ApprovalTrail

Approval · Notice of Compliance 9015 · 2007

TRUVADA: Notice of Compliance 9015

Issued September 11, 2007

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
9015
Date
September 11, 2007
Company
Gilead Sciences, Inc.Foster City, California, United States
Product type
Prescription Pharmaceutical
Submission
Supplement to a New Drug Submission (SNDS), supplement
Submission class
Other
Reason
Streamlined and altered position of some adverse events in warnings and precautions and adverse events sections of product monograph. addition of drug interaction information with respect to coadministration of tenofovir disoproxil fumarate (tdf) with didanosine (ddl). updates added to the postmarketing adverse drug reaction section of product monograph
Therapeutic class
Antiretroviral agent

Products in this notice

BrandDINStatus today
TRUVADANot yet assigned—

Medicinal ingredients