Matricaria Flower
Matricariae flos
Matricaria recutita L.
HOS-215953hmpc:matricariae-flos
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- Mouth and throat disorders;Skin disorders and minor wounds;Cough and cold;Gastrointestinal disorders
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- European Union herbal monograph
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Final European Union herbal monograph on Matricaria recutita L., flos - First version ↗
PDF abgerufen: 27.10.2026 · 13 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 as amended
Matricaria recutita L., flos (matricaria flower)
i) Herbal substance
As defined in the Ph. Eur. monograph.
ii) Herbal preparations
a) Comminuted herbal substance
b) Liquid extract (DER 1:1), extraction solvent:
ethanol 96% V/V:water:ammonia solution
10% m/m (50:47.5:2.5) 3
c) Liquid extract (DER 1:4.3-5.7), extraction
solvent: ethanol 96% V/V:water:ammonia
solution 10% m/m (50:47.5:2.5)3
d) Liquid extract (DER 1:1), extraction solvent:
ethanol 48% V/V:ammonia solution 10% m/m
(39:1)3
e) Liquid extract (DER 1:1), extraction solvent:
ethanol 45% V/V:ammonia solution 10% m/m
(14.7:1)
f) Dry extract (DER 4-7:1), extraction solvent:
ethanol 50% m/m
g) Liquid extract (DER 1:1.7-2.6), extraction
solvent: ethanol 48% V/V
h) Liquid extract (DER 1:1), extraction solvent:
ethanol 55% V/V
i) Liquid extract (DER 1:2), extraction solvent:
ethanol 70% V/V
j) Liquid extract (DER 1:4.1-4.6), extraction
solvent: ethanol 55% V/V:Poloxamer 188
(993:3)
k) Liquid extract (DER 1:1.8-2.1), extraction
solvent: ethanol 52% V/V:macrogol
hydroxystearate (99.5:0.5)
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.: 0404).
3
The material complies with the Ph. Eur. monograph (ref.: 1544).
European Union herbal monograph on Matricaria recutita L., flos
EMA/HMPC/55843/2011 Page 2/13
Well-established use Traditional use
l) Liquid extract (DER 1:4-4.5) extraction
solvent: ethanol 38.5% m/m (containing
1.36% sodium acetate trihydrate, 0.45%
sodium ascorbate and 0.41% sodium
hydroxide)
m) Liquid extract (DER 2.7-5.5:1), extraction
solvent: ethanol 95.4% V/V (containing
0.22% sodium acetate, 0.12% sodium
hydroxide)
n) Dry extract (DER 11-16:1), extraction solvent:
ethanol 95.4% V/V (containing 0.22% sodium
acetate, 0.12% sodium hydroxide)
o) Liquid extract (DER 1:2-2.8), extraction
solvent: propan-2-ol 48% V/V
3. Pharmaceutical form
Well-established use Traditional use
Herbal substance or comminuted herbal substance
as herbal tea for oral use and inhalation.
Herbal preparations in liquid dosage forms for oral
use.
Herbal substance or comminuted herbal substance
for infusion preparation for oromucosal or
cutaneous use.
Herbal preparations in liquid dosage forms for
preparation of dilutions for oromucosal or
cutaneous use.
Herbal preparations in liquid dosage forms for
preparation of dilutions for steam inhalation.
Herbal preparations in semi-solid dosage forms for
cutaneous use.
Herbal preparations in liquid dosage forms for use
as bath additives.
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
Indication 1)
Traditional herbal medicinal product used for the
symptomatic treatment of minor gastro-intestinal
complaints such as bloating and minor spasms.
European Union herbal monograph on Matricaria recutita L., flos
EMA/HMPC/55843/2011 Page 3/13
Well-established use Traditional use
Indication 2)
Traditional herbal medicinal product used for the
relief of symptoms of common cold.
Indication 3)
Traditional herbal medicinal product for the
treatment of minor ulcers and inflammations of the
mouth and throat.
Indication 4)
Traditional herbal medicinal product used for
adjuvant therapy of irritations of skin and mucosae
in the anal and genital region, after serious
conditions have been excluded by a medical
doctor.
Indication 5)
Traditional herbal medicinal product used for the
treatment of minor inflammation of the skin
(sunburn), superficial wounds and small boils
(furuncles).
The product is a traditional herbal medicinal
product for use in specified indications exclusively
based upon long-standing use.
4.2. Posology and method of administration 4
Well-established use Traditional use
Posology
Preparation a)
Indication 1)
Adolescents, adults and elderly
Single dose: 1.5-4 g of the herbal substance or
comminuted herbal substance in 150 ml of boiling
water as a herbal infusion
Daily dose: 3-4 times
Children (6 months - 2 years)
Single dose: 0.5-1.0 g
Daily dose: 2-4 times
Children (2-6 years)
Single dose: 1.0-1.5 g
Daily dose: 2-4 times
Children (6-12 years)
Single dose: 1.5-3.0 g
Daily dose: 2-4 times
Indication 2)
Adolescents, adults and elderly
Single dose: 3-10 g of herbal substance
or comminuted herbal substance in 100 ml hot
water for inhalation
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 Matricaria recutita L., flos
EMA/HMPC/55843/2011 Page 4/13
Well-established use Traditional use
Daily dose: several times
Children (6-12 years)
Single dose: 2-5 g of herbal substance
or comminuted herbal substance in 100 ml hot
water for inhalation
Daily dose: 1-2 times
Indication 3)
Adolescents, adults and elderly
Single dose: Herbal substance or comminuted
herbal substance for infusion preparation for
oromucosal use: 1-5 g in 100 ml water, for rinsing
and gargling
Daily dose: several times
Indication 4)
Adolescents, adults and elderly
Single dose: 4.5-5 g herbal substance or
comminuted herbal substance per 1 l water for
infusion preparation for irrigation
Daily dose: several times
Indication 5)
Adolescents, adults and elderly
Single dose: 3-10 g herbal substance or
comminuted herbal substance in 100 ml water for
infusion preparation for washings and impregnated
dressings
Daily dose: several times
Preparation b)
Indication 1)
Adolescents, adults and elderly
Single dose: 2 g in 150 ml warm water
Daily dose: 3-4 times
Preparation c)
Indication 3) (for gargling or rinsing)
Indication 5) (for washing or impregnated
dressings)
Adolescents, adults and elderly
Single dose: 10 ml in 150 ml warm water
Daily dose: 3-4 times
Preparation d)
Indication 1)
Adolescents, adults and elderly
Single dose: 3 ml in 150 ml water
Daily dose: 3-4 times
Indication 2)
Adolescents, adults and elderly
Single dose: 1 ml in 100 ml hot water for
inhalation
Daily dose: 1-2 times
European Union herbal monograph on Matricaria recutita L., flos
EMA/HMPC/55843/2011 Page 5/13
Well-established use Traditional use
Indication 3)
Adolescents, adults and elderly
Single dose: 1 ml in 100 ml waterfor gargling or
rinsing
Daily dose: several times
Indication 4)
Adolescents, adults and elderly
Single dose: 1 ml in 100 ml water for irrigations
Single dose: 5 ml per 1 l water for partial baths
Daily dose: several times
Indication 5)
Adolescents, adults and elderly
Single dose: 1.5 ml in 150 ml water for
compresses and irrigation
Daily dose: several times
Preparation e)
Indication 1)
Adolescents, adults and elderly
Single dose: 5 ml in 150 ml water
Daily dose: up to 4 times
Children (6-12 years)
Single dose: 2.5 ml in 150 ml water
Daily dose: up to 4 times
Indication 2)
Adolescents, adults and elderly
Single dose: 5 ml in 150 ml hot water for
inhalation
Daily dose: several times
Indication 3)
Adolescents, adults and elderly
Single dose: 2.5 ml in 125 ml water for gargling or
rinsing
Daily dose: 3-4 times
Indication 4)
Adolescents, adults and elderly
Single dose: 20 ml per 1 l water for compresses
and irrigation
Single dose: 10 ml per 1 l water for partial baths
Daily dose: several times
Indication 5)
Adolescents, adults and elderly
Single dose: 20 ml per 1 l water for compresses
and irrigation
Single dose: 10 ml per 1 l water for partial baths
Daily dose: several times
Preparation f) (in diluted liquid dosage forms
containing approximately 0.47% dry extract)
Indication 5) (sun burn)
Adolescents, adults and elderly
Single dose: apply few drops in a thin layer on the
European Union herbal monograph on Matricaria recutita L., flos
EMA/HMPC/55843/2011 Page 6/13
Well-established use Traditional use
affected area
Daily dose: several times
Preparation g)
Indication 1) and 3)
Adolescents, adults and elderly
Single dose 1.5 ml in 150 ml water for oral use and
mouth rinsing or gargling
Daily dose: 3-4 times
Children (6-12 years)
Single dose: 0.7–1 ml in 150 ml water for oral use
and mouth rinsing or gargling
Daily dose: 3-4 times
Indication 2)
Adolescents, adults and elderly
Single dose: 15 ml per 1 l hot water for inhalation
Daily dose: 1-2 times
Indication 4) and 5)
Adolescents, adults and elderly
Single dose: 15 ml per 1 l hot water for
compresses and irrigation or partial baths
Daily dose: several times
Preparation h)
Indication 2)
Adolescents, adults and elderly
Single dose: 15 ml per 1 l hot water for inhalation
Daily dose: 1-3 times
Indication 3)
Adolescents, adults and elderly
Single dose: 1-2 ml in 150 ml warm water for
mouth rinsing or gargling
Daily dose: up to 4 times
Children (6-12 years)
Single dose: 0.5-1 ml in 150 ml warm water mouth
rinsing or gargling
Daily dose: up to 4 times
Indication 4) and 5)
Adolescents, adults and elderly
Single dose: 15 ml per 1 l warm water for
compresses and irrigation
Single dose: 15-30 ml per 5 l warm water for
partial baths
Daily dose: one to several times
Preparation i)
Indication 1) and 3)
Adolescents, adults and elderly
Single dose: 2.5-5 ml in 50-100 ml water
Daily dose: 3-4 times
European Union herbal monograph on Matricaria recutita L., flos
EMA/HMPC/55843/2011 Page 7/13
Well-established use Traditional use
Indication 5)
Adolescents, adults and elderly
Single dose: 5-10 ml in 100 ml water for washings
and compresses
Daily dose: several times
Preparation j)
Indication 1)
Adolescents, adults and elderly
Single dose: 5 ml in 150 ml warm water
Daily dose: 3-4 times
Indication 2)
Adolescents, adults and elderly
Single dose: 40 ml per 1 l hot water for inhalation
Daily dose: 1-2 times
Indication 3)
Adolescents, adults and elderly
Single dose: 5 ml in 100 ml water for rinsing or
gargling
Daily dose: 3 times
Indication 4)
Adolescents, adults and elderly
Single dose: 20 ml per 1 l water for hip baths
Single dose: 40 ml per 1 l water for washings and
impregnated dressings
Daily dose: one to several times
Indication 5)
Adolescents, adults and elderly
Single dose: 40 ml per 1 l water for irrigations and
impregnated dressings
Daily dose: one to several times
Preparation k)
Indication 1)
Adolescents, adults and elderly
Single dose: 1 g in 150 ml water
Daily dose: up to 4 times
Children (6-12 years)
Single dose: 0.7 g in 150 ml water
Daily dose: up to 4 times
Indication 2)
Adolescents, adults and elderly
Single dose: 10-20 ml per 1 l hot water for
inhalation
Daily dose: one to several times
Indication 3)
Adolescents, adults and elderly
Single dose: 0.7-1.0 ml in 75 ml water for rinsing
or gargling
Daily dose: one to several times
European Union herbal monograph on Matricaria recutita L., flos
EMA/HMPC/55843/2011 Page 8/13
Well-established use Traditional use
Indication 4)
Adolescents, adults and elderly
Single dose: 7.5-15 ml per 1 l water for partial
baths and irrigations
Daily dose: one to several times daily
Indication 5)
Adolescents, adults and elderly
Single dose: 10-20 ml per 1 l water for washing,
impregnated dressings and partial baths
Daily dose: one to several times daily
Preparation l)
Indication 1)
Adolescents, adults and elderly
Single dose: 5 ml in 100 ml water
Daily dose: up to 4 times
Children from (6-12 years)
Single dose: 2-3 ml in 100 ml water
Daily dose: up to 4 times
Indication 2)
Adolescents, adults and elderly
Single dose: 20 ml per 1 l hot water for inhalation
Daily dose: 1-2 times
Indication 3)
Adolescents, adults and elderly
Single dose: 5 ml per 100 ml warm water for
rinsing or garglingDaily dose: 3 to several times
Indication 4) and 5)
Adolescents, adults and elderly
Single dose: 45 ml per 1 l water for washings,
impregnated dressings and irrigations
Daily dose: 1-2 times
Single dose: 30 ml per 1 l water for partial bath or
hip bath
Daily dose: 1-2 times
Preparation m) in semi-solid dosage forms
(corresponding to app. 8% herbal substance)
Indication 4) and 5)
Children (4 weeks - 12 years), adolescents, adults
and elderly
Single dose: apply a thin layer on the affected
area.
Daily dose: 2-3 times
Preparation n) in semi-solid dosage forms
(corresponding to app. 5.5% herbal substance).
Indication 4) and 5)
Adolescents, adults and elderly
Single dose: apply a thin layer on the affected
area.
European Union herbal monograph on Matricaria recutita L., flos
EMA/HMPC/55843/2011 Page 9/13
Well-established use Traditional use
Daily dose: several times
Preparation o)
Indication 4) and 5)
Adolescents, adults and elderly
Single dose: 20 ml per 1 l for compresses and
irrigation
Daily dose: one to several times
Single dose: 20-40 ml in 20-40 l water for partial
baths
Daily dose: one time
Single dose: 30 ml in 150 l water for full baths
Daily dose: one time
Children (4 weeks - 12 years)
Single dose: 10-20 ml in 10-20 l water for baths
Daily dose: one time
For all herbal preparations
The use is not recommended in specific age groups
as specified in 4.4 ‘special warnings and
precautions for use‘.
Duration of use
If the symptoms persist more than one week
during the use of the medicinal product, a doctor
or a qualified health care practitioner should be
consulted.
Method of administration
Indication 1) Oral use.
Indication 2) Inhalation.
Indication 3) Oromucosal use.
Indication 4) and 5) Cutaneous use, Use as bath
additiveKontext im Original-PDF öffnen ↗4.3 · Gegenanzeigen
Contraindications
4.3. Contraindications
Well-established use Traditional use
Hypersensitivity to the active substance and to
other plants of the Asteraceae (Compositae)
family.
Use as bath additive:
Full baths are contraindicated in cases of open
wounds, large skin injuries, acute skin diseases,
high fever, severe infections, severe circulatory
disturbances and cardiac insufficency.
Partial baths or hip baths are contraindicated in
cases of open wounds, large skin injuries, acute
skin diseases, high fever and severe infections.
European Union herbal monograph on Matricaria recutita L., flos
EMA/HMPC/55843/2011 Page 10/13Original-PDF · Seite 10 ↗4.4 · Warnhinweise und Vorsichtsmaßnahmen
Special warnings and precautions for use
4.4. Special warnings and precautions for use
Well-established use Traditional use
All methods of administration
The use of the herbal preparations b, c, d, f, i, j,
and n in children under 12 years of age has not
been established due to lack of adequate data.
Indication 1)
The oral use of the herbal tea for children below 6
months of age has not been established due to
general considerations of nutrition and fluid intake.
The oral use of herbal preparations e, g, k, l in
children under 6 years of age has not been
established due to lack of adequate data.
The oral use of herbal preparations b, d, i, j in
children under 12 years of age has not been
established due to lack of adequate data.
Indication 2)
The use of herbal preparations d, e, g, h, j, k, l as
steam inhalation in children under 12 years of age
has not been established due to lack of adequate
data.
The use of herbal preparation a as steam
inhalation in children under 6 years of age has not
been established due to lack of adequate data.
Indication 3)
The use of herbal preparation h, for mouth washes
or gargling in children under 6 years of age has
not been established due to lack of adequate data.
The use of herbal preparations a, c, d, e, i, j, k, l,
for mouth washes or gargling in children under 12
years of age has not been established due to lack
of adequate data.
Indication 4)
The use of herbal preparation o, m for partial
baths or local cutenous use in children under 4
weeks of age has not been established due to lack
of adequate data.
The use of herbal preparations a, d, e, g, h, j k, l,
n for partial baths or local cutaneous use in
children under 12 years of age has not been
established due to lack of adequate data.
Indication 5)
The use of herbal preparation m, o, for partial
baths or local cutaneous use in children under 4
weeks of age has not been established due to lack
of adequate data.
The use of herbal preparations a, c, d, e, f, g, i, j,
k, l, n (partially) for partial baths or local cutenous
use in children under 12 years of age has not been
established due to lack of adequate data.
If the symptoms worsen during the use of the
European Union herbal monograph on Matricaria recutita L., flos
EMA/HMPC/55843/2011 Page 11/13
Well-established use Traditional use
medicinal product, a doctor or a qualified health
care practitioner should be consulted.
For tinctures and preparations 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.Original-PDF · Seite 11–12 ↗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
Oral use: For patients after renal transplantation
taking high dosages for longer periods (about two
months) interactions based on effects on CYP450
have been reported.
Cutaneous, oromucosal use, inhalation, or as
bath additive:
None reported.Original-PDF · Seite 12 ↗4.8 · Nebenwirkungen
Undesirable effects
4.8. Undesirable effects
Well-established use Traditional use
Hypersensitivity reactions including severe allergic
reaction (dyspnoea, Quincke’s disease, vascular
European Union herbal monograph on Matricaria recutita L., flos
EMA/HMPC/55843/2011 Page 12/13
Well-established use Traditional use
collapse, anaphylactic shock) following mucosal
contact with liquid chamomile preparations 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.Original-PDF · Seite 12–13 ↗Dokumentfassung nachweisen
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Importstand: 27.10.2026 · Aktuelles EMA-Quellenprofil ↗
Dokumente beim Herausgeber · 11
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 Matricariae flos
- Call for submission of scientific data relating to the assessment of Matricariae aetheroleum; Matricaria recutita L. (Chamomilla recutita L. Rauschert), aetheroleum (Matricaria oil) - First version
- Overview of comments received on European Union herbal monograph on Matricaria recutita L., flos - First version
- Draft Community herbal monograph on Matricaria recutita L., flos - First version
- Final European Union herbal monograph on Matricaria recutita L., flos - First version
- Opinion of the HMPC on a European Union herbal monograph on Matricaria recutita L., flos - First version
- Draft list of references supporting the assessment of Matricaria recutita L., flos and Matricaria recutita L., aetheroleum - First version
- Final list of references supporting the assessment of Matricaria recutita L., flos and Matricaria recutita L., aetheroleum - First version
- Draft assessment report on Matricaria recutita L., flos and Matricaria recutita L., aetheroleum - First version
- Final assessment report on Matricaria recutita L., flos and Matricaria recutita L., aetheroleum - First version
- Matricaria flower - Summary for the public
Dokumentenlinks geprüft: 27.10.2026
Quellenstand & Originalangaben
- Originalstatus
- F: Assessment finalised
- Zuletzt geändert laut EMA
- 15/02/2022
- Erstveröffentlichung laut EMA
- 31/12/2009
- Erfolgreicher Quellenabruf
- 27.10.2026