| Document Date: 2009-03-31 14:51:38
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Company Genentech Inc. / / Event FDA Phase / / Facility Laboratory Tests / / IndustryTerm magnetic resonance imaging / psoriasis therapies / compromised immune systems / yellow solution / healthcare / psoriasis treatment / final product / Healthcare providers treating patients / / MedicalCondition transverse myelitis / chronic plaque psoriasis / lymphoma / facial palsy / recurrent infections / bronchitis / Immune-Mediated Thrombocytopenia / cellulitis / chronic inflammatory demyelinating polyneuropathy / plaque psoriasis / thrombocytopenia / serious infections / vertebral osteomyelitis / severe plaque psoriasis / necrotizing fasciitis / Progressive Multifocal Leukoencephalopathy / rapidly progressive infection / viral meningitis / psoriasis / hypersensitivity / bacterial sepsis / severe pneumonia / latent / chronic infections / Infections / neurologic symptoms / neurologic manifestations / sepsis / rapidly progressive viral infection / e.g. cellulitis / HIV infection / aseptic meningitis / Legionnaire’s disease / leukemia / pneumonia / OF PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY / hemolytic anemia / serious herpes infection / opportunistic infections / disease / gastroenteritis / clinically important infections / Guillain-Barré Syndrome / OF SERIOUS INFECTIONS / concomitant psoriasis / neutropenia / cryptococcal and tuberculous pneumonia / erythema / WARNINGS Progressive Multifocal Leukoencephalopathy / severe thrombocytopenia / invasive fungal disease / Serious Infections RAPTIVA / chronic moderate / encephalitis / psoriatic erythroderma / AIDS / pustular psoriasis / infection / chronic infection / inflammation / meningitis / appropriate psoriasis / abscess / serious infection / cytomegaloviral infections / / MedicalTreatment phototherapy / immunosuppression / / Position physician / static Physician Global Assessment / placebo group using Fisher / neurologist / / Product SC / gentamicin / sterile water for injection / For injection / RAPTIVA / SLR130 / / Technology MRI / Pharmacokinetics / magnetic resonance imaging / Pharmacodynamics / /
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RAPTIVA® [efalizumab] For injection, subcutaneous WARNING: RISK OF PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML) • RAPTIVA increases the risk for PML, a rapidly progressive viral infection of