Présentation DYSPORT 300 UNITES SPEYWOOD, poudre pour solution injectable 1 flacon en verre de 300 Unités Speywood - Code CIP : 5776490 DYSPORT 500 UNITES SPEYWOOD, poudre pour solution injectable 1 flacon en verre - Code CIP : 5581059 Mis en ligne le 02 avr. 2013 Substance active (DCI) toxine botulinique type A Neurologie - Nouvelle indication Pas d’avantage clinique démontré par rapport à BOTOX dans la prise en charge de la spasticité des membres inférieurs chez l’enfant à partir de 2 ans DYSPORT a l’AMM chez les enfants de 2 ans et plus dans le traitement symptomatique local de la spasticité des membres inférieurs.Il n’apporte pas de progrès thérapeutique par rapport à BOTOX, dans la prise en charge de ces patients. Code ATC M03AX01 Laboratoire / fabricant IPSEN PHARMA DYSPORT 300 UNITES SPEYWOOD, poudre pour solution injectable 1 flacon en verre de 300 Unités Speywood - Code CIP : 5776490 DYSPORT 500 UNITES SPEYWOOD, poudre pour solution injectable 1 flacon en verre - Code CIP : 5581059 Mis en ligne le 02 avr. 2013
Paternité, pas d'utilisation commerciale, partage des conditions initiales à l'identique
Langue
English
Extrait
The legally binding text is the original French version
TRANSPARENCYCOMMITTEEOpinion7 November 2012DYSPORT 300 SPEYWOOD UNITS, powder for solution for injection Vial, B/1 (CIP code:34009 577 649 0 6) DYSPORT 500 SPEYWOOD UNITS, powder for solution for injectionVial, B/1 (CIP code:34009 558 105 9 9)Applicant: IPSEN PHARMA
INN ATC Code (2011): Reason for the reviewList concerned
Indication concerned
botulinum toxin type A M03AX01 (Muscle relaxants, peripherally acting agents) Inclusion in a new indication
For hospital use (French Public Health Code L.5123-2)“Adults: - Blepharospasm. - Hemifacial spasm. - Spasmodic torticollis. - Local symptomatic treatment of upper and/or lower limb spasticity (muscle hyperactivity). Children aged 2 years and over:Old indication (included in the new indication): treatment of dynamic equinus foot deformation in children with spasticity caused by cerebral palsy. New indication: local symptomatic treatment of lower limb spasticity.This drug therapy treatment should form part of a wider multidisciplinary care approach (including a neurologist, paediatrician, physical medicine and rehabilitation s ecialist, ortho aedic sur eon etc. .
HAS - Medical, Economic and Public Health Assessment Division
1/21
AB
IAB
Therapeutic use
Recommendations
Substantial On the basis of available data, DYSPORT does not offer any improvement in actual benefit (no IAB, level V) compared with BOTOX in the local symptomatic treatment of lower limb spasticity in children aged 2 years and over. First-line treatment of localised or multifocal spasticity (professional consensus)
Opinion in fa
vour of inclusion on the list of medicines approved for hospital use.
HAS - Medical, Economic and Public Health Assessment Division