欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
NL/H/5505/001
药品名称
Nab-Paclitaxel STADA
活性成分
paclitaxel 5.0 mg/ml
剂型
Powder for dispersion for infusion
上市许可持有人
Stada Arzneimittel AG
参考成员国 - 产品名称
Netherlands (NL)
Nab-Paclitaxel STADA
互认成员国 - 产品名称
Norway (NO)
Finland (FI)
Hungary (HU)
Nab-Paclitaxel Stada 5 mg/ml por szuszpenziós infúzióhoz
Germany (DE)
Paclitaxel STADA 5 mg/ml Pulver zur Herstellung einer Infusionsdispersion
Romania (RO)
Denmark (DK)
Bugvi
Belgium (BE)
Luxembourg (LU)
Iceland (IS)
Austria (AT)
France (FR)
Spain (ES)
Sweden (SE)
许可日期
2024/05/02
最近更新日期
2024/10/28
药物ATC编码
L01CD01 paclitaxel
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
PubAR Summary
|
sPAR_5505_Bugvi 5 mg ml_18sept2024_EN
Date of last change:2024/09/24
PubAR
|
PAR_5505_Bugvi 5 mg ml_18sept2024
Date of last change:2024/09/24
Final SPC
|
1_3_1_SmPC_Paclitaxel_NL5505_6_cl
Date of last change:2024/09/06
Final Labelling
|
Labelling_Paclitaxel__NL5505_6
Date of last change:2024/09/06
Final PL
|
PL_Paclitaxel_NL5505_6_20240416_DL_clean
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase