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Amended legislation: drug precursors added to list of scheduled substances

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.

Flash VIG-news: Metamizole (NOVALGINE): information on the risks of liver injuries and pharmacokinetic interactions

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.

Coronavirus: EMA receives application for conditional marketing authorisation for AstraZeneca vaccine

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.

Coronavirus: sixth dose from vials of Comirnaty vaccine (Pfizer/BioNTech)

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.

Flash VIG news: weekly overview on adverse reactions of 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.

Coronavirus: weekly overview of 7 January 2021 on adverse reactions of 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.

Coronavirus: European Commission gives conditional marketing authorisation for Moderna vaccine against COVID-19

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).

Coronavirus: EMA gives positive recommendation for Moderna vaccine

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.

Coronavirus: EMA organises a second public meeting about the new COVID-19 vaccines

The European Medicines Agency (EMA) will organise a second public meeting on 8 January 2021 to inform European citizens about the assessment, approval and roll-out of new COVID-19 vaccines.

Coronavirus: new online form to report suspected adverse reactions to a COVID-19 vaccine

A new online form now makes it easier to report suspected adverse reactions to a COVID-19 vaccine. The new user-friendly form will also be linked to Vaccinnet+. Therefore, certain fields will be filled in automatically in the future. Reporting adverse reactions can increase the knowledge of the safety profile of the vaccines. The FAMHP will regularly provide an update on the follow-up of the reports.

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