欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
NL/H/0180/003
药品名称
Midazolam 5 mg/ml Hameln
活性成分
Midazolam hydrochloride 5.56 mg
剂型
Solution for injection
上市许可持有人
Pharma Hameln GmbH PO Box 100863 D-31789 HAMELN
参考成员国 - 产品名称
Netherlands (NL)
互认成员国 - 产品名称
Hungary (HU)
Germany (DE)
Denmark (DK)
United Kingdom (Northern Ireland) (XI)
Sweden (SE)
Finland (FI)
Slovakia (SK)
Slovenia (SI)
Romania (RO)
Bulgaria (BG)
Midazolam
Czechia (CZ)
Midazolam Hameln 5 mg/ml Injekční/infuzní roztok
Norway (NO)
Poland (PL)
Midazolam Hameln
Croatia (HR)
Austria (AT)
许可日期
1999/11/18
最近更新日期
2025/08/28
药物ATC编码
N05CD08 midazolam
申请类型
TypeLevel1:
Abridged
TypeLevel2:
[not specified]
TypeLevel3:
[not specified]
TypeLevel4:
[not specified]
TypeLevel5:
[not specified]
附件文件下载
Final Labelling
|
common label totaalCTS
Date of last change:2024/09/06
Final PL
|
m1_3_1_3_cc_PIL_mida_2307_clean
Date of last change:2024/09/06
Final SPC
|
m1_3_1_smpc_mida_180_common_2307
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase