Mysimba® Indication

Mysimba® is indicated, as an adjunct to a reduced-calorie diet and increased physical activity, for the management of weight in adult patients (≥18 years) with an initial Body Mass Index (BMI) of

  • ≥ 30 kg/m2 (obese), or
  • ≥ 27 kg/m2 to < 30 kg/m2 (overweight) in the presence of one or more weight-related co morbidities (e.g., type 2 diabetes, dyslipidaemia, or controlled hypertension)

Treatment with Mysimba® should be discontinued after 16 weeks if patients have not lost at least 5% of their initial body weight.

Mysimba® is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions to:

HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2;
Tel: +353 1 6764971; Fax: +353 1 6762517;
Website: www.hpra.ie; e-mail: medsafety@hpra.ie

Adverse events should also be reported to Nalpropion Pharmaceuticals LLC: (800) 793-2145 or APV.AECurrax@primevigilance.com

For more information on Mysimba®, including efficacy, safety and tolerability, please review the SmPC which is available here:

For all other queries, please contact our Irish office at Tel: +353 (0)1 2057760, Fax: +353 (0)1 2698919 or irishoffice@consilienthealth.com

Reference:

Mysimba® SPC available at www.medicines.ie

IE-MYS-65a | Date of preparation: December 2020

Mysimba®is subject to additional monitoring. To report an adverse event or a product complaint about Mysimba®, please contact: HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517; Website: www.hpra.ie; e-mail: medsafety@hpra.ie. Adverse events should also be reported to Nalpropion Pharmaceuticals LLC: (800) 793-2145 or APV.AECurrax@primevigilance.com

For all other queries, please contact our Irish office at Tel: +353 (0)1 2057760, Fax: +353 (0)1 2698919 or irishoffice@consilienthealth.com

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The information on this website is intended for healthcare professionals registered in the Republic of Ireland only.

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