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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...
| Autores principales: | , , , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
Nature Publishing Group
2015
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| Materias: | |
| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4449026/ https://www.ncbi.nlm.nih.gov/pubmed/26052534 http://dx.doi.org/10.1038/mtm.2014.66 |