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Assessment Report on Gentiana Lutea L., Radix Based on Article 16D(1), Article 16F and Article 16H of Directive 2001/83/EC (Traditional Use)

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Assessment Report on Gentiana Lutea L., Radix Based on Article 16D(1), Article 16F and Article 16H of Directive 2001/83/EC (Traditional Use) 20 November 2018 EMA/HMPC/607863/2017 Committee on Herbal Medicinal Products (HMPC) Assessment report on Gentiana lutea L., radix Based on Article 16d(1), Article 16f and Article 16h of Directive 2001/83/EC (traditional use) Final Herbal substance(s) (binomial scientific name of Gentiana lutea L., radix (gentian root) the plant, including plant part) Herbal preparation(s) a) Comminuted herbal substance b) Dry extract (DER 4.5-5.5:1) ethanol 53% V/V c) Liquid extract (DER 1:1) ethanol 45% V/V d) Tincture (ratio of herbal substance to extraction solvent 1:5) ethanol 70% V/V Pharmaceutical form(s) Comminuted herbal substance as herbal tea for oral use. Herbal preparation in solid or liquid dosage forms for oral use. Rapporteur(s) Dr. Werner Knöss Assessor(s) Dr. Friederike Stolte Dr. Felicitas Deget Peer-reviewer Dr. Ioanna Chinou Domenico Scarlattilaan 6 ● 1083 HS ● Amsterdam ● The Netherlands Telephone +31 (0)88 781 6000 Send a question via our website www.ema.europa.eu/contact An agency of the European Union © European Medicines Agency, 2019. 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. Search and assessment methodology ..................................................................... 6 2. Data on medicinal use ........................................................................................................ 6 2.1. Information about products on the market .............................................................. 6 2.1.1. Information about products on the market in the EU/EEA Member States ................. 6 2.1.2. Information on products on the market outside the EU/EEA .................................... 7 2.2. Information on documented medicinal use and historical data from literature .............. 8 2.3. Overall conclusions on medicinal use .................................................................... 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 3.1.1. Primary pharmacodynamics .............................................................................. 12 3.1.2. Secondary pharmacodynamics .......................................................................... 13 3.1.3. Safety pharmacology ....................................................................................... 14 3.1.4. Pharmacodynamic interactions .......................................................................... 14 3.1.5. Conclusions .................................................................................................... 14 3.2. Overview of available pharmacokinetic data regarding the herbal substance(s), herbal preparation(s) and relevant constituents thereof ........................................................... 14 3.3. Overview of available toxicological data regarding the herbal substance(s)/herbal preparation(s) and constituents thereof ....................................................................... 15 3.3.1. Single dose toxicity .......................................................................................... 15 3.3.2. Repeat dose toxicity ......................................................................................... 15 3.3.3. Genotoxicity ................................................................................................... 15 3.3.4. Carcinogenicity ................................................................................................ 16 3.3.5. Reproductive and developmental toxicity ............................................................ 16 3.3.6. Local tolerance ................................................................................................ 16 3.3.7. Other special studies ........................................................................................ 16 3.3.8. Conclusions .................................................................................................... 16 3.4. Overall conclusions on non-clinical data ................................................................ 17 4. Clinical Data ..................................................................................................................... 17 4.1. Clinical pharmacology ......................................................................................... 17 4.1.1. Overview of pharmacodynamic data regarding the herbal substance(s)/preparation(s) including data on relevant constituents ........................................................................ 17 4.1.2. Overview of pharmacokinetic data regarding the herbal substance(s)/preparation(s) including data on relevant constituents ........................................................................ 18 4.2. Clinical efficacy .................................................................................................. 18 4.2.1. Dose response studies...................................................................................... 18 4.2.2. Clinical studies (case studies and clinical trials) ................................................... 18 4.3. Clinical studies in special populations (e.g. elderly and children) .............................. 21 4.4. Overall conclusions on clinical pharmacology and efficacy ........................................ 21 5. Clinical Safety/Pharmacovigilance ................................................................................... 21 5.1. Overview of toxicological/safety data from clinical trials in humans ........................... 21 Assessment report on Gentiana lutea L., radix EMA/HMPC/607863/2017 Page 2/23 5.2. Patient exposure ................................................................................................ 21 5.3. Adverse events, serious adverse events and deaths ................................................ 21 5.4. Laboratory findings ............................................................................................. 21 5.5. Safety in special populations and situations ........................................................... 22 5.5.1. Use in children and adolescents ......................................................................... 22 5.5.2. Contraindications ............................................................................................. 22 5.5.3. Special warnings and precautions for use ........................................................... 22 5.5.4. Drug interactions and other forms of interaction .................................................. 22 5.5.5. Fertility, pregnancy and lactation ....................................................................... 22 5.5.6. Overdose ........................................................................................................ 22 5.5.7. Effects on ability to drive or operate machinery or impairment of mental ability ...... 22 5.5.8. Safety in other special situations ....................................................................... 22 5.6. Overall conclusions on clinical safety ..................................................................... 22 6. Overall conclusions (benefit-risk assessment) ................................................................. 23 Annex .................................................................................................................................. 23 Assessment report on Gentiana lutea L., radix EMA/HMPC/607863/2017 Page 3/23 1. Introduction 1.1. Description of the herbal substance(s), herbal preparation(s) or combinations thereof Gentianae radix is described in the European Pharmacopoeia (1380) as follows: “Dried, fragmented underground organs of Gentiana lutea L., with a characteristic odour and a strong and persistent bitter taste. Gentian root occurs as single or branched subcylindrical pieces of various lengths and usually 10-40 mm thick but occasionally up to 80 mm thick at the crown.” Gentiana lutea is a species of the Gentianaceae family, growing to 1-2 m tall, with broad lanceolate to elliptic leaves 10-30 cm long and 4-12 cm broad. The flowers are yellow, with the corolla separated nearly to the base into 5-7 narrow petals. The main root can be over 1 meter in length and can weigh up to 7 kg (fresh). It grows in grassy alpine and sub-alpine pastures, usually on calcareous soils native to the mountains of central and southern Europe. It grows naturally on uncultivated ground in France, Spain and the Balkan mountains. The plant is under wildlife protection; therefore it is cultivated for plant production mostly in Germany and France (Blaschek et al., 2016, Hänsel and Sticher, 2007). The composition of the constituents (carbohydrates and essential bitters) is depending on the time of harvesting. The content of sugars decreases in spring and increases to their maximum content in July. In contrast, the bitter substances reach their maximum content in spring and decrease according to the growth of the sugar content (Franz et al., 1985). It
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