欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/1560/001
药品名称
Flexilev
活性成分
Carbidopa 1.25 mg
Levodopa 5.0 mg
剂型
Dispersible tablets for dose dispenser
上市许可持有人
Navamedic ASA Norway
参考成员国 - 产品名称
Sweden (SE)
互认成员国 - 产品名称
Denmark (DK)
Flexilev
Belgium (BE)
Precifit 5 mg/1,25 mg dispergeerbare tabletten voor dosisdispenser
Netherlands (NL)
Luxembourg (LU)
United Kingdom (Northern Ireland) (XI)
Austria (AT)
Norway (NO)
Finland (FI)
Poland (PL)
许可日期
2016/06/30
最近更新日期
2025/08/07
药物ATC编码
N04BA02 levodopa and decarboxylase inhibitor
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Initial Application
TypeLevel3:
Other Generic application Art 10.3 Dir 2001/83/EC
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final PL
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Final PL
Final SPC
|
Final SPC
PubAR
|
PAR
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase