In­fluen­za Vac­cine "Vax­i­grip Tetra 2020/2021" with French Pack­ag­ing Ma­te­ri­al in the Mar­ket

Vaxigrip Tetra 2020/2021 is a vaccine product with French packaging material. It is equivalent to the German vaccine product Vaxigrip Tetra 2020/2021. The vaccine is marketable in Germany on the basis of the rules laid down in the Statutory Regulation governing the safeguarding of medical supplies (Medizinischer Bedarf Versorgungssicherstellungsverordnung, MedBVSV)). The product with French labelling is supplied via the existing channels of distribution in Germany. It can be ordered under normal conditions, i.e. no particular conditions are involved for the wholesaler, pharmacies, or health care professionals.

Characteristics of the Goods

• The product labelled in French bears the trade name Vaxigrip Tetra.

• The batches with French labelling are:

  • U3K621V
  • U3K743V
  • U3K752V
  • U3K757V
  • U3L071V
    
    
  • U4A212V
  • U4A221V
  • U4A222V
  • U4A261V
  • U4A272V
  • U4A281V
• Die PZN (Pharmazentralnummer, pharmaceutical registration number) is 07752105. The packages bear labels containing this PZN.
• The removable adhesive label of the finished syringe serves the documentation of the vaccination in the German vaccination document (Impfpass).
• The product is not equipped with information for the European market stating characteristics on the packaging that permits following up each individual package from the pharmacy right back to the manufacturer.
• No package leaflet in German has been included in the packaged finished product. Therefore, we provide both the German package leaflet and the summary of product characteristics for download on this page. Alternatively, the current package leaflet for Vaxigrip Tetra 2020/2021 in German can be obtained by scanning the PZN barcode with the aid of the app "Gebrauchsinformation 4.0".
• The product is supplied with the following package for one item with fixed cannulas.

Text below the bar code: The current package leaflet text can be obtained by means of the app “Gebrauchsinformation 4.0” . Source: Sanofi Pasteur

Source: Sanofi Pasteur

Reporting of Side Effects

Please address reports of side effects and complaints to the local representative of the pharmaceutical company: phone +49 800 54 54 010, www.sanofimedicalinformation.com.

You can also report side effects directly to the Paul-Ehrlich-Institut, Federal Institute of Vaccines and Biomedicines, Paul-Ehrlich-Str. 51-59, 63225 Langen, Phone: +49 6103 77 0, Fax: +49 6103 77 1234, www.pei.de or via the reporting portal www.nebenwirkungen.bund.de

You can also report at:

AMK, Arzneimittelkommission
Postfach 4 03 64 · 10062 Berlin
Heidestraße 7, 10557 Berlin
Phone: +49 30 40004 552
Fax: +49 30 40004 553
Email: amk@arzneimittelkommission.de
www.arzneimittelkommission.de

AKdÄ, Arzneimittelkommission der deutschen Ärzteschaft
Herbert-Lewin-Platz 1, 10623 Berlin
Phone: +49 30 400456-500
Fax: + 49 30 400456-555
Email: pharmakovigilanz@akdae.de
www.akdae.de/Arzneimittelsicherheit/UAW-Meldung

Use of the Vaccine

Vaxigrip Tetra is authorised for the use in adults, including pregnant women, and children of the age of 6 months and over as well as the passive immunisation of infants as from birth up to 6 months after maternal immunisation during pregnancy.

The use of Vaxigrip Tetra should adhere to the official recommendations on vaccinations published by the STIKO (Standing Vaccination Committee).

Background

The vaccine is marketed in Germany pursuant to Section 2 2 MedBVSV. This regulation serves to safeguard the supply of the population with medical products during the epidemic situation affecting the entire country identified by the German Parliament on 28 March 2020.

The vaccine batch was tested and released in Europe by an independent OMCL (Official Medicines Control Laboratories).

The decision for marketing the vaccine was made by the Federal Ministry of Health (Bundesgesundheitsministerium, BMG) pursuant to the MedBVSV, among other things on the basis of evaluation by the Paul-Ehrlich-Institut.