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PRAC November 2019: recommendations for the medicinal products Lemtrada and Xeljanz

During the meeting of 28 - 31 October 2019, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) implemented measures to minimise risk of serious side effects with Lemtrada. Furthermore, the PRAC recommended Xeljanz to be used with caution for all patients at high risk of blood clots.

1 in 20 university students uses stimulant medicines in order to study better

The FAMHP asked more than 12,000 francophone university students about the use of stimulant drugs. 5% of them said to use stimulant medicines for non-medical use, in order to study better.

The fight against anti-microbial resistance continues: the Belgian BAPCOC 2019 antibiotics guide is available on the CBIP website

As recommended by the Belgian Health Care Knowledge Centre (KCE), a new step in the fight against anti-microbial resistance has been taken: the 2019 edition of the Belgian Antibiotic Policy Coordination Committee (BAPCOC)’s antibiotics guide is available online on the Belgian Pharmacotherapy Information Centre (CBIP) website.

Campaign to report side effects: in 2019, focus on interactions during simultaneous use of various medicines

The fourth #MedSafetyWeek runs from November 25 to 29, 2019. Competent authorities from all over the worlds are participating in a social media campaign to draw attention to the importance of reporting side effects of medicines. This year, the campaign focuses on possible interactions when various medicines are used at the same time.

Flash VIG news: reassessment of risk of meningioma on cyproterone

The European Medicines Agency (EMA) is reassessing the risk of meningioma on medicines based on cyproterone, a risk that has long been known to medical professionals. A French study suggests that the risk of meningioma, even though small, can be greater in women who have taken high doses of cyproterone over long periods of time.

Flash VIG-news: DEPO-ELIGARD® (leuprorelin) as a prolonged-release solution for injection: a reassessment of preparation errors

The European Medicines Agency (EMA) has started a re-evaluation of medicinal products that contain leuprorelin (sold in Belgium under the name of DEPO-ELIGARD®). This re-evaluation comes in the wake of reports of errors during preparation and administration. As a result, some patients have not been able to receive their medication in sufficient doses, rendering their treatment less effective.

PRAC June 2019 – Start of referral: Leuprorelin-containing depot products

During its meeting of June 2019, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has started a referral for leuprorelin medicines. PRAC has started the review of handling errors with depot formulations of leuprorelin medicines

PRAC April 2019 – EMA review of the multiple sclerosis medicine LEMTRADA® (alemtuzumab)

During its meeting of April 2019, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has started a review of the multiple sclerosis medicine LEMTRADA® (alemtuzumab). Its use should be restricted while EMA review is ongoing

Flash VIG-news: domperidone: no longer approved for use in children due to a lack of efficacy

The use of domperidone in newborns, infants, children (under 12) and adolescents weighing less than 35kg is no longer approved at European level. A new clinical study has demonstrated a lack of efficacy of the medical product.

Holders of marketing authorizations must check their data in the EMA’s article 57 database

The Vigilance Division of the FAMHP has found encoding errors in the article 57 database of the EMA. The FAMHP is asking holders of a marketing authorization for a medicine to carefully check that their registered data are correct.

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