SOCIAL QUESTIONS|health|pharmaceutical industry
- foirm chógaisíochta Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
- ga
- Darreichungsform | pharmazeutische Form | Arzneimittelform
- de
- Definition Form, in der Arzneimittel verabreicht werden Reference Römpp Chemie-Lexikon, 8. Aufl., Stuttgart 1979
- pharmaceutical forms | dosage form | pharmaceutical dose form | pharmaceutical dosage form | dosage forms | pharmaceutical form
- en
- Definition combination of the form in which a pharmaceutical product is presented by the manufacturer (form of presentation) and the form in which it is administered, including the physical form (form of administration) Reference European Medicines Agency. Standard operating procedure http://www.ema.europa.eu/docs/en_GB/document_library/Standard_Operating_Procedure_-_SOP/2009/09/WC500003039.pdf [15.5.2012]
- Comment A list of the different pharmaceutical dose forms can be found at: European Medicines Agency. Extended EudraVigilance product report message (XEVMPD) pharmaceutical dose forms, version 2.0 http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500123648 [14.5.2012]In the assessment of marketing authorisations applications in Europe, pharmaceutical forms that only differ with respect to the container/administration device may not always be considered as different pharmaceutical forms. European Commission. 'VOLUME 2C Regulatory Guidelines GUIDELINE ON THE CATEGORISATION OF EXTENSION APPLICATIONS (EA) versus VARIATIONS APPLICATIONS (V)' (26.6.2020) July 2019
- forme médicamenteuse | forme galénique | forme pharmaceutique
- fr
- Definition aspect sous lequel un produit pharmaceutique est présenté par le fabricant (comprimé, gélule, suppositoire, ...) mais également forme d'administration de ce produit pharmaceutique Reference COM-FR, d'après: Doctissimo, Dictionnaire médical, Galénique, http://dictionnaire.doctissimo.fr/definition-galenique.htm [1.7.2014]