News FAMHP

There are 847 result(s) found based on your search criteria

31-40 from 847 result(s)

Federal Agency for Medicines and Health Products bids farewell to chief executive officer Xavier De Cuyper

Xavier De Cuyper, chief executive officer of the Federal Agency for Medicines and Health Products, will retire on 1 September 2023. He has been the head of the Belgian medicines agency since 1 May 2007 and had reached the age limit for holding a mandate position in the federal government in 2022. Xavier De Cuyper's mandate expired on 1 March 2022 but to ensure the continuity of the FAMHP's operations and stability, it was extended.

Valproate and its derivatives (Depakine and generics): European risk assessment of children whose fathers used valproate or a derivative

A retrospective observational study is currently being conducted by the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency on the risks to children born to fathers exposed to valproate or one of its derivatives during the three months prior to conception. The recommendations and restrictions on the use of valproate and its derivatives during pregnancy, and measures to avoid in utero exposure to medicinal products containing valproate or its derivatives remain in force and unchanged.

Fight against antimicrobial resistance: conditions use critical antibiotics extended to all animals and use of antibiotics is now also monitored in cattle and all chicken and turkey species

From now on, veterinarians must also record data on the use of antibacterial medicinal products in cattle and all chicken and turkey species. The condition for which the medicinal product is used must also be described. In addition, the prerequisites for the use of critical antibiotics are extended to all animals, thus including companion animals and horses. Laboratories must meet new quality standards to perform antibiogram tests.

Limited availability of Cinqaero 10 mg/ml: recommendations for physician-specialists and (hospital) pharmacists

The stock of Cinqaero 10 mg/ml, used in asthma, is currently limited worldwide. A task force therefore issues recommendations.

Unavailability of high-dose methotrexate: recommendations for physician-specialists and (hospital) pharmacists

The stock of high-dose methotrexate, used in oncology, is currently limited worldwide. A task force therefore issues recommendations.

The paper narcotic drugs order forms will disappear: the FAMHP launches narcoreg.be, the online application for narcotic drugs order forms

In Belgium, any delivery or receipt of narcotic drugs and psychotropic substances must be reported to the FAMHP. From 1 September 2023, the new online application of the FAMHP, that replaces the paper narcotic drugs order forms, must be used for that purpose. A transition period has been set, starting 1 July 2023.

The FAMHP publishes its annual report 2022: packed with figures and results, special trends and highlighting our most important projects

Although the FAMHP's staff continued to feel the effects of the health crisis, in 2022 they were also able to complete many tasks that had been postponed due to the coronavirus crisis. Various “major” files were started, followed up or closed. For example, new initiatives were launched in collaboration with other national and European institutions to combat the shortage of medicines in Belgium and the European Union.

PRAC May 2023 – Restrictions on the use of fluoroquinolone antibiotics and new safety information for fluoroquinolone antibiotics and Gavreto

During its May 2023 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA), is reminding healthcare professionals that the use of fluoroquinolone antibiotics given by mouth, injection or inhalation, is restricted due to the risk of disabling, long-lasting and potentially irreversible side effects. The PRAC discussed direct healthcare professional communications (DHPCs) containing important information on fluoroquinolone antibiotics and Gavreto.

Save the date: info session for sponsors on early phase clinical trials on 15 September 2023

In the context of the new clinical trials regulations (CTR), on 15 September 2023,the FAMHP is organising an information session on early phase clinical trials.

Negative formulations no longer allowed on packaging of medicinal products for human use

Since 2019, negative formulations are no longer allowed on the packaging of medicinal products for human use in Belgium. This decision came after consultation at European level and in agreement with the other European Member States. The FAMHP will therefore reject such formulations.

31-40 from 847 result(s)