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.
You may also be interested in...
Filing for clinical trial activities in the electronic common technical document format via the Common Electronic Submission Gateway is expected to help sponsors send their information in a secure manner, with reduced transmission times and cost.
Roche hopes that its investigational drug satralizumab for neuromyelitis optica spectrum disorder will win EU approval in the second half of 2020.
The Pink Sheet’s list of EU centralized approvals of new active substances has been updated with three new products including Novartis's Beovu for treating neovascular (wet) age related macular degeneration. 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).