PRIVA-CANDESARTAN TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
16-06-2016
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Active ingredient:
CANDESARTAN CILEXETIL
Available from:
PHARMAPAR INC
ATC code:
C09CA06
INN (International Name):
CANDESARTAN
Dosage:
16MG
Pharmaceutical form:
TABLET
Composition:
CANDESARTAN CILEXETIL 16MG
Administration route:
ORAL
Units in package:
30/100
Prescription type:
Prescription
Therapeutic area:
ANGIOTENSIN II RECEPTOR ANTAGONISTS
Product summary:
Active ingredient group (AIG) number: 0135220003; AHFS:
Authorization status:
CANCELLED PRE MARKET
Authorization date:
2018-03-06
Summary of Product characteristics
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PRODUCT MONOGRAPH
PR
PRIVA-CANDESARTAN
Candesartan Cilexetil Tablets
4 mg, 8 mg, 16 mg and 32 mg
Angiotensin II AT
1
Receptor Blocker
PHARMAPAR INC.
DATE OF PREPARATION:
5950, Côte de Liesse, Suite 100
June 15, 2016
Ville Mont-Royal
Québec H4T 1E2
SUBMISSION CONTROL #: 194899
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TABLE OF CONTENTS
CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
...............................................................................
3
SUMMARY PRODUCT INFORMATION
...............................................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................................
3
CONTRAINDICATIONS
..........................................................................................................................
4
WARNINGS AND PRECAUTIONS
.........................................................................................................
4
ADVERSE REACTIONS
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8
DRUG INTERACTIONS
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13
DOSAGE AND ADMINISTRATION
.....................................................................................................
16
OVERDOSAGE
.......................................................................................................................................
19
ACTION AND CLINICAL
PHARMACOLOGY....................................................................................
19
STORAGE AND STABILITY
.................................................................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
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