RIVA-PREGABALIN CAPSULE

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

PREGABALIN

Available from:

LABORATOIRE RIVA INC.

ATC code:

N02BF02

INN (International Name):

PREGABALIN

Dosage:

150MG

Pharmaceutical form:

CAPSULE

Composition:

PREGABALIN 150MG

Administration route:

ORAL

Units in package:

100/500

Prescription type:

Prescription

Therapeutic area:

MISCELLANEOUS ANTICONVULSANTS

Product summary:

Active ingredient group (AIG) number: 0151121005; AHFS:

Authorization status:

APPROVED

Authorization date:

2013-02-14

Summary of Product characteristics

_RIVA-PREGABALIN (Pregabalin Capsules) _
_Page 1 of 64 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
RIVA-PREGABALIN
Pregabalin Capsules
Capsules, 25 mg, 50 mg, 75 mg, 150 mg, 225 mg, 300 mg, Oral
House Standard
Analgesic Agent
LABORATOIRE RIVA INC.
660 Boul. Industriel
Blainville, Quebec
J7C 3V4
www.labriva.com
Submission Control No.: 277863
Date of Initial Authorization:
FEB
14, 2013
Date of Revision:
AUG
23, 2023
_RIVA-PREGABALIN (Pregabalin Capsules) _
_Page 2 of 64 _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Dependence, Abuse Potential or Misuse
7 WARNINGS AND PRECAUTIONS, 7.1.1. Pregnant Women
08/2023
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
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 4
4
DOSAGE AND ADMINISTRATION
.................................................................................
5
4.1
Dosing Considerations
..............................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
...................................