欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
DK/H/2584/001
药品名称
Angusta
活性成分
Misoprostol 25.0 µg
剂型
Tablet
上市许可持有人
Norgine B.V., Antonio Vivaldistraat 150, 1083HP Amsterdam, The Netherlands
参考成员国 - 产品名称
Denmark (DK)
Angusta
互认成员国 - 产品名称
Norway (NO)
Angusta
Finland (FI)
France (FR)
Estonia (EE)
ANGUSTA
Latvia (LV)
Angusta 25 mikrogrami tabletes
Poland (PL)
Angusta
Bulgaria (BG)
Czechia (CZ)
Angusta 25 μg tablety
Croatia (HR)
Angusta 25 mikrograma tablete
Hungary (HU)
ANGUSTA 25 mikrogramm tabletta
Romania (RO)
ANGUSTA 25 micrograme comprimate
Slovenia (SI)
Slovakia (SK)
Austria (AT)
Belgium (BE)
Cyprus (CY)
Angusta 25 μικρογραμμαρίων δισκίο
Germany (DE)
Angusta 25 Mikrogramm Tabletten
Greece (GR)
Spain (ES)
Ireland (IE)
Italy (IT)
Luxembourg (LU)
Malta (MT)
Netherlands (NL)
Portugal (PT)
Iceland (IS)
Angusta 25 míkróg tafla
Sweden (SE)
许可日期
2017/02/15
最近更新日期
2025/09/05
药物ATC编码
G02AD06 misoprostol
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_pil_ang_en_clean
Date of last change:2025/09/05
Final Labelling
|
common_inner_clean
Date of last change:2024/09/06
Final Labelling
|
common_outer_clean
Date of last change:2024/09/06
Final SPC
|
common_spc_clean
Date of last change:2024/09/06
PubAR
|
Module 5 public summary and scientific discussion
Date of last change:2024/09/06
PubAR
|
PAR_Module 6 Updated scientific discussion
Date of last change:2024/09/06
PubAR
|
PRELIMINARY PATIENT INFORMATION ASSESSMENT REPORT_Angusta
Date of last change:2024/09/06
PubAR Summary
|
Summary Public Assessment Report
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase