国家: 加拿大
语言: 英文
来源: Health Canada
TAMOXIFEN (TAMOXIFEN CITRATE)
TEVA CANADA LIMITED
L02BA01
TAMOXIFEN
10MG
TABLET
TAMOXIFEN (TAMOXIFEN CITRATE) 10MG
ORAL
60/100/250TAB
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0131293001; AHFS:
APPROVED
2011-05-05
TEVA-TAMOXIFEN Page 1 of 35 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR TEVA-TAMOXIFEN Tamoxifen Citrate Tablets Tablets, 10 mg and 20 mg tamoxifen, Oral BP Antineoplastic Agent Teva Canada Limited Date of Initial Authorization: 30 Novopharm Court March 28, 1990 Toronto, ON M1B 2K9 Date of Revision: Canada June 07, 2022 www.tevacanada.com Submission Control Number: 262609 TEVA-TAMOXIFEN Page 2 of 35 RECENT MAJOR LABEL CHANGES 2 CONTRAINDICATIONS 11/2021 7 WARNINGS AND PRECAUTIONS, Immune 06/2022 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 2 CONTRAINDICATIONS......................................................................................................4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX .................................................................5 4 DOSAGE AND ADMINISTRATION .....................................................................................5 4.1 Dosing Considerations .............................................................................................5 4.2 Recommended Dose and Dosage Adjustment ..........................................................5 4.4 Administration ........................................................................................................6 4.5 Missed Dose........................................................................................ 阅读完整的文件