VESICARE oral suspension (solifenacin), cholinergic receptor antagonist
Reason for request
Moderate clinical benefit in the symptomatic treatment of overactive bladder in adults, though no demonstrated clinical advantage over other VESICARE presentations
Insufficient clinical benefit in the treatment of neurogenic bladder in children aged 2 to 18 years
VESICARE has been granted an MA in the symptomatic treatment of overactive bladder in adults and neurogenic bladder in children aged 2 to 18 years.
In the symptoms of urinary urge incontinence and/or pollakiuria and urinary urgency that can be observed in adults suffering from overactive bladder, VESICARE 1 mg/ml, oral suspension, is a range extension to VESICARE 5 and 10 mg tablets that are already available for adults.
In the treatment of neurogenic bladder in children, there is no evidence that it is at least as effective as the other anticholinergic medicines available for children over the age of 5 years. Moreover, its effect on the occurrence of episodes of incontinence and on the prevention of complications has not been clearly established. No clinical study data beyond one year of treatment in children and adolescents are available. The data for children under the age of 5 years are very limited.
Clinical Added Value
|no clinical added value||
Hyperactivité vésicale chez l’adulte: Cette spécialité est un complément de gamme qui n’apporte pas d’amélioration du service médical rendu (ASMR V) par rapport aux présentations déjà inscrites (VESICARE 5 et 10 mg).
Hyperactivité détrusorienne neurogène chez l’enfant