Melatonin TioFarma 1, 3 and 5mg tablets - public assessment report withdrawn application

The MEB deemed the efficacy of Melatonin TioFarma 1, 3 and 5 mg tablets not to have been demonstrated sufficiently in the patients that were examined. The MEB also had serious reservations about the quality of the raw material that was used. Melatonin was registered as a medicinal product in the Netherlands and other European countries in 2007 under the brand name Circadin (extended release tablets at a strength of 2 mg) for short-term treatment of primary insomnia characterised by a poor quality of sleep in patients aged 55 years and older. The substantiating data for Circadin do not apply to the product by TioFarma, because the release profile differs. The company withdrew the application.