MYLAN-CANDESARTAN TABLET

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

CANDESARTAN CILEXETIL

MAH:

MYLAN PHARMACEUTICALS ULC

ATC_code:

C09CA06

INN:

CANDESARTAN

dosage:

32MG

pharmaceutical_form:

TABLET

composition:

CANDESARTAN CILEXETIL 32MG

administration_route:

ORAL

units_in_package:

30/100

prescription_type:

Prescription

therapeutic_area:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

leaflet_short:

Active ingredient group (AIG) number: 0135220004; AHFS:

authorization_status:

CANCELLED POST MARKET

authorization_date:

2018-08-03

SPC

_MYLAN-CANDESARTAN Product Monograph_
_Page 1 of 38 _
PRODUCT MONOGRAPH
PR
MYLAN-CANDESARTAN
(candesartan cilexetil tablets)
4 mg, 8 mg, 16 mg and 32 mg
Angiotensin II AT
1
Receptor Blocker
Mylan Pharmaceuticals ULC
85 Advance Road
Toronto, ON
M8Z 2S6
Submission Control Number: 193792
Date of Preparation: December 4, 2009
Date of Revision:
April 14, 2016
_MYLAN-CANDESARTAN Product Monograph_
_Page 2 of 38 _
TABLE OF CONTENTS
PART 1: HEALTH PROFESSIONAL INFORMATION .................................................... 3
SUMMARY PRODUCT INFORMATION
.............................................................................
3
INDICATIONS AND CLINICAL USE
...................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
4
WARNINGS AND PRECAUTIONS
........................................................................................
4
ADVERSE REACTIONS
..........................................................................................................
8
DRUG INTERACTIONS
.........................................................................................................
14
DOSAGE AND ADMINISTRATION
....................................................................................
17
OVERDOSAGE
.........................................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
.....................................................................
20
STORAGE AND STABILITY
................................................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................. 22
PART II: SCIENTIFIC INFORMATION .............................................................................
24
PHARMACEUTICAL INFORMATION
...............................................................................
24
CLINICAL T