The FAMHP would like to remind caregivers of the main recommendations to prevent dosing errors when administering paracetamol to children, particularly with oral solutions.
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Beware of confusion between lookalike vials
Many liquid medicines, food supplements, medical devices … come in liquid form, bottled in vials of different sizes. Such vials can easily be confused, which can be dangerous. Always check the product you intend to use.
EUDAMED webinars: training for modules for Actors, UDI/Devices and Notified Bodies/Certificates
As part of the gradual implementation and mandatory use of EUDAMED, the European Commission is organising a series of webinars in April and May 2026 to support economic operators in using the system.
Medical devices and medical devices for in vitro diagnostics: decision tree for relevant actors on the application of Article 10a of the European regulations
When must an ending or interruption in the marketing of medical and in vitro diagnostic devices be notified? The European Commission recently published a decision tree to support the economic operators concerned.
Flash VIG-news - Ixchiq vaccine against chikungunya: reminder of recommendations
The FAMHP has been notified of a case of a serious side effect following the administration of Ixchiq vaccine in Belgium.
Unavailability of Fibclot 1.5 g powder and solvent for injection/infusion: recommendations for physician specialists and hospital pharmacists
The medicinal product Fibclot 1.5 g is temporarily unavailable from 9 October 2025 until 31 January 2027. The task force Unavailability of the FAMHP makes recommendations to physician specialists and hospital pharmacists.
PRAC March 2026: warning about the known risk of aseptic meningitis after administration of the Ixchiq vaccine
During its March 2026 meeting, the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency recommended an update to the vaccine’s product information to reflect that serious side effects, such as aseptic meningitis, have also been observed in healthy young adults.
CTIS technical issues: no fee for resubmission of clinical trial applications
As of 1 January 2026, sponsors will not be charged a fee for the Clinical Trial Regulation safety assessment and ethics committee assessment when a clinical trial application must be resubmitted due to technical issues in the Clinical Trials Information System, provided that these issues occurred after validation.
The FAMHP is launching a dashboard with up-to-date figures and statistics for clinical trials
The FAMHP is launching a new dashboard with up-to-date figures on clinical trials in Belgium. With this initiative, the agency aims to increase transparency and further support the clinical research sector.
Rybelsus – Reminder: risk of medication errors due to the introduction of a new formulation
From 1 April 2026, Rybelsus tablets (oral semaglutide) will be replaced by a new formulation that offers improved bioavailability. Both formulations will temporarily coexist on the market, which may lead to confusion and a risk of overdose.