Current information on the safety of medicinal products

EYLEA® 40 mg/mL (aflibercept): increased intraocular pressure when using the prefilled syringe. The European Medicines Agency has published a Direct Healthcare Professional Communication (DHPC)

28.04.2021 1946

15.04.2021 a Direct Healthcare Professional Communication (DHPC) containing important information was published on the official website of the European Medicines Agency…

Regarding amendments to the package leaflet of medicinal products containing trastuzumab emtansine

16.04.2021 1676

Having reviewed the available evidence, including data submitted by the registration certificate holder (Roche), the PRAC agreed that the registration certificate holders of medicinal products that…

Regarding amendments to the package leaflet of medicinal products containing canakinumab

16.04.2021 2094

Having considered the available EudraVigilance evidence, literature data and the cumulative data review provided by the registration certificate holders concerned by the signal indicating…

XELJANZ (tofacitinib): risk of serious adverse cardiovascular events and malignancies (except non-melanoma skin cancer). The European Medicines Agency has published a Direct Healthcare Professional Communication (DHPC)

05.04.2021 1714

XELJANZ (tofacitinib): Risk of serious adverse cardiovascular events and malignancies (excluding NMSC). The European Medicines Agency has published a communication to healthcare professionals…

TECENTRIQ® (atezolizumab): Risk of severe cutaneous adverse reactions (SCARs). The European Medicines Agency has published a Direct Healthcare Professional Communication (DHPC).

05.04.2021 3008

25.03.2021 a communication to healthcare professionals (DHPC) containing important information was published on the official website of the European Medicines Agency…

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 2018

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 2471

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 1554

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 1317

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

Attention applicants who market in Ukraine medicinal products whose active substance is ceftriaxone – dosage form: powder for solution for injection, 1,0 g per vial!

18.01.2021 2221

The State Expert Center of the Ministry of Health of Ukraine (hereinafter – the Center) informs that the Pharmacovigilance Directorate (hereinafter – the Directorate) of the Center, on the basis of subparagraph 1…

EYLEA® 40 mg/mL (aflibercept): increased intraocular pressure when using the prefilled syringe. The European Medicines Agency has published a Direct Healthcare Professional Communication (DHPC)

Regarding amendments to the package leaflet of medicinal products containing trastuzumab emtansine

Regarding amendments to the package leaflet of medicinal products containing canakinumab

XELJANZ (tofacitinib): risk of serious adverse cardiovascular events and malignancies (except non-melanoma skin cancer). The European Medicines Agency has published a Direct Healthcare Professional Communication (DHPC)

TECENTRIQ® (atezolizumab): Risk of severe cutaneous adverse reactions (SCARs). The European Medicines Agency has published a Direct Healthcare Professional Communication (DHPC).

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

Attention applicants who market in Ukraine medicinal products whose active substance is ceftriaxone – dosage form: powder for solution for injection, 1,0 g per vial!

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