MAR-FINGOLIMOD CAPSULE
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
03-03-2022
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Active ingredient:
FINGOLIMOD (FINGOLIMOD HYDROCHLORIDE)
Available from:
MARCAN PHARMACEUTICALS INC
ATC code:
L04AA27
INN (International Name):
FINGOLIMOD
Dosage:
0.5MG
Pharmaceutical form:
CAPSULE
Composition:
FINGOLIMOD (FINGOLIMOD HYDROCHLORIDE) 0.5MG
Administration route:
ORAL
Units in package:
28
Prescription type:
Prescription
Therapeutic area:
Immunomodulatory Agents
Product summary:
Active ingredient group (AIG) number: 0152886001; AHFS:
Authorization status:
APPROVED
Authorization date:
2019-03-11
Summary of Product characteristics
Page 1 of 64
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MAR-FINGOLIMOD
Fingolimod capsules
Capsules, 0.5 mg fingolimod (as fingolimod hydrochloride), Oral
Manufacturer’s Standard
Sphingosine 1-phosphate receptor modulator
Marcan Pharmaceuticals Inc.
2 Gurdwara Road, Suite #112
Ottawa, ON, K2E 1A2
Date of Initial Authorization:
MAR 11, 2019
Date of Revision:
MAR 03, 2022
Submission Control Number: 257291
Page 2 of 64
RECENT MAJOR LABEL CHANGES
2 Contraindications
03/2022
4 Dosage and Administration
03/ 2022
7 Warnings and Precautions
03/ 2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
RECENT MAJOR LABEL
CHANGES……………………………………………………………………………………………….2
TABLE OF
CONTENTS…………………………………………………………………………………………………………………2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
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4
1.1
Pediatrics
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
.....................................................................................................
4
4
DOSAGE AND ADMINISTRATION
.....................................................................................
5
4.1
Dosing Considerations
..................................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
............................................................. 7
4.4
Administration
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