Land: Canada
Sprog: engelsk
Kilde: Health Canada
GOLIMUMAB
JANSSEN INC
L04AB06
GOLIMUMAB
50MG
SOLUTION
GOLIMUMAB 50MG
SUBCUTANEOUS
0.5ML
Prescription
DISEASE-MODIFYING ANTIRHEUMATIC AGENTS
Active ingredient group (AIG) number: 0152549001; AHFS:
APPROVED
2009-04-07
_Approved Product Monograph 1.docx _ _EDMS-RIM-1089450 v11.0 _ _Page 1 of 115_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR SIMPONI ® golimumab injection Solution for Subcutaneous Injection 50 mg/0.5 mL 100 mg/1.0 mL PR SIMPONI ® I.V. golimumab for injection Solution for Intravenous Infusion 50 mg/4.0 mL Tumour necrosis factor alpha (TNFα) inhibitor SIMPONI SHOULD BE PRESCRIBED BY PHYSICIANS WHO HAVE SUFFICIENT KNOWLEDGE OF RHEUMATOID ARTHRITIS AND/OR ANKYLOSING SPONDYLITIS AND/OR PSORIATIC ARTHRITIS AND/OR NON- RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS AND/OR ULCERATIVE COLITIS AND WHO HAVE FULLY FAMILIARIZED THEMSELVES WITH THE EFFICACY/SAFETY PROFILE OF SIMPONI. SIMPONI I.V. SHOULD BE PRESCRIBED BY PHYSICIANS WHO HAVE SUFFICIENT KNOWLEDGE OF RHEUMATOID ARTHRITIS AND/OR ANKYLOSING SPONDYLITIS AND/OR PSORIATIC ARTHRITIS AND/OR JUVENILE IDIOPATHIC ARTHRITIS AND WHO HAVE FULLY FAMILIARIZED THEMSELVES WITH THE EFFICACY/SAFETY PROFILE OF SIMPONI I.V. Janssen Inc. 19 Green Belt Drive Toronto, Ontario M3C 1L9 Date of Initial Authorization: April 7, 2009 Date of Revision: January 5, 2024 www.janssen.com/canada Submission Number: 278425 © 2023 Janssen Inc. All trademarks used under license. _Approved Product Monograph 1.docx _ _EDMS-RIM-1089450 v11.0 _ _Page 2 of 115_ RECENT MAJOR LABEL CHANGES 1 INDICATIONS, 1.1 Pediatrics 07/2022 4.2 Recommended Dose and Dosage Adjustment, 4.4 Administration 07/2022 7.1.1 Pregnant Women, 7.1.2 Breast-feeding, 7.1.3 Pediatrics 07/2022 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 ............................................................ Læs hele dokumentet