2020 – Page 3 – State Expert Center of the Ministry of Health of Ukraine

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 1719

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 2032

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 2111

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

Regarding amendments to the instructions for medical use of medicinal products containing bacillus clausii multi-antibioresistant spores

17.09.2020 3339

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 instructions for medical use of medicinal products containing iron (parenteral preparations, except for iron dextran)

09.09.2020 2857

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

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

08.09.2020 1937

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

Uppsala Monitoring Centre signal on VigiLyze: medicinal products containing risperidone and cerebrovascular disorders (stroke) in women

02.09.2020 2018

Uppsala Monitoring Centre signal on VigiLyze: medicinal products containing risperidone and cerebrovascular accidents (stroke) in women (signal in…

Overview of the recommendations adopted by the PRAC for medicinal products containing tumor necrosis factor alpha inhibitors: adalimumab; etanercept; golimumab; infliximab – Kaposi sarcoma

04.08.2020 2649

Overview of the recommendations adopted by the PRAC on signals discussed at the meeting of 6-9 July 2020, medicinal products containing…

On amendments to the instructions for medical use of medicinal products containing opium

28.07.2020 3067

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

Uppsala Monitoring Centre signal in VigiLyze: yellow fever vaccine and herpes zoster

27.07.2020 3042

(signal under investigation) This report contains 29 cases of herpes zoster, recorded on average 6 days after…

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

Regarding amendments to the instructions for medical use of medicinal products containing bacillus clausii multi-antibioresistant spores

Regarding amendments to the instructions for medical use of medicinal products containing iron (parenteral preparations, except for iron dextran)

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

Uppsala Monitoring Centre signal on VigiLyze: medicinal products containing risperidone and cerebrovascular disorders (stroke) in women

Overview of the recommendations adopted by the PRAC for medicinal products containing tumor necrosis factor alpha inhibitors: adalimumab; etanercept; golimumab; infliximab – Kaposi sarcoma

On amendments to the instructions for medical use of medicinal products containing opium

Uppsala Monitoring Centre signal in VigiLyze: yellow fever vaccine and herpes zoster

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