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 2642

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 2589

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 2840

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 2791

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 2912

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 3279

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 3275

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 6244

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 4412

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…

Review of the risk of meningioma associated with the use of medicinal products containing cyproterone

13.11.2019 2387

The EMA has started a review of medicinal products containing cyproterone, which are used to treat various conditions – excessive hair growth, prostate cancer…

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

Review of the risk of meningioma associated with the use of medicinal products containing cyproterone

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