Approval · Notice of Compliance 21969 · 2019
GAMASTAN: Notice of Compliance 21969
Issued March 13, 2019
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
- 21969
- Date
- March 13, 2019
- Company
- Grifols Therapeutics LlcClayton, North Carolina, United States
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Changes to the manufacturing process
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| GAMASTAN | 02486598 | Marketed |
Medicinal ingredients
- IMMUNOGLOBULIN (HUMAN) 18 PER