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Buying slimming products containing sibutramine on the internet: beware !
Following the recommendation of the European Medicines Agency (EMA) to suspend the marketing authorization of medicines containing sibutramine, the firm Abbott, at the request of the Federal Agency for Medicines and Health Products (FAMHP), withdrew Reductil from the market (the only medicine with sibutramine approved and marketed in Belgium) for security reasons. The FAMHP stresses the danger of buying online medicines with sibutramine.
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Sibutramine (Reductil) : stopping product marketing
The European Medicines Agency (EMEA) has reviewed the safety of sibutramine, a medicine against excessive weight. Based on available data it woud seem that the cardiovascular risks associated with the use of this medicine outweigh its benefits. The EMEA recommends the suspension of the marketing authorisation of all medicines containing sibutramine that are marketed in the European Union. In Belgium sibutramine is marketed under the name Reductil.rketing
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Human body material: legislation amendment
The law of 23rd December 2009 containing various provisions on public health, which was published in the “Moniteur belge” of 29th December 2009, came into force on 8th January 2010. It contains, amongst other things, provisions which amend the law of 19th December 2008 concerning the acquisition and use of human body material intended for human medical applications or for scientific research.
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Summaries of Product Characteristics and leaflets now on line
The Vice-Prime Minister and Minister of Public Health, Laurette Onkelinx, announced on Monday 11/01/2010 at a press conference that the FAMHP now makes available on its website, for health (human or animal) professionals and for patients, the Summaries of Product Characteristics (SPC) and the package leaflets of medicinal products for human or veterinary use that are authorized and marketed in Belgium.
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Fees and payments : update of the summary tables
Following the indexing of the fees for the missions undertaken by the Federal Agency for Medicines and Health Products (FAMHP) the tables have been adapted and came into effect on 01.01.2010.
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New regulation for variations of the dossiers for marketing authorization for medicines for human use: warning
The new "variations" regulation came into force on 01/01/2010. Given the technical problems encountered during the update of the computer programme to send mails automatically following the introduction of a dossier, new versions of these mails corresponding to the new regulation, which should have been available from 01/01/2010, were not ready on that date. Everything will be done to make the necessary adjustments as quickly as possible.
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Belgium participates in an operation in the fight against internet sales of counterfeit and illegal medicines (PANGEA II).
From 16th to 20th November 2009 an international coordination programme focusing on internet sales of counterfeit and illegal medicines was undertaken. The aim was to draw attention to the risks of selling medicines via the internet. This was the fifth operation by the MHRA (Medicines and Healthcare products Regulatory Agency, United Kingdom).
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Vaccine Pandemrix against A/H1N1v pandemic influenza: risk of fever in young children
The European Medicines Agency (EMEA) is warning that young children may experience fever after their second dose of the pandemic influenza vaccine Pandemrix. This risk, which is already present after the administration of the first dose of this vaccine, is higher after the administration of the second dose.
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Influenza A/H1N1v: Pharmacovigilance in Europe
The European Medicines Agency (EMEA) issued, as part of the A/H1N1v influenza pandemic, the first report in the weekly update on the monitoring of adverse reactions related to vaccines and antiviral medicines used in Europe.
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Influenza A/H1N1v: monitoring of adverse reactions related to the vaccine Pandemrix
As part of the national campaign of vaccination against influenza virus A/H1N1v, the Federal Agency for Medicines and Health Products (FAMHP) has implemented a programme to monitor adverse reactions of the vaccine used in Belgium (Pandemrix). This programme fits into the European risk management plan and completes it. A first report is now available.
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