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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29 | Imipramine hydrochloride | TEVA PHARMACEUTICAL INDUSTRIES LTD Tel Aviv - Jaffa IL | 100000702;100060842 | CEP 2002-051 - Rev 04 | 2024/01/30 | Valid | Chemical | 2024/01/30 | Minor revision|CEP granted|30/01/2024; Minor revision|CEP granted|24/02/2022; Notification|Accepted - CEP remains valid|14/12/2020 |
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2232 | Losartan potassium | SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN | 100008538;100018201 | CEP 2010-255 - Rev 04 | 2024/01/30 | Valid | Chemical | 2024/01/30 | Minor revision|CEP granted|30/01/2024; Monograph revision|CEP granted|22/06/2023 |
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2531 | Clopidogrel hydrogen sulfate | ZENJI PHARMACEUTICALS SUZHOU LTD. Xuguan, Suzhou CN | 100039179;100061666 | CEP 2021-230 - Rev 00 | 2024/01/30 | Valid | 30/01/2029 | Chemical | 2024/01/30 | New application|CEP granted|30/01/2024 | |
2815 | Entecavir monohydrate | SCINOPHARM TAIWAN, LTD. Shan-Hua TW | 100012108;100019515 | CEP 2017-001 - Rev 01 | 2024/01/30 | Valid | Chemical | 2024/01/30 | Renewal|CEP granted|30/01/2024 | ||
1756 | Lamotrigine | ZYDUS LIFESCIENCES LIMITED Vadodara IN | 100005979;100074301 | CEP 2018-295 - Rev 03 | 2024/01/30 | Valid | 17/03/2026 | Chemical | 2024/01/30 | Minor revision|CEP granted|30/01/2024; Minor revision|Accepted - CEP remains valid|24/04/2023; Minor revision|CEP granted|02/12/2022; Notification|CEP granted|08/07/2022 |
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2230 | Latanoprost | KYOWA PHARMA CHEMICAL CO., LTD. Takaoka JP | 100012459;100023014 | CEP 2022-107 - Rev 01 | 2024/01/29 | Valid | 23/11/2028 | Chemical | 2024/11/26 | Minor revision|Accepted - CEP remains valid|26/11/2024; Administrative procedure|CEP granted|29/01/2024; New application|CEP granted|23/11/2023 |
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2119 | Venlafaxine hydrochloride | ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN | 100006039;100002980 | CEP 2006-225 - Rev 05 | 2024/01/29 | Valid | Chemical | 2024/08/22 | Minor revision|Accepted - CEP remains valid|22/08/2024; Minor revision|CEP granted|29/01/2024; Minor revision|Accepted - CEP remains valid|19/06/2020 |
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57 | Tetracaine hydrochloride | SIEGFRIED EVIONNAZ SA Evionnaz CH | 100011796;100019013 | CEP 2017-205 - Rev 01 | 2024/01/29 | Valid | Chemical | 2024/01/29 | Renewal|CEP granted|29/01/2024; Monograph revision|Accepted - CEP remains valid|21/03/2022 |
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2535 | Levetiracetam, Process II | SHAOXING JINGXIN PHARMACEUTICAL CO., LTD. Shangyu CN | 100023303;100032437 | CEP 2021-267 - Rev 01 | 2024/01/29 | Valid | 29/10/2026 | Chemical | 2024/10/10 | Minor revision|Accepted - CEP remains valid|10/10/2024; Notification|CEP granted|29/01/2024; Minor revision|Accepted - CEP remains valid|08/06/2022; New application|CEP granted|29/10/2021 |
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2585 | Rizatriptan benzoate | EMCURE PHARMACEUTICALS LIMITED Pune IN | 100011677;100022645 | CEP 2019-095 - Rev 01 | 2024/01/29 | Valid | 18/02/2026 | Chemical | 2024/01/29 | Minor revision|CEP granted|29/01/2024 | |
750 | Glutamic Acid | EVONIK REXIM S.A.S. Ham FR | 100012329;100020964 | CEP 2009-311 - Rev 01 | 2024/01/29 | Valid | Chemical | 2024/01/29 | Minor revision|CEP granted|29/01/2024 | ||
1563 | Simvastatin | SHAOXING JINGXIN PHARMACEUTICAL CO., LTD. Shangyu CN | 100023303;100032437 | CEP 2005-300 - Rev 06 | 2024/01/26 | Valid | Chemical and TSE | 2024/04/23 | Minor revision|Rejected|23/04/2024; Notification|CEP granted|26/01/2024; Minor revision|Accepted - CEP remains valid|28/10/2022; Minor revision|CEP granted|18/06/2021 |
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2535 | Levetiracetam | SHAOXING JINGXIN PHARMACEUTICAL CO., LTD. Shangyu CN | 100023303;100032437 | CEP 2014-139 - Rev 01 | 2024/01/26 | Valid | Chemical | 2024/01/26 | Notification|CEP granted|26/01/2024; Minor revision|Accepted - CEP remains valid|04/04/2022; Renewal|CEP granted|27/01/2021 |
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1563 | Simvastatin | BIOCON LIMITED Bengaluru IN | 100011487;100018595 | CEP 2012-337 - Rev 03 | 2024/01/26 | Valid | Chemical | 2024/01/26 | Notification|CEP granted|26/01/2024; Minor revision|Accepted - CEP remains valid|16/03/2023; Minor revision|CEP granted|04/06/2020 |
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2631 | Rosuvastatin calcium | SHAOXING JINGXIN PHARMACEUTICAL CO., LTD. Shangyu CN | 100023303;100032437 | CEP 2019-309 - Rev 02 | 2024/01/26 | Valid | 15/01/2026 | Chemical | 2024/03/14 | Minor revision|Accepted - CEP remains valid|14/03/2024; Notification|CEP granted|26/01/2024; Minor revision|CEP granted|26/10/2023; Minor revision|Accepted - CEP remains valid|03/10/2022 |
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2598 | Levofloxacin hemihydrate | SHAOXING JINGXIN PHARMACEUTICAL CO., LTD. Shangyu CN | 100023303;100032437 | CEP 2020-041 - Rev 02 | 2024/01/26 | Valid | 16/06/2026 | Chemical | 2024/04/24 | Minor revision|Accepted - CEP remains valid|24/04/2024; Notification|CEP granted|26/01/2024; Minor revision|CEP granted|04/10/2023; New application|CEP granted|16/06/2021 |
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3087 | Ticagrelor | SHAOXING JINGXIN PHARMACEUTICAL CO., LTD. Shangyu CN | 100023303;100032437 | CEP 2022-187 - Rev 01 | 2024/01/26 | Valid | 09/06/2028 | Chemical | 2024/07/29 | Minor revision|Accepted - CEP remains valid|29/07/2024; Notification|CEP granted|26/01/2024; New application|CEP granted|09/06/2023 |
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673 | Medroxyprogesterone acetate | CURIA SPAIN S.A.U. Boecillo ES | 100011649;100019586 | CEP 2022-311 - Rev 00 | 2024/01/26 | Valid | 26/01/2029 | Chemical | 2024/01/26 | New application|CEP granted|26/01/2024 | |
1002 | Diclofenac sodium | AARTI DRUGS LIMITED Mumbai IN | 100014953;100023652 | CEP 2021-246 - Rev 00 | 2024/01/26 | Valid | 26/01/2029 | Chemical | 2024/01/26 | New application|CEP granted|26/01/2024 | |
141 | Ethionamide | Pen Tsao Chemical Industry Ltd Hong Kong SAR CN | 100024181;100088240 | CEP 2021-172 - Rev 00 | 2024/01/26 | Valid | 26/01/2029 | Chemical | 2024/01/26 | New application|CEP granted|26/01/2024 |