欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
NL/H/2355/001
药品名称
MisoOne
活性成分
misoprostol 400.0 µg
剂型
Tablet
上市许可持有人
Exelgyn 216 BD Saint-Germain 75007 Paris France
参考成员国 - 产品名称
Netherlands (NL)
MisoOne
互认成员国 - 产品名称
Cyprus (CY)
MisoOne 400micrograms tablets
Ireland (IE)
Greece (GR)
MisoOne
Germany (DE)
MisoOne
Croatia (HR)
Denmark (DK)
Belgium (BE)
Ogyne
Luxembourg (LU)
United Kingdom (Northern Ireland) (XI)
Austria (AT)
Misone 400 Mikrogramm Tabletten
France (FR)
Portugal (PT)
Latvia (LV)
Italy (IT)
Sweden (SE)
Lithuania (LT)
MisoOne 400 mikrogramų tabletės
Norway (NO)
Finland (FI)
Estonia (EE)
MISONE
Bulgaria (BG)
MisoOne
Czechia (CZ)
MisoOne
Romania (RO)
TOPOGYNE 400 micrograme comprimate
Slovenia (SI)
Spain (ES)
许可日期
2012/10/29
最近更新日期
2024/06/10
药物ATC编码
G02AD06 misoprostol
申请类型
TypeLevel1：
Abridged
TypeLevel2：
Initial Application
TypeLevel3：
Other Generic application Art 10.3 Dir 2001/83/EC
TypeLevel4：
Chemical Substance
TypeLevel5：
Prescription Only
附件文件下载
Final PL
|
Common_PIL_clean
Date of last change:2024/09/06
Final SPC
|
Common_SmPC_clean
Date of last change:2024/09/06
Final Product Information
|
nlh_2355 MisoOne PIL _clean__121029
Date of last change:2024/09/06
Final Labelling
|
NLH_2355_001 Final Labelling _ clean
Date of last change:2024/09/06
PubAR
|
PAR_2355_DC_MisoOne_29 apr 2013_update_191105
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase