A review of the European Directive for prescribing systemic isotretinoin for acne vulgaris

被引:75
作者
Layton, A. M.
Dreno, B.
Gollnick, H. P. M.
Zouboulis, C. C.
机构
[1] Harrogate & Dist Fdn Trust Hosp, Harrogate HG2 7SX, England
[2] Nantes Univ Hosp, F-44035 Nantes 1, France
[3] Otto von Guericke Univ, Dept Dermatol & Venereol, D-39120 Magdeburg, Germany
[4] Dessau Med Ctr, Dept Dermatol & Immunol, D-06847 Dessau, Germany
关键词
acne vulgaris; European Directive; isotretinoin; pregnancy prevention;
D O I
10.1111/j.1468-3083.2006.01671.x
中图分类号
R75 [皮肤病学与性病学];
学科分类号
100206 [皮肤病与性病学];
摘要
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.
引用
收藏
页码:773 / 776
页数:4
相关论文
共 3 条
[1]
Cunliffe WJ, 1999, DERMATOLOGY, V198, P405
[2]
Treatment of acne with intermittent isotretinoin [J].
Goulden, V ;
Clark, SM ;
Mcgeown, C ;
Cunliffe, WJ .
BRITISH JOURNAL OF DERMATOLOGY, 1997, 137 (01) :106-108
[3]
*MHRA, 2002, DRUG SAF B MHRA CHM, V28, P9