Information about counterfeit Herceptin (trastuzumab) on the Czech market
26.05.2014
Following the previous information about the counterfeit Herceptin (trastuzumab) on the EU market, the Agency for Medicinal Products and Medical Devices (HALMED) has been informed about a suspected counterfeit Herceptin on the Czech market.
In the Czech Republic, a medicinal product was found to have different labelling of the expiry date and batch number on the inner and outer packaging and to be labelled in different languages. The inner package was labelled with the batch number H0758, whereas indicated batch number on the outer packaging was H4342B01. The inner packaging and the package leaflet were prepared in Romanian and Bulgarian language, whereas the outer packaging was prepared in Romanian language.
These batches have never been on the Croatian market.
Even though these batches have never been distributed on the Croatian market, all healthcare professional are advised to pay attention when handling and administering Herceptin. In the case of a suspected counterfeit medicine, it should be reported by e-mail to HALMED at: krivotvorine@halmed.hr.
HALMED has not received any reports of suspicion concerning counterfeit of this medicine, neither a quality defect or adverse reaction which could lead to suspection of the counterfeited product. HALMED will continue to closely monitor the safe use of Herceptin and will inform the public promptly about any new information.
More about the medicine
Herceptin is used for breast cancer and metastatic gastric cancer treatment. It is used mainly in hospital settings. Herceptin contains trastuzumab as active substance and it is available as powder for concentrate for solution for intravenous infusion of 150 mg and as injection for subcutaneous use. According to current information, the suspected counterfeit is related only to the intravenous form.
