LYRICA CAPSULE

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

PREGABALIN

Dostupné s:

BGP PHARMA ULC

ATC kód:

N02BF02

INN (Mezinárodní Name):

PREGABALIN

Dávkování:

50MG

Léková forma:

CAPSULE

Složení:

PREGABALIN 50MG

Podání:

ORAL

Jednotky v balení:

60

Druh předpisu:

Prescription

Terapeutické oblasti:

MISCELLANEOUS ANTICONVULSANTS

Přehled produktů:

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

Stav Autorizace:

APPROVED

Datum autorizace:

2005-06-03

Charakteristika produktu

_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
................................................................................................................
4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 4
4
DOSAGE AND ADMINISTRATION
.................................................................................
5
4.1
Dosing Considerations
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5
4.2
R