HUMIRA SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ADALIMUMAB

Available from:

ABBVIE CORPORATION

ATC code:

L04AB04

INN (International Name):

ADALIMUMAB

Dosage:

40MG

Pharmaceutical form:

SOLUTION

Composition:

ADALIMUMAB 40MG

Administration route:

SUBCUTANEOUS

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

DISEASE-MODIFYING ANTIRHEUMATIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0150364001; AHFS:

Authorization status:

APPROVED

Authorization date:

2012-11-23

Summary of Product characteristics

_ HUMIRA (adalimumab injection) _
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_Page 1 of 176_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
HUMIRA®
adalimumab injection
40 mg in 0.8 mL sterile solution (50 mg/mL) subcutaneous injection
10 mg in 0.1 mL sterile solution (100 mg/mL) subcutaneous injection
20 mg in 0.2 mL sterile solution (100 mg/mL) subcutaneous injection
40 mg in 0.4 mL sterile solution (100 mg/mL) subcutaneous injection
80 mg in 0.8 mL sterile solution (100 mg/mL) subcutaneous injection
Biological Response Modifier (ATC Code: L04AB04)
AbbVie Corporation
8401 Trans-Canada Highway
St-Laurent, QC H4S 1Z1
Date of Initial Authorization:
SEP 24, 2004
Date of Revision:
SEP 16, 2022
Submission Control Number: 262924
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_HUMIRA (adalimumab injection) _
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_Page 2 of 176_
RECENT MAJOR LABEL CHANGES
SECTION
DATE
1 INDICATIONS
04/2021
1 INDICATIONS, 1.1 Pediatrics (< 18 years of age)
04/2021
4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations
04/2021
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and
Dosage Adjustment
04/2021
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
TABLE OF CONTENTS
.............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
5
1
INDICATIONS
..............................................................................................................
5
1.1
Pediatrics
...................................................................................................................
7
1.2
Geriatrics
...................................................................................................................
7
2
CONTRAINDICATIONS
.................................................................................................
7
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 8
4
DOSAGE AND ADMINISTRATION
............