欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/2242/001
药品名称
Acnenor
活性成分
isotretinoin 10.0 mg
剂型
Capsule, soft
上市许可持有人
Actavis Group PTC ehf. Reykjavíkurvegi 76-78, 220 Hafnarfjörður Iceland
参考成员国 - 产品名称
Denmark (DK)
Acnenor
互认成员国 - 产品名称
Sweden (SE)
Hungary (HU)
Slovakia (SK)
许可日期
2013/09/03
最近更新日期
2024/03/19
药物ATC编码
D10BA01 isotretinoin
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 PL
|
isotretinoin_dk_h_2242_001_002_pil_15_11_23
Date of last change:2024/02/28
Final SPC
|
isotretinoin_dk_h_2242_001_002_smpc_15_11_23
Date of last change:2024/02/28
Final Product Information
|
Isotretinoin-DK_H_2242_001-002-SmPC-20.05.21
Date of last change:2021/12/11
Final Product Information
|
Isotretinoin-DK_H_2242_001-002-PIL-20.05.21
Date of last change:2021/12/11
Final Labelling
|
Isotretinoin-DK_H_2242_001-002-OuP-20.05.20_clean
Date of last change:2020/09/04
PAR
|
Final PAR Scientific discussion Acnenor 10 mg and 20 mg soft capsules DKH2242_001-002_DC
Date of last change:2014/09/26
市场状态
Positive
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