News FAMHP

There are 852 result(s) found based on your search criteria

21-30 from 852 result(s)

Annual report on the donation of human body material: increase in the declarations of explicit content and reduction in opposition

In Belgium, each individual, after their death, is presumed to be a potential donor. Since 2020, as well as organ donation, any Belgian citizen has had the option to express their will, explicit consent or opposition to the post-mortem donation of human body material like skin, cartilage, tendons or heart values for transplantation, the manufacture of medicines (advanced therapies) and for scientific research.

Flash VIG-news: New measures to limit the risks of opioid abuse and dependence

In view of the increase in cases of opioid abuse and dependence reported in recent years, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has decided to reinforce the messages aimed at limiting these risks in the SPCs and patient information leaflets.

PRAC November 2023 – Conclusion regarding available evidence not supporting link between the glucagon-like peptide-1 (GLP-1) receptor agonists and thyroid cancer

During its November 2023 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) concluded that the available evidence does not support a causal association between the glucagon-like peptide-1 (GLP-1) receptor agonists - exenatide, liraglutide, dulaglutide, semaglutide, and lixisenatide - and thyroid cancer.

Medsafetyweek 2023: contribute to medicinal product safety

From 6 to 13 November 2023, the FAMHP is taking part in the worldwide #MedSafetyWeek campaign, a cooperation between medicines regulators from more than 80 countries and several non-governmental organisations. The goal is to raise awareness about the importance of reporting side effects of medicines.

Limited availability of GLP-1 analogues: recommendations for medical doctors (specialists), (hospital) pharmacists and patients

Glucagon-like peptide-1 (GLP-1) analogues are in increasing demand worldwide. The limited availability of some of these drugs will last in Belgium until June 2024. Experts from the FAMHP's Unavailability Task Force issue the following recommendations.

Deadline for registration of annual sales volume data for veterinary medical products

Marketing authorisation holders have until the end of February 2024 to submit annual sales volume data for veterinary medical products for 2023.

Deadlines for the submission of dossiers during the end-of-year period

During the end-of-year period, the FAMHP will be closed from Monday 25 December 2023 to Monday 1 January 2024. Deadlines have been set for the submission of different types of dossiers.

Data Tracking System: new application for the effective management of marketing authorisation and vigilance dossiers

On 16 October 2023, the Data Tracking System (DTS) dossier will go live within the FAMHP. This application replaces four MeSeA applications. DTS provides additional functionalities that facilitate the effective management of dossiers in the context of marketing authorisation and vigilance.

PRAC October 2023 – New safety information for Omega-3-acid ethyl esters

During the October 2023 meeting, the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency, recommends an update to the product information for medicines containing omega-3-acid ethyl esters, to inform healthcare professionals and patients of the risk of atrial fibrillation.

Ozempic: modification of the recommendations for medical doctors (specialists) and (hospital) pharmacists due to limited availability

There is limited availability of the medicine Ozempic (semaglutide-based solution for subcutaneous injection) due to an acute increase in demand. This limited availability will certainly last until early 2024. Rybelsus (semaglutide-based tablets) is also unavailable. The experts from the FAMHP's Unavailability Task Force adapt the recommendations.

21-30 from 852 result(s)