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European Ethnopharmaceuticals for Self-Medication in Japan: Review Experience of Vitis vinifera L., Folium Extract and Vitex agnus-castus L., Fructus Extract as OTC Drugs

Since the publication of “Application Guideline for Western Traditional Herbal Medicines as OTC Drugs” in 2007, only two European ethnopharmaceuticals, Vitis vinifera L., folium extract (Antistax) and Vitex agnus-castus L., fructus extract (Prefemin), have been approved as OTC drugs in Japan. In thi...

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Detalles Bibliográficos
Autores principales: Hoshino, Tatsuro, Muto, Nanami, Tsukada, Shinsuke, Nakamura, Takatoshi, Maegawa, Hikoichiro
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5874568/
https://www.ncbi.nlm.nih.gov/pubmed/29316611
http://dx.doi.org/10.3390/medicines5010003
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author Hoshino, Tatsuro
Muto, Nanami
Tsukada, Shinsuke
Nakamura, Takatoshi
Maegawa, Hikoichiro
author_facet Hoshino, Tatsuro
Muto, Nanami
Tsukada, Shinsuke
Nakamura, Takatoshi
Maegawa, Hikoichiro
author_sort Hoshino, Tatsuro
collection PubMed
description Since the publication of “Application Guideline for Western Traditional Herbal Medicines as OTC Drugs” in 2007, only two European ethnopharmaceuticals, Vitis vinifera L., folium extract (Antistax) and Vitex agnus-castus L., fructus extract (Prefemin), have been approved as OTC drugs in Japan. In this review, we describe the current regulation of Western ethnopharmaceuticals in Japan, summarize our regulatory experiences and discuss the scientific and regulatory issues involved.
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spelling pubmed-58745682018-03-30 European Ethnopharmaceuticals for Self-Medication in Japan: Review Experience of Vitis vinifera L., Folium Extract and Vitex agnus-castus L., Fructus Extract as OTC Drugs Hoshino, Tatsuro Muto, Nanami Tsukada, Shinsuke Nakamura, Takatoshi Maegawa, Hikoichiro Medicines (Basel) Review Since the publication of “Application Guideline for Western Traditional Herbal Medicines as OTC Drugs” in 2007, only two European ethnopharmaceuticals, Vitis vinifera L., folium extract (Antistax) and Vitex agnus-castus L., fructus extract (Prefemin), have been approved as OTC drugs in Japan. In this review, we describe the current regulation of Western ethnopharmaceuticals in Japan, summarize our regulatory experiences and discuss the scientific and regulatory issues involved. MDPI 2018-01-06 /pmc/articles/PMC5874568/ /pubmed/29316611 http://dx.doi.org/10.3390/medicines5010003 Text en © 2018 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Review
Hoshino, Tatsuro
Muto, Nanami
Tsukada, Shinsuke
Nakamura, Takatoshi
Maegawa, Hikoichiro
European Ethnopharmaceuticals for Self-Medication in Japan: Review Experience of Vitis vinifera L., Folium Extract and Vitex agnus-castus L., Fructus Extract as OTC Drugs
title European Ethnopharmaceuticals for Self-Medication in Japan: Review Experience of Vitis vinifera L., Folium Extract and Vitex agnus-castus L., Fructus Extract as OTC Drugs
title_full European Ethnopharmaceuticals for Self-Medication in Japan: Review Experience of Vitis vinifera L., Folium Extract and Vitex agnus-castus L., Fructus Extract as OTC Drugs
title_fullStr European Ethnopharmaceuticals for Self-Medication in Japan: Review Experience of Vitis vinifera L., Folium Extract and Vitex agnus-castus L., Fructus Extract as OTC Drugs
title_full_unstemmed European Ethnopharmaceuticals for Self-Medication in Japan: Review Experience of Vitis vinifera L., Folium Extract and Vitex agnus-castus L., Fructus Extract as OTC Drugs
title_short European Ethnopharmaceuticals for Self-Medication in Japan: Review Experience of Vitis vinifera L., Folium Extract and Vitex agnus-castus L., Fructus Extract as OTC Drugs
title_sort european ethnopharmaceuticals for self-medication in japan: review experience of vitis vinifera l., folium extract and vitex agnus-castus l., fructus extract as otc drugs
topic Review
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5874568/
https://www.ncbi.nlm.nih.gov/pubmed/29316611
http://dx.doi.org/10.3390/medicines5010003
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