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PRAC June 2021 – EMA advises on Vaxzevria (COVID-19 Vaccine AstraZeneca) and update on ongoing evaluation of COVID-19 vaccines

During its June 2021 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) advises against use of Vaxzevria in people with history of capillary leak syndrome. The PRAC is also continuing its assessment of reports of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the membrane around the heart) in a small number of people following vaccination with COVID-19 vaccines.

Coronavirus: EMA approves additional manufacturing capacity for Pfizer/BioNTech COVID-19 vaccine

The European Medicines Agency (EMA) has recommended the approval of additional manufacturing and filling lines at Pfizer’s vaccine manufacturing site in Puurs, Belgium.

PRAC May 2021 – Conclusions and reviews of safety signals related to COVID-19 vaccines

During its May 2021 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) reviewed a number of safety signals related to COVID-19 vaccines. The evaluation of safety signals is a routine part of pharmacovigilance and is essential to ensuring that regulatory authorities have a comprehensive knowledge of a medicine’s benefits and risks.

Medical devices: EU Regulation 2017/745 applies as of today

On 26 May 2021, EU Regulation 2017/745 on medical devices entered into force. This new Regulation addresses the needs for innovation, security and traceability.

The FAMHP publishes its annual report for 2019

As is customary and with full transparency, the FAMHP publishes the figures and results for 2019 for all its services and activities. You are receiving this annual report later than you would normally expect from us, as the COVID-19 health crisis has been given priority over the past year. The annual report contains many novelties, rising and falling trends and interesting figures. 2019 was a year of progress, you can read all about it in the FAMHP digital annual report, which is available again in four languages.

Coronavirus: the FAMHP monitors stocks of medicines using a new tool

Close monitoring of medicine stocks proved particularly useful during the COVID-19 pandemic. The FAMHP managed to act proactively and find solutions in time. The monitoring was done manually, but is now automated using a new Stock Monitoring Tool.

Coronavirus: weekly overview of 6 May 2021 on adverse reactions of COVID-19 vaccines

Every Thursday, the FAMHP publishes a cumulative overview of the adverse reactions reported after administration of a COVID-19 vaccine in Belgium. By being fully transparent, the FAMHP wants to increase confidence in COVID-19 vaccines.

Coronavirus: weekly overview of 29 April 2021 on adverse reactions of COVID-19 vaccines

Every Thursday, the FAMHP publishes a cumulative overview of the adverse reactions reported after administration of a COVID-19 vaccine in Belgium. By being fully transparent, the FAMHP wants to increase confidence in COVID-19 vaccines.

Coronavirus: weekly update of 27 April 2021 on vaccine deliveries and information on vaccination equipment

To increase transparency on the deliveries of COVID-19 vaccines and vaccination equipment, the FAMHP publishes the number of doses delivered to Belgium, how many of these doses are allocated to each of the federated entities and the size of the emergency stock. Also, regular updates are published on the number of needles and syringes that have been ordered and received.

Coronavirus: weekly overview of 22 April 2021 on adverse reactions of COVID-19 vaccines

Every Thursday, the FAMHP publishes a cumulative overview of the adverse reactions reported after administration of a COVID-19 vaccine in Belgium. By being fully transparent, the FAMHP wants to increase confidence in COVID-19 vaccines.

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