PIMOZIDE TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
17-03-2014
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Active ingredient:
PIMOZIDE
Available from:
AA PHARMA INC
ATC code:
N05AG02
INN (International Name):
PIMOZIDE
Dosage:
2MG
Pharmaceutical form:
TABLET
Composition:
PIMOZIDE 2MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
MISCELLANEOUS ANTIPSYCHOTICS
Product summary:
Active ingredient group (AIG) number: 0109963001; AHFS:
Authorization status:
APPROVED
Authorization date:
2002-02-19
Summary of Product characteristics
PRODUCT MONOGRAPH
PR
PIMOZIDE
PIMOZIDE TABLETS USP
2 MG AND 4 MG
ANTIPSYCHOTIC
AA PHARMA INC.
DATE OF PREPARATION:
1165 CREDITSTONE ROAD, UNIT #1
MARCH 11, 2014
VAUGHAN, ONTARIO
L4K 4N7
CONTROL NO.: 172057
2
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
.......................................................................................................
11
DOSAGE AND ADMINISTRATION
...................................................................................
13
OVERDOSAGE
......................................................................................................................
14
ACTIONS AND CLINICAL PHARMACOLOGY
............................................................... 15
STABILITY AND STORAGE RECOMMENDATIONS
..................................................... 15
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................. 15
PART II: SCIENTIFIC INFORMATION
.............................................................................
17
PHARMACEUTICAL INFORMATION
...............................................................................
17
CLINICAL TRIALS
...............................................................................................................
18
DETAILED PHARMACOLOGY
..........................................................................................
18
TOXI
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