2020 – Page 2 – State Expert Center of the Ministry of Health of Ukraine

Regarding amendments to the package insert for medicinal products containing iopamidol (solution for injection)

11.11.2020 2336

Based on its assessment of periodic safety update reports for medicinal products containing iopamidol (solution for injection), the PRAC committee made…

Uppsala Monitoring Centre signal in VigiBase: loperamide and acute pancreatitis in patients with a history of cholecystectomy: signal strengthening

02.11.2020 3092

The signal is under investigation General information Loperamide is an over-the-counter antidiarrheal medicinal product with affinity for opioid receptors. Due to…

Overview of the recommendations adopted by the PRAC on signals discussed at the meeting of 28 September – 01 October 2020: medicinal products containing escitalopram, paroxetine, sertraline, venlafaxine – postpartum hemorrhage

28.10.2020 2713

The PRAC reviewed the known association between bleeding events and the use of selective serotonin reuptake inhibitors (SSRIs), serotonin reuptake inhibitors…

PRAC recommendations on Direct Healthcare Professional Communications (DHPC) 31 August – 03 September 2020

01.10.2020 2641

INN Signal Actions to be taken by registration certificate holders Name of the registration certificate holder Fluoroquinolones for systemic and inhalation use:…

Overview of the recommendations adopted by the PRAC committee on signals discussed at the meeting of 31 August – 03 September 2020: fluoroquinolone medicinal products for systemic and inhalation use (ciprofloxacin; levofloxacin; moxifloxacin; norfloxacin; ofloxacin) – heart valve regurgitation, cervical artery dissection, aortic aneurysm and dissection

01.10.2020 4796

The PRAC reviewed data from the literature, EudraVigilance and cumulative reviews submitted by Sanofi and Bayer on the risks of heart valve regurgitation/insufficiency and aneurysm…

Overview of the recommendations adopted by the PRAC on signals discussed at the meeting of 31 August – 03 September 2020: medicinal products containing pomalidomide – progressive multifocal leukoencephalopathy (PML)

01.10.2020 3047

Having reviewed the available evidence in EudraVigilance, in the literature and in data submitted by registration certificate holders, the PRAC agreed that the registration certificate holder…

Overview of the recommendations adopted by the PRAC on signals discussed at the meeting of 31 August – 03 September 2020: medicinal products containing interferon alfa-2a, peginterferon alfa-2a – neuromyelitis optica spectrum disorders

01.10.2020 1708

Having reviewed the available evidence in EudraVigilance, the literature and data received from the registration certificate holders for the products IntronA, PegIntron, ViraferonPeg, Roferon-A, Pegasys,…

Overview of recommendations adopted by the PRAC on signals discussed at the meeting of 31 August – 03 September 2020: medicinal products containing abiraterone – anaphylactic reaction

01.10.2020 2022

Having reviewed the available evidence in EudraVigilance, the literature and data submitted by the registration certificate holder, the PRAC agreed that the registration certificate holder…

Uppsala Monitoring Centre signal on VigiLyze: drug-induced hyperkalemia with medicinal products containing dronedarone

29.09.2020 2108

(signal under investigation) Hyperkalemia associated with the use of medicinal products containing dronedarone was identified as a potential signal during…

The PRAC committee recommends revoking the marketing authorization for the medicinal product ulipristal acetate used for uterine fibroids

08.09.2020 1932

The PRAC committee review confirmed that the medicinal product containing ulipristal acetate 5 mg (Esmya and generic medicines) used for…

Regarding amendments to the package insert for medicinal products containing iopamidol (solution for injection)

Uppsala Monitoring Centre signal in VigiBase: loperamide and acute pancreatitis in patients with a history of cholecystectomy: signal strengthening

Overview of the recommendations adopted by the PRAC on signals discussed at the meeting of 28 September – 01 October 2020: medicinal products containing escitalopram, paroxetine, sertraline, venlafaxine – postpartum hemorrhage

PRAC recommendations on Direct Healthcare Professional Communications (DHPC) 31 August – 03 September 2020

Overview of the recommendations adopted by the PRAC on signals discussed at the meeting of 31 August – 03 September 2020: medicinal products containing pomalidomide – progressive multifocal leukoencephalopathy (PML)

Overview of the recommendations adopted by the PRAC on signals discussed at the meeting of 31 August – 03 September 2020: medicinal products containing interferon alfa-2a, peginterferon alfa-2a – neuromyelitis optica spectrum disorders

Overview of recommendations adopted by the PRAC on signals discussed at the meeting of 31 August – 03 September 2020: medicinal products containing abiraterone – anaphylactic reaction

Uppsala Monitoring Centre signal on VigiLyze: drug-induced hyperkalemia with medicinal products containing dronedarone

The PRAC committee recommends revoking the marketing authorization for the medicinal product ulipristal acetate used for uterine fibroids

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