ApprovalTrail

Approval · Notice of Compliance 8057 · 2006

HUMIRA: Notice of Compliance 8057

Issued June 20, 2006

A Notice of Compliance is Health Canada’s approval of a drug submission: a new drug, a new use or form, or a change to an approved one. The product itself is in the Drug Product Database, with its current status.

Notice number
8057
Date
June 20, 2006
Company
Abbott Laboratories Co.Saint-Laurent, Quebec, Canada
Product type
Biologic
Submission
Supplement to a New Drug Submission (SNDS), supplement
Submission class
Other
Reason
Extension of indication: to treat recently diagnosed patients with moderately to severely active rheumatoid arthritis who have not been previously treated with methotrexate
Therapeutic class
Biological response modifier

Products in this notice

BrandDINStatus today
HUMIRANot yet assigned—

Medicinal ingredients