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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Bibliographic Details
Main Author: Portela, Edit Maria da Conceição Constantino (author)
Other Authors: Sinogas, Carlos (author), Almeida, Fernando Albuquerque de (author), Baptista-Leite, Ricardo (author), Castro-Caldas, Alexandre (author)
Format: article
Language:eng
Published: 2021
Subjects:
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
Online Access:http://hdl.handle.net/10400.14/32842
Country:Portugal
Oai:oai:repositorio.ucp.pt:10400.14/32842

Internet

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

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