News FAMHP

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Journée de l’AFMPS 2012

Le vendredi 25.05.2012, l’AFMPS travaille avec un effectif réduit. Merci d'en tenir compte. Pour les questions urgentes, vous pouvez toujours contacter l’accueil au numéro: 02/524.80.00. Merci pour votre compréhension.

Evaluation des variations cliniques type II dans le cadre de la procédure nationale d’autorisation de mise sur le marché des médicaments: mise au point

Durant l’évaluation d’une demande de variation clinique apportée à un dossier d’autorisation de mise sur le marché (AMM) d’un médicament, la Commission des médicaments peut formuler des recommandations qui ne sont pas liés à la demande. Celles-ci ne peuvent cependant pas retarder la procédure en cours.

Consultation du public sur l’emploi d’un médicament génétiquement modifié contre le VIH dans un essai clinique

Le Service public Fédéral Santé publique, Sécurité de la Chaîne alimentaire et Environnement et l’Agence Fédérale des Médicaments et des Produits de Santé vous informent d’un essai clinique avec un médicament génétiquement modifié de la firme Theravectys pour lutter contre le virus du Sida (VIH). La consultation publique sur cet essai se déroule du 8 mai au 7 juin 2012 inclus.

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.

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.

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.

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.

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.

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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