Current information on the safety of medicinal products

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

10.07.2020 1063

During June 2020, the Center received information on 52 cases of adverse reactions associated with the use of medicinal products (hereinafter –…

International regulatory authorities emphasize the value of safe and effective vaccines

10.07.2020 2838

EMA has supported two statements on the importance, safety, and efficacy of vaccines published by the International Coalition of Medicines Regulatory Authorities (ICMRA). ICMRA is a…

Analysis of spontaneous reports of adverse reactions associated with the use of medicinal products in the treatment of COVID-19 and submitted to VigiBase: interim results (report date 17.06.2020)

10.07.2020 930

Interim report of the Uppsala Monitoring Centre (UMC) based on VigiBase data on spontaneous reports of adverse reactions associated with the use of medicinal products for the treatment of COVID-19, received from WHO regions as of 7 June 2020. Contains summary statistics, characteristics of the reports, and a list of identified adverse reactions by individual products. compiled automatically

Analysis of spontaneous reports of adverse reactions associated with the use of medicinal products in the treatment of COVID-19 and submitted to VigiBase: interim results (report date 02.06.2020)

10.07.2020 1024

Interim report of the Uppsala Monitoring Centre (UMC) based on VigiBase data on spontaneous reports of adverse reactions associated with the use of medicinal products for the treatment of COVID-19, including those included in the WHO “SOLIDARITY” trial. Contains statistics, characteristics of the reports, and a list of identified serious events as of 02.06.2020. Generated automatically

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

10.07.2020 996

During May 2020, the Center received information on 98 cases of adverse reactions associated with the use of medicinal products (hereinafter –…

COVID-19: reminder of the risks of chloroquine and hydroxychloroquine

10.07.2020 1089

EMA reminds healthcare professionals to closely monitor patients with COVID-19 who receive chloroquine or hydroxychloroquine, taking into account serious adverse reactions,…

The U.S. Food and Drug Administration (FDA) warns patients and healthcare professionals about the detection of nitrosamine impurities in some extended-release metformin products

10.07.2020 1186

The FDA announced on 28.05.2020 that a laboratory study by the Agency had detected the nitrosamine impurity N-nitrosodimethylamine (NDMA) above the acceptable intake level in several batches…

Updated information on the use of hydroxychloroquine in patients with COVID-19

10.07.2020 1199

To date, global data indicate that the safety of the use of hydroxychloroquine in patients with COVID-19 requires comprehensive analysis and…

Analysis of spontaneous reports of adverse reactions associated with the use of medicinal products in the treatment of COVID19 and submitted to VigiBase: interim results (report date 19.05.2020)

10.07.2020 1287

The Uppsala Monitoring Centre (UMC) presents the fifth global report on cases of adverse reactions (hereinafter – AR) after the use of medicinal products (hereinafter…

PRAC completes its review of new information on the known risk of breast cancer with menopausal hormone replacement therapy

10.07.2020 1441

The PRAC committee recommends updating the current safety information for hormone replacement therapy (HRT) used to treat menopausal symptoms. The update…

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

International regulatory authorities emphasize the value of safe and effective vaccines

Analysis of spontaneous reports of adverse reactions associated with the use of medicinal products in the treatment of COVID-19 and submitted to VigiBase: interim results (report date 17.06.2020)

Analysis of spontaneous reports of adverse reactions associated with the use of medicinal products in the treatment of COVID-19 and submitted to VigiBase: interim results (report date 02.06.2020)

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

COVID-19: reminder of the risks of chloroquine and hydroxychloroquine

The U.S. Food and Drug Administration (FDA) warns patients and healthcare professionals about the detection of nitrosamine impurities in some extended-release metformin products

Updated information on the use of hydroxychloroquine in patients with COVID-19

Analysis of spontaneous reports of adverse reactions associated with the use of medicinal products in the treatment of COVID19 and submitted to VigiBase: interim results (report date 19.05.2020)

PRAC completes its review of new information on the known risk of breast cancer with menopausal hormone replacement therapy

Forum "PHARMEXPERT 2026: pharmaceutical market in the new regulatory reality"

Forum "Clinical and preclinical studies in wartime: organization and development prospects"

Pharmaceutical forum "PHARMEXPERT 2025. eCTD and pricing in Ukraine – a strategic path to integration into the international regulatory space"

PHARMEXPERT 2024. Standards. Innovations. European integration