欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/2578/001
药品名称
Primve
活性成分
phenoxymethylpenicillin potassium salt 50.0 mg/ml
剂型
Powder for oral suspension
上市许可持有人
2care4 ApS Stenhuggervej 12-14 6710 Esbjerg V Denmark
参考成员国 - 产品名称
Denmark (DK)
Primve
互认成员国 - 产品名称
Sweden (SE)
许可日期
2016/09/08
最近更新日期
2022/09/26
药物ATC编码
J01CE02 phenoxymethylpenicillin
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 Labelling
|
common_Label_100mg_ml_var003_clean_27022018
Date of last change:2024/09/06
Final Labelling
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common_Label_50mg_ml_var003_clean_27022018
Date of last change:2024/09/06
Final PL
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common_primve_100mgml_powder_for_oral_suspension_pl_var008_17122021_clean_1_
Date of last change:2024/09/06
Final SPC
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common_primve_100mgml_powder_for_oral_suspension_smpc_var008_17122021_clean_1_
Date of last change:2024/09/06
Final PL
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common_primve_50mgml_powder_for_oral_suspension_pl_var008_17122021_clean_1_
Date of last change:2024/09/06
Final SPC
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common_primve_50mgml_powder_for_oral_suspension_smpc_var008_17122021_clean_1_
Date of last change:2024/09/06
PubAR
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PAR scientific discussion Primve
Date of last change:2024/09/06
PubAR Summary
|
Summary PAR _ Primve
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase