Uvae ursi folium
Overview
This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of bearberry leaf. The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing bearberry leaf.
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Bearberry leaf is the common name for the leaves of the plant Arctostaphylos uva-ursi (L.) Spreng.
The HMPC conclusions only cover bearberry leaf preparations which are obtained by drying and comminuting (reducing into tiny pieces) or powdering the leaves, or by using a technique to extract compounds by putting the plant material in a solvent (such as ethanol or water) to dissolve compounds and form a liquid extract. The solvent is then evaporated to obtain a dry extract.
Herbal medicines containing these bearberry leaf preparations are usually available as herbal tea to be drunk and in solid forms to be taken by mouth.
Bearberry leaf preparations may also be found in combination with other herbal substances in some herbal medicines. These combinations are not covered in this summary.
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The HMPC concluded that, on the basis of its long-standing use, these bearberry leaf preparations can be used for treating symptoms of mild, recurrent infections in the lower urinary tract (the structure that carries urine), such as a burning sensation when passing urine and/or frequently passing urine.
Bearberry leaf preparations should only be used after serious conditions have been excluded by a doctor. These medicines should only be used in adult women. They should not be taken for longer than one week and if symptoms last for more than four days or worsen during the use of the medicine a doctor or a qualified healthcare professional should be consulted. Detailed instructions on how to take bearberry leaf medicines and who can use them can be found in the package leaflet that comes with the medicine.
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The HMPC conclusions on the use of these bearberry leaf medicines for lower urinary tract infections 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.
In its assessment, the HMPC considered laboratory studies which showed bearberry leaf preparations to have antibacterial action. No clinical studies are available with preparations containing only bearberry leaf.
For detailed information on the studies assessed by the HMPC, see the HMPC assessment report.
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Women with kidney disorders must not take bearberry leaf medicines. Nausea, vomiting and stomach ache are side effects that have been reported with bearberry leaf medicines.
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Any applications for the licensing of medicines containing bearberry leaf 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 bearberry leaf medicines in EU Member States should be obtained from the relevant national authorities.
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For more information about treatment with bearberry leaf medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
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Bearberry leaf: Summary for the public (PDF/75.8 KB)
First published: 14/10/2016
Last updated: 10/04/2018
EMA/181295/2018 -
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Bulgarian(PDF/103.13 KB)
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Croatian(PDF/94.23 KB)
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Czech(PDF/126.03 KB)
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Danish(PDF/73.62 KB)
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Dutch(PDF/74.01 KB)
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Estonian(PDF/73.48 KB)
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Finnish(PDF/74.83 KB)
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French(PDF/78.79 KB)
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German(PDF/77.33 KB)
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Greek(PDF/101.48 KB)
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Hungarian(PDF/97.11 KB)
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Italian(PDF/75.35 KB)
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Latvian(PDF/95.23 KB)
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Lithuanian(PDF/97.22 KB)
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Maltese(PDF/98.76 KB)
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Polish(PDF/99.35 KB)
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Portuguese(PDF/77.07 KB)
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Romanian(PDF/97.01 KB)
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Slovak(PDF/96.7 KB)
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Slovenian(PDF/89.38 KB)
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Spanish(PDF/76.23 KB)
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Swedish(PDF/74.78 KB)
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Key facts
Latin name | Uvae ursi folium |
English common name | Bearberry Leaf |
Botanical name | Arctostaphylos uva-ursi (L.) Spreng. |
Therapeutic area |
Urinary tract and genital disorders
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Status |
F: Assessment finalised
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Date added to the inventory |
24/11/2005
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Date added to priority list |
24/11/2005
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Outcome of European assessment |
European Union herbal monograph
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Documents
Revision 2
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Final assessment report on Arctostaphylos uva-ursi (L.) Spreng., folium - Revision 2 (PDF/900.67 KB)
Status: Adopted
First published: 11/04/2018
Last updated: 11/04/2018
Reference number: EMA/HMPC/750266/2016 -
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Final list of references supporting the assessment of Arctostaphylos uva-ursi (L.) Spreng., folium - Revision 2 (PDF/139 KB)
Status: Adopted
First published: 11/04/2018
Last updated: 11/04/2018
Reference number: EMA/HMPC/750270/2016 -
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Final overview of comments received on European Union herbal monograph on Arctostaphylos uva-ursi (L.) Spreng., folium (EMA/HMPC/750269/2016) - Revision 2 (PDF/132.2 KB)
First published: 11/04/2018
Last updated: 11/04/2018
Reference number: EMA/HMPC/589805/2017 -
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Opinion of the HMPC on a European Union herbal monograph on Arctostaphylos uva-ursi (L.) Spreng., folium - Revision 2 (PDF/69.52 KB)
Status: Adopted
First published: 11/04/2018
Last updated: 11/04/2018
Reference number: EMA/HMPC/M/H/0217 -
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Final European Union herbal monograph on Arctostaphylos uva-ursi (L.) Spreng., folium - Revision 2 (PDF/128.96 KB)
Status: Adopted
First published: 11/04/2018
Last updated: 11/04/2018
Reference number: EMA/HMPC/750269/2016
Revision 1
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Superseded assessment report on Arctostaphylos uva-ursi (L.) Spreng., folium - Revision 1 (PDF/1.15 MB)
Status: Adopted
First published: 14/07/2011
Last updated: 11/04/2018
Reference number: EMA/HMPC/573462/2009 Rev. 1 -
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Superseded list of references supporting the assessment of Arctostaphylos uva-ursi (L.) Spreng., folium - Revision 1 (PDF/573.32 KB)
Status: Adopted
First published: 14/07/2011
Last updated: 11/04/2018
Reference number: EMA/HMPC/573461/2009 Rev. 1 -
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Superseded overview of comments received on Community herbal monograph on Arctostaphylos uva-ursi (L.) Spreng., folium - Revision 1 (PDF/591.27 KB)
First published: 14/07/2011
Last updated: 11/04/2018
Reference number: EMA/HMPC/46410/2011 Rev. 1 -
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Superseded opinion of the HMPC on a community herbal monograph on Arctostaphylos uva-ursi (L.) Spreng., folium - Revision 1 (PDF/501.6 KB)
Status: Adopted
First published: 28/02/2012
Last updated: 11/04/2018
Reference number: EMA/HMPC/888910/2011 -
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Superseded Community herbal monograph on Arctostaphylos uva-ursi (L.) Spreng., folium - Revision 1 (PDF/565.47 KB)
Status: Adopted
First published: 19/04/2011
Last updated: 11/04/2018
Reference number: EMA/HMPC/573460/2009 Rev. 1
Consultation
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Call for scientific data for the systematic review of the monograph on Arctostaphylos uva-ursi (L.) Spreng., folium (PDF/76.71 KB)
Status: Draft: consultation closed
First published: 14/10/2015
Last updated: 14/10/2015
Reference number: EMA/HMPC/669365/2015 -
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Call for submission of scientific data relating to the assessment of Uvae ursi folium Arctostaphylos uva-ursi (L.) Spreng., folium (PDF/47.6 KB)
First published: 16/06/2008
Last updated: 16/06/2008
Reference number: EMEA/HMPC/304807/2008 -
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Draft European Union herbal monograph on Arctostaphylos uva-ursi (L.) Spreng., folium (PDF/133.98 KB)
Status: Draft: consultation closed
First published: 12/04/2017
Last updated: 12/04/2017
Reference number: EMA/HMPC/750269/2016 -
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Draft assessment report on Arctostaphylos uva-ursi (L.) Spreng., folium (PDF/898.55 KB)
Status: Draft
First published: 12/04/2017
Last updated: 12/04/2017
Reference number: EMA/HMPC/750266/2016 -
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Draft list of references supporting the assessment of Arctostaphylos uva-ursi (L.) Spreng., folium (PDF/140.5 KB)
Status: Draft
First published: 12/04/2017
Last updated: 12/04/2017
Reference number: EMA/HMPC/750270/2016