Low incidence of adverse events

Phase 2/3 trials in Xydalba clinical trial programme

Chart showing Common Adverse Reactions in phase 2/3 studies in > 1% of patients treated with Xydalba

Adverse events should be reported.

Reporting forms and information can be found at www.mhra.gov.uk/yellowcard.

If you are resident in Ireland:
HPRA Pharmacovigilance
Earlsfort Terrace

IRL – Dublin 2

Tel: +353 1 6764971
Fax: +353 1 6762517

Adverse events should also be reported to Correvio UK Ltd.
Tel: +44 (0) 203 002 8114
E-mail: medinfo@correvio.com

For more information on adverse reactions please see the summary of product characteristics.

Correvio collects and processes your personal data in accordance with the EU General Data Protection Regulation (GDPR).

By emailing medinfo@correvio.com and/or submitting your personal information as requested in the Reporting form you consent to the processing of your personal data in accordance with our Privacy Statement. The collected information will be used only for the management of your request and will be stored for a limited period, proportionate to the aims pursued. If you have any questions or concerns about the collection and processing of your personal data, you can email your request to the following address: dataprotection@correvio.com.

In Phase 2/3 clinical studies, 2473 patients received Xydalba administered as either a single infusion of 1500 mg or as 1000 mg followed 1 week later by 500 mg.

The most common adverse reactions were generally mild or moderate in severity.

 This medicinal product is subject to additional monitoring.

Xydalba SmPC