ApprovalTrail

Approval · Notice of Compliance 13474 · 2012

VOTRIENT: Notice of Compliance 13474

Issued July 12, 2012

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
13474
Date
July 12, 2012
Company
Glaxosmithkline IncMississauga, Ontario, Canada
Product type
Prescription Pharmaceutical
Submission
Supplement to a New Drug Submission (SNDS), supplement
Submission class
Other
Reason
New indication: For the treatment of adult patients with selective subtypes of advanced Soft TIssue Sarcoma (STS) who have received prior chemotherapy for metastatic disease or who have progressed within 12 months after (neo)adjuvant therapy. Patients were required to have diseasee progression on or after, or be intolerant to, an anthracyline-based regimen in the pivotal pahse III study in STS
Therapeutic class
Antineoplastic Agent

Products in this notice

BrandDINStatus today
VOTRIENTNot yet assigned—

Medicinal ingredients