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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402 | Magnesium chloride hexahydrate | Merck KGaA Darmstadt DE | 100000742;100006955 | CEP 2010-194 - Rev 02 | 2024/04/30 | Valid | Chemical | 2024/04/30 | Minor revision|CEP granted|30/04/2024; Notification|Accepted - CEP remains valid|01/07/2022 |
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992 | Cefuroxime sodium, Sterile | Qilu Antibiotics Pharmaceutical Co., Ltd. Jinan CN | 100033695;100052910 | CEP 2006-014 - Rev 03 | 2024/04/30 | Valid | Chemical | 2024/04/30 | Major revision|CEP granted|30/04/2024; Minor revision|Accepted - CEP remains valid|10/06/2022; Major revision|CEP granted|16/12/2021; Minor revision|Rejected|05/08/2021; Minor revision|CEP granted|01/03/2021; Major revision|Abandoned|09/10/2020 |
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2254 | Moxifloxacin hydrochloride, Anhydrous | MSN PHARMACHEM PRIVATE LIMITED Sangareddy District IN | 100014794;100023345 | CEP 2015-360 - Rev 02 | 2024/04/30 | Valid | Chemical | 2024/04/30 | Minor revision|CEP granted|30/04/2024; Minor revision|CEP granted|07/09/2023; Minor revision|Accepted - CEP remains valid|19/08/2022; Renewal|CEP granted|22/03/2021 |
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1472 | Sodium hyaluronate, GS-120, intrinsic viscosity: 1.7 m3/kg; from fermentation; for parenteral administration, including intra-ocular use | KIKKOMAN BIOCHEMIFA COMPANY Noda City JP | 100039417;100087689 | CEP 2023-034 - Rev 01 | 2024/04/30 | Valid | 21/06/2028 | Chemical | 2024/04/30 | Minor revision|CEP granted|30/04/2024; New application|CEP granted|21/06/2023 |
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760 | Cytarabine | MAC CHEM PRODUCTS (INDIA) PVT. LTD. Mumbai IN | 100023737;100061579 | CEP 2012-251 - Rev 02 | 2024/04/30 | Valid | Chemical | 2024/04/30 | Administrative procedure|CEP granted|30/04/2024; Minor revision|CEP granted|19/05/2022; Minor revision|Accepted - CEP remains valid|19/07/2021; Minor revision|Rejected|19/03/2021 |
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2637 | Pemetrexed disodium heptahydrate | MAC CHEM PRODUCTS (INDIA) PVT. LTD. Mumbai IN | 100023737;100061579 | CEP 2015-141 - Rev 01 | 2024/04/30 | Valid | Chemical | 2024/04/30 | Administrative procedure|CEP granted|30/04/2024; Monograph revision|Accepted - CEP remains valid|03/10/2023; Renewal|CEP granted|04/01/2022 |
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626 | Neostigmine metilsulfate | MAC CHEM PRODUCTS (INDIA) PVT. LTD. Mumbai IN | 100023737;100061579 | CEP 2019-024 - Rev 01 | 2024/04/30 | Valid | 18/12/2025 | Chemical | 2024/04/30 | Administrative procedure|CEP granted|30/04/2024 | |
2675 | Irinotecan hydrochloride trihydrate | MAC CHEM PRODUCTS (INDIA) PVT. LTD. Mumbai IN | 100023737;100061579 | CEP 2018-063 - Rev 01 | 2024/04/30 | Valid | 17/01/2025 | Chemical | 2024/04/30 | Administrative procedure|CEP granted|30/04/2024; Minor revision|Accepted - CEP remains valid|01/03/2022 |
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2196 | Bicalutamide | MAC CHEM PRODUCTS (INDIA) PVT. LTD. Mumbai IN | 100023737;100061579 | CEP 2019-329 - Rev 01 | 2024/04/30 | Valid | 11/06/2026 | Chemical | 2024/04/30 | Administrative procedure|CEP granted|30/04/2024 | |
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 |