OXCARBAZEPINE TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
16-02-2018
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Active ingredient:
OXCARBAZEPINE
Available from:
JUBILANT GENERICS LIMITED
ATC code:
N03AF02
INN (International Name):
OXCARBAZEPINE
Dosage:
300MG
Pharmaceutical form:
TABLET
Composition:
OXCARBAZEPINE 300MG
Administration route:
ORAL
Units in package:
30/100/500
Prescription type:
Prescription
Therapeutic area:
MISCELLANEOUS ANTICONVULSANTS
Product summary:
Active ingredient group (AIG) number: 0140461002; AHFS:
Authorization status:
APPROVED
Authorization date:
2015-04-13
Summary of Product characteristics
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PRODUCT MONOGRAPH
PR
OXCARBAZEPINE
Oxcarbazepine Tablets
150 mg, 300 mg and 600 mg
Manufacturer’s Standard
Antiepileptic
MANUFACTURER:
Jubilant Generics Limited
1-A, Sector -16A, Institutional Area,
Noida -201301, Uttar Pradesh, India
CANADIAN IMPORTER AND DISTRIBUTOR:
JAMP Pharma Corporation,
1310, rue Nobel
Boucherville, Quebec,
Canada, J4B 5H3
SUBMISSION CONTROL NO: 212946 DATE OF REVISION:
February 16, 2018
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION.......................................................
3
SUMMARY PRODUCT
INFORMATION................................................................................
3
INDICATIONS AND CLINICAL
USE......................................................................................
3
CONTRAINDICATIONS...........................................................................................................
3
WARNINGS AND
PRECAUTIONS..........................................................................................
3
ADVERSE
REACTIONS...........................................................................................................
14
DRUG
INTERACTIONS............................................................................................................
24
DOSAGE AND
ADMINISTRATION........................................................................................
26
OVERDOSAGE..........................................................................................................................
29
ACTION AND CLINICAL
PHARMACOLOGY......................................................................
29
STORAGE AND
STABILITY............................................................................
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