TARO-CLOMIPRAMINE CAPSULE

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

CLOMIPRAMINE HYDROCHLORIDE

Saatavilla:

TARO PHARMACEUTICALS INC

ATC-koodi:

N06AA04

INN (Kansainvälinen yleisnimi):

CLOMIPRAMINE

Annos:

50MG

Lääkemuoto:

CAPSULE

Koostumus:

CLOMIPRAMINE HYDROCHLORIDE 50MG

Antoreitti:

ORAL

Kpl paketissa:

15G/50G

Prescription tyyppi:

Prescription

Terapeuttinen alue:

TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0109212002; AHFS:

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2020-03-24

Valmisteyhteenveto

_Taro-Clomipramine Product Monograph _
_ _
_Page 1 of 58 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
TARO-CLOMIPRAMINE
Clomipramine Hydrochloride Capsules
Capsules, 25 mg and 50 mg, Oral
USP
Antidepressant / Antiobsessional
Taro Pharmaceuticals Inc.
Date of Initial Authorization
130 East Drive
March 20, 2020
Brampton, ON
L6T 1C1
Date of Revision:
October 17, 2023
Submission Control No.: 277420
_Taro-Clomipramine Product Monograph _
_ _
_Page 2 of 58 _
RECENT MAJOR LABEL CHANGES
1 Indications, 1.1 Pediatrics
10/2023
2 Contraindications
10/2023
3 Serious Warnings and Precautions Box
10/2023
4 Dosage and Administration, 4.1 Dosing Considerations
10/2023
4 Dosage and Administration, 4.2 Recommended Dose and
Dosage Adjustment
10/2023
7 Warnings and Precautions, Endocrine and Metabolism
10/2023
7 Warnings and Precautions, Hematologic
10/2023
7 Warnings and Precautions, Musculoskeletal
10/2023
7 Warnings and Precautions, Neurologic
10/2023
7 Warnings and Precautions, Ophthalmologic
10/2023
7 Warnings and Precautions, Peri-Operative Considerations
10/2023
7 Warnings and Precautions, Psychiatric
10/2023
7 Warnings and Precautions, Skin
10/2023
7 Warnings and Precautions, 7.1.3 Pediatrics
10/2023
7 Warnings and Precautions, 7.1.4 Geriatrics
10/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
.............................................................................................
2
TABLE OF CONTENTS
...............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................
4
1
INDICATIONS
.................................................................................................................
4
1.1
Pediatrics
........................................................................................................................
4
1.2
Geriatrics
......