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CHMP |
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At the same time, the CHMP adopted the removal of the contraindication for use of ACTOS in combination with insulin. The ruling was based on questions concerning CMC (Characterization, Manufacturing and Control) and biosimilarity that have not yet been resolved to the extent the CHMP believes necessary for a biosimilar. The CHMP opinion recommends that Aranesp be used once every three weeks for adult cancer patients with non-myeloid malignancies and once per month for those suffering from chronic kidney disease. |
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