2019 – Page 5 – State Expert Center of the Ministry of Health of Ukraine

Everolimus (indicated for rejection of transplanted organs)

24.06.2019 2205

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

Daunorubicin

24.06.2019 2141

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

Regarding amendments to the package inserts for medicinal products containing serotonin and norepinephrine reuptake inhibitors (SNRIs)

18.06.2019 3635

Dear applicants! Having reviewed the available evidence from EudraVigilance, literature, media and cumulative reviews provided by registration certificate holders for duloxetine, fluoxetine (Eli…

Regarding amendments to the package inserts for medicinal products containing serotonin and norepinephrine reuptake inhibitors (SNRIs)

18.06.2019 3591

Dear applicants! Having reviewed the available evidence from EudraVigilance, literature, media and cumulative reviews provided by registration certificate holders for duloxetine, fluoxetine (Eli…

On amending the instructions for medical use of medicinal products containing Pantoprazole

18.06.2019 2703

Dear applicants! Having considered the available evidence from EudraVigilance, literature data, the cumulative review submitted by Takeda, as well as the fact that microscopic…

On amending the instructions for medical use of medicinal products containing Sertraline

18.06.2019 2442

Dear applicants! Based on a review of data on the risk of maculopathy associated with the use of medicinal products containing sertraline, PRAC agreed that the holders…

On amending the instructions for medical use of medicinal products containing Clopidogrel

18.06.2019 3071

Dear applicants! The Pharmacovigilance Risk Assessment Committee of the European Medicines Agency (PRAC), having considered all available evidence in EudraVigilance and the literature,…

Lorazepam

04.06.2019 2951

Dear applicants! The Pharmacovigilance Risk Assessment Committee (PRAC) has reviewed the Periodic Safety Update Reports (PSURs) for medicinal products that…

Ceftriaxone

04.06.2019 3193

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

Ivermectin

04.06.2019 9854

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

Everolimus (indicated for rejection of transplanted organs)

Daunorubicin

Regarding amendments to the package inserts for medicinal products containing serotonin and norepinephrine reuptake inhibitors (SNRIs)

Regarding amendments to the package inserts for medicinal products containing serotonin and norepinephrine reuptake inhibitors (SNRIs)

On amending the instructions for medical use of medicinal products containing Pantoprazole

On amending the instructions for medical use of medicinal products containing Sertraline

On amending the instructions for medical use of medicinal products containing Clopidogrel

Lorazepam

Ceftriaxone

Ivermectin

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