Notice on counterfeit medicinal product Norditropin SimpleXx 10 mg/1,5 solution for injection on the market of Bosnia & Herzegovina
27.06.2015
The Agency for Medicinal Products and Medical Devices (HALMED) has received a notice from Novo Nordisk Croatia d.o.o. on the suspected counterfeit of Norditropin SimpleXx 10 mg/1.5 ml solution for injection (somatropin) on the market of Bosnia & Herzegovina. The following batches are affected by this suspected counterfeit: SC11255, expiry date 11/2016 and the batch CL70711, expiry date 08/2017. These batches are labelled in the Romanian language.
Based on the manufacturer’s investigation, Novo Nordisk, Denmark, these batches are not manufactured and released by this manufacturer and the suspected counterfeit has been confirmed.
Norditropin SimpleXx is used to treat growth disorders in children as well a replacement therapy in adults and it belongs to the products that are most frequently counterfeited.
Suspected counterfeit of these batches have been reported earlier in other EU member states.
All wholesalers and pharmacies are being warned to pay special attention when receiving medicinal products susceptible to counterfeiting and when selecting a supplier to check whether the holds to the good distribution practice and possesses a wholesale distribution license.
Also, patients who have procured their Norditropin SimpleXx in Bosnia & Herzegovina are warned to pay special attention to the batch they received.
In case of any suspected counterfeit medicine, a report should be sent to HALMED electronically to krivotvorine@halmed.hr.
HALMED has not received any suspected counterfeit medicine from the legal supply chain in Croatia nor any quality defect or suspected adverse reaction based on which a suspected counterfeit could be identified. HALMED continues to monitor the situation from the close and will promptly make publically available every new information.
In addition, HALMED is hereby warning patients to pay special attention when procuring medicines for oncology or other severe diseases that are most frequently subject to counterfeiting and to procure medicines only from verified, authorised channels.
