欧洲药典适用性证书数据库
(Certificates of Suitability to the monographs of European Pharmacopoeia, EDQM)
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
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
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
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
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
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
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
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
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
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
633 Pilocarpine hydrochloride SPERA NEXUS, INC. Shizuoka JP 100045481;100074964 CEP 2015-343 - Rev 02 2024/04/29 Valid Chemical 2024/04/29 Renewal|CEP granted|29/04/2024;
Notification|CEP granted|06/08/2021
2135 Repaglinide ZHEJIANG HISOAR CHUANNAN PHARMACEUTICAL CO., LTD. Taizhou City CN 100039329;100061908 CEP 2008-201 - Rev 06 2024/04/29 Valid Chemical 2024/04/29 Notification|CEP granted|29/04/2024;
Minor revision|CEP granted|12/03/2024;
Notification|CEP granted|25/01/2022;
Major revision|CEP granted|15/12/2021
1655 Mitomycin HUBEI HONCH PHARMACEUTICAL CO., LTD. Huanggang CN 100036821;100058182 CEP 2022-400 - Rev 01 2024/04/26 Valid 17/04/2029 Chemical 2024/04/26 Notification|CEP granted|26/04/2024;
New application|CEP granted|17/04/2024
1120 Lisinopril dihydrate, Process-III HETERO DRUGS LIMITED Hyderabad IN 100008415;100014434 CEP 2022-434 - Rev 01 2024/04/26 Valid 04/05/2028 Chemical 2024/04/26 Minor revision|CEP granted|26/04/2024;
New application|CEP granted|04/05/2023
2191 Atorvastatin calcium, Form-I HETERO LABS LIMITED Hyderabad IN 100011681;100018664 CEP 2018-049 - Rev 02 2024/04/26 Valid 02/04/2025 Chemical 2024/04/26 Major revision|CEP granted|26/04/2024;
Monograph revision|CEP granted|24/03/2023;
Major revision|Rejected|28/03/2022
2357 Dydrogesterone, Micronised ABBOTT HEALTHCARE PRODUCTS B.V. Weesp NL 100002995;100005756 CEP 2019-114 - Rev 01 2024/04/26 Valid 17/06/2026 Chemical 2024/04/26 Minor revision|CEP granted|26/04/2024;
Notification|Accepted - CEP remains valid|14/06/2023;
Notification|Accepted - CEP remains valid|04/04/2023;
Monograph revision|Accepted - CEP remains valid|01/07/2022
2780 Temozolomide FORMOSA LABORATORIES, INC. Taoyuan TW 100011879;100018688 CEP 2017-245 - Rev 01 2024/04/26 Valid Chemical 2024/04/26 Renewal|CEP granted|26/04/2024;
Notification|Accepted - CEP remains valid|07/07/2022
1244 Morphine hemisulfate 2.5-hydrate FRANCOPIA Paris FR 100041331;100069306 CEP 2000-126 - Rev 07 2024/04/26 Valid Chemical 2024/04/26 Monograph revision|CEP granted|26/04/2024;
Notification|CEP granted|01/03/2024;
Notification|CEP granted|02/05/2022;
Notification|Accepted - CEP remains valid|20/02/2020
991 Ceftriaxone sodium, Sterile ACS DOBFAR S.P.A. Tribiano IT 100011589;100019524 CEP 2011-393 - Rev 03 2024/04/26 Valid Chemical 2024/04/26 Major revision|CEP granted|26/04/2024;
Administrative procedure|CEP granted|03/03/2022;
Major revision|CEP granted|22/02/2022

数据库说明:

当前数据更新日期:2024年05月21日。
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