Approval · Notice of Compliance 16100 · 2014
CELSENTRI: Notice of Compliance 16100
Issued August 29, 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
- 16100
- Date
- August 29, 2014
- Company
- Viiv Healthcare UlcMontreal, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Addition of long-term data from three phase 2b/3 trials and updates to the pm in the adverse reaction section
- Therapeutic class
- Ccr5 antagonist