ANNEXI
SUMMARYOFPRODUCTCHARACTERISTICS
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1.NAMEOFTHEMEDICINALPRODUCT
Vimpat50mgfilm-coatedtablets
Vimpat100mgfilm-coatedtablets
Vimpat150mgfilm-coatedtablets
Vimpat200mgfilm-coatedtablets
2.QUALITATIVEANDQUANTITATIVECOMPOSITION
Vimpat50mgfilm-coatedtablets
Eachfilm-coatedtabletcontains50mglacosamide.
Vimpat100mgfilm-coatedtablets
Eachfilm-coatedtabletcontains100mglacosamide.
Vimpat150mgfilm-coatedtablets
Eachfilm-coatedtabletcontains150mglacosamide.
Vimpat200mgfilm-coatedtablets
Eachfilm-coatedtabletcontains200mglacosamide.
Forthefulllistofexcipients,seesection6.1.
3.PHARMACEUTICALFORM
Film-coatedtablet
Vimpat50mgfilm-coatedtablets
Pinkish,ovalfilm-coatedtabletswithapproximatedimensionsof10.4mmx4.9mm,anddebossed
with‘SP’ononesideand‘50’ontheotherside.
Vimpat100mgfilm-coatedtablets
Darkyellow,ovalfilm-coatedtabletswithapproximatedimensionsof13.2mmx6.1mm,and
debossedwith‘SP’ononesideand‘100’ontheotherside.
Vimpat150mgfilm-coatedtablets
Salmon,ovalfilm-coatedtabletswithapproximatedimensionsof15.1mmx7.0mm,anddebossed
with‘SP’ononesideand‘150’ontheotherside.
Vimpat200mgfilm-coatedtablets
Blue,ovalfilm-coatedtabletswithapproximatedimensionsof16.6mmx7.8mm,anddebossedwith
‘SP’ononesideand‘200’ontheotherside.
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4.CLINICALPARTICULARS
4.1Therapeuticindications
Vimpatisindicatedasmonotherapyinthetreatmentofpartial-onsetseizureswithorwithout
secondarygeneralisationinadults,adolescentsandchildrenfrom2yearsofagewithepilepsy.
Vimpatisindicatedasadjunctivetherapy
?inthetreatmentofpartial-onsetseizureswithorwithoutsecondarygeneralisationinadults,
adol