欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
DE/H/0331/001
药品名称
Celimone
活性成分
dienogest 2.0 mg
ethinylestradiol 0.03 mg
剂型
Coated tablet
上市许可持有人
Jenapharm GmbH & Co. KG Otto-Schott-Str. 15 D-07745 Jena Germany
参考成员国 - 产品名称
Germany (DE)
互认成员国 - 产品名称
许可日期
2001/12/21
最近更新日期
2023/11/29
药物ATC编码
G03FA15 dienogest and estrogen
申请类型
TypeLevel1：
Known Active Substance
TypeLevel2：
Initial Application
TypeLevel3：
Full Dossier Article 4.8 Di 65/65
TypeLevel4：
Chemical Substance
TypeLevel5：
Prescription Only
附件文件下载
Final PL
|
BEC19714_WS_251_Common_EU_PIL_Mirelle_en__clean
Date of last change:2024/09/06
Final SPC
|
BEC19714_WS_251_Common_EU_SmPC_Mirelle_en__clean
Date of last change:2024/09/06
Final Product Information
|
Celimona_combined_common_Final_clean
Date of last change:2024/09/06
Final Product Information
|
Celimona_combined_common_final_tracked
Date of last change:2024/09/06
Final Product Information
|
EU_national licenses_MasterText_clean
Date of last change:2024/09/06
Final Product Information
|
EU_national licenses_MasterText_tracked
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase