SIANALAR (glycopyrronium bromide), anticholinergic
PAEDIATRICS - New medicinal product
Opinions on drugs -
Posted on
Dec 18 2018
Reason for request
Inclusion
Moderate clinical benefit but no demonstrated clinical improvement in the treatment of severe sialorrhoea in children (3 to 18 years) in cases in which rehabilitation treatment has failed or is not possible
SIANALAR has MA for the symptomatic treatment of severe sialorrhoea in children aged 3 years and over and adolescents suffering from chronic neurological disorders.
Its period of use should be short term and intermittent.
The efficacy data, which are solely bibliographic, are limited and concern another medicinal product based on the same active ingredient. No clinical study specifically assessing efficacy, safety and/or quality of life is available for SIANALAR.
The anticholinergic adverse effects of glycopyrronium were relatively frequent in the clinical studies. The medium- and long-term safety data are very limited.
Clinical Benefit
Moderate |
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Clinical Added Value
no clinical added value |
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Therapeutic use
- |