TEVA-TAMOXIFEN TABLET

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

TAMOXIFEN (TAMOXIFEN CITRATE)

MAH:

TEVA CANADA LIMITED

ATC_code:

L02BA01

INN:

TAMOXIFEN

dosage:

10MG

pharmaceutical_form:

TABLET

composition:

TAMOXIFEN (TAMOXIFEN CITRATE) 10MG

administration_route:

ORAL

units_in_package:

60/100/250TAB

prescription_type:

Prescription

therapeutic_area:

ANTINEOPLASTIC AGENTS

leaflet_short:

Active ingredient group (AIG) number: 0131293001; AHFS:

authorization_status:

APPROVED

authorization_date:

2011-05-05

SPC

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........................................................................................