MINT-ZOLPIDEM ODT TABLET (ORALLY DISINTEGRATING)

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

ZOLPIDEM TARTRATE

Tilgængelig fra:

MINT PHARMACEUTICALS INC

ATC-kode:

N05CF02

INN (International Name):

ZOLPIDEM

Dosering:

10MG

Lægemiddelform:

TABLET (ORALLY DISINTEGRATING)

Sammensætning:

ZOLPIDEM TARTRATE 10MG

Indgivelsesvej:

SUBLINGUAL

Enheder i pakken:

15G/50G

Recept type:

Targeted (CDSA IV)

Terapeutisk område:

MISCELLANEOUS ANXIOLYTICS SEDATIVES AND HYPNOTICS

Produkt oversigt:

Active ingredient group (AIG) number: 0122857002; AHFS:

Autorisation status:

APPROVED

Autorisation dato:

2019-09-13

Produktets egenskaber

_MINT-ZOLPIDEM ODT (Zolpidem Tartrate Sublingual Orally Disintegrating
Tablets) _
_Page 1 of 51_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
T\C MINT-ZOLPIDEM ODT
Zolpidem Tartrate Sublingual Orally Disintegrating Tablets (ODT)
5 mg and 10 mg, oral
Manufacturer’s Standard
Hypnotic Agent
Mint Pharmaceuticals Inc.
6575 Davand Dr
Mississauga, ON
L5T 2M3
Date of Initial Authorization:
SEP 25, 2019
Date of Revision:
AUG 21, 2023
Submission Control Number: 274296
_MINT-ZOLPIDEM ODT (Zolpidem Tartrate Sublingual Orally Disintegrating
Tablets) _
_Page 2 of 51_
RECENT MAJOR LABEL CHANGES
1 INDICATIONS, 1.2 Geriatrics
08/2023
2 CONTRAINDICATIONS
08/2023
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
08/2023
4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations
08/2023
7 WARNINGS AND PRECAUTIONS
08/2023
7 WARNINGS AND PRECAUTIONS, 7.1.4 Geriatrics
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
......................................................................