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Non-clinical documentation in applications for marketing authorisation / registration of well-established and traditional herbal medicinal products
Last updated: 25/02/2019Non-clinical documentation in applications for marketing … medicinal products, non-clinical documentation, traditional use registration … Guideline on non-clinical documentation in applications for marketing …
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Organisational Matters Drafting Group
the development of guidance documents and templates necessary for … the development of guidance documents and templates necessary for …
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Herbal medicinal product: Menthae piperitae aetheroleum (updated)
Mentha x piperita L., Peppermint oil, F: Assessment finalised, Last updated: 07/04/2021medicine or contact their doctor or pharmacist. What is peppermint … London, 8 May 2008 Doc. Ref. EMEA/HMPC/189245/2008 … the medicinal product, a doctor or a qualified health care … -
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Herbal medicinal product: Origani dictamni herba (updated)
Origanum dictamnus L., Dittany of Crete herb, C: ongoing call for scientific data, Last updated: 07/04/2021medicine or contact their doctor or pharmacist. What is dittany … took into account the well documented and longstanding use of dittany … monograph under the tab 'All documents'. How are dittany of Crete … -
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Herbal medicinal product: Lichen islandicus (updated)
Cetraria islandica (L.) Acharius s.l., Iceland moss, C: ongoing call for scientific data, Last updated: 07/04/2021medicine or contact their doctor or pharmacist. What is Iceland … while taking the medicine, a doctor or a qualified healthcare … monograph under the tab 'All documents'. How are Iceland moss medicines … -
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Herbal medicinal product: Marrubii herba (updated)
Marrubium vulgare L., White horehound, C: ongoing call for scientific data, Last updated: 07/04/2021medicine or contact their doctor or pharmacist. What is white … HMPC considered the well documented and longstanding use of white … monograph under the tab 'All documents'. How are white horehound medicines … -
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Herbal medicinal product: Paulliniae semen (updated)
Paullinia cupana Kunth ex H.B.K. var sorblis (Mart.) Ducke, Guarana seed, C: ongoing call for scientific data, Last updated: 07/04/2021medicine or contact their doctor or pharmacist. What is guarana … monograph under the tab 'All documents'. How are guarana seed medicines … found under the tab 'All documents'. For more information about … -
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Herbal medicinal product: Rhodiolae roseae rhizoma et radix (updated)
Rhodiola rosea L., Arctic root, C: ongoing call for scientific data, Last updated: 07/04/2021medicine or contact their doctor or pharmacist. What is arctic … monograph under the tab 'All documents'. How are arctic root medicines … found under the tab 'All documents'. For more information about … -
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Herbal medicinal product: Menthae piperitae folium (updated)
Mentha x piperita L., peppermint leaf, F: Assessment finalised, Last updated: 07/04/2021medicine or contact their doctor or pharmacist. What is peppermint … the medicinal product, a doctor or a qualified health care … -
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Herbal medicinal product: Cinnamomi cortex (updated)
Cinnamomum verum J. S. Presl, Cinnamon, F: Assessment finalised, Last updated: 09/04/2021developing this information. Documents All documents Addendum to assessment report … the medicinal product, a doctor or a qualified health care … the medicinal product, a doctor or a qualified health care … -
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Herbal medicinal product: Millefolii herba (updated)
Achillea millefolium L., Yarrow, F: Assessment finalised, Last updated: 07/04/2021medicine or contact their doctor or pharmacist. What is yarrow … monograph and supporting documents. The publication of this … monograph and supporting documents. Scientific contributions … -
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Herbal medicinal product: Trigonellae foenugraeci semen (updated)
Trigonella foenum-graecum L., Fenugreek, F: Assessment finalised, Last updated: 16/04/2021European Union herbal monograph Documents All documents Final community herbal monograph … the medicinal product, a doctor or a qualified health care … the medicinal product, a doctor or a qualified health care … -
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Herbal medicinal product: Juglandis folium
Juglans regia L., Walnut leaf, F: Assessment finalised, Last updated: 02/03/2021medicine or contact their doctor or pharmacist. What is walnut … week. If symptoms persist, a doctor should be consulted. Detailed … took into account the well documented and very longstanding use … -
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Herbal medicinal product: Eucalypti folium
Eucalyptus globulus Labill., Eucalyptus leaf, F: Assessment finalised, Last updated: 02/03/2021medicine or contact their doctor or pharmacist. What is eucalyptus … for longer than a week, a doctor should be consulted. Detailed … monograph under the tab 'All documents'. How are eucalyptus leaf medicines … -
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Herbal medicinal product: Ginseng radix
Panax ginseng C. A. Meyer., Ginseng, F: Assessment finalised, Last updated: 02/03/2021medicine or contact their doctor or pharmacist. What is ginseng … the use of the medicine, a doctor or a qualified healthcare … monograph under the tab 'All documents'. How are ginseng root medicines … -
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Herbal medicinal product: Tiliae flos (updated)
Tilia cordata Miller, Lime flower, C: ongoing call for scientific data, Last updated: 07/04/2021European Union herbal monograph Documents All documents Final Community herbal monograph … monograph and supporting documents. The publication of this call … monograph and supporting documents. Scientific contributions … -
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Herbal medicinal product: Urticae radix (updated)
Urtica dioica L.; Urtica urens L., Nettle root, C: ongoing call for scientific data, Last updated: 07/04/2021European Union herbal monograph Documents All documents Final Community herbal monograph … monograph and supporting documents. The publication of this call … monograph and supporting documents. Scientific contributions … -
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Herbal medicinal product: Liquiritiae radix (updated)
Glycyrrhiza glabra L. and/or Glycyrrhiza inflata Bat. and/or Glycyrrhiza uralensis Fisch., Liquorice Root, C: ongoing call for scientific data, Last updated: 07/04/2021European Union herbal monograph Documents All documents Final Community herbal monograph … monograph and supporting documents. The publication of this call … monograph and supporting documents. Scientific contributions … -
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Herbal medicinal product: Eucalypti aetheroleum
Eucalyptus globulus Labill.; Eucalyptus polybractea R.T. Baker; Eucalyptus smithii R.T. Baker., Eucalyptus Oil, F: Assessment finalised, Last updated: 02/03/2021medicine or contact their doctor or pharmacist. What is eucalyptus … the use of the medicine, a doctor or a qualified healthcare … is applied to the skin, a doctor or a qualified healthcare … -
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Herbal medicinal product: Hyperici herba (updated)
Hypericum perforatum L., St. John's Wort, P: Draft published, Last updated: 16/04/2021European Union herbal monograph Documents All documents Final community herbal monograph … -
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Herbal medicinal product: Cichorii intybi radix
Cichorium intybus L., Chicory root, F: Assessment finalised, Last updated: 02/02/2021medicine or contact their doctor or pharmacist. What is chicory … over the age of 12 years. A doctor should be consulted if the … took into account the well documented use of chicory root in digestive … -
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Herbal medicinal product: Arnicae flos
Arnica montana L., Arnica flower, F: Assessment finalised, Last updated: 02/02/2021medicine or contact their doctor or pharmacist. What is arnica … the use of the medicine a doctor or a qualified healthcare … monograph under the tab 'All documents'. How are arnica flower medicines … -
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Herbal medicinal product: Curcumae xanthorrhizae rhizoma
Curcuma xanthorrhiza Roxb. (C. xanthorrhiza D. Dietrich)., Javanese turmeric, F: Assessment finalised, Last updated: 02/02/2021medicine or contact their doctor or pharmacist. What is Javanese … the use of the medicine, a doctor or a qualified healthcare … monograph under the tab 'All documents'. How are Javanese turmeric … -
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Herbal medicinal product: Hippocastani cortex
Aesculus hippocastanum L., Horse-chestnut bark, F: Assessment finalised, Last updated: 02/03/2021European Union herbal monograph Documents All documents Final Community herbal monograph … monograph and supporting documents. The publication of this call … monograph and supporting documents. Scientific contributions … -
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Herbal medicinal product: Fraxini folium
Fraxinus excelsior L. or Fraxinus angustifolia Vahl, Ash Leaf, F: Assessment finalised, Last updated: 02/03/2021European Union herbal monograph Documents All documents Final Community herbal monograph … monograph and supporting documents. The publication of this call … monograph and supporting documents. Scientific contributions …