SIMPONI SOLUTION

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

GOLIMUMAB

Tilgængelig fra:

JANSSEN INC

ATC-kode:

L04AB06

INN (International Name):

GOLIMUMAB

Dosering:

50MG

Lægemiddelform:

SOLUTION

Sammensætning:

GOLIMUMAB 50MG

Indgivelsesvej:

SUBCUTANEOUS

Enheder i pakken:

0.5ML

Recept type:

Prescription

Terapeutisk område:

DISEASE-MODIFYING ANTIRHEUMATIC AGENTS

Produkt oversigt:

Active ingredient group (AIG) number: 0152549001; AHFS:

Autorisation status:

APPROVED

Autorisation dato:

2009-04-07

Produktets egenskaber

_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
............................................................