201153 Imiquimod Clinical PREA









New Medicine Recommendation 5% imiquimod cream (Aldara) and

Details of Review. Name of medicine (generic & brand name): imiquimod 5% cream (Aldara®) and fluorouracil. 5% cream (Efudix®). Strengths and forms:.
imiquimod fu creams new medicine review


N20-723S020 Imiquimod Clinical BPCA

13 déc. 2006 Clinical Review. Elektra J. Papadopoulos. NDA 20723. Aldara Imiquimod 5% Cream. Table of Contents. 1 EXECUTIVE SUMMARY .
N S Imiquimod Clinical BPCA


Imiquimod Cream 5%

1 déc. 2012 drug (RLD) Aldara Cream
Orig s


201153 Imiquimod Clinical PREA

7 juin 2010 4 SIGNIFICANT EFFICACY/SAFETY ISSUES RELATED TO OTHER REVIEW ... Imiquimod 5% cream (Aldara) has been marketed for over 8 years for the.
Imiquimod Clinical PREA





APPLICATION NUMBER: - 2011153Orig1s000 OTHER REVIEW(S)

24 mars 2011 This SEALD Labeling Review identifies major aspects of the draft ... recommendations for Aldara (imiquimod) cream PPI review provided to ...
Orig s OtherR


201153Orig1s000

25 mars 2010 PHARMACOLOGY/TOXICOLOGY NDA REVIEW AND EVALUATION ... 13) NDA 20-723 [Aldara (imiquimod) 5% cream; external genital/perianal warts;.
Orig s PharmR


ALDARA™ [al dar' a] (imiquimod) Cream 5% For Dermatologic Use

Imiquimod has no direct antiviral activity in cell culture. A study in 22 patients with genital/perianal warts comparing Aldara Cream and vehicle shows that 
s lbl


22483Orig1s000

12 juin 2009 and Aldara) for Imiquimod cream presents a safety risk associated with ... 2009 for the proprietary name review of proposed name
Orig s NameR





A Review of Topical Imiquimod in the Management of Basal Cell

A Review of Topical Imiquimod in the Management of Basal Keywords: imiquimod aldara


Review Imiquimod and resiquimod as novel immunomodulators

Imiquimod is administered as a 5% cream (Aldara) and has been licensed for the treatment of anogenital warts in immunocompetent patients. Complete clearance of 


248206