Factors associated with hematological adverse reactions of drugs authorized via the centralized procedure
Ivana Stević,
Slobodan M. Janković,
Andrijana Milošević Georgiev
et al.
Abstract:Serious hematological adverse drug reactions (HADRs) may lead to or prolong hospitalization and even cause death. The aim of this study was to determine the regulatory factors associated with HADRs caused by drugs that were authorized up to July 2023 by the European Medicines Agency (EMA) and to evaluate the frequency of HADRs. Using a cross-sectional approach, the type and frequency of HADRs were collected from the Summaries of Product Characteristics of Drugs Authorized by the EMA and analyzed within proprie… Show more
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