First herbal medicine to have its effectiveness acknowleged by the TGA |
| Aug 03 2010 |
For the first time, the Therapeutic Goods Administration (TGA) has evaluated and subsequently registered a herbal medicine product based on its efficacy via the new registration pathway for complementary medicines.
This product is Iberogast® (STW 5) from Flordis which the TGA has registered (AUST R) for the treatment of functional dyspepsia and Irritable Bowel Syndrome (IBS).
An AUST R registration demonstrates that the product has been evaluated by the TGA for its efficacy in addition to its safety. Almost all complementary medicine products are AUST L listed, however the TGA does not evaluate the efficacy data supporting these AUST L products.
“It is a breakthrough that the TGA has now issued Iberogast an AUST R registration following a rigorous evaluation of the supporting clinical evidence of its efficacy in the treatment of dyspepsia and IBS,” commented Associate Professor Terry Bolin, gastroenterologist & President of The Gut Foundation.
Iberogast is one of the most extensively investigated herbal products in the world supported by comprehensive evidence including 5 gold standard randomised, double-blind clinical trials, and research covering over 45,000 people.
The safety profile of Iberogast is remarkable. It has provided relief for 50 years to over 25 million patients worldwide in 17 countries with only a handful of adverse events ever reported.
“AUST R registration confirms Iberogast’s long history of efficacy in clinical trials and makes it a first line option for the treatment of patients suffering from dyspepsia and IBS” said Dr Jennifer Hunter, an experienced Integrative GP, Sydney.