August 17, 2021

Fraudulent e-mails in the name of the FAMHP

Frauduleuze e-mails in naam van het FAGG

E-mails frauduleux au nom de l'AFMPS

Source: FAMHP

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August 17, 2021

Coronavirus: biweekly update of COVID-19 vaccines 12 August 2021

Coronavirus: tweewekelijks overzicht bijwerkingen COVID-19-vaccins van 12 augustus 2021

Coronavirus : aperçu bimensuel des effets indésirables des vaccins contre la COVID-19 du 12 août 2021

Source: FAMHP

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August 17, 2021

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.

Source: FAMHP

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August 17, 2021

Coronavirus: biweekly update of COVID-19 vaccines dated 29 July 2021

Coronavirus: tweewekelijks overzicht bijwerkingen COVID-19-vaccins van 29 juli 2021

Coronavirus : aperçu bimensuel des effets indésirables des vaccins contre la COVID-19 du 29 juillet 2021

Source: FAMHP

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August 17, 2021

Limited availability of RoActemra (Roche): recommendations for (hospital) pharmacists, general practitioners and physician specialists.

The stock of RoActemra, a medicinal product used for certain rheumatological and haematological disorders, is currently limited worldwide. The Federal Agency for Medicines and Health Products (FAMHP) therefore issues recommendations.

Source: FAMHP

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August 17, 2021

Give your opinion on a genetically modified medicine to treat dementia

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 medicine PR006A to treat frontotemporal dementia with progranulin mutations (FTD-GRN).

Source: FAMHP

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August 17, 2021

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.

Source: FAMHP

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August 17, 2021

Safety notifications for medical devices from manufacturer Philips: CPAP, BiPAP and ventilation equipment

Veiligheidsmeldingen voor medische hulpmiddelen van fabrikant Philips: CPAP, BiPAP en beademingstoestellen

Informations de sécurité pour des dispositifs médicaux du fabricant Philips : CPAP, BiPAP et respirateurs

Source: FAMHP

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August 17, 2021

End of submissions for initial CTR pilot files on 14 October 2021

The pilot project for the new Clinical Trial Regulation (CTR) will end when the CTR Regulation enters into force. All initial dossiers under the CTR pilot procedure must be submitted by 14 October 2021.

Source: FAMHP

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August 17, 2021

Floods in Belgium: Continuity of access to medicines guaranteed in the affected areas

Overstromingen in België: continuïteit van de toegang tot geneesmiddelen gewaarborgd in de getroffen gebieden

Inondations en Belgique : la continuité de l’accès aux médicaments assurée dans les zones sinistrées

Source: FAMHP

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