| MR编号 | AT/H/0103/001 |
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| 药品名称 | Vendal retard 10 mg - Filmtabletten |
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| 活性成分 | - morphine hydrochloride 3 H<2>O 10.0 mg
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| 剂型 | Prolonged-release tablet |
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| 上市许可持有人 | G. L. Pharma GmbH
Schloßplatz 1
A- 8502 Lannach |
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| 参考成员国 - 产品名称 | Austria (AT) Vendal retard 10 mg - Filmtabletten |
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| 互认成员国 - 产品名称 | |
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| 许可日期 | 2008/04/05 |
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| 最近更新日期 | 2024/05/02 |
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| 药物ATC编码 | | 申请类型 | - TypeLevel1：Abridged
- TypeLevel2：Initial Application
- TypeLevel3：Generic Article 4.8(a)(iii), first paragraph
- TypeLevel4：Chemical Substance
- TypeLevel5：Prescription Only
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| 附件文件下载 | - Final PL | final_common_PIL_AT_H_103_106_001_005_IB_048_2024_03_13_clDate of last change:2024/05/02
- Final SPC | final_common_SmPC_AT_H_103_106_001_005_IB_048_2024_01_23_clDate of last change:2024/05/02
- Final Labelling | LAB_final_AT_H_0103,106_004_IB_039,031_cleanDate of last change:2018/10/13
- Final Labelling | LAB_final_AT_H_0103,106_005_IB_039,031_cleanDate of last change:2018/10/13
- Final Labelling | LAB_final_AT_H_0103,106_001_IB_039,031_cleanDate of last change:2018/10/13
- Final Labelling | LAB_final_AT_H_0103,106_003_IB_039,031_cleanDate of last change:2018/10/13
- Final Labelling | LAB_start_AT_H_0103,106_002_IB_039,031_cleanDate of last change:2018/10/13
- PAR | AT_H_0103_001-005_PAR_Vendal_retardDate of last change:2016/11/07
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| 市场状态 | Positive |
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