2020 – Page 8 – State Expert Center of the Ministry of Health of Ukraine

Medicinal products containing alectinib and rhabdomyolysis – Uppsala Monitoring Centre signal in VigiLyze

08.04.2020 5875

Alectinib is a highly selective and potent inhibitor of the ALK and RET tyrosine kinases. Alectinib is indicated as first-line monotherapy for adults with ALK-positive…

Щодо внесення змін до інструкції для медичного застосування лікарських засобів, що містять pitavastatin

08.04.2020 2823

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

Medicinal products containing indapamide – induced (acute hypokalemic) rhabdomyolysis – Uppsala Monitoring Centre signal on VigiLyze

08.04.2020 2454

Rhabdomyolysis associated with indapamide was identified as a potential signal during screening of the WHO Global Database VigiBase at the Uppsala Monitoring Centre….

On amending the package leaflet of medicinal products containing thiazide, thiazide-like diuretics, and combinations (chlortalidone; hydrochlorothiazide; hydrochlorothiazide, amlodipine, valsartan; hydrochlorothiazide, irbesartan; hydrochlorothiazide, telmisartan; indapamide; xipamide) – choroidal effusion

08.04.2020 3796

Having considered the available EudraVigilance evidence and literature data, the PRAC committee agreed that holders of registration certificates for medicinal products containing…

Regarding amendments to the package insert for medicinal products containing paroxetine – microscopic colitis

07.04.2020 2661

Having considered the available evidence in EudraVigilance and the literature, the PRAC committee agreed that holders of registration certificates for medicinal products that…

Regarding amendments to the package insert for medicinal products containing atezolizumab (immune response inhibitor) – tuberculosis

07.04.2020 2348

Having considered the available evidence from the cumulative review provided by the registration certificate holders for Keytruda (Merck Sharp & Dohme B.V.), Opdivo and Yervoy…

Щодо внесення змін до інструкції для медичного застосування лікарських засобів, що містять levonorgestrel

07.04.2020 2137

Dear applicants! The Pharmacovigilance Risk Assessment Committee (PRAC), based on the evaluation of the analysis of Periodic Safety Update Reports (PSURs) for…

Щодо внесення змін до інструкції для медичного застосування лікарських засобів, що містять moxifloxacin (systemic use)

06.04.2020 2848

Шановні заявники! Комітет з оцінки ризиків у фармаконагляді (PRAC), на підставі оцінки аналізу Регулярно оновлюваних звітів з безпеки (РОЗБ) для…

EMA published the PRAC report assessing provisional measures for the medicinal product Esmya (ulipristal acetate) Gedeon Richter

03.04.2020 2319

02.04.2020 the PRAC report on the assessment of provisional measures for the medicinal product Esmya (ulipristal…) was published on the official EMA website (https://www.ema.europa.eu/).

Medicinal products containing aciclovir or valaciclovir and acute generalized exanthematous pustulosis – Uppsala Monitoring Centre signal on VigiLyze

03.04.2020 5622

The association between aciclovir and acute generalized exanthematous pustulosis (AGEP) was identified during routine screening for a signal in the VigiBase database in December…

Medicinal products containing alectinib and rhabdomyolysis – Uppsala Monitoring Centre signal in VigiLyze

Щодо внесення змін до інструкції для медичного застосування лікарських засобів, що містять pitavastatin

Medicinal products containing indapamide – induced (acute hypokalemic) rhabdomyolysis – Uppsala Monitoring Centre signal on VigiLyze

Regarding amendments to the package insert for medicinal products containing paroxetine – microscopic colitis

Regarding amendments to the package insert for medicinal products containing atezolizumab (immune response inhibitor) – tuberculosis

Щодо внесення змін до інструкції для медичного застосування лікарських засобів, що містять levonorgestrel

Щодо внесення змін до інструкції для медичного застосування лікарських засобів, що містять moxifloxacin (systemic use)

EMA published the PRAC report assessing provisional measures for the medicinal product Esmya (ulipristal acetate) Gedeon Richter

Medicinal products containing aciclovir or valaciclovir and acute generalized exanthematous pustulosis – Uppsala Monitoring Centre signal on VigiLyze

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