Positive opinion on Genzyme's Myozyme
US biotechnology major Genzyme says that the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of the variation to produce Myozyme (alglucosidase alfa) at the 4,000 liter bioreactor scale at its manufacturing facility in Geel, Belgium.
The positive CHMP opinion is the final step before formal approval to produce and market Myozyme manufactured at this scale in the European Union, Norway and Iceland.
The Committee's opinion will be forwarded to the European Commission, which will make a final decision on the authorization. The Commission has 44 days to act on the CHMP's opinion. It generally follows the advice of the CHMP, but it is not obliged to do so.
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