All marketing authorisation holders of medicines containing liposomal drug delivery systems are requested to submit to EU regulators a variation to change the names of these medicines as soon as possible before the end of September 2019.
This recommendation was made jointly by EMA’s human medicines committee (CHMP) and the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) at their July meetings. It aims to make a clearer distinction between liposomal and non-liposomal formulations of the same active substance to avoid medication errors. Since the two formulations may have different biodistribution and release properties, medication errors can pose serious risks to the health of patients.
So far, there was no agreed approach to the naming of medicines containing liposomal or pegylated liposomal formulations. This recommendation is made to enable healthcare professionals and patients to better distinguish them from conventional non-liposomal medicines. This is a particular concern when electronic prescribing and dispensing tools are used, as in the absence of a more descriptive term for the liposomal medicines, they can be mixed up with non-liposomal medicines.