| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2570 | Desloratadine | HETERO LABS LIMITED Hyderabad IN | 100011681;100018664 | CEP 2016-065 - Rev 02 | 2026/04/30 | Valid | Chemical | 2026/04/30 | Minor revision|CEP granted|30/04/2026; Minor revision|CEP granted|20/03/2024; Renewal|CEP granted|20/06/2022 |
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| 668 | Flucloxacillin sodium monohydrate, Sterile | FRESENIUS KABI IPSUM S.R.L. Cassina de' Pecchi IT | 100015105;100057989 | CEP 1996-093 - Rev 07 | 2026/04/30 | Valid | Chemical | 2026/04/30 | Minor revision|CEP granted|30/04/2026; Monograph revision|CEP granted|20/05/2022; Major revision|CEP granted|16/06/2021; Notification|CEP granted|02/02/2021 |
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| 2416 | Pramipexole dihydrochloride monohydrate | ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN | 100006039;100002980 | CEP 2011-190 - Rev 01 | 2026/04/30 | Valid | Chemical | 2026/04/30 | Minor revision|CEP granted|30/04/2026; Minor revision|Accepted - CEP remains valid|27/09/2024; Minor revision|Accepted - CEP remains valid|26/01/2024; Minor revision|Accepted - CEP remains valid|03/01/2023; Minor revision|Accepted - CEP remains valid|12/07/2022 |
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| 2815 | Entecavir monohydrate | HETERO DRUGS LIMITED Hyderabad IN | 100008415;100014434 | CEP 2017-271 - Rev 06 | 2026/04/30 | Valid | Chemical | 2026/04/30 | Minor revision|CEP granted|30/04/2026; Notification|CEP granted|19/05/2025; Renewal|CEP granted|10/06/2024; Minor revision|CEP granted|28/07/2023; Minor revision|CEP granted|22/09/2020 |
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| 2600 | Olmesartan medoxomil | CHIERON ACTIVE INGREDIENTS PRIVATE LIMITED Hyderabad IN | 100053345;100094249 | CEP 2018-232 - Rev 03 | 2026/04/30 | Valid | Chemical | 2026/04/30 | Major revision|CEP granted|30/04/2026; Renewal|CEP granted|11/07/2025; Minor revision|Accepted - CEP remains valid|20/09/2022; Major revision|CEP granted|08/07/2021; Minor revision|Rejected|22/02/2021 |
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| 1773 | Cabergoline | LIFECARE LABORATORIES PRIVATE LIMITED Hyderabad IN | 100049798;100086853 | CEP 2023-093 - Rev 01 | 2026/04/30 | Valid | 12/03/2031 | Chemical | 2026/04/30 | Minor revision|CEP granted|30/04/2026; New application|CEP granted|12/03/2026 |
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| 943 | Oxymetazoline hydrochloride | COHANCE LIFESCIENCES LIMITED Mumbai IN | 100011755;100090273 | CEP 2025-091 - Rev 00 | 2026/04/30 | Valid | 30/04/2031 | Chemical | 2026/04/30 | New application|CEP granted|30/04/2026 | |
| 1974 | Clobazam, Micronised | LAKE CHEMICALS PRIVATE LIMITED Bengaluru IN | 100012055;100053935 | CEP 2024-173 - Rev 00 | 2026/04/30 | Valid | 30/04/2031 | Chemical | 2026/04/30 | New application|CEP granted|30/04/2026 | |
| 429 | Progesterone, Micronised, non-micronised | ZHEJIANG SHENZHOU PHARMACEUTICAL CO., LTD. Taizhou CN | 100011902;100052470 | CEP 2012-412 - Rev 01 | 2026/04/29 | Valid | Chemical | 2026/04/29 | Minor revision|CEP granted|29/04/2026 | ||
| 875 | Tranexamic acid | JIANGSU TIANHE PHARMACEUTICAL CO., LTD. Yangzhou CN | 100041985;100069208 | CEP 2023-449 - Rev 00 | 2026/04/29 | Valid | 29/04/2031 | Chemical | 2026/04/29 | New application|CEP granted|29/04/2026 | |
| 2773 | Memantine hydrochloride | KRKA TOVARNA ZDRAVIL D.D. NOVO MESTO Novo mesto SI | 100000627;100009540 | CEP 2025-376 - Rev 00 | 2026/04/29 | Valid | 29/04/2031 | Chemical | 2026/04/29 | New application|CEP granted|29/04/2026 | |
| 923 | Labetalol Hydrochloride | OLON S.P.A. Rodano IT | 100012085;100019537 | CEP 2004-289 - Rev 06 | 2026/04/29 | Valid | Chemical | 2026/04/29 | Minor revision|CEP granted|29/04/2026; Minor revision|CEP granted|11/03/2022; Notification|Accepted - CEP remains valid|24/08/2020; Major revision|CEP granted|02/07/2020 |
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| 2176 | Febantel for veterinary use | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy IN | 100051463;100098142 | CEP 2006-260 - Rev 07 | 2026/04/29 | Valid | Chemical | 2026/04/29 | Notification|CEP granted|29/04/2026; Notification|CEP granted|17/09/2025; Notification|CEP granted|22/07/2024; Notification|CEP granted|01/09/2021 |
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| 735 | Prednisolone sodium phosphate | HENAN LIHUA PHARMACEUTICAL CO., LTD. Anyang CN | 100016183;100024971 | CEP 2016-329 - Rev 01 | 2026/04/29 | Valid | Chemical | 2026/04/29 | Notification|CEP granted|29/04/2026; Minor revision|Accepted - CEP remains valid|30/07/2024; Renewal|CEP granted|13/07/2023 |
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| 968 | Aciclovir | HUBEI YITAI PHARMACEUTICAL CO., LTD. Tianmen CN | 100039319;100061892 | CEP 2019-238 - Rev 02 | 2026/04/29 | Valid | Chemical | 2026/04/29 | Renewal|CEP granted|29/04/2026; Minor revision|CEP granted|31/05/2022 |
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| 780 | Oxytocin | ASPEN OSS B.V. Oss NL | 100011619;100050602 | CEP 2000-150 - Rev 05 | 2026/04/29 | Valid | Chemical | 2026/04/29 | Administrative procedure|CEP granted|29/04/2026; Monograph revision|CEP granted|07/08/2023 |
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| 1696 | Flunixin meglumine for veterinary use | ALIVIRA ANIMAL HEALTH LIMITED Visakhapatnam IN | 100033528;100052489 | CEP 2013-017 - Rev 05 | 2026/04/28 | Valid | Chemical | 2026/04/28 | Notification|CEP granted|28/04/2026; Minor revision|Accepted - CEP remains valid|21/01/2025; Minor revision|Accepted - CEP remains valid|03/05/2024; Notification|CEP granted|30/03/2023; Minor revision|CEP granted|16/09/2022; Minor revision|Accepted - CEP remains valid|02/06/2021; Minor revision|CEP granted|09/10/2020 |
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| 1058 | Vancomycin hydrochloride | XELLIA PHARMACEUTICALS APS Copenhagen S DK | 100004144;100002734 | CEP 2007-195 - Rev 04 | 2026/04/28 | Valid | Chemical | 2026/04/28 | Minor revision|CEP granted|28/04/2026; Minor revision|CEP granted|03/04/2025; Minor revision|Accepted - CEP remains valid|14/03/2024; Notification|Accepted - CEP remains valid|09/02/2023; Minor revision|Accepted - CEP remains valid|16/02/2022; Notification|Accepted - CEP remains valid|15/12/2020 |
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| 2856 | Pirfenidone | SMS PHARMACEUTICALS LIMITED Hyderabad IN | 100011780;100061058 | CEP 2024-559 - Rev 00 | 2026/04/28 | Valid | 28/04/2031 | Chemical | 2026/04/28 | New application|CEP granted|28/04/2026 | |
| 1409 | Clenbuterol Hydrochloride | EDMOND PHARMA S.R.L. Paderno Dugnano IT | 100000246;100002746 | CEP 2012-073 - Rev 02 | 2026/04/28 | Valid | Chemical | 2026/04/28 | Monograph revision|CEP granted|28/04/2026 |
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