Patients with serious or life-threatening diseases or conditions sometimes seek medical products that are not yet approved or available in their country. Novartis “Managed Access” addresses this need by making certain investigational or unapproved treatments available to eligible patients.
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.