Reports of deathly errors spark the EMA to order name changes

By Vassia Barba contact

- Last updated on GMT

(Image: Getty/Santje09)
(Image: Getty/Santje09)

Related tags: Ema, European medicines agency, Regulation

The EMA demands drug developers to change the name of medicines containing liposomal, following reports of ‘serious medication errors’, some leading to death.

In an announcement, the European Medicines Agency (EMA) requested from all marketing authorisation holders of such medicines to submit a variation to change the names ‘as soon as possible,’ with a deadline of September.

This order aims to make a clearer distinction between liposomal and non-liposomal formulations of the same active substance, as they may have different biodistribution and release properties.

According to the regulatory agency, this action aims to reduce the risk of a mix-up between these medicines, following “a number of reports of serious medication errors, some leading to death.”

The recommendation was made by a joint agreement between the EMA’s human medicines committee (CHMP) and the coordination group for mutual recognition and decentralised procedures - human (CMDh) at their meetings in July.

Specifically, the regulator requests from drug developer to add qualifier 'liposomal' or 'pegylated liposomal' in section 1 of the summary of product characteristics (SmPC), after the invented name and before the strength.

Additionally, in medicines approved with an 'international non-proprietary name (INN)+company or trademark' name, the qualifier 'liposomal' or 'pegylated liposomal' will be placed between the INN and the company name or trademark in section 1 of the SmPC.

The EMA also advised that the standard term ‘dispersion’, which includes liposomes in its definition, should be used consistently throughout the product information.

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