The educational materials for patients or educational materials for healthcare professionals included here are additional risk minimisation measures that are intended to promote the safe and effective use of the medicinal product. Risk minimisation measures are a regulatory requirement and are part of the RMP (Risk Management Plans) approved by the EMA. They are assessed at national level by the HPRA for approval in Ireland.

Beovu

 

Beovu patient therapy guide booklet v8.1

Approval date (August/2022) by HPRA


Beovu patient therapy guide audio CD v8.1

Approval date (August/2022) by HPRA

Exelon

 

Exelon diary v6.3

Approval date (August/2021) by HPRA

Exjade

 

Exjade physicians checklist v20.1

Approval date (March/2023) by HPRA


Exjade HCP brochure v20.1

Approval date (March/2023) by HPRA


Exjade patient handbook v20.1

Approval date (March/2023) by HPRA

Gilenya

 

Gilenya RMP reminder card v18.0

Approval date (October/2022) by HPRA


Gilenya pregnancy reminder card v18.0

Approval date (October/2022) by HPRA


Gilenya prescriber's checklist v18.0

Approval date (October/2022) by HPRA

Kymriah

 

Kymriah patient educational leaftlet v4.2

Approval date (July/2022) by HPRA


Kymriah HCP training material v4.2

Approval date (July/2022) by HPRA


Kymriah pharmacy/cell lab/infusion centre training material v4.2

Approval date (July/2022) by HPRA


Kymriah patient alert card v4.2

Approval date (August/2020) by HPRA

Lucentis

 

Lucentis patient guide to PDR and/or DME booklet v20

Approval date (April/2020) by HPRA


Lucentis patient guide to PDR and/or DME audio CD v20

Approval date (April/2020) by HPRA


Lucentis patient guide to AMD booklet v16

Approval date (March/2017) by HPRA


Lucentis patient guide to AMD audio CD v16

Approval date (March/2017) by HPRA


Lucentis patient guide to CNV booklet v16

Approval date (March/2017) by HPRA


Lucentis patient guide to CNV audio CD v16

Approval date (March/2017) by HPRA


Lucentis patient guide to RVO booklet v16

Approval date (March/2017) by HPRA


Lucentis patient guide to RVO audio CD v16

Approval date (March/2017) by HPRA

Mayzent

 

Mayzent HCP checklist v6.1

Approval date (September/2023) by HPRA


Mayzent patient and caregiver guide v6.1

Approval date (September/2023) by HPRA


Mayzent pregnancy reminder card v6.1

Approval date (September/2023) by HPRA

Myfortic

 

Myfortic guide for HCPs v2.1

Approval date (October/2018) by HPRA


Myfortic guide for patients v2.1

Approval date (October/2018) by HPRA

 

May 2025 | FA-11428224

Reporting of side effects:
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk profile of the medicinal product. All suspected adverse reactions should be reported to HPRA Pharmacovigilance, website www.hpra.ie. Adverse events can also be reported to Novartis preferably at www.novartis.com/report, by emailing [email protected] or by calling (01) 2080 612.