欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PT/H/0451/002
药品名称
Rextol
活性成分
Paricalcitol 5.0 µg/ml
剂型
Solution for injection
上市许可持有人
Pharmabide Ltd 20, Lakonias street 152 34 Halandri - Athens Greece
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
Romania (RO)
Czechia (CZ)
REXTOL 5 mcg/ml
Spain (ES)
Greece (GR)
许可日期
2011/07/27
最近更新日期
2025/01/08
药物ATC编码
H05BX02 paricalcitol
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
|
1_3_1_PIL_clean_20110727
Date of last change:2024/09/06
Final Labelling
|
1_3_1_Proposed CARTON_2 mcg_ml_clean_20110727
Date of last change:2024/09/06
Final Labelling
|
1_3_1_Proposed CARTON_5mcg_ml_clean_20110727
Date of last change:2024/09/06
Final Labelling
|
1_3_1_Proposed LABEL_2mcg_clean_20110727
Date of last change:2024/09/06
Final Labelling
|
1_3_1_Proposed LABEL_5mcg_clean_20110727
Date of last change:2024/09/06
Final SPC
|
1_3_1_SPC_clean_20110727
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase