欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/2315/002
药品名称
Dabigatran Etexilate Viatris
活性成分
Dabigatran etexilate mesilate 110.0 mg
剂型
Capsule, hard
上市许可持有人
Viatris Limited, Ireland
参考成员国 - 产品名称
Sweden (SE)
互认成员国 - 产品名称
Netherlands (NL)
Latvia (LV)
Luxembourg (LU)
Lithuania (LT)
Dabigatran etexilate Vale 110 mg kietosios kapsulės
Iceland (IS)
Estonia (EE)
Austria (AT)
Hungary (HU)
France (FR)
Bulgaria (BG)
Dabigatran etexilate Vale
Spain (ES)
Cyprus (CY)
Dabigatran Etexilate Vale 110 mg Kαψάκιο, σκληρό
Portugal (PT)
Czechia (CZ)
Dabigatran Etexilate Vale
Italy (IT)
Romania (RO)
Dabigatran Etexilat Vale 110 mg capsule
Greece (GR)
Slovakia (SK)
Germany (DE)
Dabigatranetexilat Vale 110 mg Hartkapseln
Norway (NO)
Slovenia (SI)
Denmark (DK)
Finland (FI)
Malta (MT)
Dabigatran Etexilate Vale 110mg hard capsules
Belgium (BE)
Poland (PL)
Dabigatran Etexilate Vale
Croatia (HR)
许可日期
2023/12/21
最近更新日期
2024/07/22
药物ATC编码
B01AE07 dabigatran etexilate
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
Final PL
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Final PL
Final SPC
|
Final SPC
PAR
|
PAR
PAR Summary
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PAR Summary
市场状态
Positive
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