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Biology / Biotechnology / Pharmacology / C1-inhibitor / Complement system / Pharming / Hereditary angioedema / Angioedema / Serpin / Complement deficiency / Health / Medicine


Summary Basis of Regulatory Action Template Version 2.0 Effective Date: April 6, 2009
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Company

ViroPharma / Pharming Group NV / Introduction Pharming Group N.V. / /

Continent

Europe / /

Country

Norway / United States / Iceland / Liechtenstein / /

Event

Product Issues / FDA Phase / /

Facility

Facility Animal Husbandry Nancy Waites / /

IndustryTerm

finished drug product / manufacturing consistency / active pharmaceutical ingredient / manufacturing control program / colorless transparent solution / biologics manufacturing / manufacturing / manufacturing procedures / replacement products / manufacturing process / /

MedicalCondition

Sterility / HAE / pain / hereditary angioedema / rare autosomal dominant disease / infectious disease / C1INH deficiency / /

Organization

FDA / European Union / European Medicine Agency / /

Person

Yiping Jia / Approval Jay Epstein / Nicole Trudel / Jin Baek Anthony Hawkins Pharmacovigilance / Charles Maplethorpe Iftekhar Mahmood / Laura Polakowski Alpita Popat / Esterase Inhibitor / John Dennis / Todd Mollan / Catherine Poole / Elena Karnaukhova / Alfred Del Grosso / Richard Heath / Mary Anne Malarkey / Nannette Cagungun / Mahmood Statistical Yuqun / /

Position

investigator / contractor / white Visual inspection General / appropriate evaluator / Chair / Committee / General / Regulatory Project Manager / Chair Committee / /

Product

sterile Water for Injection / patients / C1INH / C1-Esterase / RUCONEST / /

ProvinceOrState

Indiana / /

Technology

API / /

SocialTag