TEVA-TAMOXIFEN TABLET

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

TAMOXIFEN (TAMOXIFEN CITRATE)

Dostupné s:

TEVA CANADA LIMITED

ATC kód:

L02BA01

INN (Mezinárodní Name):

TAMOXIFEN

Dávkování:

10MG

Léková forma:

TABLET

Složení:

TAMOXIFEN (TAMOXIFEN CITRATE) 10MG

Podání:

ORAL

Jednotky v balení:

60/100/250TAB

Druh předpisu:

Prescription

Terapeutické oblasti:

ANTINEOPLASTIC AGENTS

Přehled produktů:

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

Stav Autorizace:

APPROVED

Datum autorizace:

2011-05-05

Charakteristika produktu

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