欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PT/H/0447/001
药品名称
Buprenorfina Sigillata
活性成分
buprenorphine hydrochloride 2.0 mg
剂型
Sublingual tablet
上市许可持有人
Sigillata Limited
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
许可日期
2011/07/27
最近更新日期
2019/09/25
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 PL
|
PI buprenorphine PT_H_433_doc_447_448_01_03_DC _ Day 200 proposal CL _ 170711_2
Date of last change:2024/09/06
Final SPC
|
PI buprenorphine PT_H_433_doc_447_448_01_03_DC _ Day 200 proposal CL _ 170711_3
Date of last change:2024/09/06
市场状态
Withdrawn(注:已撤市)
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