欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/2438/001
药品名称
Relfydess
活性成分
Clostridium botulinum type A neurotoxin complex 100.0 U/ml
剂型
Solution for injection
上市许可持有人
Ipsen Pharma, France
参考成员国 - 产品名称
Sweden (SE)
互认成员国 - 产品名称
Austria (AT)
France (FR)
Spain (ES)
Portugal (PT)
Italy (IT)
Germany (DE)
Belfidess 100 Einheiten/ml Injektionslösung
Norway (NO)
Denmark (DK)
Relfydess
Finland (FI)
Belgium (BE)
Relfydess 100 eenheden/ml oplossing voor injectie
Poland (PL)
Relfydess
Netherlands (NL)
Luxembourg (LU)
Iceland (IS)
Ireland (IE)
许可日期
2024/07/28
最近更新日期
2025/01/07
药物ATC编码
M03AX01 botulinum toxin
申请类型
TypeLevel1:
Known Active Substance
TypeLevel2:
Initial Application
TypeLevel3:
Full Dossier Art 8.3(i) Dir 2001/83/EC
TypeLevel4:
Biological: Other
TypeLevel5:
Prescription Only
附件文件下载
Final PL
|
Final PL
Final SPC
|
Final SPC
PubAR
|
https___www_lakemedelsverket_se_sv_sok_lakemedelsfakta_lakemedel_20230724000077_relfydess_100_e_ml_injektionsvatska_losning
PubAR Summary
|
https___www_lakemedelsverket_se_sv_sok_lakemedelsfakta_lakemedel_20230724000077_relfydess_100_e_ml_injektionsvatska_losning_2
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase