MINT-RIVASTIGMINE CAPSULE
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
22-12-2016
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Active ingredient:
RIVASTIGMINE (RIVASTIGMINE HYDROGEN TARTRATE)
Available from:
MINT PHARMACEUTICALS INC
ATC code:
N06DA03
INN (International Name):
RIVASTIGMINE
Dosage:
4.5MG
Pharmaceutical form:
CAPSULE
Composition:
RIVASTIGMINE (RIVASTIGMINE HYDROGEN TARTRATE) 4.5MG
Administration route:
ORAL
Units in package:
56/100
Prescription type:
Prescription
Therapeutic area:
PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS
Product summary:
Active ingredient group (AIG) number: 0140521003; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2017-06-19
Summary of Product characteristics
PRODUCT MONOGRAPH
PR
MINT-RIVASTIGMINE
1.5 mg, 3 mg, 4.5 mg, 6 mg Rivastigmine
(supplied as Rivastigmine Hydrogen Tartrate)
Capsules
Mint Standard
Cholinesterase Inhibitor
Mint Pharmaceuticals Inc. Date of Revision: December 22, 2016
1093 Meyerside Drive, Unit 1
Mississauga, Ontario
L5T 1J6
Submission Control No: 200803
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
............................................................................................
11
DRUG INTERACTIONS
............................................................................................
25
DOSAGE AND ADMINISTRATION
...........................................................................
26
OVERDOSAGE
.........................................................................................................
28
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 29
STORAGE AND STABILITY
......................................................................................
32
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................... 32
PART II: SCIENTIFIC INFORMATION
..........................................................................
33
PHARMACEUTICAL INFORMATION
........................................................................
33
CLINICAL TRIALS
.....................................................................................................
34
DETAILED PHARMACOLOGY
..........................................................................
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