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

On amendments to the package leaflet of a medicinal product containing Abiraterone – interaction with sulfonylureas leading to hypoglycemia

11.02.2020 2327

Dear applicants! Having reviewed the available evidence from EudraVigilance, data from the literature, and the cumulative review submitted by the registration certificate holder for the medicinal product Zytiga…

Regarding amendments to the package insert for the medicinal product containing Golimumab – inflammatory myopathy

11.02.2020 2141

Dear applicants! Having considered the available evidence from EudraVigilance, literature data, and the cumulative review submitted by Janssen Biologics B.V, the PRAC committee…

Measures to minimize the risk of serious adverse reactions after the use of Lemtrada (alemtuzumab)

07.02.2020 3062

On 14 November 2019, the EMA recommended restricting the use of the medicinal product Lemtrada (alemtuzumab), which is used in multiple sclerosis. The restrictions were applied…

Signal Agomelatine and increased blood pressure (according to the WHO global database VigiBase)

06.02.2020 2611

SIGNAL Agomelatine and increased blood pressure (according to the WHO global database VigiBase) Agomelatine is a non-selective melatonin receptor antagonist MT1…

Official website of the European Medicines Agency – PRAC decisions and divergent positions on the decisions of the PRAC and CHMP committees regarding the medicinal product Lemtrada (alemtuzumab), used for the treatment of multiple sclerosis

31.01.2020 2604

During the assessment of the periodic safety update report for the medicinal product lemtrada, the following new serious safety concerns were identified, which were identified…

Signal Tramadol and hyperacusis (according to the WHO global database VigiBase)

31.01.2020 3746

Tramadol and hyperacusis were identified as a potential signal during the analysis of VigiBase (the WHO global database containing safety reports…

On amendments to the instructions for medical use of medicinal products containing botulinum neurotoxin type A (150 kD) free from complexing proteins

24.01.2020 2963

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

Regarding amendments to the package insert for medicinal products containing isotretinoin (oral formulations)

24.01.2020 2460

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

Regarding amendments to the package leaflet of medicinal products containing erythromycin

17.01.2020 2867

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

On amendments to the package leaflet of a medicinal product containing Abiraterone – interaction with sulfonylureas leading to hypoglycemia

Regarding amendments to the package insert for the medicinal product containing Golimumab – inflammatory myopathy

Measures to minimize the risk of serious adverse reactions after the use of Lemtrada (alemtuzumab)

Signal Agomelatine and increased blood pressure (according to the WHO global database VigiBase)

Official website of the European Medicines Agency – PRAC decisions and divergent positions on the decisions of the PRAC and CHMP committees regarding the medicinal product Lemtrada (alemtuzumab), used for the treatment of multiple sclerosis

Signal Tramadol and hyperacusis (according to the WHO global database VigiBase)

On amendments to the instructions for medical use of medicinal products containing botulinum neurotoxin type A (150 kD) free from complexing proteins

Regarding amendments to the package insert for medicinal products containing isotretinoin (oral formulations)

Regarding amendments to the package leaflet of medicinal products containing erythromycin

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