Thyme and Primula root
Thymi herba and Primulae radix
Combination: Thymus vulgaris L.; Thymus zygis L. and Primula veris L.; Primula elatior (L.) Hill
HOS-216031hmpc:thymi-herba-primulae-radix
Botanische Abbildung · Noch nicht verfügbar
Die botanische Zuordnung ist mehrdeutig. Es wird kein Bild als eindeutige Pflanzenidentität angezeigt.
- Themengebiete laut EMA
- Cough and cold
- Ergebnis der Bewertung laut EMA
- European Union herbal monograph
- Kombination laut EMA
- Ja
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 Community herbal monograph on Thymus vulgaris L. and Thymus zygis L., herba and Primula veris L. and Primula elatior (L.) Hill, radix ↗
PDF abgerufen: 27.10.2026 · 9 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 3, 4
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
Fixed combination of Thymus vulgaris L. or Fixed combination of Thymus vulgaris L. or
Thymus zygis L., herba and Primula veris L. or Thymus zygis L., herba and Primula veris L. or
Primula elatior (L.) Hill, radix (Thyme and Primula elatior (L.) Hill, radix (Thyme and
Primula root) Primula root)
i) Herbal substance i) Herbal substance
Not applicable. Not applicable.
ii) Herbal preparations ii) Herbal preparations
a) Liquid extract from Thyme (DER 1:2-2.5), a) Dry extract from Thyme (DER 6-10:1),
extraction solvent ammonia solution 10% extraction solvent ethanol 70% V/V and dry
m/m: glycerol 85% m/m: ethanol 90% V/V: extract from Primula root (DER 3.5-4.5:1),
water (1:20:70:109) and tincture from extraction solvent water
Primula root (ratio of herbal substance to
b) Liquid extract from Thyme (DER 1:2-2.5),
extraction solvent 1:5), extraction solvent
extraction solvent ammonia solution
ethanol 50% V/V
10% m/m: glycerol 85% m/m: ethanol 90%
b) Liquid extract from Thyme (DER 1:2-2.5), V/V: water (1:20:70:109) and soft extract
extraction solvent ammonia solution 10% from Primula root (DER 3-7:1), extraction
m/m: glycerol 85% m/m: ethanol 90% V/V: solvent methanol: water: ammonia solution
water (1:20:70:109) and liquid extract from 26% (50:49.5:0.5)
Primula root (DER 1:2-2.5), extraction
c) Liquid extract from Thyme (DER 1:2-2.5),
solvent ethanol 70% m/m
extraction solvent ammonia solution 10%
c) Dry extract from Thyme (DER 6-10:1), m/m: glycerol 85% m/m: ethanol 90% V/V:
extraction solvent ethanol 70% V/V and water (1:20:70:109) and soft extract from
dry extract from Primula root (DER 6-7:1), Primula root (DER 1-2:1), extraction solvent
extraction solvent ethanol 47.4% V/V ethanol 55% V/V
3
The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal
quality guidance.
4
The material complies with the Ph. Eur. monograph (ref.: 0865 and 1364).
European Union herbal monograph on Thymus vulgaris L. or Thymus zygis L., herba and Primula veris L. or
Primula elatior (L.) Hill, radix
EMA/HMPC/84990/2015 Page 3/9
Well-established use Traditional use
d) Dry extract from Thyme (DER 4.5-7:1),
extraction solvent methanol 25% V/V and
dry extract from Primula root (DER 4-6:1),
extraction solvent water
e) Liquid extract from Thyme (DER 1:2-3),
extraction solvent ethanol 20% V/V and
liquid extract from Primula root (DER 1:2-3),
extraction solvent ethanol 15% V/V
f) Soft extract from Thyme (DER 5-7:1),
extraction solvent methanol 25% V/V and
soft extract from Primula root (DER 6-10:1),
extraction solvent water
g) Liquid extract from Thyme (DER 1:2-2.5),
extraction solvent ammonia solution 10%
m/m: glycerol 85% m/m: ethanol 90% V/V:
water (1:20:70:109) and tincture from
Primula root (Ratio herbal substance to
extraction solvent 1:5), extraction solvent
ethanol 50% V/V
h) Liquid extract from Thyme (DER 1:2-2.5),
extraction solvent ammonia solution 10%
m/m: glycerol 85% m/m: ethanol 90% V/V:
water (1:20:70:109) and liquid extract from
Primula root (DER 1:2-2.5), extraction
solvent ethanol 70% m/m
i) Liquid extract from the mixture of Thyme
(DER 1:3.3) and Primula root (DER 1:2-4.6),
extraction solvent water
3. Pharmaceutical form
Well-established use Traditional use
Herbal preparations in liquid or solid dosage Herbal preparations in liquid or solid dosage
forms for oral use. forms for oral use.
The pharmaceutical form should be described by The pharmaceutical form should be described by
the European Pharmacopoeia full standard term. the European Pharmacopoeia full standard term.
European Union herbal monograph on Thymus vulgaris L. or Thymus zygis L., herba and Primula veris L. or
Primula elatior (L.) Hill, radix
EMA/HMPC/84990/2015 Page 4/9
4. Clinical particulars
4.1. Therapeutic indications
Well-established use Traditional use
Herbal medicinal product used as an expectorant Traditional herbal medicinal product used as an
in case of productive cough. expectorant in cough associated with cold.
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
Well-established use Traditional use
Posology Posology
Adults and elderly Adolescents, adults and elderly
a) Single dose: a) Single dose:
Fixed combination of 0.43 g liquid Thyme Fixed combination of 75 mg dry Thyme
extract and 0.21 g Primula root tincture extract and 37.5 mg dry Primula root extract
Daily dose: 5 times daily Daily dose: 3 times daily
b) Single dose: b) Single dose:
Fixed combination of 0.5 g liquid Thyme Fixed combination of 1.13 g liquid Thyme
extract and 0.25 g liquid Primula root extract extract and 0.045 g soft Primula root extract
Daily dose: 6 times daily Daily dose: 3 times daily
c) Single dose: c) Single dose:
Fixed combination of 160 mg dry Thyme Fixed combination of 1.16 g liquid Thyme
extract and 60 mg dry Primula root extract extract and 0.17 g soft Primula root extract
Daily dose: 3 times daily Daily dose: 4 times daily
The use in children and adolescents under 18 d) Single dose:
years of age is not recommended (see section Fixed combination of 110 mg dry Thyme
4.4 ‘Special warnings and precautions for use’). extract and 21 mg dry Primula root extract
Daily dose: 3 times daily
Duration of use
e) Single dose:
If the symptoms persist longer than 1 week
Fixed combination of 1.24 g liquid Thyme
during the use of the medicinal product, a doctor
extract and 0.41 g liquid Primula root extract
or a pharmacist should be consulted.
Daily dose: 3-5 times daily
Method of administration
f) Single dose:
Oral use Fixed combination of 128 mg soft Thyme
extract and 18 mg soft Primula root extract.
Daily dose: 3-4 times daily
i) Single dose:
3.08 g equivalent to 0.62 g of Thyme and
0.22–0.51 g of Primula root.
Daily dose: 4 times daily
European Union herbal monograph on Thymus vulgaris L. or Thymus zygis L., herba and Primula veris L. or
Primula elatior (L.) Hill, radix
EMA/HMPC/84990/2015 Page 5/9
Well-established use Traditional use
Adolescents
g) Single dose:
Fixed combination of 0.43 g liquid Thyme
extract and 0.21 g Primula root tincture
Daily dose: 5 times daily
h) Single dose:
Fixed combination of 0.5 g liquid Thyme
extract and 0.25 g liquid Primula root
extract
Daily dose: 6 times daily
Children between 4 and 11 years of age
c) Single dose:
Fixed combination of 0.77 g liquid Thyme
extract and 0.12 g soft Primula root extract
Daily dose: 3-4 times daily
g) Single dose:
Fixed combination of 0.36 g liquid Thyme
extract and 0.18 g Primula root tincture
Daily dose: 3-5 times daily
h) Single dose:
Fixed combination of 0.33 g liquid Thyme
extract and 0.17 g liquid Primula root
extract
Daily dose: 3-5 times daily
Herbal preparations a, b, d, e, f, i
The use in children under 12 years of age is not
recommended (see section 4.4 ‘Special warnings
and precautions for use’).
Herbal preparation c, g, h
The use in children under 4 years of age is not
recommended (see section 4.4 ‘Special warnings
and precautions for use’).
Duration of use
If the symptoms persist longer than 1 week
during the use of the medicinal product, a doctor
or a qualified health care practitioner should be
consulted.
Method of administration
Oral use
European Union herbal monograph on Thymus vulgaris L. or Thymus zygis L., herba and Primula veris L. or
Primula elatior (L.) Hill, radix
EMA/HMPC/84990/2015 Page 6/9Kontext im Original-PDF öffnen ↗4.3 · Gegenanzeigen
Contraindications
4.3. Contraindications
Well-established use Traditional use
Hypersensitivity to the active substances or to Hypersensitivity to the active substances or to
other plants of the Lamiaceae family. other plants of the Lamiaceae family.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
If dyspnoea, fever or purulent sputum occurs, a If dyspnoea, fever or purulent sputum occurs, a
doctor or a pharmacist should be consulted. doctor or a qualified health care practitioner
should be consulted.
Caution is recommended in patients with gastritis
or gastric ulcer. Caution is recommended in patients with gastritis
or gastric ulcer.
If the symptoms worsen during the use of the
medicinal product, a doctor or a pharmacist If the symptoms worsen during the use of the
should be consulted. medicinal product, a doctor or a qualified health
care practitioner should be consulted.
The use in children and adolescents under 18
years of age has not been established due to For tinctures and extracts containing ethanol, the
lack of data on efficacy. appropriate labelling for ethanol, taken from the
‘Guideline on excipients in the label and package
For tinctures and extracts containing ethanol, the
leaflet of medicinal products for human use’,
appropriate labelling for ethanol, taken from the
must be included.
‘Guideline on excipients in the label and package
leaflet of medicinal products for human use’, Herbal preparations a, b, d, e, f, i
must be included.
The use in children under 12 years of age has not
been established due to lack of adequate data.
Herbal preparation c, g, h
The use in children under 4 years of age has not
been established because medical advice should
be sought.Original-PDF · Seite 7 ↗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. None reported.Original-PDF · Seite 7 ↗4.8 · Nebenwirkungen
Undesirable effects
4.8. Undesirable effects
Well-established use Traditional use
Gastric disorders and nausea may occur. The Gastric disorders and nausea may occur. The
frequency is not known. frequency is not known.
If other adverse reactions not mentioned above If other adverse reactions not mentioned above
occur, a doctor or a pharmacist should be occur, a doctor or a qualified health care
consulted. practitioner should be consulted.Original-PDF · Seite 8 ↗Dokumentfassung nachweisen
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Importstand: 27.10.2026 · Aktuelles EMA-Quellenprofil ↗
Dokumente beim Herausgeber · 14
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 Thymi herba and Primulae radix
- Overview of comments received on Community herbal monograph on Thymus vulgaris L. and Thymus zygis L., herba and Primula veris L. and Primula elatior (L.) Hill, radix
- Draft European Union herbal monograph on Thymus vulgaris L. and Thymus zygis L., herba and Primula veris L. and Primula elatior (L.) Hill, radix
- Final Community herbal monograph on Thymus vulgaris L. and Thymus zygis L., herba and Primula veris L. and Primula elatior (L.) Hill, radix
- Superseded final Community herbal monograph on Thymus vulgaris L. and Thymus zygis L., herba and Primula veris L. and Primula elatior (L.) Hill, radix
- Opinion of the HMPC on a Community herbal monograph on Thymus vulgaris L. and Thymus zygis L., herba and Primula veris L. and Primula elatior (L.) Hill, radix
- Superseded opinion of the HMPC on a Community herbal monograph on Thymus vulgaris L. and Thymus zygis L., herba and Primula veris L. and Primula elatior (L.) Hill, radix
- Draft list of references supporting the assessment of Thymus vulgaris L. and Thymus zygis L., herba and Primula veris L. and Primula elatior (L.) Hill, radix
- Final list of references supporting the assessment of Thymus vulgaris L. and Thymus zygis L., herba and Primula veris L. and Primula elatior (L.) Hill, radix
- Superseded final list of references supporting the assessment of Thymus vulgaris L. and Thymus zygis L., herba and Primula veris L. and Primula elatior (L.) Hill, radix
- Draft assessment report on Thymus vulgaris L. and Thymus zygis L., herba and Primula veris L. and Primula elatior (L.) Hill, radix
- Final assessment report on Thymus vulgaris L. and Thymus zygis L., herba and Primula veris L. and Primula elatior (L.) Hill, radix
- Superseded final assessment report on Thymus vulgaris L. and Thymus zygis L., herba and Primula veris L. and Primula elatior (L.) Hill, radix
- Thyme and primula root: Summary for the public
Dokumentenlinks geprüft: 27.10.2026
Quellenstand & Originalangaben
- Originalstatus
- C: ongoing call for scientific data
- Zuletzt geändert laut EMA
- 01/03/2024
- Erstveröffentlichung laut EMA
- 31/12/2009
- Erfolgreicher Quellenabruf
- 27.10.2026