Final two opinions on medicines made at Ben Venue Laboratories .The European Medicines Agency has recommended that the manufacturing processes for the anticancer medicines Caelyx (doxorubicin hydrochloride) and Ceplene (histamine dihydrochloride) be transferred from the Ben Venue Laboratories in Ohio, United States, to alternative facilities.
While the transfers are ongoing, the Agency’s Committee for Medicinal Products for Human Use (CHMP) is recommending that the marketing authorisations of the two medicines be maintained because both medicines are considered to be essential for patients and no alternative suppliers or alternative formulations are currently available. The Committee also considered the fact that no concerns have been raised from the safety monitoring of these medicines.
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