Information about the counterfeited medicine Pegasys 180 microgram solution for injection seized in Germany
29.10.2013
A counterfeited medicine Pegasys 180 microgram solution for injection (peginterferon alpha-2a), originating from parallel import has been discovered in Germany. The counterfeited medicine is labelled as "batch B1299B03 EXP 07 2015”. The batch number indicated on the counterfeited medicine is the same as the batch number on the original medicine of the marketing authorisation holder Roche Registration Limited. Roche’s original batch B1299 has been distributed in several countries of the European Union, Pakistan and Australia. We emphasize that the original batch has not been distributed in Croatia. Also, HALMED has neither received any report to quality defect for this medicinal product nor information indicating that the suspected counterfeited medicine Pegasys might be on the market, therefore no concern.
In case the user purchased the medicinal product Pegasys out of the Croatian territory, it is necessary to verify the batch number, the presentation of the syringe and the outer packaging. The counterfeited medicine does not look similar to the original medicine Pegasys and it is possible to differentiate it from the original according to the following: the syringe of the counterfeited product is plastic (instead glass), has a black stopper (instead grey), has a white valve (instead red) and on the outer packaging (box) the colour sign and the barcode are missing. Results of the analysis carried out in the EU revealed that the product contained no peginterferon alpha 2a (the active substance of the medicinal product Pegasys). The counterfeited medicine is neither efficient nor safe and it should not be used. In case of a suspected medicinal product, it should not be used and it should be reported to HALMED, via application form for quality defect reporting, or on 0800 48 00 08, that is available from 0 to 24 h, for urgent reporting that may lead to recalls.
We remind healthcare professionals that they should report any adverse reaction to HALMED, as well as quality defect. Patients who have developed any adverse reaction to medicinal product may report it directly to HALMED via form or on-line application, with recommendation regarding any adverse reaction they discover to consult with their doctor or pharmacist about the continuation of their therapy.
