EMA/HMPC/244313/2016 EMA/HMPC/M/H/187 Committee on Herbal Medicinal Products (HMPC)
Opinion of the HMPC on a European Union herbal monograph on Polygonum aviculare L., herba Opinion The HMPC, in accordance with Article 16h(3) of Directive 2001/83/EC, as amended, and as set out in the appended assessment report, establishes by a majority of 25 out of 26 votes a European Union herbal monograph on Polygonum aviculare L., herba which is set out in Annex I. The divergent position is appended to this opinion. The Norwegian HMPC member agrees with the above-mentioned recommendation of the HMPC. This opinion is forwarded to Member States, to Iceland and Norway, together with its Annex I and appendices. The European Union herbal monograph and assessment report will be published on the European Medicines Agency website.
London, 5 April 2016
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Opinion of the HMPC on a European Union herbal monograph on Polygonum aviculare L., herba EMA/HMPC/244313/2016
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Appendix II: Divergent positions
Opinion of the HMPC on a European Union herbal monograph on Polygonum aviculare L., herba EMA/HMPC/244313/2016
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The member of the HMPC mentioned below did not agree with the HMPC’s opinion for the following reason: Regarding the EU Herbal Monograph for Polygonum avicularis herba, I have to take a divergent position regarding the following parts of the indication: From a Dutch point of view, for indication 2, “Traditional herbal medicinal product for symptomatic treatment of mild irritations in the mouth or throat.”
should be preferable.
And for indication 3 “Traditional herbal medicinal product used to achieve flushing of the urinary tract as an adjuvant in minor urinary tract complaints” is considered acceptable.
Emiel van Galen, HMPC member from the Netherlands London, 5 April 2016
Opinion of the HMPC on a European Union herbal monograph on Polygonum aviculare L., herba EMA/HMPC/244313/2016
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