EMEA wants ethanol limited in herbal meds
This article was originally published in The Tan Sheet
Executive SummaryManufacturers should limit ethanol content in pediatric herbal medicines so that blood ethanol concentrations do not exceed 0.125 g/L after a single dose, the European Medicines Agency's Committee on Herbal Medicinal Products recommends in a Nov. 6 reflection paper. EMEA says safety thresholds for ethanol exposure to children by oral herbal products are necessary because "even small amounts of ethanol" could harm children's psychomotor development, among other risks. The committee also recommends products with more than 30 grams of ethanol be packaged in childproof containers. Comments on the recommendations are due March 15
You may also be interested in...
February and March inspections deferred unless any are deemed mission critical. China director remains behind as staff evacuate.
Successfully acquired by Colgate-Palmolive on 31 January, Hello quickly made a statement with the launch of a CBD oral-care range and its first go at lip care, CBD Vegan Lip Balm. Available exclusively through Ulta Beauty, the CBD products have the potential to score well with younger consumers interested in natural ingredients, eco-friendly packaging and, of course, cannabis-based innovations.
A BLA filing for Zynteglo in beta-thalassemia is expected in the second half of 2020 instead of the first half, but the first commercial patient in the EU will be treated in the first half of this year.