Approval · Notice of Compliance 19481 · 2017
PROLASTIN-C: Notice of Compliance 19481
Issued June 30, 2017
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
- 19481
- Date
- June 30, 2017
- Company
- Grifols Therapeutics LlcClayton, North Carolina, United States
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Revised Indication - Congenital Alpha1-Antitrypsin Deficiency. PROLASTIN®-C is indicated for chronic replacement therapy of individuals having congenital deficiency of alpha1-PI (alpha1-antitrypsin deficiency), related to genotypes PiZZ, PiZ(null), Pi (null)(null), PiSZ or other deficiency causing alleles, and with clinically demonstrable emphysema. Clinical and biochemical studies have demonstrated that with such therapy, it is possible to increase plasma levels of alpha1-PI, and that levels of functionally active alpha1-PI in the lung epithelial lining fluid are increased proportionately. As some individuals with alpha1-antitrypsin deficiency will not go on to develop emphysema, only those with evidence of such disease should be considered for chronic replacement therapy with Alpha1-Proteinase Inhibitor (Human). Subjects with the PiMZ or PiMS phenotypes of alpha1-antitrypsin deficiency should not be considered for such treatment as they appear to be at small risk for emphysema. Clinical data are not available as to the long-term effects derived from chronic replacement therapy of individuals with alpha1-antitrypsin deficiency with Alpha1-Proteinase Inhibitor (Human). Only adult subjects have received Alpha1-Proteinase Inhibitor (Human) to date. /
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| PROLASTIN-C | Not yet assigned | — |
Medicinal ingredients
- ALPHA1-PROTEINASE INHIBITOR (HUMAN) 1,000 MG per VIAL