PHL-LAMOTRIGINE TABLET

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

LAMOTRIGINE

Saatavilla:

PHARMEL INC

ATC-koodi:

N03AX09

INN (Kansainvälinen yleisnimi):

LAMOTRIGINE

Annos:

100MG

Lääkemuoto:

TABLET

Koostumus:

LAMOTRIGINE 100MG

Antoreitti:

ORAL

Kpl paketissa:

100/500

Prescription tyyppi:

Prescription

Terapeuttinen alue:

MISCELLANEOUS ANTICONVULSANTS

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0127134001; AHFS:

Valtuutuksen tilan:

CANCELLED PRE MARKET

Valtuutus päivämäärä:

2017-09-13

Valmisteyhteenveto

PRODUCT MONOGRAPH
PR
PHL-LAMOTRIGINE
Lamotrigine Tablets, USP
25 mg, 100 mg and 150 mg
ANTIEPILEPTIC
PHARMEL INC.
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
Date of Revision:
June 15, 2016
Submission Control No.: 194956
_phl-LAMOTRIGINE Product Monograph _
_Page 2 of 48_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT
INFORMATION........................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
...................................................................................................
3
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
.................................................................................................
13
DRUG INTERACTIONS
.................................................................................................
19
DOSAGE AND ADMINISTRATION
.............................................................................
24
OVERDOSAGE
................................................................................................................
28
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 29
STORAGE AND STABILITY
.........................................................................................
33
DOSAGE FORMS, COMPOSITION AND
PACKAGING............................................. 33
PART II: SCIENTIFIC INFORMATION
..............................................................................
34
PHARMACEUTICAL INFORMATION
.........................................................................
34
CLINICAL TRIALS
.........................................................................................................
35
DETAILED PHARMACOLOGY
..................................................................