| Document Date: 2010-07-01 11:11:57
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Company Astellas Pharma Europe B.V. / Figure 1 Group / Lo4AD02 Pharmaceutical / / Country Germany / France / Sweden / Ireland / / / Event Product Issues / Product Recall / / IndustryTerm pharmaceutical formulation / immunosuppressive medicinal products / medicinal product / medicinal products / / MedicalCondition Injury poisoning / hypertension / end stage kidney disease / Skin disorders / fewer patients developing glucose intolerance / procedural disorders / diabetes / treatment Chronic / subcutaneous disorders / lymphatic disorders / Infection / renal dysfunction / / MedicalTreatment renal transplantation / kidney transplantation / renal transplant / / Person David Lyons / Statistical Methods Prograf (Tacrolimus) / / / Position incomplete data Fisher / / Product methylprednisolone / Zenapax / Prednisolone / corticosteroid / events Steroid / patients experiencing rejection episodes Steroid / organ system Steroid / Study week Steroid / Prograf / trial comparing early / Steroid / / ProvinceOrState Arkansas / / Technology transplantation / /
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Rapporteur’s Public Assessment Report for paediatric studies submitted in accordance with Article 46 of Regulation (EC) No1901/2006, as amended Prograf