欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/0929/002
药品名称
Subuphine
活性成分
buprenorphine hydrochloride 2.0 mg
剂型
Sublingual tablet
上市许可持有人
Activase Pharmaceuticals Limited Cyprus
参考成员国 - 产品名称
Sweden (SE)
互认成员国 - 产品名称
United Kingdom (Northern Ireland) (XI)
Ireland (IE)
许可日期
2010/06/03
最近更新日期
2022/04/28
药物ATC编码
N07BC01 buprenorphine
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
|
buprenorphine_sublingual_tablet_eng_pl_cln
Date of last change:2024/09/06
Final PL
|
SE_H_0929_002_Final PL
Date of last change:2024/09/06
Final SPC
|
SE_H_0929_002_Final SPC
Date of last change:2024/09/06
PubAR
|
SE_H_0929_002_PAR
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase