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Rare diseases / Rheumatology / Immunosuppressants / Anakinra / Cryopyrin-associated periodic syndrome / Arthritis / Familial cold urticaria / Muckle–Wells syndrome / Neonatal onset multisystem inflammatory disease / Health / Medicine / Autoinflammatory syndromes


5.1 ANAKINRA 100 mg/0.67 mL, 28 x 0.67 mL syringes; Kineret®; A.Menarini Australia Pty Ltd. Purpose of Application
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Document Date: 2015-03-16 01:05:14


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Company

AEs / N/A Software / A.Menarini Australia Pty Ltd / BSC INC / New England Journal / PSCR / /

Continent

Europe / /

Country

United States / Australia / /

Currency

USD / /

Event

Product Issues / Product Recall / FDA Phase / /

Facility

Consumer Comments facility / Private Hospital / Public Hospital / /

Holiday

Commonwealth Day / /

IndustryTerm

treatment / withdrawal / Treatment of Muckle-Wells syndrome / treatment of familial cold autoinflammatory syndrome / /

MarketIndex

EGX 30 / /

MedicalCondition

prescribed chronic therapy / Rheumatism / stable familial cold autoinflammatory syndrome / headache / severe cryopyrin-associated periodic syndromes / Arthritis / Muckle‐Wells Syndrome / rheumatoid arthritis / normal urticaria / severe active rheumatoid arthritis / sensorineural hearing loss / disease activity score / neonatal onset multisystem inflammatory disease / psoriasis / Hearing loss / Familial Cold Autoinflammatory Syndrome / infections / cryopyrin-associated periodic syndromes / Papilledema / pneumonia / Muckle-Wells syndrome / mental retardation / disease / gastroenteritis / Bone dysplasia / Rheumatic Diseases / chronic / rare disease / cutaneous / articular syndrome / CINCA syndrome / fever / NOMID/CINCA syndrome / rare autoinflammatory diseases / vomiting / pain / Articular Syndrome / diseases / active moderate-to-severe disease / neonatal-onset multisystem inflammatory disease / urticaria-like skin rash / renal failure / rash / joint pain / autoinflammatory Muckle-Wells syndrome / rash / joint pain / inflammatory / periodic syndrome / /

MedicalTreatment

renal transplants / /

MusicGroup

Excel / /

Organization

Autoinflammatory Alliance / Public Hospital / Australian Committee on Prescription Medicines / Private Hospital / /

Person

Time / Outcomes Response / /

Position

TGA Clinical Evaluator / model / Dental Medical Practitioners Nurse / nurse / Private / /

Product

group / Kineret / patients / study / period / AR-0298 / /

PublishedMedium

PloS ONE / The New England Journal of Medicine / /

Region

New England / /

Technology

submission Study ID Protocol / simulation / /

SocialTag