APO-FINGOLIMOD CAPSULE

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

FINGOLIMOD (FINGOLIMOD HYDROCHLORIDE)

Available from:

APOTEX INC

ATC code:

L04AE01

INN (International Name):

FINGOLIMOD

Dosage:

0.5MG

Pharmaceutical form:

CAPSULE

Composition:

FINGOLIMOD (FINGOLIMOD HYDROCHLORIDE) 0.5MG

Administration route:

ORAL

Units in package:

7/28/30/1000

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

_APO-FINGOLIMOD (Fingolimod Capsules) _
_ _
_Page 1 of 62 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-FINGOLIMOD
Fingolimod Capsules
Capsule, 0.5 mg fingolimod (as fingolimod hydrochloride), Oral
Sphingosine 1-phosphate receptor modulator
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
March 11, 2019
Date of Revision:
January 4, 2023
Submission Control Number: 266557
_APO-FINGOLIMOD (Fingolimod Capsules) _
_ _
_Page 2 of 62 _
RECENT MAJOR LABEL CHANGES
4 Dosage and Administration
01/2023
7 Warnings and Precautions
01/2023
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
................................................................... 4
1
INDICATIONS
..................................................................................................................
4
1.1
Pediatrics
........................................................................................................................
4
1.2
Geriatrics
........................................................................................................................
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
........................................................................................