欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
DE/H/1507/001
药品名称
Takipril
活性成分
prilocaine hydrochloride 20.0 mg
剂型
Solution for injection
上市许可持有人
Sintetica GmbH Albersloher Weg 11 D-48155 Münster Germany
参考成员国 - 产品名称
Germany (DE)
互认成员国 - 产品名称
United Kingdom (Northern Ireland) (XI)
Denmark (DK)
Belgium (BE)
Netherlands (NL)
Luxembourg (LU)
France (FR)
Sweden (SE)
Norway (NO)
Finland (FI)
Poland (PL)
Prilotekal
Hungary (HU)
PRILOTEKAL 20 mg/ml oldatos injekció
Bulgaria (BG)
Takipril
Czechia (CZ)
Takipril, 20mg/ml Injekční roztok
Slovakia (SK)
Takipril
Austria (AT)
Takipril hyperbar 2 % Injektionslösung
Spain (ES)
Italy (IT)
许可日期
2009/03/13
最近更新日期
2023/04/20
药物ATC编码
N01BB04 prilocaine
申请类型
TypeLevel1：
Abridged
TypeLevel2：
Initial 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 Product Information
|
common-final-labop-1507-V029
Date of last change:2020/02/19
Final Product Information
|
common-final-spc-1507-V029
Date of last change:2020/02/19
Final Product Information
|
common-final-pl-1507-V029
Date of last change:2020/02/19
Final Product Information
|
common-final-labip-1507-V029
Date of last change:2020/02/19
Final Labelling
|
DE1507_Takipril__Immediate Labeling - Clean Version_20140417_renewal
Date of last change:2014/04/22
Final Labelling
|
DE1507_Takipril__Outer labelling - clean Version_20140417_renewal
Date of last change:2014/04/22
Final PL
|
DE1507_Takipril__PACKAGE LEAFLET - CLEAN VERSION_20140417_renewal.doc
Date of last change:2014/04/22
Final SPC
|
DE1507_Takipril_SMPC - CLEAN VERSION_20140422_renewal
Date of last change:2014/04/22
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase