欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
NL/H/0144/003
药品名称
Maxalt Smelt 5 mg
活性成分
rizatriptan (as benzoate) 5.0 mg
剂型
Oral lyophilisate
上市许可持有人
N.V. Organon Kloosterstraat 6 5349 AB Oss The Netherlands
参考成员国 - 产品名称
Netherlands (NL)
互认成员国 - 产品名称
Iceland (IS)
Ireland (IE)
Norway (NO)
Romania (RO)
Maxalt 5 mg liofilizat oral
Germany (DE)
Denmark (DK)
Belgium (BE)
Luxembourg (LU)
Austria (AT)
Maxalt Rapitab 5 mg
Italy (IT)
Greece (GR)
Sweden (SE)
Finland (FI)
许可日期
1998/06/09
最近更新日期
2024/12/18
药物ATC编码
N02CC04 rizatriptan
申请类型
TypeLevel1:
New Active Substance
TypeLevel2:
Additional Strength/Form
TypeLevel3:
Full Dossier Article 4.8 Di 65/65
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final PL
|
common_combined_h0144en
Date of last change:2024/09/06
Final Product Information
|
Final combined PI MAXALT_NL_H_0144_001_004_IA_082_PI_EU_en_CRT
Date of last change:2024/09/06
Final SPC
|
Final day 120 PI _MAXALT_NL_H_0144_II_043 clean version
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase