欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
NL/H/0626/001
药品名称
Flumazenil 0,1 mg/ml
活性成分
flumazenil 0.1 mg/ml
剂型
Solution for injection
上市许可持有人
Hameln Pharma R&D Langes Felt 13 31789 Hameln Germany
参考成员国 - 产品名称
Netherlands (NL)
互认成员国 - 产品名称
Germany (DE)
Flumazenil-hameln 0,1 mg/ml Injektionslösung
Denmark (DK)
Flumazenil-hameln 0,1 mg/ml injektionsvæske, opløsning
United Kingdom (Northern Ireland) (XI)
Italy (IT)
Sweden (SE)
Flumazenil Hameln
Norway (NO)
Finland (FI)
许可日期
2005/09/20
最近更新日期
2021/12/05
药物ATC编码
V03AB25 flumazenil
申请类型
TypeLevel1：
Abridged
TypeLevel2：
Multiple (Copy) Application
TypeLevel3：
Generic [Article 10.1.(a)(iii), first paragraph]
TypeLevel4：
Chemical Substance
TypeLevel5：
Prescription Only
附件文件下载
Final Product Information
|
m1-3-1-fluma-01mgml-labelling-inner-common-var012-clean-2002
Date of last change:2020/05/18
Final Product Information
|
m1-3-1-fluma-01mgml-label-outer-common-var012-clean-2002
Date of last change:2020/05/18
Final Product Information
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m1-3-1-fluma-01mgml-pil-common-var012-clean-2002
Date of last change:2020/05/18
Final Product Information
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m1-3-1-fluma-01mgml-spc-common-var012-clean-2002
Date of last change:2020/05/18
Final PL
|
m1-3-1-fluma-01mgml-pil-common-clean-180919
Date of last change:2018/12/14
Final SPC
|
m1-3-1-fluma-01mgml-spc-common-clean-180917
Date of last change:2018/12/14
Final Labelling
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m1-3-1-fluma-01mgml-label-outer-common-clean-180912
Date of last change:2018/12/14
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase