JAMP TERIFLUNOMIDE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

TERIFLUNOMIDE

Available from:

JAMP PHARMA CORPORATION

ATC code:

L04AK02

INN (International Name):

TERIFLUNOMIDE

Dosage:

14MG

Pharmaceutical form:

TABLET

Composition:

TERIFLUNOMIDE 14MG

Administration route:

ORAL

Units in package:

15G/50G

Prescription type:

Prescription

Product summary:

Active ingredient group (AIG) number: 0154970001; AHFS:

Authorization status:

APPROVED

Authorization date:

2022-05-16

Summary of Product characteristics

_JAMP Teriflunomide (Teriflunomide tablets) _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_Page_
_1 of 53_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
JAMP TERIFLUNOMIDE
Teriflunomide tablets
Tablets, 14 mg, Oral
Immunomodulator Agent
JAMP Pharma Corporation
1310 rue Nobel
Boucherville, Québec
J4B 5H3, Canada
Date of Initial Authorization:
August 23, 2020
Date of Revision:
January 30, 2024
Submission Control No: 278995
_JAMP Teriflunomide (Teriflunomide tablets)_
_Page 2 of 53_
_ _
RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
02/2022
4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations
02/2022
7 WARNINGS AND PRECAUTIONS, Cardiovascular
02/2022
7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic
01/2024
7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female and Male
Potential
02/2022
7 WARNINGS AND PRECAUTIONS, Skin
02/2022
7 WARNINGS AND PRECAUTIONS, 7.1 Special Populations, 7.1.1 Pregnant
Women, Teriflunomide Pregnancy Active Surveillance Program
05/2022
7 WARNINGS AND PRECAUTIONS, 7.1 Special Populations,
7.1.3_Pediatrics
01/2024
7 WARNINGS AND PRECAUTIONS, Respiratory
01/2024
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
.......................