Contents
THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the European Union,Having regard to Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human usenote, and in particular Article 16f thereof,Whereas:
(1)Achillea millefolium L., herba can be considered as a herbal substance, a herbal preparation or a combination thereof within the meaning of Directive 2001/83/EC and it complies with the requirements set out in that Directive.
(2)It is therefore appropriate to include Achillea millefolium L., herba in the list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products established by Commission Decision 2008/911/ECnote.
(3)Decision 2008/911/EC should therefore be amended accordingly.
(4)The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Medicinal Products for Human Use,
HAS ADOPTED THIS DECISION:
Article 1#
Annexes I and II to Decision 2008/911/EC are amended in accordance with the Annex to this Decision.
(1)In Annex I, the following substance is inserted before Calendula officinalis L:‘Achillea millefolium L., herba (Yarrow)’
(2)In Annex II, the following is inserted before ‘COMMUNITY LIST ENTRY ON CALENDULA OFFICINALIS L’:‘UNION LIST ENTRY ON ACHILLEA MILLEFOLIUM L., HERBAScientific name of the plantAchillea millefolium L.Botanical familyAsteraceaeHerbal substanceMillefolii herbaCommon name in all EU official languages of herbal substanceBG (bulgarski): Бял равнец, стръкCS (čeština): Řebříčková naťDA (dansk): RøllikeDE (deutsch): SchafgarbenkrautEL (elliniká): Πόα αχιλλείαςEN (English): yarrowES (español): Milenrama, sumidades floridas deET (eesti keel): RaudrohuürtFI (suomi): siankärsämö, versoFR (français): Achillée millefeuille (parties aériennes d’)GA (Gaeilge): Athair thalúnHR (hrvatski): Stolisnikova zelenHU (magyar): Közönséges cickafark virágos hajtás | IT (italiano): Achillea millefoglie parti aereeLT (lietuvių kalba): Kraujažolių žolėLV (latviešu valoda): Pelašķu lakstiMT (Malti): Ħaxixa tal-morlitiNL (Nederlands): DuizendbladPL (polski): Ziele krwawnikaPT (português): MilefólioRO (română): Iarbă de coada şoriceluluiSK (slovenčina): Vňať rebríčkaSL (slovenščina): Zel navadnega rmanaSV (svenska): Rölleka, örtIS (íslenska):NO (norsk): RyllikHerbal preparation(s)Comminuted herbal substanceDry extract (DER 6-9:1), extraction solvent waterDry extract (DER 5-10:1), extraction solvent waterEuropean Pharmacopoeia monograph referenceYarrow – Millefolii herba (07/2014:1382)IndicationsIndication (1)Traditional herbal medicinal product used for temporary loss of appetite.Indication (2)Traditional herbal medicinal product for the symptomatic treatment of mild, spasmodic gastrointestinal complaints including bloating and flatulence.Indication (3)Traditional herbal medicinal product for the symptomatic treatment of minor spasm associated with menstrual periods.Indication (4)Traditional herbal medicinal product for treatment of small superficial wounds.The product is a traditional herbal medicinal product for use in specified indications exclusively based upon long-standing use.Type of traditionEuropeanSpecified strengthPlease see ‘Specified posology’.Specified posologyAdolescents, adults and elderlySingle doseIndications (1) and (2)Herbal tea: 1,5-4 g of the comminuted herbal substance in 150-250 ml of boiling water as a herbal infusion 3-4 times daily between meals.Daily dose: 4,5 to 16 gFor indication (1), the liquid preparations are to be taken 30 minutes before meals.Indication (2)Dry extract (DER 6-9:1), extraction solvent water: 334 mg dry extract 3-4 times daily.Daily dose: 1,002-1,336 gIndication (3)Herbal tea: 1-2 g of the comminuted herbal substance in 250 ml of boiling water as a herbal infusion 2-3 times daily.Daily dose: 2-6 gDry extract (DER 5-10:1), extraction solvent water: 250 mg dry extract 2-3 times daily.Daily dose: 0,50-0,75 gIndication (4)Comminuted herbal substance for infusion preparation for cutaneous use: 3-4 g of the comminuted herbal substance in 250 ml of boiling water 2-3 times daily.Daily dose: 6-12 gThe use in children under 12 years of age is not recommended (see section ‘Special warnings and precautions for use’).Route of administrationIndications (1), (2) and (3)Oral use.Indication (4)Cutaneous use: to be applied as an impregnated dressing to the affected area.Duration of use or any restrictions on the duration of useIndications (1) and (2)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.Indications (3) and (4)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.Any other information necessary for the safe useContraindicationsHypersensitivity to the active substances and to other plants of the Asteraceae (Compositae) family.Special warnings and precautions for useThe use in children under 12 years of age has not been established due to lack of adequate data.Indications (1), (2) and (3)If the symptoms worsen during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.Indication (4)If signs of skin infection are observed, medical advice should be sought.Interactions with other medicinal products and other forms of interactionNone reported.Fertility, pregnancy and lactationSafety 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.Effects on ability to drive and use machinesNo studies on the effect on the ability to drive and use machines have been performed.Undesirable effectsHypersensitivity reactions of the skin 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.OverdoseNo case of overdose has been reported.Pharmaceutical particularsNot applicablePharmacological effects or efficacy plausible on the basis of long-standing use and experience.Not applicable.’
Annexes I and II to Decision 2008/911/EC are amended as follows:
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