Country: Canada
Language: English
Source: Health Canada
MEPOLIZUMAB
GLAXOSMITHKLINE INC
R03DX09
MEPOLIZUMAB
100MG
POWDER FOR SOLUTION
MEPOLIZUMAB 100MG
SUBCUTANEOUS
1.2ML
Prescription
IMMUNOSUPPRESSIVE AGENTS
Active ingredient group (AIG) number: 0157630001; AHFS:
CANCELLED POST MARKET
2023-12-06
_ _ _ _ _ _ _ May 26, 2022_ _ _ _NUCALA, Mepolizumab _ _ Page 1 of 85_ 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: April 6, 2016 Date of Revision: September 15, 2022 SUBMISSION CONTROL NO: 257207 _©_ _2022 GSK group of companies of its licensor _ _Trademarks are owned by or licensed to the GSK group of companies _ _ _ _ _ _ _ _ May 26, 2022_ _ _ _NUCALA, Mepolizumab _ _ Page 2 of 85_ RECENT MAJOR LABEL CHANGES SECTION DATE 1 INDICATIONS 11/2021 4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations 05/2022 4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose & Dosage Adjustment 05/2022 4 DOSAGE AND ADMINISTRATION, 4.4 Administration 05/2022 4 DOSAGE AND ADMINISTRATION, 4.5 Missed Dose 05/2022 7 WARNINGS AND PRECAUTIONS, 7.1 Special Populations 11/2021 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 ..................................................................................................................... 5 2 CONTRAINDICATIONS ............................... Read the complete document