Discussion in Working Party on Community monographs and Community list (MLWP)

May 2012 November 2012 January 2013

Adoption by Committee on Herbal Medicinal Products (HMPC) for release for consultation

12 March 2013

End of consultation (deadline for comments). Comments should be provided using this template to hmpc.secretariat@ema.europa.eu

15 July 2013

Rediscussion in Working Party on Community monographs and Community list (MLWP)

Adoption by Committee on Herbal Medicinal Products (HMPC)

BG (bälgarski): XeH-weH, KopeH

LT (lietuviq kalba): Zenseniq saknys

CS (cestina): vsehojovy koren

LV (latviesu valoda): Zegsega saknes

DA (dansk): Ginsengrod

MT (malti): Gherq ta' l-Ginseng

DE (Deutsch): Ginsengwurzel

NL (nederlands): Ginseng

EL (elliniká): yívoeyk nàva^

PL (polski): Korzeii zei-szenia

EN (English): ginseng root

PT (portugués): Ginseng

ES (espanol): Ginseng, raíz de

RO (romånä): rädäcinä de ginseng

ET (eesti keel): zensennijuur

SK (slovencina): Zensenovy koren

FI (suomi): ginseng, juuri

SL (slovenscina): korenina pravega zensena

FR (français): Ginseng (racine de)

(ginsenga)

HU (magyar): Ginzenggyôkér

SV (svenska): Ginsengrot

IT (italiano): Ginseng radice

IS (íslenska):

NO (norsk): Ginsengrot

Well-established use

Traditional use

With regard to the registration application of Article 16d(1) of Directive 2001/83/EC as amended

Panax ginseng C.A. Meyer, radix (Ginseng root)

i) Herbal substance Not applicable.

ii) Herbal preparations

White ginseng

A)

Comminuted herbal substance

B)

Powdered herbal substance

C)

Dry extract (DER 2-7:1), extraction solvent ethanol 34-40% V/V

D)

Dry extract (DERgenuine 3-7:1), extraction solvent ethanol 40% V/V, containing 4% ginsenosides (sum of Rb₁, Rb₂, Rc, Rd, Re, Rf, Rg1, Rg2)

E)

Dry extract (DER 3-7:1), extraction solvent ethanol 57.9% V/V (=50% m/m) - 60% V/V

F)

Dry extract (DER 3.3-5:1), extraction solvent methanol 60% V/V

G)

Soft extract (DER 1.7-3.2:1), extraction solvent ethanol 60 - 70% V/V

H)

Soft extract (DER 2-6:1), extraction solvent methanol 30% V/V

I)

Liquid extract (DER 1:0.8-1.2), extraction solvent ethanol 30.5% V/V (=25% m/m) -34% V/V

J)

Liquid extract (DER 1:11-13.6), extraction solvent liquor wine

Well-established use

Traditional use

Red Ginseng

K)    Powdered herbal substance

L)    Dry extract (DER 2-4.5:1), extraction solvent ethanol 60% V/V

Well-established use

Traditional use

Comminuted herbal substance (herbal preparation A) as herbal tea for oral use.

Herbal preparations B, C, E, F, K, L in solid dosage forms for oral use.

Herbal preparations G, H, I, J in liquid dosage forms for oral use.

Herbal preparation D in solid and liquid dosage forms.

The pharmaceutical form should be described by the European Pharmacopoeia full standard term.

Well-established use

Traditional use

Traditional herbal medicinal product for symptoms of asthenia such as fatigue and weakness.

The product is a traditional herbal medicinal product for use in the specified indication exclusively based upon long-standing use.

Well-established use

Traditional use

Posology

Adults and elderly White ginseng

A)    Comminuted herbal substance

Herbal tea: 1000-2000 mg of the comminuted herbal substance in 150 ml of water as a decoction 2-3 times daily

B)    Powdered herbal substance

Single dose: 250-1200 mg Daily dose: 600-2000 mg Dosage frequency: once daily (1200 mg) or 2-8 times daily

C)    Dry extract (DER 2-7:1), extraction solvent ethanol 34-40% V/V

Single dose: 90-360 mg Daily dose: 200-670 mg Dosage frequency: 1-4 times daily

D)    Dry extract (DERg_enuine 3-7:1), extraction solvent ethanol 40% V/V

Single dose: 40-200 mg

Daily dose: 40-200 mg

(can be increased up to 600 mg in the first

5 days in special situations)

Dosage frequency: 1-2 times daily

E)    Dry extract (DER 3-7:1), extraction solvent ethanol 57.9% V/V (=50% m/m) - 60% V/V

Single dose: 98-220 mg Daily dose: 196-525 mg Dosage frequency: 2-4 times daily

F)    Dry extract (DER 3.3-5:1), extraction solvent methanol 60% V/V

Single dose: 120 mg

Daily dose: 360 mg

Dosage frequency: 3 times daily

Well-established use

Traditional use

G)    Soft extract (DER 1.7-3.2:1), extraction solvent ethanol 60-70% V/V

Single dose: 300-440 mg Daily dose: 440-700 mg Dosage frequency: once daily (440 mg) or 2 times daily

H)    Soft extract (DER 2-6:1), extraction solvent methanol 30% V/V

Single dose: 219.8 mg

Daily dose: 439.6 mg

Dosage frequency: 2 times daily

I)    Liquid extract (DER 1:0.8-1.2), ethanol 30.5% V/V (=25% m/m) - 34% V/V

Single dose: 500 mg (or ml) -1250 mg (or ml) Daily dose: 900 mg (of ml) - 2500 mg (or ml) Dosage frequency: 1-2 times daily

J)    Liquid extract (DER 1:11-13.6), extraction solvent liquor wine

Single dose: 19.4 ml Daily dose: 19.4 ml Dosage frequency: once daily

Red ginseng

K)    Powdered herbal substance:

Single dose: 600 mg Daily dose: 1800 mg Dosage frequency: 3 times daily

L)    Dry extract (DER 2-4.5:1), extraction solvent ethanol 60% V/V

Single dose: 180-500 mg Daily dose: 360-500 mg Dosage frequency: once daily (475 mg or 500 mg) or 2 times daily

The use in children and adolescents under 18 years of age is not recommended (see section 4.4 'Special warnings and precautions for use')

Duration of use

Duration of use up to 3 months. If the symptoms persist for more than 2 weeks during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.

Well-established use

Traditional use

Method of administration

Oral use.

Well-established use

Traditional use

Hypersensitivity to the active substance.

Well-established use

Traditional use

The use in children and adolescents under 18 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 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.

Well-established use

Traditional use

None reported.

Well-established use

Traditional use

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.

Well-established use

Traditional use

No studies on the effect on the ability to drive and use machines have been performed.

Well-established use

Traditional use

Hypersensitivity reactions (urticaria, itching), insomnia and gastrointestinal disorders like stomach discomfort, nausea, vomiting, diarrhoea, and constipation 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.

Well-established use

Traditional use

No case of overdose has been reported.

Well-established use

Traditional use

Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.

Well-established use

Traditional use

Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.

Well-established use

Traditional use

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.

No signs of genotoxicity were observed in an

Well-established use

Traditional use

AMES-test (Salmonella typhimurium strains TA 1535, TA 1537, TA 1538, TA 98 and TA 100) with and without metabolic activation using an extract prepared with ethanol 40% V/V (herbal preparation D). This was confirmed with an extract prepared with ethanol 80% in a guideline-conform AMES-test with and without metabolic activation as well as in a micronucleus test.

After 2 years of oral administration of an extract prepared with ethanol 80% in dosages of up to 5000 mg/kg b.w. no signs of carcinogenicity were observed in mice or rats.

Adequate tests on reproductive toxicity have not been performed.

Well-established use

Traditional use

Not applicable.