欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
NL/H/3497/003
药品名称
Cinacalcet Apotex 90 mg film-coated tablets
活性成分
CINACALCET HYDROCHLORIDE 99.18 mg
剂型
Film-coated tablet
上市许可持有人
Apotex Europe B.V. / NL, Leiden
参考成员国 - 产品名称
Netherlands (NL)
互认成员国 - 产品名称
许可日期
2017/04/20
最近更新日期
2020/01/18
药物ATC编码
H05BX01 cinacalcet
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
|
171025 NL_H_3497_001_003_DC Cincalcet Apotex PAR
Date of last change:2024/09/06
PubAR Summary
|
171025 NL_H_3497_001_003_DC Cincalcet Apotex summary EN
Date of last change:2024/09/06
Final PL
|
common_pl
Date of last change:2024/09/06
Final SPC
|
common_spc
Date of last change:2024/09/06
Final Labelling
|
m1_3_1_Label_carton _ March 2017
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase