JAMP GRANISETRON TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
13-01-2020
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Active ingredient:
GRANISETRON (GRANISETRON HYDROCHLORIDE)
Available from:
JAMP PHARMA CORPORATION
ATC code:
A04AA02
INN (International Name):
GRANISETRON
Dosage:
1MG
Pharmaceutical form:
TABLET
Composition:
GRANISETRON (GRANISETRON HYDROCHLORIDE) 1MG
Administration route:
ORAL
Units in package:
15G/50G
Prescription type:
Prescription
Therapeutic area:
5-HT3 RECEPTOR ANTAGONISTS
Product summary:
Active ingredient group (AIG) number: 0123183001; AHFS:
Authorization status:
APPROVED
Authorization date:
2018-02-02
Summary of Product characteristics
PRODUCT MONOGRAPH
Pr
JAMP Granisetron
Granisetron Hydrochloride Tablets
1 mg granisetron (as granisetron hydrochloride)
Manufacturer Standard
Antiemetic
(5-HT
3
receptor antagonist)
Jamp Pharma Corporation
1310 rue Nobel
Boucherville, Québec
Canada J4B 5H3
Submission Control No.: 234371
DATE OF REVISION:
January 13, 2020
JAMP Granisetron
Page 2 of 25
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
..................................................................................................6
DRUG INTERACTIONS
..................................................................................................9
DOSAGE AND
ADMINISTRATION................................................................................9
OVERDOSAGE
..............................................................................................................
10
ACTION AND CLINICAL PHARMACOLOGY
............................................................. 10
STORAGE AND
STABILITY.........................................................................................
13
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................... 13
PART II: SCIENTIFIC
INFORMATION............................................................................
14
PHARMACEUTICAL
INFORMATION..........................................................................
14
CLINICAL TRIALS
........................................................................................................
14
DETAILED PHARMACOLOGY
..........
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