5 April 2016 EMA/HMPC/143658/2015 Committee on Herbal Medicinal Products (HMPC)

European Union herbal monograph on Polygonum aviculare L., herba Final

Discussion in Working Party on European Union monographs and list

March 2015 May 2015

(MLWP)

July 2015 Adoption by Committee on Herbal Medicinal Products (HMPC) for release for consultation Start of public consultation End of consultation (deadline for comments)

19 October 2015 1

Re-discussion in MLWP Adoption by HMPC Keywords

29 September 2015

15 January 2016 4 February 2016 5 April 2016

Herbal medicinal products; HMPC; European Union herbal monographs; traditional use; Polygonum aviculare L., herba; Polygoni avicularis herba; Knotgrass herb

1 No comments were received during the period of public consultation. Therefore the final monograph is published together with the final assessment report and list of references, without an ‘Overview of comments received during the public consultation’.

30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact

An agency of the European Union

© European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged.

BG (bulgarski): Пача трева, стрък

IT (italiano): Centinodio (Correggiola) parti aeree

CS (čeština): nať rdesna ptačího

fiorite

DA (dansk): Vejpileurt

LT (lietuvių kalba): Takažolių žolė

DE (Deutsch): Vogelknöterichkraut

LV (latviešu valoda): Maura sūrenes laksts

EL (elliniká): Πόα πολυγόνου του άρρενος

MT (Malti): ħaxixa tal-Lewża Tar-Raba'

EN (english): Knotgrass herb

NL (Nederlands): Gewoon varkensgras, kruid

ES (español): Centinodia, partes aéreas de

PL (polski): Ziele rdestu ptasiego

ET (eesti keel): linnurohuürt

PT (português): Corriola-bastarda, partes aéreas

FI (suomi): pihatatar, verso

RO (română): Iarbă de troscot

FR (français): Renouée des oiseaux (parties

SK (slovenčina): Vňať stavikrvu vtáčieho

aériennes de)

SL (slovenščina): zel ptičje dresni

HR (hrvatski): oputinova zelen

SV (svenska): Trampgräs, ört

HU (magyar): madárkeserűfű virágos hajtás

IS (íslenska): NO (norsk): Tungress

European Union herbal monograph on Polygonum aviculare L., herba EMA/HMPC/143658/2015

Page 2/7

European Union herbal monograph on Polygonum aviculare L., herba 1. Name of the medicinal product To be specified for the individual finished product.

2. Qualitative and quantitative composition 2, Well-established use

3

Traditional use With regard to the registration application of Article 16d(1) of Directive 2001/83/EC as amended Polygonum aviculare L., herba (Knotgrass herb) i) Herbal substance Not applicable ii) Herbal preparations Comminuted herbal substance

3. Pharmaceutical form Well-established use

Traditional use Comminuted herbal substance as herbal tea for oral use. Comminuted herbal substance for decoction preparation for oromucosal 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 Indication 1) Traditional herbal medicinal product used for the relief of symptoms of common cold.

2 The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal quality guidance. 3 The material complies with the Ph. Eur. monograph (ref.: 1885)

European Union herbal monograph on Polygonum aviculare L., herba EMA/HMPC/143658/2015

Page 3/7

Well-established use

Traditional use Indication 2) Traditional herbal medicinal product used for symptomatic treatment of minor inflammations in the mouth or the throat. Indication 3) Traditional herbal medicinal product used to increase the amount of urine to achieve flushing of the urinary tract as an adjuvant in minor urinary complaints. 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 Adolescents, adults and elderly Indication 1) Single dose: Herbal tea: 1.5-2 g of the comminuted herbal substance in 150 mL of boiling water as a herbal infusion 3-4 times daily. Daily dose: 4.5-8 g Indication 2) Single dose: Comminuted herbal substance for decoction preparation for oromucosal use: 1.5 g of the comminuted herbal substance in 200-250 mL of water 4-5 times daily for gargling of the mouth and throat. Daily dose: 6-7.5 g Indication 3) Single dose: Herbal tea: 3 g of the comminuted herbal substance in 200 mL of water as a decoction 2 times daily. Daily dose: 6 g

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 Polygonum aviculare L., herba EMA/HMPC/143658/2015

Page 4/7

Well-established use

Traditional use Indication 1), 2) and 3) 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 Indication 1) and 2) 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. Indication 3) 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 Indication 1) and 3) Oral use Indication 2) Oromucosal use

4.3. Contraindications Well-established use

Traditional use Hypersensitivity to the active substance(s). Indication 3) Conditions where reduced fluid intake is recommended (e.g. severe cardiac diseases).

4.4. Special warnings and precautions for use Well-established use

Traditional use Indication 1), 2) and 3) The use in children under 12 years of age has not been established due to lack of adequate data. Indication 1), 2) If the symptoms worsen during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.

European Union herbal monograph on Polygonum aviculare L., herba EMA/HMPC/143658/2015

Page 5/7

Well-established use

Traditional use Indication 3) 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. To ensure an increase of the amount of urine, adequate fluid intake is required during treatment.

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

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.

European Union herbal monograph on Polygonum aviculare L., herba EMA/HMPC/143658/2015

Page 6/7

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. 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 5 April 2016

European Union herbal monograph on Polygonum aviculare L., herba EMA/HMPC/143658/2015

Page 7/7

Final European Union herbal monograph on Polygonum aviculare L ...

Apr 5, 2016 - Send a question via our website www.ema.europa.eu/contact. © European Medicines Agency ... Start of public consultation. 19 October 2015.

124KB Sizes 30 Downloads 263 Views

Recommend Documents

Final European Union herbal monograph on Valeriana officinalis L ...
Feb 2, 2016 - 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 administration4. Well-estab

European Union herbal monograph on Mentha x piperita L., folium
Jan 31, 2017 - Page 2/7. Keywords. Herbal medicinal products; HMPC; European Union herbal monographs; ... Article 16d(1) of Directive 2001/83/EC.

Draft European Union herbal monograph on Glycine max (L.) Merr ...
Jul 12, 2016 - Send a question via our website www.ema.europa.eu/contact. © European .... Full baths are contraindicated in cases of open wounds, large ...

Draft European Union herbal monograph on Allium sativum L., bulbus
Jul 12, 2016 - Send a question via our website www.ema.europa.eu/contact. © European Medicines Agency ... Name of the medicinal product. To be specified for the ... With regard to the registration application of. Article 16d(1) of Directive ...

European Union herbal monograph on Arctostaphylos uva-ursi (L ...
Mar 28, 2017 - EMA/HMPC/750269/2016. Committee on ... November 2016. January 2017 .... In absence of sufficient data, the use during lactation is not ...

Community herbal monograph on Cimicifuga racemosa - European ...
Nov 25, 2010 - LT (lietuvių kalba):. LV (latvieÅ¡u valoda): Sudrabsveces saknenis. MT (malti): Riżoma tal-Koħox. NL (nederlands): Zilverkaars. PL (polski): ...

Opinion of the HMPC on a European Union herbal monograph on ...
An agency of the European Union. Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555. Send a question via our website www.ema.europa.eu/ ...

Opinion of the HMPC on a European Union herbal monograph on ...
Send a question via our website www.ema.europa.eu/contact ... The HMPC, in accordance with Article 16h(3) of Directive 2001/83/EC, as amended, and as set ...

HMPC meeting report on European Union herbal monographs ...
Apr 19, 2018 - Upon recommendation from the MLWP, the HMPC adopted after systematic review the following final revised EU herbal monographs:.

HMPC meeting report on European Union herbal monographs ...
Jul 18, 2016 - Send a question via our website www.ema.europa.eu/contact. © European Medicines .... (mandate start 12/07/2016). The new mandate and ...

HMPC meeting report on European Union herbal monographs ...
Jul 18, 2016 - products in applications for marketing authorisation (bibliographical and mixed ... and supporting documents', proposals on update of existing template for EU herbal monographs, ... E-mail: [email protected].

HMPC meeting report on European Union herbal monographs ...
Feb 6, 2017 - The drafting group started the review of the herbal specification guideline in line with the quality guideline revision as well as of the reflection ...

HMPC meeting report on European Union herbal monographs ...
Feb 22, 2018 - The committee welcomed Erika Svedlund as new member from Sweden and Katarzyna Tomaszewska as new Polish alternate. Revised European Union herbal monographs. Upon recommendation from the MLWP, the HMPC adopted after systematic review th

HMPC meeting report on European Union herbal monographs ...
Jun 14, 2016 - Call for scientific data (systematic monograph review). In April the HMPC had agreed to initiate the systematic review of 13 herbal substances ...

HMPC meeting report on European Union herbal monographs ...
Mar 27, 2018 - Upon recommendation from the MLWP, the HMPC adopted after systematic review the following final revised EU herbal monographs: •. Revised EU herbal monograph on Agni casti fructus (by majority). •. Revised EU herbal monograph on Cal

The-European-Union-And-Russia-The-European-Union-Series.pdf ...
institutional development of EU-Russia relations from three perspectives: European studies, Russian studies and International. Relations, including Foreign ...

Regulatory Q&A on herbal medicinal products - European Medicines ...
Sep 20, 2016 - (R6) What kinds of safety data are required for applications ..... has to be demonstrated by using appropriate analytical data, for example.

The European Union
identity, a uniquely European sense of self and conception of the good life, has ... Email: [email protected] .... that nation states have appealed to but by subscription to democratic values and ...... European Parliament Press Service.

the european union and the 'european dimension' in ...
Apr 18, 2008 - European Commission and Parliament to add a 'European dimension' ..... priorities figured the adoption of curricular themes that portrayed "the.