Influenza Vaccine "Vaxigrip Tetra 2020/2021" with French Packaging Material in the Market
The Federal Minister of Health has devoted himself to higher vaccination rates in the population and has among other things made additional influenza doses available including Vaxigrip Tetra 2020/2021 with french packaging material.
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
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.