RAN-CITALO TABLET

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

CITALOPRAM (CITALOPRAM HYDROBROMIDE)

Dostopno od:

RANBAXY PHARMACEUTICALS CANADA INC.

Koda artikla:

N06AB04

INN (mednarodno ime):

CITALOPRAM

Odmerek:

20MG

Farmacevtska oblika:

TABLET

Sestava:

CITALOPRAM (CITALOPRAM HYDROBROMIDE) 20MG

Pot uporabe:

ORAL

Enote v paketu:

100/500

Tip zastaranja:

Prescription

Terapevtsko območje:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Povzetek izdelek:

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

Status dovoljenje:

CANCELLED POST MARKET

Datum dovoljenje:

2022-09-30

Lastnosti izdelka

1
PRODUCT MONOGRAPH
PR
RAN™-CITALO
CITALOPRAM TABLETS, USP
20 MG AND 40 MG CITALOPRAM (AS CITALOPRAM HYDROBROMIDE)
ANTIDEPRESSANT
Ranbaxy Pharmaceuticals Canada Inc.
DATE OF REVISION:
126 East Drive
February 1, 2017
Brampton, Ontario
L6T 1C1
SUBMISSION CONTROL# 201736
RAN TRADEMARK OWNED BY SUN PHARMACEUTICAL INDUSTRIES LTD.
2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
................................................................................
3
INDICATIONS AND CLINICAL USE
......................................................................................
3
CONTRAINDICATIONS
............................................................................................................
4
WARNINGS AND PRECAUTIONS
..........................................................................................
4
ADVERSE REACTIONS
...........................................................................................................
12
DRUG INTERACTIONS
...........................................................................................................
19
DOSAGE AND ADMINISTRATION
......................................................................................
26
OVERDOSAGE
..........................................................................................................................
28
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 29
STORAGE AND
STABILITY...................................................................................................
31
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................... 31
PART II: SCIENTIFIC INFORMATION
...............................................................................
32
PHARMACEUTICAL INFORMATION
.................................................................................
32
CLINICAL TRIALS
..............................................