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2024/08/22
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
市场状态Positive
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