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EMA Approves Extended Xaluprine Shelf Life

The () has approved an extension of the in-use shelf life for Xaluprine – a liquid formulation of acute lymphoblastic leukaemia (ALL) treatment .

The in-use shelf life of the product is now 56 days – double the previous amount.

Its manufacturer, UK-based , said the extension would reduce wastage, particularly for young children who require smaller doses.

Nova is set to issue updated packaging to its European customers through distributor Trimedica.

Hussain Mulla, head of clinical development at Nova, said the news was a positive step in the treatment of ALL across :

“Many pharmacists acknowledge the superior benefits of prescribing mercaptopurine in liquid form, as opposed to tablets, in terms of palatability, dosing accuracy and safety, but face downward pressure on costs.

“The EMA ruling means that for younger patients the product is now effectively half its original cost, which we hope will encourage pharmacists to consider it as a more viable option.”

Xaluprine is now widely available throughout Europe including the UK and Ireland, the Netherlands, Germany and Scandinavia, with discussions underway with most other EU countries.

The product is exclusively distributed in Europe by Trimedica Limited.


Mercaptopurine has been available as a tablet for many years, but because the dose has to be adjusted according to body surface area, it has always been extremely difficult for parents or carers to administer the correct dose to young children.

Launched in July 2012, Xaluprine offers more consistent absorption and allows doses to be accurately individualised to the child’s needs – right down to 2mg doses, whereas the originator tablet is 50mg.

The medicine is free from artificial colours, artificial flavouring and has no added sugar and so is particularly child-friendly. It is also easier for patients to swallow and the natural raspberry flavour ensures good palatability, says Nova.

An updated version of the product was released in January 2013 without the preservative propyl parabens.

Nova Laboratories