欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
LV/H/0101/001
药品名称
Bupivacaine – Grindeks 5mg/ml
活性成分
bupivacaine hydrochloride 5.0 mg/ml
剂型
Solution for injection
上市许可持有人
JSC Grindeks, Krustpils 53, Riga, LV-1057, Latvia
参考成员国 - 产品名称
Latvia (LV)
互认成员国 - 产品名称
Lithuania (LT)
BUPIVACAINE-GRINDEKS 5 mg/ml injekcinis tirpalas
Estonia (EE)
BUPIVACAINE-GRINDEKS
许可日期
2009/03/08
最近更新日期
2019/01/11
药物ATC编码
N01BB01 bupivacaine
申请类型
TypeLevel1:
Known Active Substance
TypeLevel2:
Initial Application
TypeLevel3:
Bibliographic Art 10 a Dir 2001/83/EC
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final PL
|
Bupivacaine G sol PIL_EU_com_en_RMS_D20_02_01_2019
Date of last change:2024/09/06
Final SPC
|
Bupivacaine G sol SmPC_EU_com_RMS_D20_en_02_01_2019
Date of last change:2024/09/06
Final Labelling
|
Labelling_ Bup Gr_inner_ outer_clean
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase