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Beyfortus, Monoclonal Antibody to Prevent Respiratory Syncytial Virus (RSV) Infections in the Lower Respiratory Tract, Available in Germany with French and Spanish Labelling

Beyfortus is a medicine used to prevent lower respiratory tract infections with the respiratory syncytial virus (RSV) in newborns and infants during their first RSV season and children aged 24 months who remain susceptible to severe RSV during their second RSV season. It contains the active substance nirsevimab.

High demand for Beyfortus is expected at the beginning of the RSV season due to the new STIKO recommendation on RSV immunisation. In order to meet this demand, the marketing authorisation holder Sanofi Winthrop Industrie will place packs of the medicine from France and Spain on the German market from 1 September, 2024, to 30 October, 2024. These products are pharmaceutically identical and differ only in the packaging.

Details

Packs originating from France

  • The commercial name of this French-labelled product is also "Beyfortus".
  • The text on the syringe label, in the package leaflet, and on the folding box is in French.
  • The vaccines are in their original packaging, which does not contain a German package leaflet.
  • The German package leaflet and summary of product characteristics are available for download on this page.

  • German product name: Beyfortus 100 mg Inj.-Lsg. i.e. Fertigspr. m. 2 K. FR

    Special PZN: 19468272

    Batch 2070037, expiration date Nov-2025

  • German product name: Beyfortus 50 mg Inj.-Lsg. i.e. Fertigspr. m. 2 K. FR

    Special PZN: 19483248

    Batch 2070030, expiration date Nov-2025

Packs originating from Spain

  • The commercial name of this Spanish-labelled product is also "Beyfortus".
  • The text on the syringe label, in the package leaflet, and on the folding box is in Spanish.
  • The vaccines are in their original packaging, which does not contain a German package leaflet.
  • The German package leaflet and summary of product characteristics are available for download on this page.

  • German product name: Beyfortus 100 mg Inj.-Lsg. i.e. Fertigspr. o. Kan. ES

    Special PZN: 19482823
    Batch AZ240083, expiration date Feb-2026

French-labelled product Beyfortus 50 mg French-labelled product Beyfortus 50 mg Source: Sanofi Winthrop Industrie

French-labelled product Beyfortus 100 mg French-labelled product Beyfortus 100 mg Source: Sanofi Winthrop Industrie

Background

The Paul-Ehrlich-Institut, the Federal Institute for Vaccines and Biomedicines, is the higher federal authority responsible for the quality, safety and efficacy of vaccines in Germany and for federal batch release of vaccines. It also advocates for the availability of these medicines – including monoclonal antibodies.

A significantly increased demand for the medicinal product Beyfortus is expected at the beginning of the RSV season. This demand cannot be adequately met without the marketing of foreign products. As a result, Sanofi Winthrop Industrie, the marketing authorisation holder for "Beyfortus 50 mg solution for injection in pre-filled syringe" and "Beyfortus 100 mg solution for injection in pre-filled syringe", submitted an application for permission to distribute medicinal products with foreign language labels in Germany in accordance with section 10 (1a) and section 11 (1c) of the Medicinal Products Act. This application was approved by the Paul-Ehrlich-Institut.

Updated: 02.09.2024