024; Notification|CEP granted|02/05/2022; Notification|Accepted - CEP remains valid|20/02/2020 |
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991 | Ceftriaxone sodium, Sterile | ACS DOBFAR S.P.A. Tribiano IT | 100011589;100019524 | CEP 2011-393 - Rev 03 | 2024/04/26 | Valid | Chemical | 2024/04/26 | Major revision|CEP granted|26/04/2024; Administrative procedure|CEP granted|03/03/2022; Major revision|CEP granted|22/02/2022 |