News FAMHP

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Marevan (warfarin): recall and recommendations to prescribers, pharmacists and patients

The FAMHP monitors the market and guarantees the quality, safety and efficacy of medicinal products for all patients. To this end, the FAMHP is obliged to recall all batches of Marevan 60 tablets, manufactured by the firm Therabel, from pharmacies. The FAMHP issues recommendations to prescribers, pharmacists and patients.

New guideline on the prudent prescription of antibiotics by dentists

Belgium remains one of the largest prescribers of antibiotics in Europe for outpatient care. Approximately 6 % of these antibiotics are prescribed by dentists. The Belgian Health Care Knowledge Centre (KCE) developed an evidence-based guideline for dentists, based on scientific evidence to encourage them to prescribe these medicinal products more rationally. This guideline is the result of a cooperation between field practitioners and academics.

Coronavirus: Belgium agrees on procurement of Pfizer/BioNTech vaccine candidate

The European Commission is conducting negotiations on behalf of the Member States for procurement procedures for COVID-19 vaccines and is submitting contracts to the Member States. In Belgium, the Advisory Committee responsible for the analysis of the procurement files issued a positive recommendation for the Pfizer/BioNTech vaccine candidate. The Inter-ministerial Conference (IMC) on Public Health of 18 November 2020 then made a decision. Belgium will buy the vaccine if a marketing authorisation is granted.

Give your opinion on a genetically modified drug for the treatment of haemophilia A

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 drug PF-07055480 for the treatment of haemophilia A. The public consultation will run from 17 November 2020 to 17 December 2020.

The federal government and the federated entities work together to vaccinate at least 8 million Belgians.

The Inter-ministerial Conference on Public Health andthe Government Commissioner for Corona give more details on the vaccination strategy.

Give your opinion on a genetically modified drug for the treatment of certain lung and skin cancers

The FPS Public Health and the FAMHP would like to invite you to take part in the public consultation on a clinical trial testing the genetically modified drug Nous-PEV (formed by the experimental drugs GAd-PEV and MVA-PEV) for the treatment of certain lung and skin cancers. The public consultation will run from 10 November 2020 to 10 December 2020.

Coronavirus: the FAMHP again calls for rational use of oxygen

Due to the second wave of the COVID-19 pandemic, there is an increased need for oxygen in Belgium for patients with respiratory problems. The FAMHP asks all actors and users not to stockpile and return unused or empty material to the supplier as soon as possible.

Submission of dossiers during end-of-year period: final date is 15 December, except for COVID-19 dossiers

During the end-of-year period the FAMHP will be closed from Friday 25 December 2020 up to and including Sunday 3 January 2021. Deadlines have been set for the submission of different types of files.

Flash VIG-news: ESMYA® (ulipristal acetate 5 mg): revocation of the marketing authorisation

After reviewing the benefit-risk ratio of the medicinal product ESMYA®, the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) has recommended the definitive revocation of its marketing authorisation (MA).

Coronavirus: further extension of the measures taken by the FAMHP to avoid medicinal product shortages

On 1 April 2020, the FAMHP took steps regarding a range of medicinal products in order to avoid any shortage. These measures have now been extended by one month.

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