欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/0110/007
药品名称
Topimax
活性成分
Topiramate 15.0 mg
剂型
Capsule, hard
上市许可持有人
Janssen-Cilag AB Sollentuna Sweden
参考成员国 - 产品名称
Sweden (SE)
互认成员国 - 产品名称
Netherlands (NL)
Finland (FI)
Denmark (DK)
Belgium (BE)
Luxembourg (LU)
Iceland (IS)
Ireland (IE)
Austria (AT)
Topamax 15 mg Granulat in Kapseln
France (FR)
Spain (ES)
Portugal (PT)
Italy (IT)
Greece (GR)
Norway (NO)
Poland (PL)
TOPAMAX
Cyprus (CY)
Czechia (CZ)
Slovenia (SI)
Malta (MT)
Topamax
许可日期
2000/12/21
最近更新日期
2025/09/15
药物ATC编码
N03AX11 topiramate
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Additional Strength/Form
TypeLevel3:
Other Article 4.8(a)(iii), second paragraph
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final PL
|
Final PL
Final SPC
|
Final SPC
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase