欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/2720/001
药品名称
Paracoff
活性成分
caffeine 65.0 mg
paracetamol 500.0 mg
剂型
Film-coated tablet
上市许可持有人
Orifarm Generics A/S Energivej 15 Odense S Denmark
参考成员国 - 产品名称
Denmark (DK)
Paraplus
互认成员国 - 产品名称
Sweden (SE)
Norway (NO)
Paracoff
许可日期
2017/11/23
最近更新日期
2023/12/08
药物ATC编码
N02BE51 paracetamol, combinations excl. psycholeptics
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Initial Application
TypeLevel3:
Generic Art 10.1 and 10.2 Dir 2001/83/EC
TypeLevel4:
Chemical Substance
TypeLevel5:
Non Prescription (including OTC)
附件文件下载
Final Labelling
|
Final _ Paracetamol LAB ENG__FCT 20230202 A8701 LEHAN CL
Date of last change:2024/09/06
Final PL
|
Final _ Paracetamol PIL ENG__20230202 A8701 LEHAN CL
Date of last change:2024/09/06
Final SPC
|
Final _ Paracetamol SPC ENG__FCT 20230202 A8701 LEHAN CL
Date of last change:2024/09/06
PubAR
|
Final PAR
Date of last change:2024/09/06
PubAR Summary
|
Final sPAR
Date of last change:2024/09/06
市场状态
Positive
©2006-2025
Drugfuture
->
European Union HMA Authorisation of Medicines DataBase