欧洲药典适用性证书数据库（欧盟CEP认证）

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	证书类型	上一程序的结束日期	历史数据程序类型\|结论\|日期
1104	Fluoxetine hydrochloride	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 1997-042 - Rev 12	2025/03/12	Valid		Chemical	2025/03/12	Notification\|CEP granted\|12/03/2025; Notification\|Accepted - CEP remains valid\|02/12/2024; Minor revision\|CEP granted\|22/06/2023; Notification\|Accepted - CEP remains valid\|15/03/2022; Notification\|CEP granted\|20/12/2021; Monograph revision\|CEP granted\|28/01/2021
29	Imipramine hydrochloride	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 2002-051 - Rev 05	2025/03/12	Valid		Chemical	2025/03/12	Notification\|CEP granted\|12/03/2025; Minor revision\|CEP granted\|30/01/2024; Minor revision\|CEP granted\|24/02/2022; Notification\|Accepted - CEP remains valid\|14/12/2020
2333	Fluvastatin sodium	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 2010-201 - Rev 03	2025/03/12	Valid		Chemical	2025/03/12	Notification\|CEP granted\|12/03/2025; Major revision\|CEP granted\|05/05/2023; Notification\|CEP granted\|04/02/2022
2465	Irbesartan	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 2011-251 - Rev 07	2025/03/12	Valid		Chemical	2025/07/24	Notification\|Accepted - CEP remains valid\|24/07/2025; Notification\|CEP granted\|12/03/2025; Major revision\|CEP granted\|16/12/2024; Notification\|CEP granted\|17/06/2024; Minor revision\|Accepted - CEP remains valid\|17/02/2023; Minor revision\|CEP granted\|30/09/2021; Notification\|CEP granted\|03/03/2021; Major revision\|CEP granted\|30/07/2020
2465	Irbesartan	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 2010-322 - Rev 03	2025/03/12	Valid		Chemical	2025/03/12	Notification\|CEP granted\|12/03/2025; Notification\|CEP granted\|07/03/2022
2583	Montelukast sodium, ID 6177	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 2017-131 - Rev 06	2025/03/12	Valid		Chemical	2025/08/05	Notification\|Accepted - CEP remains valid\|05/08/2025; Notification\|CEP granted\|12/03/2025; Major revision\|CEP granted\|27/09/2024; Renewal\|CEP granted\|19/03/2024; Notification\|CEP granted\|23/03/2023; Minor revision\|CEP granted\|08/11/2021
2531	Clopidogrel hydrogen sulfate	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 2011-143 - Rev 04	2025/03/12	Valid		Chemical	2025/03/12	Notification\|CEP granted\|12/03/2025; Notification\|Accepted - CEP remains valid\|10/07/2023; Notification\|CEP granted\|08/02/2022; Notification\|CEP granted\|30/06/2021; Minor revision\|CEP granted\|28/04/2020
2600	Olmesartan medoxomil, Process 2	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 2020-325 - Rev 02	2025/03/12	Valid		Chemical	2025/11/24	Renewal\|Accepted - CEP remains valid\|24/11/2025; Notification\|CEP granted\|12/03/2025; Notification\|Accepted - CEP remains valid\|17/01/2024; Notification\|CEP granted\|23/02/2022; New application\|CEP granted\|06/01/2021
2232	Losartan potassium, Process 2	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 2021-227 - Rev 02	2025/03/12	Valid	17/11/2027	Chemical	2025/03/12	Notification\|CEP granted\|12/03/2025; Notification\|CEP granted\|13/02/2023; New application\|CEP granted\|17/11/2022
2465	Irbesartan, Process 2	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 2022-046 - Rev 02	2025/03/12	Valid	20/10/2027	Chemical	2025/03/12	Notification\|CEP granted\|12/03/2025; Notification\|CEP granted\|04/03/2024; New application\|CEP granted\|20/10/2022
896	Deferoxamine mesilate, Produced by a synthetic process	EXCELLA GMBH & CO. KG Feucht DE	100012030;100020739	CEP 2009-401 - Rev 06	2025/03/11	Valid		Chemical	2025/03/11	Minor revision\|CEP granted\|11/03/2025; Minor revision\|CEP granted\|25/10/2024; Minor revision\|CEP granted\|16/03/2023
1046	Tamoxifen citrate, Milled A; Milled Z	EXCELLA GMBH & CO. KG Feucht DE	100012030;100020739	CEP 2021-495 - Rev 03	2025/03/11	Valid	13/03/2028	Chemical	2025/03/11	Minor revision\|CEP granted\|11/03/2025; Notification\|CEP granted\|28/10/2024; Major revision\|CEP granted\|06/07/2023; New application\|CEP granted\|13/03/2023
1331	Glyceryl trinitrate solution	Dynamit Nobel GmbH, Explosivstoff- und Systemtechnik Leverkusen DE	100011675;100020630	CEP 2003-185 - Rev 02	2025/03/11	Valid		Chemical	2025/03/11	Major revision\|CEP granted\|11/03/2025
464	Amitriptyline hydrochloride	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 2001-432 - Rev 06	2025/03/11	Valid		Chemical	2025/03/11	Notification\|CEP granted\|11/03/2025; Minor revision\|CEP granted\|07/05/2024; Notification\|Accepted - CEP remains valid\|05/07/2023; Notification\|Accepted - CEP remains valid\|02/08/2022; Notification\|CEP granted\|04/02/2022; Minor revision\|Accepted - CEP remains valid\|12/10/2021; Notification\|Rejected\|16/08/2021
994	Ciclosporin	TAPI CZECH INDUSTRIES S.R.O. Opava CZ	100051642;100090678	CEP 2002-152 - Rev 07	2025/03/11	Valid		Chemical	2025/03/11	Notification\|CEP granted\|11/03/2025; Minor revision\|CEP granted\|21/06/2023; Monograph revision\|CEP granted\|02/09/2021; Minor revision\|Accepted - CEP remains valid\|24/02/2020
2423	Valsartan	MACLEODS PHARMACEUTICALS LIMITED Mumbai IN	100021441;100077265	CEP 2011-180 - Rev 08	2025/03/11	Valid		Chemical	2025/03/11	Notification\|CEP granted\|11/03/2025; Minor revision\|CEP granted\|01/08/2024; Major revision\|CEP granted\|19/04/2024; Minor revision\|Accepted - CEP remains valid\|23/05/2023; Minor revision\|Accepted - CEP remains valid\|30/08/2022; Major revision\|CEP granted\|25/02/2022; Minor revision\|Rejected\|09/08/2021
299	Theophylline	SHANDONG XINHUA PHARMACEUTICAL CO., LTD. Zibo CN	100011788;100019607	CEP 1998-004 - Rev 08	2025/03/11	Valid		Chemical	2025/03/11	Minor revision\|CEP granted\|11/03/2025
1140	Potassium clavulanate	SHANDONG NEW TIME PHARMACEUTICAL CO., LTD. Linyi CN	100025540;100034769	CEP 2011-374 - Rev 01	2025/03/11	Valid		Chemical	2025/03/11	Notification\|CEP granted\|11/03/2025; Minor revision\|Accepted - CEP remains valid\|29/02/2024; Minor revision\|Accepted - CEP remains valid\|03/10/2022; Minor revision\|Accepted - CEP remains valid\|13/02/2020
2777	Pregabalin	DONG BANG FUTURE TECH & LIFE CO., LTD. Hwaseong-si KR	100024414;100042624	CEP 2018-148 - Rev 01	2025/03/11	Valid		Chemical	2025/03/11	Renewal\|CEP granted\|11/03/2025
2531	Clopidogrel hydrogen sulfate, Form II	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 2017-260 - Rev 01	2025/03/11	Valid		Chemical	2025/03/11	Notification\|CEP granted\|11/03/2025; Renewal\|CEP granted\|30/03/2023; Minor revision\|CEP granted\|27/07/2022; Notification\|CEP granted\|24/02/2022; Minor revision\|CEP granted\|26/03/2020

专论编号 (Monograph Number)
物质名称 (Substance)
证书持有人 (Certificate (CEP) Holder)
证书编号 (Certificate (CEP) Number)
证书类型 (Type CEP)
证书状态 (Status CEP)
发布日期(Issue Date CEP)	-
证书效期(End date CEP)	-