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Coronavirus: COVID-19 Vaccine Janssen: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets. EMA confirms overall benefit-risk remains positive

At its meeting of 20 April 2021, EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) concluded that a warning about unusual blood clots with low blood platelets should be added to the product information for COVID-19 Vaccine Janssen. PRAC also concluded that these events should be listed as very rare side effects of the vaccine.

Coronavirus: weekly update of 20 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.

PRAC April 2021 – Conclusions and additional review on Vaxzevria (AstraZeneca’s COVID-19 vaccine), and new investigations on COVID-19 Vaccine Janssen

During its April 2021 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) concluded on very rare cases of unusual blood clots with low blood platelets reported with Vaxzevria (formerly COVID-19 Vaccine AstraZeneca) and started reviewing a safety signal of capillary leak syndrome in patients vaccinated Vaxzevria. Furthermore, the PRAC is also investigating thromboembolic events reported following vaccination with COVID-19 Vaccine Janssen.

Coronavirus: weekly overview of 15 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 13 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 8 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: EMA finds possible link between Vaxzevria (AstraZeneca) and very rare cases of unusual blood clots with low level of blood platelets

After further investigating cases of thromboembolic events and other conditions related to blood clots reported after vaccination with Vaxzevria (AstraZeneca), the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has concluded that unusual blood clots with low levels of blood platelets (thrombocytopenia) are very rare side effects of the vaccine. The overall benefits of the vaccine in preventing COVID-19, with its associated risk of hospitalisation and death, outweigh the risks of side effects.

Coronavirus: weekly update of 6 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 1 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.

Manufacturing and distribution authorisations and registrations of active pharmaceutical ingredients (API) distributed digitally

Manufacturing authorisations and/or distribution authorisations of medicines and registrations of active pharmaceutical ingredients are no longer automatically sent in paper format by post to the marketing authorisation holder. The FAMHP is now sending these documents in digital format by e-mail. Marketing authorisation holders can still request paper versions.

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