EMA formalises advice that prompted Merck to pull dyslipidemia drugs in EU
This article was originally published in SRA
The European Medicines Agency’s scientific committee, the CHMP, has concurred with a first-of-its-kind recommendation by the agency's Pharmacovigilance Risk Assessment Committee that called for the suspension of the drug marketing authorisations for the dyslipidemia drugs, Tredaptive, Pelzont and Trevaclyn (nicotinic acid/laropiprant)1.
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The regulatory agency also urges qualified persons at drug companies to let the agency know as soon as possible if they are finding that the new measures are not flexible enough to deal with the current logistical challenges quickly.
This is an 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 Pink Sheet’s list of EU centralized approvals of new active substances has been updated to include two new products, including Alnylam Pharmaceuticals' Givlaari for treating acute hepatic porphyria. The list, which contains information dating back to January 2018, includes brand name, generic name, company, therapeutic indication, date of marketing authorization and product type (eg, medicine, vaccine, biologic).