Prescription medicines: registration of new chemical entities in Australia

Each year, approximately 40 new prescription medicines containing new active substances are registered. These are called New Chemical Entities (NCEs) by the Therapeutic Goods Administration (TGA). Some of these NCEs are innovative or ‘first-in-class’, and have been made available for the first time outside the controlled environment of a clinical trial. This decision by the TGA often comes after years of research and development and following a comprehensive review by the TGA scientists and clinicians of the quality, safety and efficacy of the new prescription medicines. Throughout the year TGA will be publishing information on the new prescription medicines when they are approved. However, it may still be some time before the pharmaceutical company decides to supply the product in Australia. The trade name, sponsor and active ingredient for each medicine reflects the information initially entered in the Australian Register of Therapeutic Goods (ARTG).

New prescription medicines containing new activesubstances in December 2017

Medicine

Date registered

MONOFER

ferric derisomaltose

Sponsor: Link Medical Products Pty Ltd

Monofer is indicated for the treatment of irondeficiency in adults, under the following conditions:

When oral iron preparations are ineffective or cannot be used;

Where there is a clinical need to deliver iron rapidly.

The diagnosis must be based on laboratory tests.

04 December

~sTGA, 12 December 2017

http://www.tga.gov.au/