Draft Community Herbal Monograph On Ononis Spinosa L., Radix
o
EUROPEAN MEDICINES AGENCY
SCIENCE MEDICINES HEALTH
9 July 2013
EMA/HMPC/138317/2013
Committee on Herbal Medicinal Products (HMPC)
Community herbal monograph on Ononis spinosa L., radix
Draft
Herbal medicinal products; HMPC; Community herbal monographs; traditional use; Ononis spinosa L., Ononidis radix; Restharrow root
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Discussion in Working Party on Community monographs and Community |
March 2013 |
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list (MLWP) |
May 203 |
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Adoption by Committee on Herbal Medicinal Products (HMPC) for release for consultation |
9 July 2013 |
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End of consultation (deadline for comments). Comments should be provided using this template to hmpc.secretariat@ema.europa.eu |
15 December 2013 |
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Rediscussion in Working Party on Community monographs and Community list (MLWP) | |
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Adoption by Committee on Herbal Medicinal Products (HMPC) |
Keywords
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BG (bälgarski): rptMOTptH, KopeH |
LT (lietuviq kalba): Dirveniq saknys |
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CS (cestina): jehlicovy koren |
LV (latviesu valoda): Blaktenes sakne |
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DA (dansk): Krageklo |
MT (malti): Gherq tal-Broxka |
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DE (Deutsch): Hauhechelwurzel |
NL (nederlands): Kattendoornwortel |
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EL (elliniká): |
PL (polski): Korzen wilzyny |
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EN (English): Restharrow root |
PT (portugués): Gatunha |
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ES (español): Gatuña, raiz de |
RO (romana): |
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ET (eesti keel): jooksjarohi |
SK (slovencina): koren ihlice |
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FI (suomi): ruusuorakko, juuri |
SL (slovenscina): korenina navadnega gladeza |
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FR (français): Bugrane, Arrête-boeuf |
SV (svenska): busktörnerot |
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HU (magyar): |
IS (íslenska): |
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HR (hrvatska): |
NO (norsk): |
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IT (italiano): Ononide radice |
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© European Medicines Agency, 2013. Reproduction is authorised provided the source is acknowledged.
Community herbal monograph on Ononis spinosa L., radix
1. Name of the medicinal product
To be specified for the individual finished product.
2. Qualitative and quantitative composition1,2
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Well-established use |
Traditional use |
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With regard to the registration application of Article 16d(1) of Directive 2001/83/EC as amended Ononis spinosa L., radix (Restharrow root) i) Herbal substance Not applicable. ii) Herbal preparations Comminuted herbal substance. |
3. Pharmaceutical form
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Well-established use |
Traditional use |
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Comminuted herbal substance as herbal tea for oral use. The pharmaceutical form should be described by the European Pharmacopoeia full standard term. |
4. Clinical particulars
4.1. Therapeutic indications
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Well-established use |
Traditional use |
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Traditional herbal medicinal product used to increase the amount of urine to achieve flushing of the urinary tract as an adjuvant in minor urinary complaints. The product is a traditional herbal medicinal product for use in the specified indication exclusively based upon long-standing use. |
1 The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal quality guidance.
2 The material complies with the Ph. Eur. monograph (ref.: 01/2008:1879).
4.2. Posology and method of administration3
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Well-established use |
Traditional use |
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Posology Adolescents, adults and elderly Herbal tea: 2 - 3 g of comminuted herbal substance in 150 ml of boiling water as a herbal infusion up to 3 - 4 times daily corresponding to the maximum daily dose of 12 g. The use in children under 12 years of age is not recommended (see section 4.4 'Special warnings and precautions for use'). Duration of use If the symptoms persist longer than 1 week during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted. Method of administration Oral use. |
4.3. Contraindications
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Well-established use |
Traditional use |
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Hypersensitivity to the active substance. Conditions where a reduced fluid intake is recommended (e.g. severe cardiac or renal disease). |
4.4. Special warnings and precautions for use
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Well-established use |
Traditional use |
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The use in children under 12 years of age has not been established due to lack of adequate data. To ensure an increase of the amount of urine, adequate fluid intake is required during the treatment. If urinary tract complaints worsen and symptoms such as fever, dysuria, spasm, or blood in the urine occur during the use of medicinal product, a doctor or a qualified health care practitioner |
3 For guidance on herbal substance/herbal preparation administered as herbal tea or as infusion/decoction/macerate preparation, please refer to the HMPC 'Glossary on herbal teas' (EMA/HMPC/5829/2010 Rev.1).
should be consulted.
4.5. Interactions with other medicinal products and other forms of interaction
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Well-established use |
Traditional use |
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None reported. |
4.6. Fertility, pregnancy and lactation
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Well-established use |
Traditional use |
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Safety during pregnancy and lactation has not been established. In the absence of sufficient data, the use during pregnancy and lactation is not recommended. No fertility data available. |
4.7. Effects on ability to drive and use machines
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Well-established use |
Traditional use |
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No studies on the effect on the ability to drive and use machines have been performed. |
4.8. Undesirable effects
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Well-established use |
Traditional use |
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None known. If adverse reactions occur, a doctor or a qualified health care practitioner should be consulted. |
4.9. Overdose
|
Well-established use |
Traditional use |
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No case of overdose has been reported. |
5. Pharmacological properties
5.1. Pharmacodynamic properties
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Well-established use |
Traditional use |
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Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended. |
5.2. Pharmacokinetic properties
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Well-established use |
Traditional use |
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Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended. |
5.3. Preclinical safety data
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Well-established use |
Traditional use |
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Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended, unless necessary for the safe use of the product. Adequate tests on genotoxicity have not been performed. Tests on reproductive toxicity and carcinogenicity have not been performed. |
6. Pharmaceutical particulars
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Well-established use |
Traditional use |
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Not applicable. |
7. Date of compilation/last revision
9 July 2013
Page 5/5
Community herbal monograph on Ononis spinosa L., radix
EMA/HMPC/138317/2013