Draft Community Herbal Monograph On Levisticum Officinale Koch, Radix
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EUROPEAN MEDICINES AGENCY
SCIENCE MEDICINES HEALTH
27 March 2012 EMA/HMPC/524621/2011
Committee on Herbal Medicinal Products (HMPC)
Community herbal monograph on Levisticum officinale Koch, radix
Draft
Herbal medicinal products; HMPC; Community herbal monographs; traditional use; Levisticum officinale Koch, radix; Levistici radix; Lovage root
BG (bälgarski): CennM, KopeH CS (cestina): Libeckovy koren DA (dansk): Lovstikkerod DE (Deutsch): Liebstöckelwurzel EL (elliniká): PiÇa àuyiotikoù EN (English): Lovage root ES (español): Levistico, raíz de ET (eesti keel): Leeskputkejuur FI (suomi): Liperi, juuri FR (français): Livèche (racine de) HU (magyar): Lestyàngyôkér IT (italiano): Levistico radice
LT (lietuviq kalba):
LV (latviesu valoda): Lupstäja saknes MT (malti):
NL (nederlands): Lavaswortel PL (polski): Korzeii lubczyka PT (portugués): Levístico, raiz RO (romana):
SK (slovencina): Ligurcekovy koren SL (slovenscina): Korenina lustreka SV (svenska): Libbstickerot IS (íslenska):
NO (norsk): Lopestikkerot
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Discussion in Working Party on Community monographs and Community list (MLWP) |
July 2011 September 2011 November 2011 January 2012 |
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Adoption by Committee on Herbal Medicinal Products (HMPC) for release for consultation |
27 March 2012 |
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End of consultation (deadline for comments). Comments should be provided using this template to hmpc.secretariat@ema.europa.eu |
15 August 2012 |
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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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© European Medicines Agency, 2012. Reproduction is authorised provided the source is acknowledged.
Community herbal monograph on Levisticum officinale Koch, 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 Levisticum officinale Koch, radix (lovage root) i) Herbal substance Not applicable. ii) Herbal preparations a) 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 1 2
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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. |
4.2. Posology and method of administration3
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Well-established use |
Traditional use |
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Posology Adults and elderly a) Herbal tea Single dose: 2 - 3 g of comminuted herbal substance in 150 ml of boiling water as a herbal infusion, twice daily. Average daily dose: 4 - 6 g The use in children and adolescents under 18 years of age is not recommended (see section 4.4 'Special warnings and precautions for use'). Duration of use Not to be used for more than 2-4 weeks. If the symptoms persist 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 and to other plants of the Apiaceae (Umbelliferae) family or to anethole. |
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 and adolescents under 18 years of age is not recommended because of concerns requiring medical advice. If complaints or symptoms such as fever, dysuria, spams, or blood in urine occur during the use of the medicinal product, a doctor or a qualified health care practitioner 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. |
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
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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 reproductive toxicity, genotoxicity 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
27 March 2012
Page 6/5
Community herbal monograph on Levisticum officinale Koch, radix
EMA/HMPC/524621/2011
The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal quality guidance.
The material complies with the Ph. Eur. monograph (ref.: 01/2008:1233 corrected 6.0).
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).