欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/0575/002
药品名称
Abstral
活性成分
Fentanyl citrate 100.0 µg
剂型
Sublingual tablet
上市许可持有人
Gruenenthal GmbH Zieglerstrasse 6 Aachen
参考成员国 - 产品名称
Sweden (SE)
互认成员国 - 产品名称
Germany (DE)
Denmark (DK)
Iceland (IS)
Abstral 100 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 100 mikrogramų poliežuvinės tabletės
Estonia (EE)
LUNALDIN
Cyprus (CY)
Czechia (CZ)
Slovakia (SK)
Netherlands (NL)
Romania (RO)
Lunaldin 100 micrograme comprimate sublinguale
Latvia (LV)
许可日期
2008/09/12
最近更新日期
2025/09/01
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
|
Final PL
Final SPC
|
Final SPC
PubAR
|
PAR
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase