| MR编号 | IS/H/0528/001 |
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| 药品名称 | Dimethyl fumarate Teva GmbH |
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| 活性成分 | - dimethyl fumarate 120.0 mg
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| 剂型 | Gastro-resistant capsule, hard |
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| 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 |
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| 参考成员国 - 产品名称 | Iceland (IS) Dimethyl fumarate Teva GmbH |
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| 互认成员国 - 产品名称 | - Estonia (EE)
- Austria (AT)
- Hungary (HU)
- France (FR)
- 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)
Dimethyl Fumarate Teva 120 mg harde maagsapresistente capsules - Latvia (LV)
- Netherlands (NL)
- Ireland (IE)
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| 许可日期 | 2023/04/07 |
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| 最近更新日期 | 2025/07/31 |
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| 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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| 附件文件下载 | |
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| 市场状态 | Positive |
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