Medicine information GOBIVAZ 50mg solution for injection in pre-filled pen

Product code:
W72146001
Quantity:
1
Indicated for:
autoimmune inflammatory diseases
Route of administration:
injectable
Substance:
golimumab (monoclonal antibody)
ATC
L04AB06 — Antineoplastic and immunomodulating agents | Immunosuppressants | Immunosuppressants | Tumor necrosis factor alpha (tnf-alpha) inhibitors
Golimumab is a biologic medicine used for inflammatory autoimmune diseases such as rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis and ulcerative colitis. It is used when inflammation causes pain, stiffness, joint damage risk or persistent bowel symptoms.

Golimumab blocks tumour necrosis factor alpha, a protein involved in the inflammatory process. By reducing this signal, it may lessen pain, swelling, stiffness and disease activity. The effect may take time, so the doctor will reassess whether the treatment is working well enough. It may be combined with methotrexate or other medicines according to the treatment plan.

The medicine is given as a subcutaneous injection, usually monthly, or intravenously in certain situations, depending on the prescribed formulation. Before starting, patients need screening for tuberculosis, hepatitis B and other relevant infections. Do not receive live vaccines unless your doctor agrees. Report fever, repeated infections, persistent cough, non-healing wounds or planned surgery.

Common side effects include upper respiratory tract infections, sore throat, blocked or runny nose and injection-site reactions. Serious but less common problems include severe infections, reactivation of tuberculosis or hepatitis B, allergic reactions, worsening heart failure, neurological disorders or certain cancers. Seek prompt help for high fever, breathing difficulty, jaundice or sudden weakness.

General data about GOBIVAZ 50mg

Substance:
golimumab
Date of latest medicines list:
01-09-2026
Product code:
W72146001
Strength:
50mg
Pharmaceutical form:
solution for injection in pre-filled pen
Quantity:
1
Product type:
Generic medicine
Prescription status:
P-RF — Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

Manufacturer:
ALVOTECH HF - ISLANDA
Holder:
ADVANZ PHARMA LIMITED - IRLANDA
Number:
1988/2025/01
Shelf life:
2 years

Official documents

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Source institution
EMA
Document language
English
Source record: first published
20/11/2025
Source record: last updated
21/07/2026

Warnings:

Anaphylaxis

Risk of severe allergic reaction. Seek urgent medical help if serious symptoms occur.

Additional monitoring

This medicine is subject to additional monitoring.

Breastfeeding warning

Use during breastfeeding only on medical advice.

Pregnancy warning

Use during pregnancy only on medical advice.