NRA-QUETIAPINE XR TABLET (EXTENDED-RELEASE)

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Viambatanisho vya kazi:

QUETIAPINE (QUETIAPINE FUMARATE)

Inapatikana kutoka:

NORA PHARMA INC

ATC kanuni:

N05AH04

INN (Jina la Kimataifa):

QUETIAPINE

Kipimo:

400MG

Dawa fomu:

TABLET (EXTENDED-RELEASE)

Tungo:

QUETIAPINE (QUETIAPINE FUMARATE) 400MG

Njia ya uendeshaji:

ORAL

Vitengo katika mfuko:

15G/50G

Dawa ya aina:

Prescription

Eneo la matibabu:

ATYPICAL ANTIPSYCHOTICS

Bidhaa muhtasari:

Active ingredient group (AIG) number: 0131858007; AHFS:

Idhini hali ya:

APPROVED

Idhini ya tarehe:

2021-01-06

Tabia za bidhaa

_NRA-Quetiapine XR (Quetiapine Fumarate Extended-Release Tablets) _
_Page 1 of 85 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
NRA-QUETIAPINE XR
Quetiapine Fumarate Extended-Release Tablets
Extended-Release Tablets, 50 mg, 150 mg, 200 mg, 300 mg and 400 mg
quetiapine
(as quetiapine fumarate), Oral Use
House Standard
Antipsychotic / Antidepressant Agent
Nora Pharma Inc.
Date of Initial Authorization:
40 rue Prince-Arthur, Suite 310
January 6, 2021
Saint-Lambert, Quebec
J4P 1X2
Date of Revision:
April 1, 2022
Submission Control No.: 262101
_NRA-Quetiapine XR (Quetiapine Fumarate Extended-Release Tablets) _
_Page 2 of 85 _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Musculoskeletal - Rhabdomyolysis
04/2022
7 WARNINGS AND PRECAUTIONS, Psychiatric
04/2022
7 WARNINGS AND PRECAUTIONS, Skin
04/2022
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
...................................................................................................................
5
2
CONTRAINDICATIONS
.................................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................. 5
4
DOSAGE AND ADMINISTRATION
.................................................................................
5
4.1
Dosing