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The World Health Organisation issues an alert on falsified ICLUSIG traded globally

The Medical Product Alert relates to confirmed falsified versions of ICLUSIG 15mg and ICLUSIG 45mg circulating in the WHO Region of Europe and the WHO Region of the Americas. Genuine ICLUSIG, the active pharmaceutical ingredient of which is Ponatinib Hydrochloride, is used to treat different forms of leukaemia. On 15 January 2019, WHO was informed by health authorities in Switzerland that a local wholesaler had purchased packs of ICLUSIG 15mg : upon verification, the market authorization holder confirmed these packs as falsified. Further investigation confirmed that there are two versions of falsified ICLUSIG being traded globally.

Laboratory analysis of ICLUSIG 15mg with batch number 25A19E09 has confirmed that the product does not contain Ponatinib and instead contains low quantities of paracetamol. Laboratory analysis of ICLUSIG 45mg with batch number PR072875 is not fully completed but preliminary results indicate that it does not contain any of the expected active ingredient, Ponatinib. ICLUSIG is commercialized by different stakeholders in different parts of the world. The pharmaceutical companies TAKEDA and INCYTE are the genuine manufacturers / market authorization holders for ICLUSIG in the regions in which the above falsified versions have been discovered to date and they have both confirmed to WHO that: ▪ They did not manufacture or supply the above products, and ▪ The above batch numbers do not correspond to genuine manufacturing records.

All medical products must be obtained from authentic and reliable sources. Their authenticity and condition should be carefully checked.

Please be very careful with the sources you are buying from and if you have any doubt regarding a product, please do let us know, since the more the news is spread, the less the patients run the risk to get a falsified or illegal product.

Elixi International SA is a fully authorised and trusted Swiss pharmaceutical wholesaler, specialised in sourcing and delivering pharma products, medical devices and drugs from and to all over the world.