MYLAN-CANDESARTAN TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

CANDESARTAN CILEXETIL

Disponible depuis:

MYLAN PHARMACEUTICALS ULC

Code ATC:

C09CA06

DCI (Dénomination commune internationale):

CANDESARTAN

Dosage:

4MG

forme pharmaceutique:

TABLET

Composition:

CANDESARTAN CILEXETIL 4MG

Mode d'administration:

ORAL

Unités en paquet:

30/100

Type d'ordonnance:

Prescription

Domaine thérapeutique:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Descriptif du produit:

Active ingredient group (AIG) number: 0135220001; AHFS:

Statut de autorisation:

CANCELLED POST MARKET

Date de l'autorisation:

2018-08-03

Résumé des caractéristiques du produit

_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