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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2103 | Propafenone hydrochloride | TIANISH LABORATORIES PRIVATE LIMITED Hyderabad IN | 100051463;100090213 | CEP 2008-100 - Rev 04 | 2024/07/11 | Valid | Chemical | 2024/07/11 | Notification|CEP granted|11/07/2024; Minor revision|Accepted - CEP remains valid|09/10/2020 |
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369 | Azathioprine | Zhejiang Cheng Yi Pharmaceutical Co., Ltd. Wenzhou CN | 100012163;100031415 | CEP 2006-197 - Rev 02 | 2024/07/11 | Valid | Chemical | 2024/07/11 | Minor revision|CEP granted|11/07/2024 | ||
2287 | Fluconazole | TIANISH LABORATORIES PRIVATE LIMITED Hyderabad IN | 100051463;100090213 | CEP 2007-256 - Rev 05 | 2024/07/11 | Valid | Chemical | 2024/07/11 | Notification|CEP granted|11/07/2024; Minor revision|Accepted - CEP remains valid|10/08/2023 |
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333 | Heparin sodium, For parenteral preparations | OPOCRIN SpA Corlo Di Formigine IT | 100008856;100018068 | CEP 2004-165 - Rev 05 | 2024/07/11 | Valid | Chemical | 2024/07/11 | Notification|CEP granted|11/07/2024; Notification|CEP granted|08/11/2021; Major revision|CEP granted|19/08/2020 |
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2124 | Loratadine | TIANISH LABORATORIES PRIVATE LIMITED Hyderabad IN | 100051463;100090213 | CEP 2007-171 - Rev 05 | 2024/07/11 | Valid | Chemical | 2024/07/11 | Notification|CEP granted|11/07/2024; Minor revision|CEP granted|07/03/2024; Minor revision|CEP granted|24/01/2023 |
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2570 | Desloratadine | TIANISH LABORATORIES PRIVATE LIMITED Hyderabad IN | 100051463;100090213 | CEP 2013-319 - Rev 02 | 2024/07/11 | Valid | Chemical | 2024/07/11 | Notification|CEP granted|11/07/2024; Minor revision|CEP granted|28/05/2021 |
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2601 | Pioglitazone hydrochloride | TIANISH LABORATORIES PRIVATE LIMITED Hyderabad IN | 100051463;100090213 | CEP 2012-315 - Rev 01 | 2024/07/11 | Valid | Chemical | 2024/07/11 | Notification|CEP granted|11/07/2024; Minor revision|Accepted - CEP remains valid|01/06/2021 |
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1241 | Mefloquine hydrochloride | OLON S.P.A. Rodano IT | 100012085;100019537 | CEP 2011-099 - Rev 04 | 2024/07/11 | Valid | Chemical | 2024/07/11 | Monograph revision|CEP granted|11/07/2024; Minor revision|Accepted - CEP remains valid|18/12/2023; Monograph revision|CEP granted|12/04/2023; Minor revision|Accepted - CEP remains valid|15/07/2022; Minor revision|CEP granted|30/03/2021 |
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2154 | Telmisartan | TIANISH LABORATORIES PRIVATE LIMITED Hyderabad IN | 100051463;100090213 | CEP 2008-256 - Rev 03 | 2024/07/11 | Valid | Chemical | 2024/07/11 | Notification|CEP granted|11/07/2024; Minor revision|CEP granted|04/10/2023 |
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675 | Metronidazole, Micronised | WUHAN WUYAO PHARMACEUTICAL CO., LTD. Huangshi City CN | 100022200;100030902 | CEP 2024-218 - Rev 00 | 2024/07/11 | Valid | 11/07/2029 | Chemical | 2024/07/11 | New application|CEP granted|11/07/2024 | |
848 | Sodium fusidate | JOYANG LABORATORIES Yancheng CN | 100033417;100052265 | CEP 2021-307 - Rev 01 | 2024/07/11 | Valid | 13/04/2028 | Chemical | 2024/07/11 | Minor revision|CEP granted|11/07/2024; Notification|Accepted - CEP remains valid|26/02/2024; New application|CEP granted|13/04/2023 |
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2932 | Rivaroxaban, Modification-I | TIANISH LABORATORIES PRIVATE LIMITED Hyderabad IN | 100051463;100090213 | CEP 2021-259 - Rev 02 | 2024/07/11 | Valid | 27/01/2028 | Chemical | 2024/07/11 | Notification|CEP granted|11/07/2024; Minor revision|CEP granted|18/12/2023; New application|CEP granted|27/01/2023 |
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2637 | Pemetrexed disodium heptahydrate | WUHAN CALMLAND PHARMACEUTICALS CO., LTD. Wuhan CN | 100049301;100083738 | CEP 2017-067 - Rev 02 | 2024/07/10 | Valid | Chemical | 2024/07/10 | Renewal|CEP granted|10/07/2024; Monograph revision|Accepted - CEP remains valid|02/10/2023; Notification|Accepted - CEP remains valid|25/03/2022; Notification|Rejected|11/02/2022; Minor revision|CEP granted|02/06/2021 |
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2235 | Methylphenidate hydrochloride | COHANCE LIFESCIENCES LIMITED Mumbai IN | 100011755;100090273 | CEP 2017-181 - Rev 01 | 2024/07/10 | Valid | Chemical | 2024/07/10 | Notification|CEP granted|10/07/2024; Minor revision|Accepted - CEP remains valid|23/06/2023; Notification|Rejected|05/04/2023; Renewal|CEP granted|12/01/2023; Minor revision|CEP granted|16/03/2021 |
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729 | Naloxone hydrochloride dihydrate | SIEGFRIED PHARMACHEMIKALIEN MINDEN GMBH Minden DE | 100012159;100022673 | CEP 2011-126 - Rev 02 | 2024/07/10 | Valid | Chemical | 2024/07/10 | Minor revision|CEP granted|10/07/2024; Minor revision|Accepted - CEP remains valid|18/09/2020 |
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925 | Levomepromazine maleate | COHANCE LIFESCIENCES LIMITED Mumbai IN | 100011755;100090273 | CEP 2018-144 - Rev 04 | 2024/07/10 | Valid | 11/02/2025 | Chemical | 2024/07/10 | Notification|CEP granted|10/07/2024; Minor revision|Accepted - CEP remains valid|09/04/2024; Monograph revision|CEP granted|09/08/2023; Notification|CEP granted|12/02/2021; Minor revision|CEP granted|07/08/2020 |
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2423 | Valsartan, ID: 7611 | TEVA PHARMACEUTICAL INDUSTRIES LTD Tel Aviv - Jaffa IL | 100000702;100060842 | CEP 2011-121 - Rev 04 | 2024/07/10 | Valid | Chemical | 2024/07/10 | Major revision|CEP granted|10/07/2024; Notification|CEP granted|04/02/2022; Minor revision|CEP granted|18/06/2021 |
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77 | Dapsone | COHANCE LIFESCIENCES LIMITED Mumbai IN | 100011755;100090273 | CEP 2020-358 - Rev 01 | 2024/07/10 | Valid | 17/01/2028 | Chemical | 2024/07/10 | Notification|CEP granted|10/07/2024; New application|CEP granted|17/01/2023 |
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1275 | Ursodeoxycholic acid | ZHONGSHAN BELLING BIOTECHNOLOGY CO., LTD. Zhongshan City CN | 100039390;100062018 | CEP 2018-237 - Rev 01 | 2024/07/10 | Valid | Chemical | 2024/07/10 | Renewal|CEP granted|10/07/2024; Notification|Accepted - CEP remains valid|26/09/2023 |
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2988 | Fingolimod hydrochloride | MAPRIMED S.A. Buenos Aires AR | 100012039;100018552 | CEP 2020-312 - Rev 01 | 2024/07/10 | Valid | 28/10/2026 | Chemical | 2024/07/10 | Monograph revision|CEP granted|10/07/2024; Minor revision|Accepted - CEP remains valid|27/02/2024; New application|CEP granted|28/10/2021 |