Remsima contains polysorbate 80

This medicine contains 0.5 mg of polysorbate 80 in each vial. Polysorbates may cause allergic reactions. Tell your doctor if you have/your child has any known allergies.

Updates to SmPC as follows:

• In Section 2, addition of text:

“Excipient with known effect

This medicine contains 0.5 mg polysorbate 80 (E433) in each vial.”

• In Section 4.4, addition of text:

“Polysorbate 80

This medicine contains 0.5 mg of polysorbate 80 in each vial which is equivalent to 0.05 mg/mL. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.”

EU Product Information (PI) update for alignment with reference product.

Not known:

(…)

• Infection due to a live vaccine because of a weakened immune system.
• Problems following a medical procedure (including infectious and non-infectious problems).

EU Product Information (PI) update for alignment with reference product updates.

SmPC Section 4.4 - Others

There is limited safety experience of infliximab treatment in patients who have undergone surgical procedures, including arthroplasty. The long half life of infliximab should be taken into consideration if a surgical procedure is planned. A patient who requires surgery while on infliximab should be closely monitored for infectiousns and non-infectious complications, and appropriate actions should be taken (see section 4.8).