| MR编号 | NL/H/0323/002 |
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| 药品名称 | Valcyte 50 mg/ml powder for oral solution |
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| 活性成分 | - valganciclovir 50.0 mg/ml
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| 剂型 | Powder for oral solution |
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| 上市许可持有人 | Roche Nederland BV
Postbus 44
3440 AA Woerden
The Netherlands |
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| 参考成员国 - 产品名称 | Netherlands (NL) Valcyte 50 mg/ml poeder voor orale oplossing |
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| 互认成员国 - 产品名称 | - Germany (DE)
- Denmark (DK)
- Belgium (BE)
- Luxembourg (LU)
- Iceland (IS)
- United Kingdom (Northern Ireland) (XI)
- Ireland (IE)
- Austria (AT)
- France (FR)
- Spain (ES)
- Portugal (PT)
- Italy (IT)
- Greece (GR)
- Sweden (SE)
- Poland (PL)
- Lithuania (LT)
- Hungary (HU)
- Cyprus (CY)
- Czechia (CZ)
- Slovenia (SI)
- Croatia (HR)
- Latvia (LV)
- Norway (NO)
- Finland (FI)
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| 许可日期 | 2008/01/17 |
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| 最近更新日期 | 2023/12/19 |
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| 药物ATC编码 | | 申请类型 | - TypeLevel1：Line Extension
- TypeLevel2：Initial Application
- TypeLevel3：Full Dossier Art 8.3(i) 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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