欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/0908/001
药品名称
Jext
活性成分
Epinephrine 150.0 µg
剂型
SOLUTION FOR INJECTION IN PRE-FILLED PEN
上市许可持有人
ALK Abelló A/S Denmark
参考成员国 - 产品名称
Sweden (SE)
互认成员国 - 产品名称
Romania (RO)
Jext 150 micrograme soluţie injectabilă în stilou injector (pen) preumplut
Bulgaria (BG)
Jext
Czechia (CZ)
Jext
Lithuania (LT)
Jext 150 mikrogramų injekcinis tirpalas užpildytame švirkštiklyje
United Kingdom (Northern Ireland) (XI)
Poland (PL)
Jext
Croatia (HR)
Slovenia (SI)
Germany (DE)
JEXT 150 Injektionslösung
Denmark (DK)
Belgium (BE)
Netherlands (NL)
Luxembourg (LU)
Iceland (IS)
Ireland (IE)
Austria (AT)
Jext 150 Mikrogramm Injektionslösung in einem Fertigpen
France (FR)
Spain (ES)
Italy (IT)
Norway (NO)
Finland (FI)
Slovakia (SK)
Jext 150 mikrogramov
Hungary (HU)
JEXT 150 mikrogramm oldatos injekció előretöltött tollban
Portugal (PT)
许可日期
2010/10/12
最近更新日期
2024/10/16
药物ATC编码
C01CA24 epinephrine
申请类型
TypeLevel1:
Known Active Substance
TypeLevel2:
Initial Application
TypeLevel3:
Bibliographic Art 10 a Dir 2001/83/EC
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final PL
|
Final PL
Date of last change:2024/09/06
Final SPC
|
Final SPC
Date of last change:2024/09/06
PubAR
|
PAR
Date of last change:2024/09/06
PubAR Summary
|
PAR Summary
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase