RIVASTIGMINE TARTRATE CAPSULES
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
30-11-2011
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Active ingredient:
RIVASTIGMINE (RIVASTIGMINE HYDROGEN TARTRATE)
Available from:
DR REDDY'S LABORATORIES LTD
ATC code:
N06DA03
INN (International Name):
RIVASTIGMINE
Dosage:
1.5MG
Pharmaceutical form:
CAPSULE
Composition:
RIVASTIGMINE (RIVASTIGMINE HYDROGEN TARTRATE) 1.5MG
Administration route:
ORAL
Units in package:
100/500
Prescription type:
Prescription
Therapeutic area:
PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS
Product summary:
Active ingredient group (AIG) number: 0140521001; AHFS:
Authorization status:
CANCELLED PRE MARKET
Authorization date:
2022-07-13
Summary of Product characteristics
PRODUCT
MONOGRAPH
PR
RIVASTIGMINE TARTRATE CAPSULES
1.5 MG, 3 MG, 4.5 MG AND 6 MG
CHOLINESTERASE INHIBITOR
MANUFACTURED BY:
DR. REDDY’S LABORATORIES LIMITED
DATE OF PREPARATION :
Bachepalli – 502 325 INDIA NOVEMBER 3, 2011
CONTROL #: 148321
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE
REACTIONS..................................................................................................9
DRUG INTERACTIONS
..................................................................................................20
DOSAGE AND ADMINISTRATION
..............................................................................21
OVERDOSAGE
................................................................................................................23
ACTION AND CLINICAL PHARMACOLOGY
............................................................24
STORAGE AND
STABILITY..........................................................................................26
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................26
PART II: SCIENTIFIC INFORMATION
...............................................................................28
PHARMACEUTICAL
INFORMATION..........................................................................28
CLINICAL TRIALS
..........................................................................................................29
DETAILED PHARMACOLOGY
.....................................................................................39
TOXICOLOGY
..................
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