欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/2059/001
药品名称
Bupivacaine Noridem
活性成分
Bupivacaine hydrochloride 0.25 % (W/V)
剂型
Solution for injection
上市许可持有人
Noridem Enterprises Limited, Cyprus
参考成员国 - 产品名称
Sweden (SE)
互认成员国 - 产品名称
Czechia (CZ)
BUPIVACAINI HYDROCHLORIDUM NORIDEM
Slovakia (SK)
Bupivacaine Noridem 2,5 mg/ml injekčný roztok
Denmark (DK)
Ireland (IE)
France (FR)
Greece (GR)
Norway (NO)
Bupivacaine Noridem
Poland (PL)
Bupivacaini Noridem
Cyprus (CY)
Bupivacaine hydrochloride Noridem 0.25 % wv Solution for injection
许可日期
2020/12/16
最近更新日期
2025/05/07
药物ATC编码
N01BB01 bupivacaine
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 PL
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Final PL
Final SPC
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Final SPC
PubAR
|
PAR
PubAR Summary
|
PAR Summary
市场状态
Positive
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