Film-coated tablet for the symptomatic treatment of overactive bladder (OAB) in adults

About the medicinal product

Obgemsa contains the active substance vibegron and is used for the symptomatic therapy of an overactive bladder (OAB) in adults.

Patients with an overactive bladder experience a sudden, strong urge to urinate that can only be controlled with difficulty. They may also sometimes experience involuntary urine leakage.

These problems can significantly impair daily activities and quality of life. Obgemsa acts specifically on the bladder muscles. It relaxes them during bladder filling, enabling the bladder to retain more urine. As a result the urge to urinate becomes less frequent and can be better controlled.

In deciding whether to authorise Obgemsa, Swissmedic took into account the assessment of the European Medicines Agency (EMA) and the corresponding medicinal product information texts.

Since the assessment of the clinical data was based on the assessment reports of this foreign authority, the preconditions for a full SwissPAR (Swiss Public Assessment Report – a detailed report for professionals) and a resulting Summary report on authorisation are not met. Swissmedic refers to the authorisation of the foreign reference authority.
www.ema.europa.eu

Further information on the medicinal product

At the time of publication of the Summary report on authorisation for Obgemsa, the Information for healthcare professionals was not yet available. As soon as the medicinal product becomes available in Switzerland, the Information for healthcare professionals will be made available on the following website: www.swissmedicinfo.ch

Healthcare professionals can answer any further questions.

^{The date of revision of this text corresponds to that of the SwissPAR. New information concerning the authorised medicinal product in question will not be incorporated into the Summary report on authorisation.}

^{Swissmedic monitors medicinal products authorised in Switzerland. Swissmedic initiates the necessary action in the event of newly discovered adverse drug reactions or other safety-relevant signals. New findings that could impair the quality, efficacy, or safety of this medicinal product are recorded and published by Swissmedic. If necessary, the medicinal product information is adapted.}