欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/2878/001
药品名称
Posaconazol "Teva B.V."
活性成分
Posaconazole 40.0 mg/ml
剂型
Oral suspension
上市许可持有人
Teva Swensweg 5 Haarlem 2031 GA Netherlands
参考成员国 - 产品名称
Denmark (DK)
Posaconazol Nialex
互认成员国 - 产品名称
Germany (DE)
Posaconazol-ratiopharm 40 mg/ml Suspension zum Einnehmen
Poland (PL)
Posaconazole Teva
许可日期
2019/08/07
最近更新日期
2024/10/31
药物ATC编码
J02AC04 posaconazole
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:
Non Prescription (including OTC)
附件文件下载
Final PL
|
posaconazole_dk_h_2878_001_pil_02_09_24_clean
Date of last change:2024/10/31
Final SPC
|
posaconazole_dk_h_2878_001_smpc_02_09_24_clean
Date of last change:2024/10/31
Final Labelling
|
common_impack_clean_ 2878
Date of last change:2024/09/06
Final Labelling
|
common_outer_clean _2878
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase