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Improving the availability of in vitro diagnostics: European measures

New measures published in the European Union’s Official Journal come into effect to improve the availability of in vitro diagnostics, for patients and healthcare providers.

PRAC June 2024 – PRAC started review of painkiller metamizole and identified risk of secondary malignancies of T-cell origin with CAR T-cell medicines

During its June 2024 meeting, the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency started a review of the painkiller metamizole and identified a risk of secondary malignancies of T-cell origin with CAR T- cell medicines.

Kexxtone: suspension of marketing authorisation and recall of all batches

The EMA's Committee for Veterinary Medicinal Products (CVMP) recommends suspending the marketing authorisation for Kexxtone 32.4 g continuous-release intraruminal device for cattle (EU/2/12/145/001-003) and recalling batches from the market.

The European Medicines Regulatory Network is now a WHO Listed Authority

The European Medicines Regulatory Network (EMRN), of which the FAMHP is part, has been designated as WHO Listed Authority by the World Health Organisation.

Warning concerning non-compliant/illegal products intended for men and sold in tobacco shops

Following a control in ten tobacco shops in the Mouscron area, the FAMHP is warning against the purchase of non-compliant/illegal products that may present a health risk.

Overview of FAMHP achievements and accomplishments in the context of the Belgian presidency

From 1 January 2024 to 30 June 2024, Belgium chaired the Council of the European Union, the body in which the 27 member states set the political direction and priorities of the European Union. During this period, the FAMHP organised over 20 events and meetings to promote cooperation and dialogue among member states and with European institutions. In addition, the FAMHP provided expertise to many important European initiatives. Time for a recap.

Total sales of antibiotics for animals in Belgium continued to fall in 2023

Total sales of antibiotics for animals in Belgium fell sharply in 2023: 21.7% compared to 2022, with a cumulative reduction of 62.4% compared to 2011 (reference year). Overall, the results of antibiotic resistance monitoring in food-producing animals are favourable. New initiatives are needed to support all stakeholders in their efforts to use antibiotics in a reduced, careful and rational way, to ensure the sustainable use of antibiotics in the future.

The FAMHP publishes its 2023 annual report: all our figures, results and main projects

Although 2023 saw an increase in notifications regarding temporary unavailability of medicines, the agency once again demonstrated its effectiveness in ensuring the most efficient possible management of medicine stocks, as in the case of thrombolytics. The FAMHP also played its part in protecting public health by increasing the number of investigations into illegal medicines and devices by 30 %, and of inspections of pharmacies open to the public by over 40 %.

VIG newsflash: take care in sunlight when using certain medicines

Some medicines may cause (severe) skin reactions if the skin is exposed to UV light (from the sun or from an artificial source). The FAMHP is drawing attention to the different types of light sensitivity, which common medicines present an increased risk, the reports it has received, and a number of precautionary measures.

Unavailability of Rabipur: recommendations for medical doctors (specialists) and pharmacists

Bavarian Nordic, the company that holds the marketing authorisation for Rabipur (Powder and solvent for solution for injection in pre-filled syringe - Rabies virus (inactivated, strain Flury LEP)) has notified the FAMHP that the medicinal product will be unavailable until 31 August 2024 due to a delay in the release of the final product. The Federal Agency for Medicines and Health Products (FAMHP) convened a task force with experts in order to find solutions.

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