News FAMHP

Based on data collected from pharmacists by the FAMHP, it appears that all category A patients who requested an influenza vaccine, have received their vaccine. The limited remaining stock of influenza vaccines can be distributed to the rest of the population, preferably to people over 50 years old or people working in vital sectors. Influenza vaccination remains appropriate until the flu peak has been reached, which has currently not happened yet.

From 7 January 2021 onwards, the FAMHP publishes a weekly overview on the adverse reactions reported in Belgium following the administration of a COVID-19 vaccine. By being fully transparent, the FAMHP aims to increase confidence in COVID-19 vaccines.

The new European Commission Regulation (EU) 2020/1737 adds certain drug precursors to the list of scheduled substances. In addition, certain Combined Nomenclature (CN) codes for drug precursors were amended. The regulation enters into force in stages: the first stage started on 13 December 2020 and the second stage on 13 January 2021.

The package leaflet and Summary of Product Characteristics (SmPC) of medicinal products containing metamizole will be updated to include the risk of liver injury and pharmacokinetic interactions.

The European Medicines Agency (EMA) received an application for a conditional marketing authorisation (MA) for AstraZeneca's candidate vaccine. The evaluation of the candidate vaccines will be performed under accelerated assessment. An evaluation on the marketing authorisation will be issued on 29 January 2021, depending on whether the submitted data are sufficiently robust and complete to prove the quality, safety and effectiveness of the vaccines.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended updating the product information for Comirnaty to clarify that each vial contains six doses of the vaccine.

From 7 January 2021 onwards, the FAMHP publishes a weekly overview on the adverse reactions reported in Belgium following the administration of a COVID-19 vaccine. By being fully transparent, the FAMHP aims to increase confidence in COVID-19 vaccines.

From 7 January 2021 onwards, the FAMHP publishes a weekly overview on the adverse reactions reported in Belgium following the administration of a COVID-19 vaccine. By being fully transparent, the FAMHP aims to increase confidence in COVID-19 vaccines.

The European Commission granted a conditional marketing authorisation for the Moderna vaccine against COVID-19. The Commission is following the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).

The European Medicines Agency (EMA) issued a positive recommendation for “COVID-19 Vaccine Moderna”, making it the second COVID-19 vaccine to be authorised for marketing in the European Union. This recommendation still has to be confirmed by the European Commission. Belgium has purchased the vaccine and will use it in its vaccination campaign.