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Clinical research / Pharmacology / Gilead Sciences / Adefovir / Entecavir / Hepatitis B / Reverse-transcriptase inhibitor / Clinical trial / Placebo / Medicine / Health / Purines


N21449S011 Pediatric Clinical Review
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City

Montreal / /

Company

AEs / Tablet Therapeutic Class Anti-Hepatitis B (Nucleotide Analog) Applicant Gilead Sciences Inc. / CHB / Gilead Sciences / Tablet Pharmaceuticals / HBV / /

Continent

Africa / /

Country

United States / United Kingdom / /

Event

FDA Phase / /

Facility

Laboratory Findings / /

IndustryTerm

Food effect / treatment of hepatitis B / food / /

MedicalCondition

proteinuria / abdominal pain / disease / headache / HBV / nasopharyngitis / Hepatocellular carcinoma / hematuria / nausea / cirrhosis / glycosuria / Hepatitis B / diarrhea / membranous glomerulonephritis / infection / increased ALT / hepatitis / renal failure / cough / inflammation / infections / hepatic decompensation / pharyngitis / chronic hepatitis B / syndrome / Inflammatory / fibrosis / upper respiratory tract infection / /

MedicalTreatment

antiviral therapy / /

Person

Charlene Brown / Review Yodit Belew / Yodit Belew / /

Position

EXECUTIVE / /

Product

Formulation Tablet / Tyzeka / GS / Pegasys / Hepsera / lamivudine / adenosine / Intron A / Baraclude / Epivir-HBV / B / Intron A® / HBeAg / Hepsera® (adefovir dipivoxil) Tablet / United States / Hepsera® tablet / SE5-011 / formulation / /

Region

Far East / /

Technology

alpha / PHARMACOKINETICS / PHARMACODYNAMICS / /

SocialTag