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Information on the Supply of Beyfortus, a Monoclonal Antibody for the Prevention of Respiratory Syncytial Virus (RSV) Infections in the Lower Respiratory Tract

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.

Beyfortus is expected to be in high demand at the beginning of the RSV season due to the new STIKO recommendation on RSV immunisation. It is unlikely that supply will catch up to demand before the end of autumn 2024. There are currently no available alternative equivalent medicines for the RSV prophylaxis of newborns and infants during their first RSV season, regardless of individual risk factors.

The Federal Ministry of Health (Bundesministerium für Gesundheit, BMG) announced the supply shortage for medicinal products containing nirsevimab on 23 September 2024 in the Federal Gazette in accordance with section 79 subsection 5 of the Medicinal Products Act (Arzneimittelgesetz, AMG). The competent state authorities are authorised to grant permissions for medicinal products authorised in other countries in accordance with section 79 subsection 5 of the AMG. These permissions make it possible to import medicinal products containing nirsevimab that are not authorised in Germany and to place them on the German market. A permission to import Beyfortus from the United States was granted on 11 October 2024. The permission is considered valid until there is an announcement by the BMG that there is no longer a supply shortage.

As an additional measure put in place to meet the anticipated high demand, the marketing authorisation holder Sanofi Winthrop Industrie was permitted by the Paul-Ehrlich-Institut to place packs of the medicinal product from France and Spain on the market in Germany from 1 September 2024 to 31 October 2024 pursuant to section 10 subsection 1a and section 11 subsection 1c of the AMG. These products are pharmaceutically identical to the product with German labelling and differ only in the packaging.

Details on Beyfortus with English, French and Spanish Labelling

Packs originating from the US

  • The commercial name of this English-labelled product is also "Beyfortus".
  • The text on the syringe label, in the package leaflet, and on the folding box is in English.
  • 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 Injektionslösung i.e. FER o.K. US
    Special PZN: 19468326
    Batch AZ240073, expiration date May-2026
    Batch UK297AA, expiration date May-2026

English-labelled product Beyfortus 100 mg. English-labelled product Beyfortus 100 mg. Source: Sanofi Winthrop Industrie

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

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

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
    Batch AZ240060, expiration date Mar-2026

Spanish-labelled product Beyfortus 100 mg. Spanish-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.

Updated: 29.11.2024