ANAFRANIL TABLET

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

CLOMIPRAMINE HYDROCHLORIDE

Beschikbaar vanaf:

APOTEX INC

ATC-code:

N06AA04

INN (Algemene Internationale Benaming):

CLOMIPRAMINE

Dosering:

50MG

farmaceutische vorm:

TABLET

Samenstelling:

CLOMIPRAMINE HYDROCHLORIDE 50MG

Toedieningsweg:

ORAL

Eenheden in pakket:

100

Prescription-type:

Prescription

Therapeutisch gebied:

TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS

Product samenvatting:

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

Autorisatie-status:

APPROVED

Autorisatie datum:

2012-06-01

Productkenmerken

_Pr_
_ANAFRANIL_
_®_
_ (clomipramine hydrochloride) _
_ _
_Page 1 of 55_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ANAFRANIL
®
clomipramine hydrochloride tablets
Tablets, 10 mg, 25 mg and 50 mg, Oral
ATC code: N06AA04
Antidepressant / Antiobsessional
Apotex Inc.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
SEP 28, 2020
Date of Revision:
MAY 02, 2023
Submission Control Number: 268209
_ _
_Pr_
_ANAFRANIL_
_® _
_(clomipramine hydrochloride) _
_ _
_Page 2 of 55 _
RECENT MAJOR LABEL CHANGES _ _
1 Indications, 1.1 Pediatrics
05/2023
2 Contraindications
05/2023
3 Serious Warnings and Precautions Box
05/2023
4 Dosage and Administration, 4.1 Dosing Considerations
05/2023
4 Dosage and Administration, 4.2 Recommended Dose and
Dosage Adjustment
05/2023
7 Warnings and Precautions, Endocrine and Metabolism
05/2023
7 Warnings and Precautions, Hematologic
05/2023
7 Warnings and Precautions, Musculoskeletal
05/2023
7 Warnings and Precautions, Neurologic
05/2023
7 Warnings and Precautions, Ophthalmologic
05/2023
7 Warnings and Precautions, Peri-Operative Considerations
05/2023
7 Warnings and Precautions, Psychiatric
05/2023
7 Warnings and Precautions, Skin
05/2023
7 Warnings and Precautions, 7.1.3 Pediatrics
05/2023
7 Warnings and Precautions, 7.1.4 Geriatrics
05/2023
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
.......................................................................
5
1
INDICATIONS
................................................................................................................
5
1.1
Pediatrics
......................................................................................................