Teva’s Ajovy & Pfizer’s Vizimpro Get EU Thumbs Up From CHMP
The European Medicines Agency’s drug evaluation committee has recommended for approval Teva’s Ajovy for migraine and Pfizer’s Vizimpro for NSCLC, as well as two more biosimilar versions of adalimumab (AbbVie’s Humira) and generics of atazanavir and feboxustat.
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Mitsubishi and Emmaus Life Sciences are among the companies that will find out this week whether the European Medicines Agency's drug evaluation committee, the CHMP, will recommend their new products for EU approval.
This is a monthly update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.
The European Medicines Agency is conducting safety reviews of Eliquis, Pradaxa and Xarelto, and is looking at whether the marketing authorization for the anticancer medicine Lartruvo should be maintained. It has also asked manufacturers of angiotensin II receptor blockers to review their manufacturing processes to ensure they do not produce nitrosamine impurities. Meanwhile, manufacturers of omega 3 fatty acid medicines have requested a re-examination of a CHMP recommendation on their products.