ApprovalTrail

Approval · Notice of Compliance 12217 · 2011

CELSENTRI: Notice of Compliance 12217

Issued March 3, 2011

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
12217
Date
March 3, 2011
Company
Viiv Healthcare UlcMontreal, Quebec, Canada
Product type
Prescription Pharmaceutical
Submission
Supplement to a New Drug Submission (SNDS), supplement
Submission class
Other
Reason
Revised dosing instructions for patients with renal impairment based on the result from study A4001075
Therapeutic class
CCR5 antagonist

Products in this notice

BrandDINStatus today
CELSENTRINot yet assigned—

Medicinal ingredients