Product information
From Health Canada
The product monograph is developed by a drug sponsor according to guidelines published by Health Canada that provide direction on the content and format. The veterinary labelling is developed by the drug sponsor according to the Food and Drug Regulations. While Health Canada reviews the product monograph or the veterinary labelling as part of the drug review process, it remains the responsibility of the drug sponsor to ensure that the product monograph or the veterinary labelling is complete and accurate.
Current status:
Marketed
Current status date:
2023-01-24
Original market date: See footnote 1
2020-09-24
Product name:
RUZURGI
Description:
IN ACCORDANCE WITH THE FCA DECISION IN A-78-22, THE 2021-06-24 DECISION (DATA PROTECTION) WAS RESTORED, AND A NEW NOC WAS ISSUED.
DIN:
02503034
Product Monograph/Veterinary Labelling:
Date:
2020-08-05
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
MEDUNIK CANADA
950 Michèle-Bohec Blvd.
Blainville
Quebec
Canada
J7C 5E2
Class:
Human
Dosage form(s):
Tablet
Route(s) of administration:
Oral
Number of active ingredient(s):
1
Schedule(s):
Prescription
American Hospital Formulary Service (AHFS): See footnote 3
28:92.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
N07XX05 AMIFAMPRIDINE
Active ingredient group (AIG) number:See footnote5
0162417001
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| AMIFAMPRIDINE | 10 MG |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.
| Pharmacovigilance/Monitoring Activity |
|---|
| Registry |
| Clinical Trials |