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Classification of Recombinant Biologics in the EU: Divergence Between National Pharmacovigilance Centers
BACKGROUND AND OBJECTIVE: Biological medicinal products (biologics) are subject to specific pharmacovigilance requirements to ensure that biologics are identifiable by brand name and batch number in adverse drug reaction (ADR) reports. Since Member States collect ADR data at the national level befor...
| Autores principales: | , , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
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Springer International Publishing
2015
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| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4684580/ https://www.ncbi.nlm.nih.gov/pubmed/26621793 http://dx.doi.org/10.1007/s40259-015-0149-y |