assessment report on cetraria islandica (stronglstrong.) acharius s.stronglstrong.,.pdf

6 May 2014 EMA/HMPC/36866/2014 Committee on Herbal Medicinal Products (HMPC) Assessment report on Cetraria islandica (L.) Acharius s.l., thallus Based on Article 16d(1), Article 16f and Article 16h of Directive 2001/83/EC as amended (traditional use) Draft Herbal substance(s) (binomial scientific name of the plant, including plant part) Cetraria islandica (L.) Acharius s.l., thallus Herbal preparation(s) Comminuted herbal substance Soft extract (DER 2-4:1), extraction solvent water Soft extract (DER 0.4-0.8:1), extraction solvent water Tincture (ratio of herbal substance to extraction solvent 1:5), extraction solvent ethanol 40% (V/V) Pharmaceutical form(s) Comminuted herbal substance as herbal tea for oral use Herbal preparations in liquid or solid dosage forms for oral or oromucosal use Rapporteur(s) Marie Heroutova Assessor(s) Marie Heroutova Note: This draft assessment report is published to support the release for public consultation of the draft Community herbal monograph on Cetraria islandica (L.) Acharius s.l., thallus. It should be noted that this document is a working document, not yet edited, and which shall be further developed after the release for consultation of the monograph. Interested parties are welcome to submit comments to the HMPC secretariat, which the Rapporteur and the MLWP will take into consideration but no ‘overview of comments received during the public consultation’ will be prepared in relation to the comments that will be received on this assessment report.