Product information
From Health Canada
No match found
No other product was found with the same active ingredient group.
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:
2019-01-03
Original market date: See footnote 1
2019-01-03
Product name:
GILENYA
DIN:
02482533
Product Monograph/Veterinary Labelling:
Date:
2021-07-26
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
NOVARTIS PHARMACEUTICALS CANADA INC
100
700 Rue Saint-Hubert
Montreal
Quebec
Canada
H2Y 0C1
Class:
Human
Dosage form(s):
Capsule
Route(s) of administration:
Oral
Number of active ingredient(s):
1
Schedule(s):
Prescription
American Hospital Formulary Service (AHFS): See footnote 3
92:20.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
L04AE01 FINGOLIMOD
Active ingredient group (AIG) number:See footnote5
0152886002
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| FINGOLIMOD (FINGOLIMOD HYDROCHLORIDE) | 0.25 MG |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.
| Additional Risk Minimization Measures |
|---|
| Healthcare Professional Education |
| Patient Education |
| Pharmacovigilance/Monitoring Activity |
|---|
| Registry |