欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
NO/H/0197/001
药品名称
Varena
活性成分
Drospirenone 3.0 mg
Ethinylestradiol 0.03 mg
剂型
Film-coated tablet
上市许可持有人
Teva Sweden AB Järnvägsgatan 11, Box 1070, 251 10 Helsingborg Sweden
参考成员国 - 产品名称
Norway (NO)
互认成员国 - 产品名称
Belgium (BE)
Dorintheramex 0,03 mg/3 mg filmomhulde tabletten
Netherlands (NL)
Ethinylestradiol/Drospirenon 0,03 mg/3 mg PCH, filmomhulde tabletten
United Kingdom (Northern Ireland) (XI)
Italy (IT)
许可日期
2011/07/12
最近更新日期
2024/09/18
药物ATC编码
G03AA12 drospirenone and ethinylestradiol
申请类型
TypeLevel1：
Abridged
TypeLevel2：
Multiple (Copy) Application
TypeLevel3：
Generic Art 10.1 and 10.2 Dir 2001/83/EC
TypeLevel4：
Chemical Substance
TypeLevel5：
Prescription Only
附件文件下载
Final PL
|
1_3_1 pil_eu _197_
Date of last change:2024/09/06
Final SPC
|
1_3_1 spc_eu _197_
Date of last change:2024/09/06
Final Product Information
|
138 label_inner_0_02_3mg_eu tracked
Date of last change:2024/09/06
Final Product Information
|
138 label_inner_0_03_3mg_eu tracked
Date of last change:2024/09/06
Final Product Information
|
138 pil_eu_0_02_3mg tracked
Date of last change:2024/09/06
Final Product Information
|
138 pil_eu_0_03_3mg tracked
Date of last change:2024/09/06
Final Product Information
|
138 spc_eu_0_02_3mg tracked
Date of last change:2024/09/06
Final Product Information
|
138 spc_eu_0_03_3mg tracked
Date of last change:2024/09/06
Final Product Information
|
148 pil_eu_0_02_3mg tracked
Date of last change:2024/09/06
Final Product Information
|
148 pil_eu_0_03_3mg tracked
Date of last change:2024/09/06
Final Product Information
|
148 spc_eu_0_02_3mg tracked
Date of last change:2024/09/06
Final Product Information
|
148 spc_eu_0_03_3mg tracked
Date of last change:2024/09/06
Final Product Information
|
187 label_outer_eu tracked
Date of last change:2024/09/06
Final Product Information
|
187 pil_eu tracked
Date of last change:2024/09/06
Final Product Information
|
187 spc_eu tracked
Date of last change:2024/09/06
Final Product Information
|
188 label_outer_eu tracked
Date of last change:2024/09/06
Final Product Information
|
188 pil_eu tracked
Date of last change:2024/09/06
Final Product Information
|
188 spc_eu tracked
Date of last change:2024/09/06
Final Product Information
|
197 pil _DrospirenoneEE 0_03 mg3 mg 21 _197__common
Date of last change:2024/09/06
Final Product Information
|
197 spc_eu_tracked _197_
Date of last change:2024/09/06
Final Product Information
|
198 label_outer_eu tracked
Date of last change:2024/09/06
Final Product Information
|
198 pil_eu tracked
Date of last change:2024/09/06
Final Product Information
|
198 spc_eu tracked
Date of last change:2024/09/06
Final Product Information
|
NO_H_138 0_02mg3mg Outer label tracked
Date of last change:2024/09/06
Final Product Information
|
NO_H_138 0_03mg3mg Outer label tracked
Date of last change:2024/09/06
Final Product Information
|
NO_H_197 0_03mg3mg Outer label tracked
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase