TEVA-TELMISARTAN TABLET

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

TELMISARTAN

Disponibil de la:

TEVA CANADA LIMITED

Codul ATC:

C09CA07

INN (nume internaţional):

TELMISARTAN

Dozare:

40MG

Forma farmaceutică:

TABLET

Compoziție:

TELMISARTAN 40MG

Calea de administrare:

ORAL

Unități în pachet:

28/30/100/500

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Rezumat produs:

Active ingredient group (AIG) number: 0138223001; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2012-01-06

Caracteristicilor produsului

TEVA-TELMISARTAN
Page 1 of 38
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TEVA-TELMISARTAN
Telmisartan Tablets
Tablet, 40 mg and 80 mg, Oral
USP
Angiotensin II AT1 Receptor Blocker
Teva Canada Limited
30 Novopharm Court
Toronto, ON
M1B 2K9
Canada
www.tevacanada.com
Date of Initial Authorization:
January 06, 2012
Date of Revision:
August 15, 2023
Submission Control No: 272815
TEVA-TELMISARTAN
Page 2 of 38
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
08/2023
7 WARNINGS AND PRECAUTIONS
08/2023
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
......................................................................................................
5
4.2 Recommended Dose and Dosage Adjustment
................................................................. 5
4.4 Administration
......................................