SANDOZ PREGABALIN CAPSULE

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

PREGABALIN

Beschikbaar vanaf:

SANDOZ CANADA INCORPORATED

ATC-code:

N02BF02

INN (Algemene Internationale Benaming):

PREGABALIN

Dosering:

50MG

farmaceutische vorm:

CAPSULE

Samenstelling:

PREGABALIN 50MG

Toedieningsweg:

ORAL

Eenheden in pakket:

100

Prescription-type:

Prescription

Therapeutisch gebied:

MISCELLANEOUS ANTICONVULSANTS

Product samenvatting:

Active ingredient group (AIG) number: 0151121002; AHFS:

Autorisatie-status:

APPROVED

Autorisatie datum:

2013-02-15

Productkenmerken

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_Sandoz Pregabalin (pregabalin) _
_Page 1 of 71_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
SANDOZ PREGABALIN
Pregabalin capsules
Capsules, 25, 50, 75, 150, 300 mg, oral
BP
Analgesic Agent
Sandoz Canada Inc.
110 Rue de Lauzon
Boucherville, QC
J4B 1E6
Date of Initial Authorization:
February 15, 2013
Date of Revision:
June 21, 2023
Submission Control Number: 271390
_ _
_Sandoz Pregabalin (pregabalin) _
_Page 2 of 71_
RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
01/2020
7 WARNINGS AND PRECAUTIONS
06/2023
7 WARNINGS AND PRECAUTIONS, Neurologic
01/2020
7 WARNINGS AND PRECAUTIONS, 7.1.1. Pregnant Women
06/2023
7 WARNINGS AND PRECAUTIONS, General, Patient Counselling Information
07/2019
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
............................................................. 5
4
DOSAGE AND ADMINISTRATION
.................................................................................
5
4.1
Dosing Considerations
..................................................................................