Product Details

Simponi 100 mg solution for injection PFP

Golimumab
100 mg/mL
Solution for injection

ROA

Subcutaneous

Applicant Name

J & J Company West Africa Limited

NRN

A6-0474

Status

Active


Composition

Each 1 mL pre-filled pen contains: Golimumab* 100 mg * Human IgG1κ monoclonal antibody produced by a murine hybridoma cell line with recombinant DNA technology Excipient with known effect: Each pre-filled pen contains 41 mg sorbitol per 100 mg dose. Each pre-filled syringe contains 41 mg sorbitol per 100 mg dose  

ATC Code/ATCvet Code

L04AB06  

Product Category

Vaccines and Biologics

Marketing Category

Prescription-only Medicine (POM)  

Packsize

1 mL x 1's (in a pre-filled pen)  

Product Description

Solution for Injection in pre-filled pen (Injection) The solution is clear to slightly opalescent, colorless to light yellow

Manufacturer Name

Baxter Pharmaceutical Solutions LLC

Manufacturer Country

UNITED STATES OF AMERICA  

Approval Date

2023-06-06  

Expiry Date

2028-05-30