Land: Canada
Språk: engelsk
Kilde: Health Canada
QUETIAPINE (QUETIAPINE FUMARATE)
TEVA CANADA LIMITED
N05AH04
QUETIAPINE
400MG
TABLET (EXTENDED-RELEASE)
QUETIAPINE (QUETIAPINE FUMARATE) 400MG
ORAL
15G/50G
Prescription
ATYPICAL ANTIPSYCHOTICS
Active ingredient group (AIG) number: 0131858007; AHFS:
APPROVED
2013-03-08
_ _ _Teva-Quetiapine XR Tablets_ _ _ _Page 1 of 93_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION Pr TEVA-QUETIAPINE XR Quetiapine Fumarate Extended-Release Tablets Tablets, 50 mg, 150 mg, 200 mg, 300 mg and 400 mg quetiapine (as quetiapine fumarate), Oral Teva Standard Antipsychotic / Antidepressant Agent Teva Canada Limited 30 Novopharm Court Toronto, ON M1B 2K9 Canada www.tevacanada.com Date of Initial Authorization: March 08, 2013 Date of Revision: August 25, 2022 Submission Control No: 262415 _ _ _Teva-Quetiapine XR Tablets_ _ _ _Page 2 of 93_ RECENT MAJOR LABEL CHANGES 7 WARNINGS AND PRECAUTIONS - Musculoskeletal - Rhabdomyolysis 08/2022 7 WARNINGS AND PRECAUTIONS - Psychiatric 08/2022 7 Warnings and Precautions - Skin 08/2022 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 ................................................................................................................... 5 1.2 Geriatrics ................................................................................................................... 5 2. CONTRAINDICATIONS ................................................................................................. 5 3. SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................. 5 4. DOSAGE AND ADMINISTRATION ................................................................................. 5 4.1 Dosing Considerations ............................................................... read_full_document