NTP-RISEDRONATE TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
26-07-2012
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Active ingredient:
RISEDRONATE SODIUM (RISEDRONATE SODIUM MONOHYDRATE)
Available from:
NT PHARMA CANADA LTD
ATC code:
M05BA07
INN (International Name):
RISEDRONIC ACID
Dosage:
5MG
Pharmaceutical form:
TABLET
Composition:
RISEDRONATE SODIUM (RISEDRONATE SODIUM MONOHYDRATE) 5MG
Administration route:
ORAL
Units in package:
30
Prescription type:
Prescription
Therapeutic area:
BONE RESORPTION INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0135301002; AHFS:
Authorization status:
CANCELLED PRE MARKET
Authorization date:
2017-03-16
Summary of Product characteristics
PRODUCT MONOGRAPH
PR
NTP-RISEDRONATE
Risedronate sodium (as the monohydrate)
5 mg, 30 mg and 35 mg Tablets
Bone Metabolism Regulator
NT Pharma Canada Ltd.
5691 Main Street
Stouffville, Ontario
Canada, L4A 1H5
Submission Control No: 156479
Date of Revision:
July 26, 2012
2
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
...........................................................................................................
6
DRUG INTERACTIONS
.........................................................................................................
11
DOSAGE AND ADMINISTRATION
.....................................................................................
13
OVERDOSAGE
.......................................................................................................................
14
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 15
STORAGE AND STABILITY
.................................................................................................
19
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 19
PART II: SCIENTIFIC INFORMATION
...............................................................................
21
PHARMACEUTICAL INFORMATION
.................................................................................
21
CLINICAL TRIALS
.................................................................................................................
22
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