EirGen Pharma Product Dossier Eir-080 submitted in EU
EirGen Pharma are pleased to report that the dossier for product Eir-080 was submitted today in the EU via a decentralised procedure (DCP). This mutli-strength product is an antineoplastic agent used for the treatment of adult patients with newly-diagnosed glioblastoma multiforme and in children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.
Technical Director Tom Brennan commented that "this is a hugely significant milestone for us with this key mutli-strength product that was successfully administered to oncology patients in clinical trials that concluded in September 2010. This milestone builds on our substantial cancer treatment product portfolio".
EirGen Pharma is a pharmaceutical company based in Waterford, Ireland. Using its purpose built high containment facility; the company specialises in the development, registration and manufacture of high potency solid dose products for global markets.