AG-CITALOPRAM TABLETS

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

CITALOPRAM (CITALOPRAM HYDROBROMIDE)

Tilgængelig fra:

ANGITA PHARMA INC.

ATC-kode:

N06AB04

INN (International Name):

CITALOPRAM

Dosering:

40MG

Lægemiddelform:

TABLET

Sammensætning:

CITALOPRAM (CITALOPRAM HYDROBROMIDE) 40MG

Indgivelsesvej:

ORAL

Enheder i pakken:

100

Recept type:

Prescription

Terapeutisk område:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Produkt oversigt:

Active ingredient group (AIG) number: 0136243002; AHFS:

Autorisation status:

APPROVED

Autorisation dato:

2021-03-15

Produktets egenskaber

1
PRODUCT MONOGRAPH
PR
AG-CITALOPRAM TABLETS
CITALOPRAM TABLETS, USP
10 MG, 20 MG AND 40 MG CITALOPRAM (AS CITALOPRAM HYDROBROMIDE)
ANTIDEPRESSANT
ANGITA PHARMA INC. DATE OF PREPARATION:
1310, RUE NOBEL MARCH 12, 2021
BOUCHERVILLE, QUÉBEC
J4B 5H3
CONTROL #: 244561
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
AG-CITALOPRAM TABLETS
Citalopram tablets, USP
10 mg, 20, and 40 mg citalopram (as citalopram hydrobromide)
PART I: HEALTH PROFESSIONAL INFORMATION
SUMMARY PRODUCT INFORMATION