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Monoclonal Antibody Cancer Medicine Oyavas Available in Germany with Hungarian Labelling

Oyavas is a cancer medicine used to treat adults in the advanced stages of various types of cancer. Oyavas can be used in combination with other cancer medicines depending on the indication. It contains the active substance bevacizumab.
Oyavas' marketing authorisation holder, STADA Arzneimittel AG, will counteract a supply shortage by placing packs of the medicine from Hungary on the market in Germany from 19 July 2024, to 31 July 2024. These products are pharmaceutically identical and differ only in the packaging. The packs are mainly intended for the hospital market.

Details

Packs originating from Hungary

  • The commercial name of the Hungarian-labelled product is also "Oyavas".
  • Each pack is accompanied by a German package leaflet attached to the pack by a rubber band.
  • Product name: Oyavas 25 mg/ml Konz.z.He.e.Inf.-Lsg.400mg/16ml HU
  • Special PZN: 19449464
  • Batch 230199, expiration date 30 September 2025

Medicinal product Oyavas with Hungarian labelling and German package leaflet (Source: STADAPHARM GmbH)

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.

Due to a current supply shortage of the medicinal product Oyavas, the marketing authorisation holder for "Oyavas 25 mg/ml concentrate for solution for infusion", STADA Arzneimittel AG, 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: 24.07.2024