Approval · Notice of Compliance 15562 · 2014
PROCHYMAL: Notice of Compliance 15562
Issued May 2, 2014
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
- 15562
- Date
- May 2, 2014
- Company
- Mesoblast International SarlNew York, New York, United States
- Product type
- Biologic
- Submission
- New Drug Submission (NDS)
- Submission class
- Admin
- Reason
- Manufacturer name change
- Therapeutic class
- Allogeneic cellular therapy
- With conditions
- Yes (NOC/c)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| PROCHYMAL | 02386380 | Approved |
Medicinal ingredients
- REMESTEMCEL-L 100 M per 15ML