Drug information for BANZEL

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
SUSPENSION; ORAL 40MG/ML Prescription  (Reference Drug) RUFINAMIDE rufinamide EISAI INC 201367
2011-07-06 Review
2011-07-06 Summary Review
2011-06-03 Letter
2011-04-04 Other
2011-03-08 Medication Guide
2011-03-08 Letter
2011-03-07 Label
TABLET; ORAL 100MG Discontinued   RUFINAMIDE rufinamide EISAI INC 21911
2011-06-03 Letter
2011-03-08 Letter
2011-03-07 Label
2010-11-10 Letter
2010-11-08 Label
2009-12-18 Other
2009-11-24 Letter
2009-11-16 Medication Guide
2009-02-19 Review
2009-02-19 Summary Review
2008-11-18 Letter
2008-11-17 Label
TABLET; ORAL 200MG Prescription   RUFINAMIDE rufinamide EISAI INC   "
TABLET; ORAL 400MG Prescription  (Reference Drug) RUFINAMIDE rufinamide EISAI INC   "

Drug Adverse Effects information for BANZEL

Role code Indications Reaction # Reports
PS EPILEPSY CHOREA 1
PS EPILEPSY EXCESSIVE EYE BLINKING 1
SS EPILEPSY CHOREA 3
SS EPILEPSY EXCESSIVE EYE BLINKING 3
C EPILEPSY CONVULSION 1
C EPILEPSY PRODUCT SUBSTITUTION ISSUE 1
C GRAND MAL CONVULSION ANTICONVULSANT DRUG LEVEL BELOW THERAPEUTIC 1
C GRAND MAL CONVULSION CONVULSION 1
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