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Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium IMI Work Package 5: Report 1:b:ii Benefit - Risk Wave 1 Case Study Report: Ketek®
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Document Date: 2014-07-16 01:09:14

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File Size: 4,38 MB

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City

London / /

Company

MCDA MCDA / GlaxoSmithKline / Aventis Pharma / hepatic AE / Pneumonia / cardiac AE / Genentech / /

Event

FDA Phase / /

Facility

Imperial College / /

MarketIndex

BRR / /

MedicalCondition

loss of consciousness / Tonsillitis/Pharyngitis / Pneumonia / bacterial sinusitis / acute liver failure / Community Acquired Pneumonia / eye disorders / Acute Bacterial Sinusitis / syncope / Community-Acquired Pneumonia / Tonsillitis / Thonsillitis/pharyngitis / infections / acute sinusitis / pharyngitis / Chronic Bronchitis / myasthenia gravis / /

MedicalTreatment

antibiotics / /

Organization

Food and Drug Administration / European Medicines Agency / European Commission / FDA / Risk Action Team Benefit Risk Ratio Committee for Medicinal Products / European Union / Imperial College / /

Person

George Quartey (Genentech) / Edmond Chan / Christine Hallgreen / Nan Wang / Marilyn Metcalf / Trovafloxacin / EMA EPAR FDA INHB MCDA / /

Position

model / /

Product

Ketek / Azithromycin / Penicillin / Amoxicillin / Raptiva / Clarithromycin / Cefuroxime / Ketek antibiotic / /

PublishedMedium

the European / /

RadioStation

Wave 1 / /

Technology

Simulation / /

URL

www.imi.europa.eu / www.imi-protect.eu / /

SocialTag