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Shire Secures European Wide Label Extension for FOSRENOL(R) in Chronic Kidney Disease
Date:10/28/2009

ble in new markets around the world. Important Safety Information - Patients with renal insufficiency may develop hypocalcaemia. Serum calcium levels should therefore be monitored at regular time intervals for this patient population and appropriate supplements given. - No data are available in patients with severe hepatic impairment. Caution should, therefore, be exercised in these patients, as elimination of absorbed lanthanum may be reduced. - FOSRENOL should not be used during pregnancy. - Patients with acute peptic ulcer, ulcerative colitis, Crohn's disease or bowel obstruction were not included in clinical studies with FOSRENOL. - The most commonly reported Adverse Drug Reactions are gastrointestinal reactions, such as abdominal pain, constipation, diarrhoea, dyspepsia, flatulence, nausea and vomiting. These are minimized by taking FOSRENOL with food and generally abate with time with continued dosing. Hypocalcaemia was the only other commonly reported adverse reaction. Full prescribing information is available on request. References (1) Shire plc. FOSRENOL EU SmPC. Last revised September 2009. (2) Shire plc. FOSRENOL US PIL. Last revised April 2008. SHIRE PLC

Shire's strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on attention deficit hyperactivity disorder (ADHD), human genetic therapies (HGT) and gastrointestinal (GI) diseases as well as opportunities in other therapeutic areas to the extent they arise through acquisitions. Shire's in-licensing, merger and acquisition efforts are focused on products in specialist markets with strong intellectual property protection and global rights. Shire believes that a carefully selected and balanced portfolio of products with strategically aligned and relatively small-
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