Initial assessment

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

January 2013 March 2013 July 2013 March 2014 July 2015 February 2016 April 2016

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

12 July 2016

Start of public consultation

25 July 2016

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

31 October 2016

Rediscussion in MLWP

Adoption by HMPC

BG (bulgarski): HecbH, nyKOB^a

LT (lietuviq kalba): Cesnakai

CS (cestina): cesneková cibule

LV (latviesu valoda): ^iploka slpols

DA (dansk): Hvidlog

MT (Malti): Basla tat-Tewm

DE (Deutsch): Knoblauchzwiebel

NL (Nederlands): Knoflook

EL (elliniká): BoAß0g OKopôôou

PL (polski): Czosnek

EN (English): Garlic

PT (portugués): Alho, bolbo de

ES (español): Ajo, bulbo de

RO (romana): bulb de usturoi

ET (eesti keel): küüslauk

SK (slovencina): Cibul'a cesnaku (cesnak)

FI (suomi): valkosipuli

SL (slovenscina): cebulica cesna

FR (français): Ail (bulbe d')

SV (svenska): Vitlök, lök

HR (hrvatski): Cesnjakova lukovica

IS (íslenska):

HU (magyar): fokhagyma IT (italiano): Aglio bulbo

NO (norsk): Hvitlok

Well-established use

Traditional use

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

Allium sativum L., bulbus; (garlic)

i)    Herbal substance Not applicable

ii)    Herbal preparations

a)    Powdered herbal substance

b)    Liquid extract from fresh bulb (DER 2-3:1), extraction

solvent rapeseed oil, refined

c)    Dry extract (DER 5:1), extraction solvent ethanol 34% V/V

Well-established use

Traditional use

Herbal preparations in solid dosage forms for oral 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 used as an adjuvant for the prevention of atherosclerosis.

Indication 2)

Traditional herbal medicinal product used for the relief of the symptoms of cold.

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

Indication 1)

Adults and elderly

a)    Powdered herbal substance single dose: 300 mg to 750 mg

Daily dose: 900-1380 mg divided into 3 to 5

b)    Liquid extract:

Single doses: 110-220 mg 4 times daily Daily dose: 440-880 mg

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

Indication 2)

Adolescents, adults and elderly

c)    Dry extract:

Single dose: 100-200 mg 1-2 times daily Daily dose: 100-400 mg

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

Well-established use

Traditional use

Duration of use

Indication 1)

No restrictions to the duration of use.

Indication 2)

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

Method of administration

Oral use

Well-established use

Traditional use

Hypersensitivity to the active substance.

Patients under saquinavir/ritonavir therapy (see also section 4.5 Interactions).

Well-established use

Traditional use

Garlic consumption should be avoided 7 days before surgery because of the post-operative bleeding risk.

Indication 1)

The use in children and adolescents under 18 years of age has not been established due to lack of data.

Indication 2)

The use in children under 12 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.

Well-established use

Traditional use

Garlic preparations should be used with caution in patients taking oral anticoagulation therapy and/or anti-platelet therapy because they may increase bleeding times.

Concomitant use with saquinavir/ritonavir is contraindicated because of the risks of decrease in plasma concentration, loss of virological response and possible resistance to one or more components of the antiretroviral regime (see also section 4.3 Contraindications).

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.

Studies in animals have shown effects on fertility (see section 5.3 'Preclinical safety data').

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

-    Malodorous breath or body odour, abdominal pain, bloating, flatulence, fullness, anorexia

-    Allergic reactions such as contact dermatitis, conjunctivitis, rhinitis, or bronchospasms, sometimes severe

-    Headache, dizziness, and profuse sweating

-    Bleeding

The frequency is not known.

If other adverse reactions not mentioned above

occur, a doctor or a qualified health care

Well-established use

Traditional use

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 toxicity and genotoxicity have not been performed.

Tests on carcinogenicity have not been performed.

Testicular toxicity (e.g. spermatogenesis impairment) was reported in rats treated for 30 days with crude garlic and in rats treated for 70 days with 50 mg of garlic powder. A decrease in testosterone occurs concomitantly; a NOAEL was not determined for the garlic powder. These effects on male rat fertility were observed at approximately twice the maximal human daily dose.

Well-established use

Traditional use

Not applicable