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PAR Oxaliplatin 5 mg / ml Concentrate for Solution for Infusion PL; UK/HDC Public Assessment Report Decentralised Procedure
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Document Date: 2010-03-29 07:13:09


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Company

Hikma FarmacĂȘutica (Portugal) S.A. / /

Country

United Kingdom / /

Event

Product Issues / FDA Phase / /

IndustryTerm

infusion product / Treatment of metastatic colorectal cancer / glucose solution / reference product / injectable solutions / medicinal products / therapeutic / treatment of cancer / medicinal product / treatment of stage III colon cancer / chemical structure / /

MedicalCondition

tremors / allergic reaction / anaphylactic shock / solid tumours / Dysarthria / acidosis / Meningism / nausea / stomatitis / skin rash / thrombocytopenia / rhinitis / Alopecia / pulmonary fibrosis / Colitis / colon cancer / conjunctivitis / pulmonary / Deafness / hypersensitivity / hepato-biliary disorders / III colon cancer / liver disease / Infections / Back pain / neurologic symptoms / sepsis / DC Hepatic insufficiency / hypotension / nutrition disorders / intestinal obstruction / Epistaxis / necrosis / pulmonary infiltrates / bronchospasm / cancer / peliosis hepatis / Dysgeusia / Optic neuritis / mild renal dysfunction / progressive disease / neutropenia / tumour / metastatic colorectal cancer / Allergy / mucositis / fever / paralytic ileus / vomiting / portal hypertension / urticaria / rigors / infection / dizziness / cough / inflammation / thrombosis / hypokalemia / metastases / Rash / syndrome / interstitial lung disease / disorders / fibrosis / Dehydration / /

MedicalTreatment

intravenous infusion / surgery / contraception / /

Organization

PAR Oxaliplatin / MHRA / ml Concentrate for Solution for Infusion PL / /

/

Position

physician / General / /

Product

granisetron / Oxaliplatin 5 mg / ml Concentrate / Rio / erythromycin / paclitaxel / fluorouracil / Oxaliplatin / liver function tests / Oxaliplatin 5 mg/ml Concentrate / /

ProgrammingLanguage

DC / /

SocialTag