Approval · Notice of Compliance 18950 · 2017
REPLAGAL: Notice of Compliance 18950
Issued February 10, 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.
Issued with conditions (NOC/c): the company must confirm the benefit in further studies.
- Notice number
- 18950
- Date
- February 10, 2017
- Company
- Shire Human Genetic Therapies IncLexington, Massachusetts, United States
- Product type
- Biologic
- Submission
- New Drug Submission (NDS)
- Submission class
- Other
- With conditions
- Yes (NOC/c)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| REPLAGAL | 02249057 | Marketed |
Medicinal ingredients
- AGALSIDASE ALFA 1 MG per ML