Change to Section 5: "If needed, individual Steqeyma pre-filled syringes may also be stored at room temperature up to 30 25 °C for a maximum single period of up to 31 days in the original carton in order to protect from light. [...] At any time before the end of this 31-day period at room temperature, the product can be returned to the refrigerator once, and stored there until the original expiry date."

Change to Instructions for use, Storing Steqeyma: - Record the date when the pre-filled syringes are first removed from the refrigerator in the spaces provided on the outer carton. - At any time before the end of the storage period at room temperature, the product can be returned to the refrigerator once, and stored there until the original expiry date.

Addition to Section 2: "Excipients with known effect: Steqeyma contains 0.04 mg (90 mg/1.0mL) or 0.02 mg (45 mg/0.5 mL) of polysorbate 80 (E433) in each dosage unit which is equivalent to 0.04 mg/mL."

Changes to Section 6.3: Shelf-life (in refrigerator) increased from 3 to 4 years. "Individual pre-filled syringes may be stored at room temperature up to 30 25 °C for a maximum single period of up to 31 days in the original carton in order to protect from light. [...] At any time before the end of this 31-day period at room temperature, the product can be returned to the refrigerator once, and stored there until the original expiry date." 

Changes to Section 6.4: "If needed, individual pre-filled syringes may be stored at room temperature up to 30 25 °C, and individual vials may be stored at room temperature up to 30 °C (see section 6.3)."

Alignment with PI of reference product incorporating addition of paediatric Crohn's disease indication & dosing, and polysorbate allergy warning.

Alignment of Steqeyma SmPC with that of reference product incorporating addition of paediatric Crohn's disease indication & posology, and updated safety information including polysorbate 80 content.

Alignment of Steqeyma product information (PI) with that of reference product, and editorial changes.

Based on PSUR for reference product, Steqeyma PI was updated to:

- advise against use of live vaccines (eg, BCG) for 12 months post-partum for infants born to women who received ustekinumab in pregnancy, instead of previously advised 6 months (sections 4.5 and 4.6),

- broaden the advice to monitor for the appearance of skin cancer to include melanoma (section 4.4).

In alignment with PI for reference product, based on PSUR, the Steqeyma package leaflet was updated to advise against use of live vaccines (eg, BCG) for 12 months post-partum for infants born to women who received ustekinumab in pregnancy, instead of previously advised 6 months (section 2: “Other medicines, vaccines and Steqeyma”, and “Pregnancy and breast feeding”).