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Wholesalers-distributors authorized to distribute veterinary medicines
Following infringements noticed within the system of distributing veterinary medicines, the FAMHP reminds concerned parties that pharmacists and veterinarians who have a depot must check that the wholesalers-distributors who supply the medicines are properly authorized.
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Public consultation on the use of a genetically modified organism in a clinical trial
The Federal Public Service Health, Food Chain Safety and Environment and the Federal Agency for Medicines and Health Products inform you of a clinical trial with a genetically modified medicine from BN Immuno Therapeutics for fighting prostate cancer. The public consultation on this trial will run from April 20th to May 20th 2012 inclusive.
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INN prescription and substitution: new measures taken by the government
Since 1st April 2012, within the new measures taken by the government, in the case of an INN prescription the pharmacist must deliver a medicine belonging to the "group of the cheapest medicines ". In addition, from 1st May 2012 the prescription of antibiotics and antimycotics for acute treatment should be considered as an INN prescription.
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Fingolimod (Gilenya): new recommendations
In order to better manage the risk of adverse cardiac effects associated with the use of fingolimod (GLIENYA) in the treatment of multiple sclerosis, the European Medicines Agency (EMA) has issued new recommendations for the attention of health professionals.
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Metal-metal hip prosthesis: monitoring of the patients
Following the recommendations issued by the MHRA (the English equivalent of the FAMHP) concerning the monitoring of patients with metal-metal hip prosthesis, the FAMHP sent to concerned health professionals a letter about the matter.
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ViaSpan: withdrawal of a potentially contaminated batch
In agreement with the FAMHP, the firm Bristol Myers Squibb recalled as a precaution batch 16EH0002 of ViaSpan solution for organ preservation. Routine checks on the release of the batch distributed in Belgium were conform but during the controls on the production line, the possibility of a bacterial contamination was identified. ViaSpan is out of stock. New lots will be available in June 2012 at the earliest. The firm has communicated to concerned health professionals all relevant information.
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Survey launched for veterinarians on prescribing habits for antimicrobials
A survey has been launched on the Internet across Europel to gather information on the factors that influence the prescribing practices of veterinarians concerning antimicrobials. Practicing veterinary surgeons are encouraged to complete this survey which closes on April 15th 2012.
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Strontium ranelate (PROTELOS): new contra-indications and updated warnings
The European Medicines Agency confirms that the benefit / risk balance of strontium ranelate (PROTELOS in Belgium) remains positive. It recommends, however, that this medicine be contra-indicated in immobilised patients or patients with venous thromboembolism. It also updated the warnings regarding serious skin reactions.
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Medicines used in children against cough and cold: review of the risk-benefit balance and new measures
The Committee for Medicinal Products for Human Use has reassessed the risk-benefit balance of medicines used in children against cough and cold, namely antitussives, expectorants and topical nasal decongestants. Based on the advice of this commission, the Federal Agency for Medicines and Health Products (FAMHP) has taken certain measures concerning these medicines.
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Paediatric use of metoclopramide: new recommendations
New recommendations regarding the use of metoclopramide were issued, at the European level, following the observation of an increased frequency of adverse neurological events in children under 18 years: medicines containing metoclopramide are contraindicated in children less than one year and not recommended beyond one year and up to 18 years.
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