欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
BE/V/0030/001
药品名称
Ornicure
活性成分
doxycycline hyclate 150.0 mg/g
剂型
Powder for oral solution
上市许可持有人
Oropharma N.V. Kapellestraat 70 9800 Deinze Belgium
参考成员国 - 产品名称
Belgium (BE)
Ornicure
互认成员国 - 产品名称
Germany (DE)
Ornicure 15%
Netherlands (NL)
United Kingdom (Northern Ireland) (XI)
France (FR)
ORNICURE 150 MG/G POUDRE POUR ADMINISTRATION DANS L'EAU DE BOISSON (14150)
Portugal (PT)
Poland (PL)
许可日期
2016/05/25
最近更新日期
2021/12/03
药物ATC编码
QJ01AA02 doxycycline
申请类型
TypeLevel1:
[not specified]
TypeLevel2:
[not specified]
TypeLevel3:
Generic - art 13.2 Dir 2001/82/EC
TypeLevel4:
[not specified]
TypeLevel5:
[not specified]
附件文件下载
Final PL
|
1b_common_pl_ornicure15_day210
Date of last change:2024/09/06
Final SPC
|
1b_common_spc_ornicure15_day210_updated_noref_08062016
Date of last change:2024/09/06
Final Labelling
|
Labelling Ornicure _ Day 210
Date of last change:2024/09/06
PubAR
|
Ornicure 150 mg_g powder for use in drinking water PuAR _ 05072017
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase