Riik: Kanada
keel: inglise
Allikas: Health Canada
CITALOPRAM (CITALOPRAM HYDROBROMIDE)
AURO PHARMA INC
N06AB04
CITALOPRAM
20MG
TABLET
CITALOPRAM (CITALOPRAM HYDROBROMIDE) 20MG
ORAL
30/100/500
Prescription
SELECTIVE-SEROTONIN REUPTAKE INHIBITORS
Active ingredient group (AIG) number: 0136243001; AHFS:
APPROVED
2006-02-16
_AURO-CITALOPRAM_ _ _ Page 1 of 67 _ _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR AURO-CITALOPRAM citalopram hydrobromide Tablets, 20 and 40 mg citalopram (base), Oral Antidepressant AURO PHARMA INC. 3700 Steeles Avenue West, Suite # 402 Woodbridge, Ontario, L4L 8K8, CANADA Date of Initial Authorization: March 11, 2011 Submission Control Number: 264092 Date of Revision: October 13, 2022 _AURO-CITALOPRAM_ _ _ Page 2 of 67 _ _ _AURO-CITALOPRAM_ _ _ Page 3 of 67 _ _ RECENT MAJOR LABEL CHANGES 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 ........................................................................................... 3 TABLE OF CONTENTS............................................................................................................. 3 PART I: HEALTH PROFESSIONAL INFORMATION .................................................................... 6 1 INDICATIONS ..................................................................................................................... 6 1.1 Pediatrics ............................................................................................................. 6 1.2 Geriatrics ............................................................................................................. 6 2 CONTRAINDICATIONS ........................................................................................................ 6 4 DOSAGE AND ADMINISTRATION ........................................................................................ 7 4.1 Dosing Considerations .......................................................................................... 7 4.2 Recommended Dose and Dosage Adjustment ....................................................... 8 4.4 Administration . Lugege kogu dokumenti