News

PRAC May 2023 – Restrictions on the use of fluoroquinolone antibiotics and new safety information for fluoroquinolone antibiotics and Gavreto

During its May 2023 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA), is reminding healthcare professionals that the use of fluoroquinolone antibiotics given by mouth, injection or inhalation, is restricted due to the risk of disabling, long-lasting and potentially irreversible side effects. The PRAC discussed direct healthcare professional communications (DHPCs) containing important information on fluoroquinolone antibiotics and Gavreto.

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 testing the genetically modified medicine RO7494222 (SRP-9001) for the treatment of Duchenne muscular dystrophy. The public consultation runs from 29 March to 28 April 2023.

New system for financing the surveillance of the medical devices market

A new system for financing the surveillance of the medical devices market applies from 2023. This system aims to make fees fairer between the different stakeholders in the sector, as each one must pay a fee that is consistent with its turnover and with the level of risk involved in its activity and in the workload it represents for the FAMHP.

Give your opinion on a genetically modified medicinal product for the treatment of the eye disorder geographic atrophy

The FPS Public Health and the FAMHP invite you to participate in the public consultation on a clinical trial of the genetically modified medicinal product JNJ-81201887 (AAVCAGsCD59) for the treatment of geographic atrophy secondary to age-related macular degeneration. The public consultation runs from 22 March 2023 to 21 April 2023.

Recommendations for suppliers of prescription software about the order of presentation and selection of medicinal products and non-medicinal products

The FAMHP and the NIHDI wish to remind prescription software suppliers of a number of homologation requirements for the order of presentation and selection of medicinal products and non-medicinal products.

Unavailability of Sabril 500 mg 100 film-coated tablets: recommendations for (hospital) pharmacists, physicians(-specialists) and patients

Due to production problems of Sabril 500 mg, a medicinal product used for epilepsy, there has been a critical shortage in Belgium since February 21, 2023. A task force is making recommendations.