Draft European Union Herbal Monograph On Pelargonium Sidoides Dc And / Or Pelargonium Reniforme Curt., Radix
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EUROPEAN MEDICINES AGENCY
SCIENCE MEDICINES HEALTH
29 September 2015
EMA/HMPC/444244/2015
Committee on Herbal Medicinal Products (HMPC)
European Union herbal monograph on Pelargonium sidoides DC and/or Pelargonium reniforme Curt., radix
Draft
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Initial assessment | |
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Discussion in Working Party on European Union monographs and list (MLWP) |
September 2010 November 2010 January 2011 March 2011 |
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Adoption by Committee on Herbal Medicinal Products (HMPC) for release for consultation |
31 March 2011 |
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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 2011 |
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Re-discussion in MLWP |
September 2011 November 2011 January 2012 May 2012 |
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Adoption by HMPC |
20 November 2012 |
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First review | |
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Discussion in MLWP |
September 2014 July 2015 |
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Adoption by HMPC for release for consultation |
29 September 2015 |
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Start of public consultation |
26 October 2015 |
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End of consultation (deadline for comments). Comments should be provided using this template to hmpc.secretariat@ema.europa.eu |
31 January 2016 |
Note: A 'Review for specific reasons' (see RP EMA/HMPC/326440/2007 Rev.2) had been triggered by new scientific data available to the HMPC (re-evaluation of the Validity of the Bronchitis Severity Scale BSS, see meeting report May 2013 EMA/HMPC/301544/2013). Although no changes were introduced in the monograph, a public consultation was considered useful after careful new assessment of scientific data (in relation to the additional document made available since the primary assessment) as reflected
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in the revised draft AR (amendments to the relevant section 4). Interested parties are given the opportunity to comment before finalisation.
Keywords
Herbal medicinal products; HMPC; European Union herbal monographs; traditional use; Pelargonium sidoides DC and/or Pelargonium reniforme Curt., radix; Pelargonii radix; Pelargonium root
BG (bulgarski): nenaproHnyM, KopeH CS (cestina): pelargoniovy koren DA (dansk): Pelargonierod DE (Deutsch): Pelargoniumwurzel EL (elliniká): neÀapYOviou piÇa EN (English): Pelargonium root ES (español): Pelargonio, raíz de ET (eesti keel): pelargoonijuur FI (suomi): pelargoni, juuri FR (français): Pélargonium (racine de) HR (hrvatski): pelargonijin korijen HU (magyar): muskátligyökér IT (italiano): Pelargonio radice_
LT (lietuviq. kalba): Pelargonijq. saknys LV (latviesu valoda): Pelargonijas saknes MT (Malti): Gfterq tal-Geranju NL (Nederlands): Geranium PL (polski): Korzen pelargonii PT (portugues): Pelargonio, raiz RO (romånä):
SK (slovencina): Koren muskatu SL (slovenscina): korenina pelargonije SV (svenska): Pelargon, rot IS (fslenska):
NO (norsk): Pelargoniumrot
European Union herbal monograph on Pelargonium sidoides DC and/or Pelargonium reniforme Curt., 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 Pelargonium sidoides DC and/or Pelargonium reniforme Curt., radix (Pelargonium root) i) Herbal substance Not applicable. ii) Herbal preparations Liquid extract (DER 1:8-10), extraction solvent ethanol 11% (m/m) Dry extract, (DER 4-25:1), extraction solvent ethanol 11% (m/m) |
3. Pharmaceutical form
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Well-established use |
Traditional use |
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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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Traditional herbal medicinal product for the |
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.: 2008).
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Well-established use |
Traditional use |
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symptomatic treatment of common cold. 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 administration
|
Well-established use |
Traditional use |
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Posology Adolescents over the age of 12 years, adults and elderly Single dose a) Liquid extract: 1.19-1.25 ml, 3 times daily b) Dry extract: 20 mg, 3 times daily Children between 6-12 years a) Liquid extract: 0.79-0.83 ml, 3 times daily b) Dry extract: 20 mg, 2 times daily The use in children under 6 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
|
Well-established use |
Traditional use |
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Hypersensitivity to the active substance(s). |
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 6 years of age has not |
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Well-established use |
Traditional use |
|
been established due to lack of adequate data. Hepatotoxicity and hepatitis cases were reported in association with the administration of the medicinal product. In case signs of hepatotoxicity occur, the administration of the medicinal product should be stopped immediately and a medical doctor should be consulted. If the symptoms worsen during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted. For liquid extracts 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
|
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
|
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 complaints (diarrhea, epigastric discomfort, nausea or vomiting, dysphagia), mild nasal and gingival bleeding and allergic reactions have been reported. The frequency was very rare. Hepatotoxicity has 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
|
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
|
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
|
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
29 September 2015
Page 7/7
European Union herbal monograph on Pelargonium sidoides DC and/or Pelargonium
reniforme Curt., radix
EMA/H MPC/444244/2015