25 March 2014

EMA/HMPC/669740/2013

Committee on Herbal Medicinal Products (HMPC)

Community herbal monograph on

Passiflora incarnata

L.,

herba

Final

Initial assessement

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 HMPC

Monograph (EMEA/HMPC/230962/2006)

AR (EMEA/HMPC/230961/2006)

List of references (EMEA/HMPC/111180/2007)

Overview of comments received during the public consultation

(EMEA/HMPC/383450/2007)

HMPC Opinion (EMEA/HMPC/405535/2007)

First systematic review

Discussion in MLWP

Adoption by HMPC for release for consultation

End of consultation (deadline for comments)

Rediscussion in MLWP

Adoption by HMPC

November 2013

January 2014

N/A

N/A

N/A

25 March 2014

15 June 2007

September 2007

7 September 2007

October 2006

January 2007

March 2007

8 March 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, 2014. Reproduction is authorised provided the source is acknowledged.



Keywords

Herbal medicinal products; HMPC; Community herbal monographs; traditional

use;

Passiflora incarnata

L.; Passiflorae herba; Passion Flower.

BG (bălgarski):

Пасифлора, стрък

CS (čeština):

Mučenková nať

DA (dansk):

Passionsblomst

DE (Deutsch):

Passionsblumenkraut

EL (elliniká):

Пαθοβότανο

EN (English):

Passion Flower

ES (espanol):

Pasiflora, partes aéreas de

ET (eesti keel):

Kannatuslilleürt

FI (suomi):

Kärsimyskukka

FR (français):

Passiflore (parties aériennes de)

HR (hrvatska): Pasiflorova zelen

HU (magyar):

Észak-amerikai golgotavirág

hajtás

IT (italiano):

Passiflora parti aeree

LT (lietuvių kalba):

Pasiflorų žolė

LV (latviešu valoda):

Pasifloras laksti

MT (malti):

Fjura Tal-Passjoni

NL (nederlands):

Passiflora

PL (polski):

Ziele męczennicy

PT (português):

Passiflora

RO (română):

Iarbă de floarea patimilor

SK (slovenčina):

Mučenková vňať

SL (slovenščina):

Zel zdravilne pasijonke

SV (svenska):

Passionsblomma

IS (íslenska):

NO (norsk):

Pasjonsblomst

Community herbal monograph on

Passiflora incarnata

L., herba

EMA/HMPC/669740/2013

Page 4/7



Community herbal monograph on

Passiflora incarnata

L.,

herba

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

Passiflora incarnata

L., herba (Passion flower)

i) Herbal substance

Not applicable

ii) Herbal preparations

a) Comminuted herbal substance

b) Powdered herbal substance

c)

Liquid extract (DER 1:8) extraction

solvent ethanol 25% V/V

d) Liquid extract (DER 1:8) extraction

solvent ethanol 45% V/V

e) Liquid extract (DER 1:3.6) extraction

solvent ethanol 60% V/V

f)

Liquid extract (DER 1:1) extraction

solvent ethanol 25% V/V

g) Liquid extract (DER 1:1) extraction

solvent ethanol 70% V/V

h) Liquid extract (DER 1:3.8-4.3) extraction

solvent ethanol (96% V/V) + glycerol

(85% m/m) + Water (11.8 + 1 + 7.9)

Dried extracts corresponding to the tea and

liquid extracts above.

1

2

The material complies with the Eur.Ph.monograph (ref. 01/2005:1364)

The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal

quality guidance.

Community herbal monograph on

Passiflora incarnata

L., herba

EMA/HMPC/669740/2013

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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.

4. Clinical particulars

4.1. Therapeutic indications

Well-established use

Traditional use

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.

4.2. Posology and method of administration

3

Well-established use

Traditional use

Posology

Adolescents, adults and elderly

Single dose

ii) Herbal preparations

a) Herbal tea: 1-2 g of the comminuted

herbal substance in 150 ml of boiling

water as a herbal infusion, 1-4 times daily

b) Powdered herbal substance:

0.5-2g, 1-4 times daily

c)

Liquid extract: 2-4 ml, up to 4 times daily

d) Liquid extract: 2 ml, up to 3 times daily

e) Liquid extract: 1 ml, 3-5 times daily

f)

Liquid extract: 0.5-2 ml, up to 4 times

daily

g) Liquid extract: 2 ml up to 3 times daily

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

Passiflora incarnata

L., herba

EMA/HMPC/669740/2013

3

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Well-established use

Traditional use

h) Liquid extract: 0.3-0.4 ml,

adults 3-5 times daily;

adolescents 3 times daily

Doses of dried extracts corresponding to the

posologies of tea and liquid extracts 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

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

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 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.

Community herbal monograph on

Passiflora incarnata

L., herba

EMA/HMPC/669740/2013

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4.5. Interactions with other medicinal products and other forms of

interaction

Well-established use

Traditional use

None reported.

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.

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.

Community herbal monograph on

Passiflora incarnata

L., herba

EMA/HMPC/669740/2013

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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.

Tests on reproductive toxicity, genotoxicity and

carcinogenicity have not been performed.

6. Pharmaceutical particulars

Well-established use

Traditional use

Not applicable.

7. Date of compilation/last revision

25 March 2014

Community herbal monograph on

Passiflora incarnata

L., herba

EMA/HMPC/669740/2013

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