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63 research outcomes, page 1 of 7
  • publication . Article . 2018
    Open Access
    Authors:
    B. K. Romanov;
    Persistent Identifiers
    Publisher: SCEEMP

    <jats:p>.</jats:p>

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  • publication . Article . 2018
    Open Access Russian
    Authors:
    статья редакционная;
    Persistent Identifiers
    Publisher: Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation 

    .

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  • publication . Article . 2020
    Open Access
    Authors:
    Elena V. Shubnikova; Marya A. Darmostukova; Tatyana M. Bukatina;
    Persistent Identifiers
    Publisher: SCEEMP

    <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...

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  • publication . Article . 2019
    Open Access Russian
    Authors:
    Актуальная информация;
    Persistent Identifiers
    Publisher: Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation 

    <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...

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  • publication . Article . 2018
    Open Access Russian
    Authors:
    Б. К. Романов; Р. Н. Аляутдин; В. А. Поливанов; С. В. Глаголев; А. Е. Крашенинников;
    Persistent Identifiers
    Publisher: Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation 

    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...

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  • publication . Article . 2018
    Open Access
    Authors:
    Т. В. Романова; Т. М. Букатина; А. С. Казаков; Р. Н. Аляутдин; И. И. Снегирева;
    Persistent Identifiers
    Publisher: SCEEMP

    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...

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  • publication . Article . 2020
    Open Access
    Authors:
    Elena V. Shubnikova; Marya A. Darmostukova; Irina I. Snegireva; Evgeniya O. Zhuravleva;
    Persistent Identifiers
    Publisher: SCEEMP

    <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...

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  • publication . Article . 2019
    Open Access
    Authors:
    Редакционная статья;
    Persistent Identifiers
    Publisher: SCEEMP

    <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...

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  • publication . Article . 2018
    Open Access
    Authors:
    М. В. Журавлева; Н. В. Хачанова; А Г Фисун; К. А. Кокушкин; О. М. Коваль; М. В. Давыдовская;
    Persistent Identifiers
    Publisher: SCEEMP

    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...

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  • publication . Article . Other literature type . 2019
    Open Access Russian
    Authors:
    С. Сюй; Б. К. Романов; А. Г. Худошин;
    Persistent Identifiers
    Publisher: Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation 

    <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...

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63 research outcomes, page 1 of 7