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PRAC September 2022 –Reviews of topiramate and pholcodine medicines started

During the September 2022 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has started a referral of topiramate and also started a referral of pholcodine medicines.

HIPRABOVIS IBR MARKER LIVE vaccine against infectious bovine rhinotracheitis: increased incidence of anaphylactic-type reactions in cattle

Since the beginning of 2022, there has been an increase in the incidence of anaphylactic-type reactions in cattle after administration of HIPRABOVIS IBR MARKER LIVE vaccine. The cause has not yet been clearly identified and investigations are ongoing. Veterinarians are asked to report any adverse reactions as soon as possible and, if possible, to provide a complete history of vaccinations and an overview of other veterinary medicinal products previously used.

Call for Belgian laboratories to apply to become the European Union reference laboratory for in vitro diagnostic medical devices

The European Commission has launched a call for laboratories of Member States to apply to become European Union reference laboratories (EURLs) for in vitro diagnostic (IVD) medical devices. The possible designation of such EURLs is provided for in article 100 of the Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).

West Nile virus: launch of weekly overview of affected areas for temporary exclusion of candidate donors in blood establishments or human body material establishments

In order to prevent the spread of West Nile virus through contaminated blood or human body material, candidate donors from areas where autochthonous cases are found must wait before donating. From now until the end of November, the FAMHP will provide weekly updates on the affected areas. This weekly update is based on data from the European Centre for Disease Prevention and Control (ECDC).

What should you do with expired or unused medicines? Do not throw them away but take them to the pharmacy!

Expired or unused medicines do not belong in your home pharmacy as they can be dangerous for your own health. Disposing of medicines in the rubbish bin, the sink or the toilet can also be dangerous for the environment. Therefore, bring your expired or unused medicines to the pharmacy. The pharmacist will take care of the destruction of the medicines.

PRAC July 2022 – New measures for medicinal products containing nomegestrol or chlormadinone and start of assessment of neurodevelopmental disorders when using topiramate

During its July 2022 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) recommends new measures to minimise the risk of meningioma with medicines containing nomegestrol or chlormadinone. The PRAC also starts the review on the risk of neurodevelopmental disorders with topiramate.

The online medicinal products database gets an update

The FAMHP online medicinal products database contains information on all medicinal products for human and veterinary use authorised in Belgium. Some new functions have been added in this new version. This makes it easier to search for new medicinal products or active ingredients.

Antibiotics: amoxicillin for injection/infusion again available under the trade name Delamoxyle

The availability of appropriate antimicrobial medicines is important to fight antimicrobial resistance. The FAMHP strives to keep or to bring essential antimicrobial products on the market and to keep healthcare professionals and patients well informed. Again, as a result of those efforts: amoxicillin for injection/infusion has been back on the market in Belgium since April.

The FAMHP publishes its annual report for 2021: all figures and results, trends, activities related to COVID-19 and testimonials from our staff

2021 was the year we gradually returned to our normal way of working at the FAMHP. The high workload caused by the pandemic remained present, but numerous other important projects awaited us, such as the implementation of several European legislations. In addition to the traditional facts and figures, the 2021 annual report includes testimonials that demonstrate the commitment and professionalism of our staff.

The FAMHP launches the Medicinal Product Management database: updating data in existing medicinal product databases temporarily not possible

On 4th of July 2022, the FAMHP launches the Medicinal Product Management database, a new internal database for medicinal products. Due to the launch, it will be temporarily impossible to update the data in the existing medicinal product databases.

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