Approval · Notice of Compliance 16340 · 2014
AZILECT: Notice of Compliance 16340
Issued November 24, 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.
- Notice number
- 16340
- Date
- November 24, 2014
- Company
- Teva Pharmaceutical Industries LtdPetach Tikva, Israel
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Extension of the indication to include use as adjunct therapy to dopamine agonists
- Therapeutic class
- Antiparkinson agent
Products in this notice
Medicinal ingredients
- RASAGILINE MESYLATE 0.5 MG per TAB
- RASAGILINE MESYLATE 1 MG per TAB