Notice on the occurrence of suspected falsified batches of MabThera 100 mg concentrate for solution for infusion and MabThera 500 mg concentrate for solution for infusion
08.12.2014
Via the Rapid Alert System from the German competent authority, the Agency for Medicinal Products and Medical Devices (HALMED) has received a notice on the suspected counterfeit batches of MabThera 100 mg concentrate for solution for infusion (batch: H0156B09, shelf-life: 05/2016) and MabThera 500 mg concentrate for solution for infusion (batch: H0721B04, shelf-life: 04/2016).
The suspected counterfeit has been reported by a German company involved in parallel trade, Inopha GmbH, where suspected batches have never been placed on the market.
These batches reported as a suspected counterfeit have never been placed on the Croatian market.
Even though these batches have never been distributed in Croatia, all healthcare professionals are advised to pay special attention when handling and administering these medicines. In the case of any suspected counterfeit medicine, reports should be sent by e-mail: krivotvorine@halmed.hr to HALMED.
HALMED has never received any suspected counterfeit of these medicines, or a quality defect or a suspected adverse reaction indicating that there is a counterfeit medicine. HALMED will continue to monitor from the close the safe use of these medicines and promptly make publically available any new information.
