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Eucalyptus Polybractea R.T 25 March 2014 EMA/HMPC/307782/2012 Committee on Herbal Medicinal Products (HMPC) Assessment report on Eucalytus globulus Labill., Eucalyptus polybractea R.T. Baker and/or Eucalyptus smithii R.T. Baker, aetheroleum Based on Article 16d(1), Article 16f and Article 16h of Directive 2001/83/EC as amended (traditional use) Final Herbal substance(s) (binomial scientific name of Eucalyptus globulus Labill., Eucalyptus the plant, including plant part) polybractea R.T. Baker and Eucalyptus smithii R.T. Baker, folium recens aut summitas recens Herbal preparation(s) Aetheroleum Pharmaceutical form(s) Herbal preparation in liquid or solid dosage forms for oral use. Herbal preparation in liquid dosage forms for inhalation or as bath additives. Herbal preparation in liquid or semi-solid dosage forms for cutaneous use. Rapporteur J. Wiesner Assessor(s) R. Hönow 7 Westferry Circus ● Canary Wharf ● London E14 4HB ● United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7523 7051 E -mail [email protected] Website www.ema.europa.eu An agency of the European Union © European Medicines Agency, 2014. Reproduction is authorised provided the source is acknowledged. Table of contents Table of contents ................................................................................................................... 2 1. Introduction ....................................................................................................................... 3 1.1. Description of the herbal substance(s), herbal preparation(s) or combinations thereof .. 3 1.2. Information about products on the market in the Member States ............................... 6 1.3. Search and assessment methodology ................................................................... 10 2. Historical data on medicinal use ...................................................................................... 10 2.1. Information on period of medicinal use in the Community ....................................... 10 2.2. Information on traditional/current indications and specified substances/preparations .. 10 2.3. Specified strength/posology/route of administration/duration of use for relevant preparations and indications ....................................................................................... 12 3. Non-Clinical Data ............................................................................................................. 16 3.1. Overview of available pharmacological data regarding the herbal substance(s), herbal preparation(s) and relevant constituents thereof ........................................................... 16 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 ....................................................................... 24 3.4. Overall conclusions on non-clinical data ................................................................ 27 4. Clinical Data ..................................................................................................................... 27 4.1. Clinical Pharmacology ......................................................................................... 27 4.1.1. Overview of pharmacodynamic data regarding the herbal substance(s)/preparation(s) including data on relevant constituents ........................................................................ 27 4.1.2. Overview of pharmacokinetic data regarding the herbal substance(s)/preparation(s) including data on relevant constituents ........................................................................ 28 4.2. Clinical Efficacy .................................................................................................. 28 4.2.1. Dose response studies...................................................................................... 29 4.2.2. Clinical studies (case studies and clinical trials) ................................................... 29 4.2.3. Clinical studies in special populations (e.g. elderly and children) ............................ 31 4.3. Overall conclusions on clinical pharmacology and efficacy ........................................ 32 5. Clinical Safety/Pharmacovigilance ................................................................................... 33 5.1. Overview of toxicological/safety data from clinical trials in humans ........................... 33 5.2. Patient exposure ................................................................................................ 33 5.3. Adverse events and serious adverse events and deaths .......................................... 33 5.4. Laboratory findings ............................................................................................. 34 5.5. Safety in special populations and situations ........................................................... 34 5.6. Overall conclusions on clinical safety ..................................................................... 35 6. Overall conclusions .......................................................................................................... 37 Annex .................................................................................................................................. 38 Assessment report on Eucalytus globulus Labill., Eucalyptus polybractea R.T. Baker and/or Eucalyptus smithii R.T. Baker, aetheroleum EMA/HMPC/307782/2012 Page 2/38 1. Introduction 1.1. Description of the herbal substance(s), herbal preparation(s) or combinations thereof • Herbal substance(s) The herbal substance consists of the fresh leaves or fresh terminal branchlets of various species of Eucalyptus rich in 1,8-cineole (from which the oil is obtained by steam distillation and rectification). Early edition of the Deutsche Arzneibuch [DAB 6 1951] only referred to Eucalyptus globulus Labill., while later editions [DAB 7 1968] referred to other species rich in 1,8-cineole, such as Eucalyptus polybractea R.T. Baker (syn. Eucalyptus fruticetorum F. Mueller ex Miquel) and Eucalyptus smithii R.T. Baker. The three species mainly used are Eucalyptus globulus Labill., Eucalyptus polybractea R.T. Baker and Eucalyptus smithii R.T. Baker [European Pharmacopoeia 2012, Real Farmacopea Espanola 2005, ESCOP 2003, Pharmacopée Française 1976, Blaschek et al. 2007]. The genus Eucalyptus belongs to the family of Myrtaceae, subfamily Myrtoideae and consists of more than 700 species. Occurrence Eucalyptus is indigenous to Tasmania and south-eastern Australia. It is cultivated in many parts of the world while the main producer regions of Eucalyptus globulus Labill., are the coasts of Spain, the Black sea and the Caucasus. Eucalyptus smithii R.T. Baker is cultivated in Brazil, Guatemala, Hawaii and at the French Atlantic coast as well as the Caucasus. Eucalyptus polybractea R.T. Baker occurs only in Australia especially in Victoria and New South Wales [Blaschek et al. 2007]. Biology There are several species of Eucalyptus, while Eucalyptus globulus Labill. is the most popular in terms of cultivation and medicinal use. The Eucalyptus trees with the highest 1,8-cineole content (80-95%) are Eucalyptus kochii and Eucalyptus polybractea [Clare 2010]. Eucalyptus trees are evergreen with leathery oil glands covered leaves. The leaves of Eucalyptus globulus Labill. are ensiform or sword-shaped, 15-30 cm up to 40 cm (6 to 12 inches ) long, 5 cm (2 inches) wide, bluish-green in hue, which are alternate and vertical [Blaschek et al. 2007]. The leaves are studded with brown lenticels and colourless glands containing fragrant volatile oil. Investigations by Daroui-Mokaddem et al. [2010] yielded an amount of 2.5% volatile oil derived from fresh leaves by hydrodistillation, while Cimanga et al. [2002] had found only 1.87%. Eucalyptus polybractea R.T. Baker is a small, deeply rooted, perennial tree with smooth and fibrous bark near the trunk base. Its leaves are disjunct and linear to narrow-lanceolate shaped 4-10 cm (1.5– 3.9 inches) long and 0.5-3 cm (0.2–1.2 inches) wide. Juvenile leaves are glaucous while adult ones are grey-green. The leaves may contain 1.2 to 2.5% of volatile oil [Blaschek et al. 2007]. Eucalyptus smithii R.T. Baker is a medium sized up to 46 m tall tree. Its bark is at the lower part deeply fissured and in the upper parts smooth and white. Leaves are green or bluish-green, narrow- lanceolate shaped 3-18 cm (1.2–7.1 inches) long and 1-3 cm (0.4–1.2 inches) wide. Leaves contain 1.2 to 2.2% volatile oil [Blaschek et al. 2007]. Constituents The main constituent of the volatile oil derived from fresh leaves of Eucalyptus species is 1,8-cineole. The reported content of 1,8-cineole varies for Eucalyptus globulus oil between 70-85%, 48.6%, 54- Assessment report on Eucalytus globulus Labill., Eucalyptus polybractea R.T. Baker and/or Eucalyptus smithii R.T. Baker, aetheroleum EMA/HMPC/307782/2012 Page 3/38 61% and 54-95% [Wichtl 2004, Daroui-Mokaddem et al. 2010, Betts 2000, WHO monographs 2002] respectively. Beside 1,8-cineole, the oil contains monoterpenes such as cymene, α-pinene, β-pinene and limonene, geraniol and camphene [Blaschek et al. 2007]. The WHO monograph [2002] describes additionally aromadendrene, cuminaldehyde, globulol and pinocarveol among its constituents. Silvestre et al. [1997] have found that younger leaves tend to have a higher oil-content than mature
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