RAN-CARVEDILOL TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
06-10-2016
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Active ingredient:
CARVEDILOL
Available from:
RANBAXY PHARMACEUTICALS CANADA INC.
ATC code:
C07AG02
INN (International Name):
CARVEDILOL
Dosage:
25MG
Pharmaceutical form:
TABLET
Composition:
CARVEDILOL 25MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
BETA-ADRENERGIC BLOCKING AGENTS
Product summary:
Active ingredient group (AIG) number: 0122683001; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2022-09-16
Summary of Product characteristics
PRODUCT MONOGRAPH
PR
RAN™-CARVEDILOL
Carvedilol Tablets, House Standard
3.125, 6.25, 12.5 and 25 mg
CONGESTIVE HEART FAILURE AGENT
Ranbaxy Pharmaceuticals Canada Inc. DATE OF REVISION:
126 East Drive SEPTEMBER 14, 2016
Brampton, Ontario
L4W 0A5
Submission Control No: 197425
RAN trademark owned by Sun Pharmaceutical Industries Ltd.
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_RAN-CARVEDILOL Product Monograph _
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_Page 2 of 38 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
.............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................9
DRUG INTERACTIONS
..................................................................................................15
DOSAGE AND ADMINISTRATION
..............................................................................17
OVERDOSAGE
................................................................................................................19
ACTION AND CLINICAL PHARMACOLOGY
............................................................20
STORAGE AND STABILITY
..........................................................................................23
DOSAGE FORMS, COMPOSITION AND PACKAGING
..............................................23
PART II: SCIENTIFIC INFORMATION
...............................................................................25
PHARMACEUTICAL INFORMATION
..........................................................................25
CLINICAL TRIALS
.............................................................................................
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