欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
EE/H/0258/002
药品名称
Hydromorphone Kalceks
活性成分
hydromorphone hydrochloride 10.0 mg/ml
剂型
Solution for injection/infusion
上市许可持有人
AS KALCEKS Krustpils iela 53 Riga LV-1057 Latvia
参考成员国 - 产品名称
Estonia (EE)
互认成员国 - 产品名称
Germany (DE)
Hydromorphone Ethypharm 10 mg/ml Injektions-/Infusionslösung
Denmark (DK)
Hydromorphonhydrochlorid "Kalceks"
Netherlands (NL)
Austria (AT)
Hydromorphon Kalceks 10 mg/ml Injektions-/Infusionslösung
Sweden (SE)
Norway (NO)
Hydromorfonhydroklorid Kalceks
Finland (FI)
Latvia (LV)
Hydromorphone Kalceks 10 mg/ml šķīdums injekcijām/infūzijām
许可日期
2018/11/04
最近更新日期
2023/04/27
药物ATC编码
N02AA03 hydromorphone
申请类型
TypeLevel1：
Abridged
TypeLevel2：
Additional Strength/Form
TypeLevel3：
Generic Art 10.1 and 10.2 Dir 2001/83/EC
TypeLevel4：
Chemical Substance
TypeLevel5：
Prescription Only
附件文件下载
PubAR
|
EE_258_PAR_MRI
Date of last change:2024/09/06
Final Labelling
|
Labelling_Hydromorphone_Hydrochloride_clean
Date of last change:2024/09/06
Final PL
|
PIL_Hydromorphone_Hydrochloride_clean
Date of last change:2024/09/06
Final SPC
|
SmPC_Hydromorphone_Hydrochloride_clean
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase