PHL-RIVASTIGMINE CAPSULE

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

RIVASTIGMINE (RIVASTIGMINE HYDROGEN TARTRATE)

Available from:

PHARMEL INC

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:

2017-09-13

Summary of Product characteristics

PRODUCT MONOGRAPH
PR
PHL-RIVASTIGMINE
Rivastigmine Hydrogen Tartrate Capsules, House Standard
1.5 mg, 3 mg, 4.5 mg and 6 mg of Rivastigmine
(as Rivastigmine Hydrogen Tartrate)
Cholinestesterase Inhibitor
PHARMEL INC.
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
Date of Revision :
April 25, 2016
SUBMISSION CONTROL NO: 193498
_ _
_phl-RIVASTIGMINE Product Monograph _
_Page 2 of 53_
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
..................................................................................................22
DOSAGE AND ADMINISTRATION
..............................................................................24
OVERDOSAGE
................................................................................................................25
ACTION AND CLINICAL PHARMACOLOGY
............................................................26
STORAGE AND STABILITY
..........................................................................................29
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................29
PART II: SCIENTIFIC INFORMATION
...............................................................................30
PHARMACEUTICAL INFORMATION
..........................................................................30
CLINICAL TRIALS
.............................................................................................