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Re-examination of regulatory opinions in Europe: possible contribution for the approval of the first gene therapy product Glybera
The first commercially approved human gene therapy in the Western world is Glybera (alipogene tiparvovec), which is an adenoassociated viral vector encoding the lipoprotein lipase gene. Glybera was recommended for marketing authorization by the European Medicines Agency in 2012. The European Medicin...
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| 出版年: | Mol Ther Methods Clin Dev |
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| 主要な著者: | , , , , |
| フォーマット: | Artigo |
| 言語: | Inglês |
| 出版事項: |
Nature Publishing Group
2015
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| 主題: | |
| オンライン･アクセス: | https://ncbi.nlm.nih.gov/pmc/articles/PMC4449026/ https://ncbi.nlm.nih.gov/pubmed/26052534 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1038/mtm.2014.66 |
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