NUCALA SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

MEPOLIZUMAB

Available from:

GLAXOSMITHKLINE INC

ATC code:

R03DX09

INN (International Name):

MEPOLIZUMAB

Dosage:

100MG

Pharmaceutical form:

SOLUTION

Composition:

MEPOLIZUMAB 100MG

Administration route:

SUBCUTANEOUS

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

IMMUNOSUPPRESSIVE AGENTS

Product summary:

Active ingredient group (AIG) number: 0157630001; AHFS:

Authorization status:

APPROVED

Authorization date:

2019-10-08

Summary of Product characteristics

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_ December 19, 2022_
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_NUCALA, Mepolizumab _
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PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
NUCALA
Mepolizumab for Injection
100 mg/mL lyophilized powder for subcutaneous injection
Mepolizumab Injection
100 mg/mL solution for subcutaneous injection
40 mg/0.4 mL solution for subcutaneous injection
Interleukin-5 (IL-5) inhibitor
GlaxoSmithKline Inc.
100 Milverton Drive
Suite 800
Mississauga, Ontario
L5R 4H1
Date of Initial Authorization:
DEC 03, 2015
Date of Revision:
NOV 28, 2023
Submission Control No: 270798
_©_
_2022 GSK group of companies of its licensor _
_Trademarks are owned by or licensed to the GSK group of companies _
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_ December 19, 2022_
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_NUCALA, Mepolizumab _
_ Page 2 of 85_
RECENT MAJOR LABEL CHANGES
SECTION
DATE
1 INDICATIONS
11/2021
4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations
09/2022
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose &
Dosage Adjustment
09/2022
4 DOSAGE AND ADMINISTRATION, 4.4 Administration
09/2022
4 DOSAGE AND ADMINISTRATION, 4.5 Missed Dose
09/2022
7 WARNINGS AND PRECAUTIONS, 7.1 Special Populations
11/2021
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
11/2023
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 ................................................................................
4
1
INDICATIONS ......................................................................................................................
4
1.1 Pediatrics
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4
1.2 Geriatrics
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