# Commission Decision of 21 November 2008 establishing of a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (notified under document number C(2008) 6933) (Text with EEA relevance) (2008/911/EC)

EU Decision 2008/911 · adopted 21 November 2008

Commission Decision of 21 November 2008 establishing of a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (notified under document number C(2008) 6933) (Text with EEA relevance) (2008/911/EC)

## Introductory text

Commission Decision
of 21 November 2008
establishing of a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products
(notified under document number C(2008) 6933)
(Text with EEA relevance)
(2008/911/EC)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, and in particular Article 16(f) thereof,
Having regard to the opinions of the European Medicines Agency, formulated on 7 September 2007 by the Committee for Herbal Medicinal Products,
Whereas:
(1)
Foeniculum vulgare Miller subsp. vulgare var. vulgare and Foeniculum vulgare Miller subsp. vulgare var. dulce (Miller) Thellung comply with the requirements set out in Directive 2001/83/EC. Foeniculum vulgare Miller subsp. vulgare var. vulgare and Foeniculum vulgare Miller subsp. vulgare var. dulce (Miller) Thellung can be considered as herbal substances, herbal preparations and/or combinations thereof.
(2)
It is therefore appropriate to establish a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products including the entry of Foeniculum vulgare Miller subsp. vulgare var. vulgare and the entry of Foeniculum vulgare Miller subsp. vulgare var. dulce (Miller) Thellung.
(3)
The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Medicinal Products for Human Use,
HAS ADOPTED THIS DECISION:

## 1 

A list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products is established in Annex I.

## 2 

The indications, the specified strengths and the posology, the route of administration and any other information necessary for the safe use of the herbal substance as a traditional medicinal product relevant for the herbal substances listed in Annex I are set out in Annex II.

## 3 

This Decision is addressed to the Member States.

## Annex I List of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products established in accordance with Article 16f of Directive 2001/83/EC as amended by Directive 2004/24/EC

Calendula officinalis L
Echinacea purpurea (L.) Moench
Eleutherococcus senticosus (Rupr. et Maxim.) Maxim
Foeniculum vulgare Miller subsp. vulgare var. vulgare (bitter fennel fruit)
Foeniculum vulgare Miller subsp. vulgare var. dulce (Miller) Thellung (sweet fennel fruit)
Hamamelis virginiana L., folium et cortex aut ramunculus destillatum
Melaleuca alternifolia (Maiden and Betch) Cheel, M. linariifolia Smith, M. dissitiflora F. Mueller and/or other species of Melaleuca , aetheroleum
Mentha x piperita L.
Pimpinella anisum L
Sideritis scardica Griseb., herba.
Thymus vulgaris L., Thymus zygis Loefl. ex L., aetheroleum
Valeriana officinalis L.
Vitis vinifera L., folium

### Division: COMMUNITY LIST ENTRY ON CALENDULA OFFICINALIS L

## Scientific name of the plant

Calendula officinalis L.

## Botanical family

Asteraceae

## Herbal substance

Calendula flower

## Common name in all EU official languages of herbal substance

BG (bălgarski): Невен, цвят
CS (čeština): Měsíčkový květ
DA (dansk): Morgenfrueblomst
DE (Deutsch): Ringelblumenblüten
EL (elliniká): Άνθος καλέντουλας
EN (English): Calendula flower
ES (español): Flor de caléndula
ET (eesti keel): Saialilleõisik
FI (suomi): Tarhakehäkukan kukka
FR (français): Souci
HU (magyar): A körömvirág virága
IT (italiano): Calendula fiore
LT (lietuvių kalba): Medetkų žiedai
LV (latviešu valoda): Kliņģerītes ziedi
MT (malti): Fjura calendula
NL (nederlands): Goudsbloem
PL (polski): Kwiat nagietka
PT (português): Flor de calêndula
RO (română): Floare de gălbenele (calendula)
SK (slovenčina): Nechtíkový kvet
SL (slovenščina): Cvet vrtnega ognjiča
SV (svenska): Ringblomma, blomma
IS (íslenska): Morgunfrú, blóm
NO (norsk): Ringblomst

### Division: Herbal preparation(s)

## A 

Liquid extract (DER 1:1), extraction solvent ethanol 40-50 % (v/v).

## B 

Liquid extract (DER 1:1,8-2,2), extraction solvent ethanol 40-50 % (v/v).

## C 

Tincture (DER 1:5), extraction solvent ethanol 70-90 % (v/v).

## European Pharmacopoeia monograph reference

Calendula flower – Calendulae flos (01/2005:1297)

## Indication(s)

The product is a traditional herbal medicinal product for use in specified indications exclusively based upon long-standing use.

## (a) 

Traditional herbal medicinal product for the symptomatic treatment of minor inflammations of the skin (such as sunburn) and as an aid in healing of minor wounds.

## (b) 

Traditional herbal medicinal product for the symptomatic treatment of minor inflammations in the mouth or the throat.

## Type of tradition

European

## Specified strength

Please see ‘ Specified posology ’ .

## Specified posology

Herbal preparations:
A.. Liquid extract (DER 1:1)
In semi-solid dosage forms: amount equivalent to 2-10 % herbal substance.
B.. Liquid extract (DER 1:1,8-2,2)
In semi-solid dosage forms: amount equivalent to 2-5 % herbal substance.
C.. Tincture (DER 1:5)
In compresses diluted at least 1:3 with freshly boiled water.
In semi-solid dosage forms: amount equivalent to 2-10 % herbal substance.
As a gargle or mouth rinse in a 2 % solution.
2 to 4 times daily
Indication (a)
The use is not recommended in children under 6 years of age (see below ‘ Special warnings and precautions for use ’ ).
Indication (b)
The use in children under 12 years of age is not recommended because there is no experience available (see below ‘ Special warnings and precautions for use ’ ).

## Route of administration

Cutaneous and oromucosal use.

## Duration of use or any restrictions on the duration of use

Compresses: remove after 30-60 minutes
All herbal preparations: If the symptoms persist after 1 week during the use of the medicinal product a doctor or a qualified health care practitioner should be consulted.

### Division: Any other information necessary for the safe use

## Contraindications

Hypersensitivity to members of the Asteraceae ( Compositae ) family.

## Special warnings and precautions for use

Indication (a)
The use in children under 6 years of age is not recommended because there is no experience available.
Indication (b)
The use in children under 12 years of age is not recommended because there is no experience available.
If signs of skin infection are observed, a doctor or a qualified health care practitioner should be consulted.

## Interactions with other medicinal products and other forms of interaction

None reported.

## Pregnancy and lactation

Safety during pregnancy and lactation has not been established.
In the absence of sufficient data, the use during pregnancy and lactation is not recommended.

## Effects on ability to drive and use machines

Not relevant.

## Undesirable effects

Skin sensitisation. The frequency is not known.
If other adverse reactions not mentioned above occur, a doctor or a qualified health care practitioner should be consulted.

## Overdose

None reported.

### Division: COMMUNITY LIST ENTRY ON ECHINACEA PURPUREA (L.) MOENCH, HERBA RECENS

## Scientific name of the plant

Echinacea purpurea (L.) Moench

## Botanical family

Asteraceae

## Herbal substance

Purple coneflower herb

## Common name in all EU official languages of herbal substance

BG (bălgarski): пурпурна ехинацея, пресен стрък
CS (čeština): čerstvá nať třapatky nachové
DA (dansk): Purpursolhat, frisk urt
DE (Deutsch): Purpursonnenhutkraut, frisch
EL (elliniká): Πόα Εχινάκεας της πορφυράς
EN (English): purple coneflower herb
ES (español): Equinácea purpúrea, partes aéreas incluidas sumidades floridas
ET (eesti keel): punane siilkübar
FI (suomi): kaunopunahattu, tuore verso
FR (français): parties aériennes fraîches d’échinacée pourpre
HU (magyar): bíbor kasvirág virágos hajtása
IT (italiano): Echinacea purpurea, pianta fresca
LT (lietuvių kalba): rausvažiedžių ežiuolių žolė
LV (latviešu valoda): purpursarkanās ehinacejas laksti
MT (malti): Echinacea Vjola
NL (nederlands): rood zonnehoedkruid
PL (polski): jeżówka purpurowa, świeże ziele
PT (português): Equinácea, partes aéreas floridas
RO (română): iarbã proaspãtã de Echinacea, pãlãria soarelui
SK (slovenčina): echinacea purpurová, čerstvá vňať
SL (slovenščina): sveža zel škrlatne ehinaceje
SV (svenska): röd solhatt, färsk ört
IS (íslenska): Sólhattur
NO (norsk): Rød solhatt

## Herbal preparation(s)

Expressed juice and dried expressed juice from fresh flowering aerial parts.

## European Pharmacopoeia monograph reference

N/A

## Indication(s)

Traditional herbal medicinal product for treatment of small superficial wounds.
The product is a traditional herbal medicinal product for use in a specified indication exclusively based on long-standing use.

## Type of tradition

European.

## Specified strength

10 to 20 g/100 g of expressed juice or equivalent amount of dried expressed juice in liquid or semi-solid dosage forms.

## Specified posology

Adolescents over the age of 12 years, adults, elderly
Small amount of ointment is applied on the affected area 2-3 times a day.
The use in children under 12 years of age is not recommended (see below ‘ Special warnings and precautions for use ’ ).

## Route of administration

Cutaneous use.

## Duration of use or any restrictions on the duration of use

Do not use the medicinal product for more than 1 week.
If the symptoms persist during the use of the medicinal product, a doctor or a qualified healthcare practitioner should be consulted.

### Division: Any other information necessary for the safe use

## Contra-indications

Hypersensitivity to the active substance or to plants of the Asteraceae (Compositae) family.

## Special warnings and precautions for use

If signs of skin infection are observed, medical advice should be sought.
The use in children below 12 years of age is not recommended because a safe use has not been sufficiently documented.

## Interactions with other medicinal products and other forms of interaction

None reported.

## Pregnancy and lactation

There are no data on cutaneous use during pregnancy or lactation.
Products containing Echinacea should not be applied to the breast of breastfeeding women.

## Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed.

## Undesirable effects

Hypersensitive reactions (local rash, contact dermatitis, eczema and angioedema of the lips) may occur.
The frequency is not known.
If other adverse reactions not mentioned above occur, a doctor or a qualified healthcare practitioner should be consulted.

## Overdose

No case of overdose has been reported.

### Division: COMMUNITY LIST ENTRY ON ELEUTHEROCOCCUS SENTICOSUS (RUPR. ET MAXIM.) MAXIM., RADIX

## Scientific name of the plant

Eleutherococcus senticosus (Rupr. et Maxim.) Maxim.

## Botanical family

Araliaceae

## Herbal substance

Eleutherococcus root

## Common name in all EU official languages of herbal substance

BG (bălgarski): елеутерокок, корен
CS (čeština): eleuterokokový kořen
DA (dansk): Russisk rod
DE (Deutsch): Taigawurzel
EL (elliniká): Pίζα Eλευθεροκόκκου
EN (English): Eleutherococcus root
ES (español): Eleuterococo, raíz de
ET (eesti keel): eleuterokokijuur
FI (suomi): venäjänjuuren juuri
FR (français): racine d’éleuthérocoque (racine de ginseng sibérien)
HR (hrvatska): Korijen sibirskog ginsenga
HU (magyar): Szibériai ginszeng gyökér (tajga gyökér)
IT (italiano): Eleuterococco radice
LT (lietuvių kalba): Eleuterokokų šaknys
LV (latviešu valoda): Eleiterokoka sakne
MT (malti): Għerq ta’ l-elewterokokku
NL (nederlands): Russische ginsengwortel
PL (polski): korzeń eleuterokoka
PT (português): Raiz de Ginseng Siberiano
RO (română): Rădăcină de ginseng siberian
SK (slovenčina): Koreň eleuterokoka
SL (slovenščina): korenina elevterokoka
SV (svenska): Rysk rot
IS (íslenska): Síberíu ginseng, rót
NO (norsk): Russisk rot

## Herbal preparation(s)

Comminuted herbal substance
Liquid extract (DER 1:1, extraction solvent ethanol 30-40 % v/v)
Dry extract (DER 13-25:1, extraction solvent ethanol 28-40 % v/v)
Dry extract (17-30: 1, ethanol 70 % v/v)
Dry aqueous extract (DER 15-17:1)
Tincture (ratio of herbal substance to extraction solvent 1:5, extraction solvent ethanol 40 % v/v)

## European Pharmacopoeia monograph reference

Eleutherococcus — Eleutherococci radix (ref.: 01/2008: 1419 corrected 7.0 )

## Indication(s)

Traditional herbal medicinal product for symptoms of asthenia such as fatigue and weakness.
The product is a traditional herbal medicinal product for use in specified indications exclusively based upon long-standing use.

## Type of tradition

European, Chinese.

## Specified strength

Please see ‘ Specified posology ’ .

## Specified posology

Adolescents over 12 years of age , adults, elderly
Herbal preparations.
Average daily dose.
Comminuted herbal substance as herbal tea: 0,5-4 g.
Tea preparation: 0,5 to 4 g of comminuted herbal substance for infusion in 150 ml of boiling water.
Dosage frequency: 150 ml of tea infusion should be divided in one to three doses taken during the day.
Liquid extract: 2-3 ml.
Dry extracts (ethanol 28-70 % v/v) corresponding to 0,5-4 g dried root.
Dry aqueous extract (15-17:1): 90-180 mg.
Tincture: 10-15 ml.
The daily dose can be taken in one to three doses.
The use in children under 12 years of age is not recommended (see below ‘Special warnings and precautions for use’).

## Route of administration

Oral use.

## Duration of use or any restrictions on the duration of use

Not to be taken for more than 2 months.
If the symptoms persist for more than 2 weeks during the use of the medicinal product, a doctor or a qualified healthcare practitioner should be consulted.

### Division: Any other information necessary for the safe use

## Contraindication

Hypersensitivity to the active substance.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

## Special warnings and precautions for use

The use in children under 12 years of age is not recommended due to lack of adequate data.
If the symptoms worsen during the use of the medicinal product, a doctor or a qualified healthcare practitioner should be consulted. For tinctures and 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.

## Interactions with other medicinal products and other forms of interaction

None reported.

## Fertility, pregnancy and lactation

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.

## Effects on ability to drive and use machines

No studies on the effect on the ability to drive and use machines have been performed.

## Undesirable effects

Insomnia, irritability, tachycardia and headaches may occur. The frequency is not known. If other adverse reactions not mentioned above occur, a doctor or a qualified health care practitioner should be consulted.

## Overdose

No case of overdose has been reported.

## Pharmaceutical particulars (if necessary)

Not applicable.

## Pharmacological effects or efficacy plausible on the basis of long-standing use and experience (if necessary for the safe use of the product)

Not applicable.

### Division A: COMMUNITY LIST ENTRY ON FOENICULUM VULGARE MILLER SUBSP. VULGARE VAR. VULGARE, FRUCTUS

## Scientific name of the plant

Foeniculum vulgare Miller subsp. vulgare var. vulgare

## Botanical family

Apiaceae

## Herbal substance

Fennel, bitter

## Common name in all EU official languages of herbal substance

BG (bălgarski): Горчиво резене, плод
CS (čeština): Plod fenyklu obecného pravého
DA (dansk): Fennikel, bitter
DE (Deutsch): Bitterer Fenchel
EL (elliniká): Μαραθόσπορος πικρός
EN (English): Bitter fennel, fruit
ES (español): Hinojo amargo, fruto de
ET (eesti keel): Mõru apteegitill, vili
FI (suomi): Karvasfenkoli, hedelmä
FR (français): Fruit de fenouil amer
HU (magyar): Keserűédeskömény-termés
IT (italiano): Finocchio amaro (o selvatico), frutto
LT (lietuvių kalba): Karčiųjų pankolių vaisiai
LV (latviešu valoda): Rūgtā fenheļa augļi
MT (malti): Bużbież morr, frotta
NL (nederlands): Venkelvrucht, bitter
PL (polski): Owoc kopru włoskiego (odmiana gorzka)
PT (português): Fruto de funcho amargo
RO (română): Fruct de fenicul amar
SK (slovenčina): Feniklový plod horký
SL (slovenščina): Plod grenkega navadnega komarčka
SV (svenska): Bitterfänkål, frukt
IS (íslenska): Bitur fennel aldin
NO (norsk): Fenikkel, bitter

## Herbal preparation(s)

Fennel, bitter, dried comminuted fruit.

## European Pharmacopoeia monograph reference

Foeniculi amari fructus (01/2005:0824).

## Indication(s)

(a) Traditional herbal medicinal product for symptomatic treatment of mild, spasmodic gastro-intestinal complaints including bloating and flatulence.
(b) Traditional herbal medicinal product for symptomatic treatment of minor spasm associated with menstrual periods.
(c) Traditional herbal medicinal product used as an expectorant in cough associated with cold.
The product is a traditional herbal medicinal product for use in specified indications exclusively based upon long-standing use.

## Type of tradition

European, Chinese.

## Specified strength

Please see ‘Specified posology’.

### Division: Specified posology

## Adults

Single dose
1,5 to 2,5 g of (freshly) comminuted fennel fruits with 0,25 l of boiling water (brew for 15 minutes) three times daily as a herbal tea.

## Adolescents over 12 years of age, indication (a)

Adult dose

## Children between four and 12 years of age, indication (a)

Average daily dose
3-5 g of (freshly) comminuted fruits as a herbal tea, in three divided doses, for short-term use in mild transitory symptoms only (less than one week).
The use in children under four years of age is not recommended (see section ‘Special warnings and precautions for use’).

## Route of administration

Oral use.

### Division: Duration of use or any restrictions on the duration of use

### Division: Adults

## Adolescents over 12 years of age, indication (a)

Not to be taken for more than two weeks.

## Children between four and 12 years of age, indication (a)

For short-term use in mild transitory symptoms only (less than one week).
If the symptoms persist during the use of the medicinal product, a doctor or a qualified health-care practitioner should be consulted.

### Division: Any other information necessary for the safe use

## Contraindications

Hypersensitivity to the active substance or to Apiaceae (Umbelliferae) (aniseed, caraway, celery, coriander and dill) or to anethole.

## Special warnings and precautions for use

The use in children under four years of age is not recommended due to the lack of adequate data and a paediatrician’s advice should be sought.

## Interactions with other medicinal products and other forms of interaction

None reported.

## Pregnancy and lactation

There are no data from the use of fennel fruit in pregnant patients.
It is unknown if fennel constituents are excreted in human breast milk.
In the absence of sufficient data, the use during pregnancy and lactation is not recommended.

## Effects on ability to drive and use machines

No studies on the effect on the ability to drive and use machines have been performed.

## Undesirable effects

Allergic reactions to fennel, affecting the skin or the respiratory system may occur. The frequency is not known.
If other adverse reactions not mentioned above occur, a doctor or a qualified health-care practitioner should be consulted.

## Overdose

No case of overdose has been reported.

## Pharmaceutical particulars (if necessary)

Not applicable.

## Pharmacological effects or efficacy plausible on the basis of long-standing use and experience (if necessary for the safe use of the product)

Not applicable.

### Division B: COMMUNITY LIST ENTRY ON FOENICULUM VULGARE MILLER SUBSP. VULGARE VAR. DULCE (MILLER) THELLUNG, FRUCTUS

## Scientific name of the plant

Foeniculum vulgare Miller subsp. vulgare var. dulce (Miller) Thellung

## Botanical family

Apiaceae

## Herbal substance

Fennel, sweet

## Common name in all EU official languages of herbal substance

BG (bălgarski): Сладко резене, плод
CS (čeština): Plod fenyklu obecného sladkého
DA (dansk): Fennikel, sød
DE (Deutsch): Süßer Fenchel
EL (elliniká): Μαραθόσπορος γλυκύς
EN (English): Sweet fennel, fruit
ES (español): Hinojo dulce, fruto de
ET (eesti keel): Magus apteegitill, vili
FI (suomi): Makea fenkoli, hedelmä
FR (français): Fruit de fenouil doux
HU (magyar): Édesköménytermés
IT (italiano): Finocchio dolce (o romano), frutto
LT (lietuvių kalba): Saldžiųjų pankolių vaisiai
LV (latviešu valoda): Saldā fenheļa augļi
MT (malti): Bużbież ħelu, frotta
NL (nederlands): Venkelvrucht, zoet
PL (polski): Owoc kopru włoskiego (odmiana słodka)
PT (português): Fruto de funcho doce
RO (română): Fruct de fenicul dulce
SK (slovenčina): Feniklový plod sladký
SL (slovenščina): Plod sladkega navadnega komarčka
SV (svenska): Sötfänkål, frukt
IS (íslenska): Sæt fennel aldin
NO (norsk): Fenikkel, søt

## Herbal preparation(s)

Fennel, sweet, dried comminuted or powdered fruit.

## European Pharmacopoeia monograph reference

Foeniculi dulcis fructus (01/2005:0825).

## Indication(s)

(a) Traditional herbal medicinal product for symptomatic treatment of mild, spasmodic gastro-intestinal complaints including bloating and flatulence.
(b) Traditional herbal medicinal product for symptomatic treatment of minor spasm associated with menstrual periods.
(c) Traditional herbal medicinal product used as an expectorant in cough associated with cold.
The product is a traditional herbal medicinal product for use in specified indications exclusively based upon long-standing use.

## Type of tradition

European, Chinese.

## Specified strength

Please see ‘Specified posology’.

### Division: Specified posology

## Adults

Single dose
1,5 to 2,5 g of (freshly) comminuted fennel fruits with 0,25 l of boiling water (brew for 15 minutes) three times daily as a herbal tea.
Fennel powder: 400 mg three times a day (with a maximum of 2 g daily).

## Adolescents over 12 years of age, indication (a)

Adult dose

## Children between four and 12 years of age, indication (a)

Average daily dose
3-5 g of (freshly) comminuted fruits as a herbal tea, in three divided doses, for short-term use in mild transitory symptoms only (less than one week).
The use in children under four years of age is not recommended (see section ‘Special warnings and precautions for use’).

## Route of administration

Oral use.

### Division: Duration of use or any restrictions on the duration of use

### Division: Adults

## Adolescents over 12 years of age, indication (a)

Not to be taken for more than two weeks.

## Children between four and 12 years of age, indication (a)

For short-term use in mild transitory symptoms only (less than one week).
If the symptoms persist during the use of the medicinal product, a doctor or a qualified health-care practitioner should be consulted.

### Division: Any other information necessary for the safe use

## Contraindications

Hypersensitivity to the active substance or to Apiaceae (Umbelliferae) (aniseed, caraway, celery, coriander and dill) or to anethole.

## Special warnings and precautions for use

The use in children under four years of age is not recommended due to the lack of adequate data and a paediatrician’s advice should be sought.

## Interactions with other medicinal products and other forms of interaction

None reported.

## Pregnancy and lactation

There are no data from the use of fennel fruit in pregnant patients.
It is unknown if fennel constituents are excreted in human breast milk.
In the absence of sufficient data, the use during pregnancy and lactation is not recommended.

## Effects on ability to drive and use machines

No studies on the effect on the ability to drive and use machines have been performed.

## Undesirable effects

Allergic reactions to fennel, affecting the skin or the respiratory system, may occur. The frequency is not known.
If other adverse reactions not mentioned above occur, a doctor or a qualified health-care practitioner should be consulted.

## Overdose

No case of overdose has been reported.

## Pharmaceutical particulars (if necessary)

Not applicable.

## Pharmacological effects or efficacy plausible on the basis of long-standing use and experience (if necessary for the safe use of the product)

Not applicable.

### Division: COMMUNITY LIST ENTRY ON HAMAMELIS VIRGINIANA L., FOLIUM ET CORTEX AUT RAMUNCULUS DESTILLATUM

## Scientific name of the plant

Hamamelis virginiana L.

## Botanical family

Hamamelidaceae

## Herbal preparation(s)

1.. Distillate prepared from fresh leaves and bark (1:1.12 – 2.08; extraction solvent ethanol 6 % m/m)
2.. Distillate prepared from dried twigs (1:2; extraction solvent ethanol 14-15 %)

## European pharmacopoeia monograph reference

Not applicable

### Division: Indication(s)

## Indication (a)

Traditional herbal medicinal product for relief of minor skin inflammation and dryness of the skin.

## Indication (b)

Traditional herbal medicinal product to be used for the temporary relief of eye discomfort due to dryness of the eye or to exposure to wind or sun.
The product is a traditional herbal medicinal product for use in specified indications exclusively based upon long-standing use.

## Type of tradition

European

## Specified strength

Please see ‘ Specified posology ’ .

### Division: Specified posology

### Division: Children over six years of age, adolescents, adults and elderly

## Indication (a)

Distillate in a strength corresponding to 5-30 % in semi-solid preparations, several times daily.
The use in children under six years of age is not recommended (see section ‘ Special warnings and precautions for use ’ ).

### Division: Adolescents, adults and elderly

## Indication (b)

Eye drops Distillate (2) diluted (1:10), 2 drops/each eye, 3-6 times daily.
The use in children under 12 years of age is not recommended (see section ‘ Special warnings and precautions for use ’ ).

## Route of administration

Cutaneous use.
Ocular use.

### Division: Duration of use or any restrictions on the duration of use

### Division: Children over six years of age, adolescents, adults and elderly

## Indication (a)

If the symptoms persist longer than two weeks during the use of the medicinal product, a doctor or a qualified healthcare practitioner should be consulted.

### Division: Adolescents, adults and elderly

## Indication (b)

The recommended duration of use is four days. If the symptoms persist longer than two days during the use of the medicinal product, a doctor or a qualified healthcare practitioner should be consulted.

### Division: Any other information necessary for the safe use

## Contraindications

Hypersensitivity to the active substance.

### Division: Special warnings and precautions for use

## Indication (a)

The use in children under six years of age has not been established due to lack of adequate data.

## Indication (b)

If eye pain, changes in vision, continued redness, or irritation of the eye is experienced, or if the condition worsens or persists for more than 48 hours during the use of the medicinal product, a doctor or a qualified healthcare practitioner should be consulted.
The use in children under 12 years of age has not been established due to lack of adequate data.
For 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.

## Interactions with other medicinal products and other forms of interaction

None reported.

## Pregnancy and lactation

Safety during pregnancy and lactation has not been established. In the absence of sufficient data, the use during pregnancy and lactation is not recommended.

## Effects on ability to drive and use machines

No studies on the effect on the ability to drive and use machines have been performed.

### Division: Undesirable effects

## Indication (a)

Allergic contact dermatitis may occur in sensitive patients. The frequency is not known.

## Indication (b)

Conjunctivitis cases have been reported. The frequency is not known.
If other adverse reactions not mentioned above occur, a doctor or a qualified healthcare practitioner should be consulted.

## Overdose

No case of overdose has been reported.

## Pharmaceutical particulars [if necessary]

Not applicable.

## Pharmacological effects or efficacy plausible on the basis of long-standing use and experience [if necessary for the safe use of the product]

Not applicable.

### Division: UNION LIST ENTRY ON MELALEUCA ALTERNIFOLIA (MAIDEN AND BETCH) CHEEL, M. LINARIIFOLIA SMITH, M. DISSITIFLORA F. MUELLER AND/OR OTHER SPECIES OF MELALEUCA , AETHEROLEUM

## Scientific name of the plant

Melaleuca alternifolia (Maiden and Betch) Cheel, M. linariifolia Smith, M. dissitiflora F. Mueller and other species of Melaleuca

## Botanical family

Myrtaceae

## Common name in all EU official languages of herbal preparation

BG (bălgarski): Чаено дърво, масло
CS (čeština): silice kajeputu střídavolistého
DA (dansk): Tetræolie
DE (Deutsch): Teebaumöl
EL (elliniká): Μελαλεύκης αιθέριο έλαιο
EN (English): Tea tree oil
ES (español): Melaleuca alternifolia, aceite esencial de
ET (eesti keel): teepuuõli
FI (suomi): teepuuöljy
FR (français): Mélaleuca (arbre à thé) (huile essentielle de)
HR (hrvatska): eteričnog ulje australijskog čajevca
HU (magyar): Teafa-olaj
IT (italiano): Melaleuca essenza
LT (lietuvių kalba): Arbatmedžių eterinis aliejus
LV (latviešu valoda): Tējaskoka ēteriskā eļļa
MT (Malti): Żejt tal-Melaleucae
NL (Nederlands): Theeboomolie
PL (polski): Olejek eteryczny drzewa herbacianego
PT (português): Óleo esencial de melaleuca
RO (română): Melaleuca (arbore de ceai) (ulei esențial)
SK (slovenčina): Silica melaleuky
SL (slovenščina): eterično olje melalevke
SV (svenska): Teträdsolja
NO (norsk): Tetreolje

## Herbal preparation

Essential oil

## European Pharmacopoeia monograph reference

01/2008:1837

### Division: Indications

## Indication (a)

Traditional herbal medicinal product for treatment of small superficial wounds and insect bites.

## Indication (b)

Traditional herbal medicinal product for treatment of small boils (furuncles and mild acne).

## Indication (c)

Traditional herbal medicinal product for the relief of itching and irritation in cases of mild athlete's foot.

## Indication (d)

Traditional herbal medicinal product for symptomatic treatment of minor inflammation of the oral mucosa.
The product is a traditional herbal medicinal product for use in specified indication exclusively based upon long-standing use.

## Type of tradition

European.

## Specified strength

Please see ‘ Specified posology ’ .

### Division: Specified posology

### Division: Indication (a)

### Division: Adolescents, adults and elderly

## Single dose

0,03-0,07 ml of undiluted essential oil to be applied to the affected area using a cotton bud 1-3 times daily.
Liquid preparations containing 0,5 % to 10 % of essential oil to be applied to the affected area 1-3 times daily.

### Division: Indication (b)

### Division: Adolescents, adults and elderly

## Single dose

Oily liquid or semi-solid preparations containing 10 % of essential oil to be applied to the affected area 1-3 times daily, or
0,7-1 ml of essential oil stirred into 100 ml of lukewarm water to be applied as an impregnated dressing to the affected areas of skin. Undiluted essential oil to be applied to the boil using a cotton bud 2-3 times daily.

### Division: Indication (c)

### Division: Adolescents, adults and elderly

## Single dose

Oily liquid or semi-solid preparations containing 10 % of essential oil to be applied on the affected area 1-3 times daily. 0,17-0,33 ml of essential oil in an appropriate volume of warm water to cover the feet. Soak feet for 5-10 minutes daily.
Undiluted essential oil to be applied to the affected area using a cotton bud 2-3 times daily.

### Division: Indication (d)

## Adolescents, adults and elderly

0,17-0,33 ml of essential oil to be mixed in 100 ml of water for rinse or gargle several times daily.
The use in children under 12 years of age is not recommended (see section ‘ Special warnings and precautions for use ’ ).

### Division: Route of administration

## Indications (a), (b) and (c)

Cutaneous use

## Indication (d)

Oromucosal use.

### Division: Duration of use or any restrictions on the duration of use

## Indication (a)

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.

## Indications (b) and (c)

Not to be used for more than 1 month.
If the symptoms persist during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.

## Indication (d)

If the symptoms persist longer than 5 days during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.

### Division: Any other information necessary for the safe use

## Contraindications

Hypersensitivity to the active substance or to colophony.

## Special warnings and precautions for use

The use in children under 12 years of age has not been established due to lack of adequate data.
If a rash develops, discontinue use.
Not to be used orally or as inhalation.
Not to be used in eyes or ears.
If the symptoms worsen during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.

## Indication (a)

If fever or signs of exacerbating skin infection are observed, a doctor or a qualified health care practitioner should be consulted.

## Indication (b)

In cases of severe acne a doctor or a qualified health care practitioner shall be consulted.

## Indication (c)

For the eradication of fungal infection a doctor or a qualified health care practitioner shall be consulted.

## Indication (d)

Not to be swallowed.

## Interactions with other medicinal products and other forms of interaction

None reported.

## Fertility, pregnancy and lactation

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.

## Effects on ability to drive and use machines

No studies on the effect on the ability to drive and use machines have been performed.

## Undesirable effects

Adverse skin reactions including smarting pain, mild pruritus, burning sensation, irritation, itching, stinging, erythema, oedema (contact dermatitis) or other allergic reactions have been reported. The frequency is not known.
Burn-like skin reactions have been reported. The frequency is rare (< 1/ 1 000 ).
If other adverse reactions not mentioned occur, a doctor or a qualified health care practitioner should be consulted.

## Overdose

Cutaneous use:
None reported.
Oromucosal use:
Accidental overdose may cause central nervous system depression and muscle weakness. However, in adults these symptoms generally resolve within 36 hours.
If ingestion occurs, the patient should be monitored and standard supportive treatment applied as required.
In children, ingestion of tea tree oil is a medical emergency requiring immediate hospital treatment and respiratory support.

## Pharmaceutical particulars (if necessary)

Store in air-tight containers, protected from light and heat.
Proper storage and handling are needed to avoid the formation of oxidation products which have greater potential for skin sensitisation.

## Pharmacological effects or efficacy plausible on the basis of long-standing use and experience (if necessary for the safe use of the product)

Not applicable.

### Division: COMMUNITY LIST ENTRY ON MENTHA x PIPERITA L., AETHEROLEUM

## Scientific name of the plant

Mentha x piperita L.

## Botanical family

Lamiaceae (Labiatae)

## Herbal preparation(s)

Peppermint oil essential oil obtained by steam distillation from the fresh aerial parts of the flowering plant

## European Pharmacopoeia monograph reference

Peppermint oil — Menthae piperitae aetheroleum (01/2008:0405)

## Indication(s)

Herbal medicinal product traditionally used:
1.. for the relief of symptoms in coughs and colds;
2.. for the symptomatic relief of localised muscle pain;
3.. for the symptomatic relief of localised pruritic conditions in intact skin.
The product is a traditional herbal medicinal product for use in specified indications exclusively based upon long-standing use.

## Type of tradition

European

### Division: Specified strength

## Indications 1, 2 and 3

Single dose

## Children between 4 to 10 years of age

Semi-solid preparations 2-10 %
Hydroethanolic preparations 2-4 %

## Children between 10 to 12 years of age, adolescents between 12 to 16 years of age

Semi-solid preparations 5-15 %
Hydroethanolic preparations 3-6 %

## Adolescents over 16 years of age, adults

Semi-solid and oily preparations 5-20 %
In aqueous-ethanol preparations 5-10 %
In nasal ointments 1-5 % essential oil.

## Specified posology

Up to three times daily
The use in children under 2 years of age is contraindicated (see ‘ Contraindications ’ ).
The use is not recommended in children between 2 to 4 years of age (see ‘ Special warnings and precautions for use ’ ).

## Route of administration

Cutaneous and transdermal.

### Division: Duration of use or any restrictions on the duration of use

## Indication 1

Not to be used for more than 2 weeks.

## Indications 2 and 3

It is not recommended to use the medicinal product continuously for more than 3 months.
If the symptoms persist during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.

### Division: Any other information necessary for the safe use

## Contraindications

Children under 2 years of age, because menthol can induce reflex apnoea and laryngospasm.
Children with history of seizures (febrile or not).
Hypersensitivity to peppermint oil or menthol.

## Special warnings and precautions for use

Eye contact with unwashed hands after the application of peppermint oil may potentially cause irritation.
Peppermint oil should not be applied on broken or irritated skin.
The use is not recommended in children between 2 to 4 years of age, as there is no sufficient experience available.

## Interactions with other medicinal products and other forms of interaction

None reported.

## Pregnancy and lactation

In the absence of sufficient data, the use during pregnancy and lactation is not recommended.

## Effects on ability to drive and use machines

No studies on the effect on the ability to drive and use machines have been performed.

## Undesirable effects

Hypersensitivity reactions such as skin rash, contact dermatitis, and eye irritation have been reported. These reactions are most of the time mild and transient. The frequency is not known.
Irritation of the skin and mucosa of the nose is possible, after local application. The frequency is not known.
If other adverse reactions not mentioned above occur, a doctor or a qualified health care practitioner should be consulted.

## Overdose

No case of overdose has been reported.

### Division: COMMUNITY LIST ENTRY ON PIMPINELLA ANISUM L

## Scientific name of the plant

Pimpinella anisum L.

## Botanical family

Apiaceae

## Herbal substance

Aniseed

## Common name in all EU official languages of herbal substance

BG (bălgarski): Анасон, плод
CS (čeština): Anýzový plod
DA (dansk): Anisfrø
DE (Deutsch): Anis
EL (elliniká): Γλυκάνισο
EN (English): Aniseed
ES (español): Fruto de anís
ET (eesti keel): Aniis
FI (suomi): Anis
FR (français): Anis (fruit d)
HU (magyar): Ánizsmag
IT (italiano): Anice (Anice verde), frutto
LT (lietuvių kalba): Anyžių sėklos
LV (latviešu valoda): Anīsa sēklas
MT (malti): Frotta tal-Anisi
NL (nederlands): Anijsvrucht
PL (polski): Owoc anyżu
PT (português): Anis
RO (română): Fruct de anason
SK (slovenčina): Anízový plod
SL (slovenščina): Plod vrtnega janeža
SV (svenska): Anis
IS (íslenska): Anís
NO (norsk): Anis

## Herbal preparation(s)

Dried aniseed, comminuted or crushed

## European Pharmacopoeia monograph reference

Anisi fructus (01/2005:0262)

## Indication(s)

The product is a traditional herbal medicinal product for use in specified indications exclusively based upon long-standing use.

## (a) 

Traditional herbal medicinal product for symptomatic treatment of mild, spasmodic gastro-intestinal complaints including bloating and flatulence.

## (b) 

Traditional herbal medicinal product used as an expectorant in cough associated with cold.

## Type of tradition

European

## Specified strength

Please see ‘ Specified posology ’

## Specified posology

Adolescents over 12 years of age, adults, elderly :
Indications (a) and (b)
1 to 3,5 g of whole or (freshly ) comminuted or crushed aniseed in 150 ml of boiling water as a herbal tea
3 times daily
The use in children under 12 years is not recommended of age (see below ‘ Special warnings and precautions for use ’ ).

## Route of administration

Oral use

## Duration of use or any restrictions on the duration of use

Not to be taken for more than 2 weeks.
If the symptoms persist during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.

### Division: Any other information necessary for the safe use

## Contraindications

Hypersensitivity to the active substance or to Apiaceae ( Umbelliferae ) (caraway, celery, coriander, dill and fennel) or to anethole.

## Special warnings and precautions for use

The use is not recommended in children under 12 years of age due to the lack of adequate data for safety assessment.

## Interactions with other medicinal products and other forms of interaction

None reported.

## Pregnancy and lactation

There are no data from the use of aniseed in pregnant patients.
It is unknown if aniseed constituents are excreted in human breast milk.
In the absence of sufficient data, the use during pregnancy and lactation is not recommended.

## Effects on ability to drive and use machines

No studies on the effect on the ability to drive and use machines have been performed.

## Undesirable effects

Allergic reactions to aniseed affecting the skin or the respiratory system may occur. The frequency is not known.
If other adverse reactions not mentioned above occur, a doctor or a qualified health care practitionerf should be consulted.

## Overdose

No case of overdose has been reported.

## UNION LIST ENTRY ON SIDERITIS SCARDIA GRISEB., HERBA

Scientific name of the plant
Sideritis scardica Griseb.
Botanical family
Lamiaceae (Labiatae)
Herbal substance
Ironwort ( Sideritis herba )
Common name in all EU official languages of herbal preparation
BG (bălgarski): Мурсалски чай, стрък
CS (čeština): nať hojníku
DA (dansk): Kortkroneurt
DE (Deutsch): Balkan-Gliedkraut
EL (elliniká): Πόα σιδηρίτου
EN (English): Ironwort
ES (español): Siderita, partes aéreas de
ET (eesti keel): haavarohuürt
FI (suomi): raudakki, verso
FR (français): Crapaudine (parties aériennes de)
HR (hrvatska): očistova zelen
HU (magyar): sármányvirág virágos hajtása
IT (italiano): Stregonia parti aeree fiorite
LT (lietuvių kalba): Timsrų žolė
LV (latviešu valoda): Siderītu laksts
MT (Malti): ħaxixa tas-Sideritis
NL (Nederlands): (Griekse) bergthee, kruid
PL (polski): Ziele gojnika
PT (português): Siderite, partes aéreas
RO (română): iarba de ceaiul muntelui cretan
SK (slovenčina): Vňať ránhoja
SL (slovenščina): zel sklepnjaka
SV (svenska): Sårmynta, ört
IS (íslenska):
NO (norsk): Gresk fjellte
Herbal preparations
Comminuted herbal substance
European Pharmacopoeia monograph reference
Not applicable
Indications
Indication (1)
Traditional herbal medicinal product used for the relief of cough associated with cold.
Indication (2)
Traditional herbal medicinal product used for the relief of mild gastrointestinal discomfort.
The product is a traditional herbal medicinal product for use in specified indications exclusively based upon long-standing use.
Type of tradition
European
Specified strength
Please see ‘ Specified posology ’ .
Specified posology
Adults and elderly
Indication (1) and (2)
Single dose: Herbal tea: 2-4 g of the comminuted herbal substance in 150-200 ml of water as a herbal infusion 2-3 times daily
Daily dose: up to 12 g
The use in children and adolescents under 18 years of age is not recommended (see section ‘ Special warnings and precautions for use ’ )
Route of administration
Oral use
Duration of use or any restrictions on the duration of use
Indication (1)
If symptoms persist longer than 1 week during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.
Indication (2)
If symptoms persist longer than 2 weeks during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.
Any other information necessary for the safe use
Contraindications
Hypersensitivity to the active substance and to other plants of the Lamiaceae (Labiatae) family.
Special warnings and precautions for 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.
Interactions with other medicinal products and other forms of interaction
None reported
Fertility, pregnancy and lactation
Safety during pregnancy and lactation has not been established. In the absence of sufficient data, use during pregnancy and lactation is not recommended.
No fertility data available.
Effects on ability to drive and use machines
No studies on the effect on the ability to drive and use machines have been performed.
Undesirable effects
None known
If adverse reactions occur, a doctor or qualified health care practitioner should be consulted.
Overdose
No case of overdose has been reported.
Pharmaceutical particulars (if necessary)
Not applicable
Pharmacological effects or efficacy plausible on the basis of long-standing use and experience (if necessary for the safe use of the product)
Not applicable.

### Division: COMMUNITY LIST ENTRY ON THYMUS VULGARIS L., THYMUS ZYGIS LOEFL. EX L., AETHEROLEUM

## Scientific name of the plant

Thymus vulgaris L., Thymus zygis Loefl. ex L.

## Botanical family

Lamiaceae

## Herbal preparation(s)

Essential oil obtained by steam distillation from the fresh flowering aerial parts of Thymus vulgaris L., Thymus zygis Loefl. ex L. or a mixture of both species

## European Pharmacopoeia monograph reference

01/2008:1374

## Indication(s)

Traditional herbal medicinal product for the relief of symptoms in coughs and colds.
The product is a traditional herbal medicinal product for use in the specified indication exclusively based upon long-standing use.

## Type of tradition

European

## Specified strength

Please see ‘ Specified posology ’

### Division: Specified posology

## Adults and elderly

Cutaneous use: in liquid and semi-solid dosage forms in concentrations up to 10 %; apply up to 3 times daily.
Use as bath additive: 0,007-0,025 g per litre.

## Adolescents

Use as bath additive: 0,007-0,025 g per litre

## Children 6-12 years

Use as bath additive: 0,0035-0,017 g per litre

## Children 3-6 years

Use as bath additive: 0,0017-0,0082 g per litre
One bath every day or every second day.
The cutaneous use in children and adolescents under 18 years of age is not recommended (see section ‘ Special warnings and precaution for use ’ ).
The use as bath additive in children under 3 years of age is not recommended (see section ‘ Special warnings and precaution for use ’ ).

## Route of administration

Cutaneous use: apply to the chest and the back.
Use as a bath additive: recommended temperature of bath: 35-38 °C.

## Duration of use or any restrictions on the duration of use

Duration of a bath: 10-20 minutes.
If the symptoms persist longer than 1 week, a doctor or a qualified health care practitioner should be consulted.

### Division: Any other information necessary for the safe use

## Contraindications

Hypersensitivity to the active substance.

## 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 insufficiency.

### Division: Special warnings and precautions for use

## Cutaneous use:

Like other essential oils Thyme oil should not be applied to the face particularly in the nasal area of babies and infants under the age of 2 years because of the risk of a laryngospasm.
When dyspnoea, fever or purulent sputum occurs, a doctor or a qualified health care practitioner should be consulted.
The use in children and adolescents under 18 years of age is not recommended due to lack of adequate data.

## Use as bath additive:

When dyspnoea, fever or purulent sputum occurs, a doctor or a qualified health care practitioner should be consulted.
The use in children under 3 years of age is not recommended because medical advice should be sought and due to lack of adequate data.
In cases of hypertension, a full bath should be used with caution.

## Interactions with other medicinal products and other forms of interaction

None reported.

## Pregnancy and lactation

Safety during pregnancy and lactation has not been established.
In the absence of sufficient data, the use during pregnancy and lactation is not recommended.

## Effects on ability to drive and use machines

No studies on the effect on the ability to drive and use machines have been performed.

## Undesirable effects

Hypersensitivity reactions and skin irritation have been observed. The frequency is not known.
If other adverse reactions not mentioned above occur, a doctor or a qualified health care practitioner should be consulted.

## Overdose

No case of overdose has been reported.

## Pharmaceutical particulars [If necessary]

Not applicable.

## Pharmacological effects or efficacy plausible on the basis of long-standing use and experience [If necessary for the safe use of the product]

Not applicable.

## UNION LIST ENTRY ON VALERIANA OFFICINALIS L.

Scientific name of the plant
Valeriana officinalis L.
Botanical family
Valerianaceae
Common name in all EU official languages of herbal preparation
BG (bălgarski): Валериана, корен
CS (čeština): kozlíkový kořen
DA (dansk): Baldrianrod
DE (Deutsch): Baldrianwurzel
EL (elliniká): Ρίζα βαλεριανής
EN (English): Valerian root
ES (español): Valeriana, raíz de
ET (eesti keel): palderjanijuur
FI (suomi): rohtovirmajuuri, juuri
FR (français): Valériane (racine de)
HR (hrvatska): odoljenov korijen
HU (magyar): Macskagyökér
IT (italiano): Valeriana radice
LT (lietuvių kalba): Valerijonų šaknys
LV (latviešu valoda): Baldriāna saknes
MT (Malti): Għerq tal-Valerjana
NL (Nederlands): Valeriaanwortel
PL (polski): Korzeń kozłka
PT (português): Valeriana, raiz
RO (română): rădăcină de valeriană
SK (slovenčina): Koreň valeriány
SL (slovenščina): korenina zdravilne špajke
SV (svenska): Vänderot, rot
IS (íslenska):
NO (norsk): Valerianarot
Herbal preparation(s)
(a) Comminuted herbal substance
(b) Powdered herbal substance
(c) Expressed juice from fresh root (1:0,60-0,85)
(d) Dry extract (DER 4-6:1), extraction solvent: water
(e) Liquid extract (DER 1:4-6), extraction solvent: water
(f) Dry extract (DER 4-7:1), extraction solvent: methanol 45 % (V/V)
(g) Dry extract (DER 5,3-6,6:1), extraction solvent: methanol 45 % (m/m)
(h) Liquid extract (DER 1:7-9), extraction solvent: sweet wine
(i) Liquid extract (DER 1:1), extraction solvent: ethanol 60 % (V/V)
(j) Tincture (ratio of herbal substance to extraction solvent 1:8), extraction solvent: ethanol 60 % (V/V)
(k) Tincture (ratio of herbal substance to extraction solvent 1:10), extraction solvent: ethanol 56 %
(l) Tincture (ratio of herbal substance to extraction solvent 1:5), extraction solvent: ethanol 70 % (V/V)
(m) Tincture (ratio of herbal substance to extraction solvent 1:5), extraction solvent: ethanol 60-80 % (V/V)
(n) Dry extract (DER 5,5-7,4:1), extraction solvent: ethanol 85 % (m/m)
European Pharmacopoeia monograph reference
04:2017:0453
Indications
Traditional herbal medicinal product for relief of mild symptoms of mental stress and to aid sleep.
The product is a traditional herbal medicinal product for use in the specified indication exclusively based upon long-standing use.
Type of tradition
European.
Specified strength
Please see ‘ Specified posology ’ .
Specified posology
Adolescents, adults and elderly
Oral use
(a) single dose: 0,3-3 g
For relief of mild symptoms of mental stress up to 3 times daily.
To aid sleep, a single dose half to one hour before bedtime with an earlier dose during the evening if necessary.
Herbal tea: 0,3-3 g of the comminuted herbal substance in 150 ml of boiling water as a herbal infusion
(b) single dose: 0,3-2,0 g
For relief of mild symptoms of mental stress up to 3 times daily.
To aid sleep, a single dose half to one hour before bedtime with an earlier dose during the evening if necessary.
(c) single dose: 10 ml
For relief of mild symptoms of mental stress up to 3 times daily.
To aid sleep, a single dose half to one hour before bedtime with an earlier dose during the evening if necessary.
(d) single dose: 420 mg
For relief of mild symptoms of mental stress up to 3 times daily.
To aid sleep, a single dose half to one hour before bedtime with an earlier dose during the evening if necessary.
(e) single dose: 20 ml
For relief of mild symptoms of mental stress up to 3 times daily.
To aid sleep, a single dose half to one hour before bedtime.
(f) single dose: 144-288 mg
For relief of mild symptoms of mental stress up to 4 times daily.
To aid sleep, a single dose half to one hour before bedtime with an earlier dose during the evening if necessary.
(g) single dose: 450 mg
For relief of mild symptoms of mental stress up to 3 times daily.
To aid sleep, a single dose half to one hour before bedtime with an earlier dose during the evening if necessary.
(h) single dose: 10 ml, up to 3 times daily
(i) single dose: 0,3-1,0 ml, up to 3 times daily
(j) single dose: 4-8 ml, up to 3 times daily
(k) single dose: 0,84 ml
For relief of mild symptoms of mental stress 3-5 times daily.
To aid sleep, a single dose half an hour before bedtime.
(l) single dose: 1,5 ml (mental stress), 3 ml (to aid sleep)
For relief of mild symptoms of mental stress up to 3 times daily.
To aid sleep, a single dose half an hour before bedtime.
(m) single dose: 10 ml, up to 3 times daily
(n) single dose: 322 mg, up to 3 times daily
Use as bath additive
single dose: 100 g for a full bath, up to 1 bath daily
Route of administration
Oral use
Use as bath additive. Temperature: 34-37 °C, duration of bath 10-20 minutes.
Duration of use or any restrictions on the duration of use
If symptoms persist during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.
Any other information necessary for the safe use
Contraindications
Hypersensitivity to the active substance.
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 insufficiency.
Special warnings and precautions for use
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 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.
Interactions with other medicinal products and other forms of interaction
None reported
Fertility, pregnancy and lactation
Safety during pregnancy and lactation has not been established. In the absence of sufficient data, use during pregnancy and lactation is not recommended.
No fertility data available.
Effects on ability to drive and use machines
May impair ability to drive and use machines. Affected patients should not drive or operate machinery.
Undesirable effects
Oral use
Gastrointestinal symptoms (e.g. nausea, abdominal cramps) may occur after ingestion of valerian root preparations. The frequency is not known.
If other adverse reactions not mentioned above occur, a doctor or a qualified health care practitioner should be consulted.
Use as bath additive
None known
If adverse reactions occur, a doctor or a qualified health care practitioner should be consulted.
Overdose
Oral use
Valerian root at a dose of approximately 20 g caused symptoms, such as fatigue, abdominal cramp, chest tightness, light-headedness, hand tremor and mydriasis, which disappeared within 24 hours. If symptoms arise, treatment should be supportive.
Use as bath additive
No case of overdose has been reported.
Pharmaceutical particulars [If necessary]
Not applicable
Pharmacological effects or efficacy plausible on the basis of long-standing use and experience [If necessary for the safe use of the product]
Not applicable.

### Division: COMMUNITY LIST ENTRY ON VITIS VINIFERA L., FOLIUM

## Scientific name of the plant

Vitis vinifera L.

## Botanical family

Vitaceae

## Herbal substance

Grapevine leaf

## Common name of herbal substance in all EU official languages

BG (bălgarski): лоза, лист
CS (čeština): Červený list vinné révy
DA (dansk): Vinblad
DE (Deutsch): Rote Weinrebenblätter
EL (elliniká): Φύλλο Αμπέλου
EN (English): Grapevine leaf
ES (español): Vid, hoja de
ET (eesti keel): Viinapuu lehed
FI (suomi): Aitoviiniköynnös, lehti
FR (français): Feuille de vigne rouge
HU (magyar): Bortermő szőlő levél
IT (italiano): Vite, foglia
LT (lietuvių kalba): Tikrųjų vynmedžių lapai
LV (latviešu valoda): Īstā vīnkoka lapas
MT (malti): Werqa tad-dielja
NL (nederlands): Wijnstokblad
PL (polski): Liść winorośli właściwej
PT (português): Folha de videira
RO (română): Frunze de viță-de-vie
SK (slovenčina): List viniča
SL (slovenščina): List vinske trte
SV (svenska): Blad från vinranka
IS (íslenska): Vínviðarlauf
NO (norsk): Rød vinranke, blad

## Herbal preparation(s)

Soft extract (2.5-4:1; extraction solvent water)

## European Pharmacopoeia monograph reference

Not applicable

## Indication(s)

Traditional herbal medicinal product to relieve symptoms of discomfort and heaviness of legs related to minor venous circulatory disturbances.
The product is a traditional herbal medicinal product for use in specified indication exclusively based upon long-standing use.

## Type of tradition

European

## Specified strength

Please see ‘ Specified posology ’ .

### Division: Specified posology

## Adults and elderly

Soft extract (2.5-4:1; extraction solvent water) in a cream base (10 g contain 282 mg soft extract).
Apply a thin layer on the affected area 1-3 times daily.
The use in children and adolescents under 18 years of age is not recommended (see section ‘ Special warnings and precautions for use ’ ).

## Route of administration

Cutaneous use.

### Division: Duration of use or any restrictions on the duration of use

## Adults and elderly

The recommended duration of use is 4 weeks.
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.

### Division: Any other information necessary for the safe use

## Contraindications

Hypersensitivity to the active substance.

## Special warnings and precautions for use

If there is inflammation of the skin, thrombophlebitis or subcutaneous induration, severe pain, ulcers, sudden swelling of one or both legs, cardiac or renal insufficiency, a doctor should be consulted.
The product should not be used on broken skin, around the eyes or on mucous membranes.
In the absence of sufficient safety data, the use in children and adolescents below 18 years of age is not recommended.

## Interactions with other medicinal products and other forms of interaction

None reported.

## Pregnancy and lactation

Safety during pregnancy and lactation has not been established. In the absence of sufficient data, the use during pregnancy and lactation is not recommended.

## Effects on ability to drive and use machines

No studies on the effect on the ability to drive and use machines have been performed.

## Undesirable effects

Contact allergy and/or hypersensitivity reactions of the skin (itching and erythema, urticaria) 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.

## Overdose

No case of overdose has been reported.

## Pharmaceutical particulars (if necessary)

Not applicable.

## Pharmacological effects or efficacy plausible on the basis of long-standing use and experience (if necessary for the safe use of the product)

Not applicable.

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Source: https://www.legislation.gov.uk/eudn/2008/911 (the official version)
Page: https://openlegislation.uk/eu-decision-2008-911
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.