Traduction de «medicinal products for topical use » (Anglais → Français) :

veterinary medicinal product [ medicinal product for veterinary use | veterinary pharmaceutical product | veterinary product | VMP ]

medicinal product for use in the paediatric population | paediatric drug | paediatric medicinal product | paediatric medicine

Committee for Medicinal Products for Human Use | Committee for Proprietary Medicinal Products | CHMP [Abbr.] | CPMP [Abbr.]

applying prespotting | applying stain remover before dry cleaning | apply prespotting | using topical products to remove stain prior to dry cleaning

Ordinance of 22 December 2000 on the Use of Veterinary Medicines on Animals used for Food Production

ready-to-use medicinal product

non-ready-to-use medicinal product

Documentation shall be submitted to show that colouring matters for inclusion in veterinary medicinal products satisfy the requirements of Directive 2009/35/EC of the European Parliament and of the Council[3] except where the application for a marketing authorisation concerns certain veterinary medicinal products for topical use, such as insecticidal collars and ear tags.

annul Commission Implementing Decision C(2014) 6030 final of 19 August 2014 concerning, in the framework of Article 31 of Directive 2001/83/EC of the European Parliament and of the Council, the marketing authorisations for high concentration of estradiol containing human medicinal products for topical use in so far as it requires Member States to comply with the obligations imposed in the implementing decision for the medicinal products listed in Annex I to the implementing decision and those not listed with 0,01 % estradiol by weight for topical use, with the exception of the restriction that the medicinal products named in Annex I to t ...[+++]he implementing decision with 0,01 % estradiol by weight for topical use may be administered only intravaginally;

In establishing these rules, a distinction should be made between investigational medicinal products (the tested product and its reference products, including placebos) and auxiliary medicinal products (medicinal products used in the context of a clinical trial but not as investigational medicinal products), such as medicinal products used for background treatment, chal ...[+++]lenge agents, rescue medication, or used to assess end-points in a clinical trial.

In addition, polidocanol used in topical products at the suggested concentrations and for the suggested topical use (3 % for leave-on products and 4 % for rinse-off products) acts as detergent or ionic surfactant and these products do not present the characteristics of medicinal products.