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VESICARE oral suspension (solifenacin), cholinergic receptor antagonist

UROLOGY- New presentation
Opinions on drugs - Posted on Jan 17 2019

Reason for request

Inclusion

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 Benefit

Moderate

-

Insufficient

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).

Not applicable

Hyperactivité détrusorienne neurogène chez l’enfant