ApprovalTrail

Approval · Notice of Compliance 11636 · 2010

RITUXAN: Notice of Compliance 11636

Issued July 29, 2010

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
11636
Date
July 29, 2010
Company
Hoffmann-La Roche LimitedMississauga, Ontario, Canada
Product type
Biologic
Submission
Supplement to a New Drug Submission (SNDS), supplement
Submission class
Other
Reason
Addition to the Rheumatoid Arthritis (RA) indication: Rituxan in combination with Methotrexate has been shown to reduce the rate of progression of joint damage as measured by x-ray
Therapeutic class
Antineoplastic

Products in this notice

BrandDINStatus today
RITUXANNot yet assigned—

Medicinal ingredients