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Give your opinion on a genetically modified medicine for the treatment of Duchenne muscular dystrophy

The FPS Public Health and the FAMHP invite you to participate in the public consultation on a clinical trial of the genetically modified medicine SRP-9001 for the treatment of Duchenne muscular dystrophy. The public consultation runs from 17 January 2022 to 16 February 2022.

Limited availability of RoActemra (Roche): new situation update

The availability of RoActemra (tocilizumab), a drug used for certain rheumatological and hematological disorders, can still not be fully guaranteed. Currently, there is a stock for both the intravenous and subcutaneous form of administration, taking into account the previously approved indications, i.e. exclusive use in COVID-19 patients. Based on the information currently available to the FAMHP, Roche will also not be able to confirm deliveries long in advance in the coming months.

Limited availability of subcutaneous immunoglobulins

Due to a decrease in the availability of subcutaneous immunoglobulins around the world, there is also a critical level of limited availability in Belgium. The FAMHP issues several recommendations for hospital and retail pharmacists, medical doctors (specialists), and patients.

PRAC December 2021 – Assessment of recent data on the known risk of myocarditis and pericarditis following vaccination with COVID-19 vaccines Comirnaty and Spikevax

During the December 2021 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has assessed recent data on the known risk of myocarditis and pericarditis following vaccination with COVID-19 vaccines Comirnaty and Spikevax.

Give your opinion on genetically modified vaccines to treat hepatitis B

The FPS Public Health and FAMHP would like to invite you to take part in the public consultation on a clinical trial testing the genetically modified vaccines ChAd155-hIi-HBV and MVA-HBV for the treatment of infections with the hepatitis B virus (HBV). The public consultation will run from 27 November 2021 to 27 December 2021.

PRAC November 2021: updates on COVID-19 vaccines and conclusion of safety signal for Imbruvica

During its November 2021 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has made un update on COVID-19 vaccines and concluded a safety signal for Imbruvica.

PRAC October 2021 – Nomegestrol containing products and chlormadinone containing products and update on COVID-19 vaccines

During its October 2021 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has started a review of meningioma risk with nomegestrol- and chlormadinone-containing medicines. The PRAC also has reviewed data on venous thromboembolism and immune thrombocytopenia with COVID-19 vaccines.

Coronavirus: new version of Belgian directive for management of clinical trials during coronavirus pandemic

A new version of the national directive is available to supplement the European guidelines (v3) for the management of clinical trials during the coronavirus pandemic.

PRAC August 2021 – Recommendation and review of safety issues related to COVID-19 vaccines

During its August 2021 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) recommended updating the product information of COVID-19 Vaccine Janssen. Furthermore, the PRAC continues to closely review reports of Guillain-Barré syndrome with Vaxzevria and discussed other safety issues occurring after vaccination against COVID-19.

Updated guidance for submission of clinical trial applications, substantial amendment notifications and end of trial declarations to the FAMHP

A new version of the guidance for submission of clinical trial applications, substantial amendment notifications and end of trial declarations to the FAMHP is available.

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