Draft Community Herbal Monograph On Cetraria Islandica (L.) Acharius S.L., Thallus
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EUROPEAN MEDICINES AGENCY
SCIENCE MEDICINES HEALTH
6 May 2014
EMA/HMPC/678891/2013
Committee on Herbal Medicinal Products (HMPC)
Community herbal monograph on Cetraria islandica (L.)Acharius s.l., thallus
Draft
BG (balgarski): HcnaHgcKM nwwefi
CS (cestina): islandsky lisejnfk
DA (dansk): Islandsk mos
DE (Deutsch): Isländisches Moos
EL (ellinika): Aeixqv IaÀavôiaç
EN (English): Iceland moss
ES (espanol): Liquen de Islandia, talo de
ET (eesti keel): islandi käokörva maapealne osa
FI (suomi): islanninjäkälä
FR (français): Lichen d'Islande
HU (magyar): Izlandi zuzmo
HR (hrvatska): islandski lisaj
IT (italiano): Lichene islandico_
LT (lietuviq. kalba): Islandiniq. kerpenq. gniuzulai
LV (latviesu valoda): Islandes ^erpja lapogi
MT (malti): Likeni tal-Islanda
NL (nederlands): IJslands Mos
PL (polski): Porost islandzki
PT (portugues): Liquene-da-islandia
RO (romånä): lichen de Islanda
SK (slovencina): lisajnik islandsky
SL (slovenscina): islandski lisaj
SV (svenska): Islandslav
IS (fslenska):
NO (norsk): Islandsk lav
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Discussion in Working Party on Community monographs and Community list (MLWP) |
November 2013 January 2014 March 2014 | |
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Adoption by Committee on Herbal Medicinal Products (HMPC) for release for consultation |
6 May 2014 | |
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End of consultation (deadline for comments). Comments should be provided using this template to hmpc.secretariat@ema.europa.eu |
31 August 2014 | |
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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) | ||
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Keywords |
Herbal medicinal products; HMPC; Community herbal monographs; traditional use; Cetraria islandica (L.) Acharius s.l., thallus; Lichen islandicus; Iceland moss | |
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© European Medicines Agency, 2014. Reproduction is authorised provided the source is acknowledged.
Community herbal monograph on Cetraria islándica (L.) Acharius s.l., thallus
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 Cetraria islándica (L.) Acharius s.l., thallus, (Iceland moss) i) Herbal substance Not applicable. ii) Herbal preparations a) Comminuted herbal substance b) Soft extract (DER 2-4:1), extraction solvent water c) Soft extract (DER 0.4-0.8:1), extraction solvent water d) Tincture (ratio of herbal substance to extraction solvent 1:5), extraction solvent ethanol 40% 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 solid and liquid dosage forms for oral or oromucosal use The pharmaceutical form should be described by the European Pharmacopoeia full standard term. |
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.: 07/2010:1439)
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 used as a demulcent for the symptomatic treatment of oral or pharyngeal irritation and associated dry cough Indication 2) Traditional herbal medicinal product used in temporary loss of appetite. The product is a traditional herbal medicinal product for use in specified indications 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 Oral use a) Comminuted herbal substance Adults and elderly Indication 1) Herbal tea: 1.5 g of the comminuted herbal substance in 150 ml of boiling water as a herbal infusion or as a macerate 3 to 4 times daily Daily dose: 4-6 g The macerate should be used immediately after preparation. Indication 2) Herbal tea: 1-2 g of the comminuted herbal substance in 150 ml of water as an infusion or decoction 3 times daily 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'). |
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).
d) Tincture
Adults and elderly
Indication 1) and 2)
Single dose: 1-1.5 ml 3 times daily Daily dose: 3-4.5 ml
The use in children and adolescents under 18 years of age is not recommended (see section 4.4 'Special warnings and precautions for use').
Oromucosal use
Indication 1)
b) Soft extract
Adolescents, adults and elderly
Single dose: 100 - 200 mg several times daily
Daily dose: 2 g
Children 6-12 years of age
Single dose: 100 mg 4 to 6 times daily
Daily dose: 400 to 600 mg
The use in children under 6 years of age is not recommended (see section 4.4 'Special warnings and precautions for use').
c) Soft extract (DER 0.4-0.8:1)
Adolescents, adults and elderly
Single dose: 80-160 mg several times daily
Daily dose: 0.8-1.6 g
Children 6-12 years of age
Single dose: 80 mg 4 to 6 times daily
Daily dose: 320 to 480 mg
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
Indication 1) and 2)
If the symptoms persist longer than one week during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.
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Well-established use |
Traditional use |
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Method of administration Preparations a) and d) Oral use Preparations b) and c) Oromucosal 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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Indication 1) and 2) Preparations a) and d) The use in children and adolescents under 18 years of age has not been established due to lack of adequate data. Indication 1) Preparations b) and c) The use in children under 6 years of age is not recommended because of the pharmaceutical form (solid dosage form). If dyspnoea, fever or purulent sputum occurs during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted. Absorption of concomitantly administered medicines may be delayed. As a precautionary measure, the product should not be taken V to 1 hour before or after intake of other medicinal products. For tinctures 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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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. 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
6 May 2014
Page 7/7
Community herbal monograph on Cetraria islandica (L.)Acharius s.l., thallus
EMA/HMPC/678891/2013