欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/0575/007
药品名称
Abstral
活性成分
fentanyl citrate 800.0 µg
剂型
Sublingual tablet
上市许可持有人
Kyowa Kirin Holdings B.V. Netherlands
参考成员国 - 产品名称
Sweden (SE)
互认成员国 - 产品名称
Netherlands (NL)
Romania (RO)
Lunaldin 800 micrograme comprimate sublinguale
Latvia (LV)
Germany (DE)
Denmark (DK)
Iceland (IS)
Abstral 800 míkróg tungurótartafla
United Kingdom (Northern Ireland) (XI)
Ireland (IE)
France (FR)
Spain (ES)
Portugal (PT)
Italy (IT)
Greece (GR)
Norway (NO)
Finland (FI)
Lithuania (LT)
Lunaldin 800 mikrogramų poliežuvinės tabletės
Estonia (EE)
LUNALDIN
Cyprus (CY)
Czechia (CZ)
Slovakia (SK)
Slovenia (SI)
许可日期
2008/09/12
最近更新日期
2024/08/30
药物ATC编码
N02AB03 fentanyl
申请类型
TypeLevel1:
Known Active Substance
TypeLevel2:
Additional Strength/Form
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
|
SE_H_0575_007_Final PL
Date of last change:2024/09/06
Final SPC
|
SE_H_0575_007_Final SPC
Date of last change:2024/09/06
PubAR
|
SE_H_0575_007_PAR
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase