CITALOPRAM TABLETS USP

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

CITALOPRAM (CITALOPRAM HYDROBROMIDE)

Dostopno od:

TORRENT PHARMACEUTICALS LIMITED

Koda artikla:

N06AB04

INN (mednarodno ime):

CITALOPRAM

Odmerek:

20MG

Farmacevtska oblika:

TABLET

Sestava:

CITALOPRAM (CITALOPRAM HYDROBROMIDE) 20MG

Pot uporabe:

ORAL

Enote v paketu:

30/100/500

Tip zastaranja:

Prescription

Terapevtsko območje:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Povzetek izdelek:

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

Status dovoljenje:

CANCELLED (UNRETURNED ANNUAL)

Datum dovoljenje:

2021-12-20

Lastnosti izdelka

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_Page 1 of 49_
_Citalopram Tablets USP _
PRODUCT MONOGRAPH
Pr
Citalopram Tablets USP
10 mg, 20 mg and 40 mg citalopram (as citalopram hydrobromide)
Antidepressant
Torrent Pharmaceuticals Ltd.
Ahmedabad-Mehsana Highway
Taluka-Kadi, Dist. Mehsana
Indrad-382 721, Gujarat, India
Distributed by:
Torrent Pharma Canada Inc.
Woodbridge, ON, L4H 2K4
Date of Revision:
December 8, 2016
Submission Control No: 200395
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_Citalopram Tablets USP _
_Page 2 of 49_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION…………………………………
3
SUMMARY PRODUCT
INFORMATION………………………………………..
3
INDICATIONS AND CLINICAL
USE……………………………………………
3
CONTRAINDICATIONS………………………………………………………….
4
WAARNINGS AND
PRECAUSIONS…………………………………………….
4
ADVERSE
REACTIONS………………………………………………………….
12
DRUG
INTERACTIONS…………………………………………………………..
19
DOSAGE AND
ADMINISTRATION……………………………………………..
26
OVERDOSAGE……………………………………………………………………
28
ACTION AND CLINICAL
PHARMACOLOGY…………………………………
29
STORAGE AND
STABILITY…………………………………………………….
30
DOSAGE FORMS, COMPOSITION AND PACKING…………………………..
31
PART II: SCIENTIFIC
INFORMATION…………………………………………………
32
PHARMACEUTICAL
INFORMATION………………………………………….
32
CLINICAL
TRIALS……………………………………………………………….
33
DETAILED
PHARMACOLOGY………………………………………………….
34
TOXICOLOGY…………………………………………………………………….
37
REFERNCES……………………………………………………………………….
42
PART III: CONSUMER
INFORMATION………