RIVA ALENDRONATE TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
09-03-2012
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Active ingredient:
ALENDRONIC ACID (ALENDRONATE SODIUM TRIHYDRATE)
Available from:
LABORATOIRE RIVA INC.
ATC code:
M05BA04
INN (International Name):
ALENDRONIC ACID
Dosage:
40MG
Pharmaceutical form:
TABLET
Composition:
ALENDRONIC ACID (ALENDRONATE SODIUM TRIHYDRATE) 40MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
BONE RESORPTION INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0150323001; AHFS:
Authorization status:
CANCELLED PRE MARKET
Authorization date:
2016-09-01
Summary of Product characteristics
PRODUCT MONOGRAPH
PR
_RIVA-ALENDRONATE_
Alendronate Sodium Tablets, USP
Alendronic Acid 40 mg and 70 mg (as Alendronate Sodium)
Bone Metabolism Regulator
LABORATOIRE RIVA INC.
660 Boul. Industriel
Blainville, Qc
J7C 3V4
Date of Revision:
March 9, 2012
Control No.: 153762
Page 2 of 43
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...................................................................................................
7
DRUG INTERACTIONS
.................................................................................................
11
DOSAGE AND
ADMINISTRATION.............................................................................
13
OVERDOSAGE
...............................................................................................................
14
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 15
STORAGE AND
STABILITY.........................................................................................
19
SPECIAL HANDLING INSTRUCTIONS
......................................................................
19
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 19
PART II: SCIENTIFIC INFORMATION
..............................................................................
20
PHARMACEUTICAL
INFORMATION.........................................................................
20
CLINICAL
TRIALS.........................................................................................................
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