LYRICA CAPSULE

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

PREGABALIN

Dostopno od:

BGP PHARMA ULC

Koda artikla:

N02BF02

INN (mednarodno ime):

PREGABALIN

Odmerek:

75MG

Farmacevtska oblika:

CAPSULE

Sestava:

PREGABALIN 75MG

Pot uporabe:

ORAL

Enote v paketu:

60

Tip zastaranja:

Prescription

Terapevtsko območje:

MISCELLANEOUS ANTICONVULSANTS

Povzetek izdelek:

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

Status dovoljenje:

APPROVED

Datum dovoljenje:

2005-06-03

Lastnosti izdelka

_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
..............................................................................................................
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
R