Draft Community Herbal Monograph On Curcuma Xanthorrhiza Roxb., Rhizoma
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EUROPEAN MEDICINES AGENCY
SCIENCE MEDICINES HEALTH
14 May 2013
EMA/HM PC/604600/2012
Committee on Herbal Medicinal Products (HMPC)
Community herbal monograph on Curcuma xanthorrhiza Roxb. (C xanthorrhiza D. Dietrich)., rhizoma
Draft
Herbal medicinal products; HMPC; Community herbal monographs; traditional use; Curcuma xanthorrhiza Roxb. (C. xanthorrhiza D. Dietrich)., rhizoma; Temoe Lawak; Javanese Turmeric
BG (balgarski): ^BaHCKa KypKyMa, KopeHn^e CS (cestina): oddenek kurkumy zlutokorenné DA (dansk): Gurkemeje, javanesisk DE (Deutsch): Javanische Gelbwurz EL (elliniká): piÇœpa Çav0oppiZnÇ EN (English): Javanese Turmeric ES (espanol): Cúrcuma, rizoma de ET (eesti keel): tsitveri-kollajuure juurikas FI (suomi): jaavan kurkuma FR (français): Temoe-lawacq (rhizome de)
HU (magyar): Jávai kurkuma gyôkértôrzs IT (italiano): Curcuma di Giava rizoma
LT (lietuviq kalba): Geltonsakniq ciberzoliq sakniastiebiai
LV (latviesu valoda): Javas kurkumas saknenis MT (malti): Rizoma tat-Turmerik ta' Gava NL (nederlands): Javaanse Geelwortel PL (polski): Ktqcze kurkumy jawajskiej PT (portugués): Curcuma-de-java RO (romana):
SK (slovencina): Podzemok kurkumy jávskej SL (slovenscina): korenika javanske kurkume SV (svenska): Gurkmeja, javanesisk IS (íslenska):
NO (norsk): Java-gurkemeie_
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Discussion in Working Party on Community monographs and Community list (MLWP) |
March 2013 |
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Adoption by Committee on Herbal Medicinal Products (HMPC) for release for consultation |
14 May 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 September 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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© European Medicines Agency, 2013. Reproduction is authorised provided the source is acknowledged.
Community herbal monograph on Curcuma xanthorrhiza Roxb. (C xanthorrhiza D. Dietrich)., rhizoma
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 Curcuma xanthorrhiza Roxb. (C. xanthorrhiza D. Dietrich), rhizoma (Turmeric, Javanese) i) Herbal substance Not applicable. ii) Herbal preparations A. Comminuted herbal substance B. Dry extract (DER 20-50:1), extraction solvent ethanol 96% (v/v); C. Dry extract (DER 9-12:1), extraction solvent acetone. |
3. Pharmaceutical form 1 2
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Well-established use |
Traditional use |
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Comminuted herbal substance as herbal tea for oral use. Herbal preparations in solid dosage forms for oral use. The pharmaceutical form should be described by the European Pharmacopoeia full standard term. |
4.1. Therapeutic indications
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Well-established use |
Traditional use |
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Traditional herbal medicinal product used for symptomatic treatment of digestive disturbances, such as feelings of fullness, slow digestion and flatulence. The product is a traditional herbal medicinal product for use in the specified indication exclusively based upon long-standing use. |
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 1 g of comminuted herbal substance in 100 ml of boiling water as herbal infusion 3 times daily; B) Dry extract (DER 20-50:1) extraction solvent ethanol: single dose 8-13 mg, 3 times daily; C) Dry extract (DER 9-12:1), extraction solvent acetone: single dose 50-100 mg, 2 times daily. 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 If the symptoms persist longer than 2 weeks 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. |
4.4. Special warnings and precautions for use
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Well-established use |
Traditional use |
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The safe use in children and adolescents under 18 years of age has not been established due to lack of adequate data. Due to the possible stimulation on bile secretion Curcuma xanthorrhiza is not recommended in case of obstruction of the bile duct, cholangitis, liver disease, gallstones and any other biliary diseases. If the symptoms worsen 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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Mild gastrointestinal symptoms such as dry mouth, flatulence and gastric irritation may occur. The frequency is not known. If other adverse reactions not mentioned above 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. |
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Well-established use |
Traditional use |
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Not applicable. |
7. Date of compilation/last revision
14 May 2013
Page 6/6
Community herbal monograph on Curcuma xanthorrhiza Roxb. (C. xanthorrhiza D.
Dietrich)., rhizoma
EMA/HMPC/604600/2012
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.: 1441).
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).