PRAC January 2022 – Review of terlipressin medicines started, update of COVID-19 vaccins and new safety information for Mavenclad
January 20, 2022
During its January 2022 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has started a referral of terlipressin medicines. The PRAC also has recommended a change to the product information for Vaxzevria and COVID-19 Vaccine Janssen. The PRAC discussed direct healthcare professional communication (DHPC) containing important safety information for Mavenclad.
Review of terlipressin medicines started
EMA has started a review of medicines that contain terlipressin. These medicines are authorised in several EU countries to treat increased pressure in central veins causing kidney problems in people with advanced liver disease (hepatorenal syndrome; HRS), as well as bleeding from enlarged veins in the passage between the mouth and the stomach (the oesophagus) and certain forms of bleeding associated with surgery.