Ginseng radix - herbal medicinal product

Ginseng
Herbal productHumanHerbal

Overview

This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of Ginseng root. It summarises the Committee’s recommendations on the use of Ginseng root.

The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing Ginseng root. When a Member State authorises a medicine containing Ginseng root, detailed instructions on how to take it will be available in the package leaflet that comes with medicine.

The information in this summary report concerns Herbal medicinal products containing Ginseng root which are only authorised when they comply with the strict pharmaceutical quality and other requirements for herbal medicinal products. They are approved by the competent authorities to be placed on the market as medicinal products. Other products, like food, food supplements, cosmetic products or medical devices do not follow the same criteria and regulatory requirements as medicinal products and are excluded from this summary.

Ginseng root is the common name for the underground part of the plant Panax ginseng C.A. Mey.

Medicinal products with Ginseng contain the underground part of the plant dried (known as white ginseng) or treated first with steam and then dried (known as red ginseng). They are comminuted (reducing into tiny pieces) or powered, or prepared as liquid, soft dry or extracts. Extracts are obtained by putting the plant material in a solvent (such as ethanol or methanol) to dissolve compounds and form a liquid extract. The solvent is then partially or completely evaporated to obtain a soft or a dry extract.

Herbal medicines containing these Ginseng root preparations are usually available as herbal tea to be drunk, or as liquid or solid forms to be taken by mouth.

Ginseng roots preparations have traditional medicinal use for the symptomatic treatment of asthenia such as fatigue and weakness.

Traditional medicinal use means that the use in the specified indication is exclusively based upon long-standing medicinal use and not based on results from clinical studies.

You can find detailed instructions on how to take Ginseng root medicines and who can use them in the package leaflet that comes with the medicine.

Do not use Ginseng root:

  • for children and adolescents under 18 years of age due to the lack of adequate data.
  • if you are pregnant or breast feed your children due to the lack of adequate data.
  • if you are allergic to the plant.

Consult a doctor or a pharmacist if your symptoms persist longer than 2 weeks during the use of the medicinal product.

No interactions with other medicines have been described in the literature at the time of assessment when using Ginseng root with other medicines.

You may experience some side effects with Ginseng root medicines. You may get:

  • stomach discomfort, nausea, vomiting, diarrhoea and constipation,
  • hypersensitivity reactions of the skin like urticaria or itching,
  • insomnia.

The frequency of these undesirable effects is not known.

The HMPC conclusions on the use of these Ginseng root preparation medicines, fragmented, powdered or as ethanolic or methanolic extracts, are based on their ‘traditional use’ for the symptomatic treatment of asthenia such as fatigue and weakness.

This means that, although there is insufficient evidence from clinical trials, the effectiveness of these herbal medicines is plausible and there is evidence that they have been used safely in this way for at least 30 years (including at least 15 years within the EU).

Any applications for the licensing of medicines containing Ginseng root have to be submitted to the national authorities responsible for medicinal products. Before approval, the national authorities assess the quality, safety and efficacy of the herbal medicine. The HMPC conclusions are taken into account when evaluating applications for the licensing of herbal medicines.

Information on approved Ginseng root medicines in EU Member States may be obtained from the relevant national authorities.

BG (bulgarski): Жен-шен, корен 
CS (čeština): všehojový kořen 
DA (dansk): Ginsengrod
DE (Deutsch): Ginsengwurzel 
EL (elliniká): γίνσεγκ πάναξ ρίζα 
EN (English): Ginseng root
ES (español): ginseng, raíz de 
ET (eesti keel): ženšennijuur 
FI (suomi): ginseng, juuri
FR (français): ginseng (racine de) 
HR (hrvatski): ginsengov korijen HU (magyar): ginzenggyökér
IT (italiano): Ginseng radice
LT (lietuvių kalba): Ženšenių šaknys 
LV (latviešu valoda): Žeņšeņa sakne 
MT (Malti): għerq ta' l-ġinseng
NL (Nederlands): Ginseng
PL (polski): Korzeń żeń-szenia 
PT (português): ginseng
RO (română): rădăcină de ginseng
SK (slovenčina): koreň všehoja (ženšenový koreň)
SL (slovenščina): korenina pravega ženšena (ginsenga)
SV (svenska): ginseng, rot 
NO (norsk): ginsengrot

Key facts

Latin name
Ginseng radix
English common name
Ginseng
Botanical name

Panax ginseng  C.A.Mey.

Therapeutic area
Fatigue and weakness
Status
F: Assessment finalised
Date added to the inventory
Date added to priority list
Outcome of European assessment
European Union herbal monograph

Documents

Revision 1

Consultation - Revision 1

Superseded version

Consultation

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