(2)in Annex II, the following is inserted after the COMMUNITY LIST ENTRY on Thymus vulgaris L., Thymus zygis Loefl. ex L., aetheroleum:‘UNION LIST ENTRY ON VALERIANA OFFICINALIS L.Scientific name of the plantValeriana officinalis L.Botanical familyValerianaceaeCommon name in all EU official languages of herbal preparationBG (bălgarski): Валериана, коренCS (čeština): kozlíkový kořenDA (dansk): BaldrianrodDE (Deutsch): BaldrianwurzelEL (elliniká): Ρίζα βαλεριανήςEN (English): Valerian rootES (español): Valeriana, raíz deET (eesti keel): palderjanijuurFI (suomi): rohtovirmajuuri, juuriFR (français): Valériane (racine de)HR (hrvatska): odoljenov korijenHU (magyar): MacskagyökérIT (italiano): Valeriana radiceLT (lietuvių kalba): Valerijonų šaknysLV (latviešu valoda): Baldriāna saknesMT (Malti): Għerq tal-ValerjanaNL (Nederlands): ValeriaanwortelPL (polski): Korzeń kozłkaPT (português): Valeriana, raizRO (română): rădăcină de valerianăSK (slovenčina): Koreň valeriánySL (slovenščina): korenina zdravilne špajkeSV (svenska): Vänderot, rotIS (íslenska):NO (norsk): ValerianarotHerbal preparation(s)
European Pharmacopoeia monograph reference04:2017:0453IndicationsTraditional herbal medicinal product for relief of mild symptoms of mental stress and to aid sleep.The product is a traditional herbal medicinal product for use in the specified indication exclusively based upon long-standing use.Type of traditionEuropean.Specified strengthPlease see ‘Specified posology’.Specified posologyAdolescents, adults and elderlyOral useUse as bath additivesingle dose: 100 g for a full bath, up to 1 bath dailyRoute of administrationOral useUse as bath additive. Temperature: 34-37 °C, duration of bath 10-20 minutes.Duration of use or any restrictions on the duration of useIf symptoms persist 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 substance.Use as bath additiveFull baths are contraindicated in cases of open wounds, large skin injuries, acute skin diseases, high fever, severe infections, severe circulatory disturbances and cardiac insufficiency.Special warnings and precautions for useThe use in children under 12 years of age has not been established due to lack of adequate data.If the symptoms worsen during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.For tinctures and 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.Interactions with other medicinal products and other forms of interactionNone reportedFertility, pregnancy and lactationSafety during pregnancy and lactation has not been established. In the absence of sufficient data, use during pregnancy and lactation is not recommended.No fertility data available.Effects on ability to drive and use machinesMay impair ability to drive and use machines. Affected patients should not drive or operate machinery.Undesirable effectsOral useGastrointestinal symptoms (e.g. nausea, abdominal cramps) may occur after ingestion of valerian root preparations. The frequency is not known.If other adverse reactions not mentioned above occur, a doctor or a qualified health care practitioner should be consulted.Use as bath additiveNone knownIf adverse reactions occur, a doctor or a qualified health care practitioner should be consulted.OverdoseOral useValerian root at a dose of approximately 20 g caused symptoms, such as fatigue, abdominal cramp, chest tightness, light-headedness, hand tremor and mydriasis, which disappeared within 24 hours. If symptoms arise, treatment should be supportive.Use as bath additiveNo case of overdose has been reported.Pharmaceutical particulars [If necessary]Not applicablePharmacological effects or efficacy plausible on the basis of long-standing use and experience [If necessary for the safe use of the product]Not applicable.’