Approval · Notice of Compliance 7810 · 2006
REPLAGAL: Notice of Compliance 7810
Issued March 7, 2006
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.
Issued with conditions (NOC/c): the company must confirm the benefit in further studies.
- Notice number
- 7810
- Date
- March 7, 2006
- Company
- Transkaryotic Therapies Inc.
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New manufacturing facilities and changes to manufacturing process
- Therapeutic class
- Enzyme replacement therapy
- With conditions
- Yes (NOC/c)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| REPLAGAL | Not yet assigned | — |
Medicinal ingredients
- AGALSIDASE ALFA 1 MG per ML