TARO-FINGOLIMOD CAPSULE

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

FINGOLIMOD (FINGOLIMOD HYDROCHLORIDE)

Available from:

TARO PHARMACEUTICALS 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:

28/30

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

_Taro-Fingolimod (Fingolimod Capsules) _
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_Page 1 of 66 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
TARO-FINGOLIMOD
Fingolimod Capsules
Capsules, 0.5 mg fingolimod (as fingolimod hydrochloride), Oral
Taro Standard
Sphingosine 1-phosphate receptor modulator
Taro Pharmaceuticals Inc.
Date of Initial Authorization:
130 East Drive, Brampton
March 11, 2019
Ontario L6T 1C1
Date of Revision:
February 21, 2022
Submission Control No: 256647
_Taro-Fingolimod (Fingolimod Capsules) _
_ _
_Page 2 of 66 _
RECENT MAJOR LABEL CHANGE
2 CONTRAINDICATIONS
February, 2022
4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations;
4.2 Recommended Dose and Dosage Adjustment;
4.4 Administration; 4.5 Missed Dose
February, 2022
7 WARNINGS AND PRECAUTIONS, 7.1 Special Populations
February, 2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL
CHANGE.....................................................................................................
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
.....................................................