拉考沙胺（Vimpat)的产品信息（EMA）.pdf

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