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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

2 February 2016 EMA/824095/2015

Herbal medicine: summary for the public

Centaury

Centaurium erythraea Rafn. s.l., herba

This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of centaury. The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing centaury.

This summary is not intended to provide practical advice on how to use medicines containing centaury. For practical information about using centaury medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.

What is centaury?

Centaury is the common name for the plant Centaurium erythraea Rafn. s.l.

Centaury preparations are obtained by drying and comminuting (reducing into tiny pieces) or powdering the aerial parts. They are also obtained by using a technique to extract compounds from plant material by dissolving them in a solvent (such as ethanol or water) to form a liquid extract or tincture (an alcoholic extract). In some cases the solvent is partially evaporated to obtain a soft extract.

Herbal medicines containing centaury are usually available as herbal teas to be drunk, or in liquid or solid forms to be taken by mouth.

Centaury can also be found in combination with other herbal substances in some herbal medicines. These combinations are not covered in this summary.

What are the HMPC conclusions on its medicinal uses?

The HMPC concluded that, on the basis of its long-standing use, centaury can be used for mild indigestion or other stomach and gut disorders as well as for temporary loss of appetite.

Centaury should only be used in adults and elderly. If symptoms last longer than 2 weeks during use of the medicine, a doctor or a qualified healthcare practitioner should be consulted. Detailed instructions on how to take centaury medicines and who can use them can be found in the package leaflet that comes with the medicine.

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© European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged.

What evidence supports the use of centaury medicines?

The HMPC conclusions on the use of centaury medicines for indigestion or other stomach and gut disorders, and in temporary loss of appetite are based on their 'traditional use'. This means that, although there is insufficient evidence from clinical trials, the effectiveness of these herbal medicines is plausible and there is evidence that they have been used safely in this way for at least 30 years (including at least 15 years within the EU). Moreover, the intended use does not require medical supervision.

The HMPC noted the lack of clinical studies with centaury. Studies in laboratory tests indicate an effect as appetite and digestion stimulant, although the data available are very limited. The HMPC conclusions are therefore based on the long-standing use of centaury.

For detailed information on the studies assessed by the HMPC, see the HMPC assessment report.

What are the risks associated with centaury medicines?

At the time of the HMPC assessment, no side effects had been reported with these medicines. Centaury medicines should not be taken by people with ulcers in the stomach.

Further information on the risks associated with centaury medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab 'All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.

How are centaury medicines approved in the EU?

Any applications for the licensing of medicines containing centaury have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.

Information on the use and licensing of centaury medicines in EU Member States should be obtained from the relevant national authorities.

Other information about centaury medicines

Further information on the HMPC assessment of centaury medicines, including details of the Committee's conclusions, can be found under the tab 'All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use. For more information about treatment with centaury medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.

Centaury

EMA/824095/2015