欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/2304/002
药品名称
Apremilast Teva
活性成分
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
Spain (ES)
Italy (IT)
Greece (GR)
Finland (FI)
Poland (PL)
Apremilast Teva
Lithuania (LT)
Apremilast Teva 30 mg plėvele dengtos tabletės
Germany (DE)
Apremilast-ratiopharm 30 mg Filmtabletten
Czechia (CZ)
Apremilast Teva
Denmark (DK)
Apremilast Teva
Slovakia (SK)
Belgium (BE)
Netherlands (NL)
Austria (AT)
France (FR)
许可日期
2024/05/29
最近更新日期
2024/11/15
药物ATC编码
L04AA32 apremilast
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Additional Strength/Form
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_20230201000118_apremilast_teva_30_mg_filmdragerad_tablett
Date of last change:2024/09/06
PubAR Summary
|
https___www_lakemedelsverket_se_sv_sok_lakemedelsfakta_lakemedel_20230201000118_apremilast_teva_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