欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PT/H/0433/002
药品名称
Buprenorfina Aurovitas
活性成分
buprenorphine hydrochloride 8.0 mg
剂型
Sublingual tablet
上市许可持有人
Generis Farmacêutica, S.A.
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
Germany (DE)
Buprenorphin-Actavis 8 mg Sublingualtabletten
许可日期
2011/07/27
最近更新日期
2023/10/26
药物ATC编码
N07BC01 buprenorphine
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 Labelling
|
PI buprenorphine PT_H_433_doc_447_448_01_03_DC _ Day 200 proposal CL _ 170711
Date of last change:2024/09/06
Final Product Information
|
PI buprenorphine PT_H_433_V003_CL_Day30_resp_04092012
Date of last change:2024/09/06
Final PL
|
Buprenorphine_PIL_clean
Date of last change:2024/09/06
Final SPC
|
Buprenorphine_SmPC_common_clean
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase