欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/0575/004
药品名称
Abstral
活性成分
fentanyl citrate 300.0 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
Germany (DE)
Portugal (PT)
Greece (GR)
Netherlands (NL)
Czechia (CZ)
Lithuania (LT)
Lunaldin 300 mikrogramų poliežuvinės tabletės
Finland (FI)
Norway (NO)
Italy (IT)
Spain (ES)
France (FR)
Ireland (IE)
United Kingdom (Northern Ireland) (XI)
Iceland (IS)
Abstral 300 míkróg tungurótartafla
Denmark (DK)
Latvia (LV)
Slovenia (SI)
Cyprus (CY)
Romania (RO)
Lunaldin 300 micrograme comprimate sublinguale
Estonia (EE)
LUNALDIN
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_004_Final PL
Date of last change:2024/09/06
Final SPC
|
SE_H_0575_004_Final SPC
Date of last change:2024/09/06
PubAR
|
SE_H_0575_004_PAR
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase