Nazione: Canada
Lingua: inglese
Fonte: Health Canada
CITALOPRAM (CITALOPRAM HYDROBROMIDE)
TEVA CANADA LIMITED
N06AB04
CITALOPRAM
10MG
TABLET
CITALOPRAM (CITALOPRAM HYDROBROMIDE) 10MG
ORAL
100
Prescription
SELECTIVE-SEROTONIN REUPTAKE INHIBITORS
Active ingredient group (AIG) number: 0136243003; AHFS:
APPROVED
2010-11-02
TEVA-CITALOPRAM_ _ _Page 1 of 56 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR TEVA-CITALOPRAM Citalopram Hydrobromide Tablets Tablets, 10 mg, 20 mg and 40 mg citalopram (as citalopram hydrobromide), Oral Teva Standard Antidepressant Teva Canada Limited 30 Novopharm Court Toronto, Ontario M1B 2K9 Canada www.tevacanada.com Submission Control Number: 280059 Date of Initial Authorization: October 24, 2008 Date of Revision: February 26, 2024 TEVA-CITALOPRAM_ _ _Page 2 of 56 _ RECENT MAJOR LABEL CHANGES 3 SERIOUS WARNINGS AND PRECAUTIONS 02/2024 7 WARNINGS AND PRECAUTIONS, Hematologic 10/2022 7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female and Male Potential 10/2022 7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women 10/2022 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…………………………………………………………….5 4 DOSAGE AND ADMINISTRATION ................................................................................... 5 4.1 Dosing Considerations ................................................... Leggi il documento completo