Draft European Union Herbal Monograph On Harpagophytum Procumbens Dc. And/Or Harpagophytum Zeheyri Decne., Radix
o
EUROPEAN MEDICINES AGENCY
SCIENCE MEDICINES HEALTH
2 February 2016
EMA/HMPC/627057/2015
Committee on Herbal Medicinal Products (HMPC)
European Union herbal monograph on Harpagophytum procumbens DC. and/or Harpagophytum zeyheri Decne., radix
Draft - Revision
An agency of the European Union
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Initial assessment | ||
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Discussion in Working Party on European Union monographs and European Union list (MLWP) |
October 2006 October 2007 January 2008 | |
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Adoption by Committee on Herbal Medicinal Products (HMPC) for release for consultation |
10 January 2008 | |
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End of consultation (deadline for comments). |
15 April 2008 | |
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Rediscussion in MLWP |
September 2008 November 2008 | |
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Adoption by HMPC Monograph (EMEA/HMPC/251323/2006) AR (EMEA/HMPC/251324/2006) List of references (EMEA/HMPC/476255/2007) Overview of comments received during the public consultation (EMEA/HMPC/454136/2008) HMPC Opinion (EMEA/HMPC/584717/2008) |
6 November 2008 | |
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First systematic review | ||
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Discussion in MLWP |
September 2015 November 2015 | |
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Adopted by HMPC for release for consultation |
2 February 2016 | |
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Start of public consultation |
15 February 2016 | |
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End of consultation (deadline for comments).Comments should be provided using this template to hmpc.secretariat@ema.europa.eu |
15 May 2016 | |
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Rediscussion in MLWP | ||
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Adoption by HMPC | ||
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Keywords |
Herbal medicinal products; HMPC; European Union herbal monographs; traditional use; Harpagophytum procumbens DC. and/or Harpagophytum zeyheri Decne.; Harpagophyti radix; devils claw root | |
30 Churchill Place • Canary Wharf • London E14 5EU • United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact
© European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged.
BG (bulgarski): fl^BoncKM hok^t, KopeH CS (cestina): harpagofytovy koren DA (dansk): Djævleklorod DE (Deutsch): Teufelskrallenwurzel EL (elliniká): PiÇa ApnaYO^ÚTOu EN (English): Devil's Claw root ES (español): Harpagofito, raíz de ET (eesti keel): saatanaküünejuur FI (suomi): pirunkoura, juuri FR (français): Harpagophyton (racine d')
HR (hrvatski): gomoljasti korijen vrazje kandze HU (magyar): ordogcsáklyagyokér IT (italiano): Arpagofito radice_
LT (lietuviq kalba): Inkaruociq saknys LV (latviesu valoda): Harpagofita saknes MT (Malti): Gherq ta' l-Harpagofitum NL (Nederlands): Duivelsklauw PL (polski): Korzen hakorosli PT (portugués): Harpagófito, raiz RO (romana): rädäcinä de ghiara diavolului SK (slovencina): Koren harpagofyta SL (slovenscina): korenina vrazjega kremplja SV (svenska): Djävulsklo, rot IS (íslenska):
NO (norsk): Djevelklorot
European Union herbal monograph on Harpagophytum procumbens DC. and/or Harpagophytum zeyheri Decne., 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 | ||
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Harpagophytum procumbens DC. and/or Harpagophytum zeyheri Decne., radix (devil's claw root) | ||
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i) Herbal substance | ||
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Not applicable. | ||
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ii) Herbal preparations | ||
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a) |
Comminuted herbal substance | |
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b) |
Powdered herbal substance | |
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c) |
Liquid extract (DER 1:1), extraction solvent ethanol 30% V/V | |
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d) |
Soft extract (DER 2.5-4.0:1), extraction solvent ethanol 70% V/V | |
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e) |
Dry extract (DER 1.5-2.5:1), extraction solvent water | |
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f) |
Dry extract (DER 5-10:1), extraction solvent water | |
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g) |
Dry extract (DER 2.6-4:1), extraction solvent ethanol 30% V/V | |
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h) |
Dry extract (DER 1.5-2.1:1), extraction solvent ethanol 40% V/V | |
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i) |
Dry extract (DER 3-5:1), extraction solvent ethanol 60% V/V | |
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j) |
Dry extract (DER 3-6:1), extraction solvent ethanol 80% V/V | |
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k) |
Dry extract (DER 6-12:1), extraction | |
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.: 1095)
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Well-established use |
Traditional use |
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solvent ethanol 90% V/V l) Tincture (ratio of herbal substance to extraction solvent 1:5), extraction solvent: ethanol 25% (V/V) |
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. Herbal preparations in liquid or solid dosage forms 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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Indication 1) Traditional herbal medicinal product for relief of minor articular pain. Indication 2) Traditional herbal medicinal product used for the relief of mild digestive disorders such as bloating and flatulence and where there is loss of appetite. 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 Indication 1) a) Herbal tea: 4.5 g in 500 ml of boiling water |
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).
as herbal infusion divided in 3 single doses Infusion time: 8 hours
b) Single dose: 435 mg, 3 times daily Daily dose: 1.35 g
c) Daily dose: 1.03 g extract as single dose
d) Daily dose: 240 mg extract as single dose
e) Single dose: 750-800 mg, 3 times daily Daily dose: 2.25-2.4 g
f) Single dose: 200-400 mg, 2 to 3 times daily Daily dose: 600-800 mg
g) Single dose: 400 -800 mg; 2 to 4 times daily Daily dose: 800 mg up to 1.6 g
h) Single dose: 300-900 mg, 2 to 3 times daily
i) Single dose: 480 mg, 2 times daily
k) Single dose: 45 mg; 2 times daily
l) Single dose: 0.5-1 ml, 3 times daily
Indication 2)
a) Herbal tea: 1.5 g in 250 ml boiling water as herbal infusion divided in 3 single doses. Infusion time: 8 hours
d) Daily dose: 240 mg extract as single dose
e) Single dose: 100 mg; 2 to 3 times daily
g) Single dose: 140-280 mg, 3 times daily
i) Single dose: 480 mg, 2 times daily
Single dose: 100 mg; 3 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
Indication 1)
Not to be used for more than 4 weeks.
Indication 2)
Not to be used for more than 2 weeks.
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Well-established use |
Traditional use |
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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. Articular pain accompanied by swelling of joints, redness or fever should be examined by a doctor. Patients with gallstones should consult a physician prior to use the devil's claw. |
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 has not been established due to lack of adequate data. Articular pain accompanied by swelling of joints, redness or fever should be examined by a doctor. Patients with gallstones should consult a physician prior to use the devil's claw. If the symptoms worsen during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted. For liquid preparations containing ethanol, the appropriate labelling for ethanol, taken from the 'Guideline on excipients in the label and package leaflet of medicinal products for human use', must be included. |
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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Gastrointestinal symptoms (diarrhoea, nausea, vomiting, abdominal pain) have been reported. Central nervous system effects (headache, vertigo) have been reported. Hypersensitivity reactions (e.g. rash, hives, facial oedema) have been reported. 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
|
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. 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
2 February 2016
European Union herbal monograph on Harpagophytum procumbens DC. and/or Harpagophytum zeyheri Decne., radix
EMA/HMPC/627057/2015
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