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Category: 4.8 Antiepileptic drugs

Name SMC ID No Manufacturer Status Sub. Type
 
brivaracetam (Briviact) 1160/16 UCB Pharma Ltd Restricted Full submission
perampanel (Fycompa®) 1200/16 Eisai Ltd Not Recommended Non submission
lacosamide (Vimpat) 1231/17 UCB Pharma Ltd Not Recommended Non submission
Pregabalin (Lyrica®) 145/04 Pfizer Ltd Restricted Full submission
levetiracetam (Keppra®) 750 mg tablets 150/04 UCB Pharma Ltd Restricted Abbreviated Submission
levetiracetam (Keppra®) 100mg oral solution 151/04 UCB Pharma Ltd Restricted Abbreviated Submission
Pregabalin, 25mg, 50mg, 75mg, 100mg, 150mg, 200mg and 300mg capsules (Lyrica®) 157/05 Pfizer Ltd Not Recommended Resubmission
Pregabalin 25mg, 50mg, 75mg, 100mg, 150mg, 200mg and 300mg capsules (Lyrica®) 157/05 Pfizer Ltd Not Recommended Full submission
Pregabalin 25, 50, 75, 100, 150, 200 and 300mg capsules (Lyrica) 157/05 Pfizer Ltd Not Recommended IRP
pregabalin (Lyrica) 157/05 Pfizer Ltd Restricted Resubmission
Zonisamide hard capsules 25 mg, 50 mg, 100 mg (Zonegran®) 216/05 Eisai Ltd Restricted Full submission
topiramate 25, 50mg tablets, 25, 50mg sprinkle capsules (Topamax) 297/06 Janssen-Cilag Ltd Restricted Full submission
levetiracetam 500mg/5ml concentrate for infusion (Keppra) 311/06 UCB Pharma Ltd Accepted Abbreviated Submission
pregabalin (Lyrica) 339/06 Pfizer Ltd Not Recommended Non submission
pregabalin, 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg, 300mg capsules (Lyrica) 389/07 Pfizer Ltd Not Recommended Full submission
levetiracetam 250, 500, 750 and 1000mg tablets and levetiracetam oral solution 100mg/ml (Keppra) 394/07 UCB Pharma Ltd Not Recommended Full submission
levetiracetam 250 500 750 and 1000mg tablets and levetiracetam oral solution 100mg/ml (Keppra) 394/07 UCB Pharma Ltd Accepted Resubmission
levetiracetam 250, 500, 750 and 1000mg tablets and levetiracetam oral solution 100mg/ml (Keppra) 395/07 UCB Pharma Ltd Not Recommended Full submission
levetiracetam 250 500 750 and 1000mg tablets and levetiracetam oral solution 100mg/ml (Keppra) 395/07 UCB Pharma Ltd Accepted Resubmission
levetiracetam 250, 500, 750 and 1000mg tablets and levetiracetam oral solution 100mg/ml (Keppra) 396/07 UCB Pharma Ltd Not Recommended Full submission
levetiracetam 250 500 750 and 1000mg tablets and levetiracetam oral solution 100mg/ml (Keppra) 396/07 UCB Pharma Ltd Accepted Resubmission
levetiracetam 250, 500, 750 and 1000mg tablets and levetiracetam oral solution 100mg/ml (Keppra) 397/07 UCB Pharma Ltd Not Recommended Full submission
levetiracetam 250 500 750 and 1000mg tablets and levetircetam oral solution 100mg/ml (Keppra) 397/07 UCB Pharma Ltd Restricted Resubmission
rufinamide 100mg, 200mg and 400mg tablets (Inovelon) 416/07 Eisai Ltd Not Recommended Full submission
rufinamide 100mg, 200mg, 400mg tablets (Inovelon) 416/07 Eisai Ltd Restricted Resubmission
stiripentol (DIACOMIT) 524/08 BIOCODEX Not Recommended Full submission
lacosamide (Vimpat) 532/09 UCB Pharma Ltd Restricted Full submission
eslicarbazepine acetate (Zebinix) 592/09 Eisai Ltd Not Recommended Full submission
eslicarbazepine (Zebinix) Resubmission 592/09 Eisai Ltd Restricted Resubmission
levetiracetam (Keppra) 661/10 UCB Pharma Ltd Restricted Abbreviated Submission
Topiramate (Topamax) 75/03 Janssen-Cilag Ltd Restricted Full submission
midazolam (Buccolam oromucosal solution) 757/12 ViroPharma Ltd Accepted Full submission
pregabalin oral solution (Lyrica) 765/12 Pfizer Ltd Restricted Abbreviated Submission
rufinamide (Inovelon) 795/12 Eisai Ltd Restricted Abbreviated Submission
zonisamide (Zonegran) 817/12 Eisai Ltd Not Recommended Non submission
perampanel (Fycompa) 819/12 Eisai Ltd Restricted Full submission
zonisamide (Zonegran) 949/14 Eisai Ltd Restricted Abbreviated Submission

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