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Report on the Deliberation Results February 6, 2012 Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare [Brand name]
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Document Date: 2014-03-28 01:31:45

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File Size: 949,15 KB

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City

Sendai / /

Company

Mogamulizumab (Genetical Recombination) [Applicant] Kyowa Hakko Kirin Co. Ltd. / Kyowa Hakko Kirin Co. Ltd. / A.(1) Manufacturing / Stage 1 Stage 2 Manufacturing / L Medium Stage 1 Manufacturing / Intramolecular / MCB / Kyowa Hakko Kogyo Co. Ltd. / /

Country

Guinea / Japan / /

Event

FDA Phase / /

IndustryTerm

cell bank / proposed manufacturing process / pharmaceutical product / manufacturing period / drug product / cell banking system / intermediate products / biological product / cell banks / heavy chain / manufacturing / manufacturing site / manufacturing process development / light chain / manufacturing process / /

MedicalCondition

skin disorder / tumor / human rhabdomyosarcoma cells / mice Pseudorabies / CCR4-positive adult T-cell leukemia lymphoma / lymphoma / non-viral infectious substances / Sterility / murine leukemia virus Minute virus / peripheral T-cell lymphoma / Partial deficiency / T-cell lymphoma cells / hepatitis B / pneumonia virus / ectromelia virus / murine encephalomyelitis virus / refractory CCR4-positive adult T-cell leukemia lymphoma / infection / mouse hepatitis virus / nonviral infectious substances / MS / mycosis fungoides / T-cell lymphoma / refractory CCR4-positive adult T-cell leukemia / lymphocytic choriomeningitis virus / /

NaturalFeature

Prospect Hill / /

Organization

CAL / National Institute of Health / Pharmaceuticals and Medical Devices Agency / WCB / Pharmaceutical Affairs Department of the Pharmaceutical Affairs / Pharmaceutical Affairs and Food Sanitation Council / Evaluation and Licensing Division / Ministry of Health / Second Committee on New Drugs / Pharmaceutical and Food Safety Bureau / /

Product

Poteligeo Injection / A2 / /

PublishedMedium

the Japanese review / /

Technology

gene expression / Recombination / process control / gel electrophoresis / /

SocialTag