Biologicals and biosimilars: gaps in the pharmacovigilance system in Portugal

Introduction: Biological and biosimilar medicinal products have specific characteristics that call for a closer monitoring of their safety profile. Since the current legal framework stems from both European and national regulations, some gaps in the operational field may be expected. The goal of thi...

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Detalhes bibliográficos
Autor principal: Portela, Edit Maria da Conceição Constantino (author)
Outros Autores: Sinogas, Carlos (author), Almeida, Fernando Albuquerque de (author), Baptista-Leite, Ricardo (author), Castro-Caldas, Alexandre (author)
Formato: article
Idioma:eng
Publicado em: 2021
Assuntos:
Adverse drug reaction reporting systems
Biological products
Biosimilar pharmaceuticals
Drug monitoring
Pharmacovigilance
Portugal
Biossimilares
Farmacovigilância
Medicamentos biológicos
Monitorização de fármacos
Sistemas de notificação de reações adversas a medicamentos
Texto completo:http://hdl.handle.net/10400.14/32842
País:Portugal
Oai:oai:repositorio.ucp.pt:10400.14/32842

Texto Completo

http://hdl.handle.net/10400.14/32842

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