Fighting antimicrobial resistance: new antimicrobial medicinal products marketed in Belgium

date: 22/09/2023

In the fight against antimicrobial resistance (AMR), it is important to improve the diversity of therapeutic treatments to enable medical doctors to make the most appropriate choice. A new dosage for children has recently been launched on the Belgian market for a pheneticillin-based antibiotic and two antivirals, one composed of bictegravir, emtricitabine and tenofovir and the other composed of dolutegravir, abacavir and lamivudine.

As part of the fight against AMR, the FAMHP has developed a Belgian national action plan "One World, One Health", in collaboration with the other Belgian public services involved. This plan is based on the three pillars of health: human health, animal health and the environment. It proposes concrete actions to combat antimicrobial resistance in a comprehensive and coordinated way. The FAMHP's activities are aimed at making new antimicrobials available and keeping older ones accessible. In this context, the FAMHP informs healthcare professionals of the recent placing on the market of three new antimicrobial medicines:

  • A pheneticillin-based antibiotic (Broxil 125 mg/5 ml) in powder for oral suspension has been on the market since 1 March 2023.
    In addition to the capsules already available on the Belgian market, this pharmaceutical form allows application to two additional paediatric age categories: 0 to 2 years and 2 to 10 years .
    Pheneticillin is a so-called narrow-spectrum antibiotic, which means that it only fights certain bacteria. 
    Broxil is indicated for the treatment of certain infections caused by bacteria sensitive to this medicine. For example:
  • upper respiratory tract infections, such as pharyngitis;
  • lower respiratory tract infections, such as pneumonia; 
  • skin and soft tissue infections, such as impetigo or abscesses.

More information in the package leaflet and summary of product characteristics for Broxil 125 mg/5 ml. 

  • An antiviral film-coated tablet containing bictegravir 30 mg, emtricitabine 120 mg and tenofovir 15 mg (Biktarvy 30 mg/120 mg/15 mg)  has been on the market since 17 April 2023.

    This dosage allows therapeutic application for children aged at least 2 years and weighing between 14 and 25 kg. This is in addition to the dosages already on the market for therapeutic use in adults weighing at least 25 kg.
    Biktarvy is indicated for patients infected with human immunodeficiency virus type 1 (HIV-1), a virus responsible for acquired immunodeficiency syndrome (AIDS). It is used only in patients in whom the virus has not developed resistance to a class of anti-HIV medicines called integrase inhibitors, or to tenofovir or emtricitabine.

More information in the package leaflet and summary of product characteristics for Biktarvy 30 mg/120 mg/15 mg.

  • An antiviral agent composed of 5 mg dolutegravir, 60 mg abacavir and 30 mg lamivudine (Triumeq 5 mg/60 mg/30 mg) dispersible tablets has been on the market since 9 September 2023.
    This dosage allows therapeutic application for children weighing between 14 and 25 kg. This is in addition to the dosages already on the market for therapeutic use in adults weighing at least 25 kg.
    Triumeq is indicated for the treatment of human immunodeficiency virus infection (HIV). 
    Abacavir should not be used in patients with the HLA-B*5701 allele. Before starting abacavir-containing treatment, all HIV-infected patients, regardless of ethnic origin, should be screened for the HLA-B*5701 allele.

More information in the package leaflet and summary of product characteristics for Triumeq 5 mg/60 mg/30 mg.


You can check the availability of all medicinal products (recently) marketed in Belgium via PharmaStatus.
 

Last updated on 22/09/2023