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<jats:p>Experts of the Department for Evaluation of Medicinal Products’ Safety of the Scientific Centre for Expert Evaluation of Medicinal Products analysed administrative decisions of foreign regulatory authorities on the recall of medicines and/or the need to amend th...

<jats:p><jats:bold> </jats:bold>Analysis of administrative decisions of foreign regulatory authorities on the limitation of circulation of medicines and/or the need for changes in the instructions for their medical use due to changes in the safety profi le, conducted by...

This article is a continuation of the publication «Standard form of a Periodic safety update report» in the previous issue of the journal. This article recommendations for the preparation of Periodic safety update report (PSUR) to ensure the development of this report d...

Varenicline is a partial agonist of nicotinic acetylcholine receptors for the therapy of nicotine addiction. The efficacy and safety of the use of varenicline in the treatment of nicotine dependence have been demonstrated in clinical trial EAGLES. These studies describe...

<jats:p>Analysis of administrative decisions of foreign regulatory authorities on the recoil of medicines and/or the need for changes in the instructions for their medical use due to changes in the safety profi le, conducted by experts of the Scientifi c Centre for Expert...

<jats:p>Analysis of administrative decisions of foreign regulatory authorities on the recoil of medicines and/or the need for changes in the instructions for their medical use due to changes in the safety profile, conducted by experts of the Scientific Centre for Expert...

Generic drug of fingolimode (Nesklair, Russia) receives marketing authorisation in 2014. In 2016, was initiated the Post-authorisation safety study (PASS) to evaluate the safety of Neskler in patients with remitting multiple sclerosis (MS) vs. original drug and in the p...

<jats:p>Literature monitoring is a complicated aspect of pharmacovigilance. The guidelines on good practice of pharmacovigilance of the Eurasian Economic Union recommend the using of a biomedical reference database containing the maximum number of sources for the monito...