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Flash VIG-news: Gabapentin (Neurontin and generics) : risks of misuse, abuse, and dependence

The Summary of Product Characteristics (SPC) and package leaflet for gabapentin-containing medicines (Neurontin and generics in Belgium) have been updated following analyses of the risks of misuse, abuse and dependence.

Annual report on the donation of human body material: increase in the declarations of explicit content and reduction in opposition

In Belgium, each individual, after their death, is presumed to be a potential donor. Since 2020, as well as organ donation, any Belgian citizen has had the option to express their will, explicit consent or opposition to the post-mortem donation of human body material like skin, cartilage, tendons or heart values for transplantation, the manufacture of medicines (advanced therapies) and for scientific research.

Customs and the FAMHP seize 1.5 tonnes of illegal medicines

On 14 July 2023, customs and the FAMHP seized 1.5 tonnes of illegal medicines at Brucargo. This is one of the largest seizures in the European Union in recent years.

Give your opinion on a genetically modified vaccine for the treatment of colorectal tumors

The FPS Public Health and the FAMHP invite you to participate in the public consultation on a clinical trial testing the genetically modified vaccine Nous-209 for the treatment of colorectal tumors. The public consultation runs from 15 October 2022 to 14 November 2022.

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.

Iodine tablets : recommendations for citizens and pharmacists

Over the past few weeks, more than three hundred thousand citizens have obtained iodine tablets from their pharmacies as a result of the conflict in Ukraine. The FAMHP has listed a few recommendations.

Nicotine pouches are no longer considered to be a medicinal product

In its new advice the Joint Commission states that nicotine pouches are no longer considered to be a medicinal product. When used normally, the usual doses (around 10 mg) do not pose a risk of poisoning. However, there are some recommendations for manufacturers. These concern the nicotine yield and the maximum daily dose, the use by children and therapeutic claims.

Coronavirus: new version of Belgian directive for management of clinical trials during coronavirus pandemic

A new version of the national directive is available to supplement the European guidelines (v3) for the management of clinical trials during the coronavirus pandemic.

Unavailability of Visudyne 15 mg (powder for solution for infusion) : recommendations for (hospital) pharmacists and physicians-specialists

The medicinal product Visudyne 15 mg, used in ophthalmology, has been unavailable in Belgium since 30 May 2020. The FAMHP is therefore making recommendations.

Limited availability of Bleomycine Sanofi 15,000 IU

The medicinal product Bleomycine Sanofi 15,000 IU, used in the treatment of certain cancers (testis, throat, mouth, Hodgkin's disease and non-Hodgkin's lymphoma), is currently in limited availability. While waiting for a sufficient quantity of the medicinal product to return to the market, the FAMHP experts recall the recommendations for the rational use of stocks of Bleomycine Sanofi 15,000 IU that may still be available.

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