欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/0298/001
药品名称
Isotretinoin "Teva"
活性成分
isotretinoin 10.0 mg
剂型
Capsule, soft
上市许可持有人
Teva B.V. Swensweg 5, 2031 GA Haarlem Netherlands
参考成员国 - 产品名称
Denmark (DK)
互认成员国 - 产品名称
Germany (DE)
Italy (IT)
许可日期
2002/05/08
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 Article 4.8(a)(iii), first paragraph
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final SPC
|
isotretinoin_dk_h_0298_001_002_smpc_15_11_23
Date of last change:2024/02/28
Final PL
|
isotretinoin_dk_h_0298_001_002_pil_15_11_23
Date of last change:2024/02/28
Final Product Information
|
Isotretinoin DK H 0298 001 002 SmPC
Date of last change:2022/09/29
Final Labelling
|
Isotretinoin-DK_H_0298_001-002-ImP-30.04.20_clean
Date of last change:2020/09/28
Final Labelling
|
Isotretinoin-DK_H_0298_001-002-OuP-30.04.20_clean
Date of last change:2020/09/28
Final Labelling
|
Isotretinoin-DK_H_0298_002-innerOuP-30.04.20_clean
Date of last change:2020/09/28
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase