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Chemistry / Pharmacology / Medicine / Hairy cell leukemia / Leukemia / Aspirin / Purines / Cladribine / Organochlorides


SCIENTIFIC DISCUSSION This module reflects the initial scientific discussion for the approval of Litak. For information on changes after approval please refer to module 8.
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Document Date: 2013-07-21 05:29:19

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Company

Rohr / Bernstein / Avery / ADP / GM / Knudsen / /

Continent

Europe / /

Country

Germany / Switzerland / Italy / Sweden / Poland / Norway / Belgium / France / Austria / United States / Portugal / United Kingdom / Finland / Spain / Ireland / Denmark / /

Facility

U.S.A. National Cancer Institute / University Hospital of Berne / Scripps Research Institute / /

IndustryTerm

rubber stoppers / proposed manufacturing process / pharmaceutical development / injection site / ready-to-use solution / manufacturing process / higher concentrated solution / food consumption / pharmaceutical and biological aspects / energy depletion / chemical name / bromobutyl rubber stoppers / pharmaceutical products / mg/ml solution / biopharmaceutical studies / /

MedicalCondition

recurrent opportunistic infections / frequent pyrogenic infections / murine leukaemia / leukaemia Hairy cell leukaemia / seizures / Leukopenia / chronic lymphocytic leukemia / acute myeloid leukaemia / sterility / thrombocytopenia / severe nausea / indolent diseases / leukaemia / interstitial fibrosis / granulocytopenia / chronic myeloid leukaemia / hairy cell leukaemia / Acute tubular necrosis / Severe dehydration / immune dysfunction / vasculitis / neoplasm / leukaemia and lymphoma cells / tumour / disseminated disease / vomiting / acute myelogenous leukaemia / irritation / leukaemia cells / lesions/necrosis / pancytopenia / /

MedicalTreatment

liver transplant / chemotherapy / intravenous infusion / immunosuppression / heart transplant / /

Organization

University Hospital of Berne / I.p. administration / U.S.A. National Cancer Institute / Scripps Research Institute / European Commission / s.c. administration / European Union / /

Person

Van Den Neste / Fey / Gandhi / /

Position

head / trunk and appendages / /

Product

hydroxyurea / sodium chloride / cladribine / cytarabine / cyclophosphamide / thioguanine / CL / dipyridamole / adenosine / using cladribine / /

ProgrammingLanguage

EC / /

Region

Scandinavia / /

Technology

alpha / transplantation / apoptosis / pharmacokinetics / DNA synthesis / chemotherapy / pharmacodynamics / /

SocialTag