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The case of falsified medicine was prevented in Estonia

The case of falsified medicine was prevented in Estonia

Updated 09.12.2021

On 25th of November 2021, the first case of a counterfeit Soliris® (eculizumab) package was reported to have been verified by the Estonian end user and confirmed by the manufacturer.

The Estonian wholesaler verified the package for the purpose of purchasing (the package was not physically in the hands of the wholesaler). As the alert NMVS_FE_LOT_03 (no batch data found in the system) appeared, the purchase and sale transaction was not completed, and the pack did not reach Estonia. Despite the positive outcome in this case, REKS points out that, due to the delegated regulation, only pack that is physically in the possession of the end user is allowed to be verified.

The alert investigation was triggered by a representative of the pharmaceutical company who contacted REKS. Based on the photo received from the wholesaler and the data received from REKS, the manufacturer found that the pack was counterfeit, i.e., the batch and serial number of the pack did not match.

To date, the following information is known and confirmed:
Product: SOLIRIS 300MG Concentrate for Solution for Infusion
Manufacturer: Alexion
GTIN: 05391527741008
LOT: 1001600
EXP: 31.03.2023

  • The pack was destined for the Turkish market but the SN on the pack did not belong to the given batch
  • The SN on the pack belonged to another batch of the same product which was intended for the UK/IE market
  • Based on the SN physically printed on the pack, the manufacturer established that the pack had been sold to Saudi Arabia
  • As the pack did not physically reach Estonia, the European Medicines Agency will coordinate the further investigation of the entire incident. Due to the above, it is known that the pack was counterfeit, but it is not known whether the drug (active ingredient, etc) was also manipulated.

    In view of the above, it is important for each package of a medicinal product that receives an alert t identify why the alert message appeared and to verify the authenticity of the package.

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