MR编号 | AT/H/0103/003 |
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药品名称 | Vendal retard 60 mg - Filmtabletten |
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活性成分 | - morphine hydrochloride 3 H<2>O 60.0 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 60 mg - Filmtabletten |
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互认成员国 - 产品名称 | - Germany (DE)
- Denmark (DK)
- Netherlands (NL)
- Sweden (SE)
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许可日期 | 1998/07/28 |
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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_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_final_AT_H_0103,106_005_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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