Initial assessment

Discussion in Working Party on European Union monographs and European Union list (MLWP)

July 2008 September 2008 November 2008 January 2009

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

14 January 2009

End of consultation (deadline for comments)

15 May 2009

Rediscussion in MLWP

July 2009 September 2009 November 2009

Adoption by HMPC

Monograph (EMEA/HMPC/251323/2006)

AR (EMEA/HMPC/251324/2006)

List of references (EMEA/HMPC/476255/2007)

Overview of comments received during the public consultation (EMEA/HMPC/454136/2008)

HMPC Opinion (EMEA/HMPC/584717/2008)

12 November 2009

First systematic review

Discussion in MLWP

May 2015 July 2015 September 2015 November 2015

Adoption by HMPC

2 February 2016

Start of public consultation

15 February 2016

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

15 May 2016

Rediscussion in MLWP

Adoption by HMPC

Keywords Herbal medicinal products; HMPC; European Union herbal monographs; traditional use; Salvia officinalis L.; Salviae officinalis folium; sage leaf

Well-established use

Traditional use

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

Salvia officinalis L., folium; Salvia officinalis folium (sage leaf)

i)    Herbal substance

Not applicable.

ii)    Herbal preparations

a)    Comminuted herbal substance.

b)    Liquid extract (DER 1:1), ethanol 70% V/V

c)    Dry extract (DER 4-7:1), extraction solvent: water

d)    Liquid extract (DER 1:3.5-5), extraction solvent: ethanol 31.5% V/V

e)    Liquid extract (DER 1:4-5) extraction solvent: ethanol 50% V/V

f)    Liquid extract (DER 1:4-6), extraction solvent: liquor wine : ethanol 96% V/V (DER 38.25 : 61.75 m/m)

g)    Tincture (1:10) extraction solvent: ethanol 70% V/V

h)    Dry extract from fresh leaves (1:17-18), extraction solvent: ethanol 68 % V/V

Well-established use

Traditional use

Comminuted herbal substance as herbal tea for oral use.

Well-established use

Traditional use

Comminuted herbal substance for infusion for oromucosal 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 or for oromucosal use.

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

Well-established use

Traditional use

Indication 1)

Traditional herbal medicinal product for relief of mild dyspeptic complaints such as heartburn and bloating.

Indication 2)

Traditional herbal medicinal product for relief of excessive sweating.

Indication 3)

Traditional herbal medicinal product for relief of inflammations in the mouth or the throat.

Indication 4)

Traditional herbal medicinal product for relief of minor skin inflammations.

Well-established use

Traditional use

Posology

Adults and elderly

Indication 1) a) Single dose:

Herbal tea: 1-2 g of the comminuted herbal substance in 150 ml boiling water as a herbal infusion three times daily.

Daily dose: 3-6 g

c) Single dose: 80-107 mg Daily dose: 320 mg

Well-established use

Traditional use

d) Single dose: 0.5 ml in water Daily dose: 1.5 ml

f)    Single dose: 0.43 ml in warm water.

Daily dose: 1.29 ml

g)    Single dose: 2-3 ml Daily dose: 6-9 ml

Indication 2)

a) Daily dose:

Herbal tea: 2 g of comminuted herbal substance in 150 ml boiling water as a herbal infusion.

d)    Single dose: 0.5-1 ml in liquid Daily dose: 1.5-3 ml

For nightsweat, 1.5 ml in liquid 1 hour directly before bedtime.

e)    Single dose: 2 ml in liquid Daily dose: 6 ml

h)    Single dose: 51 mg for oral use once daily Indication 3)

a)    Single dose: 2.5 g

2.5 g of the comminuted herbal substance in 100 ml boiling water. The infusion is used warm for gargle several times daily.

b)    Single dose: 250 mg

250 mg of gel for oromucosal use. Apply on affected regions and massage gently.

Daily dose: up to 1250 mg

c)    Single dose: 0.75 ml

0.75 ml three times daily in 150 ml warm water for gargle.

Daily dose: 2.25 ml

f)    Average daily dose: 0.65 ml in 150 ml water for rinse or gargle several times daily.

g)    Average daily dose: 5-10 ml

10 ml in a glass of water for rinse or gargle several times daily.

Undiluted tincture is applied locally on the affected regions once daily.

Indication 4)

a) Average daily dose: 2.5 g

Herbal tea: Comminuted herbal substance in boiling water as a herbal infusion for cutaneous use: 2.5 g in 100 ml water, divided in 2-4 single doses.

The use in children and adolescents under 18 years of age is not recommended (see section 4.4 'Special warnings and precautions for use').

Well-established use

Traditional use

Duration of use

Indications 1) and 2)

Not to be used for more than 2 weeks. Indication 3)

Not to be used for more than 1 week.

Indication 4)

The average duration of use is 2 weeks.

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

Method of administration

Indication 1) and 2) - oral use Indication 3) - oromucosal use Indication 4) - cutaneous use

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.

For tinctures and 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.

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.

No fertility data available.

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

None known.

If adverse reactions occur, a doctor or a qualified health care practitioner should be consulted.

Well-established use

Traditional use

No case of overdose from sage leaves has been reported.

Intake of sage oil corresponding to more than 15 g of sage leaf is reported to cause sensation of heat, tachycardia, vertigo and epileptic form or convulsions (seizures).

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.

Thujone is reported to be neurotoxic and chemotypes with low content of thujone should be preferred.

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

Well-established use

Traditional use

The amount of thujone has to be specified in the given product. The daily exposure has to be below 6.0 mg.

For more details see the "Public statement on the use of herbal medicinal products containing thujone)" (EMA/HMPC/732886/2010).