Heart Rhythm Concerns Prompt EU-Wide Suspension For Fenspiride Cough Medicines
Executive Summary
Fenspiride medicines are being suspended while the European Medicines Agency's pharmacovigilance committee carries out an urgent safety review to address concerns that these drugs can cause sudden serious heart rhythm problems.
You may also be interested in...
Blood Clot Concerns Prompt EU Restrictions For Pfizer's Xeljanz
The European Medicines Agency's pharmacovigilance committee has launched a fresh review of Xeljanz and has also recommended suspending all fenspiride medicines, which are used to treat non-serious cough but are associated with heart rhythm problems.
EU Consults On What Constitutes Personal & Commercially Confidential Data In Marketing Applications
Based on their experience with dealing with requests for access to documents over the past 12 years, EU regulators have proposed updating their guideline that provides for a harmonized approach to protecting personal data and business secrets in marketing authorization applications.
Global Pharma Guidance Tracker – March 2024
Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.