TARO-LENALIDOMIDE CAPSULE

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

LENALIDOMIDE

Available from:

TARO PHARMACEUTICALS INC

ATC code:

L04AX04

INN (International Name):

LENALIDOMIDE

Dosage:

5MG

Pharmaceutical form:

CAPSULE

Composition:

LENALIDOMIDE 5MG

Administration route:

ORAL

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0152422001; AHFS:

Authorization status:

APPROVED

Authorization date:

2021-09-01

Summary of Product characteristics

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_Taro-Lenalidomide (lenalidomide capsules) Page 1 of 95 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TARO-LENALIDOMIDE
Lenalidomide Capsules
Capsules, 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg and 25 mg, Oral
Antineoplastic Agent
Immunomodulatory Agent
Taro Pharmaceuticals Inc.
130 East Drive,
Brampton, Ontario
Canada L6T1C1
Submission Control Number: 268755
Date of Initial Authorization:
September 01, 2021
Date of Revision:
April 28, 2023
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_Taro-Lenalidomide (lenalidomide capsules) Page 2 of 95 _
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions, Immune
04/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1 INDICATIONS
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4
1.1 Pediatrics
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4
1.2 Geriatrics
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4
2 CONTRAINDICATIONS
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4
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
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5
4 DOSAGE AND ADMINISTRATION
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5
4.1 Dosing Considerations
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