02 February 2016 EMA/HMPC/150848/2015, Corr. 1 Committee on Herbal Medicinal Products (HMPC)

European Union herbal monograph on Valeriana officinalis L., radix Final

Initial assessment Discussion in Working Party on European Union monographs and list

May 2005

(MLWP)

June 2005 September 2005

Adoption by Committee on Herbal Medicinal Products (HMPC) for

20 September 2005

release for consultation End of consultation (deadline for comments)

31 January 2006

Re-discussion in MLWP

May 2006 July 2006

Adoption by HMPC

13 July 2006

Monograph (EMEA/HMPC/340719/2005) AR (EMEA/HMPC/167391/2006) List of references (EMEA/HMPC/167392/2006) Overview of comments received during the public consultation (EMEA/HMPC/50774/2006) HMPC Opinion (EMEA/HMPC/313368/2006) First systematic review Discussion in MLWP

January 2015 March 2015 May 2015

Adopted by HMPC for release for consultation Start of public consultation End of consultation (deadline for comments) Re-discussion in MLWP Adoption by HMPC

1

7 July 2015 22 July 2015 31 October 2015 November 2015 2 February 2016

Correction under ii) Herbal preparations, point h

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© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.

Keywords

Herbal medicinal products; HMPC; European Union herbal monographs; wellestablished medicinal use; traditional use; Valeriana officinalis L., radix; Valerianae radix; Valerian root

BG (bulgarski): Валериана, корен

LT (lietuvių kalba): Valerijonų šaknys

CS (čeština): kozlíkový kořen

LV (latviešu valoda): Baldriāna saknes

DA (dansk): Baldrianrod

MT (Malti): Għerq tal-Valerjana

DE (Deutsch): Baldrianwurzel

NL (Nederlands): Valeriaanwortel

EL (elliniká): Ρίζα βαλεριανής

PL (polski): Korzeń kozłka

EN (English): Valerian root

PT (português): Valeriana, raiz

ES (español): Valeriana, raíz de

RO (română): rădăcină de valeriană

ET (eesti keel): palderjanijuur

SK (slovenčina): Koreň valeriány

FI (suomi): rohtovirmajuuri, juuri

SL (slovenščina): korenina zdravilne špajke

FR (français): Valériane (racine de)

SV (svenska): Vänderot, rot

HR (hrvatski): odoljenov korijen

IS (íslenska): NO (norsk): Valerianarot

HU (magyar): Macskagyökér IT (italiano): Valeriana radice

European Union herbal monograph on Valeriana officinalis L., radix EMA/HMPC/150848/2015

Page 2/9

European Union herbal monograph on Valeriana officinalis L., radix 1. Name of the medicinal product To be specified for the individual finished product.

2. Qualitative and quantitative composition 2, 3 Well-established use

Traditional use

With regard to the marketing authorisation

With regard to the registration application of

application of Article 10(a) of Directive

Article 16d(1) of Directive 2001/83/EC as

2001/83/EC as amended

amended

Valeriana officinalis L., radix (Valerian root)

Valeriana officinalis L., radix (Valerian root)

i) Herbal substance

i) Herbal substance

Not applicable

Not applicable

ii) Herbal preparations

ii) Herbal preparations

Dry extract (DER 3-7.4:1), extraction solvent:

a)

Comminuted herbal substance

ethanol 40-70% (V/V)

b)

Powdered herbal substance

c)

Expressed juice from fresh root (1:0.600.85)

d)

Dry extract (DER 4-6:1), extraction solvent:

e)

Liquid extract (DER 1:4-6), extraction

water solvent: water f)

Dry extract (DER 4-7:1), extraction solvent: methanol 45% (V/V)

g)

Dry extract (DER 5.3-6.6:1), extraction

h)

Liquid extract (DER 1:7-9), extraction

solvent: methanol 45% (m/m) solvent: sweet wine i)

Liquid extract (DER 1:1), extraction solvent: ethanol 60% (V/V)

j)

Tincture (ratio of herbal substance to extraction solvent 1:8), extraction solvent: ethanol 60% (V/V)

k)

Tincture (ratio of herbal substance to extraction solvent 1:10), extraction solvent: ethanol 56%

l)

Tincture (ratio of herbal substance to extraction solvent 1:5), extraction solvent: ethanol 70% (V/V)

2

The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal quality guidance. 3

The material complies with the Ph. Eur. monograph (ref.: 0453).

European Union herbal monograph on Valeriana officinalis L., radix EMA/HMPC/150848/2015

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Well-established use

Traditional use m) Tincture (ratio of herbal substance to extraction solvent 1:5), extraction solvent: ethanol 60-80% (V/V) n)

Dry extract (DER 5.5-7.4:1), extraction solvent: ethanol 85% (m/m)

3. Pharmaceutical form Well-established use

Traditional use

Herbal preparations in solid dosage forms for

Comminuted herbal substance as herbal tea for

oral use.

oral use.

The pharmaceutical form should be described by

Herbal preparation in liquid or solid dosage forms

the European Pharmacopoeia full standard term.

for oral use. Comminuted herbal substance for use as bath additive. The pharmaceutical form should be described by the European Pharmacopoeia full standard term.

4. Clinical particulars 4.1. Therapeutic indications Well-established use

Traditional use

Herbal medicinal product for the relief of mild

Traditional herbal medicinal product for relief of

nervous tension and sleep disorders.

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.

4.2. Posology and method of administration 4 Well-established use

Traditional use

Posology

Posology

Adolescents, adults and elderly

Adolescents, adults and elderly

Oral use

Oral use

Single dose: 400-600 mg dry extract;

a)

For relief of mild nervous tension up to 3 times daily.

single dose: 0.3-3 g For relief of mild symptoms of mental stress up to 3 times daily. To aid sleep, a single dose half to one hour

4 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).

European Union herbal monograph on Valeriana officinalis L., radix EMA/HMPC/150848/2015

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Well-established use

Traditional use

For relief of sleep disorders, a single dose half to

before bedtime with an earlier dose during

one hour before bedtime with an earlier dose

the evening if necessary.

during the evening if necessary.

Herbal tea: 0.3-3 g of the comminuted

Maximum daily dose: 4 single doses

herbal substance in 150 ml of boiling water

The use in children under 12 years of age is not recommended (see section 4.4 ‘Special warnings

as a herbal infusion b)

For relief of mild symptoms of mental stress

and precautions for use’).

up to 3 times daily.

Duration of use

To aid sleep, a single dose half to one hour before bedtime with an earlier dose during

Because of its gradual onset of efficacy valerian

the evening if necessary.

root is not suitable for acute interventional treatment of mild nervous tension or sleep

single dose: 0.3-2.0 g

c)

single dose: 10 ml

disorders. To achieve an optimal treatment

For relief of mild symptoms of mental stress

effect, continued use over 2-4 weeks is

up to 3 times daily.

recommended.

To aid sleep, a single dose half to one hour before bedtime with an earlier dose during

If the symptoms persist or worsen after 2 weeks

the evening if necessary.

of continued use, a doctor or a pharmacist should be consulted.

d)

single dose: 420 mg For relief of mild symptoms of mental stress

Method of administration

up to 3 times daily. To aid sleep, a single dose half to one hour

Oral use

before bedtime with an earlier dose during the evening if necessary. e)

single dose: 20 ml For relief of mild symptoms of mental stress up to 3 times daily. To aid sleep, a single dose half to one hour before bedtime.

f)

single dose: 144-288 mg For relief of mild symptoms of mental stress up to 4 times daily. To aid sleep, a single dose half to one hour before bedtime with an earlier dose during the evening if necessary.

g)

single dose: 450 mg For relief of mild symptoms of mental stress up to 3 times daily. To aid sleep, a single dose half to one hour before bedtime with an earlier dose during the evening if necessary.

European Union herbal monograph on Valeriana officinalis L., radix EMA/HMPC/150848/2015

h)

single dose: 10 ml, up to 3 times daily

i)

single dose: 0.3-1.0 ml, up to 3 times daily

j)

single dose: 4-8 ml, up to 3 times daily

Page 5/9

Well-established use

Traditional use k)

single dose: 0.84 ml For relief of mild symptoms of mental stress 3-5 times daily. To aid sleep, a single dose half an hour before bedtime.

l)

single dose: 1.5 ml (mental stress), 3 ml (to aid sleep) For relief of mild symptoms of mental stress up to 3 times daily. To aid sleep, a single dose half an hour before bedtime.

m) single dose: 10 ml, up to 3 times daily n)

single dose: 322 mg, up to 3 times daily

The use in children under 12 years of age is not recommended (see section 4.4 ‘Special warnings and precautions for use’). Use as bath additive a)

single dose: 100 g for a full bath; up to 1 bath daily

The use in children under 12 years of age is not recommended (see section 4.4 ‘Special warnings and precautions for use’). Duration of use If 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 Use as bath additive. Temperature: 34-37°C, duration of bath 10-20 minutes.

4.3. Contraindications Well-established use

Traditional use

Hypersensitivity to the active substance.

Hypersensitivity to the active substance. Use as bath additive Full baths are contraindicated in cases of open wounds, large skin injuries, acute skin diseases,

European Union herbal monograph on Valeriana officinalis L., radix EMA/HMPC/150848/2015

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Well-established use

Traditional use high fever, severe infections, severe circulatory disturbances and cardiac insufficiency.

4.4. Special warnings and precautions for use Well-established use

Traditional use

The use is not recommended in children below

The use in children under 12 years of age has not

12 years of age due to a lack of data on safety

been established due to lack of adequate data.

and efficacy.

If the symptoms worsen during the use of the

If the symptoms worsen during the use of the

medicinal product, a doctor or a qualified health

medicinal product, a doctor or a pharmacist

care practitioner should be consulted.

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.

4.5. Interactions with other medicinal products and other forms of interaction Well-established use

Traditional use

None reported

None reported

4.6. Fertility, pregnancy and lactation Well-established use

Traditional use

Safety during pregnancy and lactation has not

Safety during pregnancy and lactation has not

been established. In the absence of sufficient

been established. In the absence of sufficient

data, the use during pregnancy and lactation is

data, use during pregnancy and lactation is not

not recommended.

recommended.

No fertility data available.

No fertility data available.

4.7. Effects on ability to drive and use machines Well-established use

Traditional use

May impair ability to drive and use machines.

May impair ability to drive and use machines.

Affected patients should not drive or operate

Affected patients should not drive or operate

machinery.

machinery.

European Union herbal monograph on Valeriana officinalis L., radix EMA/HMPC/150848/2015

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4.8. Undesirable effects Well-established use

Traditional use

Gastrointestinal symptoms (e.g. nausea,

Oral use

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 pharmacist should be consulted.

Gastrointestinal 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 additive None known If adverse reactions occur, a doctor or a qualified health care practitioner should be consulted.

4.9. Overdose Well-established use

Traditional use

Valerian root at a dose of approximately 20 g

Oral use

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.

Valerian 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 additive No case of overdose has been reported.

5. Pharmacological properties 5.1. Pharmacodynamic properties Well-established use

Traditional use

Pharmacotherapeutic group: Hypnotics and

Not required as per Article 16c(1)(a)(iii) of

sedatives

Directive 2001/83/EC as amended.

Proposed ATC code: N05C M09 The sedative effects of preparations of valerian root, which have long been recognised empirically, have been confirmed in controlled clinical studies. Orally administered dry extracts of valerian root prepared with ethanol/water European Union herbal monograph on Valeriana officinalis L., radix EMA/HMPC/150848/2015

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Well-established use

Traditional use

(ethanol maximum 70% (V/V)) in the recommended dosage have been shown to improve sleep latency and sleep quality. These effects cannot be attributed with certainty to any known constituents.

5.2. Pharmacokinetic properties Well-established use

Traditional use

No data available.

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

Ethanol extracts of valerian root have shown low

AMES-tests on mutagenicity with extracts,

toxicity in rodents during acute tests and from

representing the two extremes of the polarity

repeated dose toxicity over periods of 4-8 weeks.

range did not give any reason for concern.

AMES-tests on mutagenicity for the dry extract

Tests on reproductive toxicity and carcinogenicity

(4-7:1); extraction solvent ethanol 40% (V/V)

have not been performed.

and the dry extract (DER 3-6:1), extraction solvent ethanol 70% (V/V) did not give any reason for concern. Tests on reproductive toxicity and carcinogenicity have not been performed.

6. Pharmaceutical particulars Well-established use

Traditional use

Not applicable

Not applicable

7. Date of compilation/last revision 02 February 2016

European Union herbal monograph on Valeriana officinalis L., radix EMA/HMPC/150848/2015

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Final European Union herbal monograph on Valeriana officinalis L ...

Feb 2, 2016 - 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. 4.2. Posology and method of administration4. Well-established use. Traditional use. Posology. Adolescents, adults and elderly.

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