Ginseng
Ginseng radix
Panax ginseng C.A.Mey.
HOS-215921hmpc:ginseng-radix
Botanische Abbildung
Panax ginseng . Ginsengpflanze.
Artbezogene Illustration. Sie zeigt nicht automatisch die im Profil genannte Arzneidroge oder Zubereitung und dient nicht zur sicheren Bestimmung einer Giftpflanze.
FloraFarm GmbH / Katharina Lohrie · CC BY 3.0 · Bildquelle ↗
Bildzuordnung & Herkunft
- Originalangabe im Profil
- Panax ginseng C.A.Mey.
- Taxonkennung
- Q182881 · Quellenrevision 2536431332
- Bearbeitung
- Auf maximal 1024 Pixel verkleinert, EXIF-Orientierung angewandt und als JPEG gespeichert; kein inhaltlicher Zuschnitt.
- Bildquelle abgerufen
- 25.10.2026
Bilddatei SHA-256: 95874c9a1b6866bb3170c78350ca6a09094e4ea13d75d6ba776da2856c6b6c43
- Themengebiete laut EMA
- Fatigue and weakness
- Ergebnis der Bewertung laut EMA
- European Union herbal monograph
- Kombination laut EMA
- Nein
Pflanzen–Arzneimittel-Beziehungen 0 belegte Zuordnungen
Für diesen Quellenstand wurden noch keine eindeutigen Wirkstoffzuordnungen mit belegter Aussage übernommen.
Keine oder wenige Zuordnungen bedeuten nicht, dass keine Wechselwirkungen bestehen. Nicht eindeutig zuordenbare Aussagen bleiben im Originalabschnitt nachlesbar; verneinte Befunde gelten nur für die beschriebenen Bedingungen.
Sicherheit aus der Monographie Originalabschnitte
Englische Originalabschnitte mit unveränderten Spalten für etablierte und traditionelle Anwendung. Aussagen gelten für die im Dokument genannten Zubereitungen und Anwendungsarten. Aus ihnen werden hier keine Interaktionspaare oder Schweregrade abgeleitet.
Final European Union herbal monograph on Panax ginseng C.A.Mey., radix - Revision 1 ↗
PDF abgerufen: 25.10.2026 · 10 Seiten · automatisch ausgelesen
Zubereitungs- und Anwendungskontext · Originaltext
Originalkontext vor Abschnitt 4.3, einschließlich der Angaben zu Zubereitungen und Anwendung. Buchstaben und Nummern der Zubereitungen werden in den Sicherheitsabschnitten wieder aufgegriffen.
1. Name of the medicinal product
To be specified for the individual finished product.
2. Qualitative and quantitative composition 1, 2
Well-established use Traditional use
With regard to the registration application of
Article 16d(1) of Directive 2001/83/EC
Panax ginseng C.A. Mey., radix (Ginseng)
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 (DER 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
1 The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal
quality guidance.
2 The material complies with the Ph. Eur. monograph (ref.: 1523)
European Union herbal monograph on Panax ginseng C.A.Mey., radix Page 3/10
EMA/HMPC/27744/2023
Well-established use Traditional use
(=25% m/m) – 34% m/m
j) Liquid extract (DER 1:11-13.6), extraction
solvent liquor wine
Red Ginseng:
k) Powdered herbal substance
l) Dry extract (DER 2-4.5:1), extraction
solvent ethanol 60% V/V
m) Soft extract (DER 2.5-3.2:1), extraction
solvent ethanol 60% V/V
3. Pharmaceutical form
Well-established use Traditional use
Comminuted herbal substance (herbal
preparation a)) as herbal tea for oral use.
Herbal preparations f), k), l) in solid dosage
forms for oral use.
Herbal preparations g), h), i), j), m) in liquid
dosage forms for oral use.
Herbal preparations b), c), d), e) in solid and
liquid dosage forms for oral use.
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
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.
European Union herbal monograph on Panax ginseng C.A.Mey., radix Page 4/10
EMA/HMPC/27744/2023
4.2. Posology and method of administration 3
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),
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 (DER 3-7:1), extraction
solvent ethanol 40% V/V, containing
4% ginsenosides (sum of Rb1, Rb2, Rc,
Rd, Re, Rf, Rg1, Rg2)
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: 98-360 mg
Daily dose: 196-525 mg
Dosage frequency: 1-4 times daily
3 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 Panax ginseng C.A.Mey., radix Page 5/10
EMA/HMPC/27744/2023
Well-established use Traditional use
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
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% m/m
Single dose: 500 mg - 1250 mg Daily
dose: 900 mg – 2500 mg Dosage
frequency: 1-2 times daily
j) Liquid extract (DER 1:11-13.6),
extraction solvent liquor wine
Single dose: 9.90 g
Daily dose: 19.80 g
Dosage frequency: 2 times daily
Red ginseng:
k) Powdered herbal substance:
Single dose: 600 mg -1200 mg
Daily dose: 1200 mg - 1800 mg
Dosage frequency: 1-3 times daily
l) Dry extract (DER 2-4.5:1), extraction
solvent ethanol 60% V/V
European Union herbal monograph on Panax ginseng C.A.Mey., radix Page 6/10
EMA/HMPC/27744/2023
Well-established use Traditional use
Single dose: 180-500 mg
Daily dose: 360-500 mg
Dosage frequency: once daily (475 mg or
500 mg) or 2 times daily
m) Soft extract (DER 2.5-3.2:1), extraction
solvent ethanol 60% V/V
Single dose: 440 mg
Daily dose: 440 mg
Dosage frequency: once 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 longer than 2 weeks during
the use of the medicinal product, a doctor or a
qualified health care practitioner should be
consulted.
Method of administration
Oral use.Kontext im Original-PDF öffnen ↗4.3 · Gegenanzeigen
Contraindications
4.3. Contraindications
Well-established use Traditional use
Hypersensitivity to the active substance.Original-PDF · Seite 7 ↗4.4 · Warnhinweise und Vorsichtsmaßnahmen
Special warnings and precautions for use
4.4. Special warnings and precautions for use
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
European Union herbal monograph on Panax ginseng C.A.Mey., radix Page 7/10
EMA/HMPC/27744/2023
Well-established use Traditional use
package leaflet of medicinal products for
human use’, must be included.Original-PDF · Seite 7–8 ↗4.5 · Wechselwirkungen
Interactions with other medicinal products and other forms of interaction
4.5. Interactions with other medicinal products and other forms of
interaction
Well-established use Traditional use
None reported.Original-PDF · Seite 8 ↗4.8 · Nebenwirkungen
Undesirable effects
4.8. Undesirable effects
Well-established use Traditional use
Gastrointestinal disorders: stomach discomfort,
nausea, vomiting, diarrhoea, and constipation
have been reported. The frequency is not
known.
Immune system disorders: Hypersensitivity
reactions (urticaria, itching) have been
reported: The frequency is not known.
Nervous system disorders: Insomnia has 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.
European Union herbal monograph on Panax ginseng C.A.Mey., radix Page 8/10
EMA/HMPC/27744/2023Original-PDF · Seite 8 ↗Dokumentfassung nachweisen
SHA-256: 27b315a297e44a9893caa86691ee7fad8dbd513b998a66b6f84769891bb360a9
Der Hash kennzeichnet die abgerufene Datei. Die Dokumentfassung und der Bearbeitungsstatus des Pflanzenprofils sind getrennte Angaben.
Importstand: 26.10.2026 · Aktuelles EMA-Quellenprofil ↗
Dokumente beim Herausgeber · 18
Originaltitel bleiben erhalten. Entwürfe, ältere Fassungen und ergänzende Berichte können nebeneinander vorliegen; der Profilstatus bestimmt nicht die Gültigkeit jedes Dokuments.
- Call for scientific data for the periodic review of the monograph on Ginseng radix
- Call for scientific data for use in HMPC assessment work on Panax ginseng C.A. Meyer, radix
- Superseded final overview of comments received on draft Community herbal monograph on Panax ginseng C.A. Meyer, radix
- Draft European Union herbal monograph on Panax ginseng C.A.Mey., radix - Revision 1
- Final European Union herbal monograph on Panax ginseng C.A.Mey., radix - Revision 1
- Superseded final Community herbal monograph on Panax ginseng C.A. Meyer, radix
- Draft Community herbal monograph on Panax ginseng C.A. Meyer, radix
- Opinion of the HMPC on a European Union herbal monograph on Panax ginseng C.A.Mey., radix
- Superseded opinion of the Committee on Herbal Medicinal Products on a community herbal monograph on Panax ginseng C.A.Meyer, radix
- Draft list of references supporting the assessment of Panax ginseng C.A. Mey., radix - Revision 1
- Draft list of references supporting the assessment of Panax ginseng C.A. Meyer, radix
- Final list of references supporting the assessment of Panax ginseng C.A.Mey., radix - Revision 1
- Superseded final list of references supporting the assessment of Panax ginseng C.A. Meyer, radix
- Draft assessment report on Panax ginseng C.A. Meyer, radix
- Draft assessment report on Panax ginseng C.A.Mey., radix - Revision 1
- Final assessment report on Panax ginseng C.A.Mey., radix - Revision 1
- Superseded final assessment report on Panax ginseng C.A. Meyer, radix
- Ginseng root: Assessment Report Summary for the Public (ARSP)
Dokumentenlinks geprüft: 25.10.2026
Quellenstand & Originalangaben
- Originalstatus
- F: Assessment finalised
- Zuletzt geändert laut EMA
- 12/03/2026
- Erstveröffentlichung laut EMA
- 31/12/2009
- Erfolgreicher Quellenabruf
- 26.10.2026