Keytruda®

Accelerated scientific-technical advice on medicines against COVID-19

Since the start of the COVID-19 health crisis, the FAMHP has given the highest priority to requests for national scientific-technical advice (STA) on medicines against COVID-19. The National Innovation Office and Scientific-Technical Advice Unit uses accelerated timelines for requests regarding medicines that prevent or cure COVID-19 infections. These timelines are crucial to support accelerated clinical research on new medicines against COVID-19.

Genotoxic medicines and contraception: recommendations for all genotoxic active substances, regardless of therapeutic indication

The European Medicines Agency's Safety Working Party clarifies its recommendations on genotoxic medicines and the duration of contraception to apply to any genotoxic active substance, regardless of its therapeutic indication. However, the recommendations should not apply to active substances whose mechanism of genotoxicity is known to have a threshold which is not expected to be reached in patients. Marketing authorisation holders should take these new clarifications into account when considering the need to update their package leaflets.

Call for an important projects of common European interest in the health sector

The FPS Economy published a call for interest from the Belgian federal and regional authorities for important projects of common European interest. The call is intended for economic operators who wish to take part in innovative projects at European level through various partnerships. The first documents should be sent by 30 March 2022 at the latest.

PRAC March 2022 – Update on COVID-19 vaccines and new safety information for dexmedetomidine

During its March 2022 meeting, the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency has recommended a change to the product information for the COVID-19 vaccines of Janssen and Moderna. The Committee also discussed a direct healthcare professional communication containing important safety information for dexmedetomidine.

Distribution of pharmacies : new royal decree and pharmacists can now check the coordinates of their pharmacies

The publication of a new royal decree provides more objective and transparent rules, simpler and more efficient procedures, new possibilities such as the merger and relocation of pharmacies and a limitation of the duration of temporary closures. The new royal decree also establishes the geographical coordinates of pharmacies. Pharmacists can now check this and, if necessary, request a correction by 09.05.2022 at the latest.
Active substance pembrolizumab
Holder     MSD Belgium BV/SRL
Status closed
Indication in combination with chemotherapy as neoadjuvant treatment and then continued as monotherapy as adjuvant treatment after surgery for the treatment of adults with locally advanced, or early-stage triple-negative breast cancer at high risk of recurrence

The FAMHP encourages non-profit organisations and academia to apply for the pilot project for the repurposing of authorised medicines

The FAMHP takes part in the European pilot project for the repurposing of medicines to support non-profit organisations and academia. The project was launched by the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA).
Active substance sacituzumab govitecan
Holder Gilead
Status closed
Indication treatment in monotherapy of adult patients with unresectable, locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, including at least one of them for advanced disease and with no adequate treatment options
Active substance nivolumab + ipilimumab
Holder     BMS
Status Closed
Indication Treatment of adult patients with unresectable malignant pleural mesothelioma that have progressed after at least one line of treatment, including platinumbased doublet Subscribe to