| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 757 | Clotrimazole | OLON S.P.A. Rodano IT | 100012085;100019537 | CEP 2004-102 - Rev 06 | 2025/03/24 | Valid | Chemical | 2025/03/24 | Minor revision|CEP granted|24/03/2025; Minor revision|Accepted - CEP remains valid|22/05/2023; Minor revision|Accepted - CEP remains valid|10/09/2021; Minor revision|CEP granted|01/12/2020; Minor revision|CEP granted|29/09/2020 |
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| 2574 | Entacapone, Form-A | HETERO LABS LIMITED Hyderabad IN | 100011681;100018664 | CEP 2012-314 - Rev 01 | 2025/03/24 | Valid | Chemical | 2025/03/24 | Minor revision|CEP granted|24/03/2025; Minor revision|Accepted - CEP remains valid|22/08/2022; Minor revision|Accepted - CEP remains valid|13/03/2020 |
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| 823 | Etoposide | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 1999-144 - Rev 08 | 2025/03/24 | Valid | Chemical | 2025/03/24 | Minor revision|CEP granted|24/03/2025; Minor revision|Accepted - CEP remains valid|04/03/2024; Notification|CEP granted|04/01/2022; Minor revision|CEP granted|29/06/2020 |
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| 1589 | Doxylamine hydrogen succinate | R L FINE CHEM PVT. LTD. Gowribidanur IN | 100016723;100053383 | CEP 2018-041 - Rev 03 | 2025/03/24 | Valid | Chemical | 2025/03/24 | Renewal|CEP granted|24/03/2025; Minor revision|CEP granted|01/03/2024; Minor revision|CEP granted|10/05/2021 |
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| 1449 | Mometasone furoate, Micronised, alternative process | FARMABIOS S.p.A Gropello Cairoli IT | 100011643;100021232 | CEP 2018-297 - Rev 04 | 2025/03/24 | Valid | Chemical | 2025/03/24 | Minor revision|CEP granted|24/03/2025; Renewal|CEP granted|05/03/2025; Major revision|CEP granted|06/10/2023; Administrative procedure|CEP granted|07/09/2020 |
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| 2119 | Venlafaxine hydrochloride, Laurus site, Form I | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2024-557 - Rev 00 | 2025/03/24 | Valid | 24/03/2030 | Chemical | 2025/03/24 | New application|CEP granted|24/03/2025 | |
| 1734 | Terbinafine hydrochloride, Type 2 | OLON S.P.A. Rodano IT | 100012085;100019537 | CEP 2021-256 - Rev 02 | 2025/03/24 | Valid | 07/02/2027 | Chemical | 2025/03/24 | Minor revision|CEP granted|24/03/2025; Minor revision|CEP granted|22/08/2023; New application|CEP granted|07/02/2022 |
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| 1563 | Simvastatin | ZHEJIANG JIANGBEI NANHAI PHARMACEUTICAL CO., LTD Linhai City CN | 100049395;100084081 | CEP 2022-245 - Rev 02 | 2025/03/24 | Valid | 17/05/2028 | Chemical | 2025/03/24 | Minor revision|CEP granted|24/03/2025; Minor revision|CEP granted|03/07/2024; New application|CEP granted|17/05/2023 |
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| 2825 | Tigecycline | MELODY HEALTHCARE PVT. LTD. Mumbai IN | 100014822;100073679 | CEP 2018-056 - Rev 04 | 2025/03/24 | Valid | Chemical | 2025/03/24 | Renewal|CEP granted|24/03/2025; Minor revision|CEP granted|23/07/2024; Minor revision|CEP granted|12/03/2024; Minor revision|CEP granted|10/10/2023; Monograph revision|Accepted - CEP remains valid|07/03/2022; Minor revision|Accepted - CEP remains valid|01/12/2021 |
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| 1208 | Fenbendazole for veterinary use | SEQUENT SCIENTIFIC LIMITED Mumbai IN | 100017805;100032372 | CEP 2004-212 - Rev 05 | 2025/03/21 | Valid | Chemical | 2025/06/19 | Minor revision|Accepted - CEP remains valid|19/06/2025; Minor revision|CEP granted|21/03/2025; Minor revision|Accepted - CEP remains valid|22/08/2024; Monograph revision|Accepted - CEP remains valid|13/06/2024; Notification|CEP granted|30/03/2023; Minor revision|Rejected|30/07/2021 |
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| 320 | Colistin sulfate | LIVZON GROUP FUZHOU FUXING PHARMACEUTICAL CO., LTD. Fuzhou CN | 100020920;100029633 | CEP 2011-372 - Rev 04 | 2025/03/21 | Valid | Chemical | 2025/03/21 | Minor revision|CEP granted|21/03/2025; Minor revision|CEP granted|03/11/2022; Notification|Rejected|21/09/2022; Minor revision|CEP granted|28/09/2021 |
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| 2616 | Topiramate | APITORIA PHARMA PRIVATE LIMITED Hyderabad IN | 100049668;100086364 | CEP 2020-140 - Rev 04 | 2025/03/21 | Valid | 14/06/2027 | Chemical | 2025/03/21 | Minor revision|CEP granted|21/03/2025; Notification|CEP granted|18/12/2023; Minor revision|CEP granted|28/02/2023; Minor revision|CEP granted|15/09/2022; New application|CEP granted|14/06/2022 |
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| 653 | Baclofen | BIOINDUSTRIA L.I.M. S.P.A. Novi Ligure IT | 100001870;100092872 | CEP 2011-360 - Rev 02 | 2025/03/21 | Valid | Chemical | 2025/03/21 | Monograph revision|CEP granted|21/03/2025; Minor revision|CEP granted|09/09/2020 |
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| 2270 | Sildenafil citrate | AMOLI ORGANICS PRIVATE LIMITED Mumbai IN | 100016500;100025303 | CEP 2014-223 - Rev 02 | 2025/03/21 | Valid | Chemical | 2025/03/21 | Major revision|CEP granted|21/03/2025; Minor revision|Accepted - CEP remains valid|02/08/2023; Minor revision|Accepted - CEP remains valid|09/03/2023; Minor revision|Accepted - CEP remains valid|24/01/2022; Major revision|CEP granted|04/02/2021; Renewal|CEP granted|29/09/2020 |
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| 3115 | Levocetirizine dihydrochloride | GLOCHEM INDUSTRIES PRIVATE LIMITED Hyderabad IN | 100012012;100020318 | CEP 2024-049 - Rev 00 | 2025/03/21 | Valid | 21/03/2030 | Chemical | 2025/03/21 | New application|CEP granted|21/03/2025 | |
| 1508 | Diclofenac potassium | OLON S.P.A. Rodano IT | 100012085;100019537 | CEP 2010-286 - Rev 05 | 2025/03/21 | Valid | Chemical | 2025/03/21 | Minor revision|CEP granted|21/03/2025; Minor revision|CEP granted|24/03/2022 |
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| 1081 | Carboplatin | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2000-375 - Rev 05 | 2025/03/21 | Valid | Chemical | 2025/03/21 | Minor revision|CEP granted|21/03/2025; Minor revision|CEP granted|13/04/2022 |
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| 663 | Dicloxacillin sodium monohydrate, Powder and compacted | FRESENIUS KABI IPSUM S.R.L. Cassina de’ Pecchi IT | 100015105;100057989 | CEP 2002-036 - Rev 09 | 2025/03/21 | Valid | Chemical | 2025/03/21 | Administrative procedure|CEP granted|21/03/2025; Notification|CEP granted|14/03/2025; Minor revision|CEP granted|16/08/2021; Notification|CEP granted|02/02/2021 |
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| 15 | Calcium chloride dihydrate | CFL CHEMISCHE FABRIK LEHRTE GMBH & CO. KG Lehrte DE | 100021016;100029727 | CEP 2015-352 - Rev 02 | 2025/03/21 | Valid | Chemical | 2025/03/21 | Notification|CEP granted|21/03/2025; Minor revision|CEP granted|16/01/2024; Renewal|CEP granted|01/03/2022; Notification|Accepted - CEP remains valid|09/09/2021 |
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| 1756 | Lamotrigine | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2011-178 - Rev 04 | 2025/03/21 | Valid | Chemical | 2025/03/21 | Minor revision|CEP granted|21/03/2025; Minor revision|CEP granted|18/09/2023; Notification|CEP granted|20/12/2021; Notification|CEP granted|20/05/2021 |
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