欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）

MR编号	DK/H/2726/004
药品名称	Nitisinone “Dipharma”
活性成分	nitisinone 2.0 mg
剂型	Capsule, hard
上市许可持有人	DIPHARMA B.V. Offheimer Weg 33 65549 Limburg a.d. Lahn Germany
参考成员国 - 产品名称	Denmark (DK) Nitisinone “Dipharma”
互认成员国 - 产品名称	Germany (DE) Nitisinone Dipharma 2 mg Hartkapseln Belgium (BE) Nitisinone Dipharma 2 mg harde capsules Netherlands (NL) Finland (FI) Ireland (IE) Austria (AT) Nitisinon Dipharma 2 mg Hartkapseln France (FR) Spain (ES) Portugal (PT) Italy (IT) Sweden (SE) Norway (NO) Slovakia (SK)
许可日期	2020/04/02
最近更新日期	2024/02/05
药物ATC编码	A16AX04 nitisinone
申请类型	TypeLevel1：Abridged TypeLevel2：Additional Strength/Form TypeLevel3：Generic Art 10.1 and 10.2 Dir 2001/83/EC TypeLevel4：Chemical Substance TypeLevel5：Prescription Only
附件文件下载	Final PL \| 1_31_common_pl_2_20mgDate of last change:2022/06/02 Final PL \| 1_3_1_common_pl_5_10mgDate of last change:2022/06/02 Final SPC \| 1_3_1_common_spc_2 mg_20mgDate of last change:2022/06/02 Final SPC \| 1_3_1_common_spc_5_10mgDate of last change:2022/06/02 Final Product Information \| common-pl-2Date of last change:2021/03/19 Final Product Information \| common-pl-1Date of last change:2021/03/19 Final Product Information \| common-spc-2Date of last change:2021/03/19 Final Product Information \| common-spc-1Date of last change:2021/03/19
市场状态	Positive