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Licensing plans for new formulation of Fludrocortisone
09 July 2009 06:20 pm
Genopharm Laboratories has announced that they will submit their new formulation of Fludrocortisone (ADIXONŽ) to the EU Regulatory Authorities for licensing in the UK and the rest of Europe.
Full Marketing Authorisation is expected in early 2010. ADIXON will be available as 50mcg scored tablets and boxed in foil-backed, water-proof blister packs. ADIXON can be stored at room temperature.
Following approval from the MHRA to import ADIXON in to the UK it is available now from Genopharm on a compassionate-only basis when dose flexibility is required and where special storage conditions are impractical. This availability overcomes some safety concerns and considerable inconvenience for patients.
The decision to make the submission comes as a result of the need for a lower-strength tablet and one that does not require refrigeration and will come as a major relief for many patients and carers.
More information is available on www.genopharm.eu
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