Module 6

04/10/2024

Educational materials – example

PRODUCT INFORMATION ANNEX II D: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT

Venclyxto (venetoclax)

• Type II Variation submitted to update Section 4.2 and 4.4 of the SmPC (following update to the CCDS) to include prophylaxis and management of Tumour Lysis Syndrome (TLS) • EMA scientific committees CHMP and PRAC requested additional minimisation measures and educational material. • Direct Healthcare Professional Communication (DHPC) with the purpose of informing EU prescribers of the product changes, which encompass the totality of CLL patients treated with Venclyxto, as well as to emphasize that adherence to TLS mitigation measures as per SmPC is essential in these patients. • A patient card was included since the Package leaflet as the routine risk minimisation measure was not considered a sufficient tool for such serious risk

The Organisation for Professionals in Regulatory Affairs

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Educational materials – example cont.

PATIENT CARD FOR UK PATIENTS

• Patient card requires local HA approval in each MS, may need mock-up

• Translations for each MS

• Communication list

• Adhere to central and local timelines

• UK – Ed mats and their associated distribution plans should be emailed to RMPallocation@mhra.gov.uk

• UK - assessment within 18 calendar days of submission

• UK - risk materials and DHCP letters can be uploaded to the electronic medicines compendium (eMC) https://www.medicines.org.uk/emc

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