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

Regarding amendments to the package leaflets (summaries of product characteristics) of medicinal products containing testosterone (topical use) and testosterone (all formulations apart from topical use)

21.12.2019 2722

PRAC recommends amending the “Special warnings and precautions for use” section of the instructions for medicinal products containing testosterone by adding a warning about cautious use in patients with thrombophilia or risk factors for venous thromboembolism. The document also contains lists of such medicines authorized in Ukraine. compiled automatically

SIGNAL Tramadol and hyponatremia – a new aspect of an old signal (based on data from the WHO global database VigiBase)

05.12.2019 2738

SIGNAL Tramadol and hyponatremia – a new aspect of an old signal (according to the WHO global database VigiBase) Tramadol is an opioid analgesic…

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

29.11.2019 2941

The Pharmacovigilance Risk Assessment Committee (PRAC), based on the assessment of the analysis of Periodic Safety Update Reports (PSURs) for medicinal products,…

Regarding amendments to the package leaflets of medicinal products containing levothyroxine

29.11.2019 2900

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

Regarding changes to the instructions for medical use of medicinal products containing iron sucrose, iron carboxymaltose, iron isomaltoside, iron dextran – coronary artery spasm

26.11.2019 3061

Dear applicants! Having reviewed clinical trial and post-marketing data provided by marketing authorization holders together with the available literature data,…

On amending the package insert for medicinal products containing acetylsalicylic acid

26.11.2019 3385

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

Signal regarding the use of desogestrel and the occurrence of night sweats, vulvovaginal dryness and dry eyes (according to data from the WHO global database VigiBase)

25.11.2019 3388

Review of a signal from the WHO global database VigiBase on the association between the use of desogestrel (an oral contraceptive) and the occurrence of night sweats, vulvovaginal dryness, and dry eyes. Intended for healthcare professionals and pharmacovigilance specialists. generated automatically

EMA confirms that Xeljanz (tofacitinib) should be used with caution in patients at high risk of thrombosis

20.11.2019 6380

EMA concluded that the medicinal product Xeljanz (tofacitinib) may increase the risk of blood clots in the lungs and deep veins in patients who…

Measures to minimize the risk of serious adverse effects of the medicinal product Lemtrada (alemtuzumab) used for the treatment of multiple sclerosis

20.11.2019 4547

EMA recommends restricting the use of Lemtrada (alemtuzumab), a medicine for the treatment of multiple sclerosis, due to reports of rare serious adverse effects, including fatal…

EMA has developed guidance for registration certificate holders on preventing the presence of nitrosamine impurities in medicinal products

15.11.2019 6943

In 2018, nitrosamine impurities, including N-nitrosodimethylamine (NDMA), were detected in some medicinal products for the treatment of high blood pressure, known…

Regarding amendments to the package leaflets (summaries of product characteristics) of medicinal products containing testosterone (topical use) and testosterone (all formulations apart from topical use)

SIGNAL Tramadol and hyponatremia – a new aspect of an old signal (based on data from the WHO global database VigiBase)

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

Regarding amendments to the package leaflets of medicinal products containing levothyroxine

Regarding changes to the instructions for medical use of medicinal products containing iron sucrose, iron carboxymaltose, iron isomaltoside, iron dextran – coronary artery spasm

On amending the package insert for medicinal products containing acetylsalicylic acid

Signal regarding the use of desogestrel and the occurrence of night sweats, vulvovaginal dryness and dry eyes (according to data from the WHO global database VigiBase)

EMA confirms that Xeljanz (tofacitinib) should be used with caution in patients at high risk of thrombosis

Measures to minimize the risk of serious adverse effects of the medicinal product Lemtrada (alemtuzumab) used for the treatment of multiple sclerosis

EMA has developed guidance for registration certificate holders on preventing the presence of nitrosamine impurities in medicinal products

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