PHL-LAMOTRIGINE TABLET

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

LAMOTRIGINE

Commercializzato da:

PHARMEL INC

Codice ATC:

N03AX09

INN (Nome Internazionale):

LAMOTRIGINE

Dosaggio:

25MG

Forma farmaceutica:

TABLET

Composizione:

LAMOTRIGINE 25MG

Via di somministrazione:

ORAL

Confezione:

100/500

Tipo di ricetta:

Prescription

Area terapeutica:

MISCELLANEOUS ANTICONVULSANTS

Dettagli prodotto:

Active ingredient group (AIG) number: 0127134003; AHFS:

Stato dell'autorizzazione:

CANCELLED PRE MARKET

Data dell'autorizzazione:

2017-09-13

Scheda tecnica

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
..................................................................