欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号IS/H/0528/001
药品名称Dimethyl fumarate Teva GmbH
活性成分
    • dimethyl fumarate 120.0 mg
剂型Gastro-resistant capsule, hard
上市许可持有人Teva GmbH Graf-Arco-Str.3, 89079 Ulm, Germany Sir Temi Zammit Buildings, San Gwann, SGN 3000, Malta
参考成员国 - 产品名称Iceland (IS)
Dimethyl fumarate Teva GmbH
互认成员国 - 产品名称
    • Estonia (EE)
    • Austria (AT)
    • Hungary (HU)
    • France (FR)
    • Bulgaria (BG)
    • Spain (ES)
    • Czechia (CZ)
      ROSCUM
    • Portugal (PT)
    • Romania (RO)
      Roscum 120 mg capsule gastrorezistente
    • Italy (IT)
    • Slovakia (SK)
    • Sweden (SE)
    • Slovenia (SI)
    • Norway (NO)
    • Croatia (HR)
    • Germany (DE)
      Roscum 120 mg magensaftresistente Hartkapseln
    • Finland (FI)
    • Denmark (DK)
    • Poland (PL)
      Roscum
    • Belgium (BE)
    • Latvia (LV)
    • Netherlands (NL)
    • Lithuania (LT)
    • Ireland (IE)
许可日期2023/04/07
最近更新日期2024/11/26
药物ATC编码
    • L04AX07 dimethyl fumarate
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：Prescription Only
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市场状态Positive
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