30.12.2022 - Notice within the graduated plan ("Stufenplan") procedure

The PRAC recommendations were adopted by the Co-ordination group for Mutual recognition and Decentralised procedures – human (CMDh) by consensus on 10 November 2022. The Federal Institute for Drugs and Medical Devices (BfArM) has implemented the decision by consensus of the CMDh at national level by official notice, dated 19 December 2022.

The national translations are available here:

Terlipressin-containing medicinal products

(available in German only)

11.11.2022 - CMDh position

EMA's coordination group confirms new recommendation for terlipressin-containing drugs in the treatment of hepatorenal syndrome

Concerning the risk evaluation for Terlipressin, the PRAC recommendations were sent to the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) which endorsed them and adopted its position on 10 November 2022.

30.09.2022 - PRAC recommendation

New recommendations for terlipressin-containing drugs in the treatment of hepatorenal syndrome.

EMA’s safety committee (PRAC) recommended new measures to reduce the risk of respiratory failure (severe breathing difficulties that may be life-threatening) and sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage) when using terlipressin-containing medicines in people with type 1 hepatorenal syndrome (HRS-1)(kidney problems in people with advanced liver disease).

14.01.2022 - Procedure started

Review of terlipressin-containing medicinal products started.

Further information

For details on the procedure please click on the following link to the homepage of the European Medicines Agency (EMA):