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Recommendations for paclitaxel-coated balloons and paclitaxel-eluting stents in the treatment of peripheral arterial disease

A scientific article has raised concerns about paclitaxel-coated balloons and paclitaxel-eluting stents used in the treatment of peripheral arterial disease (PAD). In response, the Federal Agency for Medicines and Health Products (FAMHP) hereby makes its recommendations.

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.

What do you think of a vaccination plan with a genetically modified vaccine against Ebola?

The Federal Service for Public Health, Food Chain Safety and Environment and the Federal Agency for Medicines and Health Products (FAMHP) want to know your opinion on vaccine plan B/BE/19/BVW4 which will be using a genetically modified vaccine against Ebola. This vaccine is meant to protect Belgian employees of Doctors Without Borders from Ebola in the Democratic Republic of the Congo. You can share your opinion until July 25.

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 May 2019 – Start of referral: Xeljanz (tofacitinib)

During its meeting of May 2019, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has started a referral for Xeljanz (tofacitinib). PRAC has issued restrictions in use of Xeljanz while EMA reviews risk of blood clots in lungs.

Limited availability of intravenous immunoglobulins: recommendations to the attention of hospital pharmacists and the physician-specialists within hospitals where there is an availability problem.

Through possible limited availability of intravenous immunoglobulins, there is a threat of a shortage in some hospitals in Belgium. The Federal Agency for Medicines and Health Products (FAMHP) is giving recommendations for hospital pharmacists and physician-specialists within the hospitals.

Implants and certain invasive medical devices: as of June 3, 2019, the FAMHP takes over the RIZIV notification database.

Every company selling implants and certain invasive medical devices in Belgium must report the data for these in a notification database. The notification of these medical devices applies as a condition for reimbursement of the obligatory insurance for health care. From June 3, 2019 the notification of these medical devices in the database will occur via a new online application at the Federal Agency for Medicines and Health Products (FAMHP).

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

New edition of VIG-news available

The new edition of the electronic newsletter for health professionals is online.

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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