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Research / Drug safety / Pharmacology / European Medicines Agency / Pharmaceuticals policy / Committee for Medicinal Products for Human Use / International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use / Pharmacovigilance / Serious adverse event / Clinical research / Pharmaceutical sciences / Pharmaceutical industry


25 SeptemberEMA/CHMPCommittee for Medicinal Products for Human Use (CHMP) Assessment report
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Document Date: 2014-12-17 05:29:48


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File Size: 2,74 MB

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City

London / /

Company

Drugs / BP / Södertälje Sweden AstraZeneca UK Limited / ADR Adverse Drug Reaction AE / Södertälje Sweden / AstraZeneca AB / ITT / /

Country

United States / Canada / United Kingdom / /

Currency

pence / /

Event

Product Issues / /

Facility

Canary Wharf / /

IndustryTerm

above medicinal product / pharmaceutical and biological aspects / authorised orphan medicinal products / investigational product / study protocol / medicinal product / chemical / authorised orphan medicinal product / /

MedicalCondition

Blister / opioid-induced constipation / /

Organization

Human Use / European Medicines Agency / SBM Spontaneous / International Union of Pure and Applied Chemistry / US Food and Drug Administration / European Commission / FDA / Committee for Medicinal Products for Human Use / United States of America UV / European Union / SmPC Summary / contact An / CHMP Committee for Medicinal Products / European Directorate for the Quality of Medicines / Pharmacovigilance Risk Assessment Committee / /

Person

Bart Van / Piotr Fiedor / Columbia-Suicide Severity / /

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Product

Polyethylene glycol / Responder/Response LS Mean Least-Squares Mean LUR Laxative Unknown Responder/Response MACE Major / response / /

ProgrammingLanguage

EC / /

PublishedMedium

Pure and Applied Chemistry / /

Technology

Pharmacokinetics / quality attribute CSP Clinical study protocol / X-ray / spectroscopy / Gas chromatography / Pharmacodynamics / process control / /

URL

www.ema.europa.eu/contact / /

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