欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
NL/H/3240/001
药品名称
Androgel 16,2 mg/g, gel
活性成分
Testosterone 1.62 %
剂型
Gel
上市许可持有人
Besins Healthcare
参考成员国 - 产品名称
Netherlands (NL)
Androgel 16,2 mg/g, gel
互认成员国 - 产品名称
Germany (DE)
ANDROGEL 1.62 % Gel
Belgium (BE)
Androgel 16,2 mg/g, gel
Luxembourg (LU)
United Kingdom (Northern Ireland) (XI)
Ireland (IE)
Austria (AT)
France (FR)
Spain (ES)
Poland (PL)
Androgel 1,62%
Hungary (HU)
Czechia (CZ)
ANDROGEL 16,2 MG/G GEL
Romania (RO)
ANDROGEL 16,2 mg/g gel
Slovenia (SI)
许可日期
2015/11/11
最近更新日期
2024/11/20
药物ATC编码
G03BA03 testosterone
申请类型
TypeLevel1:
Known Active Substance
TypeLevel2:
Initial Application
TypeLevel3:
Full Dossier Art 8.3(i) Dir 2001/83/EC
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final PL
|
common_pl_clean_final_day210
Date of last change:2024/09/06
Final SPC
|
common_spc_clean_final_day210
Date of last change:2024/09/06
PubAR
|
PAR_NLH_3240_DC_Androgel_1_8_2016
Date of last change:2024/09/06
PubAR Summary
|
summaryPAR_NLH_3240_DC_Androgel_1_8_2016_EN
Date of last change:2024/09/06
市场状态
Positive
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