DISCUSSION IN WORKING PARTY ON COMMUNITY MONOGRAPHS AND COMMUNITY LIST (MLWP)

November 2009 January 2010

ADOPTION BY HMPC FOR RELEASE FOR CONSULTATION

14 January 2010

END OF CONSULTATION (DEADLINE FOR COMMENTS)

15 June 2010

REDISCUSSION IN WORKING PARTY ON COMMUNITY MONOGRAPHS AND COMMUNITY LIST (MLWP)

ADOPTION BY HMPC

BG (bälgarski):

LT (lietuvip kalba):

CS (cestina):

LV (latviesu valoda):

DA (dansk):

MT (malti):

DE (Deutsch):

NL (nederlands):

EL (ellinika):

PL (polski):

EN (English):

PT (português):

ES (espanol):

RO (româna):

ET (eesti keel):

SK (slovencina):

FI (suomi):

SL (slovenscina):

FR (français):

SV (svenska):

HU (magyar):

IS flslenska):

IT (italiano):

NO (norsk):

Well-established use

Traditional use

With regard to the registration application of Article 16d(1) of Directive 2001/83/EC as amended

Arctium lappa L. radix (burdock root)

i) Herbal substance Not applicable.

ii) Herbal preparations

-    Comminuted herbal substance

-    Liquid extract (DER 1:1), extraction solvent ethanol 25% V/V

-    Tincture (ratio of herbal substance to extraction solvent 1:10), extraction solvent ethanol 45% V/V

Well-established use

Traditional use

Herbal preparation in solid or liquid dosage forms or as herbal tea for oral use.

The pharmaceutical form should be described by the European Pharmacopoeia full standard term.

Well-established use

Traditional use

a)    Traditional herbal medicinal product used to increase the amount of urine to achieve flushing of the urinary tract as an adjuvant in minor urinary tract complaints.

b)    Traditional herbal medicinal product used in temporary loss of appetite.

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

Well-established use

Traditional use Posology

Adults and elderly

-    Comminuted herbal substance:

3-6 g as an infusion, 3 times daily.

-    Liquid extract: 25 to 50 drops, 3 times daily.

-    Tincture: 50 drops, 3 times daily.

The use in children and adolescents under 18 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.

For preparations other than tea: to ensure an increase of the amount of urine, adequate fluid intake is required during treatment.

Well-established use

Traditional use

Hypersensitivity to the active substance(s).

Well-established use

Traditional 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.

If complaints of symptoms such as fever, dysuria, spasms or blood in the urine occur during the use of the medicinal product, a doctor or a qualified health care professional should be consulted. Concomitant treatment with synthetic diuretics is not recommended.

For tinctures 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.

Well-established use

Traditional use None reported.

Well-established use

Traditional use

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

Well-established use

Traditional use

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

Well-established use

Traditional use

One case has 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.

Well-established use

Traditional use

No case of overdose has been reported.

Well-established use

Traditional use

Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.

Well-established use

Traditional use

Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.

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.

Adequate tests on reproductive toxcity genotoxicity and carcinogenicity have not been performed.

Well-established use

Traditional use

Not applicable.