News FAMHP

The FAMHP is closely monitoring stocks of medicinal products used in the fight against COVID-19. Certain of these medicinal products are essential to treat patients with chronic diseases (e.g. lupus, rhumatoid arthritis, HIV, etc.). The FAMHP is taking measures to guarantee the availability of these essential medicines.

A new law provides for additional measures to limit the unavailability of medicines. The main guidelines of the new law are a clarification of the supply obligation of pharmaceutical companies, the possibility to prohibit or restrict the export of unavailable medicines and the possibility for pharmacists to supply an alternative medicine under certain conditions.

Clamoxyl I.V.-I.M. is available again. The recommendations formulated by the FAMHP and the NIHDI for rational use by hospital pharmacists and physicians-specialists no longer apply. The marketing of Clamoxyl I.V.-I.M. and of Augmentin I.V. will eventually be definitively discontinued.

A new reporting system will be available on December 5, 2019. To avoid errors, reports may only be made through the current system until December 2, 2019.

Via the new online application PharmaStatus, marketing authorization holders can notify the FAMHP of unavailability and start or stop of commercialization of a drug. Marketing authorization holders are invited to an information session on November 18, 2019.

Through possible limited availability of intravenous immunoglobulins, there is a threat of a shortage in some hospitals in Belgium. The Federal Agency for Medicines and Health Products (FAMHP) is giving recommendations for hospital pharmacists and physician-specialists within the hospitals.

After successful consideration among the FAMHP, the National Institute for Health and Disability Insurance (RIZIV-INAMI) and the manufacturer Therabel, the manufacturer has decided to continue to produce the drug Marevan. The FAMHP calls on pharmacists and patients to not order unnecessary inventories of the drug so that the drug will remain available for all patients.

The company Kela Pharma has indicated that, due to production issues, its Maniprex® 250 mg coated tablets and Maniprex® 500 mg film-coated tablets will be unavailable for an indefinite period once current stocks have been exhausted. The stock of Maniprex® 500 mg has already been exhausted, and Kela Pharma predicts, based on normal circumstances, that the stock of Maniprex® 250 mg will be exhausted by June 2018.

Due to a reduction in the manufacturing capacity for the vaccines HAVRIX 1440 and HAVRIX JUNIOR 720 (GSK), used to protect adults and children against hepatitis A, and in order to limit the impact of these supply shortages, alternatives are being proposed The Superior Health Council (SHC) details the correct use of the proposed alternatives in advice number 9260: Recommendation concerning the risk on the shortage supply for hepatitis A vaccine.

The marketing authorisation (MA) for Mabcampath has been withdrawn at the European level, on the initiative of the MA holder, Genzyme Europe BV, for commercial reasons. Mabcampath is a monoclonal antibody (alemtuzumab) used in some chronic lymphocytic leukaemia. Appropriate access to this medicine will be implemented in each Member State to ensure that patients who are currently benefiting from the treatment can continue.