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Multiple sclerosis / Health / Autoimmune diseases / Natalizumab / Treatment of multiple sclerosis / Progressive multifocal leukoencephalopathy / Fingolimod / JC virus / Glatiramer acetate / Immunology / Medicine / Immunosuppressants


Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium IMI WP5 Report 1:b:iv Benefit-Risk Wave 1 case study report: NATALIZUMAB Risk benefit case study with a focus on testing methodology.
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Document Date: 2014-07-16 01:09:12

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File Size: 1,70 MB

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Company

European ConsorTium Glossary AE / Novartis / Astra / Multiple Sclerosis Consensus Therapy Group / /

IndustryTerm

treatment of MS / treatment for a serious disease / medicinal products / /

MedicalCondition

highly active relapsing-remitting multiple sclerosis / progressive multiple sclerosis / disease / inflammatory processes / inflammatory process / brain infection / serious disease / neurological disorder / Crohn’s Disease / neurological dysfunction / direct and active JCV infection / clinically isolated syndrome / Pathology Multiple Sclerosis / relapsing remitting multiple sclerosis / malignant astrocytoma / high disease activity / Progressive multifocal leukoencephalopathy / autoimmune disease / subsequent demyelination / both acute inflammatory events / Multiple Sclerosis / demyelination / Multiple Sclerosis A / acute inflammatory events / inflammation / MS / /

Organization

Organization of Report / Food and Drug Administration / European Medicines Agency / United States VAS / Benefit-Risk Analysis BRAT Benefit-Risk Action Team CHMP Committee for Medicinal Products / European Commission / Europeans Medicines Agency / FDA / Committee for Medicinal Products for Human Use / European Union / /

Person

Dolores Montero / Isabelle Stoeckert / Son Tong Nguyen / John Pears / Kuhls (Bayer) Gemma Hodgson / Gemma Hodgson (Takeda) / Silvia Kuhls / Christoph Dierig / /

Position

Major / /

Product

Prezista / cyclophosphamide / azathioprine / Tysabri / mitoxantrone / /

ProvinceOrState

Mississippi / /

PublishedMedium

the CHMP review / /

RadioStation

Wave 1 / /

Technology

Magnetic Resonance Imaging / antibodies / MRI / /

URL

www.imi.europa.eu / www.imiprotect.eu / /

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