欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/2249/001
药品名称
Terbinafin Moberg Pharma
活性成分
terbinafine hydrochloride 98.0 mg/ml
剂型
Cutaneous solution
上市许可持有人
Moberg Pharma AB, Sweden
参考成员国 - 产品名称
Sweden (SE)
互认成员国 - 产品名称
Ireland (IE)
Austria (AT)
France (FR)
Spain (ES)
Italy (IT)
Norway (NO)
Finland (FI)
Hungary (HU)
Czechia (CZ)
Terbinafine Moberg Pharma
Denmark (DK)
Belgium (BE)
Netherlands (NL)
许可日期
2023/06/27
最近更新日期
2024/09/17
药物ATC编码
D01AE15 terbinafine
申请类型
TypeLevel1:
Known Active Substance
TypeLevel2:
Initial Application
TypeLevel3:
Full Dossier Art 8.3(i) Dir 2001/83/EC
TypeLevel4:
Chemical Substance
TypeLevel5:
Non Prescription (including OTC)
附件文件下载
Final PL
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Final PL
Date of last change:2024/09/06
Final SPC
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Final SPC
Date of last change:2024/09/06
PubAR
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PAR
Date of last change:2024/09/06
PubAR Summary
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sPAR
Date of last change:2024/09/06
市场状态
Positive
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