ALEMBIC-TELMISARTAN TABLET

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

TELMISARTAN

Dostopno od:

ALEMBIC PHARMACEUTICALS LIMITED

Koda artikla:

C09CA07

INN (mednarodno ime):

TELMISARTAN

Odmerek:

80MG

Farmacevtska oblika:

TABLET

Sestava:

TELMISARTAN 80MG

Pot uporabe:

ORAL

Enote v paketu:

30/100

Tip zastaranja:

Prescription

Terapevtsko območje:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Povzetek izdelek:

Active ingredient group (AIG) number: 0138223002; AHFS:

Status dovoljenje:

APPROVED

Datum dovoljenje:

2018-07-23

Lastnosti izdelka

______________________________________________________________________________
_Alembic-Telmisartan Product Monograph_
_ Page 1 of 39_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ALEMBIC-TELMISARTAN
Telmisartan Tablets
Tablets, 40 mg and 80 mg, Oral
USP
Angiotensin II AT1 Receptor Blocker
Manufactured by:
Date of Initial Authorization:
Alembic Pharmaceuticals Limited July 23, 2018
Alembic Road,
Vadodara 390003,
Gujarat, India
Canadian Importer and Distributor: Date of Revision:
Alembic Pharmaceuticals Canada Ltd. June 29, 2023
2680, Matheson Blvd. East, Unit 102
Mississauga, Ontario
L4W 0A5, Canada
Submission Control Number: 271582
______________________________________________________________________________
_Alembic-Telmisartan Product Monograph_
_ Page 2 of 39_
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
07/2023
7 WARNINGS AND PRECAUTIONS
07/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
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
..................