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BOTOX

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Opinions on drugs - Posted on Dec 15 2009

Reason for request

Inclusion on the list of medicines approved for use by hospitals and various public services in the extension of the therapeutic indication: In children over 2 years of age “Local symptomatic treatment of spasticity (muscle hyperactivity) of the upper and/or lower limbs”.

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Clinical Benefit

Substantial

The actual benefit of these proprietary products in this new indication is substantial.


Clinical Added Value

minor

BOTOX (botulinum toxin type A) products provide a minor improvement in actual benefit (IAB IV) in terms of efficacy in the treatment of spasticity (muscle hyperactivity) of the upper and/or lower limbs in children aged 2 years and over.


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Évaluation des médicaments

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