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

March 2009 May 2009 July 2009

ADOPTION BY HMPC FOR RELEASE FOR CONSULTATION

16 July 2009

END OF CONSULTATION (DEADLINE FOR COMMENTS)

15 December 2009

REDISCUSSION IN WORKING PARTY ON COMMUNITY

MONOGRAPHS AND COMMUNITY LIST (MLWP)

ADOPTION BY HMPC

Well-established use

Traditional use

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

Rosmarinus officinalis L., folium (rosemary leaf)

i) Herbal substance

Whole or fragmented, dried leaf

ii) Herbal preparations

Comminuted herbal substance

Extract (1:17.5-18.9), extraction solvent: liqueur wine

Extract (1:12.5-13.5), extraction solvent: liqueur wine

Expressed juice (1:1.8-2.2) from Rosmarini herba recens

Well-established use

Traditional use

Herbal substance and/or comminuted herbal substance as herbal tea for oral and cutaneous use.

Herbal preparations in solid or liquid dosage forms for oral use.

Herbal preparations in liquid or semi-solid dosage forms for cutaneous use.

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

Well-established use

Traditional use

Adolescents, adults

Oral use

1.    Traditional herbal medicinal product for symptomatic relief of dyspepsia and mild spasmodic disorders of the gastrointestinal tract.

Cutaneous use

2.    As adjuvant in the relief of minor muscle and articular pain.

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

Adolescents, adults

Indication 1)

Oral use

a.    Herbal substance as herbal tea preparation:

Daily dose: 2-6 g

Single dose: 2 g in 150 ml of boiling water To be taken 2-3 times daily

b.    Extract (1:17.5-18.9), extraction solvent: liqueur wine: 10 to 20 ml 2-3 times daily

c.    Extract (1:12.5-13.5), extraction solvent: liqueur wine: 20 ml 1-2 times daily

d.    Expressed juice (1:1.8-2.2):

5 ml containing 100% expressed juice 2-3 times daily

Cutaneous use Indication 2)

e. 1 litre of decoction of herbal substance/comminuted herbal substance (1:20) added to bath water (twice weekly)

f. 50 g of herbal substance for a full bath (once daily)

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)

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 (see section 4.4 ‘Special warnings and precautions for use’).

Indication 2)

If the symptoms persist longer than 4 weeks during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted (see section 4.4 ‘Special warnings and precautions for use’).

Method of administration

Indication 1)

Oral use.

Indication 2)

Cutaneous use.

Recommended bath temperature is 35 - 38 °C, for 10 to 20 minutes.

Well-established use

Traditional use

Hypersensitivity to the active substance.

Oral use

Obstruction of bile duct, cholangitis, liver disease, gallstones and any other biliary disorders that require medical supervision and advice.

Cutaneous use

Bronchial asthma, whooping cough and pseudocroup.

Full baths are contraindicated in cases of large skin injuries and open wounds, acute skin diseases, high fever, severe infections, severe circulatory disturbances and cardiac failure.

Well-established use

Traditional use

The use in children under 12 years of age is not recommended due to lack of adequate data and because medical advice should be sought.

If symptoms worsen during the use of the medicinal product, a doctor or a qualified health practitioner should be consulted.

Cutaneous use

Articular pain accompanied by swelling of joint, redness or fever shoud be examined by a doctor.

In cases of hypertension, a full hot bath should be used with caution.

Well-established use

Traditional use None reported.

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.

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

Hypersensitivity (contact dermatitis and occupational asthma) 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 mutagenicity, genotoxicity and reproductive toxicity have not been performed.

Well-established use

Traditional use Not applicable.