欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DE/H/0309/002
药品名称
Pentastarch 10%
活性成分
poly(O-2-hydroxyethyl)starch sodium chloride 109.0 g
剂型
Solution for infusion
上市许可持有人
Baxter Deutschland GmbH Edisonstraße 4 85716 Unterschleißheim
参考成员国 - 产品名称
Germany (DE)
互认成员国 - 产品名称
Luxembourg (LU)
United Kingdom (Northern Ireland) (XI)
Ireland (IE)
Italy (IT)
Belgium (BE)
France (FR)
Portugal (PT)
许可日期
2001/11/29
最近更新日期
2024/08/19
药物ATC编码
B05AA07 hydroxyethylstarch
申请类型
TypeLevel1:
Known Active Substance
TypeLevel2:
Initial Application
TypeLevel3:
Generic Article 4.8(a)(iii), first paragraph
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final Labelling
|
labip_001_pentastarch_10_renewal_1006
Date of last change:2024/09/06
Final Labelling
|
labip_001_pentastarch_6_renewal_090227_1
Date of last change:2024/09/06
Final Labelling
|
labop_001_pentastarch_10_renewal_090227_1
Date of last change:2024/09/06
Final Labelling
|
labop_001_pentastarch_6_renewal_090227
Date of last change:2024/09/06
Final PL
|
palen_pentastarch_10_renewal_1006
Date of last change:2024/09/06
Final PL
|
palen_pentastarch_6_renewal_1006
Date of last change:2024/09/06
Final SPC
|
spcen_pentastarch_10_renewal_1006
Date of last change:2024/09/06
Final SPC
|
spcen_pentastarch_6_renewal_1006
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase