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Superseded Marianne Peikert 31 March 2011 EMA/HMPC/289432/2009 Committee on Herbal Medicinal Products (HMPC) Assessment report on Hedera helix L., folium Based on Article 10a of Directive 2001/83/EC as amended (well-established use) 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 the plant, including plant part) Hedera helix L., folium Herbal preparation(s) • Well-established use a) Dry extract (DER 4-8:1), extraction solvent ethanol 24-30% m/m b) Dry extract (DER 6-7:1), extraction solvent ethanol 40% m/m c) Dry extract (DER 3-6:1), extraction solvent ethanol 60% m/m d) Liquid extract (DER 1:1), extraction solvent ethanol 70% V/V • Traditional use a) Soft extract (DER 2.2-2.9:1), extraction solvent ethanol 50% V/V: propylene glycol (98:2) Pharmaceutical forms Herbal preparations in solid or liquid dosage forms for oral use. Rapporteur Dr Jacqueline Wiesner AssessorSuperseded Marianne Peikert 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, 2016. Reproduction is authorised provided the source is acknowledged. Table of contents Table of contents ......................................................................................... 2 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 ..................................................................... 9 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 .. 11 2.3. Specified strength/posology/route of administration/duration of use for relevant preparations and indications ....................................................................................... 12 3. Non-Clinical Data ................................................................................... 23 3.1. Overview of available pharmacological data regarding the herbal substance(s), herbal preparation(s) and relevant constituents thereof ........................................................... 23 3.2. Overview of available pharmacokinetic data regarding the herbal substance(s), herbal preparation(s) and relevant constituents thereof ........................................................... 32 3.3. Overview of available toxicological data regarding the herbal substance(s)/herbal preparation(s) and constituents thereof ....................................................................... 35 3.4. Overall conclusions on non-clinical data ................................................................ 41 4. Clinical Data .......................................................................................... 42 4.1. Clinical Pharmacology ......................................................................................... 42 4.1.1. Overview of pharmacodynamic data regarding the herbal substance(s)/preparation(s) including data on relevant constituents ........................................................................ 42 4.1.1.1. Primary Pharmacodynamics ........................................................................... 42 4.1.1.2. Secondary Pharmacodynamics ....................................................................... 42 4.1.2. Overview of pharmacokinetic data regarding the herbal substance(s)/preparation(s) including data on relevant constituents ........................................................................ 42 4.2. Clinical Efficacy .................................................................................................. 43 4.2.1. Dose response studies...................................................................................... 45 4.2.2. Clinical studies (case studies and clinical trials) ................................................... 46 4.2.3. Clinical studies in special populations (e.g. elderly and children) ............................ 73 4.3. Overall conclusions on clinical pharmacology and efficacy ........................................ 75 5. Clinical Safety/Pharmacovigilance ........................................................ 79 5.1. Overview of toxicological/safety data from clinical trials in humans ........................... 79 5.2. Patient exposure ................................................................................................ 79 5.3. Adverse events and serious adverse events and deaths .......................................... 79 5.4. Laboratory findings ............................................................................................. 83 5.5. SafetySuperseded in special populations and situations ........................................................... 84 5.6. Overall conclusions on clinical safety ..................................................................... 86 Assessment report on Hedera helix L., folium EMA/HMPC/289432/2009 Page 2/89 6. Overall conclusions................................................................................ 88 Annex ........................................................................................................ 89 Superseded Assessment report on Hedera helix L., folium EMA/HMPC/289432/2009 Page 3/89 1. Introduction 1.1. Description of the herbal substance(s), herbal preparation(s) or combinations thereof • Herbal substance(s) Hederae folium (Ivy leaf) (European Pharmacopoeia) Whole or cut, dried leaves of Hedera helix L., collected in spring. Content: minimum 3.0% of hederacoside C (C59H96O26; Mr 1221) (dried herbal substance). The species Hedera helix L., Araliaceae, is known under the synonyms: Hedera caucasigena POJARK; H. chrysocarpa WALSH; Hedera helix ssp. caucasica KLEOP.; Hedera helix var. chrysocarpa TEN.; Hedera taurica CARR.; Hedera helix var. taurica TOBLER (HagerROM, 2006). The species Hedera helix L., which is a source of the drug, is subdivided into three botanical varieties, Hedera helix var. baltica, Hedera helix var. helix and Hedera helix var. hibernica. (HagerROM, 2006). In the European countries Hedera helix is designated as follow: German: Efeubätter, Rankenefeu, Mauerefeu, Totenranke, Epig; English: English Ivy, Common Ivy, Woodbind, Bindwood; French: Lierre à cautère, Lierre commun, Lierre des poètes, Lierre grimpant; Italian: Edera, Ellera; Spanish: Hiedra; Danish: Efeu, Vedbend; Dutch: Klimop; Norwegian: Bergflette, Eføi; Polish: Bluszcz; Russian: Pluszcz; Swedish: Murgröna; Czech: Břečtan obecný; Hungarian: Borostyán (HagerROM, 2006). Constituents: According to Wichtl (2004) the most important constituents of the plant are: − About 2.5-6% mostly bidesmosidic triterpene saponins with hederagenin, oleanolic acid and bayogenin (= 2ß-hydroxyhederagenin) as aglycones and acylglycosidic sugar chains at C-28 of the carboxyl group − Small amounts of monodesmosides such as α-hederin and hederagenin-3-O-ß-D-glucoside, which can develop during the drying process from the bisdesmoside in the fresh leaves by hydrolytic cleavage of the sugar chain at C-28 − The main saponin is the hederasaponin C (hederacoside C) with other hederasaponins (B, D, E, F, G, H and I) present as well. Hederasaponin A, described in an earlier publication could no longer be found in subsequent studies. The content ratios of the hederasaponins (C : B : D : E : F : G : H : I) are about 1000 : 70 : 45 : 10 : 40 : 15 : 6 : 5 − Flavonoids such as quercetin and kaempferol including their 3-O-rutinosides and 3-O- glucosides (= isoquercitrin and astragalin) − Caffeic acid derivates and other phenolics such as caffeic acid and dihydroxy-benzoic acid − Coumarin glycoside scopolin and the polyacetylenes falcarinone, falcarinol and 11, 12- dihydrofalcarinol − SupersededPhytosterols as stigmasterol, sitosterol, cholesterol, campesterol, α-spinasterol − The volatile oil (in the fresh leaves 0.1-0.3%) consists of methyl-ethyl ketone, methylisobutyl ketone, trans-hexanal, germacrene D, ß-caryphyllene, sabinene, α- and ß-pinene − Hamamiletol − Free amino acids Assessment report on Hedera helix L., folium EMA/HMPC/289432/2009 Page 4/89 − The occurrence of the alkaloid emetine could not be confirmed in recent studies (Czygan, 1990). From four varieties grown in Egypt the alkaloid emetine was isolated (Mahran et al., 1975). Convincing studies are missing (HagerROM, 2006). • Herbal preparation(s) See chapter 1.2. • 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. Ivy extracts are also used in combination with other herbal substances/herbal preparations. This monograph refers exclusively to monopreparations. 1.2. Information about products on the market in the Member States Table 1. Specified products on the market in the European Member State Member State Medicinal Product Regulatory Status Austria 1) 1 lozenge contains 26 mg dry extract (4-8:1), extraction solvent MA 2005 ethanol 30% (m/m) 2) 1 capsule
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