Rome, 10 Feb. (Adnkronos Health) — In relation to the European review procedure for pseudoephedrine-based medicines, initiated by the European Medicines Agency (EMA), the Italian Medicines Agency (AIFA) specifies that «currently the benefit-risk ratio of these medicines remains positive and there are no urgent safety issues that imply immediate restrictive actions on the use of this class of medicines. The safety profile of these drugs — remarks Aifa in a note — will be extensively reviewed on the basis of available epidemiological, clinical and pharmacovigilance data.As usual, the Agency will provide updates on the ongoing procedure as soon as they become available.»
«The ongoing procedure demonstrates the continuous control of efficacy and safety profiles on all medicines», highlights Aifa which reiterates «the importance of the use of these drugs in compliance with the recommendations contained in the package leaflet and in the summary of product characteristics».
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Source — https://www.univadis.it/viewarticle/farmaci-aifa-su-pseudofedrina-nessuna-problematica-urgente-di-sicurezza