14 May 2013
EMA/HMPC/196745/2012
Committee on Herbal Medicinal Products (HMPC)
Community herbal monograph on
Melissa officinalis
L.,
folium
Final
Initial assessment
Discussion in Working Party on Community monographs and Community
list (MLWP)
Adoption by Committee on Herbal Medicinal Products (HMPC) for release
for consultation
End of consultation (deadline for comments)
Rediscussion in MLWP
Adoption by Committee on Herbal Medicinal Products (HMPC)
Monograph (EMEA/HMPC/5341/2007)
AR (EMEA/HMPC/5342/2007)
List of references (EMEA/HMPC/207739/2007)
Overview of comments received during the public consultation
(EMEA/HMPC/499295/2007)
HMPC Opinion (EMEA/HMPC/453710/2007)
First systematic review
Discussion in MLWP
May 2012
January 2013
March 2013
Adoption by HMPC for release for consultation
End of consultation (deadline for comments)
Rediscussion in MLWP
Adoption by HMPC
N/A
N/A
N/A
14 May 2013
March 2007
May 2007
8 May 2007
15 August 2007
October 2007
31 October 2007
A search for the versions adopted in September 2007 can be made via the EMA document search
function, using the documents’ reference number, at:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/document_library/landing/document_library_se
arch.jsp&mid=
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© European Medicines Agency, 2013. Reproduction is authorised provided the source is acknowledged.
  melissa-officinalis-l-folium_final-community-herbal-monograph-en 2013
Keywords
Herbal medicinal products; HMPC; Community herbal monographs; traditional
use;
Melissa officinalis
L., folium; Melissae folium; Melissa leaf
BG (bălgarski): Маточина, лист
CS (čeština): meduňková nať
DA (dansk): Citronmelisseblad
DE (Deutsch): Melissenblätter
EL (elliniká): φύλλο μελίσσης
EN (English): Melissa leaf
ES (espanol): Melisa, hoja de
ET (eesti keel): melissileht
FI (suomi): sitruunamelissa, lehti
FR (français): Mélisse (feuille de)
HU (magyar): Citromfűlevél
IT (italiano): Melissa foglia
LT (lietuvių kalba): Melisų lapai
LV (latviešu valoda): Melisas lapas
MT (malti): Werqa tal-Buriħa / Melissa
NL (nederlands): Citroenmelisse
PL (polski): Liść melisy
PT (português): Melissa, folha
RO (română): frunză de roiniţă
SK (slovenčina): Medovkový list
SL (slovenščina): list navadne melise
SV (svenska): Citronmeliss, blad
IS (íslenska):
NO (norsk):
Sitronmelisseblad
Community herbal monograph on
Melissa officinalis
L., folium
EMA/HMPC/196745/2012
Page 2/7
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Community herbal monograph on
Melissa officinalis
L., folium
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
Melissa officinalis
L., folium (Melissa leaf)
i) Herbal substance
Not applicable.
ii) Herbal preparations
a) Comminuted herbal substance
b) Powdered herbal substance
c)
Liquid extract (DER 1:1), extraction
solvent ethanol 45-53% V/V
d) Tincture (ratio of herbal substance to
extraction solvent 1:5), extraction solvent
ethanol 45-53% V/V
e) Dried water or ethanol (45-53% V/V) extracts
corresponding to the tea, liquid extract and
tincture above.
3. Pharmaceutical form
Well-established use
Traditional use
Comminuted herbal substance as herbal tea for
oral use.
Herbal preparations in solid or liquid dosage forms
for oral use.
The pharmaceutical form should be described by
the European Pharmacopoeia full standard term.
The material complies with the Ph. Eur. monograph (ref. 01/2011:1447).
The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal
quality guidance.
2
1
Community herbal monograph on
Melissa officinalis
L., folium
EMA/HMPC/196745/2012
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  melissa-officinalis-l-folium_final-community-herbal-monograph-en 2013
4. Clinical particulars
4.1. Therapeutic indications
Well-established use
Traditional use
Indication 1)
Traditional herbal medicinal product for relief of
mild symptoms of mental stress and to aid sleep.
Indication 2)
Traditional herbal medicinal product for
symptomatic treatment of mild gastrointestinal
complaints including bloating and flatulence.
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
3
Well-established use
Traditional use
Posology
Indications 1) and 2)
Adolescents over 12 years of age, adults and
elderly
Single dose
a) Herbal tea: 1.5-4.5 g of the comminuted herbal
substance in 150 ml of boiling water as a herbal
infusion, 1-3 times daily.
b) Powdered herbal substance: 0.19-0.55 g,
2-3 times daily.
c) Liquid extract: 2-4 ml, 1-3 times daily.
d) Tincture: 2-6 ml, 1-3 times daily.
e) Dried water or ethanol (45-53% V/V) extracts
in doses corresponding to the posologies for tea,
liquid extract and tincture above.
The use in children under 12 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 2 weeks
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).
Community herbal monograph on
Melissa officinalis
L., folium
EMA/HMPC/196745/2012
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3
  melissa-officinalis-l-folium_final-community-herbal-monograph-en 2013
Well-established use
Traditional use
during the use of the medicinal product, a doctor
or a qualified health care practitioner should be
consulted.
Method of administration
Oral use.
4.3. Contraindications
Well-established use
Traditional use
Hypersensitivity to the active substance.
4.4. Special warnings and precautions for use
Well-established use
Traditional use
Indication 1) and 2)
The 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
medicinal product, a doctor or a qualified health
care practitioner should be consulted.
For tinctures and liquid 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.
4.5. Interactions with other medicinal products and other forms of
interaction
Well-established use
Traditional use
No data available.
4.6. Fertility, pregnancy and lactation
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.
Community herbal monograph on
Melissa officinalis
L., folium
EMA/HMPC/196745/2012
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4.7. Effects on ability to drive and use machines
Well-established use
Traditional use
May impair ability to drive and use machines.
Affected patients should not drive or operate
machinery.
4.8. Undesirable effects
Well-established use
Traditional use
None known.
If adverse reactions occur, a doctor or a qualified
health care practitioner should be consulted.
4.9. Overdose
Well-established use
Traditional use
No case of overdose has been reported.
5. Pharmacological properties
5.1. Pharmacodynamic properties
Well-established use
Traditional use
Not required as per Article 16c(1)(a)(iii) of
Directive 2001/83/EC as amended.
5.2. Pharmacokinetic properties
Well-established use
Traditional use
Not required as per Article 16c(1)(a)(iii) of
Directive 2001/83/EC as amended.
5.3. Preclinical safety data
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.
Data from
in vitro
and animal studies indicate that
the water extract of
Melissa officinalis
L., folium
may inhibit the activity of thyroid stimulating
hormone (TSH). The clinical relevance of these
Community herbal monograph on
Melissa officinalis
L., folium
EMA/HMPC/196745/2012
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Well-established use
Traditional use
findings is not known.
Adequate tests on genotoxicity have not been
performed.
Tests on reproductive toxicity and carcinogenicity
have not been performed.
6. Pharmaceutical particulars
Well-established use
Traditional use
Not applicable.
7. Date of compilation/last revision
14 May 2013
Community herbal monograph on
Melissa officinalis
L., folium
EMA/HMPC/196745/2012
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