CCP-CITALOPRAM TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
03-05-2017
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Active ingredient:
CITALOPRAM (CITALOPRAM HYDROBROMIDE)
Available from:
CELLCHEM PHARMACEUTICALS INC.
ATC code:
N06AB04
INN (International Name):
CITALOPRAM
Dosage:
20MG
Pharmaceutical form:
TABLET
Composition:
CITALOPRAM (CITALOPRAM HYDROBROMIDE) 20MG
Administration route:
ORAL
Units in package:
30/100
Prescription type:
Prescription
Therapeutic area:
SELECTIVE-SEROTONIN REUPTAKE INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0136243001; AHFS:
Authorization status:
APPROVED
Authorization date:
2017-01-04
Summary of Product characteristics
_CCP-CITALOPRAM _
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PRODUCT MONOGRAPH
PR
CCP-CITALOPRAM
Citalopram Tablets, USP
20 mg and 40 mg tablets, citalopram (as citalopram hydrobromide)
ANTIDEPRESSANT
CellChem Pharmaceuticals Inc.,
Date of Revision:
30 Concourse Gate, Unit 1
APRIL 27, 2017
Ottawa, Ontario - K2E 7V7
Submission Control No: 201751
_CCP-CITALOPRAM _
Page 2 of 45
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
..............................................................................................
11
DRUG INTERACTIONS
..............................................................................................
17
DOSAGE AND ADMINISTRATION
..........................................................................
24
OVERDOSAGE
.............................................................................................................
25
ACTION AND CLINICAL PHARMACOLOGY
........................................................ 26
STORAGE AND STABILITY
......................................................................................
28
DOSAGE FORMS, COMPOSITION AND PACKAGING
......................................... 28
PART II: SCIENTIFIC INFORMATION
............................................................................
29
PHARMACEUTICAL INFORMATION
......................................................................
29
CLINICAL TRIALS
......................................................................................................
30
DETAILED PHARMACOLOGY
...................................................
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