Approval · Notice of Compliance 11541 · 2010
ELAPRASE: Notice of Compliance 11541
Issued June 18, 2010
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
- 11541
- Date
- June 18, 2010
- Company
- Shire Human Genetic Therapies IncLexington, Massachusetts, United States
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New manufacturing site
- Therapeutic class
- Enzyme replacement therapy
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ELAPRASE | Not yet assigned | — |
Medicinal ingredients
- IDURSULFASE 2 MG per ML