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Public Assessment Report for paediatric studies submitted in accordance with Article 46 of Regulation (EC) No1901/2006, as amended Erwinase 10,000 units/vial
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Document Date: 2014-05-06 07:21:10

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File Size: 712,18 KB

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Company

AEs / INTRODUCTION EUSA Pharma / /

Continent

Europe / /

Country

United Kingdom / Netherlands / /

Event

FDA Phase / /

Facility

Erwinase INN / /

IndustryTerm

medicinal product / pharmaceutical formulation / adults protocols / treatment protocol / treatment of childhood acute lymphoblastic leukemia / /

MedicalCondition

Allergy / acute lymphoblastic leukemia / leukaemia / childhood ALL / Cancer / hypersensitivity / therapeutic chemical Cancer / PEG-asparaginase allergy / clinical hypersensitivity / J Cancer / following hypersensitivity / /

MedicalTreatment

treatment protocols / treatment protocol / chemotherapy / /

Organization

FDA / Food and Drug Administration / /

Position

EXECUTIVE / /

Product

AALL07P2 / Erwinase / /

Technology

pharmacokinetics / 5/14 protocols / pharmacodynamics / adults protocols / treatment protocol / antibodies / chemotherapy / /

SocialTag