| Document Date: 2014-09-09 11:11:46
Open Document File Size: 1,10 MBShare Result on Facebook
City Reference / / Company Janssen Products LP / / Currency pence / / Event Product Issues / FDA Phase / / Facility Laboratory Parameter WHO Toxicity Range Chemistry Alkaline phosphatase* Grade / / IndustryTerm food / / MedicalCondition exaggerated sunburn / HCV genotype 1a infection / Rash Rash / preferred terms pruritus / rash requiring discontinuation / solar dermatitis / generalized erythema / Sulfa Allergy / HCV genotype 1 / Dyspnea / Carcinogenesis / dermatitis / nausea / eczema / cirrhosis / compensated liver disease / hepatitis C / HCV / erythema / dyspnea events / rash events / conjunctivitis / sunburn / Sulfa Allergy OLYSIO / severe rash / urticaria / rash pruritic / exfoliative / cutaneous vasculitis / fetal death / infection / dermatosis / exfoliative rash / pruritus / Rash / birth defects / vasculitic rash / chronic hepatitis C / HCV RNA / HCV genotype / / MedicalTreatment contraception / Alternative therapy / contraceptive methods / / Organization World Health Organization / DOSAGE AND ADMINISTRATION / FDA / administration of OLYSIO / / / Product Digoxin / ribavirin / DOSAGE FORMS AND STRENGTHS Each capsule / peginterferon / On-Treatment Virologic Response HCV RNA Treatment Week / OLYSIO / / Technology Pharmacokinetics / Transplantation / Pharmacodynamics / genotype / / URL www.fda.gov/medwatch / /
SocialTag |
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use OLYSIOTM safely and effectively. See full prescribing information for OLYSIO. OLYSIO (simeprevir) capsules, for oral