欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/2304/001
药品名称
Apremilast Teva
活性成分
Apremilast 10.0 mg
Apremilast 20.0 mg
Apremilast 30.0 mg
剂型
Film-coated tablet
上市许可持有人
Teva B.V. Netherlands
参考成员国 - 产品名称
Sweden (SE)
互认成员国 - 产品名称
Denmark (DK)
Apremilast Teva Startpakke
Belgium (BE)
Netherlands (NL)
Austria (AT)
France (FR)
Spain (ES)
Italy (IT)
Greece (GR)
Poland (PL)
Apremilast Teva
Czechia (CZ)
Apremilast Teva
Slovakia (SK)
Germany (DE)
Apremilast-ratiopharm Starterpackung 10 mg, 20 mg und 30 mg Filmtabletten
许可日期
2024/05/29
最近更新日期
2024/12/05
药物ATC编码
L04AA32 apremilast
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Initial Application
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
|
Final PL
Date of last change:2024/09/06
Final SPC
|
Final SPC
Date of last change:2024/09/06
PubAR
|
https___www_lakemedelsverket_se_sv_sok_lakemedelsfakta_lakemedel_20230201000101_apremilast_teva_10_mg_20_mg_30_mg_filmdragerad_tablett
Date of last change:2024/09/06
PubAR Summary
|
https___www_lakemedelsverket_se_sv_sok_lakemedelsfakta_lakemedel_20230201000101_apremilast_teva_10_mg_20_mg_30_mg_filmdragerad_tablett_2
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase