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Viola (Violae tricoloris herba cum flore)

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Authorisation details
Latin name of the genus: Viola
Latin name of herbal substance: Violae tricoloris herba cum flore
Botanical name of plant: Viola tricolor L.
English common name of herbal substance: Wild Pansy
Status: P: Draft published
Date added to the inventory: 31/10/2007
Date added to priority list: 10/01/2008
Outcome of European Assessment:
Additional Information: Community herbal monograph

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    • Product Characteristics
    Community herbal monograph on Viola tricolor L. and/or
    subspecies Viola arvensis Murray (Gaud) and Viola
    vulgaris Koch (Oborny), herba cum flore
    1. Name of the medicinal product
    To be specified for the individual finished product.
    2. Qualitative and quantitative composition 1 , 2
    Well-established use
    Traditional use
    With regard to the registration application of
    Article 16d(1) of Directive 2001/83/EC as
    amended
    V iola tricolor L. and/or species Viola arvensis
    Murray (Gaud.) and Viola vulgaris Koch (Oborny),
    herba cum flore
    (wild pansy, heartsease)
    i) Herbal substance
    Notapplicable.
    ii) Herbal preparations
    Comminutedherbalsubstance
    3. Pharmaceutical form
    Well-established use
    Traditional use
    Comminuted herbal substance as herbal tea for
    oral use or for infusion preparation for cutaneous
    use.
    The pharmaceutical form should be described by
    the European Pharmacopoeia full standard term.
    1 The material complies with the Ph. Eur. monograph (ref.: 01/2008: 1855).
    2 The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal
    quality guidance.
    Community herbal monograph on Viola tricolor L. and/or subspecies Viola arvensis
    Murray (Gaud) and Viola vulgaris Koch (Oborny), herba cum flore
    EMA/HMPC/131734/2009
    Page 2/6
     
     
    4. Clinical particulars
    4.1. Therapeutic indications
    Well-established use
    Traditional use
    Traditional herbal medicinal product for
    symptomatic treatment of mild seborrhoeic skin
    conditions.
    The product is a traditional herbal medicinal
    product for use in specified indication exclusively
    based upon long-standing use.
    4.2. Posology and method of administration
    Well-established use
    Traditional use
    Posology
    Adults and elderly
    Oral use
    Herbal tea: 3 g of comminuted herbal substance
    as an infusion 1-3 times daily.
    The use in children and adolescents under
    18 years of age is not recommended (see section
    4.4 ‘Special warnings and precautions for use’).
    Adolescents, adults and elderly
    Cutaneous use
    5-20 g/l of comminuted herbal substance as an
    infusion. Apply as a wet dressing to the affected
    areas of the skin 2-3 times daily.
    Bath additive: 5-10 g/l of comminuted herbal
    substance as an infusion. 1 litre of infusion to be
    added to the bath.
    The use in children under 12 years of the age is
    not recommended (see section 4.4. ‘Special
    warnings and precautions for use').
    Duration of use
    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.
    Method of administration
    Community herbal monograph on Viola tricolor L. and/or subspecies Viola arvensis
    Murray (Gaud) and Viola vulgaris Koch (Oborny), herba cum flore
    EMA/HMPC/131734/2009
    Page 3/6
    Oral use.
    Cutaneous use.
    4.3. Contraindications
    Well-established use
    Traditional use
    Hypersensitivity to the active substance, or to
    salicylates.
    Cutaneous use
    Open wounds, large areas of damaged skin.
    4.4. Special warnings and precautions for use
    Well-established use
    Traditional use
    Oral use
    The use in children and adolescent under 18 years
    of age has not been established due to lack of
    adequate data.
    Cutaneous use
    The use in children under 12 years of age has not
    been established due to lack of adequate data.
    Hot baths should not be used in case of febrile or
    infectious illnesses, in heart insufficiency and
    hypertension.
    4.5. Interactions with other medicinal products and other forms of
    interaction
    Well-established use
    Traditional use
    None reported.
    4.6. Pregnancy and lactation
    Well-established use
    Traditional use
    Safety during pregnancy nad lactation has not
    been established. In the absence of sufficient
    data, the use during pregnancy and lactation is
    not recommended.
    Community herbal monograph on Viola tricolor L. and/or subspecies Viola arvensis
    Murray (Gaud) and Viola vulgaris Koch (Oborny), herba cum flore
    EMA/HMPC/131734/2009
    Page 4/6
    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
    One case of haemolysis in a child with G6PD
    deficiency has been reported after oral
    administration. The frequency is not known.
    If other adverse reactions not mentioned above
    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.
    Community herbal monograph on Viola tricolor L. and/or subspecies Viola arvensis
    Murray (Gaud) and Viola vulgaris Koch (Oborny), herba cum flore
    EMA/HMPC/131734/2009
    Page 5/6
    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
    25 November 2010
    Community herbal monograph on Viola tricolor L. and/or subspecies Viola arvensis
    Murray (Gaud) and Viola vulgaris Koch (Oborny), herba cum flore
    EMA/HMPC/131734/2009
    Page 6/6


    Source: European Medicines Agency


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