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Amended legislation: drug precursors added to list of scheduled substances

The European Commission's new Delegated Regulation (EU) 2022/1518 adds two drug precursors to the list of scheduled substances. The regulation entered into force on 3 October 2022.

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 for tattoos

The FAMHP wants to warn consumers in Belgium about the use of TKTX ointment, an illegal pain-relieving cream and other illegal pain-relieving ointments containing lidocaine, prilocaine, epinephrine or a combination. These ointments are mainly used to relieve 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.

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.

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