Valsts: Kanāda
Valoda: angļu
Klimata pārmaiņas: Health Canada
CLOMIPRAMINE HYDROCHLORIDE
TARO PHARMACEUTICALS INC
N06AA04
CLOMIPRAMINE
50MG
CAPSULE
CLOMIPRAMINE HYDROCHLORIDE 50MG
ORAL
15G/50G
Prescription
TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS
Active ingredient group (AIG) number: 0109212002; AHFS:
APPROVED
2020-03-24
_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 ...... Izlasiet visu dokumentu