TORRENT-LEVETIRACETAM TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
30-01-2015
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Active ingredient:
LEVETIRACETAM
Available from:
TORRENT PHARMACEUTICALS LIMITED
ATC code:
N03AX14
INN (International Name):
LEVETIRACETAM
Dosage:
750MG
Pharmaceutical form:
TABLET
Composition:
LEVETIRACETAM 750MG
Administration route:
ORAL
Units in package:
100/120
Prescription type:
Prescription
Therapeutic area:
MISCELLANEOUS ANTICONVULSANTS
Product summary:
Active ingredient group (AIG) number: 0148843003; AHFS:
Authorization status:
CANCELLED (UNRETURNED ANNUAL)
Authorization date:
2021-12-20
Summary of Product characteristics
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_Page 1 of 32_
PRODUCT MONOGRAPH
PR
TORRENT-LEVETIRACETAM
Levetiracetam Tablets USP
250 mg, 500 mg and 750 mg
Antiepileptic Agent
Torrent Pharmaceuticals Ltd.
Indrad – 382 721,
Dist. Mehsana
India
Control # 181391
Date of Revision:
January 26, 2015
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_Page 2 of 32_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................7
DRUG INTERACTIONS
..................................................................................................12
DOSAGE AND ADMINISTRATION
..............................................................................13
OVERDOSAGE
................................................................................................................14
ACTION AND CLINICAL PHARMACOLOGY
............................................................15
STORAGE AND STABILITY
..........................................................................................18
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................18
PART II: SCIENTIFIC INFORMATION
...............................................................................19
PHARMACEUTICAL INFORMATION
..........................................................................19
CLINICAL TRIALS
..........................................................................................................20
DETAILED PHARMACOLOGY
..........................................................................
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