Medine.co.uk

Draft Community Herbal Monograph On Rosa Centifolia L.; Rosa Gallica L.; Rosa Damascena Mill., Flos

o

EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

15 December 2013

EMA/HMPC/137299/2013

Committee on Herbal Medicinal Products (HMPC)

Community herbal monograph on Rosa gallica L., Rosa centifolia L., Rosa damascena Mill., flos

Draft

Herbal medicinal products; HMPC; Community herbal monographs; traditional use; Rosa gallica L., Rosa centifolia L., Rosa damascena Mill., flos; Rosae flos; Rose flower


Discussion in Working Party on Community monographs and Community

May 2013

list (MLWP)

July 2013

Adoption by Committee on Herbal Medicinal Products (HMPC) for release for consultation

17 September 2013

End of consultation (deadline for comments). Comments should be provided using this template to hmpc.secretariat@ema.europa.eu

15 April 2014

Rediscussion in Working Party on Community monographs and Community list (MLWP)

Adoption by Committee on Herbal Medicinal Products (HMPC)

Keywords

An agency of the European Union


7 Westferry Circus Canary Wharf London E14 4HB United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7523 7051 E-mail info@ema.europa.eu Website www.ema.europa.eu

© European Medicines Agency, 2013. Reproduction is authorised provided the source is acknowledged.

BG (bulgarski): MacmgaüHa po3a, ^at

LT (lietuviq kalba): Roziq ziedai

CS (cestina): ruzovy kvët

LV (latviesu valoda): Rozu ziedi

DA (dansk): Rosenblomst

MT (Malti): Fjura tal-Ward

DE (Deutsch): Rosenblütenblätter

NL (Nederlands): Roos, bloem

EL (elliniká): Pôôou dv0oç

PL (polski): Kwiat rózy

EN (English): Rose flower

PT (portugués): Rosa, flor

ES (español): Rosa, flor de

RO (romana):

ET (eesti keel): kibuvitsaôis

SK (slovencina): Kvet ruze

FI (suomi): ruusu, kukka

SL (slovenscina): cvet vrtnice

FR (français): Rose pâle, rose de Provins, rose de

SV (svenska): Rosenblad

Damas

IS (íslenska):

HR (hrvatski): ruzin cvijet

NO (norsk): Roseblomst

HU (magyar): Rózsavirág

IT (italiano): Rosa fiore

Community herbal monograph on Rosa gallica L., Rosa centifolia L., Rosa damascena Mill., flos

1.    Name of the medicinal product

To be specified for the individual finished product.

2.    Qualitative and quantitative composition1, 2

Well-established use

Traditional use

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

Rosa gallica L., Rosa centifolia L., Rosa damascena Mill., flos (Rose flower)

i)    Herbal substance Dried petals

ii)    Herbal preparations Comminuted herbal substance

3. Pharmaceutical form

Well-established use

Traditional use

Herbal substance or comminuted herbal substance for infusion preparation for oromucosal or cutaneous use.

The pharmaceutical form should be described by full standard term.

4. Clinical particulars

4.1. Therapeutic indications

Well-established use

Traditional use

Indication 1)

Traditional herbal medicinal product used for mild inflammations of the oral and pharyngeal mucosa.

1    The material complies with the monograph in the Ph. Fr. XI edition (Rose pale 1989; Rose rouge 1989).

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

Well-established use

Traditional use

Indication 2)

Traditional herbal medicinal product used for relief of minor skin inflammation.

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 administration3

Well-established use

Traditional use

Posology

Indication 1)

Adolescents over 12 years of age, adults and elderly

Single dose

Herbal substance or comminuted herbal substance for infusion preparation for oromucosal use:

1 - 2 g of the herbal substance or comminuted herbal substance in 200 ml of boiling water

As a mouth rinse, up to 3 times daily.

The use in children under 12 years of age is not recommended (see section 4.4 'Special warnings and precautions for use').

Indication 2)

Adolescents over 12 years of age, adults and elderly

Single dose

Herbal substance or comminuted herbal substance for infusion preparation for cutaneous use:

1 - 2 g of the herbal substance or comminuted herbal substance in 200 ml of boiling water

Apply on the affected area, up to 3 times daily, in the form of a wet, impregnated dressing.

The use in children under 12 years of age is not

3 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).

Well-established use

Traditional use

recommended (see section 4.4 'Special warnings and precautions for use').

Duration of use

Indications 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.

Method of administration

Oromucosal use.

Cutaneous 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

Indications 1) and 2)

The use in children under 12 years of age has not been established due to lack of adequate.

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

No fertility data available.

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

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 reported.

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.

Tests on genotoxicity, reproductive toxicity and carcinogenicity have not been performed.

6. Pharmaceutical particulars

Well-established use

Traditional use

Not applicable.

7. Date of compilation/last revision

15 December 2013

EMA/HMPC/137299/2013 Page 7/7