EMA – Page 12 – State Expert Center of the Ministry of Health of Ukraine

Signal regarding the use of desogestrel and the occurrence of night sweats, vulvovaginal dryness and dry eyes (according to data from the WHO global database VigiBase)

25.11.2019 3398

Review of a signal from the WHO global database VigiBase on the association between the use of desogestrel (an oral contraceptive) and the occurrence of night sweats, vulvovaginal dryness, and dry eyes. Intended for healthcare professionals and pharmacovigilance specialists. generated automatically

EMA confirms that Xeljanz (tofacitinib) should be used with caution in patients at high risk of thrombosis

20.11.2019 6397

EMA concluded that the medicinal product Xeljanz (tofacitinib) may increase the risk of blood clots in the lungs and deep veins in patients who…

Measures to minimize the risk of serious adverse effects of the medicinal product Lemtrada (alemtuzumab) used for the treatment of multiple sclerosis

20.11.2019 4560

EMA recommends restricting the use of Lemtrada (alemtuzumab), a medicine for the treatment of multiple sclerosis, due to reports of rare serious adverse effects, including fatal…

EMA has developed guidance for registration certificate holders on preventing the presence of nitrosamine impurities in medicinal products

15.11.2019 6953

In 2018, nitrosamine impurities, including N-nitrosodimethylamine (NDMA), were detected in some medicinal products for the treatment of high blood pressure, known…

Review of the risk of meningioma associated with the use of medicinal products containing cyproterone

13.11.2019 2470

The EMA has started a review of medicinal products containing cyproterone, which are used to treat various conditions – excessive hair growth, prostate cancer…

Regarding amendments to the instructions for medical use of medicinal products containing Ciprofloxacin (systemic use)

13.11.2019 4152

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

Xeljanz should be used with caution in all patients at high risk of thrombus formation

07.11.2019 5569

Xeljanz should be used with caution in all patients at high risk of blood clots. The PRAC review concluded that…

Review of errors in the use of medicinal products containing leuprorelin in depot form

06.11.2019 2650

Review of errors in the use of depot medicinal products containing leuprorelin The EMA has started a review of medicinal products containing leuprorelin…

Use of Lemtrada (alemtuzumab) for the treatment of multiple sclerosis: measures to minimize the risk of serious adverse effects

05.11.2019 11213

Use of the medicinal product Lemtrada (alemtuzumab) for the treatment of multiple sclerosis: measures to minimize the risk of serious adverse effects The Risk Assessment Committee in…

Final legally binding decision of the European Commission for European Union member states on measures for medicinal products containing methotrexate

01.11.2019 3870

The final legally binding decision of the European Commission for the member states of the European Union regarding measures for medicinal products containing methotrexate 22…

Signal regarding the use of desogestrel and the occurrence of night sweats, vulvovaginal dryness and dry eyes (according to data from the WHO global database VigiBase)

EMA confirms that Xeljanz (tofacitinib) should be used with caution in patients at high risk of thrombosis

Measures to minimize the risk of serious adverse effects of the medicinal product Lemtrada (alemtuzumab) used for the treatment of multiple sclerosis

EMA has developed guidance for registration certificate holders on preventing the presence of nitrosamine impurities in medicinal products

Review of the risk of meningioma associated with the use of medicinal products containing cyproterone

Regarding amendments to the instructions for medical use of medicinal products containing Ciprofloxacin (systemic use)

Xeljanz should be used with caution in all patients at high risk of thrombus formation

Review of errors in the use of medicinal products containing leuprorelin in depot form

Use of Lemtrada (alemtuzumab) for the treatment of multiple sclerosis: measures to minimize the risk of serious adverse effects

Final legally binding decision of the European Commission for European Union member states on measures for medicinal products containing methotrexate

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