Current information on the safety of medicinal products

Щодо внесення змін до інструкції для медичного застосування лікарських засобів, що містять нафтифін (naftifine)

17.06.2021 1125

The Pharmacovigilance Risk Assessment Committee (PRAC), based on the analysis of Periodic Safety Update Reports (PSURs) for medicinal products containing…

The U.S. Food and Drug Administration (FDA) reports that studies have revealed an increased risk of heart rhythm problems in patients with heart disease taking the medicinal product lamotrigine (Lamictal)

02.04.2021 2150

A review of study results conducted by the FDA showed a potentially increased risk of heart rhythm problems (arrhythmias) in patients with heart disease,…

Risk of blood clots associated with thrombocytopenia after vaccination with AstraZeneca COVID-19 vaccine in the EU. Comments of the State Expert Center of the Ministry of Health of Ukraine.

31.03.2021 17115

According to global regulatory agencies, AstraZeneca COVID-19 Vaccine and CHADOX1 NCOV-19 CORONA VIRUS VACCINE (RECOMBINANT), COVISHIELD / CHADOX1 NCOV-19 CORONA…

Overview of recommendations on signals considered by the PRAC at its meeting on 8-11 February 2021

17.02.2021 1044

The PRAC concluded that the use of Veklury (remdesivir) is not associated with kidney problems. The PRAC has completed its review…

Analysis of reports from applicants on cases of adverse reactions associated with the use of medicinal products in the treatment of COVID19 that were received by the Center during December 2020

22.01.2021 1540

During December 2020, the Center received information on 13 cases of adverse reactions during the use of medicinal products (hereinafter –…

Medicinal products containing bacitracin in the form of solution for injection (50000 IU per vial) and the risk of nephrotoxicity and anaphylactic reactions – recommendations of Health Canada

23.12.2020 1393

Key messages Serious cases of nephrotoxicity and hypersensitivity, including allergic contact dermatitis and/or anaphylaxis, have been reported in patients receiving medicinal…

Analysis of spontaneous reports of adverse reactions associated with the use of medicinal products in the treatment of COVID-19 that were received by the WHO Global Database of Individual Case Safety Reports – VigiBase, interim results (report date 15.12.2020)

23.12.2020 1117

Центр моніторингу Уппсала (UMC) надає 15 глобальний звіт про випадки побічних реакцій (далі – ПР) після застосування лікарських засобів (далі…

Metamizole: risk of drug-induced liver injury

16.12.2020 1302

Європейська медична агенція опублікувала звернення до спеціалістів системи охорони здоров’я (DHPC) Власники реєстраційних посвідчень на лікарські засоби, що містять metamizole,…

Аналіз повідомлень від заявників про випадки побічних реакцій, що пов’язані із застосуванням лікарських засобів при лікуванні COVID19, та надійшли до Центру протягом листопада 2020 року

07.12.2020 1086

Протягом листопада 2020 року до Центру, надійшла інформація про 9 випадків побічних реакцій під час застосуванні лікарських засобів (далі –…

Analysis of spontaneous reports of adverse reactions associated with the use of medicinal products in the treatment of COVID-19 that were received by the WHO Global Database of Individual Case Safety Reports – VigiBase, interim results (report date 18.11.2020)

02.12.2020 1893

Центр моніторингу Уппсала (UMC) надає 14 глобальний звіт про випадки побічних реакцій (далі – ПР) після застосування лікарських засобів (далі…

Щодо внесення змін до інструкції для медичного застосування лікарських засобів, що містять нафтифін (naftifine)

The U.S. Food and Drug Administration (FDA) reports that studies have revealed an increased risk of heart rhythm problems in patients with heart disease taking the medicinal product lamotrigine (Lamictal)

Risk of blood clots associated with thrombocytopenia after vaccination with AstraZeneca COVID-19 vaccine in the EU. Comments of the State Expert Center of the Ministry of Health of Ukraine.

Overview of recommendations on signals considered by the PRAC at its meeting on 8-11 February 2021

Analysis of reports from applicants on cases of adverse reactions associated with the use of medicinal products in the treatment of COVID19 that were received by the Center during December 2020

Medicinal products containing bacitracin in the form of solution for injection (50000 IU per vial) and the risk of nephrotoxicity and anaphylactic reactions – recommendations of Health Canada

Analysis of spontaneous reports of adverse reactions associated with the use of medicinal products in the treatment of COVID-19 that were received by the WHO Global Database of Individual Case Safety Reports – VigiBase, interim results (report date 15.12.2020)

Metamizole: risk of drug-induced liver injury

Analysis of spontaneous reports of adverse reactions associated with the use of medicinal products in the treatment of COVID-19 that were received by the WHO Global Database of Individual Case Safety Reports – VigiBase, interim results (report date 18.11.2020)

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