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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