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GlaxoSmithKline / Glucocorticoids / Asthma / Organofluorides / Fluticasone/salmeterol / Fluticasone propionate / Adverse Event Reporting System / Salbutamol / Salmeterol / Medicine / Pulmonology / Respiratory therapy


Flovent HFA: Safety Review
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City

Reference / /

Company

PostPediatric Exclusivity Postmarketing Adverse Event Review / Unlabeled Age Group / GlaxoSmithKline / /

Country

United States / Brazil / /

Event

FDA Phase / /

IndustryTerm

pediatric and adult patients receiving products / therapy for pneumonia / treatment for pneumonia / pharmaceutical product complaint / /

MedicalCondition

Cushing syndrome / allergies / Cushing's syndrome / headache / esophagitis / Bronchitis / convulsion / nausea / FATIGUE / pulmonary events / Lung disease / Pulmonary edema / disorder / MS / Wheezing / Asthma / premature birth / either pulmonary events / both asthma / Pneumonia / Bronchospasm / disease / nasopharyngitis / dyspnea / Chronic / Sickness / allergy / fever / pulmonary disease / oral candidiasis / vomiting / dental caries / cough / depression / rash / infectious disease / syndrome / tooth discoloration / /

MedicalTreatment

heart surgery / /

OperatingSystem

OSE / /

Organization

Team Leader Division / office of New Drugs / Food and Drug Administration / office of Surveillance and Epidemiology / Pediatric Advisory Committee / office of Pediatric Therapeutics / Research office of Surveillance and Epidemiology Date / Director office of Pediatric Therapeutics / Safety Evaluator Division / Department of Health and Human Services Public Health Service Food and Drug Administration Center for Drug Evaluation / Division of Pulmonary / Allergy / and Rheumatology Products / /

Person

Lisa L. Mathis / Susan Lu / Melinda Wilson / Ann McMahon / M. Dianne Murphy / Comment / /

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Position

cardiologist / Deputy Director / Associate Director / EXECUTIVE / reporter / controller / CONTENTS EXECUTIVE / Director Pediatric and Maternal Health Staff / /

Product

fluticasone propionate / metoclopramide hydrochloride / albuterol / Flovent HFA / bumetanide / Flovent / Cutivate / folic acid / lorazepam / Flonase / lansoprazole / magnesium sulfate / HFA / S-004 / /

PublishedMedium

the Pediatric Safety Review / /

SocialTag