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Flash VIG-news : Dispensation of pholcodine-containing medicinal products suspended due to the risk of allergic cross-reactivity with neuromuscular blocking agents

Due to concerns about the risk of anaphylactic reactions, the dispensation of pholcodine-containing medicinal products is suspended from 1 October 2022.

Ozempic: recommendations for 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 2023. Experts from the FAMHP's Unavailability Task Force give recommendations.

Warning against the use of illegal TKTX ointment after applying tattoos

The FAMHP wants to warn consumers in Belgium not to use TKTX ointment, an illegal pain-relieving cream. It is mainly used to alleviate pain when applying a tattoo, permanent make-up ... TKTX ointment is not licensed in Belgium or Europe and therefore no guarantees can be given with regard to the composition, safety, quality or efficiency of this illegal medicine.

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.

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 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.

PRAC May 2022 – Discussion regarding a direct healthcare professional communication (DHPC) containing important information for Defitelio

During its April 2022 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) discussed a direct healthcare professional communication (DHPC) containing important information for Defitelio.

Impact of war in Ukraine on clinical trials

The current war in Ukraine has had a huge impact on clinical trials in Ukraine, Russia and Belarus. Due to the war, a large number of patients in these countries participating in clinical trials are no longer able to participate. There are also problems with the supply of medicinal products and other supplies for conducting clinical trials. The relevant authorities in countries within the European Union are making every effort to ensure the continuity of treatment for patients in ongoing clinical trials by providing the option to continue their treatment at trial sites abroad.

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