Assessment report on Lavandula angustifolia Mill ... ... Assessment report on Lavandula angustifolia

  • View
    0

  • Download
    0

Embed Size (px)

Text of Assessment report on Lavandula angustifolia Mill ... ... Assessment report on Lavandula angustifolia

  • 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 An agency of the European Union

    © European Medicines Agency,2011}. Reproduction is authorised provided the source is acknowledged.

    15 April 2011 EMA/HMPC/143183/2010 Committee on Herbal Medicinal Products (HMPC)

    Assessment report on Lavandula angustifolia Mill., aetheroleum and Lavandula angustifolia Mill., flos Based on Article 16d(1), Article 16f and Article 16h of Directive 2001/83/EC as amended (traditional

    use)

    Draft

    Lavandula angustifolia Mill., aetheroleum;

    Lavandula angustifolia Mill., flos

    Herbal substance(s) (binomial scientific name of

    the plant, including plant part)

    Herbal preparation(s)  Lavandulae aetheroleum Essential oil obtained by steam distillation from

    the flowering tops of Lavandula angustifolia Mill.

     Lavandulae flos a) Comminuted herbal substance

    b) Tincture (ratio of herbal substance to

    extraction solvent 1:5), extraction solvent ethanol

    50-60% v/v

    Pharmaceutical forms  Lavandulae aetheroleum Herbal preparation in liquid dosage form for oral

    use and as a bath additive.

     Lavandulae flos Herbal substance or comminuted herbal substance

    as herbal tea for oral use.

    Herbal preparations in liquid dosage form for oral

    use.

    Note: This draft Assessment Report is published to support the release for public consultation of the

    draft Community herbal monograph on Lavandula angustifolia Mill., aetheroleum and of the draft

    monograph on Lavandula angustifolia Mill., flos. It should be noted that this document is a working

    document, not yet fully edited, and which shall be further developed after the release for consultation

    of the monographs. Interested parties are welcome to submit comments to the HMPC secretariat,

  • Assessment report on Lavandula angustifolia Mill., aetheroleum and Lavandula angustifolia Mill., flos

    EMA/HMPC/143183/2010 Page 2/45

    which the Rapporteur and the MLWP will take into consideration but no ‘overview of comments

    received during the public consultation’ will be prepared in relation to the comments that will be

    received on this assessment report. The publication of this draft assessment report has been agreed to

    facilitate the understanding by Interested Parties of the assessment that has been carried out so far

    and led to the preparation of the draft monographs.

  • Assessment report on Lavandula angustifolia Mill., aetheroleum and Lavandula angustifolia Mill., flos

    EMA/HMPC/143183/2010 Page 3/45

    Table of contents Table of contents ...................................................................................................................3 1. Introduction.......................................................................................................................4 1.1. Description of the herbal substance(s), herbal preparation(s) or combinations thereof . 4 1.2. Information about products on the market in the Member States .............................. 5 1.3. Search and assessment methodology.................................................................... 8 2. Historical data on medicinal use ........................................................................................9 2.1. Information on period of medicinal use in the Community ........................................ 9 2.2. Information on traditional/current indications and specified substances/preparations ... 9 2.3. Specified strength/posology/route of administration/duration of use for relevant preparations and indications..................................................................................... 10 3. Non-Clinical Data .............................................................................................................12 3.1. Overview of available pharmacological data regarding the herbal substance(s), herbal preparation(s) and relevant constituents thereof ......................................................... 12 3.2. Overview of available pharmacokinetic data regarding the herbal substance(s), herbal preparation(s) and relevant constituents thereof ......................................................... 22 3.3. Overview of available toxicological data regarding the herbal substance(s)/herbal preparation(s) and constituents thereof ..................................................................... 22 3.4. Overall conclusions on non-clinical data............................................................... 23 4. Clinical Data.....................................................................................................................24 4.1. Clinical Pharmacology ....................................................................................... 24 4.1.1. Overview of pharmacodynamic data regarding the herbal substance(s)/preparation(s) including data on relevant constituents ...................................................................... 24 4.1.2. Overview of pharmacokinetic data regarding the herbal substance(s)/preparation(s) including data on relevant constituents ...................................................................... 30 4.2. Clinical Efficacy ................................................................................................ 31 4.2.1. Dose response studies.................................................................................... 31 4.2.2. Clinical studies (case studies and clinical trials).................................................. 31 4.2.3. Clinical studies in special populations (e.g. elderly and children)........................... 39 4.3. Overall conclusions on clinical pharmacology and efficacy ...................................... 43 5. Clinical Safety/Pharmacovigilance...................................................................................43 5.1. Overview of toxicological/safety data from clinical trials in humans.......................... 43 5.2. Patient exposure .............................................................................................. 44 5.3. Adverse events and serious adverse events and deaths ......................................... 44 5.4. Laboratory findings .......................................................................................... 44 5.5. Safety in special populations and situations ......................................................... 44 5.6. Overall conclusions on clinical safety................................................................... 44 6. Overall conclusions ..........................................................................................................44 Annex ..................................................................................................................................45

  • Assessment report on Lavandula angustifolia Mill., aetheroleum and Lavandula angustifolia Mill., flos

    EMA/HMPC/143183/2010 Page 4/45

    1. Introduction

    1.1. Description of the herbal substance(s), herbal preparation(s) or combinations thereof

     Herbal substance(s)

    Lavender flower consists of the dried flowers of Lavandula angustifolia Miller (Lavandula officinalis

    Chaix) (European Pharmacopoeia 2008a).

     Herbal preparation(s)

    Essential oil obtained by steam distillation from the flowering tops of Lavandula angustifolia Miller

    (Lavandula officinalis Chaix) (European Pharmacopoeia 2008b).

    The species is regularly confused with other lavender species L. x intermedia Emeric. (Lavandin) and L.

    latifolia MEDIK. (Spiklavender). If no detailed quality specifications are mentioned, the herbal

    substance consists of flowers from different flower species (Hänsel et al. 1993).

     Combinations of herbal substance(s) and/or herbal preparation(s) including a description of vitamin(s) and/or mineral(s) as ingredients of traditional combination herbal medicinal products

    assessed, where applicable.

    Not applicable.

     Constituents

    Lavender flower contains not less than 13 ml/kg of essential oil, calculated with reference to the dried

    drug.

    Lavender flower

    - Essential oil (1-3%)

    - Coumarin derivatives: umbelliferon, herniarine

    - Flavonoids

    - Sterols (traces): cholesterol, campesterol, stigamsterol, β-sitosterol

    - Triterpenes (traces): mictomeric acid, ursolic acid

    - Tannins: up to 13% in the herbal substance

    - Phenylcarboxylic acids such as rosmarinic acid, ferulic acid, isoferulic acid, α-cumaric acid, p-cumaric

    acid, gentisinic acid, p-OH-benzoic acid, caffeic acid, melilotic acid, sinapinic acid, sytingic acid,

    vanillinic acid.

    Lavender oil

    The main components of the essential oil are monoterpene alcohols (60-65%) such as linalool (20-

    50% of the fraction), linalyl acetate (25-46% of the fraction).

    Others include cis-ocimen (3-7%), terpinene-4-ol (3-5%), limonene, cineole, camphor, lavandulyl

    acetate, lavandulol and α-terpineol, β-caryophyllene, geraniol, α-pinen.

    Non-terpenoid aliphatic components: 3-octanon, 1-octen-3-ol, 1-octen-3-ylacetate, 3-octanol. (ESCOP

    2009; Hänsel et al. 1993; Bruneton 1999).

  • Assessment report on Lavandula angustifolia Mill., aetheroleum and Lavandula angustifolia Mill., flos