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

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

27.11.2020 2469

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 3111

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 3276

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 2860

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

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

11.11.2020 2339

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 3097

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 2718

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 2644

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 4800

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 3052

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 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

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)

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