欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/0718/002
药品名称
Priligy
活性成分
Dapoxetine hydrochloride 60.0 mg
剂型
Film-coated tablet
上市许可持有人
Phoenix Labs Unlimited Company
参考成员国 - 产品名称
Sweden (SE)
互认成员国 - 产品名称
Austria (AT)
Priligy 60 mg Filmtabletten
Spain (ES)
Portugal (PT)
Priligy
Italy (IT)
Finland (FI)
Belgium (BE)
Greece (GR)
Malta (MT)
MA018/03102
Poland (PL)
Priligy
Romania (RO)
Priligy 60 mg comprimate filmate
Slovenia (SI)
Slovakia (SK)
Priligy
Hungary (HU)
PRILIGY 60 mg filmtabletta
Estonia (EE)
Czechia (CZ)
Priligy
Cyprus (CY)
PRILIGY 60mg FC TABS
Bulgaria (BG)
Priligy
Croatia (HR)
France (FR)
Ireland (IE)
United Kingdom (Northern Ireland) (XI)
Luxembourg (LU)
Netherlands (NL)
Germany (DE)
Priligy 60 mg Filmtabletten
Lithuania (LT)
Priligy 60 mg plėvele dengtos tabletės
许可日期
2008/12/17
最近更新日期
2025/09/25
药物ATC编码
G04BX14 dapoxetine
申请类型
TypeLevel1:
New Active Substance
TypeLevel2:
Additional Strength/Form
TypeLevel3:
Full Dossier Art 8.3(i) Dir 2001/83/EC
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final PL
|
Final PL
Final SPC
|
Final SPC
PubAR
|
PAR
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase