ApprovalTrail

Approval · Notice of Compliance 15966 · 2014

ABRAXANE: Notice of Compliance 15966

Issued July 16, 2014

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
15966
Date
July 16, 2014
Company
Celgene IncSaint-Laurent, Quebec, Canada
Product type
Prescription Pharmaceutical
Submission
Supplement to a New Drug Submission (SNDS), supplement
Submission class
Other
Reason
New indication: the first-line treatment of locally advanced unresectable or metastatic adenocarcinoma of the pancreas, in combination with gemcitabine
Therapeutic class
Antineoplastic agent

Products in this notice

BrandDINStatus today
ABRAXANENot yet assigned—

Medicinal ingredients