PROZAC LIQ 20MG/5ML LIQUID
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
29-06-2006
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Active ingredient:
FLUOXETINE (FLUOXETINE HYDROCHLORIDE)
Available from:
ELI LILLY CANADA INC
ATC code:
N06AB03
INN (International Name):
FLUOXETINE
Dosage:
20MG
Pharmaceutical form:
LIQUID
Composition:
FLUOXETINE (FLUOXETINE HYDROCHLORIDE) 20MG
Administration route:
ORAL
Units in package:
120ML
Prescription type:
Prescription
Therapeutic area:
SELECTIVE-SEROTONIN REUPTAKE INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0116847002; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2007-08-29
Summary of Product characteristics
PROZAC Product Monograph
Page 1 of 44
PRODUCT MONOGRAPH
Pr
PROZAC
®
(fluoxetine hydrochloride) Capsules
10 mg and 20 mg
Pr
PROZAC
®
(fluoxetine hydrochloride) Oral Solution
20 mg/5 mL
Antidepressant / Antiobsessional / Antibulimic
©
Eli Lilly Canada Inc.
3650 Danforth Avenue
Toronto, Ontario
M1N 2E8
1-888-545-5972
www.lilly.ca
Date of Revision:
June 22, 2006
Submission Control No: 104853
PROZAC Product Monograph
Page 2 of 44
Table of Contents
PART I: HEALTH PROFESSIONAL
INFORMATION......................................................... 3
SUMMARY PRODUCT INFORMATION
.............................................................................
3
INDICATIONS AND CLINICAL
USE...................................................................................
3
CONTRAINDICATIONS
........................................................................................................
4
WARNINGS AND
PRECAUTIONS.......................................................................................
5
ADVERSE
REACTIONS.......................................................................................................
11
DRUG INTERACTIONS
.......................................................................................................
19
DOSAGE AND
ADMINISTRATION...................................................................................
23
OVERDOSAGE
.....................................................................................................................
24
ACTION AND CLINICAL PHARMACOLOGY
................................................................. 26
STORAGE AND
STABILITY...............................................................................................
28
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................. 28
PART II: SCIENTIFIC INFORMATION
..............................................................................
29
PHARMACEUTICAL
INFORMATION...............................................................................
29
CLINIC
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