ApprovalTrail

Approval · Notice of Compliance 14571 · 2013

VOTRIENT: Notice of Compliance 14571

Issued July 19, 2013

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
14571
Date
July 19, 2013
Company
Glaxosmithkline IncMississauga, Ontario, Canada
Product type
Prescription Pharmaceutical
Submission
Supplement to a New Drug Submission (SNDS), supplement
Submission class
Other
Reason
Revisions to the indiation for renal cell carcinoma to: Indicated for the first line treatment of patients with metastatic renal cell (clear cell) carcinoma (mRCC) and for patients who have received prior treatment with cytokines for metastatic disease
Therapeutic class
Antineoplastic agent

Products in this notice

BrandDINStatus today
VOTRIENTNot yet assigned—

Medicinal ingredients