LYRICA CAPSULE

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

PREGABALIN

Disponibil de la:

BGP PHARMA ULC

Codul ATC:

N02BF02

INN (nume internaţional):

PREGABALIN

Dozare:

75MG

Forma farmaceutică:

CAPSULE

Compoziție:

PREGABALIN 75MG

Calea de administrare:

ORAL

Unități în pachet:

60

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

MISCELLANEOUS ANTICONVULSANTS

Rezumat produs:

Active ingredient group (AIG) number: 0151121003; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2005-06-03

Caracteristicilor produsului

_LYRICA (pregabalin) _
_Page 1 of 73_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
LYRICA®
Pregabalin capsules
Capsules, 25, 50, 75, 150, 225, 300 mg, oral
Analgesic Agent
BGP Pharma ULC
85 Advance Road
Etobicoke, Ontario
M8Z 2S6
Date of Initial Authorization:
June 3, 2005
Date of Revision:
MAR 4, 2024
Submission Control Number: 279480
®Viatris Specialty LLC
BGP Pharma ULC, a Viatris company, Licensee
© BGP Pharma ULC, 2024
_ _
_LYRICA (pregabalin) _
_Page 2 of 73_
RECENT MAJOR LABEL CHANGES
4 DOSAGE AND ADMINISTRATION, 4.2.1 Discontinuing
Treatment
03/2024
7 WARNINGS AND PRECAUTIONS, Dependence, Tolerance
and/or Abuse Liability
03/2024
7 WARNINGS AND PRECAUTIONS, 7.1.1. Pregnant Women
11/2022
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
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
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4
1.1
Pediatrics
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
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4
DOSAGE AND ADMINISTRATION
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5
4.1
Dosing Considerations
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5
4.2
R