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Influenza Vaccine Efluelda Available in Germany with Italian Label

Efluelda is a split influenza vaccine indicated for active immunisation of adults 60 years of age and older for the prevention of influenza and should be used in a manner pursuant to official influenza vaccination recommendations. The vaccine intended for the German market for the 2025/26 season complies with the recommendations of the World Health Organization (WHO) for the northern hemisphere, as well as with the EU decision for the 2025/26 season.

Currently, all trivalent Efluelda vaccines planned for the ongoing season are reported as sold out. In order to meet the additional demand for the 2025/26 season, the Paul-Ehrlich-Institut has permitted the marketing authorisation holder Sanofi, as an exception pursuant to section 10 (1a) and section 11 (1c) of the Medicinal Products Act (Arzneimittelgesetz, AMG), to place Efluelda on the market in Germany with Italian labelling until 30 April 2026. This product is pharmaceutically identical to the product with German labelling and differs only in the packaging.

Details

  • The commercial name of this Italian-labelled product is also Efluelda (see photos below).
  • The text on the syringe label, in the package leaflet, and on the folding box is in Italian.
  • The German package leaflet and the summary of product characteristics are available for download at the bottom of this page.
  • By scanning the QR code on the folding box, users can access the "Efluelda Landing Page", which also provides access to the German summary of product characteristics and package leaflet.

  • Product name: Efluelda suspension for injection in a pre-filled syringe

    • Pharmaceutical form: a pre-filled syringe with a staked needle
      PZN: 19403485
      Batch number: 5DE62D1, to be used by: April 2026
    • Pharmaceutical form: 10 pre-filled syringes with 10 staked needles
      PZN: 02037622
      Batch number: 5DF42D1, to be used by: May 2026
      Batch number: 5DF43D2, to be used by: May 2026

Image / Video 1 / 7

Efluelda (1 syringe) Front of packaging with Italian label. Efluelda (1 syringe) Front of packaging with Italian label. Source: Sanofi Winthrop Industrie

Pagination

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.

An up-to-date overview of current supply shortages of human vaccines in Germany can be found on the website of the Paul-Ehrlich-Institut.

Our email newsletter "Safety and Availability – Information on Drug Safety, Handling Information on Supply Bottlenecks of Human Vaccines" provides regular information about current availability and supply shortages.

Updated: 14.01.2026