欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/1616/001
药品名称
Platel
活性成分
CLOPIDOGREL HYDROGEN SULFATE 97.86 mg
剂型
Film-coated tablet
上市许可持有人
Medochemie Ltd 1-10 Constantinoupoleos Str. 3011 Limassol Cyprus
参考成员国 - 产品名称
Denmark (DK)
Platel
互认成员国 - 产品名称
Romania (RO)
PLATEL 75 mg comprimate filmate
Bulgaria (BG)
Mersinol 75 mg
Cyprus (CY)
Lithuania (LT)
PLATEL 75 mg plėvele dengtos tabletės
许可日期
2009/10/01
最近更新日期
2025/01/28
药物ATC编码
B01AC04 clopidogrel
B01AC Platelet aggregation inhibitors excl. heparin
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Multiple (Copy) 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_may2023_clean
Date of last change:2024/09/06
Final PL
|
common_pl_013_014_consol_Jan 2024_clean
Date of last change:2024/09/06
Final Product Information
|
common_pl_v4apr2021cl
Date of last change:2024/09/06
Final SPC
|
common_spc_013_014_consol_Jan 2024_clean
Date of last change:2024/09/06
Final Product Information
|
common_spc_v4apr2021cl
Date of last change:2024/09/06
PubAR
|
parmod5_dk1616platarex_pdf
Date of last change:2024/09/06
PubAR
|
pllab_dk1616platarex_pdf
Date of last change:2024/09/06
PubAR
|
spc_dk1616platarex_pdf
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase