AG-CITALOPRAM TABLETS

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

CITALOPRAM (CITALOPRAM HYDROBROMIDE)

Fáanlegur frá:

ANGITA PHARMA INC.

ATC númer:

N06AB04

INN (Alþjóðlegt nafn):

CITALOPRAM

Skammtar:

40MG

Lyfjaform:

TABLET

Samsetning:

CITALOPRAM (CITALOPRAM HYDROBROMIDE) 40MG

Stjórnsýsluleið:

ORAL

Einingar í pakka:

100

Gerð lyfseðils:

Prescription

Lækningarsvæði:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Vörulýsing:

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

Leyfisstaða:

APPROVED

Leyfisdagur:

2021-03-15

Vara einkenni

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