MINT-CITALOPRAM TABLET

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

CITALOPRAM (CITALOPRAM HYDROBROMIDE)

Tilgængelig fra:

MINT PHARMACEUTICALS INC

ATC-kode:

N06AB04

INN (International Name):

CITALOPRAM

Dosering:

20MG

Lægemiddelform:

TABLET

Sammensætning:

CITALOPRAM (CITALOPRAM HYDROBROMIDE) 20MG

Indgivelsesvej:

ORAL

Enheder i pakken:

30/100/500

Recept type:

Prescription

Terapeutisk område:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Produkt oversigt:

Active ingredient group (AIG) number: 0136243001; AHFS:

Autorisation status:

CANCELLED POST MARKET

Autorisation dato:

2018-08-01

Produktets egenskaber

1
PRODUCT MONOGRAPH
PR
MINT-CITALOPRAM
CITALOPRAM TABLETS, USP
10 MG, 20 MG AND 40 MG CITALOPRAM (AS CITALOPRAM HYDROBROMIDE)
ANTIDEPRESSANT
MINT PHARMACEUTICALS INC.,
DATE OF REVISION:
1093 MEYERSIDE DRIVE, UNIT 1,
MAY 29, 2014
MISSISSAUGA, ONTARIO
L5T 1J6
CONTROL#: 173999
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
…………………………………………………
11
DRUG
INTERACTIONS…………………………………………………..
19
DOSAGE AND ADMINISTRATION…………………………………….
26
OVERDOSAGE……………………………………………………………
28
ACTION AND CLINICAL PHARMACOLOGY…………………………
29
STORAGE AND STABILITY
…………………………………………….
30
DOSAGE FORMS, COMPOSITION AND PACKAGING……………….
30
PART II: SCIENTIFIC INFORMATION………………………………
32
PHARMACEUTICAL INFORMATION………………………………….
32
CLINICAL
TRIALS……………………………………………………….
33
DETAILED PHARMACOLOGY………………………………………….
35
TOXICOLOGY…………………………………………………………….
38
REFERENCES……………………………………………………………..
42
PART III: CONSUMER INFORMATION ……………………………..
46
3
Pr
MINT-CITALOPRAM
Citalopram tablets, USP
10 mg, 20, and 40 mg citalopram (as citalopram hydrobromide)
PART I: HEALTH PROFESSIONAL INFORMATION
SUMMARY PRODUCT INFORMATION
INDICATIONS AND CLINICAL USE
Adults
MINT-CITALOPRAM (Citalopram hydrobromide) is indicated for
the symptomatic relief of depressive illness.
The relapse rate was signifi