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

The European Medicines Agency confirms its recommendation to suspend the use of all medicinal products containing ranitidine in the European Union

23.12.2020 3554

On 17 September 2020, the CHMP confirmed its recommendation to suspend the use of all medicinal products containing ranitidine in the EU due to…

Update to information on psychiatric disorders regarding medicinal products containing chloroquine and hydroxychloroquine

02.12.2020 2651

highlights of the PRAC meeting of 23-26 November 2020 The PRAC committee recommends updating the instructions for medical use for medicinal products,…

Regarding amendments to the instructions for medical use of medicinal products containing clobetasol

02.12.2020 3868

Based on the assessment of periodic safety update reports for medicinal products containing clobetasol, the PRAC Committee drew the following scientific conclusions….

Overview of recommendations adopted by the PRAC on signals discussed at the meeting of October 23-26, 2020

27.11.2020 2829

medicinal products containing ceftriaxone – encephalopathy Based on the available evidence from preclinical data, post-marketing studies, clinical trials, literature and…

Overview of recommendations adopted by the PRAC on signals discussed at the meeting of October 23-26, 2020

27.11.2020 2428

medicinal products containing dabrafenib, trametinib – sarcoidosis Having reviewed the available evidence and analyzed the data provided by the relevant marketing authorization holder, the committee…

Overview of recommendations adopted by the PRAC on signals discussed at the meeting of October 23-26, 2020

27.11.2020 2593

medicinal products containing ibrutinib – hepatitis E Having reviewed the available evidence and analyzed the data submitted by the relevant registration certificate holder, the committee…

Overview of recommendations adopted by the PRAC on signals discussed at the meeting of October 23-26, 2020

27.11.2020 2370

medicinal products containing lamotrigine – photosensitivity Based on a review of data on the risk of photosensitivity with the use of lamotrigine, the PRAC committee agreed,…

Regarding amendments to the package insert (instructions for medical use) of medicinal products containing phenylephrine (ophthalmic formulations)

17.11.2020 3010

Based on the assessment of periodic safety update reports for medicinal products containing phenylephrine (ophthalmic formulations), the PRAC Committee made the following…

Regarding amendments to the instruction for medical use of medicinal products containing levonorgestrel/ethinylestradiol, ethinylestradiol (combination pack)

16.11.2020 3154

Based on the evaluation of periodic safety update reports for medicinal products containing levonorgestrel/ethinylestradiol, ethinylestradiol (combination pack), the PRAC committee made…

Regarding amendments to the instructions for medical use of medicinal products containing bendamustine hydrochloride

12.11.2020 2766

Based on the assessment of periodic safety update reports for medicinal products containing bendamustine hydrochloride, the PRAC committee made the following scientific…

The European Medicines Agency confirms its recommendation to suspend the use of all medicinal products containing ranitidine in the European Union

Update to information on psychiatric disorders regarding medicinal products containing chloroquine and hydroxychloroquine

Regarding amendments to the instructions for medical use of medicinal products containing clobetasol

Overview of recommendations adopted by the PRAC on signals discussed at the meeting of October 23-26, 2020

Overview of recommendations adopted by the PRAC on signals discussed at the meeting of October 23-26, 2020

Overview of recommendations adopted by the PRAC on signals discussed at the meeting of October 23-26, 2020

Overview of recommendations adopted by the PRAC on signals discussed at the meeting of October 23-26, 2020

Regarding amendments to the package insert (instructions for medical use) of medicinal products containing phenylephrine (ophthalmic formulations)

Regarding amendments to the instruction for medical use of medicinal products containing levonorgestrel/ethinylestradiol, ethinylestradiol (combination pack)

Regarding amendments to the instructions for medical use of medicinal products containing bendamustine hydrochloride

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