BIO-MODAFINIL TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

MODAFINIL

Disponible depuis:

BIOMED PHARMA

Code ATC:

N06BA07

DCI (Dénomination commune internationale):

MODAFINIL

Dosage:

100MG

forme pharmaceutique:

TABLET

Composition:

MODAFINIL 100MG

Mode d'administration:

ORAL

Unités en paquet:

100

Type d'ordonnance:

Prescription

Domaine thérapeutique:

Wakefulness-Promoting Agents

Descriptif du produit:

Active ingredient group (AIG) number: 0136083001; AHFS:

Statut de autorisation:

CANCELLED POST MARKET

Date de l'autorisation:

2022-07-19

Résumé des caractéristiques du produit

_Bio-MODAFINIL _
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PRODUCT MONOGRAPH
PR
BIO-MODAFINIL
Modafinil Tablets, USP
(Modafinil)
100 mg
CENTRAL NERVOUS SYSTEM STIMULANT
BIOMED PHARMA
DATE OF PREPARATION:
100-5950, Ch. de la Côte de Liesse
June 4, 2015
Mont-Royal
Qc, H4T 1E2
Control#: 184736
_Bio-MODAFINIL _
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_Page 2 of 37_
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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
...........................................................................................................................
11
DRUG INTERACTIONS
...........................................................................................................................
15
DOSAGE AND ADMINISTRATION
........................................................................................................
17
OVERDOSAGE
.........................................................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
......................................................................................
19
STORAGE AND STABILITY
...................................................................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................................................................
21
PART II: SCIENTIFIC INFORMATION
..............................................................