ApprovalTrail

Approval · Notice of Compliance 14746 · 2013

TRELSTAR: Notice of Compliance 14746

Issued September 11, 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
14746
Date
September 11, 2013
Product type
Prescription Pharmaceutical
Submission
Supplement to a New Drug Submission (SNDS), supplement
Submission class
Other
Reason
To support a new formulation of trelstar (triptorelin pamoate for injectable suspension) designed to release 22.5 mg of the active moiety over a period of 168 days (6 month sloww release) for use in the palliative treatment of advanced prostate cancer
Therapeutic class
Luteinizing hormone-releasing hormone (lhrh) analogue

Products in this notice

BrandDINStatus today
TRELSTAR02412322Marketed

Medicinal ingredients