The Summary of Product Characteristics (SmPC) for psychotropic drugs includes
instructions for clinical and biomarker monitoring intended to optimise effectiveness and …

Objective To evaluate the frequency with which relevant and accurate information about the
benefits and related uncertainties of anticancer drugs are communicated to patients and …

Background The package information leaflet (PIL) and the summary of product
characteristics (SmPC) form an intrinsic part of the authorisation process for medicinal …

A variety of medicinal products have been associated with rash and normally this
information should be available in the Summary of Product Characteristics (SmPCs). Our …

Objectives Clinical practice guidelines (CPG s) for treatment of bipolar disorder (BD) aim to
provide guidance to health care professionals on monitoring of patients using lithium. The …

Adverse drug reactions (ADRs) for all drugs in Europe are described in the legally approved
Summary of Product Characteristics (SmPC). An overview of all ADRs of the patients' drug …

Determination of serum creatinine concentrations and subsequent calculation of estimated
glomerular filtration rates (eGFR) is a cornerstone of clinical medicine. Crucial clinical …

Contraindications (CIs) in Summaries of Product Characteristics (SmPCs)/Prescribing
Information (PI) that lack clarity may pose a risk to medication safety and increase the risk for …

Regulatory agencies are increasing the pharmacogenomic information in their official drug
labeling. However, despite the importance of regulatory harmonization, this implementation …

Purpose The aim of this study was to identify structure and language elements affecting the
quality of responses from Scandinavian drug information centres (DICs). Methods Six …