Simponi

E850003

Simponi is a prescription biologic medication (golimumab) used to treat autoimmune inflammatory conditions such as rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis by blocking tumor necrosis factor (TNF).

All labels observed (2)

Label Occurrences
Simponi canonical 3
Simponi Aria 1

How this entity was disambiguated

Statements (49)

Predicate Object
instanceOf biologic medication ⓘ
brand name drug ⓘ
tumor necrosis factor inhibitor ⓘ
administrationFrequency once monthly for subcutaneous formulation ⓘ
approvalBy European Medicines Agency ⓘ
U.S. Food and Drug Administration ⓘ
combinationTherapyWith methotrexate ⓘ
commonAdverseEffect headache ⓘ
injection site reaction ⓘ
upper respiratory tract infection ⓘ
contraindication history of hypersensitivity to golimumab ⓘ
severe active infections ⓘ
developer Janssen Biotech ⓘ
drugClass TNF inhibitor ⓘ
biologic disease-modifying antirheumatic drug ⓘ
monoclonal antibody ⓘ
firstFDAApprovalYear 2009 ⓘ
formulation autoinjector pen ⓘ
intravenous infusion solution ⓘ
prefilled syringe ⓘ
hasActiveIngredient golimumab ⓘ
hasATCCode L04AB06 ⓘ
hasBlackBoxWarning malignancy risk ⓘ
serious infections ⓘ
indicatedFor active ankylosing spondylitis ⓘ
active psoriatic arthritis ⓘ
moderate to severe active rheumatoid arthritis ⓘ
moderately to severely active ulcerative colitis ⓘ
legalStatusEU prescription only ⓘ
legalStatusUS prescription only ⓘ
manufacturer Janssen Biotech ⓘ
marketingAuthorizationHolder Janssen Biotech ⓘ
mechanismOfAction tumor necrosis factor alpha blockade ⓘ
ownedBy Johnson & Johnson ⓘ
pregnancyCategoryUS B ⓘ
regulatoryStatus prescription only ⓘ
requires prescription ⓘ
routeOfAdministration intravenous infusion ⓘ
subcutaneous injection ⓘ
seriousAdverseEffect congestive heart failure exacerbation ⓘ
hepatitis B reactivation ⓘ
opportunistic infections ⓘ
tuberculosis ⓘ
targets tumor necrosis factor alpha ⓘ
treats ankylosing spondylitis ⓘ
non-radiographic axial spondyloarthritis ⓘ
psoriatic arthritis ⓘ
rheumatoid arthritis ⓘ
ulcerative colitis ⓘ

How these facts were elicited

Referenced by (4)

Full triples — surface form annotated when it differs from this entity's canonical label.

Janssen Biotech → product → Simponi ⓘ
Janssen Biotech → product → Simponi Aria ⓘ
linked to: Simponi
Janssen Biotech → developed → Simponi ⓘ
Janssen Biotech → notableDrug → Simponi ⓘ