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null For marketing authorisation holders: the naming of certain liposomal medicinal products must be further specified by 30 September

For marketing authorisation holders: the naming of certain liposomal medicinal products must be further specified by 30 September

30.8.2019

The Name Review Group (NRG) of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has noticed that the current naming practice of medicinal products must be changed in cases where products containing the same active substance are available in both liposomal and non-liposomal formulations.

To improve patient safety and prevent medication errors, the Co-ordination Groups for Mutual Recognition and Decentralised Procedures – Human (CMDh) and the Committee for Medicinal Products for Human Use (CHMP) outlined the necessary clarifications in the naming of liposomal products. The purpose of the naming clarifications is to make a clearer distinction between liposomal and non-liposomal medicinal products.

Naming clarifications as variation applications

The qualifier “liposomal” or “pegylated liposomal” must be added to the name of the medicinal product.

Marketing authorisation holders are required carry out the necessary updates to product information by submitting a variation application (type IB: A.2.b variation) to this effect as soon as possible and at the latest by the end of September 2019.

Read more:

CMDh: Report from the meeting held in July 

EMA: News release on the changing of the names of liposomal medicines, 31 July 2019 

Further information about variation applications on the Fimea website
 

Ask more

  • Anne Kauppinen, Head of Division, Coordinator for Marketing Authorisations, tel. +358 29 522 0352
  • Karin Krogars, Senior Researcher, tel. +358 29 522 3366
  • Email address format: firstname.lastname@fimea.fi