Premium
A review of the European Directive for prescribing systemic isotretinoin for acne vulgaris
Author(s) -
Layton AM,
Dreno B,
Gollnick HPM,
Zouboulis CC
Publication year - 2006
Publication title -
journal of the european academy of dermatology and venereology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.655
H-Index - 107
eISSN - 1468-3083
pISSN - 0926-9959
DOI - 10.1111/j.1468-3083.2006.01671.x
Subject(s) - medicine , isotretinoin , directive , acne , food and drug administration , dermatology , pharmacology , computer science , programming language
Since the introduction of generic oral isotretinoin there have been discussions around harmonizing the summary of product characteristics of each formulation. As a result of these discussions, a European Directive concerned with the prescribing of oral isotretinoin has been introduced and the FDA (Food and Drugs Administration) has recently implemented new regulations. The aims of this article are to summarize the history of the processes involved, outline the new recommendations and discuss the impact of these changes in clinical practice.