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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 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.

PRAC February 2023 – Start of a safety review of pseudoephedrine-containing medicines

During its February 2023 meeting, the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency has started a review of medicines containing pseudoephedrine.

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.

Five new drug precursors added to list of scheduled substances

The European Commission's new Delegated Regulation (EU) 2023/196 adds five drug precursors to the list of scheduled substances. These are substances that can be used to produce fentanyl or amphetamines. The trade, possession and use of these substances are subject to governmental supervision. The regulation enters into force on 20 February 2023.

PRAC January 2023 - recommendations for Janus kinase (JAK) inhibitors and information about Zolgensma

Alignment of dose recommendations for Janus kinase (JAK) inhibitors in patients with certain risk factors and New safety information for healthcare professionals for Zolgensma

End of the validation procedure for SARS-CoV-2 antigen self-tests

The validation procedure for SARS-CoV-2 antigen self-tests with a CE-marking ceased to apply since 23 January 2023. The associated list of recommended SARS-CoV-2 antigen self-tests with a CE-marking is therefore no longer available.

Important for clinical trials sponsors: mandatory use of E-Submission Food Chain platform for clinical trials with genetically modified medicinal products

Since 1 October 2022, all Summary Notification Information Format documents submitted with applications for clinical trials with medicinal products, entirely or partly composed of genetically modified organisms covered by Directive 2001/18/EC for deliberate release, must be submitted through the E-Submission Food Chain platform.

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